Improved survival among patients enrolled in oncology phase 1 trials in recent decades.

Abstract:

PURPOSE:This study aimed to compare the survival of patients enrolled in phase 1 trials in recent decades. METHODS:The medical records of consecutive patients with advanced cancer who participated in single-agent oncology phase 1 trials from 1995 to 2015 at a single institution were retrospectively investigated. RESULTS:A total of 267 (34.1%) patients participated in 1995-2004 and 516 (65.9%) participated in 2005-2015. The median follow-up period was 25.4 months (range 1.3-166.9). The response rate did not differ significantly between the two periods (3.9% vs. 6.2%, p = 0.17). The median survival times were 9.5 (95% confidence interval 8.4-11.2) months in 1995-2004 and 11.8 (95% confidence interval 10.9-13.3) months in 2005-2015 (p = 0.0009). The enrolment period was an independent prognostic factor of overall survival according to multivariate analysis (hazard ratio: 0.85, 95% confidence interval 0.72-0.99, p = 0.042). CONCLUSIONS:In our single-centre, retrospective analysis, the trends in patients characteristic were consistent with those of Western countries, and the overall survival of cancer patients enrolled in oncology phase 1 trials tended to improve in recent decades, suggesting that patient selection, the population that benefits from investigational agents and treatment after phase 1 trials have improved.

authors

Ebata T,Shimizu T,Koyama T,Shimomura A,Iwasa S,Kondo S,Kitano S,Yonemori K,Fujiwara Y,Yamamoto N

doi

10.1007/s00280-019-03992-2

subject

Has Abstract

pub_date

2020-02-01 00:00:00

pages

449-459

issue

2

eissn

0344-5704

issn

1432-0843

pii

10.1007/s00280-019-03992-2

journal_volume

85

pub_type

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