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Phase I and II Trials of Vinorelbine With Carboplatin for Patients 75 Years of Age or Older With Previously Untreated Non–Small-Cell Lung Cancer


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Title: Phase I and II Trials of Vinorelbine With Carboplatin for Patients 75 Years of Age or Older With Previously Untreated Non–Small-Cell Lung Cancer
Authors: Takatani, Hiroshi / Nakamura, Yoichi / Nagashima, Seiji / Soda, Hiroshi / Kinoshita, Akitoshi / Fukuda, Minoru / Fukuda, Masaaki / Soejima, Yoshifumi / Kasai, Takashi / Nakatomi, Katsumi / Iida, Tetsuya / Oka, Mikio / Tsukamoto, Kazuhiro / Kohno, Shigeru
Issue Date: Sep-2012
Publisher: Elsevier
Citation: Clinical Lung Cancer, 13(5), pp.347-351; 2012
Abstract: The safety and efficacy of platinum-based combination chemotherapy for elderly patients with advanced Non-Small-cell lung cancer (NSCLC) remains unclear. We conducted phase I and phase II trials of a combination of vinorelbine and carboplatin for patients <75 years of age and with advanced NSCLC. Previously untreated patients (<75 years of age) with stage IIIB or IV NSCLC were enrolled. Based on a 4-week cycle, vinorelbine was given on days 1 and 8, and carboplatin was given on day 1. Dose-limiting toxicity was defined as grade 4 hematologic toxicity that lasted 4 days or more, febrile neutropenia; grade 3 or worse nonhematologic toxicities; or the omission of vinorelbine administration on day 8 in the first cycle. Thirteen patients were enrolled in phase I. dose-limiting toxicity was grade 4 neutropenia that lasted 4 days or more, observed in 2 of 4 patients at level 4. Phase II study used the dose of level 3 (20 mg/m 2 vinorelbine, area under the curve of 4 mg/mL/min carboplatin). Forty-two patients were enrolled. The response rate was 14.6% of 41 assessable patients (95% CI, 3.8-25.4). The median time to progression was 98 days (95% CI, 61-135 days), and the median survival time was 366 days (95% CI, 321-411 days). All toxicities were mild and manageable. Use of 20 mg/m 2 vinorelbine on days 1 and 8, followed by carboplatin area under the curve of 4 mg/mL/min on day 1 every 4 weeks warrants a phase III study for elderly patients with advanced NSCLC.
Keywords: Carboplatin / Elderly patients / Non-Small-cell lung cancer / Vinorelbine
URI: http://hdl.handle.net/10069/30241
ISSN: 15257304
DOI: 10.1016/j.cllc.2011.11.007
Rights: © 2012 Elsevier Inc. / NOTICE: this is the author’s version of a work that was accepted for publication in Clinical Lung Cancer. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Clinical Lung Cancer, 13, 5(2012)
Type: Journal Article
Text Version: author
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/30241

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