A Randomized Phase II Study of a Combination of Docetaxel and S-1 versus Docetaxel Monotherapy in Patients with Non-small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy Results of Okayama Lung Cancer Study Group (OLCSG) Trial 0503

作者：Segawa Yoshihiko^*; Kiura Katsuyuki; Hotta Katsuyuki; Takigawa Nagio; Tabata Masahiro; Matsuo Keitaro; Yoshioka Hiroshige; Hayashi Hidetoshi; Kawai Haruyuki; Aoe Keisuke; Maeda Tadashi; Ueoka Hiroshi; Tanimoto Mitsune

来源：Journal of Thoracic Oncology, 2010, 5(9): 1430-1434.

• Docetaxel
• Non-small cell lung cancer
• Second-line chemotherapy
• S-1

Background: The survival impact of single-agent treatment with docetaxel, the standard regimen for relapsed patients with non-small cell lung cancer (NSCLC), remains modest We conducted a randomized phase II study to evaluate the efficacy and safety of the combination of docetaxel and S-I in the second-line setting
Methods: Patients with relapse of NSCLC after first-line platinum-based chemotherapy were randomly assigned to docetaxel alone (60 mg/m(2), day I. q3 weeks, arm A) or a combination of docetaxel (40 mg/m(2). day 1. q3 weeks) and S-I (80 mg/m(2), days 1-15, arm B) The primary end point was response rate, whereas secondary endpoints included overall survival, progression-free survival, and toxicity
Results: Between 2005 and 2008, a total of 60 patients were enrolled in the study The objective response rates were 20 7% and 16 1% in arms A and B. respectively (p = 0 81) Progression-free survival was comparable in the two arms (median 3 7 versus 3 4 months. p = 0 27), whereas overall survival time was longer in arm A (22 9 versus 8 7 months, p = 0 02) The major toxicity was myelosuppression with grade neutropenia in 89 7% of patients versus 64 5% in arms A and B. respectively
Conclusions: This study suggests that docetaxel monotherapy should continue to be considered the standard for second-line chemotherapy against NSCLC

• 出版日期2010-9