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Mariano Provencio
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EP1.14 - Targeted Therapy (ID 204)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.14-11 - Real-Life Data of Osimertinib in Pretreated Patients with Advanced Non-Small Cell Lung Cancer Harboring EGFR T790M Mutation (Now Available) (ID 697)
08:00 - 18:00 | Author(s): Mariano Provencio
- Abstract
Background
Several clinical trials have demonstrated the efficacy and safety of osimertinib in pretreated patients with advanced non-small cell lung cancer (NSCLC) harbouring EGFR T790M resistance mutation. However, clinical real-world data on patient characteristics and efficacy of the drug is limited.
Method
We reviewed the medical records of T790M mutation-positive lung cancer patients treated with osimertinib between May 2016 and February 2019 in our institution. We calculated progression-free survival (PFS) and overall survival (OS) from osimertinib initiation.
Result
The study included 22 patients with a mean age of 59.6 years. 59% (13/22) were female and 100% had adenocarcinoma histology. We had an unusual high frequency of tobacco use in our series as 40.9% (9/22) of our patients were smokers (3/22) o former-smokers (6/22), with a mean of 35 pack-year (sd, 28.5). 45.5% (10/22) had exon 21 L858R mutations, whereas 54.5% (12/22) harboured exon 19 deletions (19del). One patient simultaneously had an exón 19 deletion and exon 20 S768I mutation. Osimertinib was used in second, third and fourth line in 50% (11/22), 27% (6/22) and 23% (5/22) of patients, respectively.
All patients had liquid biopsy blood samples obtained prior to the start of the treatment, and T790M mutation could be detected in 86.4% (19/22), with a mean mutant-allele fraction of 4,11% (standard deviation 8.65, min 0, max 37.7). T790M was detected only in tissue in 2 patients and exclusively in cerebrospinal fluid in 1 of them.
At the time of starting osimertinib, patients had a median of 3 metastatic sites (min 1, max 6), being the most frequent locations the lung (73%), the bone (64%), the pleura (59%), the central nervous system (23%) and the peritoneum (14%).
Median follow-up duration was 10 months (IQR, 4.7-22.67). To the date, 63% (14/22) have experienced progression of the disease. Median PFS in our series was 8.9 (95% CI, 4.9-17.9 ) months, whereas median OS since osimertinib initiation was 18.2 (95% CI, 8.8-NE) months.
Regarding to toxicity, 12 patients referred adverse events, 82.6% of which were mild (G1), being the most frequent toxicities neutropenia (9%), diarrhoea (9%), hypertransaminasemia (9%) and asthenia (9%). Only 1 G3 event was recorded (asymptomatic hyperamilasemia).
Conclusion
The efficacy of osimertinib in real-world practice was similar the observed in clinical trials, with a favourable adverse effect profile. Liquid biopsy is an effective non-invasive method to assess the presence of the T790M resistance mutation prior to the start of osimertinib.
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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
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.16-28 - ALK Translocated Patients: Survival in an Unselected Population (ID 1426)
08:00 - 18:00 | Author(s): Mariano Provencio
- Abstract
Background
Lung cancer is the leading cause of death from cancer in our environment. About 5% have ALK translocation, which is more frequent in young, Asian women and non-smoking patients. In the last years, multiple treatments have been developed for patients with ALK translocation, improving prognosis and reaching overall survivals (OS) of more than two years.
Method
A cohort of 34 patients diagnosed of non-small cell lung cancer with ALK translocation were retrospectively analyzed in our center between 2008-2018. Baseline demographics characteristics were described. OS was calculated as the main objective.
Result
Patients were followed a median of 47 months (IQR 30-203). Median age was 59 years (IQR 36-83), being 47% male and 53% female. 44% were never smokers and 58% had any comorbidities. At diagnosis, 83% were symptomatic and the most frequent metastases were bone ones (32%).
Complete baseline characteristics are shown in Table 1.
Median OS was 32 months (IQR 15-78). 1-year, 2-year and 3- year survival was 75%, 69% 49.9% respectively. Kaplan-Meier curve is shown in Figure 1.
Conclusion
The ALK translocation and targeted treatments have led to a dramatic improvement in overall survival in clinical trials confirmed in our series.
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ES02 - Management of Oncogene Addicted Patients with Stage III NSCLC (ID 5)
- Event: WCLC 2019
- Type: Educational Session
- Track: Treatment of Locoregional Disease - NSCLC
- Presentations: 1
- Now Available
- Moderators:Carlos Camps, Helena A Yu
- Coordinates: 9/08/2019, 10:30 - 12:00, Vancouver (2003)
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ES02.04 - Concurrent, Sequential and Combination Immunotherapy Regimens in LA-NSCLC (Now Available) (ID 3158)
10:30 - 12:00 | Presenting Author(s): Mariano Provencio
- Abstract
- Presentation
Abstract
Immunotherapy in Oncogenic-Addicted Stage III Patients
At diagnosis of non small cell lung cáncer (NSCLC), at least 40% of patients are diagnosed at an advanced stage and a third locally advanced disease (stage III). The results of stage IIIA with induction treatment of clinical practice outside the clinical trial show a median survival of 22 months and a 3-year survival rate of 34%. Concurrent definitive chemoradiation has been established as the standard of care for unresectable stage IIIB (N3 disease) NSCLC, with a median overall survival (OS) of approximately 17 months. Strategies that have been investigated include induction chemotherapy, immunotherapy (IO), concomitant chemoradiotherapy, intensified radiotherapy and adjuvant treatment.
