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M.D. Danese
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P1.01 - Advanced NSCLC (ID 757)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.01-051 - Nivolumab Versus Chemotherapy as Post-Platinum Therapy for Advanced Non-Small Cell Lung Cancer in a Real-world Setting (ID 8483)
09:30 - 16:00 | Author(s): M.D. Danese
- Abstract
Background:
Nivolumab, an immune checkpoint inhibitor, is approved for advanced non-small cell lung cancer (NSCLC) after platinum-based chemotherapy, based on results of 2 pivotal studies (CheckMate 017 and 057). This prospective observational study (CA209-118) compared outcomes with nivolumab versus chemotherapy as post-platinum therapy for NSCLC in a real-world community setting.
Method:
This analysis, as of May 16, 2017, included patients with advanced NSCLC who completed an initial course of platinum-based chemotherapy and started subsequent treatment prior to November 16, 2016, with a minimum of 6 months of potential follow-up. Patients receiving experimental therapy, immunotherapy other than nivolumab, or tyrosine kinase inhibitors for EGFR/ALK-mutated NSCLC were excluded. Patients in this non-randomized study were grouped by receipt of nivolumab or chemotherapy as first post-platinum therapy and followed until death, study discontinuation, or initiation of subsequent immunotherapy. Unadjusted and adjusted survival analyses were conducted. For adjusted analysis, multivariate regression was performed that included age, ECOG performance status score, time since stage IV diagnosis, smoking status, and squamous histology as covariates.
Result:
Of 383 eligible patients, 161 received post-platinum nivolumab and 222 received post-platinum chemotherapy, including 158 who received a regimen recommended by the National Comprehensive Cancer Network (docetaxel, pemetrexed, gemcitabine, ramucirumab + docetaxel, or erlotinib) and 40 who received a second platinum-based regimen. Baseline characteristics were well balanced between treatment groups, except that the percentage of men was higher in the nivolumab versus chemotherapy group (59% vs 49%). Mean age was 66 years, and 79% of patients had non-squamous histology. In all, 65% of patients in the nivolumab group and 69% in the chemotherapy group started post-initial platinum therapy ≤1 year after stage IV diagnosis. Median survival from the start of post-initial platinum therapy was 11.5 months (95% confidence interval [CI]: 7.9, not reached) in the nivolumab group and 8.3 months (95% CI: 6.1, 11.0) in the chemotherapy group. Unadjusted survival analyses showed a reduction in mortality risk of 20% with nivolumab versus chemotherapy (hazard ratio = 0.80; 95% CI: 0.59, 1.08); adjusted survival analyses yielded comparable results. In the nivolumab and chemotherapy groups, respectively, 9% and 18% of patients discontinued due to adverse effects; 41% and 49% discontinued due to death or disease progression.
Conclusion:
The results of this early survival analysis from a prospective study in a real-world community setting were similar to those seen in randomized trials, further supporting the benefit of nivolumab over chemotherapy in previously treated advanced NSCLC.
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P1.15 - SCLC/Neuroendocrine Tumors (ID 701)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.15-003 - Survival by Response to First-line Platinum-Based Therapy Among Patients With Extensive Disease Small Cell Lung Cancer (ID 7334)
09:30 - 16:00 | Author(s): M.D. Danese
- Abstract
Background:
Patients with extensive disease small cell lung cancer (ED-SCLC) have limited treatment options after recurrence, and their overall survival (OS) remains poor. This study explored the OS benefit of second-line therapy in patients with platinum-refractory versus platinum-sensitive ED-SCLC.
Method:
Linked data from Surveillance, Epidemiology, and End Results program and Medicare claims were used. Eligible patients were ≥66 years of age, and had pathologically confirmed first primary ED-SCLC diagnosis between January 1, 2007 and December 31, 2011 and Medicare Parts A and B coverage. Patients were followed from diagnosis until death, end of follow-up, second primary cancer diagnosis, or switch to managed care coverage. Therapy was determined using Medicare claims for outpatient chemotherapy, and lines of therapy were inferred from changes and gaps in therapy. Platinum-refractory status was defined in 2 ways based on criteria used in clinical trial enrollment and from clinical guidelines: 1) a gap of ≤90 days between the last administration of first-line therapy and the start of second-line therapy and 2) a gap of ≤183 days from start of first-line therapy to the start of second-line therapy. Cox proportional hazards models were used to identify factors associated with OS from the start of second-line therapy.
Result:
In all, 1059 patients with ED-SCLC received first-line platinum-based therapy. At diagnosis, mean age was 73 years, 53% were male, 87% were white, 30% had ≥1 indicator of mobility limitations, and 21% lived in a high-poverty area. Median OS for all patients was 4.3 months. There were 572 patients (54%) classified as platinum-refractory according to ≥1 definition, of whom 402 (70%) were classified as refractory according to both definitions. Based on the 90-day gap and the 183-day gap, respectively, median OS was 3.7 and 3.8 months for platinum-refractory patients, and 5.3 and 5.1 months for platinum-sensitive patients. In adjusted models using both definitions, factors associated with significantly shorter OS included male sex, stage IV disease at diagnosis, and platinum-refractory status.
Conclusion:
Median survival was <6 months for both platinum-refractory and platinum-sensitive patients, with refractory patients faring slightly worse. These findings highlight the need for new treatments for patients with ED-SCLC irrespective of their platinum sensitivity.
