Introduction/Background

The administration schedule of capecitabine for the treatment of metastatic colorectal cancer (mCRC) in clinical trials has been 14 days of drug with 7 days off in a 21 day cycle (14/7). In an effort to improve tolerability, an alternative every other week treatment (7/7) is often administered. The purpose of this study was to determine the safety and efficacy of administering 7/7 compared with 14/7 capecitabine dosing.

Materials and Methods

In this retrospective study, mCRC patients received capecitabine on a 7/7 or 14/7 schedule. The primary objective was to determine the tolerability of the respective dosing schedules, defined according to frequency of dose reductions and treatment delays. Secondary objectives included comparisons of objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety of dosing strategies.

Results

Of 175 included patients, 73 (41.7%) received the capecitabine 7/7 schedule and 102 (58.3%) received the 14/7 schedule. There was a statistically significant difference between the 7/7 and 14/7 groups with regard to dose reductions (4% vs. 29%; P < .001) and treatment delays (22% vs. 43%; P = .004). The incidence of any adverse effects (45% vs. 72%; P < .001) and specifically, palmar-plantar erythrodysesthesia (18% vs. 45%; P < .001), were significantly higher in the 14/7 group. No significant difference was seen with regard to ORR, PFS, or OS.

Conclusion

Patients with mCRC who received the 7/7 schedule had significantly fewer dose reductions and treatment delays compared with patients who received the 14/7 schedule. Although no difference in efficacy outcomes were observed, prospective studies are needed to confirm these findings.

中文翻译：

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卡培他滨治疗转移性结直肠癌患者 7 天/7 天与 14 天/7 天休息时间表的安全性和有效性：回顾性研究

介绍/背景

在临床试验中，卡培他滨用于治疗转移性结直肠癌 (mCRC) 的给药时间表是 14 天的药物，在 21 天的周期 (14/7) 中停药 7 天。为了提高耐受性，通常每隔一周进行一次替代治疗 (7/7)。本研究的目的是确定与 14/7 卡培他滨给药相比，7/7 给药的安全性和有效性。

材料和方法

在这项回顾性研究中，mCRC 患者按 7/7 或 14/7 时间表接受卡培他滨。主要目标是确定各个给药方案的耐受性，根据剂量减少和治疗延迟的频率进行定义。次要目标包括比较客观缓解率 (ORR)、无进展生存期 (PFS)、总生存期 (OS) 和给药策略的安全性。

结果

在纳入的 175 名患者中，73 名 (41.7%) 接受卡培他滨 7/7 计划，102 (58.3%) 接受 14/7 计划。7/7 和 14/7 组在剂量减少（4% 对 29%；P  < .001）和治疗延迟（22% 对 43%；P  = .004）方面存在统计学显着差异.  在 14/7 组中，任何不良反应的发生率（45% 对 72%；P  < .001），特别是掌跖感觉异常（18% 对 45%；P < .001）明显更高。在 ORR、PFS 或 OS 方面没有发现显着差异。

结论

与接受 14/7 计划的患者相比，接受 7/7 计划的 mCRC 患者的剂量减少和治疗延迟显着减少。虽然没有观察到疗效结果的差异，但需要前瞻性研究来证实这些发现。