Medline ® Abstract for Reference 96
A randomized controlled trial of gemcitabine plus cisplatin versus gemcitabine alone in the treatment of metastatic pancreatic cancer.
Chao Y, Wu CY, Wang JP, Lee RC, Lee WP, Li CP
Cancer Chemother Pharmacol. 2013 Sep;72(3):637-42. Epub 2013 Aug 3.
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.
Cancer Center, Taipei Veterans General Hospital, Taipei, Taiwan.