The role of IO in NSCLC with oncogenic-addicted tumors is so far unclear. In EGFR-mutation positive patients there seems to be a worse effect of IO compared to those patients without actionable mutations,; nevertheless, no safe conclusions can be drawn due to the lack of randomized trials addressing this clinical issue. The available information from second lines with IO in patients with actionable mutations, is currently found in 2 meta-analyses[1].
These meta-analyses show OS benefit between EGFR wild-type vs mutated patients with a Hazard Ratio (HR) of 0.67, p< 0.001, consistent in all the trials. There was no OS advantage for those with EGFR mutant tumors, with a HR of 1.11, p=0.54.
Of note, data from other studies were not included in these meta-analyses. Study CA209-012 showed patients with EGFR mutation, overall response rate (ORR) 14% mutated vs 30% in wild type and PFS at 24 weeks: 14% vs 51% respectively[2].
In KEYNOTE-001, best ORR based on mutation status was 15.8% in patients with EFGR mutation vs 37.1% without mutation, and 60% were unknown. Overall PD-L1 subgroups, EGFR mutated patients had lower ORR than patients with EGFR-wild type tumors. ORR was 20 % in TPS > 50% and 0% in patients with TPS<1% vs 12.7% in EGFR wild type[3]. An update of this study, and median OS in patients with EGFR mutation was 6 months (mo) (95%CI, 4.4-8.8) and 12 mo (95%CI, 9.2-14.3) in patients wild-type[4].
In the Immunotarget Cohort study, patients with EGFR-mutation had response rates of 12% and PFS of 2.1 mo and with a positive correlation in patients with high expression of PDL1 and response.
The BIRCH[5] study, also not included in the meta-analyses, provides us with similar information, with higher response rates in patients with higher expression of PDL1 (31% vs 23%), even achieving similar PFS to wild type patients (7.6 vs 7.7 mo) or OS with 28.5 mo (20.1, NE) in mutant vs 20.1 mo (15.5, 31.1) in wild-type. The phase II ATLANTIC trial testing durvalumab as third-line treatment included the largest cohort of EGFR mutant patients treated with IO after progression of TKI and chemotherapy. According to PD-L1 expression (< 25% or ≥ 25%), durvalumab achieved a response rate (RR) of 3.6% and 14.1%, a similar median PFS 1.9 months and a median OS of 9.9 months and 13.3 months, respectively[6].
Despite improvements in the treatment of stage IV NSCLC with the introduction and dissemination of checkpoint inhibitors, very little progress has been made in the treatment of stage III. The PACIFIC trial was the first study to show a clear benefit for the approach. Patients were enrolled regardless of PD-L1 expression, and those with EGFR mutations were also eligible. The subgroup of patients with EGFR mutations did not clearly benefit from durvalumab maintenance. These patients were equally represented in the durvalumab (6%) and placebo (5.9%) arms. The HR was 0.76 in this setting, and whether because of a small sample size or true lack of efficacy, the findings were not significant (95% CI, 0.35–1.64).
In NADIM Study, a Phase II, with neoadjuvant chemotherapy and immunotherapy in stage III, unprecedented pCR rates observed (around 70%) and with down-staging around 90%. We did not include patients with actionable mutations, and we do not have information about other trials using chemo and IO. In KN 189 using combination of chemo and IO in stage IV, no sensitizing EGFR or ALK alteration were included. In the ImPOWER 150 study[7] comparing the use of bevacizumab plus atezolizumab plus carboplatin, plus paclitaxel versus carboplatin plus paclitaxel plus bevacizumab in first-line stage IV, provides interesting results in PFS, with a HR of 0.41 (95% CI: 0.22-0.78), in patients with common mutations (already treated with TKIs) in the arm with atezolizumab plus chemo better than the control arm.
In the light of these results, we may conclude that other biomarkers such as a tumor mutational burden (TMB) could be used in the future, but low TMB is especially significant among the oncogenic alterations strongly related with never-smokers, such as EGFR mutation and ALK rearrangements. Therefore, these data suggest a role for actionable mutations testing in the stage III setting and for additional trials specifically targeting EGFR-mutant patients and stage III disease.
[1] Lee CK, Man J, Lord S et al. Clinical and molecular characteristics associated with survival among patients treated with checkpoint inhibitors for advanced non-small cell lung carcinoma.A systematic review and meta-analysis. JAMA Oncol 2017
[2] Gettinger S, Chow LQ, Borghaei H et al. Nivolumab monotherapy for first-line treatment of advanced non-samll cell lung cancer. JCO, DOI: 10.1200/JCO.2016.66.9929.
