ASCO 2015：化疗后卡培他滨单药维持对mCRC的疗效

Tags: 卡培他滨化疗作者：MedSci 更新：2015-05-29

第51届美国临床肿瘤学会（ASCO）年会即将在期待中拉开序幕。中山大学肿瘤医院的徐瑞华教授团队带来的一项多中心、随机III期临床研究将进行壁报展示。这项研究是第一个评估XELOX或FOLFOX诱导治疗后使用卡培他滨维持，与观察相比，直至一线治疗中出现疾病进展为止的有效性和安全性的随机研究（摘要号3580）。

结直肠癌（CRC）是最常见的恶性肿瘤之一。所有晚期CRC在一线治疗后都将会发生进展。因此，需要急迫寻找一个有效、低毒性的维持方案以延长无进展生存期(PFS)。一些临床研究表示一线治疗后维持方案能够延长PFS。

该研究团队之前的一个非随机的小样本研究表明，使用XELOX一线治疗后随后使用卡培他滨作为维持疗法，能够显著延长中位至进展时间（TTP）。因此，研究人员这次计划启动第一个评估XELOX或FOLFOX诱导治疗后使用卡培他滨维持对比观察直至一线治疗中出现进展的有效性和安全性的随机研究。

患者均接受18-22周XELOX 或FOLFOX后获得客观缓解或稳定。将这些患者按1:1比例分为接受卡培他滨维持治疗组和仅观察组，直到疾病发生进展。卡培他滨组在每3周的第1-14天每天用1,000 mg/m2两次。研究的首要观察终点为PFS，其定义为初始治疗至第一次记录疾病进展或死亡的间期。

此意向性治疗人群包括275名患者（卡培他滨维持组，n=136；观察组，n=139）；两组基线特征无明显差异。中位随访时间为29.0个月（范围，0-62.5个月）。卡培他滨维持组中位无病生存期明显长于观察组（11.0个月，[95% 置信区间(CI) 9.45到12.5m] vs. 8.0个月，[95%CI 7.2m到8.8m]; p < 0.001）。与观察组相比，卡培他滨维持组最常见的3级或4级毒副反应是嗜中性白血球减少症、手足综合征和黏膜炎。

与观察组相比，XELOX或FOLFOX诱导治疗后使用单药卡培他滨单药维持可以提高mCRC患者的预后。

摘要原文

Background: Colorectal cancer (CRC) is one of the most common malignant tumors. All advanced CRC will progress after first-line treatment. Therefore, it is emergent to seek an efficient and low toxic maintaining regimen to prolong progression free survival (PFS). Some clinical researches demonstrated that maintaining treatment followed first-line treating could extend PFS. Our previous non-randomized small sample study indicated that patients receiving first-line treatment of XELOX followed by capecitabine as maintaining therapy had significantly prolonged median time to progression (TTP). Therefore, we plan to initiate the first randomized study to evaluate the efficacy and safety of maintenance therapy with capecitabine following induction of (XELOX) or (FOLFOX) versus observation until progression in first-line therapy in metastatic CRC.

Methods: This is a multi-center, randomized phase III study. Patients who received 18-22 weeks chemotherapy with XELOX or FOLFOX and achieved objective response or stable disease were randomized 1:1 to received maintenance therapy of capecitabine (1,000 mg/m2 twice a day from days 1–14, every 3 weeks) or only observation until disease progression. The primary endpoint was PFS, which was defined as the interval between initial treatment and the first documentation of disease progression or death.

Results: The intent-to-treat population comprised 275 patients (capecitabine maintenance, n= 136; observation, n=139); there were no significant differences in baseline characteristics. The median follow-up was 29.0 months (range, 0–62.5 months). Median PFS in capecitabine maintenance group was significantly longer than the observation group (11.0 months [95% confidence interval (CI) 9.45 to 12.5m] versus. 8.0months, [95%CI 7.2m to 8.8m]; p < 0.001). The most common grade 3 or 4 toxicities in capecitabine maintenance versus observation were neutropenia, hand–foot syndrome, and mucositis.

Conclusions: Maintenance therapy with capecitabine single agent following induction of XELOX or FOLFOX improved the outcome in patients with mCRC, as compared with the observation group. Clinical trial information: NCT02027363

来源：MedSci原创

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ASCO 2015：化疗后卡培他滨单药维持对mCRC的疗效

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