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

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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)38-41
Number of pages4
JournalBritish Journal of Cancer
Volume84
Issue number1
DOIs
Publication statusPublished - 2001

Keywords

  • Carboplatin
  • Paclitaxel
  • Small cell lung cancer

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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