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S. Novello
Moderator of
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ISS05 - Industry Supported Symposium: Orchestrating Progress for Patients with Squamous Cell Lung Cancer - Eli Lilly and Company (ID 439)
- Event: WCLC 2016
- Type: Industry Supported Symposium
- Track:
- Presentations: 4
- Moderators:S. Novello
- Coordinates: 12/05/2016, 07:30 - 08:30, Strauss 2
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ISS05.01 - Squamous Cell Lung Cancer – A Different Tune (ID 6859)
07:30 - 08:30 | Author(s): J.F. Vansteenkiste
- Abstract
Abstract not provided
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ISS05.02 - Hitting the Right Notes for Clinical Efficacy (ID 6860)
07:30 - 08:30 | Author(s): J. Gosney
- Abstract
Abstract not provided
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ISS05.03 - Fine Tuning Patient Outcomes by Selecting the Right Treatment, for the Right Patient, at the Right Time (ID 6861)
07:30 - 08:30 | Author(s): D.R. Gandara
- Abstract
Abstract not provided
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ISS05.04 - Harmonising Patients Understanding of their Diagnosis and Treatment Plan: Introducing the Squamous Cell Lung Cancer Patient Booklet (ID 6862)
07:30 - 08:30 | Author(s): S. Novello
- Abstract
Abstract not provided
Author of
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ISS05 - Industry Supported Symposium: Orchestrating Progress for Patients with Squamous Cell Lung Cancer - Eli Lilly and Company (ID 439)
- Event: WCLC 2016
- Type: Industry Supported Symposium
- Track:
- Presentations: 1
- Moderators:S. Novello
- Coordinates: 12/05/2016, 07:30 - 08:30, Strauss 2
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ISS05.04 - Harmonising Patients Understanding of their Diagnosis and Treatment Plan: Introducing the Squamous Cell Lung Cancer Patient Booklet (ID 6862)
07:30 - 08:30 | Author(s): S. Novello
- Abstract
Abstract not provided
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OA03 - Immunotherapy Checkpoint Inhibitors in Advanced NSCLC (ID 367)
- Event: WCLC 2016
- Type: Oral Session
- Track: Chemotherapy/Targeted Therapy/Immunotherapy
- Presentations: 1
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OA03.07 - KEYNOTE-010: Durable Clinical Benefit in Patients with Previously Treated, PD-L1-Expressing NSCLC Who Completed Pembrolizumab (ID 6769)
11:00 - 12:30 | Author(s): S. Novello
- Abstract
- Presentation
Background:
Checkpoint inhibitors such as the anti–PD-1 monoclonal antibody pembrolizumab have demonstrated antitumor activity and a manageable safety profile in several advanced malignancies. Although checkpoint inhibitors are rapidly becoming a standard-of-care therapy in multiple tumor types, the optimal treatment duration has not been established. We assessed outcomes in patients who completed the maximum 24 months of pembrolizumab in the phase 3 KEYNOTE-010 study (NCT01905657), in which pembrolizumab provided superior OS over docetaxel in patients with previously treated, PD-L1–expressing advanced NSCLC.
Methods:
1034 patients with advanced NSCLC that progressed after ≥2 cycles of platinum-based chemotherapy (and an appropriate therapy for targetable EGFR and ALK aberrations if present) and had a PD-L1 tumor proportion score ≥1% were randomized 1:1:1 to pembrolizumab 2 or 10 mg/kg Q3W or to docetaxel 75 mg/m[2] until disease progression, intolerable toxicity, or physician or patient decision; the maximum duration of pembrolizumab was 24 months of uninterrupted treatment or 35 cycles, whichever was later. Response was assessed per RECIST v1.1 by independent central review every 9 weeks. After completion of 24 months/35 cycles, patients continued to undergo imaging every 9 weeks; patients with subsequent disease progression were eligible for a second treatment course if they did not receive other anticancer therapy after stopping pembrolizumab.
Results:
In the overall population, median OS was longer (10.5 months for pembrolizumab Q2W, 13.4 months for pembrolizumab Q3W, and 8.6 months for docetaxel) and 24-month OS rates were higher (30.1%, 37.5%, and 14.5%, respectively) with pembrolizumab compared with docetaxel. Of the 691 patients allocated to pembrolizumab, 47 patients received 35 cycles of pembrolizumab and were included in this analysis. As of the September 30, 2016 data cutoff date, all patients had completed all 35 cycles of treatment, but one withdrew from the study treatment after completing 35 cycles. Best overall response (ORR) among these 47 patients was complete response (CR) in 3 (6%) patients and partial response (PR) in 39 (83%) patients, for an ORR of 89%; 5 (11%) patients experienced stable disease (SD). Two of these patients experienced disease progression since stopping pembrolizumab and two of these patients resumed pembrolizumab therapy. As of the cutoff date, none of the 47 patients had died.
Conclusion:
With long-term follow-up, the OS benefit has been maintained and pembrolizumab continues to demonstrate superiority over docetaxel. Pembrolizumab provides durable clinical benefit with few patients progressing after completing two years of therapy.
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OA04 - Epidemiology and Prevention of Lung Cancer (ID 370)
- Event: WCLC 2016
- Type: Oral Session
- Track: Epidemiology/Tobacco Control and Cessation/Prevention
- Presentations: 1
- Moderators:L. Petruželka, S. Shastri
- Coordinates: 12/05/2016, 11:00 - 12:30, Schubert 4
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OA04.07 - Clinical Characteristics of Lung Adenocarcinoma in the Young: Results from the Genomics of Young Lung Cancer Study (ID 5578)
11:00 - 12:30 | Author(s): S. Novello
- Abstract
- Presentation
Background:
Background: Lung cancer is increasingly recognized as a heterogeneous disease comprised of genomically defined subtypes with distinct targetable genomic alterations. However, it is unknown whether established lung cancer risk factors differ between these genomically distinct subtypes. In this study of the genomics of young lung cancer (GoYLC), we present preliminary results of lifestyle risk factors by specific genomic alteration to better characterize lung cancer in the young.
