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. 2001 Jan 1;84(1):38–41. doi: 10.1054/bjoc.2000.1541

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

C Gridelli 1, L Manzione 2, F Perrone 3, E Veltri 4, R Cioffi 5, M Grazia Caprio 6, L Frontini 7, A Rossi 1,2, E Barletta 1, M L Barzelloni 1, D Bilancia 2, C Gallo 8
PMCID: PMC2363602  PMID: 11139310

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/m23-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. © 2001 Cancer Research Campaign http://www.bjcancer.com

Keywords: paclitaxel, carboplatin, small cell lung cancer

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Selected References

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