[3] Hellman M et al. Efficacy of pembrolizumab in key subgroups of patients with advanced NSCLC. 16th World Conference on Lung Cancer, 2015.
[4] Leighl NB, Hellamn MD, Hui R, et al. KEYNOTE-001: 3-year overall survival for patients with advanced NSCLC treated with pembrolizumab. ASCO 2017.
[5] Carcereny E, Felip E, Reck M, et al. Updated efficacy results from the BIRCH study: First-line atezolizumab therapy in PD-L1 –selected patients with advanced NSCLC. World Conference on Lung Cancer 2017.
[6] Garassino MC, Cho B-C, Kim J-H, Mazières J, Vansteenkiste J, Lena H, et al. Durvalumab as third-line or later treatment for advanced non-small-cell lung cancer (ATLANTIC): an open-label, single-arm, phase 2 study. Lancet Oncol 2018;19:521–36.
[7] Socinski M, Jotte RM, Capuzzo F, et al. Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC. NEJM DOI: 10.1056/NEJMoa176948.
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MA02 - Miscellaneous Topics in the Management of Early Stage Lung Cancer (ID 116)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Treatment of Early Stage/Localized Disease
- Presentations: 1
- Now Available
- Moderators:Mireia Serra-Mitjans, Thomas A. D'Amico
- Coordinates: 9/08/2019, 10:30 - 12:00, Interlaken (1988)
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MA02.01 - Reccurrence Pattern After Adjuvant Customized Chemotherapy Based on BRCA Expression Level (SCAT Trial) (Now Available) (ID 2760)
10:30 - 12:00 | Author(s): Mariano Provencio
- Abstract
- Presentation
Background
•Postop platinum-based CT improves outcomes in completely resected NSCLC with nodal involvement, (St II-IIIA). Customization is feasible in adjuvant setting (tissue availability) . Analysis of expressionin genes involved in DNA repair could be use to select CT regiment. •BRCA1 plays an important role in DNA repair pathways and functions as a differential regulator of response to cisplatin and antimicrotubuleagents. SCAT trial results found that for low BRCA1 levels subgroup Cis-Gemcitabine was superior to Cis-Docetaxel and in high BRCA1 levels subgroup Docetaxel single agent without platinum achieved similar survival to Cis-Doc. Analysis of recurrence pattern in different subgroups of the trials has been performed
Method
From Jun/2007 to May/2013 591 patients were screened and 500 p were included (108 in Control arm treated with Cisplatin-Docetaxel and 392 in Experimental arm treated with Cisplatin-Gemcitabine, Cisplatin-Docetaxel or Docetaxel alone according terciles BRCA1 expression level). With a cut-off September 30th 2018 and a median follow-up of 60 months, recurrence pattern are analysed in each arm and subgroup treatment and comparison are made for incidence of risk of recurrence, single/multiple recurrence, thoracic/extrathoracic and site of metastases (liver, bone, brain)
Result
Cumulative recurrence 232/456 evaluable patients (p) (50.8%). Recurrence were seen in 182/354 patients treated in experimental arm and in 50/102 p treated in the control arm (RR 1.04; 0.83-1.30) (p=0.672). Majority of recurrences 159/232 (68.5%) were single site recurrence. Intrathoracic recurrences in 121/232 (52%) while extrathoracic metastatic disease 111/232 (47.8%). No significant differences were seen for single/multiple, intra/extrathoracic recurrences between experimental and control arm. More frequent distant metastatic sites were: bone (42 p), brain (38 p) and liver (11 p) In the experimental group between different treatments no significant differences were found for the overall metastatic rate or for the single/multiple, intrathoracic/extrathoracic recurrences. For specific metastatic sites related to experimental treatment a significant reduction of risk of brain metastases were found in the experimental group with high level BRCA1 treated with Docetaxel single agent (p=0.0016)
Conclusion
For NSCLC resected patients with lymph node involvement (Stages II-IIIA) risk of recurrence remains high with cumulative rate > 50%. There were no differences in the Relative Risk (1.04) of recurrence when control and experimental arm are compared. Majority of recurrences were single site (68.5%) and intrathoracic (52%) but distant metastases developed in 47.8% os p. More frequent metastatic site was bone, followed by brain and liver. Brain metastases risk were significant lower for patients with low BRCA1 expression treated with single agent Docetaxel
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MA08 - Pawing the Way to Improve Outcomes in Stage III NSCLC (ID 127)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Treatment of Locoregional Disease - NSCLC
- Presentations: 1
- Now Available
- Moderators:Simon Ekman, Helena A Yu
- Coordinates: 9/08/2019, 15:15 - 16:45, Tokyo (1982)
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MA08.11 - SLCG SCAT Trial: Surgical Audit to Lymph Node Assessment Based on IASLC Recommendations (Now Available) (ID 2252)
15:15 - 16:45 | Author(s): Mariano Provencio
- Abstract
- Presentation
Background
The Spanish Lung Cancer Group (SLCG) developed a multicenter trial in which completely resected pathological N positive NSCLC patients received different schemes of adjuvance based on level of tumoral BRCA expression (SCAT trial). We assess here surgical topics, with an in-depth analysis of quality of lymphadenectomy based on IASLC recommendations, evaluating their effect on survival.
