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Rosario Garcia Campelo
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MS02 - What Molecular Screening for Which Patients? (ID 65)
- Event: WCLC 2019
- Type: Mini Symposium
- Track: Targeted Therapy
- Presentations: 4
- Now Available
- Moderators:Rosario Garcia Campelo, Santiago Ponce
- Coordinates: 9/08/2019, 10:30 - 12:00, Vienna (2016)
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MS02.01 - Platform Selection in an Era of Increasing Numbers and Types of Relevant Biomarkers (Now Available) (ID 3446)
10:30 - 12:00 | Presenting Author(s): David P Carbone
- Abstract
- Presentation
Abstract
30 years ago, the selection of therapy for lung cancer patients was simple, with only a few choices available, and very little personalization beyond that which can be defined by standard light microscopy and physical exam. The treatment of lung cancer patients today has greatly improved with the discovery of features of tumors and patients that enable the selection of specific targeted and immunotherapy approaches resulting in substantially improved quality and quantity of life. Selection of the appropriate therapeutic based on these features makes huge differences in the lives of these patients, and many studies are now showing that starting with the matched therapy improves survival over switching to it after trying “one size fits all” therapy.
Scientific advances are introducing more and more of these markers every year, and while this is undoubtedly a good thing for our patients, each of them has sensitivity, specificity, and platform issues that need to be defined, and adds a level of complexity to lung cancer management that is unprecedented. Individually, many of these features are rare so that the vast majority of individual assays performed are negative, further adding to clinical frustration. Technology has advanced to allow the testing of hundreds or thousands of gene sequences in a single analysis, but other markers are not simple gene sequence alterations, but rather gene rearrangements, protein expression alterations, and some RNA expression profiles that require testing on different platforms. As a result, optimal tumor profiling can involve several different analyses, can cost a significant amount of money, and take a significant amount of time to return a result in a disease where both time and resources available are scarce. Biopsy adequacy also becomes an issue with multi-platform testing, and the availability of blood-based testing lessens this issue for certain types of testing, but introduces issues of limited sensitivity and scope of analyses.
Layered upon this are the different health care systems and availability of testing platforms found worldwide, each of which has to make hard decisions about doing the best thing for their patients within these local constraints. However, the impact on patient outcomes and the health care system of missing a key tumor feature and the selection of inappropriate and potentially toxic therapy, in a world where a single dose of a drug costs several times the cost of the testing makes cost of testing less of an issue than sample adequacy, speed of results availability, accuracy of results interpretation, and availability of matching drugs.
In this section, the clinical and technical features of the currently available platforms in use and their advantages and disadvantages will be reviewed and compared.
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MS02.02 - Liquid Biopsy: Who, When, What and How (Now Available) (ID 3445)
10:30 - 12:00 | Presenting Author(s): Christian Rolfo
- Abstract
- Presentation
Abstract
Presentation Title: Liquid Biopsy: Who, When, What and How
Prof. Dr. Christian Rolfo, MD, PhD, MBA, Dr.h.c., Director of Thoracic Medical Oncology and Early Clinical Trials at University of Maryland Medical Center, Greenebaum Comprehensive Cancer Center, 22 S Greene Street Rm. N9E08, Baltimore, MD 21201.
Liquid biopsy (LB) refers to a multitude of biomarkers that can be isolated with minimally invasive methods from human body fluids (blood, saliva, urine, ascites, pleural effusion, etc.) that include cell free DNA (cfDNA), circulating tumor cells (CTCs), microRNAs (miRNAs), long non coding RNAs (lncRNAs), and exosomes (Fig. 1). Plasma genotyping of cfDNA entered clinical practice in non-small cell lung cancer (NSCLC) for detection of EGFRmutations in both treatment-naïve and EGFR-mutated NSCLC after progression to EGFR tyrosine kinase inhibitors (TKIs) as an alternative source to tissue when histological samples are insufficient or when a biopsy is not feasible. Indeed according to the LB IASLC statement1, plasma cfDNA analysis should be offered to the same population candidate for molecular testing using DNA isolated from tissue (all non-squamous NSCLC subjects, or adenosquamous or in patients with clinical features suggestive of the presence of a molecular driver) in cases with insufficient tumor tissue specimens or where tissue specimens are not obtainable. Moreover, LB is indicated for the identification of acquired resistance mutations in EGFR-mutated NSCLCs progressing during treatment with first- or second-generation EGFR TKIs, reserving tissue re-biopsy in case of negative or inconclusive results.
The PCR-based cobas EGFR Mutation Test v2 was the first FDA approved LB test for NSCLC, although several limitations on sensitivity of this technique. Fortunately, LB is a rapidly evolving field and several commercial and “in house”NGS platforms have been developed, allowing a more comprehensive plasma genotyping that include genetic rearrangements (such as ALK, ROS1, RET, and NTRK) as well as other relevant oncogene drivers, including mutations of BRAF, HER2, MET, and KRAS. Some of the vendors have a Medicare reimbursement in United States. Recently, the multicenter prospective Noninvasive versus Invasive Lung Evaluation (NILE) study demonstrated that a validated and highly sensitive plasma 73-gene NGS test (Guardant360) used at the time of diagnosis of NSCLC was non-inferior to standard-of-care tissue genotyping in identifying guideline-recommended genomic biomarkers, allowing a guideline-complete genotyping in a higher proportion of patients with a shorter median turnaround time2. These results support the rationale for a “blood-first” approach, reserving tissue for PD-L1 immunohistochemistry or in case of negative liquid biopsy testing. In addition to cfDNA, cfRNA is a novel approach to enhance the comprehensive analysis of circulating biormakers.
Furthermore, the increasing use of more sensitive detection methods, such as NGS, poses novel technical and biological challenges in our clinical practice, including the identification of non tumor-related mutations due to clonal hematopoiesis (CH), increased risk of false positive in presence of low variation allelic fraction (VAF), need for standardization and validation of the analytical methods, definition of requirements for appropriate report and interpretation of the results. Novel technologies such as CH-filtering ultradeep NGS have been tested with promising results3. Moreover, the adoption of molecular tumor board is essential for helping oncologists in interpreting NGS testing results4, using evidence-based scales, such as OncoKB and ESCAT tiers5,6.
Recently, LB use has been advocated in immunotherapy-treated patients as a minimally invasive method that can allow a real time monitoring of treatment response and interpretation of challenging radiographic situations, overcoming the limits of conventional radiological assessment methods7,8. Further prospective studies are needed to better clarify the role of cfDNA as a predictive biomarker for immune checkpoint blockage in NSCLC. LB can also allow the estimation of tumor mutational burden (TMB) in plasma, proving a valuable alternative to tissue. Exploratory analyses of two large randomized phase III studies explored the potential utility of blood TMB (bTMB) as predictive biomarker for immunotherapy, using two different platforms (Foundation Medicine and GuardantOMNI)9,10. The results of these studies support bTMB as potential biomarker for immunotherapy in NSCLC. Further prospective studies will clarify the role of bTMB in treatment selection of patient candidate for immunotherapy, as well as the optimal cut-off value, the minimum number of genes necessary for TMB estimation, and the specific mutations useful.
