Nagio Takigawa    Department   Kawasaki Medical School  Kawasaki Medical School, Department of General Internal Medicine 4,    Position   Professor
Article types	原著
Language	English
Peer review	Peer reviewed
Title	Treatment-related death in patients with small-cell lung cancer in phase III trials over the last two decades
Journal	Formal name：PLoS ONE Abbreviation：PLoS ONE
Volume, Issue, Page	7(8),pp.e42798
Author and coauthor	Ochi Nobuaki, Hotta Katsuyuki, Takigawa Nagio, Oze Isao, Fujiwara Yoshiro, Ichihara Eiki, Hisamoto Akiko, Tabata Masahiro, Tanimoto Mitsune, Kiura Katsuyuki
Publication date	2012/08
Summary	INTRODUCTION: Treatment-related death (TRD) remains a serious problem in small-cell lung cancer (SCLC), despite recent improvements in supportive care. However, few studies have formally assessed time trends in the proportion of TRD over the past two decades. The aim of this study was to determine the frequency and pattern of TRD over time. METHODS: We examined phase 3 trials conducted between 1990 and 2010 to address the role of systemic treatment for SCLC. The time trend was assessed using linear regression analysis. RESULTS: In total, 97 trials including nearly 25,000 enrolled patients were analyzed. The overall TRD proportion was 2.95%. Regarding the time trend, while it was not statistically significant, it tended to decrease, with a 0.138% decrease per year and 2.76% decrease per two decades. The most common cause of death was febrile neutropenia without any significant time trend in its incidence over the years examined (p = 0.139). However, deaths due to febrile neutropenia as well as all causes in patients treated with non-platinum chemotherapy increased significantly (p = 0.033). CONCLUSIONS: The overall TRD rate has been low, but not negligible, in phase III trials for SCLC over the past two decades.
DOI	10.1371/journal.pone.0042798