Method
Phase-III SLCG-SCAT trial included patients with completely resected (R0) NSCLC with pathological hilar and/or ipsilateral mediastinal lymph node (LN) involvement. Patients from SLCG-SCAT trial in which complete pathologic report with information about mediastinal lymph node dissection was available (including number of lymph nodes assessed and involved by tumor in each hilar and mediastinal region), were included for our study. We also analyzed data about estimated overall survival (OS) and disease-free survival (DFS). All patients underwent surgical resection in high-volume departments of thoracic surgery.
Result
Lymph node assessment
From the whole series (451 patients), in 33.7%, 17.7% and 49.9% of cases, regions 7, 10 and 11 respectively were not assessed. No lymph nodes were biopsied from region 8, 9 and 12 in 80%, 61.9% and 91.1% of cases, respectively. Region 10 was that with the higher number of lymph nodes resected (medium 4.64). From them, 27.9% were involved by tumor. Median assessed mediastinal regions was 4. In 21.1% of patients, lymph nodes from only one or two regions were obtained. In most of the patients (91.8%), one or two N1 regions were assessed. From 272 patients with N1 (no N2) involvement, 15.4% had no N2 regions biopsied, 20.2% had one N2 region evaluated and only 39.7% had three or more N2 regions assessed. On the other hand, from 179 patients with positive N2, 8.9% had no N1 regions biopsied and 54.7% had one. From 409 patients with at least one N2 lymph node resected, 120 (29.3%) shown the highest region involved. Number of mediastinal regions assessed and affected, and number of lymph nodes resected and affected were significantly higher in patients with N1 plus N2 disease than those with isolated N1 or N2 involvement.
Survival
Median follow-up was 52.3 months. Five-year OS was 55.7% (CI95% 50.8%-60.3%). Differences were found on OS regarding type of lymph node involvement (N1, N2 or both) (p=0.002). Five-year OS was 61.7% (CI95%:55.4%-67.4%), 51.5% (CI95%:39.2%-62.4%) and 42.3% (CI95%:32.1-52.2%) for patients with N1, N2 and N1+N2 disease, respectively. No differences were found in survival regarding total number of N1 or N2 regions evaluated. Both number of regions involved and number of lymph nodes with tumor were significantly related to worse prognosis.
Conclusion
International recommendations for surgical lymph node assessment in NSCLC were not deemed for the design of the trial and were not followed in a high proportion of cases. Patterns of N1 and N2 involvement shown to impact prognosis. The design of trials assessing surgical series of patients undergoing complete resection requires the control of surgical procedures in order to avoid recruitment biases.
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MA16 - Prioritizing Use of Technology to Improve Survival of Lung Cancer Subgroups and Outcomes with Chemotherapy and Surgery (ID 142)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Treatment in the Real World - Support, Survivorship, Systems Research
- Presentations: 1
- Now Available
- Moderators:Jair Bar, Navneet Singh
- Coordinates: 9/09/2019, 15:45 - 17:15, Interlaken (1988)
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MA16.03 - Big Data Analysis for Personalized Medicine in Lung Cancer Patients (Now Available) (ID 2532)
15:45 - 17:15 | Author(s): Mariano Provencio
- Abstract
- Presentation
Background
The use of Big Data in healthcare is in its early days, and most of the potential for value creation remains unclaimed.
Electronic Health Records (EHR) contain a large amount of information about the patient's condition, which can potentially revolutionize the clinical practice, such information is seldom considered due to the complexity of its extraction and analysis. We report on a first integration of an NLP framework for the analysis of clinical records of lung cancer in Puerta de Hierro University Hospital (HUPHM).
Method
A cohort of 1000 patients diagnosed of non-small cell lung cancer (NSCLC) from 2009 to 2018 at HUPHM were included in this observational study. Unstructured clinical data were obtained from the EHR. The semantic indexing and the information analysis was performed by the Politecnica University of Madrid, using Big Data and machine learning techniques. Clinical notes were converted into usable data, and combined with genomic data, images and bibliography, such as PubMed or Drugbank.
Result
A total of 251.730 documents were analyzed (240.851 notes and 10.879 reports). These heterogeneous sources of information were analyzed and integrated in an interactive user interface (Figure 1). As a result, all this large amounts of data turns into actionable and exploitable information for clinicians and authorities for planning public health policies and also create new clinical trials.
The interactive platform will allow the clinician obtain immediate and personalized information of each patient and will elaborate predictive models for long survivors, identify risk patients, reduce overtreatments, etc.
