Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
Background: From Nov. 2008 to Dec. 2013, the Japan Clinical Oncology Group
(JCOG) conducted a randomized phase III trial (JCOG0707), which compared
the survival benefit of UFT and S-1 for completely resected pathological (p-)
stage I (T1>2 cm and T2 in the 6th TNM classification) NSCLC and a total of 963
patients were enrolled. Recently, there is a growing concern that those who
participated in clinical trials are highly selected and do not represent the “realworld”
population. Hereby, we conducted a multicenter observational study
of patients excluded from JCOG0707 trial during the study period. Methods:
We retrospectively collected and analyzed the patients’ backgrounds, tumor
profiles, post-surgical treatment of the patients who underwent R0 resection
of p-stage I (T1>2cm and T2 in TNM 6th) NSCLC by lobectomy or larger lung
resection but were excluded from JCOG0707 from Japanese multi-centers.
Results: Of the 48 institutions which took part in JCOG0707, 34 (enrolling 917
or 95.2% of all JCOG0707 patients) participated in this multicenter study, and
5006 patients were enrolled. Among them, 2617 (52.3%) patients fulfilled
the eligibility criteria, but were not enrolled to JCOG0707 mainly due to
patients’ decline (69.2%), or physicians’ discretion (20.5%). The accrual rate
to JCOG0707 was various by institutions (4.1 to 46.1%), but was 25.9% (917
/ [917+2617]) as a whole. Total number of p-stage I and eligible patients at
each institution did not correlate the accrual rate (R2=0.003 and 0.046). In
the remaining 2389 (47.7%) patients, main ineligible reasons included the
existence of active multiple cancer (29.1%), physicians’ decision based on
the patients’ comorbidities (19.4%), delayed recovery from surgery (14.1%),
and high age ≥81 years (10.7%). Majority of patients received no adjuvant
chemotherapy (n = 3338, 66.7%). This proportion differed according to
p-T factor (T1: 75.3% vs. T2 : 57.8%, p