Carboplatin plus paclitaxel in extensive small cell lung cancer: a multicentre phase 2 study.

Abstract:

:A multicentre phase 2 trial (single-stage design) was undertaken to test the efficacy and toxicity of carboplatin (AUC 6 according to Calvert) plus paclitaxel (175 mg/m(2)3-h infusion) every 4 weeks in the first line treatment of patients affected by extensive small cell lung cancer. The primary end-point of the trial was the objective response rate. 31 objective responses among 50 patients were considered necessary to proceed to a phase 3 trial. 48 patients were enrolled (median age 59 years). Treatment was very well tolerated. 3 patients (6.2%) had a complete response and 23 (47.9%) a partial response, for an overall response rate of 54.2% (95% CI: 39.2-68.6). Median time to progression was 5.7 months (95% CI: 5.2-6.2). Median survival was 9.6 months (95% CI: 7.2-14.6), with a median follow-up time of alive patients of 12 months. At 1 year, the probability of being progression-free or alive was 0.16 and 0.43, respectively. In conclusion, carboplatin plus paclitaxel as given in the present study is very well tolerated but not sufficiently active to warrant phase 3 comparison with standard chemotherapy regimens.

journal_name

Br J Cancer

authors

Gridelli C,Manzione L,Perrone F,Veltri E,Cioffi R,Caprio MG,Frontini L,Rossi A,Barletta E,Barzelloni ML,Bilancia D,Gallo C

doi

10.1054/bjoc.2000.1541

subject

Has Abstract

pub_date

2001-01-05 00:00:00

pages

38-41

issue

1

eissn

0007-0920

issn

1532-1827

pii

S0007092000915416

journal_volume

84

pub_type

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