References
Rolfo C, et al. J Thorac Oncol 2018
Leighl N, et al. Clin Cancer Res 2019
Li BT, et al. Ann Oncol 2019
Rolfo C, et al. ESMO Open 2018
Chakravarty D, et al. JCO Precis Oncol 2017
Mateo J, et al. Ann Oncol 2018
Anagnostou V, et al. Cancer Res. 2019
Guibert N, et al. ASCO-SITC 2019
Peters S, et al. AACR Annual meeting 2019
Gandara DR, et al. Nat Med 2018
Figure 1Liquid biopsy in NSCLC – Who, When, What and How? (Credit: created with BioRender)
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MS02.03 - Achieving Effective Lung Cancer Genotyping While Balancing Constrained Resources (Now Available) (ID 3444)
10:30 - 12:00 | Presenting Author(s): Lynette M Sholl
- Abstract
- Presentation
Abstract
Modern oncologic practice for patients with non-small cell lung carcinoma (NSCLC) demands real time data for an increasing numbers of tumor biomarkers. As a result, laboratories are embracing panel-based approaches to tumor molecular profiling, a trend that is facilitated by the adoption of next generation sequencing (NGS) assays. NGS assays may be designed for highly sensitive and focused detection of hotspot mutations (typically by amplicon sequencing) or broader, more comprehensive profiling for detection of a wide variety of alterations in oncogenes and tumor suppressor genes (typically by hybrid capture technology). There are benefits and drawbacks to both approaches. In general, amplicon sequencing offers speed and sensitivity but limited scope and a propensity for PCR-related artifacts that may adversely affect detection of certain mutation types. In contrast, hybrid capture techniques offer tremendous breadth, enabling capture of 100s of genes to whole genomes, but are limited by sensitivity and longer turnaround time.1 Preanalytic steps including sample acquisition, pathologist review to confirm sample adequacy, and nucleic acid extraction often comprise the majority of the turnaround time required to complete focused tumor tissue molecular profiling. Some assays have been optimized for turnaround times of just a few hours- these assays bypass the separate nucleic acid extraction step,2 but are limited by the few number of mutational targets detected, ultimately requiring the use of multiple simultaneous or sequential focused panels.3 This practice, while perhaps the optimal current model from the standpoint of patient care, may be financially prohibitive for many laboratories. This approach additionally requires careful stewardship of patient tissues, as the use of multiple competing assays and may lead to exhaustion of tumor tissue and incomplete tumor molecular profiling. For patients with limited tissue, a considered plan incorporating input from the treating physician, surgical pathologist, and molecular laboratorian should developed early in order to guide assay priority and ensure adequate tissue is available to confirm any unexpected or contradictory results. When the turnaround time for comprehensive large panel testing is clinically acceptable, this approach may be theoretically more cost effective and in most cases will deliver information for essential and emerging biomarkers.4 It is important to keep in mind, however, that even comprehensive DNA-based assays may lack optimal sensitivity for certain structural variants (fusions, large insertion-deletion events), and it may be necessary to couple these tests with focused RNA-based panels optimized for transcript fusion detection.5
1. Rizzo JM, Buck MJ. Key principles and clinical applications of "next-generation" DNA sequencing. Cancer Prev Res (Phila). 2012;5(7):887-900.
2. Ilie M, Butori C, Lassalle S, et al. Optimization of EGFR mutation detection by the fully-automated qPCR-based Idylla system on tumor tissue from patients with non-small cell lung cancer. Oncotarget. 2017;8(61):103055-103062.
3. Lindeman NI, Cagle PT, Aisner DL, et al. Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors: Guideline From the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. J Mol Diagn. 2018;20(2):129-159.
4. Sireci AN. Single Genes, Panels, and Next-Generation Sequencing Platforms: A Financial Perspective. Arch Pathol Lab Med. 2018;142(7):790-791.
5. Benayed R, Offin M, Mullaney K, et al. High Yield of RNA Sequencing for Targetable Kinase Fusions in Lung Adenocarcinomas with No Mitogenic Driver Alteration Detected by DNA Sequencing and Low Tumor Mutation Burden. Clin Cancer Res. 2019.
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MS02.04 - The Role of Molecular Board (Now Available) (ID 3447)
10:30 - 12:00 | Presenting Author(s): Lara Pijuan
- Abstract
- Presentation
Abstract
The Role of Molecular Board
Lung Tumor Board is a multidisciplinary group of specialists who are responsible for diagnosing and deciding the best treatment for a patient with lung cancer. In cancers with little to no metastatic evidence, the case is handed over to surgeons or sometimes to radiotherapists for local and curative treatment. But in cases of locally advanced or metastatic stages, the patient visits the oncologist alone or in conjunction with the radiotherapists for a more systemic approach. A few years ago, the patient was presented to tumor board immediately, but now because we are in the age of precision medicine, the oncologist can gather more information about the tumour itself to initiate the best personalized treatment for each patient’s cancer. In fact, the oncologist requires 3 types of information: accurate histological diagnosis, molecular characteristics of the tumor, and PD-L1 expression.
Prior to the creation of this molecular tumor board, this information could be given by mail, mobile phone messaging, phone call or in person, since all the information usually arrives a few days after the patient is presented at Lung Tumor Board. If all this information is presented in a room with all the specialists involved in obtaining it, the data can be better analysed and the therapeutic decision making will be much more precise. Hence the idea of creating a MTB with oncologists, pathologists, biologists, bioinformatics, technicians, palliative care, and residents to review the different results for a lung cancer patient.
The type of patients to present in this type of Molecular Tumour Board is widely variable, but usually fall into one of these 6 categories:
1) Newly diagnosed patients with metastatic disease.
The MTB would reaffirm that there is sufficient material and that all the molecular or immunohistochemical techniques are underway (EGFR, BRAF, ALK, ROS1, and PD-L1). Oncologists re-assign the patient for the next MTB to review final results. The pathologist also comments on the percentage of tumour cellularity, so that technicians and biologists can make optimized calculations of the cuts and the type of sample that the biologist has to work with (biopsy and/or cell block and/or cytological smears).
2) Patients with progressive disease with a known molecular marker.
They can be patients where the oncologist repeats sampling. Usually the patient is more familiar to the biologist because he receives liquid biopsies to monitor the disease and the pathologist only knows the patient if he has a re-biopsy.
3) Patients with possible disease progression, pseudoprogression or hyperprogression after immunotherapy.
4) Patients with molecular results received from outside (FM, FOne, clinical trials)
The patient is more familiar to the oncologist who treats him and who has decided to send a sample for a clinical trial or external platform. They are presented in the MTB in order to reaffirm the mutation or translocation found with technology available in the center or maybe it can be consulted outside.
