Real-world effectiveness of nivolumab plus ipilimumab and second-line therapy in Japanese untreated patients with metastatic renal cell carcinoma: 2-year analysis from a multicenter retrospective clinical study (J-cardinal study)

被引：10

作者：

Kojima, Takahiro ^{[1
,2
]}

Kato, Renpei ^{[3
]}

Sazuka, Tomokazu ^{[4
]}

Yamamoto, Hayato ^{[5
]}

Fukuda, Shohei ^{[6
]}

Yamana, Kazutoshi ^{[7
]}

Nakaigawa, Noboru ^{[8
]}

Sugino, Yusuke ^{[9
]}

Hamamoto, Shuzo ^{[10
]}

Ito, Hiroaki ^{[11
]}

Murakami, Hiroshi ^{[12
]}

Obara, Wataru ^{[3
]}

机构：

[1] Univ Tsukuba, Fac Med, Dept Urol, Ibaraki, Japan

[2] Aichi Canc Ctr Hosp, Dept Urol, Nagoya, Aichi, Japan

[3] Iwate Med Univ, Dept Urol, Morioka, Iwate, Japan

[4] Chiba Univ, Dept Urol, Grad Sch Med, Chiba, Japan

[5] Hirosaki Univ, Dept Urol, Grad Sch Med, Aomori, Japan

[6] Tokyo Med & Dent Univ, Dept Urol, Tokyo, Japan

[7] Niigata Univ, Grad Sch Med & Dent Sci, Dept Urol Mol Oncol, Niigata, Japan

[8] Yokohama City Univ, Dept Urol, Grad Sch Med, Yokohama, Kanagawa, Japan

[9] Mie Univ, Dept Nephro Urol Surg & Androl, Grad Sch Med, Tsu, Mie, Japan

[10] Nagoya City Univ, Grad Sch Med Sci, Dept Nephrourol, Nagoya, Aichi, Japan

[11] Bristol Myers Squibb KK, Oncol Med, Tokyo, Japan

[12] Ono Pharmaceut Co Ltd, Oncol Med Affairs, Tokyo, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2022年 / 52卷 / 11期

关键词：

nivolumab; ipilimumab; renal cell carcinoma; real-world; Japan; MOLECULAR TARGETED THERAPY; KINASE INHIBITORS; SUBGROUP ANALYSIS; OPEN-LABEL; EFFICACY; SAFETY; AXITINIB; SUNITINIB; SORAFENIB; EXPERIENCE;

D O I：

10.1093/jjco/hyac124

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The effectiveness of nivolumab plus ipilimumab for untreated renal cell carcinoma patients in the real-world setting in Japan at 2-year analysis was comparable to that of CheckMate 214. Background Nivolumab plus ipilimumab combination therapy is one of the standard therapies for untreated renal cell carcinoma patients with an International Metastatic Renal Cell Carcinoma Database Consortium intermediate/poor risk. We have previously reported the 1-year analysis results of the effectiveness and safety of nivolumab plus ipilimumab combination therapy in the real-world setting in Japan. Here, we report the effectiveness of nivolumab plus ipilimumab combination therapy and of second-line therapy, using 2-year analysis. Methods This retrospective observational study enrolled Japanese patients with previously untreated metastatic renal cell carcinoma who initiated nivolumab plus ipilimumab combination therapy between August 2018 and January 2019. Data were collected from patients' medical records at baseline and at 3 months, 1 year and 2 years after the last enrollment. Results Of the 45 patients enrolled, 10 patients (22.2%) each had non-clear cell renal cell carcinoma and Eastern Cooperative Oncology Group performance status >= 2 at baseline. Median follow-up period was 24.0 months; objective response rate was 41.5%, with 6 patients achieving complete response; median progression-free survival was 17.8 months and 24-month progression-free survival and overall survival rates were 41.6 and 59.1%, respectively. Second-line therapy achieved an objective response rate of 20%; median progression-free survival was 9.8 months. Median progression-free survival 2 was 26.4 months. Conclusions The effectiveness of nivolumab plus ipilimumab combination therapy at 2-year analysis in the real-world setting in Japan was comparable to that reported in CheckMate 214. The current analysis also demonstrated the effectiveness of second-line therapy after nivolumab plus ipilimumab combination therapy.

引用

页码：1345 / 1352

页数：8

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