Phase II trial of capecitabine plus modified cisplatin (mXP) as first-line therapy in Japanese patients with metastatic gastric cancer (KSCC1104).
Phase II trial of capecitabine plus modified cisplatin (mXP) as first-line therapy in Japanese patients with metastatic gastric cancer (KSCC1104).
复制标题
DOI：
10.1007/s00280-016-3204-6
复制
发表时间：
2017-01
影响因子：
3
通讯作者：
Kyushu Study Group of Clinical Cancer
中科院分区：
文献类型：
--
作者：
Satake H;Iwatsuki M;Uenosono Y;Shiraishi T;Tanioka H;Saeki H;Sugimachi K;Kitagawa D;Shimokawa M;Oki E;Emi Y;Kakeji Y;Tsuji A;Akagi Y;Natsugoe S;Baba H;Maehara Y;Kyushu Study Group of Clinical Cancer
卡培他滨联合顺铂(XP)是转移性胃癌(MGC)的标准疗法。然而，尽管先前III期试验的结果表明日本患者应该减少顺铂的剂量，但没有临床数据支持这一点。在这里，我们进行了一项多中心研究，以评估改良XP(MXP)对日本MGC患者的疗效和安全性。既往未经治疗的MGC患者每3周接受一次MXP治疗(顺铂60 mg/m2，第1天；卡培他滨1000 mg/m2，第1-14天，每日2次)。主要终点是实体瘤的反应评估标准-确认的总反应率(ORR)。样本量计划为40，阈值ORR值为30%，期望值为50%，单侧α为0.05，Beta值约为0.2。42例患者入选。一名患者不符合资格标准；因此，总共评估了41名患者。结果：完全缓解2例，部分缓解16例，稳定14例，进展8例，无评价1例。确诊ORR为43.9%(95%可信区间28.7~59.1%)。中位无进展生存期和中位总生存期分别为4.6个月和11.3个月。最常见的3级或4级不良反应是中性粒细胞减少(37.5%)、贫血(24.4%)、厌食(24.4%)和恶心(12.2%)。日本MGC患者使用MXP的一线化疗没有达到其主要目标。然而，它确实显示出有希望的应答率和可接受的耐受性。
Capecitabine plus cisplatin (XP) is a standard therapy for metastatic gastric cancer (mGC). However, while results from previous phase III trials suggested that the cisplatin dosage should be reduced in Japanese patients, no clinical data exist to support this. Here, we conducted a multicenter study to evaluate the efficacy and safety of modified XP (mXP) in Japanese patients with mGC. Patients with previously untreated mGC received mXP (cisplatin 60 mg/m2 on day 1 plus capecitabine 1000 mg/m2 twice daily on days 1–14) every 3 weeks. The primary endpoint was the Response Evaluation Criteria in Solid Tumors-confirmed overall response rate (ORR). A sample size of 40 was planned for a threshold ORR of 30% and an expected value of 50%, with a one-sided α of 0.05 and a beta of approximately 0.2. Forty-two patients were enrolled. One patient did not fulfill the eligibility criteria; therefore, a total of 41 patients were assessed. The results were as follows: complete response in 2 patients, partial response in 16, stable disease in 14, progressive disease in 8, and no evaluation in 1. The confirmed ORR was 43.9% (95% confidence interval 28.7–59.1%). The median progression-free survival and median overall survival were 4.6 and 11.3 months, respectively. The most common grade 3 or 4 adverse events were neutropenia (37.5%), anemia (24.4%), anorexia (24.4%), and nausea (12.2%). First-line chemotherapy with mXP in Japanese patients with mGC did not reach its primary objective. However, it did show a promising response rate and an acceptable tolerability profile.