Open AccessPembrolizumab for treating advanced urothelial carcinoma in patients with impaired performance status: Analysis of a Japanese nationwide cohort
Author(s) -
Ito Katsuhiro,
Kobayashi Takashi,
Kojima Takahiro,
Hikami Kensuke,
Yamada Takeshi,
Ogawa Kosuke,
Nakamura Kenji,
Sassa Naoto,
Yokomizo Akira,
Abe Takashige,
Tsuchihashi Kazunari,
Tatarano Shuichi,
Inokuchi Junichi,
Tomida Ryotaro,
Fujiwara Maki,
Takahashi Atsushi,
Matsumoto Kazumasa,
Shimizu Kosuke,
Araki Hiromasa,
Kurahashi Ryoma,
Osaki Yu,
Tashiro Yu,
Uegaki Masayuki,
Ogawa Osamu,
Kitamura Hiroshi,
Nishiyama Hiroyuki
Publication year - 2021
Publication title -
cancer medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.403
H-Index - 53
ISSN - 2045-7634
DOI - 10.1002/cam4.3863
Subject(s) - medicine , pembrolizumab , cohort , hazard ratio , oncology , proportional hazards model , multivariate analysis , retrospective cohort study , gastroenterology , cancer , confidence interval , immunotherapy
Background The benefits of pembrolizumab in patients with advanced urothelial carcinoma (UC) and impaired performance status (PS) remain unknown. This study assessed the safety and efficacy of pembrolizumab in patients with platinum‐refractory UC and Eastern Cooperative Oncology Group PS ≥2 to identify which subgroups may benefit from this drug. Methods This retrospective nationwide cohort study collected clinicopathological information for 755 patients from 59 institutions. The overall response rate (ORR) and overall survival (OS) were compared among the patients with PS 0–1, 2, and 3–4. Multivariate analysis was conducted to identify factors predicting OS in patients with PS ≥2. Results The numbers of patients with PS 0–1, 2, and 3–4 were 602, 98, and 55, respectively; the ORRs in these groups were 29.5, 15.3, and 9.1%, respectively, and the median OS times were 14.3, 3.1, and 2.4 months, respectively. In multivariate Cox regression analysis, a neutrophil–lymphocyte ratio (NLR) ≥3.5 (hazard ratio [HR] = 1.897) and liver metastasis (HR = 2.072) were associated with OS in the PS ≥2 subgroup. The median OS of patients with PS ≥2 without either risk factor was 6.8 months, compared with 3.1 months for patients with one risk factor and 2.3 months for patients with both risk factors. Conclusions PS ≥2 portended worse ORR and OS than PS ≤1 despite a comparable safety profile. Among the patients with impaired PS, patients with NLR <3.5 and no liver metastasis may most greatly benefit from pembrolizumab therapy.