Phase I/II study of induction chemotherapy using carboplatin plus irinotecan and sequential thoracic radiotherapy (TRT) for elderly patients with limited-stage small-cell lung cancer (LD-SCLC): The final results of TORG 0604

Date

08 Oct 2016

Session

Poster Display

Presenters

Yuki Misumi

Citation

Annals of Oncology (2016) 27 (6): 493-496. 10.1093/annonc/mdw389

Authors

Y. Misumi1, H. Okamoto1, K. Naoki2, Y. Hosomi3, T. Ogura4, N. Masuda5, K. Minato6, T. Yokoyama7, K. Kishi8, M. Nishikawa9, T. Kato10, N. Seki11, I. Goto12, K. Watanabe1

Author affiliations

  • 1 Department Of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 240-8555 - Yokohama/JP
  • 2 Department Of Respiratory Medicine, Keio University School of Medicine, Tokyo/JP
  • 3 Department Of Thoracic Oncology And Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo/JP
  • 4 Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama/JP
  • 5 Respiratory Medicine, Kitasato University Hospital, Sagamihara/JP
  • 6 Department Of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota/JP
  • 7 Department Of Respiratory Medicine, Kyorin university Hospital, Mitaka/JP
  • 8 Dept. Of Respiratory Medicine, Toranomon Hospital, 105-8470 - Tokyo/JP
  • 9 Department Of Respiratory Medicine, Fujisawa Municipal Hospital, Fujisawa/JP
  • 10 Department Of Respiratory Medicine, Kanagawa Cancer Center, Yokohama/JP
  • 11 Department Of Medical Oncology, Teikyo University, Tokyo/JP
  • 12 Department Of Respiratory Medicine, Osaka Medical College, Takatsuki/JP
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Resources

Background

The role of irinotecan for elderly patients with LD-SCLC has been unclear, and the timing of TRT combined with chemotherapy has not been fully evaluated.

Methods

Patients aged > 70 years with untreated, measurable, LD-SCLC, performance status (PS) 0-2, 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 4 cycles, and sequential TRT (54Gy in 27 fractions). Carboplatin doses were based on AUC of 4 and 5 (levels 1 and 2, respectively), with a fixed irinotecan dose (50 mg/m2). Primary objectives of the phase II study were efficacy, adverse events, and feasibility.

Results

Forty-one patients were enrolled (median age75 years [range 70-86 years); males 31; PS 0/1/2, n = 22/18/1]. The number of patients with carboplatin dose-limiting toxicities at levels-1 (n = 6) and -2 (n = 6) were 1(grade 3 hypertension) and 2 (grade 4 thrombocytopenia), respectively. The phase II trial was expanded to 29 additional patients receiving the level 1 carboplatin dose. The median number of chemotherapy cycles was 4 (range 1-4), and the median radiation dose was 54Gy (range 36-60).Toxicities were generally mild. There were 5 complete and 30 partial responses (response rate 90%).With a median follow-up of 80.4 months (n = 41), the median progression-free and overall survival times were 12.5 and 27.5 months, respectively.

Conclusions

Induction chemotherapy of carboplatin plus irinotecan and sequential TRT was well tolerated and effective for elderly patients with LD-SCLC. Additional confirmatory studies are warranted.

Clinical trial identification

Legal entity responsible for the study

Thoracic Oncology Reserch Group (TORG)

Funding

Nippon Kayaku, Taiho, Lilly, Sanofi, Chugai, Astra Zeneca, Daiichi Sankyo, Shionogi

Disclosure

All authors have declared no conflicts of interest.

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