5) Surgical patients with multiple adenocarcinomas that require definitive staging.
The patient is most familiar to the pathologist who diagnosed the surgical tumor. They are presented in order to know molecular details of multiple synchronous tumours.
6) Patients that wish to utilize stored material for new diagnostic studies/techniques
For reasons of disease progression, the patient may enter a clinical trial or has the option of systemic treatment, so some studies that were not previously performed in are required.
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EP1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 206)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Treatment in the Real World - Support, Survivorship, Systems Research
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.16-01 - A Spanish Initiative to Know the Unmet Needs of Women with Lung Cancer: "Circulos Program" (Now Available) (ID 1847)
08:00 - 18:00 | Presenting Author(s): Rosario Garcia Campelo
- Abstract
Background
The personal and family impact of an oncological disease can only be adequately understood and managed from a biopsychosocial perspective. Lung cancer experience has a profound impact on the well-being of both patient and family caregiver and is largely influenced by communication within the family environment. Lung cancer impact can be especially significant when women are affected.
Method
The objective of this study was to develop an informative program for women with lung cancer, implementing the development of strategies in order to get a deepening knowledge of their perceived needs. Additionally, we aimed to define and design new useful resources that may help other women with lung cancer. A qualitative research allowed to collect data on the experiences in the circle of women and their families, and the identification of the needs and the coping resources used of the participants. The collection of these data was what led to the development of the tools used to develop the support strategies.
Result
A total of 10 women with lung cancer from Galicia (Spain) participated in 7 sessions. At the personal and psychological level in the women circle, needs were related to improve medical information they get from their physicians, share information and experiences with women in the same situation, more holistic-human care, and the need for more supporting groups. About the social and labor environment, they expressed concern about the social stigma associated with lung cancer, and the culpability for having smoked as well as the concern related to the interruption of working life. The family environment also expressed the need for emotional support and preparation for families and caregivers to be able to support the patient, the need to provide them with strategies to improve the situation, and the need to overcome initial isolation through working groups. Regarding resources, women´s circle was mainly focused on occupying time with new activities, humor and not stigmatizing the disease and the professionals who assist them.
Conclusion
“Círculos program”, even being a pilot program, show the benefits of a more humane approach to the treatment of lung cancer in women, with a better understanding of patients and families needs. More similar programs should be done in order to improve the quality of life of these patients and their transit through this disease.
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MA03 - Clinomics and Genomics (ID 119)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:Heather A Wakelee, Wilfried Ernst Erich Eberhardt
- Coordinates: 9/08/2019, 10:30 - 12:00, Colorado Springs (1994)
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MA03.06 - Efficacy Results of Selective AXL Inhibitor Bemcentinib with Pembrolizumab Following Chemotherapy in Patients with NSCLC (Now Available) (ID 2271)
10:30 - 12:00 | Author(s): Rosario Garcia Campelo
- Abstract
- Presentation
Background
The RTK AXL is implicated in epithelial-to-mesenchymal transition, negative regulation of anti-tumour immunity and resistance to multiple therapies including immune checkpoint inhibitors.
Bemcentinib (BGB324) is a first-in-class, oral, highly selective and potent AXL inhibitor which has been demonstrated to enhance anti-PD1 therapy.
Method
This phase II trial (Cohort A, NCT03184571) enrolled 48 advanced lung adenocarcinoma patients with progression on or after no more than one prior line of platinum-based chemotherapy. Patients with EGFR/ALK mutations were included in this study and must have progressed on or after at least one standard targeted therapy. The primary endpoint was ORR according to RECIST v1.1. Additional endpoints included efficacy according to biomarker expression, DCR, PFS, OS, and safety. Tumour biopsies were analysed for PD-L1 expression (22C3 pharmDx), AXL by IHC, and infiltrating immune cells.
Result
As of April 2019, the trial was fully recruited: median age 65 (range 39-82) yrs, 61% male, 76% smokers or ex-smokers.
At time of writing, a total of 210 treatment cycles had been completed by all patients. 17 patients were ongoing.
17 of 32 biomarker-evaluable patients (53%) were PD-L1 negative, 13 (41%) had TPS 1-49%, and 2 (6%) had TPS >50%. Of 28 biomarker-evaluable patients, 14 (50%) expressed AXL on their tumours.
Among patients who had at least 1 evaluable on-treatment scan: 5 responses were observed in 13 AXL positive patients (38%), and 7 in 30 patients with TPS 0-49% (23%). There were 10 responses observed among 34 evaluable patients overall (29%).
In Stage 1, two of the 4 AXL positive responses are ongoing; mDoR is not mature in the AXL positive patients. mPFS was 5.9 mo in AXL positive patients (n=10, 3.0-NR) and 4.0 mo (95% CI 1.9-NR) overall (n=24). mOS was not mature.
The most common TRAEs (occurring in >10% of patient in both stages) were transaminase increases (34%), asthenia/fatigue (30%), diarrhoea (26%), nausea (13%), anaemia (11%), decreased appetite (11%), and pruritus (11%). All cases of transaminase increase were reversible and resolved with concomitant administration of systemic corticosteroids and interruption of study treatments.
Conclusion
Patients had predominantly low or no PD-L1 expression; approximately half were AXL positive. The combination of bemcentinib and pembrolizumab was well tolerated and showed promising efficacy in previously treated IO-naïve NSCLC patients, particularly in those with AXL positive disease, including PD-L1 negative patients. Mature ORR for both stages, as well as 12-month OS for stage 1 will be presented at the meeting.
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MA22 - Partnering with Patients to Understand Stigma, Disparities and Values Leading to Improved Lung Cancer Care (ID 154)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Advocacy
- Presentations: 1
- Now Available
- Moderators:Diego Villalón, Christina Sit
- Coordinates: 9/09/2019, 15:45 - 17:15, Amsterdam (2011)
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MA22.05 - Assessment of Gender Differences in the Psychosocial and Economic Impact on Patients with Stage IV Non-Small Cell Lung Cancer (Now Available) (ID 718)
15:45 - 17:15 | Author(s): Rosario Garcia Campelo
- Abstract
- Presentation
Background
Incidence of lung cancer in women is rising overtime reporting evident gender-based differences in epidemiology, biology, and treatment outcome. However, little is known about gender-differences regarding psychological, economic and social aspects. The objectives of this prospective study are to evaluate the psychosocial and economic impact of metastatic non-small cell lung cancer (NSCLC), according to gender. Additionally, to assess the emotional burden and the economic impact of the disease on the primary caregiver from a gender perspective
Method
Multicenter, prospective, observational, study of two cohorts of patients with metastatic NSCLC (male and female) in Oncology departments of 20 Spanish hospitals. The following measurement tools were used: the APGAR questionnaire (family functionality: adaptability, partnership, growth, affection, and resolve), the Relationship impact scale, the DUKE-UNC scale (perceived socio-affective support), the patient and the caregiver economic impact scale and the Zarit scale (caregiver burden). All questionnaires were performed at the first visit, repeated 4 months later and following the first and second disease progression.
