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J.R. Penrod
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MA 01 - SCLC: Research Perspectives (ID 650)
- Event: WCLC 2017
- Type: Mini Oral
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:John V Heymach, Eun Kyung Cho
- Coordinates: 10/16/2017, 11:00 - 12:30, Room 503
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MA 01.09 - Treatment Patterns in Extensive Disease Small Cell Lung Cancer Across the United States, Europe, and Japan (ID 8479)
12:00 - 12:05 | Author(s): J.R. Penrod
- Abstract
- Presentation
Background:
Small cell lung cancer (SCLC) comprises ~10-15% of lung cancers. The majority of patients with SCLC present with extensive disease (ED) and have extremely poor outcomes; <5% survive 2 years. Although first-line (1L) treatment is typically platinum-based, many patients are platinum-resistant with few effective options after relapse. The study objective was to compare treatment patterns across regions and by platinum resistance/sensitivity.
Method:
This study used data from the Oncology Monitor (Ipsos Healthcare), a global clinical database of oncology patients collected through retrospective medical chart reviews. Treating physicians were invited to submit information on their patients with SCLC treated from January 2014 through December 2016 in the United States (US), the European Union 5 (EU5; France, Germany, Italy, Spain, and the United Kingdom), or Japan.
Result:
A total of 5849 patients with SCLC were included (2605 in the US, 2203 in the EU5, and 1041 in Japan). Mean age was 65.6 years (standard deviation: 8.8); 66.3% were male and 94.0% diagnosed with ED. In all, 73.4% of patients were receiving 1L, 19.8% second-line (2L), and 6.8% third-or-later-line therapy. Platinum/etoposide was the most frequently prescribed 1L therapy, although it was significantly more common in the US (87.0%) than the EU5 (82.1%) or Japan (73.3%) (P<0.05). Cisplatin/etoposide was prescribed more often in 1L in the EU5 (40.8%) than in the US (26.6%) or Japan (23.7%) (P<0.0001). Platinum/irinotecan was an uncommon 1L treatment in the US (2.0%) and EU5 (0.5%) but common in Japan (22.7%; P<0.0001). Platinum-resistance (relapse within ≤3 months of 1L treatment completion) was observed in >40% of patients (US: 45.4%, EU5: 40.9%, Japan: 56.1%). Regardless of platinum-resistance versus sensitivity, the most common 2L treatment in the US and EU5 was topotecan (42.3% vs 47.6%) and (59.5% vs 56.1%), and amrubicin in Japan (52.1% vs 53.1%). Among platinum-resistant patients in the US, EU5, and Japan, 27.3%, 10.8%, and 36.4% received a platinum-based 2L therapy. Additionally, 52.3%, 66.7%, and 44.9% of platinum-sensitive patients did not receive 2L platinum re-challenge.
Conclusion:
Current NCCN and ESMO guidelines (endorsed by JSMO) recommend platinum-resistant patients receive non–platinum-based 2L therapies. The guidelines also recommend that platinum-sensitive patients (relapse >6 months) receive the original 1L regimen as a 2L re-challenge. However, this real-world study found that a significant proportion of platinum-resistant patients were re-challenged with a 2L platinum-based therapy. Conversely, in patients where platinum re-challenge is recommended, a large proportion did not receive platinum-based therapies in 2L.
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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 - 09:30 | Author(s): J.R. Penrod
- 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.
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P2.07 - Immunology and Immunotherapy (ID 708)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.07-034 - Health Status in Patients with Small-Cell Lung Cancer Treated with Nivolumab Alone or Combined with Ipilimumab: CheckMate 032 (ID 9400)
09:30 - 09:30 | Author(s): J.R. Penrod
- Abstract
Background:
CheckMate 032 (NCT01928394) is an open-label, phase 1/2 trial evaluating the efficacy and safety of nivolumab monotherapy and nivolumab plus ipilimumab in patients with advanced or metastatic solid tumors. In this study, nivolumab ± ipilimumab showed durable responses, encouraging survival, and manageable safety in patients with small-cell lung cancer (SCLC) that progressed after ≥1 previous platinum-containing regimens. An exploratory objective is to describe changes in patient-reported health status using the EuroQoL-5 Dimensions (EQ-5D) instrument.
Method:
The EQ-5D visual analog scale (VAS; scale: 0–100 [worst–best health]; minimally important difference [MID]=7) was assessed in the treatment period at baseline (week 1 prior to study drug administration) and then every 2 weeks in the nivolumab (3 mg/kg) arm and at baseline and then every 3 weeks in the nivolumab (1 mg/kg) plus ipilimumab (3 mg/kg) arm through week 13, and in both arms at subsequent tumor assessments (every 6 weeks until week 24 and every 12 weeks thereafter). After treatment discontinuation, the EQ-5D was assessed at follow-up visits 1 and 2, and at survival visits. EQ-5D VAS mean and mean within-patient change from baseline were estimated at each assessment. Time to first deterioration (TTD) in health status was also evaluated.
Result:
In the nivolumab (n=245) and nivolumab plus ipilimumab (n=156) arms, EQ-5D VAS completion rates were 90% and 85%, respectively, at baseline and remained ≥60% at the last assessment (≥5 patients/arm; weeks 97 and 121, respectively). Baseline mean EQ-5D VAS scores for the nivolumab and nivolumab plus ipilimumab arms were 67.1 and 65.2, respectively, scores similar to a lung cancer population norm (68). With monotherapy, EQ-5D VAS mean within-patient changes from baseline suggested health status stability while on treatment (estimated changes
Conclusion:
Preliminary EQ-5D VAS results from CheckMate 032 showed that on-treatment health status in patients with recurrent SCLC remained stable with nivolumab and improved (ie, increases in scores exceeded the MID) with nivolumab plus ipilimumab. For patients remaining on treatment for ≥6 months, mean EQ-VAS scores in both arms trended towards the population norm.