Abstract
Objectives: We conducted a phase II study to evaluate the combination of bi-weekly docetaxel and S-1, a novel oral fluorouracil derivative, for patients with previously treated non-small cell lung cancer. Methods: Patients received S-1 on days 1-14 and docetaxel on days 1 and 15 of each 28-day cycle. The primary endpoint was overall response rate (ORR). Results: We enrolled 35 pts from 7 institutions (Feb. 2007-Sep. 2008). Patient characteristics: male/female, 23/12; median age, 64 years; and PS, 0/1 (17/18). The ORR was 26% (95% confidence interval, 11-40). The median progression-free survival was 4.1 months and the median overall survival was 16.3 months. Hematologic grade 3/4 toxicity included neutropenia (31%) and anemia (11%). Major non-hematologic grade 3 toxicity included diarrhea (17%). Conclusions: The combination of S-1 and bi-weekly docetaxel is an active regimen with a tolerable toxicity for previously treated NSCLC. Further evaluation of this regimen is warranted.
Highlights
Fluoropyrimidines are effective anti-cancer drugs against many types of cancer, including non-small cell lung cancer (NSCLC)
The combination of S-1 and cisplatin was effective and tolerable in patients with advanced NSCLC, with an overall response rate of 47%, a median survival time of 11 months, and a one-year survival rate of 45% (Ichinose et al, 2004). These results indicate that S-1 has good antitumor activity against NSCLC and that it is a good candidate as a non-platinum agent in the treatment of this disease
Epidermal growth factor receptor (EGFR) status was examined in 16 patients, including 3 (19%) patients who harbored EGFR-tyrosine kinase inhibitor (TKI)-sensitive mutations
Summary
Fluoropyrimidines are effective anti-cancer drugs against many types of cancer, including non-small cell lung cancer (NSCLC). The combination of S-1 and cisplatin was effective and tolerable in patients with advanced NSCLC, with an overall response rate of 47%, a median survival time of 11 months, and a one-year survival rate of 45% (Ichinose et al, 2004). These results indicate that S-1 has good antitumor activity against NSCLC and that it is a good candidate as a non-platinum agent in the treatment of this disease. Its safety and efficacy suggest the combination of daily oral S-1 and bi-weekly docetaxel as an attractive non-platinum option in second-line chemotherapy for previously treated NSCLC patients
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