Result
Of the 333 pts included, 104 were females and 229 male, of whom 63% and 97%, respectively, were smokers/ex-smokers (p=0.0001). More women than men (85% vs 70%) had adenocarcinomas . The median overall survival was longer in women but did not reach statistical significance [17.1 vs 11.0 months, HR 0.732 (95% CI 0.534 to 1.005), p=0.0524]. Most families considered themselves functional (high score in APGAR questionnaire) with no changes in their partner relationship and social support was evaluated as optimal for majority of patients. Around a quarter of interviewed patients said their economic situation was a little worse after the lung cancer diagnosis, without remarkable differences by gender. Statistically significant differences were found between both groups regarding the caregiver´s relationship to the patient (more parents were the caregiver in females than in males) (p <0.0001) and the caregiver’s employment situation (more employed caregivers in females) (p<0.0001). Most caregivers of both sexes considered that taking care of their relative did not pose a significant burden. No remarkable differences by gender were found between the different variables across the study.
Conclusion
This study provides a preliminary insight into gender-related characteristics in the management of advanced NSCLC and its impact on the emotional, social and economic burden of patients and their caregivers, and recall the high priority of researching in cancer from a gender perspective
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OA13 - Ideal Approach to Lung Resection and Novel Perioperative Therapy (ID 146)
- Event: WCLC 2019
- Type: Oral Session
- Track: Treatment of Early Stage/Localized Disease
- Presentations: 1
- Now Available
- Moderators:Tomasz Grodzki, Kenji Suzuki
- Coordinates: 9/10/2019, 11:30 - 13:00, Toronto (1985)
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OA13.05 - NADIM Study: Updated Clinical Research and Outcomes (Now Available) (ID 1670)
11:30 - 13:00 | Author(s): Rosario Garcia Campelo
- Abstract
- Presentation
Background
Patients with stage IIIA (N2 or T4N0) are potentially curable but median overall survival is only around 15 months
Method
A Phase II, single-arm, open-label multicenter study of resectable stage IIIA N2-NSCLC in adult patients with CT plus IO as neoadjuvant treatment: 3 cycles of nivolumab (NV) 360 mg IV Q3W + paclitaxel 200 mg/m2 + carboplatin AUC 6 IV Q3W followed by adjuvant NV treatment for 1 year. After completing neoadjuvant therapy, all patients underwent tumor assessment prior to surgery. Surgery was performed during the 3rd or 4th week after day 21 of the 3rd neoadjuvant treatment cycle. The study aimed to recruit 46 patients. The primary endpoint was Progression-Free Survival (PFS) at 24 months. Efficacy was explored using objective pathologic response criteria. Here we present the final data on all study patients that underwent surgical assessment.
Result
At the time of submission, the 46 patients had been included. None of the patients were withdrawn from the study preoperatively due to progression or toxicity. 41 patients had undergone surgery and all tumors were deemed resectable with R0 resection in all cases. Intention to treat analysis shows 35 patients (85%; 95% CI, 71; 94%) achieved major pathologic response (MPR) of which 25 (71%; 95% CI, 54; 85%) were complete pathologic responses (CPR). Downstaging was seen in 38 (93%; 95% CI, 80; 98%) of cases. The median follow-up was 13.8 months (P25; P75: 11.7; 16.6 months) for both the whole series and resected patients, and 12 month PFS was 95.7% (95% CI, 84; 99%).
Conclusion
This is the first multicentric study to test CT-IO in the neoadjuvant setting in stage IIIA. Neoadjuvant CT-IO with nivolumab in resectable IIIA NSCLC yields a complete pathologic response rate that is higher than ever seen previously, together with a promising PFS which may translate into increased overall survival. EudraCT Number: 2016-003732-20. Clinical trial information: NCT 03081689.
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P1.01 - Advanced NSCLC (ID 158)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 4
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.01-111 - ATEZO-BRAIN, A Single-Arm Phase II Study of Atezolizumab Combined with Chemotherapy in Stage IV NSCLC Patients with Untreated Brain Metastases (ID 733)
09:45 - 18:00 | Author(s): Rosario Garcia Campelo
- Abstract
Background
Brain metastases (BM) are a frequent complication in non-small cell lung cancer (NSCLC), have significant impact on quality of life and are associated with poor prognosis. Systemic therapies might be an alternative approach to whole brain radiotherapy (WBRT) to avoid cognitive-related adverse events. Immune checkpoint inhibitors (ICI) showed intracranial activity in advanced NSCLC patients with BM. However clinical data about efficacy and safety of immune checkpoint inhibitors in combination with chemotherapy in patients with untreated BM are limited and further research in this setting is needed. We hypothesize that addition of ICI to conventional platinum-based chemotherapy may increase intracranial tumor response and provide clinically relevant benefit in terms of PFS, OS and quality of life to the patients with asymptomatic and non-previously treated BM.
Method
This is an ongoing multicenter, open-label, single-arm phase 2 study (EUDRACT: 2017-005154-11) to evaluate the efficacy and safety of atezolizumab 1200 mg combined with 4-6 cycles of carboplatin AUC 5 and pemetrexed 500mg/m2 every 3 weeks followed by maintenance with atezolizumab 1200 mg plus pemetrexed 500mg/m2 every 3 weeks in stage IV non-squamous NSCLC patients with untreated synchronous BM. Patients should have multiple and measurable BM, adequate performance status and organic function, do not harbor EGFR or ALK genomic alterations, be treatment naïve and do not have any contraindication to receive immunotherapy. Exclusion criteria consist of active neurological symptoms, dexamethasone dose ≥ 4 mg QD, prior treatment with brain radiotherapy, presence of leptomeningeal carcinomatosis, spinal or hemorrhagic metastases in the central nervous system. Primary endpoints are progression-free survival (PFS) at 12 weeks according to RANO-BM and RECIST v1.1 criteria and safety based on CTCAE v4. Both primary endpoints will be assessed in 40 patients in 15 sites using a Bayesian approach. Patients will undergo tumor assessments by body CT scan and brain MRI at baseline every 6 weeks for the first 12 weeks and thereafter tumor assessments will be performed every 9 weeks until disease progression or loss of clinical benefit. Secondary endpoints: intracranial and systemic objective response rate and duration of response. Exploratory endpoints: to assess neurocognitive function and quality of life; to determine time to neurological deterioration and time to need of salvage brain radiotherapy. Enrollment started on August 2018 and currently 12 patients have been included in the study.
