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OA15 - Targeted Agents and Immunotherapy for Small Cell Lung Cancer (ID 152)
- Event: WCLC 2019
- Type: Oral Session
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Now Available
- Moderators:Raffaele Califano, Charles M Rudin
- Coordinates: 9/10/2019, 14:30 - 16:00, Hilton Head (1978)
OA15.02 - Carboplatin-Etoposide Versus Topotecan as Second-Line Treatment for Sensitive Relapsed Small-Cell Lung Cancer: Phase 3 Trial (Now Available) (ID 546)
14:30 - 16:00 | Author(s): Gwenaëlle Legarff
Topotecan is currently the only drug approved in Europe in second line setting for small-cell lung cancer (SCLC). This study investigates whether the doublet carboplatin-Etoposide was superior to topotecan monotherapy as second-line treatment in patients with sensitive relapsed SCLC.Method
this open-label, multicenter, phase 3 trial randomized patients with SCLC that responded to first-line platin etoposide doublet treatment but showed evidence of disease relapse or progression at least 90 days after completion of the first-line treatment. Enrolled patients were randomly assigned (1:1) to receive combination chemotherapy (Six cycles of 3-weeks Carboplatin, AUC 5, day 1 and Etoposide 100 mg/Sqm/d 1-3, intra-venous) or oral Topotecan (2.3 mg/Sqm/d 1-5, every 3 weeks). Primary endpoint was progression free survival (PFS). Secondary endpoints were overall survival (OS), objective response rate (ORR), quality of life and tolerance in the intention-to-treat population, (clinical trialgouv: NCT02738346)Result
178 patients were screened and 164 randomized in 36 centers, with 82 assigned to each treatment group (age: 64.5 ± 7.2 years, men: 72.8%, PS 0/1/>1: 34.7%/56.3%/ 9%. Median PFS was significantly longer in combination chemotherapy group (4.7 months, 95% CI: 3.9-5.5) compare to topotecan group (2.7 months, 95% CI: 2.3-3.2), HR: 0.6, 95% CI 0.4-0.8, p < 0.002. The ORR were significantly more important in the combination chemotherapy than in topotecan arm (ORR 49 % vs 25 %, p < 0,002), but without difference in term of median OS, 7.5 months (95% CI: 5.4-8.7) in combination chemotherapy group versus 7.4 months (95% CI.6.0-9.3) in topotecan arm. Grade 3/4 neutropenia were significantly more common in the topotecan group than in the combination chemotherapy group (35.8% vs 19.7 %, p < 0.001. There is a non-significant trend for more febrile neutropenia in topotecan arm compare to combination arm (13.6 % 6.2 %, p = 0.19, and no difference for grade 3/4 thrombopenia, 35.8 % vs 30.9 %, and anemia, 24.6 % vs 21 %, for topotecan and combination arms, respectively. Two treatment-related deaths occurred in the topotecan arm (febrile neutropenia with sepsis), none in the combination arm. Results of quality of life outcomes will be presented at the meeting.Conclusion
platin - etoposide re-challenge can be considered as a standard second-line chemotherapy for sensitive relapsed SCLC.
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P2.14 - Targeted Therapy (ID 183)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
P2.14-65 - Efficacy of Dabrafenib Plus Trametinib Combination in Patients with BRAF V600E–Mutant NSCLC in Real World Setting (ID 307)
10:15 - 18:15 | Author(s): Gwenaëlle Legarff
Dabrafenib plus trametinib (D-T) combination is approved in Europe Union for BRAFV600E–mutant metastatic non-small cell lung cancer(NSCLC) but there is few published data’s on this efficacy and tolerance outside clinical trail results.
Objective: to assess efficacy and tolerance of D-T in real world setting.Method
Retrospective, multicentric study including BRAF V600E-positive advanced NSCLC receiving D-T outside a clinical trial. Overall survival (OS) and progression free survival (PFS) were analyzed in all population and according lines of D-T treatment (first line treatment or subsequent line treatments).Result
the analysis included 40 BRAF V600E advanced NSCLC patients managed in 14 centers; at diagnosis: mean age 71 ±9.6 years , female 55 %, adenocarcinoma 95 %, currents/formers smokers 17.5%/50 %, At D-T initiation: PS 0-1/2 or+: 86.8%/13.2% , loss weight> 5%: 24%, symptomatic disease: 92%, stage IV: 95% , mean metastatic site: 2.3 (main metastatic sites: pleura: 46%, bone: 33%, respectively).Mean line of treatment before D-T: 1.5. D-T was a first line treatment in 22.5 %, second line or more 77.5% (25% received one BRAF TKI before). Median time between diagnosis and D-T treatment was 0.7 [95%CI: 0.2-1.3] months in first line setting and 17.3 [95%CI: 10.8-27.2] months.
At the time of analysis 67.5% patients were in treatment with D-T and median follow up since beginning of D-T treatment was 8.7[95%CI: 5-12]months in whole population [7,5, 95%CI: 1-12.3]months for patients treated in first line). D-T dose was modified for 32.5.0% of the patients and definitively discontinued for 12,5 % because of severe adverse events.
Median PFS and OS were not reach and follow up is continued.
The mature results of PFS and OS (whole population and subgroups) will be showed to the WLCC meeting.Conclusion
Section not applicable