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Phase I study of the combination of nedaplatin and gemcitabine in previously untreated advanced squamous cell lung cancer

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Abstract

Purpose

The objectives of this phase I trial were to evaluate the toxicity of the nedaplatin/gemcitabine regimen, determine the maximum tolerated doses (MTDs) of these agents, and observe the anti-tumor effects of this regimen on advanced squamous cell lung cancer.

Methods

Patients with previously untreated advanced squamous cell lung cancer were eligible if they had a performance status of 0 or 1 with adequate organ function. The doses of gemcitabine (days 1 and 8) and nedaplatin (day 8) studied were 800/70, 1,000/80, 1,000/90, and 1,000/100 (mg/m2), repeated every 3 weeks.

Results

Toxicity and response could be assessed in all 13 patients enrolled. The patients included 12 men and one woman with a median age of 69 years (range 57–81 years). Three patients had stage IIIB disease and 10 patients had stage IV disease. The MTDs were reached at 1,000 mg/m2 gemcitabine and 80 mg/m2 nedaplatin. The most frequent toxic effects were thrombocytopenia and neutropenia; grade 3 or 4 thrombocytopenia was observed in 23% of patients, and grade 3 or 4 neutropenia was seen in 46% of patients. Non-hematologic toxicities were mild. Grade 3 fatigue, nausea/vomiting, and appetite loss occurred in two patients. The overall response rate was 62%.

Conclusions

We recommend doses of 800 mg/m2 gemcitabine and 70 mg/m2 nedaplatin for phase II study. This combination chemotherapeutic regimen is active and well tolerated.

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Conflict of interest statement

The authors indicate no potential conflicts of interest.

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Authors and Affiliations

  1. Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Syogoin-Kawaracho, Sakyo-ku, Kyoto, 606-8507, Japan

    Katsuhiro Masago, Young Hak Kim, Yukimasa Hatachi, Akiko Fukuhara, Kaoru Irisa, Hiroki Nagai, Yuichi Sakamori, Yosuke Togashi & Michiaki Mishima

  2. Division of Integrated Oncology, Institute of Biomedical Research and Innovation, Kobe, Japan

    Shiro Fujita

  3. Department of Multidisciplinary Cancer Treatment, Kyoto University, Kyoto, Japan

    Tadashi Mio

Authors
  1. Katsuhiro Masago
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  2. Shiro Fujita
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  3. Young Hak Kim
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  4. Yukimasa Hatachi
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  5. Akiko Fukuhara
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  6. Kaoru Irisa
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  7. Hiroki Nagai
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  9. Yosuke Togashi
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  11. Michiaki Mishima
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Correspondence to Katsuhiro Masago.

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Masago, K., Fujita, S., Kim, Y.H. et al. Phase I study of the combination of nedaplatin and gemcitabine in previously untreated advanced squamous cell lung cancer. Cancer Chemother Pharmacol 67, 325–330 (2011). https://doi.org/10.1007/s00280-010-1321-1

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  • DOI: https://doi.org/10.1007/s00280-010-1321-1

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