TY - JOUR
T1 - A phase II study of cisplatin plus S-1 with concurrent thoracic radiotherapy for locally advanced non-small-cell lung cancer
T2 - The Okayama lung cancer study group trial 0501
AU - Nogami, Naoyuki
AU - Takigawa, Nagio
AU - Hotta, Katsuyuki
AU - Segawa, Yoshihiko
AU - Kato, Yuka
AU - Kozuki, Toshiyuki
AU - Oze, Isao
AU - Kishino, Daizo
AU - Aoe, Keisuke
AU - Ueoka, Hiroshi
AU - Kuyama, Shoichi
AU - Harita, Shingo
AU - Okada, Toshiaki
AU - Hosokawa, Shinobu
AU - Inoue, Koji
AU - Gemba, Kenichi
AU - Shibayama, Takuo
AU - Tabata, Masahiro
AU - Takemoto, Mitsuhiro
AU - Kanazawa, Susumu
AU - Tanimoto, Mitsune
AU - Kiura, Katsuyuki
N1 - Publisher Copyright:
© 2014 Elsevier Ireland Ltd.
PY - 2015
Y1 - 2015
N2 - Background: Although cisplatin-based chemotherapy combined with thoracic irradiation (TRT) is a standard treatment for unresectable, locally advanced non-small cell lung cancer (NSCLC), this treatment outcome has remained unsatisfactory. We had previously conducted a phase I trial of cisplatin plus S-1, an oral 5-fluorouracil derivative, and TRT, which were safe and effective. Methods: In this phase II trial, 48 patients with stage III NSCLC received cisplatin (40mg/m2 on days 1, 8, 29 and 36) and S-1 (80mg/m2 on days 1-14 and 29-42) and TRT (60Gy). The primary endpoint was the response rate. Results: A partial response was observed in 37 patients (77%; 95% confidence interval: 63-88%). At a median follow up of 54 months, the median progression-free survival and median survival time were 9.3 and 31.3 months, respectively. No difference in efficacy was observed when the patients were stratified by histology. Toxicities were generally mild except for grade 3 or worse febrile neutropenia and pneumonitis of 8% and 4%, respectively. No patient developed severe esophagitis. At the time of this analysis, 35 (73%) of the 48 patients recurred; 15 (31%) showed distant metastasis, 17 (35%) had loco-regional disease, and 2 (4%) showed both loco-regional disease and distant metastasis. Conclusions: This chemoradiotherapy regimen yielded a relatively favorable efficacy with mild toxicities in patients with locally advanced NSCLC.
AB - Background: Although cisplatin-based chemotherapy combined with thoracic irradiation (TRT) is a standard treatment for unresectable, locally advanced non-small cell lung cancer (NSCLC), this treatment outcome has remained unsatisfactory. We had previously conducted a phase I trial of cisplatin plus S-1, an oral 5-fluorouracil derivative, and TRT, which were safe and effective. Methods: In this phase II trial, 48 patients with stage III NSCLC received cisplatin (40mg/m2 on days 1, 8, 29 and 36) and S-1 (80mg/m2 on days 1-14 and 29-42) and TRT (60Gy). The primary endpoint was the response rate. Results: A partial response was observed in 37 patients (77%; 95% confidence interval: 63-88%). At a median follow up of 54 months, the median progression-free survival and median survival time were 9.3 and 31.3 months, respectively. No difference in efficacy was observed when the patients were stratified by histology. Toxicities were generally mild except for grade 3 or worse febrile neutropenia and pneumonitis of 8% and 4%, respectively. No patient developed severe esophagitis. At the time of this analysis, 35 (73%) of the 48 patients recurred; 15 (31%) showed distant metastasis, 17 (35%) had loco-regional disease, and 2 (4%) showed both loco-regional disease and distant metastasis. Conclusions: This chemoradiotherapy regimen yielded a relatively favorable efficacy with mild toxicities in patients with locally advanced NSCLC.
KW - Chemotherapy
KW - Cisplatin
KW - Phase II trial
KW - Radiation
KW - S-1
KW - Stage III
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U2 - 10.1016/j.lungcan.2014.11.001
DO - 10.1016/j.lungcan.2014.11.001
M3 - Article
C2 - 25534129
AN - SCOPUS:84922544249
VL - 87
SP - 141
EP - 147
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
IS - 2
ER -