TY - JOUR
T1 - A randomized phase III study comparing continuation and discontinuation of PD-1 pathway inhibitors for patients with advanced non-small-cell lung cancer (JCOG1701, SAVE study)
AU - Nomura, Shogo
AU - Goto, Yasushi
AU - Mizutani, Tomonori
AU - Kataoka, Tomoko
AU - Kawai, Shoko
AU - Okuma, Yusuke
AU - Murakami, Haruyasu
AU - Tanaka, Kentaro
AU - Ohe, Yuichiro
N1 - Funding Information:
This study has been supported in part by the National Cancer Center Research and Development Fund (29-A-3) and by the Japan Agency for Medical Research and Development (AMED) under Grant Number JP19ck0106457h0002. The ancillary biomarker study is partly supported by Guardant Health, Inc.
Publisher Copyright:
© The Author(s) 2020. Published by Oxford University Press. All rights reserved.
PY - 2020/7/1
Y1 - 2020/7/1
N2 - The development of PD-1 pathway inhibitors has dramatically altered the treatment of advanced/recurrent non-small-cell lung cancer patients. However, the prognostic significance of their ongoing usage is controversial, especially for patients who have not progressed for a period of time. If discontinuation has no negative impact on survival, suspension may reduce side effects from toxicity and help alleviate the economic burdens on health insurance systems and patients. This randomized controlled trial enrolls patients who have responded well to PD-1 pathway inhibitors for >12 months. The aim is to confirm the non-inferiority of discontinuation of PD-1 pathway inhibitors, relative to continuation, in terms of overall survival. A total of 216 patients will be enrolled over 3 years. This trial has been registered in the Japan Registry for Clinical Trials as jRCT1031190032 (https://jrct.niph.go.jp/). An ancillary study examining the prognostic and predictive role of circulating tumor DNA using Guardant360® is planned.
AB - The development of PD-1 pathway inhibitors has dramatically altered the treatment of advanced/recurrent non-small-cell lung cancer patients. However, the prognostic significance of their ongoing usage is controversial, especially for patients who have not progressed for a period of time. If discontinuation has no negative impact on survival, suspension may reduce side effects from toxicity and help alleviate the economic burdens on health insurance systems and patients. This randomized controlled trial enrolls patients who have responded well to PD-1 pathway inhibitors for >12 months. The aim is to confirm the non-inferiority of discontinuation of PD-1 pathway inhibitors, relative to continuation, in terms of overall survival. A total of 216 patients will be enrolled over 3 years. This trial has been registered in the Japan Registry for Clinical Trials as jRCT1031190032 (https://jrct.niph.go.jp/). An ancillary study examining the prognostic and predictive role of circulating tumor DNA using Guardant360® is planned.
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U2 - 10.1093/jjco/hyaa054
DO - 10.1093/jjco/hyaa054
M3 - Article
C2 - 32424430
AN - SCOPUS:85088486439
SN - 0368-2811
VL - 50
SP - 821
EP - 825
JO - Japanese journal of clinical oncology
JF - Japanese journal of clinical oncology
IS - 7
ER -
