Dataset Information

Real-World Data Analysis of Pembrolizumab Monotherapy for NSCLC Using Japanese Postmarketing All-Case Surveillance Data.

ABSTRACT:

Introduction

Pembrolizumab is a programmed death-ligand 1 inhibitor that was initially indicated for monotherapy in patients with advanced lung cancer. The Japanese Lung Cancer Society conducted an observational study on pembrolizumab using confirmative data obtained through postmarketing all-case surveillance (PMACS), which was performed by a pharmaceutical company under the Japanese law in 2017.

Methods

This multicenter observational study was conducted by the Japanese Lung Cancer Society using PMACS data with the newly created central registration system regarding patients with NSCLC who received pembrolizumab monotherapy between February 1, 2017 and June 30, 2017; a new database was created by adding the clinical information regarding prognosis for 3 years after therapy to the existing data collected by PMACS.

Results

A total of 300 patients from 43 facilities were enrolled in this study. The median overall survival and progression-free survival after pembrolizumab initiation were 558 and 188 days, respectively. Moreover, the 1- and 3-year survival rates were 58.9% and 33.7%, respectively. Results of multivariate analysis revealed performance status (p < 0.0001), histology (p = 0.0118), previous chemotherapy (p = 0.0007), programmed death-ligand 1 expression status (p = 0.0195), and previous steroid use (p = 0.0460) as significant factors that affected overall survival. The toxicity profile was similar to that previously reported.

Conclusions

In this first attempt to use PMACS data, we successfully collected clinical information and found the real-world efficacy and safety of pembrolizumab.

SUBMITTER: Terai H

PROVIDER: S-EPMC9579417 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Real-World Data Analysis of Pembrolizumab Monotherapy for NSCLC Using Japanese Postmarketing All-Case Surveillance Data.

Terai Hideki H Soejima Kenzo K Shimokawa Asanao A Horinouchi Hidehito H Shimizu Junichi J Hase Tetsunari T Kanemaru Ryota R Watanabe Kana K Ninomiya Kiichiro K Aragane Naoko N Yanagitani Noriko N Sakata Yoshihiko Y Seike Masahiro M Fujimoto Daichi D Kasajima Masashi M Kubo Akihito A Kusumoto Sojiro S Oyamada Yoshitaka Y Fujiwara Keiichi K Mori Masahide M Hashimoto Midori M Shingyoji Masato M Kodani Masahiro M Sakamoto Jin J Agatsuma Toshihiko T Kashiwabara Kosuke K Inomata Minehiko M Tachihara Motoko M Tanaka Kazuhisa K Hayashihara Kenji K Koyama Nobuyuki N Matsui Kaoru K Minato Koichi K Jingu Daisuke D Sakashita Hiroyuki H Hara Satoshi S Naito Tomoyuki T Okada Asuka A Tanahashi Masayuki M Sato Yuki Y Asano Koichiro K Takeda Takayuki T Nakazawa Kensuke K Harada Toshiyuki T Shibata Kazuhiko K Kato Tatsuo T Miyaoka Etsuo E Yoshino Ichiro I Gemma Akihiko A Mitsudomi Tetsuya T

JTO clinical and research reports 20220901 11

<h4>Introduction</h4>Pembrolizumab is a programmed death-ligand 1 inhibitor that was initially indicated for monotherapy in patients with advanced lung cancer. The Japanese Lung Cancer Society conducted an observational study on pembrolizumab using confirmative data obtained through postmarketing all-case surveillance (PMACS), which was performed by a pharmaceutical company under the Japanese law in 2017.<h4>Methods</h4>This multicenter observational study was conducted by the Japanese Lung Canc ...[more]

PMID: 36275911

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Dataset Information

Real-World Data Analysis of Pembrolizumab Monotherapy for NSCLC Using Japanese Postmarketing All-Case Surveillance Data.

Introduction

Methods

Results

Conclusions

Publications

Real-World Data Analysis of Pembrolizumab Monotherapy for NSCLC Using Japanese Postmarketing All-Case Surveillance Data.

Similar Datasets

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