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Annals of Oncology 13:1454-1459, 2002
© 2002 European Society for Medical Oncology

Original Paper

A phase II randomised trial comparing the cisplatin–etoposide combination chemotherapy with or without carboplatin as second-line therapy for small-cell lung cancer

J. P. Sculier+, J. J. Lafitte, J. Lecomte, T. Berghmans, J. Thiriaux, O. Van Cutsem, A. Efremidis, V. Ninane, M. Paesmans, P. Mommen and J. Klastersky

Department of Medicine, Institut Jules Bordet, Bruxelles, Belgium

Received 17 December 2001; revised 25 February 2002; accepted 26 March 2002

Background:

A phase II randomised trial was performed with patients with SCLC to determine if the addition of carboplatin to cisplatin–etoposide might improve the response rate in second-line therapy.

Patients and methods:

Sixty-five eligible patients were randomised: 31 for CE (cisplatin 20 mg/m2 and etoposide 100 mg/m2 on days 1–3) and 34 for CCE (carboplatin 200 mg/m2 on day 1, cisplatin 30 mg/m2 on days 2–3, etoposide 100 mg/m2 on days 1–3).

Results:

Eighty-two per cent of these patients had an objective response to first-line therapy and, among responders, 63% had a treatment-free interval of >3 months after previous therapy. The best response rates were 29% [95% confidence interval (CI) 13–45] and 47% (95% CI 30–64) for CE and CCE, respectively, with median survival times of 4.3 and 7.6 months. Dose-intensity analysis revealed a significant improvement in the relative dose-intensity and etoposide absolute dose-intensity for CE. Toxicity was tolerable and comparable between the two study arms.

Conclusion:

CCE appears to be associated with a high objective response rate. The phase II randomised study design suggests that a comparison between the two regimens in a phase III trial would be interesting, but will probably be difficult to perform for reasons of accrual.

Key words: carboplatin, cisplatin, etoposide, salvage therapy, small-cell lung cancer


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