Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
Department of Respiratory Medicine, Hokkaido Cancer Center, Sapporo, Japan.
Med Oncol. 2022 Aug 16;39(11):163. doi: 10.1007/s12032-022-01755-3.
We conducted a multicenter phase II trial to evaluate the efficacy and safety of S-1 and irinotecan combination therapy in patients with epidermal growth factor receptor-mutated non-small-cell lung cancer treated with epidermal growth factor receptor tyrosine kinase inhibitors. Epidermal growth factor receptor-mutated non-small-cell lung cancer patients treated with epidermal growth factor receptor tyrosine kinase inhibitors and platinum-based chemotherapy received 80 mg/m S-1 on days 1-14 and 70 mg/m irinotecan on days 1 and 8 of a 21-day cycle. The primary endpoint was disease control rate 8 weeks after enrollment. The secondary endpoints were progression-free survival, overall response rate, and safety. We enrolled 25 patients from five hospitals. The patients underwent a median of four cycles. The disease control rate, 8 weeks after enrollment, was 84% (95% confidence interval 63.9-95.5%). Progression-free survival and overall survival were 5.0 and 17.1 months, respectively. The overall response rate was 52.0%. Grade ≥ 3 adverse events were reported in 56.0% of patients: hematological toxicities of leukopenia (44%), neutropenia (52%), anemia (20%), thrombocytopenia (20%), and febrile neutropenia (16%). Non-hematological toxicities of grade ≥ 3 included elevated alanine aminotransferase (4%), anorexia (8%), nausea (4%), diarrhea (16%), and pulmonary embolism (4%). None developed grade 5 toxicities. Combination therapy with S-1 and irinotecan in patients with epidermal growth factor receptor-mutated non-small-cell lung cancer treated with epidermal growth factor receptor tyrosine kinase inhibitors and platinum-based chemotherapy demonstrated high effectiveness with tolerable toxicities. Future phase III studies are needed to evaluate the role of this treatment in such patients.
我们进行了一项多中心 II 期临床试验，以评估 S-1 和伊立替康联合治疗方案在表皮生长因子受体突变型非小细胞肺癌患者中的疗效和安全性，这些患者在接受表皮生长因子受体酪氨酸激酶抑制剂和铂类化疗治疗后。表皮生长因子受体突变型非小细胞肺癌患者在接受表皮生长因子受体酪氨酸激酶抑制剂和铂类化疗治疗后，接受 S-1（第 1 天至第 14 天，80mg/m2）和伊立替康（第 1 天和第 8 天，70mg/m2），每 21 天为一个周期。主要终点是入组后 8 周的疾病控制率。次要终点包括无进展生存期、总缓解率和安全性。我们从五家医院招募了 25 名患者。患者接受了中位数为四个周期的治疗。入组后 8 周的疾病控制率为 84%（95%置信区间 63.9-95.5%）。无进展生存期和总生存期分别为 5.0 个月和 17.1 个月。总缓解率为 52.0%。56.0%的患者出现了≥3 级不良事件：白细胞减少症（44%）、中性粒细胞减少症（52%）、贫血症（20%）、血小板减少症（20%）和发热性中性粒细胞减少症（16%）等血液学毒性；丙氨酸氨基转移酶升高（4%）、厌食症（8%）、恶心（4%）、腹泻（16%）和肺栓塞（4%）等≥3 级非血液学毒性。没有患者发生 5 级毒性。在接受表皮生长因子受体酪氨酸激酶抑制剂和铂类化疗治疗的表皮生长因子受体突变型非小细胞肺癌患者中，S-1 和伊立替康联合治疗方案具有较高的疗效和可耐受的毒性。需要进一步开展 III 期临床试验，以评估该治疗方案在这类患者中的作用。