Result
Clinical trial in progress
Conclusion
Clinical trial in progress
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P1.01-124 - Health-Related Quality of Life (HRQoL) Data in a Phase 3 Study of First-Line Brigatinib vs Crizotinib in NSCLC (ALTA-1L) (ID 507)
09:45 - 18:00 | Presenting Author(s): Rosario Garcia Campelo
- Abstract
Background
Results from ALTA-1L (NCT02737501) showed that brigatinib vs crizotinib as first-line ALK therapy significantly improves progression-free survival (PFS; HR: 0.49, 95% CI, 0.33, 0.74) in advanced ALK+ NSCLC. HRQoL was evaluated as a secondary objective.
Method
ALK+ NSCLC patients were randomized 1:1 to brigatinib or crizotinib as first-line ALK therapy. HRQoL was assessed with the EORTC QLQ-C30 and LC13. Change from baseline, duration of improvement, and time to worsening were analyzed in the ITT-PRO population (n=131 for both groups).
Result
HRQoL compliance was >90% for both groups. Brigatinib substantially improved overall HRQoL vs crizotinib, as demonstrated by the estimated mean difference on change from baseline (4.1, P<0.05; Figure 1) and duration of improvement for GHS/QoL (HR=0.16, P<0.001; Figure 2), which was also supported by improvement in several functional domains and symptoms (Figure 1). No domains significantly favored crizotinib. Similar results were also observed in patients with baseline CNS metastases.
Conclusion
Consistent with the prolongation of PFS seen in first-line treatment of advanced ALK+ NSCLC, brigatinib improved HRQoL and prolonged the duration of improvement in GHS/QoL, and the majority of functional and symptom domains vs crizotinib.
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P1.01-72 - A Phase II Study of Selective AXL Inhibitor Bemcentinib and Pembrolizumab in Patients with NSCLC Refractory to Anti-PD(L)1 (ID 1632)
09:45 - 18:00 | Author(s): Rosario Garcia Campelo
- Abstract
Background
The RTK AXL is implicated in epithelial-to-mesenchymal transition, negative regulation of anti-tumour immunity and resistance to multiple therapies including immune checkpoint inhibitors.
Bemcentinib (BGB324) is a first-in-class, oral, highly selective and potent AXL inhibitor which has been demonstrated to enhance anti-PD1 therapy.
The combination of bemcentinib and pembrolizumab was well tolerated and showed promising efficacy in previously treated IO-naïve NSCLC patients (Cohort A, NCT03184571), particularly in those with AXL positive disease, including PD-L1 negative patients.
The novel combination is now being assessed in patients refractory to anti-PD-(L)1 therapy, considering the emerging need in this population and AXL’s role as a mediator of resistance.
Method
This is an open-label, single-arm, 2-stage phase II study (Cohort B, NCT03184571) to evaluate the safety and efficacy of bemcentinib (200mg/d) in combination with pembrolizumab (200mg/q3wk) in patients post anti-PD-(L)1 therapy. The primary endpoint is overall response rate (ORR), and additional endpoints include efficacy by biomarker expression, duration of response (DoR), disease control rate (DCR), progression free survival (PFS), overall survival (OS), and safety. Clinical efficacy endpoints are based on tumour imaging evaluable by RECIST v1.1.
Eligible patients received a maximum of 2 prior lines of therapy, with the most recent course having included a PD-(L)1 inhibitor. To be eligible, patients must have exhibited disease control (CR/PR/SD) for at least 6 months on prior PD-(L)1 inhibitor therapy with disease progression occurring within 12 weeks since last dose.
Bemcentinib will be administered as a loading dose of 400mg on days 1, 2 and 3 followed by a dose of 200mg once daily. A fixed dose of 200 mg pembrolizumab will be given by intravenous infusion over 30 minutes every 3 weeks. Bemcentinib and pembrolizumab will be given until disease progression, unacceptable dose toxicity, or for a maximum of 35 cycles.
Tumour specimens will be analysed for PD-L1 expression (22C3 pharmDx), AXL by IHC, and infiltrating immune cells.
The pre-specified efficacy threshold for continuation into the second stage is 1 objective response among the first 13 patients, at which point up to a further 16 patients may be evaluated, for a total of 29 patients.
Result
Section not applicable
Conclusion
Section not applicable
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P1.01-93 - Metastases Sites as a Prognostic Factor in a Real-World Multicenter Cohort Study of Spanish ALK-Positive NSCLC Patients (p) (ID 1377)
09:45 - 18:00 | Author(s): Rosario Garcia Campelo
- Abstract
Background
ALK gene rearrangements are detected in 3-7% of Non-Small-Cell-Lung-Cancer (NSCLC) p. EML4-ALK translocation was first identified as an oncogene in NSCLC p in 2007. To date, published real-world data on the prognostic factors of patients with ALK-positive advanced NSCLC in Spain are limited. We aim to evaluate the effect of number of metastases (M1) organs on overall survival (OS) in a multicenter cohort of Spanish ALK-positive NSCLC p diagnosed between 2008 and 2017.
Method
We included p with stage IV at diagnosis since 2011 to April 2018. OS (months [m]) was estimated with the Kaplan-Meier method. Survival curves were compared between groups of p using the log-rank test. Hazard risk (HR) to death was estimated with multivariable Cox model, adjusted by site of metastases, gender, age and first line type of treatment.
Result
Out of the 163 p in the cohort a total of 98 p were included, with a median follow-up of 28.6 m and 45 deaths reported. Characteristics at diagnosis were median age 58 years, female 46.9%, never-smokers 59.2%, 50% with comorbidities, PS by ECOG 0-1 93%, 58.2% lung M1, 45.9% central nervous system M1, 42.9% bone M1, 22.4% liver M1 and 29.6% pleural M1.
54.3% p and 89.4% p were treated with ALK inhibitors as first line and second line respectively. The median OS was 34.4 months, being 46.9 months in p treated with ALK inhibitors and 38.8 months in p treated with chemotherapy as first line (p= 0.9).
There were 72 p who presented M1 in more than one organ and 26 p in a single organ. The risk of death increased with greater number of organs involved at diagnosis (HR= 3.0, p=.016), and presenting liver M1 at diagnosis (HR=2.2, p=.046, with OS of 19.1 m), compared to p single site involvement (OS: 45.4 m).
Conclusion
OS was worse with increased metastatic sites involved at diagnosis in p with ALK positive NSCLC, being liver M1 associated with the highest risk of mortality. Brain metastases at diagnosis were not a prognostic factor for OS in our series.
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P1.03 - Biology (ID 161)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Biology
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.03-15 - Non-Invasive Detection of Secondary Resistance Mutations in ALK-Positive NSCLC Patients by Next-Generation Sequencing (ID 1658)
09:45 - 18:00 | Author(s): Rosario Garcia Campelo
- Abstract
Background
ALK inhibitors have led to important improvements in ALK-positive non-small cell lung cancer (NSCLC) patient’s survival and quality of life. However, despite the good responses, resistance mutations inevitably emerge. Several resistance mutations in ALK domain have been describe. Remarkably different mutations can confer different sensitivities to different ALK inhibitors. However, 2nd and 3rd line treatment is often prescribe empirically without knowing the molecular mechanism underlying treatment failure.