Methods:
Methods: Beginning in July of 2014, patients diagnosed with a bronchogenic lung cancer under the age of 40 were recruited to the GoYLC study. Informed consent was obtained in-person and virtually (online), allowing patients to participate globally, regardless of proximity to study sites (https://www.openmednet.org/site/alcmi-goyl). To date, this study has accrued a total of 101 cases, of which 85 are adenocarcinoma (AC). Stage 4 AC is the focus of this analysis.
Results:
Results: Among the 63 stage 4 AC cases, the most common genomic alterations were ALK rearrangements (n=28; 44% of stage 4 AC cases) and EGFR mutations (n=17; 27%) while the other genomic alterations (n=18; 29%) include ROS1, BRCA2, HER2, P53, RET and ATM. The prevalence of active smoking and/or exposure to passive smoking was highest among those with ALK (64%), intermediate for those with EGFR (47%) and lowest for those with other genomic alterations (39%). However, the prevalence of only active smoking was lowest among those with ALK (28%), followed by EGFR (35%) and highest for those with other genomic alterations (39%). The majority of patients with ALK rearrangements or EGFR mutations reported no family history of lung cancer (82% and 88%, respectively), compared with 67% among those with other genomic alterations.
Conclusion:
Conclusion: These preliminary results suggest that lifestyle characteristics and family history in young lung cancer patients may differ by genomic alteration. Passive smoke exposure was more prevalent among those with ALK rearrangements or EGFR mutations. Those with other genomic alterations, albeit, a heterogeneous group, were least likely to be exposed to passive smoking and more likely to be active smokers. We are continuing to enroll participants and are expanding the epidemiologic characterization to all study patients to evaluate if risk factors also differ by tumor stage and histology (Data to be presented). Importantly, this analysis lays the groundwork for the development of our more comprehensive epidemiology of young lung cancer study that may identify potential lifestyle and environmental risk factors related to specific genomic alterations.
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OA06 - Prognostic & Predictive Biomarkers (ID 452)
- Event: WCLC 2016
- Type: Oral Session
- Track: Biology/Pathology
- Presentations: 1
- Moderators:F. Shepherd, Y. Yatabe
- Coordinates: 12/05/2016, 14:20 - 15:50, Strauss 1
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OA06.06 - Druggable Alterations Involving Crucial Carcinogenesis Pathways Drive the Prognosis of Squamous Cell Lung Carcinoma (SqCLC) (ID 5342)
14:20 - 15:50 | Author(s): S. Novello
- Abstract
- Presentation
Background:
We previously built and validated a risk classification model for resected SqCLC by combining clinicopathological predictors to discriminate patients’ (pts) prognosis (Pilotto JTO 2015). Here we (AIRCMFAG project no. 14282) investigate the molecular portrait of prognostic outliers to identify differentially expressed, potentially druggable alterations.
Methods:
Based on the published 3-class model, 176 and 46 pts with good and bad prognosis, respectively, were identified. Somatic Mutations (SM) and Copy Number Alterations (CNA) were evaluated with Next Generation Sequencing (NGS) for 59 genes (Ion Proton system, Ion Ampliseq custom panel). Moreover, RNA expression assays, immunohistochemistry (IHC) and immunofluorescence (FISH) were performed. Descriptive statistic was adopted and continuous variables were dichotomized according to AUC or medians.
Results:
Herein, the analysis of 60 pts (good/poor 27/33) is reported. In the overall population, the median rate of SM (3.3%) is lower compared to the median rate of CNA (28.3%), without significant differences between the two prognostic groups. The most frequent SM resulted to be missense (66.7%) and nonsense (20.3%) mutations, whereas the copy number gain is the most common CNA (76.7%), The distribution of relevant alterations in the main carcinogenesis pathways in term of SM, CNA and expression (by RNA, IHC and FISH), according to the prognostic subgroups, are reported in the table.Pathway Gene [method] Good [%] Poor [%] p-value Squamous differentiation SOX [CNA] 74.1 51.5 0.11 TP63 [CNA] 37.0 21.2 0.25 Epithelial to mesenchymal transition SNAI1 [RNA] 59.2 90.9 0.006 Vimentin [RNA] 44.4 69.7 0.07 mTOR PI3KCA [SM] 0 9.0 0.24 RICTOR [CNA] 3.7 27.3 0.017 p-mTOR [IHC] 11.1 18.1 0.5 Tyrosine kinase receptors DDR2 [SM] 11.1 0 0.085 FSR2 [CNA] 3.7 18.1 0.12 MET [FISH] 11.1 24.2 0.32 FGFR3 [FISH] 25.9 42.4 0.28 Cell cycle regulators CDKN2A [CNA] 22.2 3.0 0.38 SMAD4 [CNA] 33.3 57.6 0.074 Immune checkpoints PD-L1 [IHC] 18.5 6.1 0.23 PD-1 [RNA] 51.8 93.9 <0.0001
Conclusion:
Although performed on a limited number of pts, such comprehensive analysis of DNA, RNA and proteins, using different methodologies, is feasible and allow identifying potentially druggable prognostic modulators, such as RICTOR/PI3K/mTOR signaling pathway. The possibility to inhibit this pathway with selective agents is currently under investigation in in vitro preclinical models.
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OA22 - Novel Trials and Biomarkers in Malignant Pleural Mesothelioma (ID 403)
- Event: WCLC 2016
- Type: Oral Session
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
- Moderators:H. Pass, N. Van Zandwijk
- Coordinates: 12/07/2016, 14:20 - 15:50, Strauss 3
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OA22.02 - Nintedanib plus Pemetrexed/Cisplatin in Patients with MPM: Phase II Findings from the Placebo-Controlled LUME-Meso Trial (ID 4191)
14:20 - 15:50 | Author(s): S. Novello
- Abstract
- Presentation
Background:
Standard first-line treatment for patients with unresectable malignant pleural mesothelioma (MPM) is pemetrexed/cisplatin, yielding a median overall survival (OS) of only ~1 year, thus new approaches are required. As demonstrated by the bevacizumab MAPS study, inhibition of the VEGF pathway is of interest as a treatment approach for MPM. Nintedanib is an oral, triple angiokinase inhibitor of VEGFR, PDGFR and FGFR. This study will evaluate the efficacy and safety of nintedanib plus pemetrexed/cisplatin in patients with advanced MPM.
