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Romain Corre
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MA05 - Update on Clinical Trials and Treatments (ID 123)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Mesothelioma
- Presentations: 1
- Now Available
- Moderators:Seiki Hasegawa, Enrico Ruffini, Angel Artal
- Coordinates: 9/08/2019, 13:30 - 15:00, Melbourne (1991)
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MA05.05 - Post-Discontinuation Treatments in IFCT-GFPC-0701 MAPS Trial: Real-World Effectiveness of 2nd-Line (2L) Treatments for Mesothelioma (Now Available) (ID 815)
13:30 - 15:00 | Author(s): Romain Corre
- Abstract
- Presentation
Background
MAPS phase 3 trial assessing the addition of bevacizumab to pemetrexed-cisplatin doublet set a new standard of care in malignant pleural mesothelioma (MPM) patients, showing 18.8 months median overall survival (OS) with triplet combo. While both arms were well balanced in terms of 2L treatments, the size of the OS benefit from second-line treatments remains controversial.
Method
Long-term survival data were collected in the 342 MAPS patients alive at the end of the first-line (1L) treatments, in both arms. Median OS and 2-year survivals were calculated from the initiation of 2L. Multivariate analysis using Cox model included the stratification variables of the MAPS trial, along with the treatment arm (with or without bevacizumab).
Result
342/442(77.4%) patients received 2L treatment for disease progression after MAPS trial, of which 324 received chemotherapy (CT), 18 palliative radiotherapy (RT), while 100/442 (22.6%) remained untreated. 160/342 patients (46.8%) had a platinum-based doublet CT. 163 patients (47.7%) received a single-drug CT. 172/324 (53.1%) received a pemetrexed-containing regimen (alone or with platinum), 84 (25.9%) a gemcitabine-based CT, 16 (4.9%) vinorelbin alone, 48 (14.8%) gemcitabine alone, while in 12 (3.7%) single-agent bevacizumab was resumed. Median age was lower in patients with doublet CT (64.4 years, IQR 60.2-68.9) vs. single-drug CT patients (66.3 years, IQR 61.5-70.3), patients receiving RT (68.5 years, IQR 63.3-70.5) or untreated patients (67.8 years, IQR 63.4-71) (p=0.007). There were more PS=2 patients (10%) in the untreated group, compared with 0.6%, 1.8% and 5.6% in those receiving doublet, monotherapy or radiotherapy, respectively (p<0.001). A lower proportion of patients receiving 2L doublet CT had sarcomatoid/biphasic MPM (11.2%) compared with 21.5%, 38.9% and 25% in those with single-arm agent, RT or untreated, respectively (p=0.002). When compared with those treated with 2L single-agent, patients with 2L doublet had more frequently objective response (11.9 vs. 3.1%, p=0.005) and disease control (60.3 vs. 34.6%, p<0.0001). From the date of 2L therapy initiation, median OS was 3.2 months, 95%CI [1.7-5.0] for RT vs. 7.0 months 95%CI[5.6-7.8] for single-agent CT, or 12.2 months 95%CI [9.5-14.1] for doublet CT. HRs were adjusted for 1L treatment type (bevacizumab-containing or not), PS, smoking, and histology. Adj.HR (single-agent vs. doublet) was 1.21, 95% CI(0.96-1.53), p=0.11. Adj.HR (monotherapy vs. RT) was 0.39, 95%CI[0.24-0.65], p=0.0003. Adj.HR (combination CT vs. RT) was 0.32 95%CI[0.19-0.54], p<0.0001. 1-year OS was 11.8%, 95%CI [0.0-27.1], 48.7%, 95%CI [39.9-57.5], and 32.9%, 95%CI [25.1-40.6], in patients with RT alone, single agent CT or combination CT, while 2-year OS was 0%, 14.2%, and 20.0% respectively.
Conclusion
Second-line monotherapy only gave a 7-months median OS in MPM patients, comparing unfavorably to 11.9 and 15.9-months median OS with 2nd/3rd-line nivolumab or nivolumab+ipilimumab respectively, in the IFCT-1501 MAPS-2 randomized phase 2 trial. Conversely, 2L platinum-based chemo, in younger fit patients, still gave a 12.2-months median OS, not statistically different from monotherapy in the multivariate analysis, as a consequence of PS influence, although clinically meaningful. Based on these results, immunotherapy might be preferred for 2L/3L MPM patients, while monotherapy CT shows limited survival benefit.
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MA07 - Clinical Questions and Potential Blood Markers for Immunotherapy (ID 125)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Immuno-oncology
- Presentations: 1
- Now Available
- Moderators:David R Spigel, Roberto Ferrara
- Coordinates: 9/08/2019, 13:30 - 15:00, Vancouver (2003)
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MA07.06 - Immunotherapy Re-Challenge After Nivolumab Treatment in Advanced Non-Small Cell Lung Cancer in French Real-World Setting (Now Available) (ID 1281)
13:30 - 15:00 | Author(s): Romain Corre
- Abstract
- Presentation
Background
Real‐world evidence of nivolumab as treatment for advanced non-small cell lung cancer (aNSCLC) can complement evidence from clinical trials to optimize routine usage and personalization of care. Further, little is known about treatment options and outcomes after discontinuation of nivolumab.