Conclusion
By using Big Data we will be able to exploit large amounts of clinical information and combine them with multiple databases developing interactive user interface, increasing lung cancer knowledge and directing medicine towards a more personalized one.
This work was supported by the EU H2020 programme, under grant agreement Nº 727658 ( Project iASiS).
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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): Mariano Provencio
- 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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OA09 - Lung Cancer: A Preventable Disease? (ID 134)
- Event: WCLC 2019
- Type: Oral Session
- Track: Prevention and Tobacco Control
- Presentations: 1
- Now Available
- Moderators:Bienvenido Barreiro, Carolyn Dresler
- Coordinates: 9/09/2019, 11:00 - 12:30, Melbourne (1991)
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OA09.06 - Residential Radon, Smoking and Lung Cancer Risk. A Case-Control Study in a Radon Prone Area (Now Available) (ID 1260)
11:00 - 12:30 | Author(s): Mariano Provencio
- Abstract
- Presentation
Background
Residential radon is the second risk factor of lung cancer following tobacco consumption and the main one in never smokers, according to the WHO and USEPA statements. The joint effect of tobacco and radon exposure has been little studied and residential radon is a neglected risk factor of this disease. We aim to show lung cancer risk for different combinations of tobacco consumption and residential radon exposure on the risk of lung cancer.
Method
Pooling case-control study in a radon-prone area where we have combined individual information from 5 different multicentric case-control studies. 11 Spanish hospitals from 4 different regions have taken part. All case-control studies had a similar methodology, including incident, primary, and histologically confirmed lung cancer cases and controls attending hospital for trivial surgery not related with tobacco consumption. Cases and controls were older than 30 and controls were matched with cases using a frequency-based sampling using age and gender distribution of cases. Detailed information was obtained regarding tobacco consumption, and a radon device was placed in the participants’ dwelling for at least three months. We calculated lung cancer risk for each category of tobacco consumption and radon exposure taking as a reference those participants never smokers and with an indoor radon concentration below 50 Bq/m3. All Odds Ratios are accompanied by their 95% confidence intervals.
Result
We included 1691 cases and 1698 controls with a similar distribution on age and gender. Heavy smokers exposed to low radon concentrations (< 50Bq/m3) posed a risk of lung cancer of 12.6, compared to 31.3 for heavy smokers exposed to indoor radon higher than 200 Bq/m3. The different odds ratios and confidence intervals for each category of exposure appear in the Table.
Conclusion
There is an interaction between indoor radon and tobacco. Risk of lung cancer increases significantly when both risk factors are present.
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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 | Presenting Author(s): Mariano Provencio
- 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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P1.03 - 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): Mariano Provencio
- 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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P1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 186)
- Event: WCLC 2019
- Type: 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, 09:45 - 18:00, Exhibit Hall
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P1.16-12 - An Analysis of Healthcare Use and the Cost Associated to End-of-Life Care of Lung Cancer Patients in a Spanish Hospital (Now Available) (ID 896)
09:45 - 18:00 | Presenting Author(s): Mariano Provencio
- Abstract
Background
Despite various studies have demonstrated that the consumption of healthcare services by cancer patients, and therefore healthcare costs, increases during the end-of-life period, there are insufficient studies which focus specifically on lung cancer. Thus we aim to study the consumption of healthcare services and its cost in end-of-life lung cancer patients attended in the Puerta de Hierro University Hospital, Spain.
Method
The Cross Industry Standard Process for Data Mining (CRISP-DM) was applied to integrate and analyze activity data extracted from the Electronic Patient Record (EPR) and clinical data of lung cancer patients from a previous study. A cohort of 224 deceased patients, diagnosed between 01/01/2009 and 31/12/2016, was analyzed to determine the use of healthcare services together with the time-related distribution of such use and associated cost during the end-of-life period.
Result
Overall, 82% of the patients received outpatient care, 68% received emergency service care, 53% experienced some period of hospitalization during the last 30 days of their life, and 38% of the patients died during hospitalization. The cost of hospitalization amounted to 88% of the total (excluding the cost of outpatient administered medication and radiotherapy treatment), with the cost of emergency services and consultations being 2.3% and 9.6%, respectively. In total, 58% of the healthcare assistance cost occurred during the last 6 months of life, and 21% in the last 30 days. The costs during the last 30 days represented 36% of the cost during the last 6 months.
Conclusion
Integrating activity data from EPR and clinical structured data from lung cancer patients and applying CRISP-DM has allowed us to describe end-of-life healthcare which could be used to plan resources and improve the quality of care in these patients.