Methods:
Patients with unresectable MPM (chemo-naïve, ECOG PS 0–1) were stratified by histology (epithelioid/biphasic) and randomised (1:1) to receive up to 6 cycles of pemetrexed (500 mg/m[2])/cisplatin (75 mg/m[2]) on Day 1 plus nintedanib (200 mg bid)/placebo on Days 2–21. Patients without disease progression received maintenance treatment with nintedanib/placebo. The primary endpoint was progression-free survival (PFS).
Results:
87 patients were randomised to receive pemetrexed/cisplatin, plus nintedanib/placebo. Patient characteristics were comparable between the groups. PFS was longer in the nintedanib vs the placebo arm, in both the overall study population and in epithelioid patients (Table 1). Preliminary OS data also favour nintedanib. All patients experienced at least one adverse event (AE, any grade), with 7% of patients in the nintedanib arm discontinuing due to AEs, vs 15% with placebo. Serious AEs occurred in 36% vs 42% of patients in the nintedanib and placebo arms, respectively. The most common ≥grade 3 AEs occurring in nintedanib vs placebo patients were neutropenia (34% vs 10%), ALT increase (14% vs 2%) and gamma glutamyltransferase increase (14% vs 0%).
Conclusion:
Nintedanib plus pemetrexed/cisplatin demonstrated clinical efficacy with improved PFS and a tolerable safety profile in patients with unresectable MPM. Based on these promising findings, this Phase II study was extended to a confirmatory Phase III trial, which is currently enrolling patients. Clinical trial identifier: NCT01907100.
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P1.05 - Poster Session with Presenters Present (ID 457)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Early Stage NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.05-050 - External Validation of a Prognostic Model for Squamous-Cell Lung Cancer and Impact of Adjuvant Treatment in >1,300 Patients (ID 5297)
14:30 - 15:45 | Author(s): S. Novello
- Abstract
Background:
A risk classification model able to powerfully discriminate the prognosis of resected squamous-cell lung cancer (R-SqCLC) patients (pts) was developed (Pilotto JTO 2015). Herein, we validate the model in a larger multicenter series of >1,300 R-SqCLC pts (AIRC project 14282).
Methods:
R-SqCLC pts in 6 different institutions (01/2002 - 12/2012) were considered eligible. Each patient was assigned with a prognostic score to identify the individual risk of recurrence, on the basis of the clinico-pathological data according to the develop model (age, T-descriptor according to TNM 7th edition, nodes, and grading). Kaplan-Meier analysis for disease-free/cancer-specific/overall survival (DFS/CSS/OS) was performed according to the published 3-class risk model (Low: score 0-2; Intermediate: score 3-4; High: score 5-6). Harrell’s C-statistics was adopted for model validation. The effect of adjuvant chemotherapy (ACT) was adjusted with the Propensity Score (PS).
Results:
Data from 1,375 pts from 6 institutions were gathered (median age: 68 years; male/female: 86.8%/13.2%; T-descriptor 1–2/3–4: 73.3%/26.7%; nodes 0/>0: 53.4%/46.6%; stages I-II/III-IV: 71.7%/28.3%); 384 pts (34.5%) underwent ACT. With a median follow-up of 55 months (95% CI 51-59), pts at Low-Risk had a significantly longer DFS in comparison with Intermediate- (HR 1.67, 95% CI 1.40-2.01) and High-Risk (HR 2.46, 95% CI 1.90-3.19) pts, as well as for CSS (HR 1.79, 95% CI 1.48-2.17; HR 2.33, 95% CI 1.76-3.07) and OS (HR 2.46, 95% CI 1.80-3.36; HR 4.30, 95% CI 2.92-6.33). C-statistics was 68.3 (95% CI 63.5-73.1), 68.0 (95% CI 63.2-72.9), and 66.0 (95% CI 61.6-71.1), for DFS, CSS and OS, respectively. 60-months DFS for Low-, Intermediate- and High-Risk pts was 51.0%, 33.5% and 25.8%, respectively (p<0.0001). 60-months CSS for Low-, Intermediate- and High-Risk pts was 82.7%, 64.7% and 53.3%, respectively (p<0.0001). 60-months OS for Low-, Intermediate- and High-Risk pts was 56.7%, 37.9% and 30.9%, respectively (p<0.0001). A significant benefit in DFS was found in favor of ACT (p=0.005), with no difference in CSS (p=0.57), although a trend in OS (p=0.16). Overall, no significant differences for ACT were found in DFS, CSS and OS when survival was corrected with PS analysis, although CSS and OS curves visually separate with a trend for ACT in Intermediate- and High-Risk pts.
Conclusion:
The prognostic performance of the previously developed model was validated in a larger R-SqCLC pts’ series. Considering the overall dismal prognosis of such disease, the efficacy of ACT requires to be clearly established for Intermediate- and High-Risk pts, as well as that should be questioned for Low-Risk pts.
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P1.06 - Poster Session with Presenters Present (ID 458)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.06-005 - An International Cohort of Patients with Small Cell Lung Cancer after a Non-Small Cell Lung Carcinoma Oncogene or Non-Oncogene Addicted (ID 4531)
14:30 - 15:45 | Author(s): S. Novello
- Abstract
Background:
Phenotypic transformation from Non-small cell lung cancer (NSCLC) to small cell lung cancer (SCLC) is a resistance mechanism in tyrosine kinase inhibitors (TKIs) treated EGFR mutant tumors. SCLC is also however less frequently diagnosed in patients without EGFR mutations treated with chemotherapy. These transformations are rare and little is known about the clinical and therapeutic characteristics of these patients. In this study we describe and compare the characteristics of SCLC arising from mutant or non mutant NSCLC.
