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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.

Abstract：

BACKGROUND: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. PATIENTS AND METHODS: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. RESULTS: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. CONCLUSION: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.

journal_name

Clin Lung Cancer

journal_title

Clinical lung cancer

authors

Takatani H,Nakamura Y,Nagashima S,Soda H,Kinoshita A,Fukuda M,Fukuda M,Soejima Y,Kasai T,Nakatomi K,Iida T,Oka M,Tsukamoto K,Kohno S

doi

10.1016/j.cllc.2011.11.007

subject

Has Abstract

pub_date

2012-09-01 00:00:00

pages

347-51

issue

5

eissn

1525-7304

issn

1938-0690

pii

S1525-7304(11)00298-1

journal_volume

13

pub_type

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