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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
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.01-12 - A Phase I/II Trial of IO102 and Pembrolizumab With/Without Chemotherapy as First-line Treatment of Metastatic NSCLC (ID 706)
10:15 - 18:15 | Presenting Author(s): Mariano Provencio
- Abstract
Background
Immunotherapy has significantly changed the treatment landscape of non-small cell lung cancer (NSCLC) with no driver mutations. However, despite the addition of anti-PD-1/PD-L1 therapies to the clinical armamentarium only a subset of patients derives durable benefit. IO102 is a novel, second generation, HLA-A unrestricted immune modulating T-win® vaccine targeting IDO. IO102 has a dual mode of action; remodulation of the tumour micro-environment through elimination of immune suppressive cells, and induction of CD8 T-cell mediated killing of IDO-expressing tumor cells. Our first-generation IDO vaccine (IO101) has shown promising antitumor activity and a favorable safety in heavily pretreated NSCLC patients (Iversen, CCR 2013).
Method
Phase I/II, international, multicenter, open-label, randomized trial with two parallel cohorts. Cohort A: IO102 (100µg s.c.) and pembrolizumab (200 mg) (PD-L1 ≥ 50%); Cohort B: IO102, pembrolizumab and carboplatin plus pemetrexed (PD-L1 < 50%). The maximum treatment duration is 35 cycles (app. 2 years). Key eligibility criteria include metastatic NSCLC or non-squamous NSCLC (cohort B) with no prior treatment for metastatic NSCLC and no driver mutations.
Phase I is a non-randomized safety run-in with 6 patients per cohort investigating one dose level of the experimental arms. Only one DLT is allowed in each cohort. Phase II is following Sargent’s two-stage, three-outcome optimum design (Sargent, ClinTrial2001) with a 2:1 randomization in the cohorts. Cohort A: IO102 and pembrolizumab versus pembrolizumab alone; Cohort B: IO102, pembrolizumab and chemotherapy vs. pembrolizumab and chemotherapy. Provision of blood and tumour tissue is required for biomarker studies.
The primary endpoint is safety and objective response rate (ORR) per RECIST 1.1 in Phases I and II, respectively. Secondary endpoints include ORR per iRECIST, duration of response, progression free survival, overall survival, and biomarkers including immunoscore in tissue, tumour mutational burden and immunomonitoring in blood.
The study is enrolling in Europe. First patient was entered in September 2018 and recruitment is expected to continue throughout 2019: EudraCT Number 2018-000139-28 / IND Number: 018081.
Result
Section not applicable
Conclusion
Section not applicable
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P2.03 - Biology (ID 162)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Biology
- Presentations: 2
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.03-16 - Agreement Between Different Methodologies for Non-Invasive p.T790M and EGFR Sensitizing Mutation Testing (ID 1965)
10:15 - 18:15 | Author(s): Mariano Provencio
- Abstract
Background
Tyrosine kinase inhibitors (TKIs) are the current standard of care for patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC). However, most patients progressed within 1 to 2 years. The EGFR p.T790M mutation is the most common resistance mechanism to first and second generation EGFR TKIs. The identification of p.T790M mutation is of considerable clinical relevance as osimertinib has demonstrated clinical efficacy in this setting. Guidelines recommend testing for the p.T790M mutation in blood at relapse to TKIs, and re-biopsy only in case of a negative result. Several blood based methodologies for detection of EGFR mutations have been developed in the recent years. However, the number of comparison studies between platforms is very limited.
Method
This is a multicenter, cross-sectional study (ClinicalTrials.gov Identifier: NCT03363139) performed by the Spanish Lung Cancer Group. Samples from 75 consecutive EGFR mutant NSCLC patients were collected at disease progression to first line TKI treatment. The presence of EGFR mutations in the cfDNA was evaluated in 39 samples by 7 methodologies, namely: Cobas® EGFR Mutation Test v2 (Roche Diagnostics), Therascreen EGFR Plasma RGQ PCR Kit (Qiagen), QuantStudio® 3D Digital PCR System (Thermofisher), a 5′-nuclease real-time PCR (TaqMan®) assay in presence of PNA, OncoBEAM EGFR (Sysmex Inostics), NGS with two different gene panels: Oncomine® (Thermofisher) and Lung Cancer Panel (Qiagen). The agreement between methodologies was assessed using the kappa coefficient (K) and its corresponding 95% confidence intervals (95% CI). For quantitative variables the concordance correlation coefficient (ccc) was used.
Result
Complete results are available for 39 patients. Overall, the agreement between all methodologies for the detection of p.T790M mutation as well as the original EGFR sensitizing mutation was good (K=0.669; 95CI: 0.504-0.835 and K=0.750 95CI: 0.599-0.899 respectively). Remarkably, the agreement between FDA-approved methodologies for p.T790M detection was almost perfect (K=0.926; 95CI: 0.712-1) and good for the EGFR sensitizing mutations (K=0.657; 95CI: 0.417-0.902). Similarly, the agreement between NGS-based methodologies for the detection of p.T790M and the EGFR activating mutations was very high (K=0.843; 95CI: 0.567-1 and K=0.872 95CI: 0.595-1 respectively). Moreover, concordance between both technologies for p.T790M and EGFR sensitizing mutation mutant allele frequency was excellent (ccc=0.956; 95CI: 0.906-1 and ccc=0.980 95CI: 0.950-1 respectively). The proportion of samples that were positive for p.T790M detection varied from 28% (PCR based technologies) to 37% depending on the methodology.
