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A phase II study of biweekly gemcitabine and carboplatin in completely resected stage IB-IIIA non-small cell lung cancer

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Abstract

Purpose

We conducted a prospective study to evaluate the efficacy and safety of biweekly gemcitabine and carboplatin combination treatment in patients with resected non-small cell lung cancer (NSCLC).

Methods

Patients with completely resected stage IB to IIIA NSCLC were treated with four cycles of gemcitabine (1000 mg/m2, days 1 and 15) plus carboplatin [area under the time-concentration curve (AUC) 5 mg/mL/min, day 1] every 4 weeks as adjuvant chemotherapy.

Results

Forty-three patients were enrolled in this study. The median number of treatment cycles was four. The completion rate of chemotherapy was 79.1%. Major grade 3/4 hematological adverse events included leukocytopenia (27.9%) and neutropenia (53.5%), whereas non-hematological toxicities were generally mild. Ten patients (23.3%) required chemotherapy treatment schedule delay, and one patient required one dose level reduction because of drug fever. Median disease-free survival was 78.6 months [95% confidence interval (CI) 39.5–not reached (NA)] and median overall survival was not reached (95% CI 83.7–NA).

Conclusions

Biweekly administration of gemcitabine and carboplatin is effective and well tolerated for patients with completely resected NSCLC as an adjuvant chemotherapy.

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Acknowledgements

We thank Dr. Kuniaki Suzuki and Dr. Yosuke Kamide for their help with the data collection.

Author information

Authors and Affiliations

  1. Department of Respiratory Medicine, Shibukawa Medical Center, Shibukawa, Gunma, Japan

    Reiko Sakurai, Yoshio Tomizawa, Akihiro Yoshii, Yosuke Miura, Hiroaki Tsurumaki & Ryusei Saito

  2. Division of Allergy and Respiratory Medicine, Integrative Center of Internal Medicine, Gunma University Hospital, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan

    Reiko Sakurai, Yosuke Miura, Hiroaki Tsurumaki & Takeshi Hisada

  3. Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan

    Reiko Sakurai, Yosuke Miura & Masanobu Yamada

  4. Department of Oncology Clinical Development, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan

    Kyoichi Kaira

  5. Oncology Center, Gunma University Hospital, Maebashi, Gunma, Japan

    Noriaki Sunaga

  6. Department of Thoracic Surgery, Shibukawa Medical Center, Shibukawa, Gunma, Japan

    Osamu Kawashima

Authors
  1. Reiko Sakurai
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  2. Yoshio Tomizawa
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  3. Akihiro Yoshii
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  4. Yosuke Miura
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  5. Hiroaki Tsurumaki
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  7. Noriaki Sunaga
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  8. Osamu Kawashima
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  9. Takeshi Hisada
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  11. Ryusei Saito
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Corresponding author

Correspondence to Reiko Sakurai.

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Conflict of interest

Author Reiko Sakurai declares that she has no conflict of interest. Author Yoshio Tomizawa declares that he has no conflict of interest. Author Akihiro Yoshii declares that he has no conflict of interest. Author Yosuke Miura declares that he has no conflict of interest. Author Hiroaki Tsurumaki declares that he has no conflict of interest. Author Kyoichi Kaira declares that he has no conflict of interest. Author Noriaki Sunaga declares that he has no conflict of interest. Author Osamu Kawashima declares that he has no conflict of interest. Author Takeshi Hisada declares that he has no conflict of interest. Author Masanobu Yamada declares that he has no conflict of interest. Author Ryusei Saito declares that he has no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Additional information

Yoshio Tomizawa—Deceased.

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Sakurai, R., Tomizawa, Y., Yoshii, A. et al. A phase II study of biweekly gemcitabine and carboplatin in completely resected stage IB-IIIA non-small cell lung cancer. Cancer Chemother Pharmacol 81, 103–109 (2018). https://doi.org/10.1007/s00280-017-3439-x

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  • DOI: https://doi.org/10.1007/s00280-017-3439-x

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