Method
21 samples from ALK-positive NSCLC patients were collected at disease progression. Circulating Nucleic Acids were isolated from platelets, exosomes and plasma. Libraries were prepared using 20ng of template and Oncomine™ Pan-Cancer Cell-Free Assay. Samples were sequenced on an Ion GeneStudio S5 Plus System. Sequencing data was first analyzed using Torrent Suite software. Subsequently variant calling, annotation and filtering was performed on the Ion Reporter (v5.10) platform using the Oncomine TagSeq Pan-Cancer Liquid Biopsy w2.1 workflow.
Result
In 14 (67%) patients a somatic mutation was identified in the plasma sample collected at disease progression. The average number of mutations detected per sample was 2.6. Noteworthy, 14 mutations were found in oncogenes that have been previously associated with ALK inhibitors resistance (5 mutations in ALK locus, 4 mutations in PIK3CA, 1 mutation in EGFR, 1 mutation in KIT, 1 mutation in KRAS, 1 mutation in MTOR and 1 mutation in MYC). The rest of mutations (N=21) were found in TP53 gene. Secondary resistance mutation in ALK locus occurred in 24% of the cases. Specifically, p.G1269A (N=2), p.G1202E (N=1), p.R1275Q (N=1) mutations were found in ALK-positive NSCLC who had progressed on crizotinib and p.G1202R mutation was found in 1 ALK-positive NSCLC who had progressed on ceritinib.
Conclusion
Secondary ALK-TKI resistance mutations could be detected using liquid biopsies in a high proportion of patients. Non-invasive molecular profiling of samples collected at disease progression is feasible being useful for further treatment selection in ALK-positive NSCLC patients.
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P1.04 - Immuno-oncology (ID 164)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.04-19 - Association Between Efficacy and irAEs in Patients with Advanced Non-Small Cell Lung Cancer Receiving Immune-Checkpoint Inhibitors (ID 2020)
09:45 - 18:00 | Author(s): Rosario Garcia Campelo
- Abstract
Background
Immune-checkpoint inhibitors (ICIs) are a standard treatment in advanced non-small cell lung cancer (NSCLC). They can induce immune-related adverse events (irAEs) that may compromise treatment continuation.
We report our experience in advanced NSCLC patients receiving ICIs, the incidence of irAEs and its correlation with efficacy.
Method
267 patients with advanced NSCLC receiving ICIs in two Spanish institutions from March 2013 to August 2018 were analyzed. IrAEs were graded following CTCAE v4.0. Kaplan Meier and log-rank tests were used to evaluate progression-free (PFS) and overall survival (OS) using landmark analysis.
Result
Median age was 66.1 years [26-85], 70% were male. 86 (32%) patients presented squamous and 181 (68%) non-squamous histology. Most frequent ICIs were nivolumab (44%), pembrolizumab (26%) and atezolizumab (17%), used as monotherapy (78%), in combination with chemotherapy (12%) or with anti-CTLA4 (9%). 30% patients were treated with ICIs in first line and 70% in second line or beyond. Median duration of treatment was 2.8 months [0.1-56.4].
152 patients (57%) experienced a total of 255 irAEs, and the median number of irAEs/patient was 1 [0-5]. Most frequent irAEs was skin toxicity (34%), followed by diarrhea (16%) and hypothyroidism (11%). 36 patients (14%) presented grade 3-4 irAEs and there were 5 treatment-related deaths: 4 pneumonitis and 1 hepatitis. Patients receiving ICIs in second line or beyond experienced significantly less irAEs (49%) than those treated in first line (74%) (p <0.001).
With a median follow-up time of 8.5 months [0.3-56.4], the landmark analysis showed that PFS was significantly longer in patients with irAEs: 12.4 months (95%CI, 1.9-22.9) vs 4.1 months (95%CI, 2.6-5.6) (p < 0.001). Similarly, OS among patients with irAEs was significantly higher: 28.2 months (95%CI, not calculated) vs 12.5 months (95%CI, 10.8-14.2) (p < 0.001). Disease control rate was significantly better in patients with irAEs: 77% vs 39%, odds ratio 0.20 (95%CI, 0.11-0.34) (p < 0.001). Besides, duration of response was significantly longer: 6.1 months [0.5-50] vs 2.6 months [0.2-51.9] (p < 0.001).
44 patients (17%) discontinued treatment due to toxicity. Within this group, 66% patients did not progress after immunotherapy, in contrast to 29% in the rest of the population (p < 0.001).
Multivariable analysis revealed that cutaneous, endocrinological and reumathological toxicities were significantly associated with increased OS.
Conclusion
The presence of irAEs in advanced NSCLC patients treated with ICIs was associated with better outcomes. Patients who discontinued ICIs due to toxicity showed a higher disease control rate.
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P2.01 - Advanced NSCLC (ID 159)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.01-10 - Real Clinical Practice Study to Evaluate 2 Line Treatment Based on Comprenhensive Genomic Profiling in NSCLC. LungONE Study (Now Available) (ID 1558)
10:15 - 18:15 | Author(s): Rosario Garcia Campelo
- Abstract
Background
Cancer is a genomic disease and molecular-targeted therapy plays an increasingly important role in the treatment of advanced NSCLC. The current standard of care (SoC) indication for NSCLC is defined by genomic biomarkers to classify the tumor as a carrier of a therapeutic approved target. However, the current standard of practice for molecular testing in NSCLC in Spain is highly heterogeneous, depending on several factors such as hospital size, resources, laboratory equipment and experience. In addition, there are several other markers and/or genomic signatures which are not determined due to the current lack of scientific evidence, i.e. MSI, TMB, KRAS, BRAF, RET, MET, HER2 and NTKR, which could guide physician second line treatment choice, including clinical trial options. The aim of this study is to evaluate the impact on decision making in the 2nd line treatment using a comprehensive genomic profiling (CGP) in advanced/metastatic NSCLC with adenocarcinoma histology.
Method
Section not applicable
Result
Section not applicable
Conclusion
This is a multicenter, prospective, single-cohort study to describe the clinical management of the 2nd line SoC treatment in patients with locally advanced/metastatic NSCLC with adenocarcinoma histology, when a comprehensive genomic profile based on FoundationOne®CDx or FoundationOne® Liquid test, is provided. 12 academic institutions in Spain were selected and 180 patients were planned to be recruited. The principal objective is to evaluate if there is any change in planned 2nd line treatment decisions after receiving the CGP report. Secondary objectives for this study are:1) to identify non-previously detected actionable molecular aberrations by conventional molecular assays; 2) to evaluate the economic impact in terms of use of healthcare resources of the CGP vs. standard diagnostic panels; and 3) to describe each patient’s status 2 years after the inclusion of the last patient in the study. Patients will follow usual clinical pathways for biomarker analysis and a comprehensive genomic profiling in the remaining tissue through FoundationOne® CDx, will be conducted or liquid biopsy with FoundationOne® Liquid, if exhausted. To be enrolled in the study, patients must have an ECOG between 0 and 2 and biomarkers ALK, EGFR, ROS1 must have been assayed (negative or unknown results). Enrolment begun on October 2018 and, to date, a total of 110 patients have been included.
