Ineligibility for the PACIFIC trial in unresectable stage III non-small cell lung cancer patients
Recently, based on results of the PACIFIC trial, durvalumab after chemoradiotherapy (CRT) became the standard therapy for unresectable stage III non-small cell lung cancer (NSCLC). However, in the PACIFIC trial, patients were recruited and randomized after CRT, and certain patients were considered ineligible after CRT in the real world. No study has been conducted on the patients who were ineligible for the PACIFIC trial, and hence, we conducted a retrospective study on them.
We identified 82 patients with stage III NSCLC who received definitive platinum-based concurrent CRT and had World Health Organization performance status of 0–1. We investigated the proportion, clinical characteristics, and prognoses of patients who became ineligible for the PACIFIC trial after CRT.
After CRT, 19 of 82 patients (23%) became ineligible for the PACIFIC trial. Comparison between eligible and ineligible patients revealed that old age (p = 0.042), male gender (p = 0.031), and radiation therapy with V20 ≥ 35% (p = 0.032) were associated with ineligibility after CRT. Moreover, ineligible patients showed shorter PFS (6.6 vs. 15.7 months, hazard ratio [HR] 2.61, 95% confidence interval [CI] 1.16–5.89, p = 0.016) and shorter OS (18.6 vs. 44.3 months, HR 3.03, 95% CI 1.29–7.10, p = 0.007) than eligible patients.
Our study revealed the clinical characteristics and prognoses of patients who became ineligible for the PACIFIC trial after CRT. Physicians should be careful while prescribing CRT for patients with characteristics such as old age, male gender, and radiation therapy with V20 ≥ 35%.
KeywordsNon-small cell lung cancer Definitive chemoradiotherapy Durvalumab Eligibility criteria Outcome
The authors thank Keiko Sakuragawa for her administrative assistance.
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Compliance with ethical standards
Conflict of interest
Dr. Hosoya, Dr. Fujimoto, Dr. Kogo, Dr. Kokubo and Dr. Tomii received lecture fees from AstraZeneca K.K. (Tokyo, Japan). Dr. Fujimoto and Dr. Kogo received research funding from AstraZeneca K.K. (Tokyo, Japan) for separate studies. All remaining authors have no conflicts of interest to declare.
All study procedures complied with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments.
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