Virtual Library

Start Your Search

Roland Schott

Author of

  • +

    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
    • +

      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): Roland Schott

      • Abstract
      • Presentation
      • Slides


      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.


      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)


      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.


      platin - etoposide re-challenge can be considered as a standard second-line chemotherapy for sensitive relapsed SCLC.

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.