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P2.04 - Immuno-oncology (ID 167)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 3
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.04-10 - Biomarkers of Pathological Response on Neo-Adjuvant Chemo-Immunotherapy Treatment for Resectable Stage IIIA NSCLC Patients (ID 1466)
10:15 - 18:15 | Author(s): Rosario Garcia Campelo
- Abstract
Background
PD1/PDL1 treatments have become the main therapy in advanced stages of NSCLC due to its significant increase in overall survival (OS), but recently, combination with chemotherapy in locally advanced stages is showing promising results. Many studies have described peripheral blood immune cells parameters as biomarkers of response to immunotherapy. In our study, we described the effect of neo-adjuvant chemo-immunotherapy treatment in Complete Blood Count (CBC) and Peripheral Blood Mononuclear Cells (PBMCs) phenotype, as well as, the association of these parameters with the degree of pathological response.
Method
Immune cell populations of 46 resectable stage IIIA NSCLC patients treated with neo-adjuvant chemo-immunotherapy from NADIM clinical trial were analysed. Samples were extracted before initiating the neo-adjuvant treatment with nivolumab plus carboplatin and at the third cycle before patients underwent surgery. We classified patients in 3 subgroups of pathological response assessed in the resection specimen: complete response (pCR), major response (<10% viable tumour) and incomplete response (>10% viable tumour, pIR). Wilcoxon and Mann-Whitney U statistic test were used to evaluate differences between pre and post treatment and between pathological responses groups respectively.
Result
From 46 patients, 5 patients did not undergo surgery, so they were excluded from the analysis. Absolute numbers of Leucocytes, Eosinophil, Monocytes, Neutrophils, Haemoglobin and Platelets from hemograms were significantly reduced after neo-adjuvant treatment. However, no changes were observed for Lymphocytes, Basophils, LDH levels or the Lung Immune Prognostic Index (LIPI). Additionally, post-treatment Neutrophil-to-Lymphocyte (NLR), Myeloid-to-Lymphoid lineage (M:L) and Platelets-to-Lymphocytes (PLR) ratios were decreased. Remarkably, from all the CBC absolute numbers and ratios, only PLR variation showed differences between pCR and pIR.
On the other hand, percentages of PBMCs (T cells, B cells, NK cells and macrophages) did not vary after neo-adjuvant treatment, however activation of CD4 T cells and NK cells as well as PD-1 receptor expression on immune cells were downregulated after neo-adjuvant chemo-immunotherapy. Interestingly, these variations correlate with pCR.
Conclusion
In our study, PLR, PD-1 expression, CD4 T cells and NK cells activation are predictive biomarkers of response to treatment. Thus, a higher decrease on PLR post neo-adjuvant treatment is associated to pCR. Moreover, a decrease of PD-1 expression in CD4, CD8 and NK cells, as well as, a reduction of CD4 T cells and NK cells activation after neo-adjuvant treatment, are associated to pCR.
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P2.04-28 - NeoCOAST: Neoadjuvant Durvalumab Alone or with Novel Agents for Resectable, Early-Stage (I–IIIA) Non‑Small Cell Lung Cancer (ID 56)
10:15 - 18:15 | Presenting Author(s): Rosario Garcia Campelo
- Abstract
Background
Resectable, early‑stage non‑small cell lung cancer (NSCLC) is a potentially curable disease.The current standard of care is surgery with or without adjuvant or neoadjuvant platinum‑based doublet chemotherapy. However, over half of patients eventually relapse after surgery and die from NSCLC. Clinical studies have shown that neoadjuvant programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) checkpoint inhibitors may yield clinically meaningful pathological responses in patients with resectable NSCLC.1–3 The NeoCOAST trial is a multidrug platform study to assess the PD-L1 checkpoint inhibitor durvalumab alone or in combination with novel agents, with the goal of identifying new treatment strategies to improve clinical outcomes of patients with resectable, early-stage NSCLC.
Method
NeoCOAST (NCT03794544) is a phase 2, open-label, randomized trial that will initially evaluate the clinical activity and safety of neoadjuvant durvalumab alone or in combination with the novel agents oleclumab (MEDI9447), monalizumab (IPH2201) and danvatirsen (AZD9150), in patients with resectable, stage I (>2 cm) to IIIA NSCLC. New treatment arms evaluating other durvalumab combinations may be added based on emerging preclinical and clinical data. The primary endpoint is major pathological response rate in the resected tumor specimen after treatment with neoadjuvant durvalumab alone or in combination with novel agents. Secondary objectives include feasibility of tumor resection surgery within 14 days of the end of the 4-week treatment period, safety, pathological complete response rate, pharmacokinetics and immunogenicity. Correlative translational analyses include tumor genomics, changes in the tumor microenvironment, and T cell populations. NeoCOAST is open for accrual with an estimated total target enrollment of up to 40 patients per treatment arm.
References
1Forde PM, et al. N Engl J Med. 2018;378:1976–86.
2Rusch V, et al. MA04.09. Presented at IASLC 19th World Conference on Lung Cancer, 23–26 September 2018, Toronto, Canada.
3Cascone T, et al. LBA49. Presented at European Society of Medical Oncology Congress, 19–23 October 2018, Munich, Germany 2018.
Result
Section not applicable
Conclusion
Section not applicable
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P2.04-52 - Impact of Corticosteroids and Antibiotics on Efficacy of Immune-Checkpoint Inhibitors in Patients with Advanced Non-Small Cell Lung Cancer (ID 2015)
10:15 - 18:15 | Author(s): Rosario Garcia Campelo
- Abstract
Background
Immune-checkpoint inhibitors (ICIs) are a standard-of-care in advanced non-small cell lung cancer (NSCLC). Corticosteroids are frequently used in symptomatic advanced NSCLC patients, but their immunosuppressive effect may reduce the efficacy of ICIs.
Here we report our experience in patients with NSCLC and the potential impact of on-treatment use of corticosteroids and antibiotics.
Method
Medical records of 267 patients with advanced NSCLC receiving ICIs from March 2013 to August 2018 were reviewed. Corticosteroid usage at the time of initiation or during ICIs treatment and administration of antibiotics from three months before the initiation of ICIs to 3 months after treatment end were collected. Kaplan Meier and log-rank tests were used to evaluate progression-free (PFS) and overall survival (OS). A multivariable analysis was performed to study the influence of clinical characteristics on treatment efficacy.
