Background

Older or frail patients are often underrepresented in clinical trials for metastatic colorectal cancer (mCRC). We here assessed the efficacy and safety of 5-fluorouracil (5-FU)–leucovorin plus bevacizumab in such patients.

Methods

The study (OGSG 0802) was designed as a single-arm, open-label, multicenter phase II trial. Eligible patients had mCRC and at least one of the following: an age of ≥ 65 years, an Eastern Cooperative Oncology Group performance status of 1 or 2, a serum albumin level of ≤ 3.5 g/dL, incompatibility with oxaliplatin or irinotecan, and a history of abdominal or pelvic radiotherapy. Patients received 5-FU (600 mg/m²) and l-leucovorin (200 mg/m²) on days 1, 8, and 15 together with bevacizumab (5 mg/kg) on days 1 and 15 every 4 weeks. The primary end point was objective response rate (ORR), and secondary end points were progression-free survival (PFS), overall survival (OS), and safety.

Results

Forty-one patients were enrolled and eligible. Median age was 76 years (range 56–90 years), and 51% of patients had a performance status of 0. The ORR was 36.6% [95% confidence interval (CI) 22.1–53.1%], median PFS was 9.4 months (95% CI 7.4–17.7 months), and median OS was 24.0 months (95% CI 19.9 months—not reached). The most common treatment-related adverse events of grade ≥ 3 were neutropenia (24%), anorexia (10%), leukopenia (7%), and mucositis/stomatitis (7%). There were no treatment-related deaths.

Conclusion

Weekly 5-FU–leucovorin with biweekly bevacizumab may be a tolerable and effective treatment option for older or frail patients with mCRC.

中文翻译：

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5-氟尿嘧啶-亚叶酸钙+贝伐单抗用于未接受化疗的年龄较大或体弱的转移性结直肠癌患者的II期研究（OGSG 0802）

背景

年龄较大或体弱的患者在转移性结直肠癌（mCRC）的临床试验中通常代表性不足。我们在这里评估了5-氟尿嘧啶（5-FU）-亚叶酸钙+贝伐单抗在此类患者中的疗效和安全性。

方法

该研究（OGSG 0802）设计为单臂，开放标签，多中心II期临床试验。符合条件的患者患有mCRC并具有以下至少一项：年龄≥65岁，东部合作肿瘤小组的工作状态为1或2，血清白蛋白水平≤3.5 g / dL，与奥沙利铂或伊立替康不相容，以及腹部或骨盆放疗史。患者每4周在第1、8和15天接受5-FU（600 mg / m ²）和l-亚叶酸（200 mg / m ²）以及在第1和15天接受贝伐单抗（5 mg / kg）。主要终点为客观缓解率（ORR），次要终点为无进展生存期（PFS），总体生存期（OS）和安全性。

结果

入组的41例患者符合条件。中位年龄为76岁（范围56-90岁），有51％的患者表现为0。ORR为36.6％[95％置信区间（CI）为22.1-53.1％]，中位PFS为9.4个月（ 95％CI 7.4-17.7个月），中位OS​​为24.0个月（95％CI 19.9个月-未达到）。≥3级最常见的与治疗相关的不良事件是中性粒细胞减少症（24％），厌食症（10％），白细胞减少症（7％）和粘膜炎/口腔炎（7％）。没有与治疗有关的死亡。

结论

对于年龄较大或体弱的mCRC患者，每周一次5-FU-亚叶酸和贝伐单抗双周治疗可能是一种可以耐受且有效的治疗选择。