Updated analysis of nivolumab and ipilimumab combination therapy in Japanese patients with advanced melanoma
Updated analysis of nivolumab and ipilimumab combination therapy in Japanese patients with advanced melanoma
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日本晚期黑色素瘤患者纳武单抗和伊匹单抗联合治疗的最新分析
DOI：
10.1111/1346-8138.16669
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发表时间：
2022
期刊：
影响因子：
--
通讯作者：
Yamazaki N.
中科院分区：
文献类型：
--
作者：
Takahashi A;Namikawa K;Ogata D;Jinnai S;Nakano E;Yamazaki N.
在临床实践中，对尼伏单抗和伊普利单抗(N + I)联合治疗日本晚期不能切除黑色素瘤的有效性和安全性进行了重新评估。研究对象包括100名日本晚期黑色素瘤患者。总有效率为24%，完全缓解(CR)为6%，部分缓解为18%。单纯治疗组有效率为33.3%，先期治疗组有效率为15.4%，病情进展后接受一线抗程序性死亡1抗体单抗治疗后再接受二线N- + I治疗的有效率为16.1%。皮肤黑色素瘤有效率为32.7%，单纯组有效率为47.8%。非肢端黑色素瘤、肢端黑色素瘤和粘膜黑色素瘤的有效率分别为34.9%、25%和16.7%。所有患者的中位无进展生存期(PFS)为3.25 月(单纯治疗组和治疗前组分别为6.5和2.5个月)。中位总生存期(OS)为14.5个月(单纯组为25.25个月，治疗前组为7.5个月)。非肢端黑色素瘤、肢端黑色素瘤或粘膜黑色素瘤患者的PFS或OS无显著差异。综合治疗获得CR的患者3年PFS和OS均为100%。89%的病例发生不良事件，56%的病例达到或超过3级。尽管由于患者背景不同，不能进行直接比较，但在临床实践中，日本患者的N + I联合治疗在临床实践中往往不如全球研究和非亚洲患者。皮肤黑色素瘤治疗-单纯组有效率最高。最好的肿瘤反应与生存结果相关，在获得CR的病例中，PFS和OS良好。三级和四级不良事件的比例与全球研究中的比例一样高。
The efficacy and safety of nivolumab and ipilimumab (N + I) combination therapy for Japanese patients with advanced unresectable melanoma was re‐evaluated in clinical practice. One hundred Japanese patients with advanced melanoma were included. The overall response rate was 24%; complete response (CR), 6%; partial response, 18%. The response rates were 33.3% in the systemic therapy‐naïve and 15.4% in the prior‐treatment groups, and 16.1% for patients who were treated with first‐line anti‐programmed death 1 antibody monotherapy followed by second‐line N + I therapy after progression of the disease. The response rate for cutaneous melanoma was 32.7%, and 47.8% in the naïve group. Response rates for non‐acral, acral, and mucosal melanoma were 34.9%, 25%, and 16.7%, respectively. The median progression‐free survival (PFS) for all patients was 3.25 months (6.5 and 2.5 months in the naïve and prior‐treatment groups, respectively). Median overall survival (OS) was 14.5 months (25.25 and 7.5 months in the naïve and prior‐treatment groups, respectively). There were no significant differences in PFS or OS for patients with non‐acral, acral, or mucosal melanoma. The 3‐year PFS and OS were both 100% in patients who achieved CR with combination therapy. Adverse events occurred in 89% and were grade three or higher in 56% of cases. Although direct comparisons cannot be made due to different patient backgrounds, N + I combination therapy in Japanese patients in clinical practice tended to be inferior when compared to global study and non‐Asian patients in clinical practice. The highest response rate was in the cutaneous melanoma therapy‐naïve group. The best tumor response was associated with survival outcome, and the PFS and OS were good in cases where CR was obtained. The proportion of grade three and four adverse events was as high as that in the global study.
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影响因子：
51.1
作者：
da Silva, Ines Pires;Ahmed, Tasnia;Long, Georgina V.
通讯作者：
Long, Georgina V.
影响因子：
8.4
作者：
Namikawa, Kenjiro;Kiyohara, Yoshio;Yamazaki, Naoya
通讯作者：
Yamazaki, Naoya
2015年太平洋化学展
DOI：
--
发表时间：
2015
期刊：
影响因子：
--
作者：
通讯作者：
--
影响因子：
45.3
作者：
D'Angelo, Sandra P.;Larkin, James;Wolchok, Jedd D.
通讯作者：
Wolchok, Jedd D.
影响因子：
158.5
作者：
Robert, Caroline;Long, Georgina V.;Ascierto, Paolo A.
通讯作者：
Ascierto, Paolo A.