Result
146 patients (55%) received corticosteroids: 63 (43%) for the treatment of irAEs and 83 (57%) for the management of baseline conditions. Prednisone (40%) and dexamethasone (35%) were the most commonly used types of corticosteroids. Median dose of prednisone equivalent was 50mg daily [5-1250mg], 92% patients received ≥10mg of prednisone equivalent daily. Median duration of corticosteroids was 59 days [0.5-83.0].
OS was longer in the group of patients that did not receive corticosteroids or received <10mg prednisone equivalent daily: 14.7 months (95%CI, 11.1-18.3) vs 8.3 months (95%CI, 6.9-9.8) (p = 0.009). No differences in PFS were observed: 4.6 months (95%CI, 2.9-6.3) vs 4.2 months (95%CI, 2.5-5.9) (p = 0.359).
Patients receiving corticosteroids for baseline condition presented shorter median overall survival than the rest of the study population: 6.5 months (95%CI, 4.6-8.3) vs 16.5 months (95%CI, 12.1-20.8) (p <0.001). Multivariable analysis identified corticosteroids usage as an independent variable related to poorer outcomes.
141 patients (52.8%) received antibiotics. Quinolone (37%) and penicillin (33%) were the most commonly used groups of antibiotics. No correlation between the usage of antibiotics and efficacy of ICIs was found, with median OS of 10.2 months (95%CI, 6.4-13.9) vs 12.5 months (95%CI, 9.9-15.0) (p = 0.924).
Conclusion
In our series, corticosteroid use of ≥10mg of prednisone equivalent daily was associated with significantly poorer outcomes, especially when given for baseline condition. No correlation was found between antibiotics and survival. It is important to underline that the use of corticosteroids may simply identify a population with higher volume and aggressive tumors. Prudent use of corticosteroids needs to be warranted.
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P2.05 - Interventional Diagnostic/Pulmonology (ID 168)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Interventional Diagnostics/Pulmonology
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.05-12 - Analysis of Biomarkers in Lung Cancer in Spain (ID 854)
10:15 - 18:15 | Author(s): Rosario Garcia Campelo
- Abstract
Background
The analysis of biomarkers in lung cancer (LC) is currently one of the most important care needs, given the importance of their presence in the selection of specific treatments. Our objective was to know the implementation degree of these tests in a large cohort of patients in Spain using the Thoracic Tumor Registry (TTR) of the Grupo Español de Cáncer de Pulmón (Spanish Lung Cancer Group).
Method
The TTR is an observational cohort multicenter study of the LC in Spain. Information on patients (p) enrolled from August 2016 to December 2018. The study is conducted according to the Declaration of Helsinki and approved by the institutional review board of each participating institute. The registry was approved by the Spanish Drug Agency as a non-post-authorization, non-interventional study.
Result
A total of 7,872 patients from 58 Spanish sites were enrolled. Analysis of molecular markers considering all the LC stages: A molecular test, the most frequent being the EGFR test, was performed in 4,456 patients (67.5%). The proportion of biomarker evaluation has varied over time, ranging from 57.9% prior to 2012 up to 73.7% in 2017.
Molecular markers in patients with stage IV. Three thousand four hundred forty-six (3,446) patients (52.2%) had a stage IV on diagnosis. The molecular assessment of some biomarkers reached 81.4% of all the patients, there being differences between Regional Communities in regard to the molecular tests made.
There was performed some biomarker test in 92% of the 2570 patients with stage IV and adenocarcinoma histology. The analysis of ALK was tested in 79% of the patients, this being in 40% only 2 years ago. ROS was studied in 20% of the cases and EGFR in 92%.
Conclusion
Although no national plan exists for molecular biomarker analysis in LC in Spain, the implementation of the biomarkers analysis in all the hospitals that contribute to the TTR is high, as close to the maximum as possible. The increase in the ALK analysis in the last period is relevant. As regional differences exist, it would be of interest to go in depth to study its cause
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P2.10 - Prevention and Tobacco Control (ID 176)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Prevention and Tobacco Control
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.10-02 - Smoking Habit in Lung Cancer in Spain (ID 732)
10:15 - 18:15 | Author(s): Rosario Garcia Campelo
- Abstract
Background
Tobacco is the leading cause of lung cancer. The fight against the smoking habit is essential and should be continuous, to detect the national situation that makes it possible to design health care policies against this consumption. To do so, the Grupo Español de Cáncer de Pulmón (Spanish Lung Cancer Group) made this analysis within the context of the Thoracic Tumor Registry (TTR).
Method
The TTR is an observational cohort multicenter study in Spain. The study is conducted according to the Declaration of Helsinki and approved by the institutional review board of each participating site. The registry was approved by the Spanish Drug Agency, as a non-post-authorization, non-interventional study.
Result
We collected data from 6,600 patients diagnosed of lung cancer from 58 different Spanish hospital sites.
A total of 3,039 patients were former smokers (46%), 2,611 were active smokers (39%) and only 866 (12%) patients stated to be non-smokers; the status in 2% is unknown. If we make a comparison by gender regarding the presence of this habit, large differences (p-valor < 0.001) are observed, with a greater number of non-smokers in women (37 % vs. 4.5% in males), while the percentage of former smokers is much higher in the males (53.4% vs. 27.9% in women) and a minor difference in active smokers (42.1% vs. 34.4% in women).
Significant differences were observed in the study on the distribution of the smoking habit by gender and year of diagnosis. An increase is also observed in the last two years regarding the percentage of patients who were active smoked, both for the total population as well as for each one of the two genders separately. The increase is greater among the women and, also, the number of women who are active smokers is greater in recent years.
Mean age of onset of the smoking habit is 18.2 years. Significant differences are observed between both genders (p-valor < 0.001), with a mean age of initiation of 17.9 years in the men (95%CI 17.6-18.2 years) and 19.2 years in the women (95%CI 18.5-19.8 years). Significant differences between Regional Communities were also found in the mean age at onset of the habit, with much lower levels in the Valencian Community (16.6 years) or Navarra (16.9 years) regarding other communities, such as the Region of Murcia (22.9 years) or the Balearic Islands (21.6 years)
Conclusion
Lung cancer in Spain is associated to tobacco consumption in 85% of the cases diagnosed. Consumption has shown an increase in both genders in recent years and is especially rapid and worrisome in women. Anti-smoking campaigns should be reactivated and the causes of the regional differences analyzed in depth
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SH01 - Highlight of the Previous Day (ID 98)
- Event: WCLC 2019
- Type: Highlight of the Previous Day Session
- Track:
- Presentations: 1
- Now Available
- Moderators:Isabelle Opitz, Ritsuko Komaki-Cox
- Coordinates: 9/09/2019, 11:00 - 12:30, San Francisco (2009)
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SH01.04 - Targeted Therapy (Now Available) (ID 3661)
11:00 - 12:30 | Presenting Author(s): Rosario Garcia Campelo
- Abstract
- Presentation
Abstract not provided
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