1469P - Phase I/II study of induction chemotherapy of carboplatin and irinotecan followed by sequential thoracic radiotherapy (TRT) for elderly patients wi...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer agents
Small Cell Lung Cancer
Surgical Oncology
Therapy
Biological Therapy
Radiation Oncology
Presenter Yuki Misumi
Citation Annals of Oncology (2014) 25 (suppl_4): iv511-iv516. 10.1093/annonc/mdu355
Authors Y. Misumi1, H. Okamoto1, K. Naoki2, Y. Hosomi3, Y. Takagi4, T. Kato5, N. Masuda6, A. Takakura7, K. Minato8, Y. Miura9, T. Yokoyama10, S. Takata11, K. Kishi12, M. Nishikawa13, F. Oshita14, N. Seki15, I. Goto16, K. Watanabe1
  • 1Department Of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 240-8555 - Yokohama/JP
  • 2Respiratory Medicine, Keio University School of Medicine, 160-0035 - Tokyo/JP
  • 3Department Of Thoracic Oncology And Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo/JP
  • 4Department Of Thoracic Oncology And Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 113-0021 - Tokyo/JP
  • 5Department Of Respiratory Medicine, Kanagawa Cardiovasucular and Respiratory Center, 2360051 - Yokohama/JP
  • 6Department Of Respiratory Medicine, Kitasato University School of Medicine, JP-252-0374 - Kanagawa/JP
  • 7Derartment Of Respiratory Medicine, Kitasato University Hospital, Kawasaki/JP
  • 8Department Of Respiratory Medicine, Gunma Prefectural Cancer Center, Oota/JP
  • 9Derartment Of Respiratory Medicine, Gunma Prefectural Cancer Center, oota/JP
  • 10Department Of Respiratory Medicine, Kyorin University Hospital, Tokyo/JP
  • 11Respiratory Medicine, Kyorin university Hospital, Tokyo/JP
  • 12Dept. Of Respiratory Medicine, Toranomon Hospital, 105-8470 - Tokyo/JP
  • 13Respiratory Medicine, Fujisawa City Hospital, Fujisawa/JP
  • 14Department Of Thoracic Oncology, Kanagawa Cancer Center Hospital, Yokohama/JP
  • 15Division Of Medical Oncology, Department Of Internal Medicine, Teikyo University, 173-8606 - Tokyo/JP
  • 16Respiratory Medicine, Osaka Medical College Hospital, Takatsuki/JP

Abstract

Aim

The effect of irinotecan in treatments for LD-SCLC in the elderly is unclear, and the optimal timing of TRT when combined with chemotherapy has not been fully evaluated. We report a phase I/II trial of induction chemotherapy with 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/m2. 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 12.4 and 27.1 months, respectively.

Conclusions

Induction chemotherapy with carboplatin plus irinotecan followed by sequential TRT was well tolerated and highly active in elderly patients with LD-SCLC. Further confirmatory studies are warranted.

Disclosure

All authors have declared no conflicts of interest.