Author of

• 15558

  +

  P3.07 - Poster Session/ Small Cell Lung Cancer (ID 223)

  • Event: WCLC 2015
  • Type: Poster
  • Track: Small Cell Lung Cancer
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)

  • 15573

    +

    P3.07-015 - Final Report of Phase I/II Study of Induction Carboplatin and Irinotecan Followed by TRT for Elderly Patients with LD-SCLC: TORG 0604 (ID 3232)

    09:30 - 09:30  |  Author(s): Y. Misumi
    • Abstract

    Background:
    In elderly patients with LD-SCLC, the role of irinotecan has been unclear and the timing of TRT combined with chemo-therapy has not been fully evaluated. Furthermore, no standard treatment has been established for them. We report a phase I/II trial of induction chemotherapy of carboplatin and irinotecan followed by sequential TRT in this population.
    
    Methods:
    Patients with untreated, measurable LD-SCLC >70 years with performance status (PS) 0 to 2 and adequate organ function were eligible. Treatment consisted of induction with carboplatin on day 1 and irinotecan on days 1 and 8 every 21 days for four cycles. TRT of 54Gy in 27 fractions was then administered sequentially. Carboplatin dose was escalated from AUC of 4 to 5 (Levels 1 and 2, respectively)　with a fixed dose of irinotecan at 50 mg/m[2]. The primary objective of the phase II portion was evaluation of efficacy.
    
    Results:
    A total of 41 patients were enrolled [median age 75 years, range 70-86 years; 31 male, 10 female; PS 0/1/2: 22/18/1]. At Level 1 (n=6), one patient experienced dose-limiting toxicity (DLT) as Grade 3 hypertension. At Level 2 (n=6), two patients experienced DLT as Grade 4 thrombocytopenia. Therefore, level 1 was chosen as the recommended dose. The phase II trial was then expanded by 35 patients in the level 1 based on the Simon minimax design. In all cohorts, the median chemotherapy cycle was 4 (1/2/3/4 courses administered as 4/2/2/33); median radiation dose was 54Gy (range 36-60). Toxicities were generally mild, as expected.　Gr 3/4 leukopenia and thrombocytopenia were both observed in six (15%) patients. No Gr 3/4 diarrhea or esophagitis was noted. Although Gr 3 febrile neutropenia and Gr 3 pneumonitis were seen in two patients each, no treatment-related deaths occurred. There were five complete responses and 32 partial responses, for a response rate of 90%. With median follow-up of 80.4 months (n=41), median progression-free and overall survival times were 11.2 and 27.1 months, respectively.
    
    Conclusion:
    Induction chemotherapy with carboplatin plus irinotecan followed by sequential TRT was well tolerated and highly effective in elderly patients with LD-SCLC. Further confirmatory studies are warranted.