Feasibility of adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent maintenance therapy with S-1 for completely resected non-small-cell lung cancer: results of the Setouchi Lung Cancer Group Study 1001

• Published in: International journal of clinical oncology Vol. 22; no. 2; pp. 274 - 282
• Main Authors: Okumura, Norihito, Sonobe, Makoto, Okabe, Kazunori, Nakamura, Hiroshige, Kataoka, Masafumi, Yamashita, Motohiro, Nakata, Masao, Kataoka, Kazuhiko, Yamashita, Yoshinori, Soh, Junichi, Yoshioka, Hiroshige, Hotta, Katsuyuki, Matsuo, Keitaro, Sakamoto, Junichi, Toyooka, Shinichi, Date, Hiroshi
• Format: Journal Article
• Language: English
• Published: Tokyo Springer Japan 01-04-2017; Springer Nature B.V
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - pathology; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer Research; Carboplatin - administration & dosage; Carcinoma, Large Cell - drug therapy; Carcinoma, Large Cell - pathology; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - pathology; Chemotherapy, Adjuvant; Drug Combinations; Feasibility Studies; Female; Humans; Lung cancer; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Medicine; Medicine & Public Health; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - pathology; Neoplasm Staging; Oncology; Original Article; Oxonic Acid - administration & dosage; Prognosis; Surgical Oncology; Survival Rate; Tegafur - administration & dosage; Young Adult; Non-small-cell lung cancer; Carboplatin; Adjuvant chemotherapy; Maintenance therapy; S-1
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-016-1067-9

Background
This multicenter study evaluated the feasibility of novel adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent, long-term maintenance with S-1 in patients with completely resected stage II–IIIA non-small-cell lung cancer (NSCLC).
Methods
Patients received four cycles of S-1 (80 mg/m
2
/day for 2 weeks, followed by 2 weeks rest) plus carboplatin (area under the curve 5, day 1) followed by S-1 (80 mg/m
2
/day for 2 weeks, followed by a 1-week rest). Patients unable to continue S-1 plus carboplatin because of severe toxicity converted to single-agent S-1 maintenance. The duration of adjuvant chemotherapy was 10 months in both situations. The primary endpoint was feasibility, defined as the proportion of patients who completed four cycles of S-1 plus carboplatin and single-agent S-1 maintenance for 10 months. The treatment completion rate was determined; treatment was considered feasible if the lower 90% confidence interval (CI) was ≥50%.
Results
Eighty-nine patients were enrolled, of whom 87 were eligible and assessable. Seventy-eight patients (89.7%) completed four cycles of S-1 plus carboplatin and 55 (63.2%) completed the following S-1 maintenance therapy for a total of 10 months. The treatment completion rate was 63.2% (90% CI, 54.4–71.2%), indicating feasibility. There were no treatment-related deaths. Grade 3/4 toxicities included neutropenia (13.8%), thrombocytopenia (11.5%), and anorexia (4.6%). The 2-year relapse-free survival rate was 59.8%.
Conclusions
We concluded that adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent maintenance therapy with S-1 is feasible and tolerable in patients with completely resected NSCLC.
Clinical registration number
UMIN000005041.