Carboplatin (CBDCA), S-1 and concurrent thoracic radiotherapy (TRT) for elderly patients with locally advanced non-small cell lung cancer (NSCLC): A phase II study.

Authors

null

Seiji Niho

Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan

Seiji Niho , Shigeki Umemura , Yukio Hosomi , Hiroaki Okamoto , Keiji Nihei , Hiroshi Tanaka , Toyoaki Hida , Koichi Goto , Tetsuo Akimoto , Yuichiro Ohe

Organizations

Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan, Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan, Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan, Tokyo Komagome Hospital, Bunkyo-Ku Tokyo, Japan, Department of Respiratory Medicine, Niigata Cancer Center Hospital, Niigata, Japan, Department of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya, Japan, National Cancer Center Hospital East, Kashiwa, Japan, Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan

Research Funding

Other

Background: S-1 is an oral anticancer agent containing a mixture of tegafur, 5-chloro-2, 4-dihydroxypyridine, and potassium oxonate, which has been shown to have a radiosensitizing effect in preclinical models. Recent phase II studies have shown that chemoradiotherapy using cisplatin and S-1 yields promising PFS durations of 15 to 20 months in non-elderly (less than 75 years old) patients with locally advanced NSCLC. We conducted a phase II study of CBDCA, S-1 and TRT for elderly patients with locally advanced NSCLC. Methods: The eligibility criteria included patients with unresectable stage III NSCLC, a chemotherapy-naïve status, PS 0 to 1, and age ≥ 71 years. Patients received CBDCA (AUC 3) on day 1 and S-1 (40mg/m2 twice daily) on days 1 to 14, q4w, up to 4 cycles, plus concurrent TRT at a total dose of 60Gy. The primary endpoint was 1-year PFS rate. The sample size was set at 28 patients, with a one-sided alpha of 0.05, beta of 0.2, and expected and threshold values for primary endpoints of 50% and 30%. Results: Between Feb 2014 and Dec 2016, 28 patients were enrolled in this study. All 28 patients were eligible and assessable. Baseline characteristics as follows: median age (range) 77 (71-83) years; women, n = 3 (11%); ECOG PS of 0, n = 15 (54%); stage IIIB, n = 8 (29%); tumor histopathological type: adeno, n = 12 (43%), squamous, n = 13 (46%), and NSCLC-NOS, n = 3 (11%). All 4 cycles of CBDCA plus S-1 could be completed in 15 patients (54%). TRT at 60 Gy was completed in 26 patients (93%). Response rate was 71%. Grade 3-4 toxicities included neutropenia (7%), thrombocytopenia (21%), hypoalbuminemia (7%), hyponatremia (11%), anorexia (7%), fatigue (7%), and colitis (7%). Grade 3 radiation pneumonitis was observed in 5 patients (18%). No treatment-related death was observed. The 1-year PFS rate was 56% (90% CI, 40.0 to 71.7%), and the median PFS was 13.9 months (95%CI, 4.8 to 23.0 months) with a median follow-up period of 18.2 months in censored cases. Conclusions: Combination chemotherapy of CBDCA plus S-1 and concurrent TRT had promising efficacy in elderly patients with locally advanced NSCLC; however, radiation pneumonitis was frequently observed. Clinical trial information: UMIN000005794.

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Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Track

Lung Cancer

Sub Track

Local-Regional Non–Small Cell Lung Cancer

Clinical Trial Registration Number

UMIN000005794

Citation

J Clin Oncol 36, 2018 (suppl; abstr 8530)

DOI

10.1200/JCO.2018.36.15_suppl.8530

Abstract #

8530

Poster Bd #

136

Abstract Disclosures