Methods:
We performed a multicentric retrospective collection (27 centers in France and Italy) of cases. Between 2005 and 2015, patients with stage III or IV NSCLC with a secondary transformation to SCLC with histological proof were included.
Results:
Forty seven cases of SCLC transformation were collected, 34 in EGFR mutant and 13 in non. Most of the patients (n=37, 82%) were stage IV, (n=27, 57%) female and (n=26, 76%) had an exon 19 mutation. The last treatment before transformation was a TKI in 23 (68%) cases in the mutant group and in 3 (23%) patients (erlotinib) in the non-mutant. Median time to SCLC transformation was 17 [IQR, 11-29] months in the mutant group and 26 [IQR 23-36] months in the other (p=0.03). Molecular analyses were not performed in the non mutant group, 25 (74%) had molecular analyses in the EGFR mutant. A driver mutation was identified in 22/25 (88%) patients: in most of the cases the same as the initial, 1 case of ALK fusion and 1 of PI3K mutation. Thirty patients (88%) received at least one line of treatment after transformation in the mutant group, in all cases a platinum-etoposide (P-E) chemotherapy. Median survival from initial diagnosis in the EGFR mutant group was significantly worse 28 [17-41] months vs 49 [36-118] months in the non EGFR mutant group (p=0.01). After transformation, the same tendency was observed with a median survival of 8 [3-12] months for the EGFR mutated patients vs 13 [6-15] months for the non EGFR mutated patients (p=0.06).
Conclusion:
SCLC that occurs in EGFR mutant treated by TKIs is more aggressive than classic SCLC, and differs on epidemiological characteristics. These transformed SCLC are not fully explained and we need to define the molecular characteristics of this cohort, before and after transformation and if funded the whole genome sequencing of the tumors to understand this TKIs mechanism of resistant.
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P1.06-046 - Can We Better Manage Advanced NSCLC in the Elderly with the New Therapeutic Agents? Preliminary Analysis of a Real-Life Multicenter Study (ID 5814)
14:30 - 15:45 | Author(s): S. Novello
- Abstract
Background:
Systemic treatment of NSCLC has profoundly changed over the past years with novel therapeutic strategies recently implemented in clinical practice. Benefit of these novel agents in elderly patients (pts) is uncertain, given the paucity of prospective data in this population. Moreover, elderly pts are often undertreated, due to comorbidities and toxicity concerns. Therefore, we aimed to evaluate the access, safety and outcome with novel therapeutic agents in pts ≥ 70 years (yrs).
Methods:
We planned an observational study to retrospectively evaluate consecutive elderly patients (≥ 70 yrs) with metastatic NSCLC treated at 9 Italian Centers between January 2014 and December 2015. Data collected include clinical and pathological characteristics, treatment types, safety and outcome report.
Results:
220 patients with stage IV NSCLC were included in this preliminary analysis (53% IVa, 47% IVb). Median age was 74,5 (range 70-85) and 69% were male. 15% of pts aged 80 years or older. ECOG PS was 0, 1, 2 in 37%, 51% and 12% of pts, respectively. According to comprehensive geriatric assessment, 59% of pts were fit, 28% vulnerable and 13% frail. Histology was 23% squamous cell carcinoma, 72% non-squamous cell carcinoma and 5% NOS. EGFR mutation was diagnosed in 24% of cases; 1,4% and 1% of pts had ALK and ROS-1 translocations, respectively. 90% of pts received a systemic therapy: 48% a platinum doublet chemotherapy (CHT), 27% a mono-CHT, 25% an EGFR tyrosine kinase inhibitor (TKI). Only 1% of pts were treated with antiangiogenic drugs. Immunotherapy (IT) was administered in 16% of all treated pts. 7% of pts received only BSC. Second- and third-line treatment were given to 44% and 8% of pts, respectively. 51% of pts who received second line treatment and 60% of pts treated with a third line therapy had a novel therapeutic agent (II line TKI 20%, IT 31%; III line TKI 33%, IT 27%). 31% of pts were included in clinical trials. A dose reduction was reported in 41% of therapies and the discontinuation rate was 9%. Survival data are not mature at this time.
Conclusion:
Our data, albeit preliminary, suggest an evolution in the management of NSCLC in the elderly. The interesting activity and the good safety profile encourage the use of novel agents also in this setting of NSCLC. Adequate selection of elderly pts and personalized approach are still matters of debate. Use of adapted schedule and dose reduction could warrant a good compromise between safety and efficacy.
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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03a-017 - Chemotherapy-Induced Nausea and Vomiting (CINV) in Italian Lung Cancer Patients: Assessment by Physician, Nurse and Patient (ID 4903)
14:30 - 15:45 | Author(s): S. Novello
- Abstract
Background:
Despite therapeutic advances, CINV still represents a common side-effect of chemotherapy and often its perception is not equal between patients and healthcare professionals. Aims of this study were to evaluate the agreement degree among clinicians, patients and nurses about CINV and other relevant items, and to understand whether anxiety, as well as other demographical and treatment-related factors, could play a role in CINV development.
Methods:
A dedicated survey was designed in agreement with a psychologist: 11 aspects (anxiety, mood, weakness, appetite, nausea, vomiting, pain, somnolence, breath, general status, and trust in treatments) were investigated through Numerical Rating Scale in four consecutive evaluations (T0, T1, T2 and T3) during first-line chemotherapy. From August 2015 to February 2016, the survey was administered in 11 Oncologic Institutions to 188 stage III/IV lung cancer patients and to their oncologists and nurses. Clinician versus patient (CvP), nurse versus patient (NvP) and clinician versus nurse (CvN) agreements were estimated in relation with the investigated items, applying Weighted Cohen's kappa and the grid of Landis and Koch. A multivariate logistic model was applied to evaluate factors possibly influencing anticipatory CINV development as perceived by patients before initiating chemotherapy (T0). Generalized Equation Estimates (GEE) for repeated measures were used to evaluate factors possibly influencing CINV development overall at T1, T2 and T3.
