Open AccessTreatment-Related Death in Patients with Small-Cell Lung Cancer in Phase III Trials over the Last Two Decades
Author(s) -
Nobuaki Ochi,
Katsuyuki Hotta,
Nagio Takigawa,
Isao Oze,
Yoshiro Fujiwara,
Eiki Ichihara,
Akiko Hisamoto,
Masahiro Tabata,
Mitsune Tanimoto,
Katsuyuki Kiura
Publication year - 2012
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0042798
Subject(s) - medicine , lung cancer , neutropenia , incidence (geometry) , febrile neutropenia , clinical trial , chemotherapy , cancer , physics , optics
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.