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Phase II study of irinotecan and cisplatin with concurrent split-course radiotherapy in limited-disease small cell lung cancer

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Abstract

Background

Irinotecan and cisplatin are one of active regimens for patients with extensive-stage small cell lung cancer (SCLC). To determine the efficacy and toxicity of irinotecan and cisplatin with concurrent split-course thoracic radiotherapy in limited-disease (LD) SCLC, we conducted a phase II study.

Patients and methods

Thirty-four patients fulfilling the following eligibility criteria were enrolled: chemotherapy-naïve, good performance status (PS 0–1), age ≤75, LD-SCLC, and adequate organ function. The patients received irinotecan 40 mg/m2 i.v. on days 1, 8, and 15, and cisplatin 60 mg/m2 i.v. on day 1. Four cycles of chemotherapy were repeated every 4 weeks. Split-course thoracic radiotherapy of once-daily 2 Gy/day commenced on day 2 of each chemotherapy cycle, with 26 and 24 Gy administered in the first and second cycles, respectively.

Results

Thirty-four patients were eligible and assessable for response, toxicity, and survival. Patients’ characteristics were as follows: male/female = 29/5; PS 0/1 = 18/16; median age (range) = 67 (50–73); and stage IB/IIA/IIB/IIIA/IIIB = 2/2/3/16/11. The overall response was 100 % (CR 8, PR 26). Grade 4 leukopenia, neutropenia, grade 3–5 pneumonitis, diarrhea, and esophagitis occurred in 24, 38, 6, 3, and 0 %, respectively. There were 2 treatment-related deaths from pneumonitis. The median time to tumor progression was 14.3 months. The median overall survival time and the 2- and 5-year survival rates were 44.5 months, 66.7 and 46.1 %, respectively. No tumor progression was observed in patients with CR.

Conclusion

Irinotecan plus cisplatin with concurrent split-course thoracic radiotherapy was effective and tolerable in untreated LD-SCLC.

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Conflict of interest

The authors report no potential conflict of interest.

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Authors and Affiliations

  1. Department of Chemotherapy, Japanese Red Cross Nagasaki Genbaku Hospital, 3-15 Mori-machi, Nagasaki, 852-8511, Japan

    Minoru Fukuda

  2. Second Department of Internal Medicine, Nagasaki University Hospital, Nagasaki, Japan

    Yoichi Nakamura, Hiroyuki Yamaguchi, Takaya Ikeda, Koichi Izumikawa & Shigeru Kohno

  3. Department of Internal Medicine, Nagasaki Prefecture Shimabara Hospital, Nagasaki, Japan

    Akitoshi Kinoshita

  4. Department of Respiratory Medicine, Ureshino Medical Center, Saga, Japan

    Yoshifumi Soejima

  5. Department of Internal Medicine, Nagasaki Municipal Medical Center, Nagasaki, Japan

    Hiroshi Takatani

  6. Department of Respiratory Medicine, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan

    Masaaki Fukuda

  7. Department of Internal Medicine, Sasebo General Hospital, Nagasaki, Japan

    Hiroshi Soda

  8. Department of Radiological Sciences, Nagasaki University Hospital, Nagasaki, Japan

    Nobuyuki Hayashi

  9. Division of Medicinal Treatment, Department of Clinical Pharmacy, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan

    Kazuhiro Tsukamoto

  10. Department of Respiratory Disease, Kawasaki Medical School, Okayama, Japan

    Mikio Oka

Authors
  1. Minoru Fukuda
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  2. Yoichi Nakamura
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  6. Takaya Ikeda
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  8. Hiroshi Takatani
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  9. Masaaki Fukuda
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  10. Hiroshi Soda
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  11. Nobuyuki Hayashi
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  12. Kazuhiro Tsukamoto
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  13. Mikio Oka
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  14. Shigeru Kohno
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Corresponding author

Correspondence to Minoru Fukuda.

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Fukuda, M., Nakamura, Y., Kinoshita, A. et al. Phase II study of irinotecan and cisplatin with concurrent split-course radiotherapy in limited-disease small cell lung cancer. Cancer Chemother Pharmacol 70, 645–651 (2012). https://doi.org/10.1007/s00280-012-1952-5

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  • DOI: https://doi.org/10.1007/s00280-012-1952-5

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