Results:
The incidence of CINV as reported by patients varied from 40.3% at T0 to 71.3% at T3. Both CvP and NvP concordances on the investigated items were mainly moderate, slightly increasing over time and becoming substantial for some items, in particular when evaluating NvP concordances. Pre-chemotherapy anxiety in all its mild (Odds Ratio [OR]: 4.99; 95% Confidence Interval [CI]: 1.26 – 19.81), moderate (OR: 4.89; 95% CI: 1.29; 18.50) and severe (OR: 4.70; 95% CI: 1.10; 19.98) manifestations, as well as mild (OR: 10.02; 95% CI: 3.27; 30.64), moderate (OR: 11.23; 95% CI: 3.54; 35.67) and severe (OR: 12.86; 95% CI: 2.83; 58.48) anxiety experienced after chemotherapy start, exposed patients to a higher risk of anticipatory CINV and of acute/delayed CINV respectively, as confirmed by the multivariate logistic model at T0 and by GEE overtime.
Conclusion:
Even if clinical staff revealed to be aware and sensitive about patients status and perceptions, CINV still represents a problem among patients undergoing chemotherapy, with this study further confirming that particular attention should be given to anxiety due to its key role in CINV development.
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P2.03b - Poster Session with Presenters Present (ID 465)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03b-063 - Molecular Profiling in Advanced Non-Small-Cell Lung Cancer: Preliminary Data of an Italian Observational Prospective Study (ID 4529)
14:30 - 15:45 | Author(s): S. Novello
- Abstract
Background:
Molecular profiling of advanced non-small-cell lung cancer (NSCLC) is recommended according to patients’ histological and clinical features. Despite the existence of national guidelines, routine care is still heterogeneous. Aim of this observational study was to obtain prospectively a clinical practice picture of molecular testing and therapeutic choices in advanced NSCLC patients.
Methods:
Newly diagnosed metastatic or recurrent NSCLC patients enrolled in 38 Italian centres, from November 2014 to November 2015, have been included in the study. Baseline information were collected about molecular profiling performed and therapies.
Results:
A total of 1787 patients were enrolled (64% males, 36% females; median age 67 years-old; 22% never smokers, 31% current smokers, 47% former smokers; 75% adenocarcinoma, and 73% with PS ECOG 0 or 1). The 73.9% of diagnosis was histological, while 26.1% was cytological. 1382 (77%) patients were tested for one or more molecular analysis during the history of disease, for a total of 3532 molecular tests. Only 405 patients did not receive any molecular test. 32.3% of patients presented a genetic alteration: EGFR mutation was reported in 17.8% of cases (319/1787), ALK translocation in 8.8% (82/926), KRAS mutation in 31.9% (154/482), MET amplifications in 15.8% (10/63), BRAF mutations in 3.7% (9/241), ROS1 translocation in 4% (11/269), HER2 mutation in 3.3% (3/89) of cases and FGFR alteration was found in 3 cases (only 15 tested). Considering patients younger than 45 years, never smokers and females, an EGFR mutation was detected in 25.4%, 43.5% and 30.6%, respectively. While 15.6%, 9.5% and 6.3% were ALK rearranged, respectively. For patients receiving an EGFR tyrosine-kinase inhibitor as first-line treatment, among those whose data are evaluable (79.2%), the median interval from diagnosis to first-line was 35 days. EGFR mutated patients received first-line erlotinib, gefitinib and afatinib in 9.4%, 39.1% and 33.8% of cases, respectively. At time of analysis, ALK-rearranged patients received an ALK inhibitor (crizotinib, alectinib or ceritinib) as first and/or second-line in 71.9% of cases. 29.3% of all patients received a maintenance therapy, mainly with pemetrexed (91.2% of cases).
Conclusion:
Routine molecular assessing is properly performed according to the national guidelines. A selection bias in including only those patients performing molecular tests, may explain the high proportion of patients with a molecular alteration. The low number of patients tested for ALK could be partially related to the impossibility to prescribe Crizotinib in first- line. In more than 70% of cases EGFR mutated patients received gefitinib or afatinib as first-line treatment.
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P2.06 - Poster Session with Presenters Present (ID 467)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.06-027 - Randomized Phase II Study of Anetumab Ravtansine or Vinorelbine in Patients with Metastatic Pleural Mesothelioma (ID 5671)
14:30 - 15:45 | Author(s): S. Novello
- Abstract
Background:
Mesothelioma is a rare but aggressive cancer with a poor prognosis. Mesothelin is a cell surface protein that is highly expressed in mesothelioma and other epithelial cancers. Anetumab ravtansine (BAY 94-9343), a novel fully human anti-mesothelin IgG1 antibody conjugated to the maytansinoid tubulin inhibitor DM4, has shown encouraging efficacy in mesothelioma patients in a phase I study. To further explore the possible benefit of antibody-drug conjugate therapy for mesothelioma, we initiated a randomized, open-label, active-controlled, phase II trial to evaluate the efficacy and safety of anetumab ravtansine in patients with metastatic pleural mesothelioma (MPM) overexpressing mesothelin and who have previously progressed on platinum/pemetrexed-based first-line chemotherapy (NCT02610140).
Methods:
Patients (≥18 years) with unresectable locally advanced or metastatic MPM are eligible. Patients should have recurrent or relapsing disease after having previously receiving first-line treatment with pemetrexed-based chemotherapy, with or without bevacizumab. Obligatory biomarker sampling will be performed on all patients at pre-screening and mesothelin-positivity as determined by Ventana MSLN (SP74) companion diagnostic assay as a requirement for entry. The primary objective is to test the superiority of anetumab ravtansine monotherapy over vinorelbine in progression-free survival (PFS) per modified RECIST criteria for MPM per central review. The secondary objectives of this study include overall survival, patient-reported outcomes (PRO), tumor response, and safety. Exploratory objectives include immunogenicity of anetumab ravtansine, pharmacokinetics, and biomarkers of response. Approximately 210 patients will be randomized in a 2:1 ratio to receive anetumab ravtansine 6.5 mg/kg Q3W or vinorelbine 30 mg/m[2] QW. Novel study methods include a grading system for AEs of special interest and the PRO instruments.
