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Annals of Oncology 13:1080-1086, 2002
© 2002 European Society for Medical Oncology

Original Paper

Three-week versus four-week schedule of cisplatin and gemcitabine: results of a randomized phase II study

H. Soto Parra1,+, R. Cavina1, F. Latteri1, A. Sala1, M. Dambrosio2, G. Antonelli3, E. Morenghi1, M. Alloisio4, G. Ravasi4 and A. Santoro1

1 Department of Medical Oncology and Hematology and 4 Division of Thoracic Surgery, Istituto Clinico Humanitas, Rozzano-Milan; 2 Division of Medical Oncology, Multimedica Hospital, Sesto San Giovanni; 3 Division of Medical Oncology, San Vincenzo Hospital, Taormina-Messina, Italy

Received 26 September 2001; revised 24 January 2002; accepted 19 February 2002

Background:

The cisplatin and gemcitabine (GC) regimen is usually administered as a 4- or 3-week schedule; however, the best schedule to use is still unclear. We therefore started a randomized phase II trial to compare toxicity and dose intensity (DI) between these two GC schedules.

Patients and methods:

Ninety-six patients with non-small-cell lung cancer (NSCLC) and an additional 11 patients with an advanced epithelial neoplasm [bladder (n = 5), head and neck (n = 3), cervix (n = 1), esophageal (n = 1) or unknown primary carcinoma (n = 1)] were randomized to receive cisplatin 70 mg/m2 intravenously on day 2 plus either gemcitabine 1000 mg/m2 on days 1, 8 and 15 of a 28-day cycle or gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle. Planned DI (PDI) for the 4-week schedule was 750 mg/m2/week for gemcitabine and 17.5 mg/m2/week for cisplatin; for the 3-week regimen PDI was 666 mg/m2/week and 23 mg/m2/week for gemcitabine and cisplatin, respectively.

Results:

From July 1998 to March 2000, 107 patients were randomized. Grade 3/4 neutropenia was observed in 27.8% of patients in the 3-week versus 22.5% in the 4-week arm (P = 0.69), while grade 3/4 thrombocytopenia was higher in the 4-week arm (29.5% versus 5.5% of patients; P = 0.14). A total of 398 cycles of therapy were delivered. Overall, 51% of cycles were modified in dose, timing or both in the 4-week arm, and 19% in the 3-week arm. The 21-day schedule of GC leads to a similar received DI of gemcitabine and higher cisplatin DI. Both regimens had activity in NSCLC, with a response rate of 39% (38% for the 4-week arm, and 42% for the 3-week arm).

Conclusions:

The 3-week schedule has similar DI to the 4-week schedule. However the 3-week regimen has a better compliance profile and a comparable response rate in NSCLC, supporting the use of such a schedule.

Key words: chemotherapy, cisplatin, dose intensity, gemcitabine, NSCLC


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