Salah-Eldin Manal A, Ebrahim Mohamed A, AL-Ashry Mohamed S
Department of Medical Oncology, Mansoura University, Mansoura, Egypt.
Anticancer Drugs. 2009 Mar;20(3):191-6. doi: 10.1097/CAD.0b013e328325a9ec.
A phase II study was conducted to assess the efficacy and toxicity of combination therapy with capecitabine and cisplatin in patients with de-novo advanced gastric cancer, and in patients with refractory/recurrent gastric cancer after previous nonplatinum-based therapy. Sixty-four patients were enrolled in the study. Of these, 50 patients had untreated gastric cancer, and 14 had received previous therapy with nonplatinum-based therapy. All patients received oral capecitabine 1250 mg/m2 twice daily, days 1-14, and intravenous cisplatin 60 mg/m2 on day 1. This cycle was repeated every 3 weeks. Among the 50 previously untreated patients, three achieved complete response, and 19 had partial response, giving a response rate of 44% in the intention-to-treat population. The median time to progression and median overall survival were 6 months [95% confidence interval (CI): 1.4-10.6] and 9 months (95% CI: 5.7-12.3), respectively. In patients who had received previous therapy, clinical usefulness was evaluated resulting in response rate of 14%, disease control rate of 28.5%, and median overall survival of 4 months (95% CI: 3.1-4.9). The principal grade 3/4 adverse events were neutropenia (20%), anemia (14%). No neutropenic fever or treatment-related deaths. Capecitabine in combination with cisplatin is effective and well tolerated as first-line treatment in patients with advanced gastric cancer. Unfortunately, we could not positively suggest the usefulness of the same combination regimen as salvage therapy in patients with progressive or recurrent disease after nonplatinum-based therapy.
开展了一项II期研究，以评估卡培他滨与顺铂联合治疗对初治晚期胃癌患者以及先前接受过非铂类治疗的难治性/复发性胃癌患者的疗效和毒性。64例患者入组该研究。其中，50例患者为未经治疗的胃癌患者，14例患者先前接受过非铂类治疗。所有患者在第1 - 14天每天口服卡培他滨1250 mg/m²，分两次服用，并在第1天静脉注射顺铂60 mg/m²。每3周重复此周期。在50例先前未经治疗的患者中，3例达到完全缓解，19例部分缓解，意向性治疗人群的缓解率为44%。中位疾病进展时间和中位总生存期分别为6个月[95%置信区间（CI）：1.4 - 10.6]和9个月（95% CI：5.7 - 12.3）。在先前接受过治疗的患者中，评估了临床疗效，缓解率为14%，疾病控制率为28.5%，中位总生存期为4个月（95% CI：3.1 - 4.9）。主要的3/4级不良事件为中性粒细胞减少（20%）、贫血（14%）。未发生中性粒细胞减少性发热或治疗相关死亡。卡培他滨联合顺铂作为晚期胃癌患者的一线治疗有效且耐受性良好。不幸的是，对于先前接受过非铂类治疗后病情进展或复发的患者，我们无法肯定地推荐相同的联合方案作为挽救治疗的有效性。