Results:
This trial is open and currently accruing patients globally.
Conclusion:
Section not applicable.
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02b-009 - Plasma and Tissue Inflammatory and Angiogenic Biomarkers to Explore Resistance to EGFR-TKIs and Association with VeriStrat Status (ID 5750)
14:30 - 15:45 | Author(s): S. Novello
- Abstract
Background:
VeriStrat is a proteomic test validated to be prognostic and predictive of overall survival (OS) to EGFR Tyrosine Kinase Inhibitors (TKIs) in EGFR wild type patients[1]. Serum Amyloid A1 (SAA1) and its two truncated forms are responsible for 4 of the 8 peaks overexpressed in Veristrat (VS) Poor classified patients. The aim of the study was to explore if the microenvironment, with its complex network mediated by inflammation and angiogenesis could represent the base of the aggressive disease behavior of VS Poor subjects. Moreover, the activity of the immune escape axis PD-1/PD-L1 was explored.
Methods:
Plasma biomarkers analyses were retrospectively performed on plasma baseline samples of 244 patients enrolled in the PROSE trial[1], while exploratory tissue analysis was performed on 37 available histological specimens. Circulating levels of HGF, VEGF, FGF, Cromogranin A (CgA) and its pro- and anti-angiogenic fragments (fragment 1-373 and 1-76, respectively) were determined by an ELISA assay. PD-L1 expression both on tumor cells and inflammatory elements of the tumor microenvironment, and the tissue expression (T) of HGF and its receptor c-MET were measured by immunohistochemistry.
Results:
CgA, HGF, VEGF, and FGF plasma levels were statistically significantly higher in VS Poor subjects. High plasma HGF levels were associated with lower PFS (3.4 versus 2.0 months, HR 1.67; 95% CI 1.25-2.23; p<0.001) and OS (11.2 versus 6.4 months, HR 1.64; 95% CI 1.12-2.23 p=0.002). High PD-L1- tumor expression was associated with worse PFS (5.9 versus 1.9 months, HR 2.28; 95% C.I. 1.14-4.57; p<0.020) and a trend for lower OS (14.6 versus 6.7 months, HR 1.47; 95% CI 0.85-2.53; p=0.165), but not significantly associated with VS status (p=0.656). At the multivariate analysis, CgA, HGF and VEGF were independently associated with VS Poor status. When clinical variables were also included (histology and PS), multivariate analysis evidenced VEGF as the only independent biomarker associated with the VS Poor classification (p=0.0013). Plasma HGF levels (HR 2.083; 95% C.I. 1.306-3.321; p=0.0021) and tumor PD-L1 expression (HR 2.579; 95% CI 1.036-6.421; p=0.0417) remained independent prognostic biomarkers for shorter PFS.
Conclusion:
Inflammation and angiogenesis appear to be associated with the complex processes at the base of the Veristrat signature. Plasma HGF levels and tumor tissue PD-L1 are prognostic in terms of a worse PFS, but VeriStrat remains the only highly reproducible clinically relevant biomarker associated with OS. [1]V Gregorc et al, The Lancet Oncology, p713, 15(7),2014.
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P3.02b-080 - Analysis of Patient-Reported Symptom Response with Osimertinib (AZD9291) Treatment for Advanced Non-Small-Cell Lung Cancer (ID 4592)
14:30 - 15:45 | Author(s): S. Novello
- Abstract
Background:
We evaluated whether self-reported symptoms significantly improved in advanced non-small-cell lung cancer patients receiving osimertinib 80mg once-daily and the effect of adjusting by objective tumour response status (OTRS).
Methods:
In phase II trials (AURA extension, N=201, NCT01802632 and AURA2, N=210, NCT02094261) patients completed the European Organisation for Research and Treatment of Cancer QLQ-LC13. In AURA extension paper-based questionnaires were used every 6 weeks until treatment discontinuation; in AURA2 data were collected electronically weekly for 6 weeks, then every 3 weeks until death. Statistical analyses determined the change from baseline in selected symptoms overall/by OTRS. Least squares means (95% CIs) were calculated using linear mixed models for repeated measures.
Results:
Tables show the change in some symptoms overall/by OTRS. Table 1. Symptom change overall/by OTRS (AURA extension).
