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

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

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)325-330
Number of pages6
JournalCancer Chemotherapy and Pharmacology
Issue number2
Publication statusPublished - Feb 2011
Externally publishedYes


  • Gemcitabine
  • Nedaplatin
  • Phase I
  • Squamous cell lung cancer

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)


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