Japanese Journal of Clinical Oncology Advance Access originally published online on February 2, 2006
Japanese Journal of Clinical Oncology 2006 36(2):80-84; doi:10.1093/jjco/hyi230
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© 2006 Foundation for Promotion of Cancer Research
Weekly Short Infusion of Taxotere at a 4 Week Cycle in Chinese Patients with Advanced NSCLC Who Have Failed or Relapsed after the Frontline Platinum-based Non-Taxane Chemotherapy—A Phase II Trial
1 Department of Internal Medicine, Buddhist Tzu Chi General Hospital, 2 Division of Pulmonary and Critical Care Medicine and 3 Division of Hematology-Oncology, Chang Gung Memorial Hospital, Taipei, Taiwan
For reprints and all correspondence: Thomas Chang Yao Tsao, Department of Internal Medicine, Buddhist Tzu Chi General Hospital, Taipei, Taiwan, 10 Lane 43, Fuxing Road, Xindian, Taipei County 231, Taiwan. E-mail: tcyt{at}tzuchi.com.tw
Received December 22, 2004; accepted December 12, 2005
Background: This Phase II study was conducted to evaluate the efficacy and toxicity of weekly docetaxel at a 4 week cycle in second-line therapy for patients with advanced non-small cell lung cancer (NSCLC) who failed to respond or relapsed after the frontline platinum-based, non-taxane regimen.
Methods: Patients with histologically confirmed and progressive NSCLC after one platinum-based, non-taxane regimen were eligible for this study. Performance status of 0–2 and adequate organ function were required. Patients were treated with docetaxel 40 mg/m2/week for three consecutive weeks then following 1 week of rest. Cycles were repeated every 4 weeks for a maximum total of six cycles. Docetaxel was administered intravenously for 30 min with dexamethasone premedication.
Results: Fifty-three patients were eligible for this study. Hematologic toxicity was very mild and with the major toxicity of anemia. Non-hematologic toxicities were modest, Grades 3–4 mucositis, diarrhea and peripheral neuropathy occurred in 6–13% of patients and caused dose modifications. Fatigue (48%) was common but not severe with only 6% of Grades 3–4 toxicity. The overall response rate (ORR) was 13% [95% confidence interval (CI), 3.9–23%]. The median survival time (MST) for all patients was 25.0 weeks (95% CI, 12.7–37.3), and the 1 year survival was 31% (95% CI, 17–58%). For patients with PS 0–1, MST was 29.7 weeks and 1 year survival was 36%.
Conclusions: Weekly docetaxel appeared to be well tolerated as second-line therapy for patients with NSCLC. The efficacy for this regimen was comparable with the standard 3 week schedule but hematologic toxicity was markedly reduced. A schedule of three consecutive weeks, with a 1 week break, may diminish the frequency of fatigue and diarrhea when compared with a schedule of six consecutive weeks.
Key Words: weekly docetaxel • second-line therapy • non-small cell lung cancer