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

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/m(2)), 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/m(2) gemcitabine and 80 mg/m(2) 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/m(2) gemcitabine and 70 mg/m(2) nedaplatin for phase II study. This combination chemotherapeutic regimen is active and well tolerated.

• Authors: Katsuhiro Masago, Shiro Fujita, Young Hak Kim, Yukimasa Hatachi, Akiko Fukuhara, Kaoru Irisa, Hiroki Nagai, Yuichi Sakamori, Yosuke Togashi, Tadashi Mio, Michiaki Mishima
• Journal: Cancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 67 Issue 2 Pg. 325-30 (Feb 2011) ISSN: 1432-0843 [Electronic] Germany
• PMID: 20401614 (Publication Type: Clinical Trial, Phase I, Journal Article)

Chemical References

• Organoplatinum Compounds
• Deoxycytidine
• nedaplatin
• Gemcitabine

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use, toxicity)
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Female
• Hematologic Diseases (chemically induced)
• Humans
• Lung Neoplasms (diagnosis, drug therapy)
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neoplasms, Squamous Cell (diagnosis, drug therapy)
• Organoplatinum Compounds (administration & dosage)
• Survival Analysis
• Treatment Outcome
• Gemcitabine