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T. Hishida
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P1.05 - Poster Session with Presenters Present (ID 457)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Early Stage NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.05-063 - Multicenter Observational Study of Patients with Resected Early-Staged NSCLC, Who Were Excluded from an Adjuvant Chemotherapy Trial (ID 4713)
14:30 - 14:30 | Author(s): T. Hishida
- Abstract
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 “real-world” 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<0.001) and the JCOG0707 eligibility (ineligible population: 77.6% vs. eligible population: 56.7%, p<0.001). Standard UFT and experimental S-1 were given in 1550 (31.0%) and 21 (0.4%) patients, respectively. Among those who received adjuvant UFT, 971 (62.6%) took UFT for one year or longer.
Conclusion:
Only selected population of candidate patients, even if they met the eligibility criteria, were enrolled to JCOG0707 adjuvant chemotherapy trial for early-stage NSCLC. The “excluded” patients were mainly treated with observation alone or standard UFT treatment. Further analysis of this “excluded” population, including long-term survival, should be necessary for external validation of the randomized trial results.
