Hotta Katsuyuki, Nishio Makoto, Saito Haruhiro, Okamoto Isamu, Nakahara Yasuharu, Hayashi Hidetoshi, Hayama Manabu, Laud Peter, Jiang Haiyi, Paz-Ares Luis, Azuma Koichi
Department of Respiratory Medicine, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700 8558, Japan.
Center for Innovative Clinical Medicine, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700 8558, Japan.
Int J Clin Oncol. 2021 Jun;26(6):1073-1082. doi: 10.1007/s10147-021-01899-8. Epub 2021 Apr 7.
In the phase 3 CASPIAN study (NCT03043872), first-line durvalumab plus etoposide and cisplatin or carboplatin (EP) significantly improved OS versus EP alone in patients with extensive-stage (ES)-SCLC (HR 0.73 [95% CI 0.59-0.91; p = 0.0047]). Here we report results for a preplanned subgroup analysis of patients recruited in Japan.
Treatment-naïve patients with ES-SCLC received either 4 cycles of durvalumab 1500 mg plus EP q3w followed by maintenance durvalumab 1500 mg q4w until disease progression or up to 6 cycles of EP q3w. The primary endpoint was OS. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), safety, and tolerability.
In the Japan subgroup, 18 patients were randomized to durvalumab plus EP and 16 patients to EP. At the interim analysis with a median follow-up of 12.5 months in the subgroup, OS numerically favored durvalumab plus EP versus EP (HR 0.77 [95% CI 0.26‒2.26]; median not reached vs 15.2 months). PFS was similar for durvalumab plus EP versus EP (HR 0.90 [95% CI 0.43‒1.89]). Confirmed ORR was 89% with durvalumab plus EP versus 69% with EP. Adverse events (AEs) of CTCAE grade 3 or 4 were reported in 78% versus 94% of patients in the durvalumab plus EP versus EP arms. There were no AEs leading to treatment discontinuation or death in the Japan subgroup.
First-line durvalumab plus EP was effective and well tolerated in Japanese patients with ES-SCLC. Despite the small size of the Japan subgroup, results were generally consistent with the global study population.
在3期CASPIAN研究（NCT03043872）中，对于广泛期（ES）小细胞肺癌（SCLC）患者，一线使用度伐利尤单抗联合依托泊苷和顺铂或卡铂（EP）相较于单纯使用EP显著改善了总生存期（OS）（风险比[HR]0.73[95%置信区间（CI）0.59 - 0.91；p = 0.0047]）。在此，我们报告对日本招募患者进行的一项预先计划的亚组分析结果。
初治的ES - SCLC患者接受4个周期的度伐利尤单抗1500 mg联合EP，每3周一次，随后接受度伐利尤单抗1500 mg维持治疗，每4周一次，直至疾病进展，或接受6个周期的EP，每3周一次。主要终点为OS。次要终点包括无进展生存期（PFS）、客观缓解率（ORR）、安全性和耐受性。
在日本亚组中，18例患者被随机分配至度伐利尤单抗联合EP组，16例患者被分配至EP组。在亚组中位随访12.5个月的中期分析中，OS在数值上有利于度伐利尤单抗联合EP组而非EP组（HR 0.77[95%CI 0.26 - 2.26]；未达到中位生存期vs 15.2个月）。度伐利尤单抗联合EP组与EP组的PFS相似（HR 0.90[95%CI 0.43 - 1.89]）。度伐利尤单抗联合EP组的确认ORR为89%，而EP组为69%。度伐利尤单抗联合EP组与EP组分别有78%和94%的患者报告了3级或4级的不良事件（AE）。在日本亚组中，没有AE导致治疗中断或死亡。
一线度伐利尤单抗联合EP在日本ES - SCLC患者中有效且耐受性良好。尽管日本亚组规模较小，但结果总体上与全球研究人群一致。