Conclusion
NGS and PCR-based methodologies show a good to excellent agreement for the detection of EGFR mutations, including the p.T790M. Our results support the use of liquid biopsies for non-invasive testing of clinically relevant mutations (Data from the whole cohort will be presented at the meeting).
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P2.03-33 - ctDNA Levels Significantly Predicts Survival in NSCLC Patients with an EGFR Activating Mutation (ID 2016)
10:15 - 18:15 | Author(s): Mariano Provencio
- Abstract
Background
Circulating tumor DNA (ctDNA) have been shown to be useful for non-invasive biomarker testing in non-small cell lung cancer (NSCLC). In addition, there is growing evidence supporting that ctDNA levels can be useful for tumor response to treatment monitoring. Nevertheless, data from large prospective clinical longitudinal studies still limited.
Method
300 plasma samples from 100 advanced NSCLC patients, with tumors harboring an EGFR activating mutation and treated with a first line tyrosine Kinase inhibitor were analyzed. Samples were collected before the start of treatment, at first follow up evaluation, at 7 month and at disease progression. ctDNA was analyzed by dPCR.
Result
Median follow up was 11.3 months. There were not significant differences in progression free survival (PFS) or overall survival (OS) according to treatment (erlotinib, afatinib or gefitinib). Patients harboring a deletion in exon 19 or a mutation in exon 21 exhibited better survival than those with an insertion in exon 20 (P<0.001). dPCR detected EGFR sensitizing mutation in 77% of the pre-treatment samples. ctDNA levels before the start of the treatment did not significantly predict survival, although a tendency was observed, with patients with high levels of ctDNA showing poorer outcome. On the contrary, patients in which the EGFR sensitizing mutation was undetectable at first follow up had a markedly better PFS and OS (HR=2.7; 95IC= 1.4-5.5 and HR= 5.5 95IC: 1.8-17 respectively). In the same way, patients in which the EGFR sensitizing mutation remained negative at 7months had a significantly increased PFS (HR: 2.8; 95IC: 1.2-6.6). None of the patients with undetectable levels at 7 months has deceased.
Conclusion
ctDNA levels is of prognostic significance in EGFR positive NSCLC patients with advance disease and can be useful to monitor treatment outcome
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P2.04 - Immuno-oncology (ID 167)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- 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): Mariano Provencio
- 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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P2.05 - Interventional Diagnostic/Pulmonology (ID 168)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Interventional Diagnostics/Pulmonology
- Presentations: 2
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.05-10 - Liquid Biopsy: Association Between the Burden of Disease in Patients with EGFR-Mutated NSCLC and the Frequency of Its Detection in Blood (ID 2384)
10:15 - 18:15 | Presenting Author(s): Mariano Provencio
- Abstract
Background
In the management of patient’s whit non small cell lung cancer (NSCLC) with EGFR mutations after progression to first and second generation tyrosine kinasa inhibitors (TKI), the mechanism of resistance is very important. Our objective is to analyse the appearance kinetics of the T790M by means of digital PCR techniques in liquid biopsy.
Method
We conducted a multicenter study with 100 patients with EGFR-mutated NSCLC, treated with first-line TKI therapy. We analyze the ctDNA by dPCR before the start of treatment, at first follow up evaluation, at 6 months and at disease progression.
Result
We included a total of 100 patients from July 2016 to December of 2017. Seven patients with Exon 20 insertion in EGFR were excluded (final sample 93). The median of follow-up was 12 months. There were not significant differences in progression free survival (PFS) or overall survival (OS) according to treatment (erlotinib, gefitinib or afatinib). dPCR detected EGFR sensitizing mutation in 77% of the pre-treatment samples. Of these cases, EGFR sensitizing mutation was detected in 75% of the patients with stage IVA and 85% in stage IVB respectively, p=0,075. The resistance mutation p.T790M was detected in 52% of the samples collected at disease progression. The probability to detect the resistance mutation p.T790M by liquid biopsy, is greater if the pre-treatment sample was positive for EGFR sensitizing mutation (11% vs 62%) p 0,009. In cases with progression of the disease the percent of detection of p.T790M was 52% and 54% in patients with Exon 19 deletion and L858R mutation respectively. The OS in patients with progression of the disease and p.T790M negative was 85% at 12 months (95%CI: 60%-94%) and 75% with p.T790M positive (95%CI: 49%-88%), p=0,01.
Conclusion
The burden of disease in patients with NSCLC mutated with EGFR is related to the appearance of sensitivity and resistance mutations in liquid biopsy. The probability to detect the resistance mutation p.T790M in blood, is greater if the pre-treatment sample was positive for EGFR sensitizing mutation.