NR, non-responder; R, responder; w, weeks Table 2. Symptom change overall/by OTRS (AURA2).Least squares mean symptom scores (95% CI) 6w 12w 18w 24w Cough Total -13.76 (-16.27,-11.26) -11.56 (-14.46,-8.67) -12.12 (-15.12,-9.12) -8.65 (-11.88,-5.42) NR -12.74 (-16.97,-8.51) -8.24 (-13.22,-3.27) -8.06 (-13.58,-2.54) -10.47 (-16.91,-4.04) R -13.73 (-16.84,-10.62) -12.63 (-16.19,-9.08) -13.65 (-17.27,-10.02) -7.81 (-11.59,-4.04) Dyspnoea Total -8.14 (-10.08,-6.21) -8.87 (-10.75,-7.00) -8.40 (-10.25,-6.56) -5.95 (-8.06,-3.83) NR -7.33 (-10.63,-4.03) -6.10 (-9.32,-2.88) -7.06 (-10.47,-3.64) -3.39 (-7.58,0.80) R -8.58 (-10.99,-6.16) -10.27 (-12.56,-7.98) -8.89 (-11.10,-6.67) -6.91 (-9.40,-4.42) Chest pain Total -10.36 (-12.63,-8.09) -8.56 (-11.17,-5.95) -9.76 (-11.99,-7.53) -9.21(-11.79,-6.63) NR -10.45 (-14.33,-6.57) -7.12 (-11.65,-2.58) -7.81 (-12.02,-3.61) -3.81 (-9.02,1.39) R -10.56 (-13.41,-7.71) -9.46 (-12.70,-6.22) -10.76 (-13.46,-8.06) -11.15 (-14.16,-8.13)
NR, non-responder; R, responder; w, weeksLeast squares mean symptom scores (95% CI) 6w 12w 18w 24w Cough Total -11.52 (-14.51,-8.53) -10.55 (-13.63,-7.48) -12.06 (-15.22,-8.89) -10.91 (-14.19,-7.63) NR -7.33 (-13.25,-1.42) -3.89 (-10.22,2.45) -1.36 (-8.21,5.50) -1.39 (-9.03,6.26) R 13.61 (-17.13,-10.08) -12.98 (-16.58,-9.39) -14.97 (-18.61,-11.32) -12.78 (-16.51,-9.05) Dyspnoea Total -3.99 (-6.18,-1.80) -5.31 (-7.55,-3.07) -4.73 (-7.03,-2.44) -4.23 (-6.60,-1.87) NR 1.35 (-2.94,5.65) 2.55 (-1.99,7.10) -0.37 (-5.23,4.49) -2.29 (-7.65,3.08) R -5.56 (-8.14,-2.98) -7.52 (-10.14,-4.90) -5.85 (-8.50,-3.20) -4.89 (-7.59,-2.18) Chest pain Total -8.12 (-10.64,-5.60) -7.55 (-10.13,-4.98) -5.97 (-8.61,-3.34) -4.82 (-7.55,-2.10) NR -3.27 (-8.12,1.59) 0.09 (-5.06,5.23) 4.13 (-1.39,9.65) 5.29 (-0.84,11.42) R 9.68 (-12.59,-6.78) -9.91 (-12.87,-6.95) -8.29 (-11.29,-5.30) -7.55 (-10.60,-4.49)
Conclusion:
Overall, a significant reduction in symptoms was observed for 6 months with osimertinib treatment, with improvement observed as early as 6 weeks. Patients with OTRS had greater symptom improvement, although this was more apparent in AURA2 than in AURA extension over time. This difference may be explained by symptom collection post-progression in the later trial, AURA2.
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P3.06 - Poster Session with Presenters Present (ID 492)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Trial Design/Statistics
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.06-008 - Employing Remote Web Consenting and Social Media to Facilitate Enrollment to an International Trial on Young Lung Cancer (ID 4180)
14:30 - 15:45 | Author(s): S. Novello
- Abstract
Background:
In 2014, the Addario Lung Cancer Medical Institute (ALCMI) launched a prospective study to characterize somatic and germline genomics of adolescents and young adult (AYA) patients under the hypothesis that lung cancer diagnosis at younger ages (<40) are more likely to have targetable genomic alterations. It is estimated that less than 2% of those newly diagnosed with lung cancer globally are AYA, thus presenting a striking recruitment challenge.
Methods:
The study workflow includes a dedicated website enabling e-consenting so patients can participate remotely from anywhere in the world, including the underserved, and employs social media to share our trial. We have an integrated data and bio repository that allows for seamless communication and completion of study activities including routing of blood and tumor specimens. ALCMI's "sister" foundation, the Bonnie J. Addario Lung Cancer Foundation, played a key role in educating patient and caregiver communities, including a social media campaign.
Results:
Accrual opened July 23, 2014. In the first 5 weeks of the study, 37 subjects consented versus the 5 projected. Of the 37 initially consented, 35 enrolled via the remote web-portal. As of June 15 2016, 104 subjects are enrolled (128 consented) in the study from 10 countries following a social media campaign of 89 discrete postings resulting in 21,062 active users out of 391,222 individual viewers and 675,680 impressions. Of the 104 subjects enrolled to date, 49% entered the study via the remote study portal with the balance recruited locally by participating ALCMI study sites. 45% of total accruals to date resulted from the education outreach by patient advocacy and patient to patient social networking.Figure 1
Conclusion:
This study clearly demonstrates the utility, speed and feasibility of remote, web-based screening and consenting platforms supported by patient-centric, advocate-driven social media efforts as novel approaches to "bringing research to the patient" for global clinical trials.
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SC10 - Squamous Cell NSCLC (ID 334)
- Event: WCLC 2016
- Type: Science Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:D.R. Gandara, M. Sebastian
- Coordinates: 12/05/2016, 16:00 - 17:30, Strauss 3
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SC10.04 - Second-Line Therapy and Beyond in Squamous Cell NSCLC (ID 6640)
16:00 - 17:30 | Author(s): S. Novello
- Abstract
- Presentation
Abstract:
Lung cancer is the leading cause of cancer-related mortality worldwide with 1.59 million deaths in 2012 and, with an estimated 1.8 million new lung cancer cases, it accounts for about 13% of total cancer diagnoses[1]. Non-small cell lung cancer (NSCLC) represents around 85% of all lung cancers with the majority of patients in advanced stages of the disease when diagnosed. Squamous cell carcinoma (SqCC) is the second most common histology in NSCLC accounting for 20-30% of cases[2]. Compared to the most frequent advanced lung adenocarcinoma, for which targeted therapies are available in case of presence of actionable mutations, treatment options for advanced lung SqCC have not changed with the same vividness in the last decade. But, to date, we can definitely say that also for these patients, the research has made progresses and new therapeutic scenarios are now open. Docetaxel and erlotinib were the only standard second-line treatment options for lung SqCC until, in December, 2014, the US Food and Drug Administration (FDA) approved ramucirumab (an anti-VEGFR-2 antibody) in combination with docetaxel, for the treatment of metastatic NSCLC patients who progressed during or after a platinum-based chemotherapy. In March 2015 nivolumab (an immune-checkpoint-inhibitor) was approved, for treatment of patients with metastatic SqCC, who progressed