A randomized controlled trial of gemcitabine plus cisplatin versus gemcitabine alone in the treatment of metastatic pancreatic cancer.

PURPOSE

To compare the efficacy and toxicity of single-agent gemcitabine with gemcitabine plus cisplatin (G + C) in patients with metastatic pancreatic cancer

METHODS

Forty-six patients with metastatic pancreatic cancer were randomized to receive gemcitabine alone (n = 25; 1,000 mg m(-2)) or G + C (n = 21; 1,000 mg m(-2) gemcitabine and 25 mg m(-2) cisplatin). Treatments were administered once a week for 3 weeks and repeated every 4 weeks.

RESULTS

Patient characteristics were comparable between the gemcitabine alone and G + C groups. The gemcitabine dose intensity was similar between the gemcitabine alone and G + C groups (684 ± 32  vs. 617 ± 31 mg m(-2) week(-1)). The cisplatin dose intensity was 15.1 ± 0.9 mg m(-2) week(-1) × 9.9 ± 1.8 weeks. Partial response rates were 8 % (2/25) for gemcitabine alone and 4.8 % (1/21) for G + C (p = 1). The median survival and median time to progression were 7.7 and 4.6 months for gemcitabine alone and 7.9 and 3.6 months for G + C, respectively (p = 0.752 and p = 0.857, respectively). Clinical benefit was 36 % for gemcitabine alone and 29 % for G + C (p = 0.592). Quality-adjusted life months were 5.6 ± 0.3 for the gemcitabine alone group and 3.8 ± 0.2 for the G + C group (p < 0.001). The frequency of grade 3/4 neutropenia (8 vs. 19 %) and anemia (8 vs. 10 %) and the number of hospitalization days per month of survival (4.7 ± 1.3 vs. 6.3 ± 1.6 days; p = 0.431) were not significantly different between patients who received gemcitabine alone and those who received G + C. However, patients in the G + C group had a higher rate of thrombocytopenia than did patients in the gemcitabine alone group (62 vs. 24 %; p = 0.009).

CONCLUSIONS

Gemcitabine alone and G + C had comparable and modest response rates in metastatic pancreatic cancer, but gemcitabine alone produced less toxicities than did G + C.