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P2.05-12 - Analysis of Biomarkers in Lung Cancer in Spain (ID 854)
10:15 - 18:15 | Author(s): Mariano Provencio
- 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: 2
- Now Available
- 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): Mariano Provencio
- 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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P2.10-05 - Indoor Radon and Lung Cancer Risk. A Pooling Study on the Second Risk Factor for Lung Cancer (Now Available) (ID 277)
10:15 - 18:15 | Author(s): Mariano Provencio
- Abstract
Background
Residential radon is the second risk factor of lung cancer following tobacco consumption, according to WHO (World Health Organization) and United States EPA statements. It is recognized as the first cause of lung cancer in never-smokers by both organizations. Nevertheless, case-control studies performed in radon prone areas are still scarce and with limited sample sizes. We aim to know the relationship between residential radon and lung cancer risk in a study performed in a radon-prone area, and where inhabitants live for a long time in the same dwelling.
Method
We have pooled results from 5 different case-control studies performed in the same geographical area to assess the relationship between indoor radon and lung cancer. One of these studies was focused specifically in never smokers and other in Small Cell Lung Cancer. All cases and controls were older than 30 and cases had a confirmed diagnosis of lung cancer. Controls were selected for attending hospital for trivial surgery. Controls were selected through a frequency-based sampling based on age and gender distribution of cases. The information and questionnaires collected was the same in all studies, with special focus on tobacco consumption. Radon devices of an alpha track type were placed at the participants’ homes for at least three months. Odds Ratios of lung cancer due to radon exposure have been calculated adjusted by age, gender, and tobacco consumption.
Result
We included 1691 cases and 1698 controls. Median age was 63 and 67, respectively, and females comprised 33% of both cases and controls. Adenocarcinoma was the most frequent histology (43%) and participants lived a median of 30 years in the same dwelling. The table show the risk of lung cancer due to radon exposure.
Conclusion
Residential radon is a relevant risk factor for lung cancer, even below concentrations established as safe by USEPA and WHO.
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P2.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 187)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment in the Real World - Support, Survivorship, Systems Research
- Presentations: 2
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.16-20 - Big Data and Survival Predictors in Lung Cancer Patients (ID 1943)
10:15 - 18:15 | Author(s): Mariano Provencio
- Abstract
Background
Lung cancer is the most common and fatal one (18% of all cancer deaths). Parameters which imply better survival are still unknown.
The objective of this project is to turn the large amount of data from each patient into exploitable information.
Method
Between 2008-2019, 935 non-small cell lung cancer patients from our hospital were enrolled in an observational study.
Unstructured data was obtained from the patient Electronic Health Records.
Politecnica University from Madrid made the information analysis using Big Data and machine learning techniques.
Result
A total of 251.730 documents have been analyzed from 935 patients, 54% in stage IV.
EGFR/ALK mutation was found in 9%, showing better OS than non-mutated (23.5 months vs 12 months, log-rank p=0.016). Survival curves are shown in figure 1.
In a multivariate analysis (table 1), independent predictors of mortality were male sex, squamous histology and PS status. Additionally, independent predictors of survival were receiving immunotherapy, surgery treatment or developing endocrine toxicities.
Conclusion
Big data is a very useful tool to exploit a large amount of lung cancer data, increasing knowledge about these disease and allowing the development of survival predictive models.
This work was supported by the EU H2020 programme, under grant agreement Nº 727658 (Project iASiS).
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P2.16-34 - Is Prophylactic Cranial Irradiation Useful in Real World? (Now Available) (ID 1398)
10:15 - 18:15 | Author(s): Mariano Provencio
- Abstract
Background
Small cell lung cancer (SCLC) is the most aggressive lung cancer subtype. Just one third of patients are diagnosed as limited stage (LS), in which the goal is to perform a radical treatment. However, the majority will develop metastasis, being in central nervous system (CNS) one of the most frequent. In patients with LS, after systemic treatment, prophylactic cranial irradiation (PCI) should be considered. Nevertheless, the effectiveness of PCI has been a controversial issue in terms of overall survival (OS).
Method
A cohort of 81 patients diagnosed of localized SCLC were retrospectively analyzed in our center over a 10-year period (January 2008-December 2017). Brain imagen was done before chemo-radiotherapy (CRT) and repeated before PCI. Baseline demographics characteristics and brain metastases rate incidence were described.
Result
From 81 patients, 48 received PCI and 33 did not. Complete baseline characteristics from both groups are shown in table 1. No differences were found in performance status at diagnosis between groups . From those who did not receive PCI, 8 (26%) had developed brain metastases after CRT and before PCI. Brain metastases incidence rate in PCI subgroup was 9/100 people per year vs 35/100 people per year in those who did not receive PCI, in whom 54.5% had brain or systemic progression before PCI planning. Progression free survival in both subgroups was 13.5 months and OS was 21.2 months.
Conclusion
In our series, PCI had a significant effect in decreasing brain metastases. This study also confirms the requirement of brain imaging to confirm lack of brain metastases after initial CRT and before PCI.