Method
Based on the National hospitals database (PMSI), we built a retrospective cohort of all NSCLC patients (ICD code: C34*) starting nivolumab in 2015-2016 and followed them until Dec 2017. Information on patients’ baseline characteristics (demographics, comorbidities, treatment history) was retrieved. Nivolumab treatment was considered discontinued if ≥3 infusions were missed. Time to treatment discontinuation (TTD) and overall survival (OS) were estimated with Kaplan-Meier methodology. Re-challenged patients were analyzed according to their first nivolumab treatment duration i.e. <3; 3-6; ≥6 months.
Result
We identified 10,452 NSCLC patients initiating nivolumab during the inclusion period (male: 71%; mean age; 63.8±9.6 years; squamous histology: 44%; cerebral metastasis: 17.4%; median aNSCLC history: 12.5 months; previous curative surgery: 15.6%; median time since first chemotherapy: 10.5 months; mean dose of nivolumab: 213±54mg). Median TTD and OS were 2.8 months and 11.6 months. One-year and 2-year OS rates were 48.8% and 27.4%. Overall, 5118 (53.4%) patients received subsequent systemic therapy after nivolumab discontinuation. Among them, 1517 patients (29.6%) were re-treated with anti-PD1 agents (nivolumab: 98.8%) either after a therapeutic break (‘immunotherapy resumption group’: n=1127; mTTD: 4.1 months; mOS: 14.9 months from second initiation) or after chemotherapy (‘immunotherapy re-challenge group’: n=390; mTTD: 3.0 months; mOS: 18.2 months from second initiation). The Figure presents OS curves of the ‘re-challenge group’ according to first nivolumab treatment duration.
Conclusion
After nivolumab discontinuation, around 30% of patients received immunotherapy again, either as a resumption or as a re-challenge following non-immunotherapy treatment. The influence of the first nivolumab treatment duration on re-challenged patients' OS should be further investigated.
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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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P2.04-03 - Nivolumab Outcomes in Octogenarian Patients with Advanced Non-Small Cell Lung Cancer in French Real-World Setting (ID 1974)
10:15 - 18:15 | Author(s): Romain Corre
- Abstract
Background
Around 10% of patients newly diagnosed non-small cell lung cancer (NSCLC) in France are octogenarian. Knowledge about nivolumab outcomes in such specific population is still limited and real-world data represent a valuable source of information. The aim of this study was to examine use and outcomes of nivolumab in elderly patients aged ≥80 years.
Method
Based on the National hospitals database (PMSI), we built a retrospective cohort of all NSCLC patients (ICD code: C34*) initiating nivolumab in 2015-2016 in second- or later-line setting and followed them until Dec 2017. Information on patients’ baseline characteristics (demographics, comorbidities, treatment history) was retrieved for elderly (≥80 years) and non-elderly (<80 years), and time to treatment discontinuation (TTD) with nivolumab and overall survival (OS) were estimated with Kaplan-Meier methodology.
Result
Among 10,452 NSCLC patients initiating nivolumab during the inclusion period, 514 (4.9%) were 80 years or over. Mean age at baseline was 82.5 years (±2.4) in elderly and 62.8 years (±8.8) in non-elderly. Compared to non-elderly, patients were more frequently men in elderly group (p<0.001) and had more frequently prevalent hypertension and diabetes (p<0.001). Cerebral metastasis, renal failure, COPD, pulmonary insufficiency and other pulmonary chronic diseases were statistically less frequent in the elderly group (p<0.001). TTD curves showed identical median of treatment duration between both groups (2.8 months). Median OS were found similar between elderly and non-elderly patients (11.5 vs 11.6 months) and, long-term survivals were also comparable with 1-year and 2-year OS rates. Characteristics and outcomes are presented in the table.
ConclusionCharacteristics and outcomes < 80 years
(N=9938)≥ 80 years
(N=514)p-value Demographics Gender – Male 7019 (70.6%) 401 (78%) < 0.001 Mean age (±SD) 62.8 y (±8.8) 82.5 y (±2.4) < 0.001 Median age (Q1-Q3) 64 y (57-69) 82 y (81-84) < 0.001 Comorbidities Hypertension 1844 (18.6%) 142 (27.6%) < 0.001 Diabetes 871 (8.8%) 63 (12.3%) < 0.001 Renal failure 460 (4.6 %) 19 (3.7%) < 0.001 Chronic obstructive pulmonary disease 1298 (13.1%) 50 (9.7%) < 0.001 Pulmonary insufficiency 149 (1.5%) 4 (0.8%) < 0.001 Other chronic pulmonary diseases 870 (8.8%) 33 (6.4%) < 0.001 Cerebral metastasis 1771 (17.8%) 29 (5.6%) < 0.001 Lung cancer management care Diagnosis to nivolumab initiation - Median (Q1–Q3) 12.4 mo (6.7–24.0) 14.2 mo (7.9–29.9) 0.002 Nivolumab TTD - Median (Q1–Q3) 2.8 mo (1.4–6.7) 2.8 mo (1.5–6.5) N.S. Nivolumab discontinuation 9120 (91.8%) 473 (92.0%) N.S. Subsequent systemic treatment 4908 (53.8%) 210 (44.4%) < 0.001 Overall survival (OS) Median OS (Q1 –Q3) 11.6 mo (4.1-26.2) 11.5 mo (5.0-25.2) N.S. 1-year OS rate 48.8% 47.5% N.S. 2-year OS rate 27.3% 25.8% N.S. N.S.: non significant ; TTD: time to discontinuation
A small percentage of patients initiating nivolumab during the study period were aged 80 years or over (<5%). Elderly profile suggests a cautious selection by clinicians, which may also explain similar outcomes than ones in the non-elderly population.