during or after a platinum-based chemotherapy and pembrolizumab (another immune-checkpoint-inhibitor) was approved in October, in the same setting of patients but whose tumors expressed PD-L1 (evaluated with the approved specific companion diagnostic, the PD-L1 IHC-22C3 pharmDx test). Finally, in April 2016, afatinib (an EGFR tyrosine-kinase inhibitor) was approved for treatment of patients with metastatic SqCC progressing after a platinum-based chemotherapy[3][,[4],[5],[6]]. It has been suggested that SqCC patients treated with docetaxel had a poorer survival compared to non-SqCC patients hypothesizing that docetaxel may be less effective in squamous compared with non-squamous lung cancer[7]. This was also evidenced in the phase III study (REVEL), in which squamous and non-squamous NSCLC patients were treated with docetaxel with or without ramucirumab: an OS benefit was seen with ramucirumab-docetaxel in the whole population (10.5 vs 9.1 months, HR 0.86, 95% CI 0.75–0.98, p = 0.023). In those patients who presented squamous cell histology (25%) the OS benefit, when treated with ramucirumab-docetaxel, was 9.5 months (4.4–17.6) vs 8.2 months (3.6–14.9, HR: 0.88, 95% CI 0.69–1.13) in placebo-docetaxel subgroup, while in those with non-squamous disease a better OS was described (11.1 months, Interquartile Range, IQR 5.3–24.3) in the ramucirumab-docetaxel group, vs 9.7 months (4.4–19.6) in the control group (HR 0.83, 95% CI 0.71–0.97), however it needs to be noted that subgroup analyses in this study were not pre-planned[4]. In LUX-Lung 8, a phase III study of second-line afatinib vs erlotinib, which enrolled squamous patients only, OS was 7.9 vs 6.8 months (HR 0.81, 95% CI 0.69–0.95, p = 0.007), in the afatinib subgroup vs erlotinib one[7]. Survival benefits highlighted in these studies when compared to older studies with docetaxel, while statistically significant, evidenced modest developments in the treatment of advanced-stage SqCC, as a consequence, novel therapeutic approaches have been considered and well accepted in the oncology community as well as largely awaited. Research on tumor immunosurveillance led to the development of PD-1 immune-checkpoint-inhibitors, such as nivolumab and pembrolizumab, and the PD-L1 inhibitors atezolizumab (MPDL3280A), durvalumab (MEDI4736) and avelumab (MSB0010718C)[8]. Nivolumab produced response rates equal to 15 to 17% with a median OS of 8.2 to 9.2 months, in phase I and II trials, among previously treated patients with advanced SqCC[5]. Then in the phase III CheckMate 017, Nivolumab induced a median OS of 9.2 months (95% CI, 7.3-13.3) vs 6 months (95% CI, 5.1-7.3) with docetaxel. The results in the docetaxel group were worst than expected. The risk of death was 41% lower with nivolumab than with docetaxel (HR, 0.59; 95% CI, 0.44-0.79; p < 0.001)[5]. PD-L1 expression is largely debated and its specific influence in the squamous population still needs further elucidations, since a total of 83% of the patients who underwent randomization (225 of 272 patients) in this trial had quantifiable PD-L1 expression and PD-L1 was assessed on archival tumor tissue, which may not have reflected its real status at the time of treatment[5]. SqCC is considered the tumor with the second highest amount of molecular aberrations, (eg, FGFR1 amplification, PIK3K3 abnormalities, DDR2 mutations), providing a plausible explanation about heterogeneity of treatment responses and efficacy results in the second-line setting[9]. However, despite the identification of those specific molecular alterations, progress in targeting oncogenic drivers in SqCC still runs behind adenocarcinoma. There is a need to develop predictive and specific molecular biomarkers, that might identify subgroups of patients with lung SqCC that are most likely to benefit from targeted treatments or immunotherapic approaches. In this context Pilotto et al. elaborated a project with the aim to evaluate the molecular profile of resected SqCC in order to identify those immunologic pathways and molecular aberrations potentially able to estimate the probability of disease recurrence (prognostic factors) and to characterize novel biomarkers, whose targeting with specific drugs could potentially limit the oncogenic potential and change the natural history of this disease (predictive factors). Preliminary results of this study were consistent with literature data: several molecular alterations might be identified [PIK3CA, MET, FGFR3, DDR2, FRS2, CDKN2A, SMAD4, PD-L1] and some of them might impact on the biological behavior of SqCC contributing in the determination of patients prognosis[10]. These data will be further presented at WCLC this year. In conclusion, as more treatment options turn out to be available for patients, it will become essential to tailor those choices on patient’s unique molecular characteristics and his own needs, identifying the best sequence of treatments, especially in the era of rising healthcare costs and longer lifespan of advanced lung cancer patients. References [1] WHO Statistics. http://www.who.int/mediacentre/factsheets/fs297/en/ [Accessed on 21 August , 2016]. [2] Travis WD. Pathology of lung cancer. Clin Chest Med 2011; 32: 669–92. [3] Garon EB et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet 2014; 384: 665–73. [4] Brahmer J et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med 2015; 373(2):123-35. [5] FDA approves Keytruda for advanced non-small cell lung cancer. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465444.htm [Accessed on 21 August , 2016]. [6] Soria JC et al. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial Lancet Oncol 2015; 16: 897–907. [7] LE Ang Y et al. Profile of nivolumab in the treatment of metastatic squamous non-small-cell lung cancer. OncoTargets and Therapy 2016:9 3187–3195. [8] Melosky B et al. Pointed Progress in Second-Line Advanced Non–Small-Cell Lung Cancer: The Rapidly Evolving Field of Checkpoint Inhibition. J Clin Oncol 2016;34:1676-1688. [9] The Cancer Genome Atlas Research Network. Comprehensive genomic characterization of squamous cell lung cancers. Nature 2012; 489(7417): 519–525. [10] S. Pilotto et al. Analyzing prognostic outliers to unravel biologically and clinically relevant molecular and immunologic pathways: a model from resected squamous cell lung carcinoma (R-SQCLC). Poster presented at 58 Annual Meeting of the Italian Cancer Society helded in Verona on 5-8 September 2016.
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