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Annals of Oncology 8:525-529, 1997
© 1997 European Society for Medical Oncology

research-article

Single-agent gemcitabine versus cisplatin-etoposide: Early results of a randomised phase II study in locally advanced or metastatic non-small-cell lung cancer

C. Manegold1,, B. Bergman2, A. Chemaissani3, W. Dornoff4, P. Drings1, P. Kellokumpu-Lehtinen5, K. Liippo6, K. Mattson7, J. v. Pawel8, S. Ricci9, C. Sederholm10, R. A. Stahel11, G. Wagenius12, N. v. Walree13 and W. ten Bokkel-Huinink14

1Thoraxklinik Heidelberg, Germany
2Salgrenska Sjukhuset Goteborg, Sweden
3Städtisches Krankenhaus Köln-Merheim, Germany
4Mutterhaus der Borromäerinnen Trier, Germany
5Tampere University Hospital Pinkonlinna, Finland
6Turku University Hospital Paimio, Finland
7University Hospital Helsinki, Finland
8Zentralkrankenhaus Gautmg Germany
9S. Chiara Hospital Pisa, Italy
10Universitets Sjukhuset Linkoping, Sweden
11Universitätsspital Zürich Switzerland
12Akademsika Sjukhuset Uppsala, Sweden
13Sint Antonius Ziekenhuis Nieuwegein, The Netherlands
14Netherlands Cancer Institute Amsterdam, The Netherlands

Correspondence to: Prof. Dr. C. Manegold Thoraxklinik Department of Medical Oncology Amalienstrasse 5 D-69126 Heidelberg Germany

BACKGROUND: This randomised study was designed to determine the response rate, survival and toxicity of single-agent gemcitabine and cisplatin-etoposide in chemo-naïve patients with locally advanced or metastatic non-small-cell lung cancer.

PATIENTS AND METHODS: Gemcitabine 1,000 mg/m2 was given as a 30 min intravenous infusion on days 1, 8, 15 of a 28-day cycle, cisplatin 100 mg/m2 on day 1, and etoposide 100 mg/m2 on days 1 (following cisplatin), 2 and 3. Major eligibility criteria included histologically confirmed non-small-cell lung cancer, measurable disease, Zubrod PS 0–2; no prior chemotherapy, no prior radiation of the measured lesion, and no CNS metastases.

RESULTS: 146 patients were enrolled, 71 patients on gemcitabine and 75 patients on cisplatin-etoposide. Patient characteristics were well matched across both arms. Sixty-six gemcitabine patients and 72 cisplatin-etoposide patients were evaluable. Partial responses were seen in 12 gemcitabine patients (18.2%; 95% CI: 9.8–30) and 11 cisplatin-etoposide patients (15.3%; 95% CI: 7.9–25.7). Early indications show no statistical differences between the two treatments with respect to time to disease progression or survival. Haematological and laboratory toxicity were moderate and manageable. However, hospitalisation because of neutropenic fever was required for 6 (8%) cisplatin-etoposide patients but not for any gemcitabine patients. Non-haematological toxicity was more pronounced with significant differences in nausea and vomiting (grade 3 and 4: 11% gemcitabine vs. 29% cisplatin-etoposide; despite the allowance for 5-HT3 antiemetics during the first cycle of cisplatin-etoposide), and alopecia (grade 3 and 4: 3% gemcitabine vs. 62% cisplatin-etoposide).

CONCLUSIONS: In this randomised study, single-agent gemcitabine was at least as active but better tolerated than the combination cisplatin-etoposide.

cisplatin, etoposide, gemcitabine, non-small-cell lung cancer, randomised phase II study


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