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01.02.2011 | Original Article

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

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

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 2/2011

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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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Titel: Phase I study of the combination of nedaplatin and gemcitabine in previously untreated advanced squamous cell lung cancer
verfasst von: Katsuhiro Masago
Shiro Fujita
Young Hak Kim
Yukimasa Hatachi
Akiko Fukuhara
Kaoru Irisa
Hiroki Nagai
Yuichi Sakamori
Yosuke Togashi
Tadashi Mio
Michiaki Mishima
Publikationsdatum: 01.02.2011
Verlag: Springer-Verlag
Erschienen in: Cancer Chemotherapy and Pharmacology / Ausgabe 2/2011
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-010-1321-1

Springer Medizin

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