Cancer Center, Taipei Veterans General Hospital, Taipei, Taiwan.
Cancer Chemother Pharmacol. 2013 Sep;72(3):637-42. doi: 10.1007/s00280-013-2239-1. Epub 2013 Aug 3.
To compare the efficacy and toxicity of single-agent gemcitabine with gemcitabine plus cisplatin (G + C) in patients with metastatic pancreatic cancer
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.
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).
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.
比较单药吉西他滨与吉西他滨联合顺铂（G+C）在转移性胰腺癌患者中的疗效和毒性。
46 例转移性胰腺癌患者随机分为吉西他滨单药组（n=25；1000mg/m2）或 G+C 组（n=21；1000mg/m2 吉西他滨和 25mg/m2 顺铂）。治疗方案为每周 1 次，连续 3 周，每 4 周重复。
吉西他滨单药组和 G+C 组患者的特征相似。吉西他滨单药组和 G+C 组的吉西他滨剂量强度相似（684±32 与 617±31mg/m2/周）。顺铂剂量强度为 15.1±0.9mg/m2/周×9.9±1.8 周。吉西他滨单药组和 G+C 组的部分缓解率分别为 8%（2/25）和 4.8%（1/21）（p=1）。吉西他滨单药组和 G+C 组的中位生存时间和中位无进展生存时间分别为 7.7 和 4.6 个月和 7.9 和 3.6 个月（p=0.752 和 p=0.857）。吉西他滨单药组和 G+C 组的临床获益率分别为 36%和 29%（p=0.592）。吉西他滨单药组和 G+C 组的质量调整生命月数分别为 5.6±0.3 和 3.8±0.2（p<0.001）。吉西他滨单药组和 G+C 组的 3/4 级中性粒细胞减少症（8%比 19%）和贫血症（8%比 10%）的频率以及每月生存天数的住院天数（4.7±1.3 比 6.3±1.6 天；p=0.431）无显著差异。然而，G+C 组患者的血小板减少症发生率高于吉西他滨单药组（62%比 24%；p=0.009）。
吉西他滨单药和 G+C 在转移性胰腺癌中具有相似且适度的反应率，但吉西他滨单药的毒性低于 G+C。
