Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Kitakyushu, Fukuoka, Japan.
Int J Clin Oncol. 2019 May;24(5):508-515. doi: 10.1007/s10147-018-01391-w. Epub 2019 Jan 2.
Dose modification of chemotherapy for metastatic colorectal cancer (MCRC) is often needed, especially in second-line and later-line treatments due to adverse events of previous treatment and poor patient condition. No study has focused on ramucirumab plus modified dose of FOLFIRI for MCRC, and whether low relative dose intensity (RDI) affects treatment efficacy has not been clarified.
MCRC patients who received ramucirumab plus FOLFIRI, which consisted of 150 mg/m of irinotecan, at six institutions were retrospectively analyzed.
A total of 43 patients were assessed. Median age was 63 years, and 22 patients (51%) were women. Twenty-six patients (60%) were given ramucirumab plus FOLFIRI as second-line therapy, and 17 (40%) as third or later-line. The median relative dose intensity (RDI) of irinotecan was 60.6%, which is lower than that in the pivotal phase 3 study (RAISE), and other agents showed the same trend. Median progression-free survival was 4.8 [95% confidence interval (CI) 3.2-5.7] months for all patients, 5.4 (95% CI 3.5-7.2) months for second-line patients, and 2.8 (95% CI 1.6-5.8) months for third or later-line patients. Median overall survival was 17.3 (95% CI 11.5-22.4) months for all patients. Patients with irinotecan RDI less than 60% showed similar treatment efficacy. Hematological toxicities of grade 3 or worse were observed in 21 patients, but all were manageable.
Low RDI did not compromise the treatment efficacy of ramucirumab plus modified FOLFIRI for MCRC patients.
转移性结直肠癌（MCRC）的化疗剂量调整通常是必要的，尤其是在二线及以后的治疗中，因为之前治疗的不良反应和患者状况不佳。没有研究专门针对雷莫芦单抗联合改良剂量 FOLFIRI 治疗 MCRC，也不清楚低相对剂量强度（RDI）是否会影响治疗效果。
对在六家机构接受雷莫芦单抗联合 FOLFIRI（伊立替康剂量为 150mg/m2）治疗的 MCRC 患者进行回顾性分析。
共评估了 43 例患者。中位年龄为 63 岁，22 例（51%）为女性。26 例（60%）患者接受雷莫芦单抗联合 FOLFIRI 二线治疗，17 例（40%）为三线或更后线治疗。伊立替康的中位相对剂量强度（RDI）为 60.6%，低于关键性 III 期研究（RAISE）中的 RDI，其他药物也呈现出相同的趋势。所有患者的中位无进展生存期为 4.8[95%置信区间（CI）3.2-5.7]个月，二线患者为 5.4（95%CI 3.5-7.2）个月，三线或更后线患者为 2.8（95%CI 1.6-5.8）个月。所有患者的中位总生存期为 17.3（95%CI 11.5-22.4）个月。RDI 低于 60%的患者治疗效果相似。观察到 21 例患者出现 3 级或更严重的血液学毒性，但均可控。
低 RDI 并不影响雷莫芦单抗联合改良 FOLFIRI 治疗 MCRC 患者的疗效。
