III. Medizinische Klinik, Hämatologie und Onkologie, Universitätsmedizin Mannheim, Mannheim, Germany.
J Cancer Res Clin Oncol. 2014 May;140(5):829-37. doi: 10.1007/s00432-014-1619-1. Epub 2014 Feb 21.
We conducted a multicenter phase II study to assess the toxicity and efficacy of a combination of mitomycin C (MMC) and capecitabine in pretreated patients with metastatic or locally advanced gastric cancer.
Thirty-nine patients (77 % male) between 33 and 78 years (median 66) with pretreated locally advanced or metastatic esophagogastric adenocarcinoma and eastern cooperative oncology group performance status of ≤2, measurable lesions, and adequate organ functions were recruited into the study. Eight patients (21 %) had received more than one prior chemotherapy regimen. Treatment consisted of three-weekly MMC 10 mg/m(2) day 1 and capecitabine 2,000 mg/m(2) (day 1-14; repeated day 22).
A median of three cycles of therapy was administered. Grade 3 toxicity occurred in 20 patients (54 %). Main grade 3 adverse events were thrombocytopenia (11 %, n = 4), fatigue (8 %, n = 3), and neuropathy (8 %, n = 3). Two events of grade 4 toxicity were reported (5 %) (dyspnea and elevation of alkaline phosphatase due to bone metastases). Partial remission was noticed in 10.3 % (n = 4), stable disease in 33.3 % (n = 13) adding to a tumor control rate of 43.6 %. The median progression-free and overall survival were 2.8 and 5.6 months, respectively.
The combination of MMC and capecitabine exhibited a favorable tolerability profile in pretreated patients with gastric cancer. The disease control rate compares adequately with that of other phase II and phase III trials for second-line therapy in gastric cancer. This regimen may be considered as an alternative second-line treatment, especially for patients not suitable for or pretreated with taxanes and/or irinotecan.
我们进行了一项多中心 II 期研究，以评估在预处理的转移性或局部晚期胃癌患者中联合使用丝裂霉素 C（MMC）和卡培他滨的毒性和疗效。
招募了 39 名（77%为男性）年龄在 33 至 78 岁（中位数为 66 岁）的患者，他们患有预处理的局部晚期或转移性胃食管腺癌，东部合作肿瘤组的体能状态为≤2，可测量病变和足够的器官功能。8 名患者（21%）接受了超过一种先前的化疗方案。治疗包括每周一次 MMC 10mg/m²（第 1 天）和卡培他滨 2000mg/m²（第 1-14 天；第 22 天重复）。
中位数接受了三个周期的治疗。20 名患者（54%）出现了 3 级毒性。主要的 3 级不良事件是血小板减少症（11%，n=4）、疲劳（8%，n=3）和神经病变（8%，n=3）。报告了 2 例 4 级毒性事件（5%）（呼吸困难和碱性磷酸酶升高，由骨转移引起）。部分缓解率为 10.3%（n=4），稳定疾病率为 33.3%（n=13），肿瘤控制率为 43.6%。中位无进展生存期和总生存期分别为 2.8 和 5.6 个月。
在预处理的胃癌患者中，MMC 和卡培他滨联合治疗显示出良好的耐受性。疾病控制率与其他二线治疗胃癌的 II 期和 III 期试验相当。该方案可被视为二线治疗的一种替代方案，特别是对于不适合接受紫杉烷类和/或伊立替康治疗或已接受预处理的患者。
