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A phase I and extension study of S-1 and carboplatin for previously untreated patients aged 75 years or more with advanced non-small cell lung cancer -TCOG 1101-

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Abstract

Purpose

Combination carboplatin and S-1 is active in the treatment of non-small cell lung cancer (NSCLC). However, data on this combination for elderly patients with NSCLC are insufficient.

Methods

Eligibility criteria were no prior chemotherapy, Stage IIIB or IV NSCLC, performance status 0–1, age ≥ 75 years, and adequate hematological, hepatic, and renal functions. Carboplatin was administered on day 1 and S-1 was administered orally, twice a day, between days 1 and 14, repeated every 3 weeks. In phase I, the primary purpose was determination of the recommended dose. Starting doses of carboplatin and S-1 were area under the curve (AUC) of 4 and 80 mg/m2/day, respectively. In the extension study, the effects and tolerability of this combination therapy of recommended dose were confirmed.

Results

A total of 10 patients were entered into phase I and 14 patients were entered into the extension study. The recommended doses for this drug combination are AUC 5 for carboplatin and 80 mg/m2/day every 3 weeks for S-1. With carboplatin and S-1 combination therapy at the recommended dose, the response rate was 30.0% [95% confidence interval (CI) 12–54%] and the disease control rate was 90.0% (95% CI 68–99%). Thrombocytopenia and neutropenia were major adverse events.

Conclusions

The recommended doses for this combination therapy are carboplatin AUC 5 and S-1 80 mg/m2/day every 3 weeks, and this combination is effective with tolerable toxicities for advanced NSCLC patients ≥ 75 years old.

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Funding

This study was supported by The Tokyo Cooperative Oncology Group.

Author information

Authors and Affiliations

  1. Division of Thoracic Oncology, Department of Medical Oncology, Tochigi Cancer Center, 4-9-13 Yonan, Utsunomiya, Tochigi, 320-0834, Japan

    Takashi Kasai

  2. Division of Thoracic Oncology, Department of Thoracic Diseases, Tsuboi Cancer Center Hospital, Fukushima, Japan

    Kiyoshi Mori

  3. Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo, Japan

    Kazuma Kishi

  4. Division of Respiratory Medicine, Ibaraki Prefectural Central Hospital and Regional Cancer Center, Ibaraki, Japan

    Takayuki Kaburagi & Yutaka Yamada

  5. Division of Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan

    Yukio Hosomi & Makiko Yomota

  6. Division of Thoracic Oncology, Gunma Cancer Center, Gunma, Japan

    Hisao Imai & Koichi Minato

  7. Department of Respiratory Medicine, Respiratory Center, Toranomon Hospital, Tokyo, Japan

    Syuhei Moriguchi

  8. Department of Pulmonary Medicine, Oncology and Infectious Disease, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan

    Masahiro Seike & Akihiko Gemma

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  1. Takashi Kasai
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  2. Kiyoshi Mori
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Kasai, T., Mori, K., Kishi, K. et al. A phase I and extension study of S-1 and carboplatin for previously untreated patients aged 75 years or more with advanced non-small cell lung cancer -TCOG 1101-. Int J Clin Oncol 25, 867–875 (2020). https://doi.org/10.1007/s10147-020-01629-6

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  • DOI: https://doi.org/10.1007/s10147-020-01629-6

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