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Original Research: LUNG CANCER |

A Randomized Trial of Different Docetaxel Schedules in Non-small Cell Lung Cancer Patients Who Failed Previous Platinum-Based Chemotherapy*

Yuh-Min Chen, MD, PhD, FCCP; Jen-Fu Shih, MD; Reury-Perng Perng, MD, PhD, FCCP; Chun-Ming Tsai, MD; Jacqueline Whang-Peng, MD
Author and Funding Information

*From the Chest Department (Drs. Chen, Shih, Perng, and Tsai), Taipei Veterans General Hospital, School of Medicine, National Yang-Ming University, Taipei, Taiwan; and the Division of Cancer Research (Dr. Whang-Peng), National Health Research Institute, Taipei, Taiwan.

Correspondence to: Yuh-Min Chen, MD, PhD, Chest Department, Taipei Veterans General Hospital, 201, Section 2, Shih-pai Rd, Taipei 112, Taiwan, Republic of China; e-mail: ymchen@vghtpe.gov.tw



Chest. 2006;129(4):1031-1038. doi:10.1378/chest.129.4.1031
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Study objective: Docetaxel has shown activity in the second-line treatment of non-small cell lung cancer (NSCLC). Phase II studies have suggested that weekly therapy with docetaxel probably has a better toxicity profile than the conventional schedule of once every 3 weeks. Our aim was to evaluate and compare the efficacy of different docetaxel schedules in NSCLC patients who did not respond to previous platinum-based chemotherapy.

Setting: National teaching hospital in Taiwan.

Methods: Treatment consisted of the following: (1) docetaxel, 35 mg/m2 IV infusion (D35) on days 1, 8, and 15 every 4 weeks; (2) docetaxel, 40 mg/m2 IV (D40) on days 1 and 8 every 3 weeks; and (3) docetaxel, 75 mg/m2 IV (D75) on day 1 every 3 weeks. Patients were randomized at a ratio of 2:2:1, with the D75 arm as the control arm. From 2002 to 2004, 161 patients were enrolled into the study.

Results: The number of patients enrolled in each arm of the study was as follows: D35 group, 64 patients; D40 group, 64 patients; D75 group, 33 patients. The mean ages of patients were as follows: D35 group, 65 years of age; D40 group, 63 years of age; D75 group, 64 years of age. The median number of cycles of chemotherapy received in each group was as follows: D35 group, 4; D40 group, 3; D75 group, 4. The objective response rates were as follows: D35 group, 17.2%; D40 group, 10.9%; D75 group, 6.1% (p = 0.615). The major toxicity was myelosuppression. Grades 3/4 leukopenia and neutropenia were significantly higher in the D75 arm of the study (p < 0.001). Drug-induced pneumonitis occurred more frequently in patients on a weekly schedule than in those on a schedule of every 3-weeks (p = 0.05). The median survival times were as follows: D35 group, 8.4 months; D40 group, 7.2 months; and D75 group, 9.5 months (p = 0.855). The 1-year survival rates were 32.8%, 31.9%, and 28.7%, respectively. Lung cancer symptom scores showed no obvious differences among the different treatment arms, except for some minor items.

Conclusions: Weekly docetaxel chemotherapy produces less myelosuppression, and better compliance and response rates than the conventional chemotherapy administered every 3 weeks. These effects were more evident in the D35 group weekly schedule than in the D40 weekly schedule. However, physicians should pay more attention to the possibility of a higher frequency of docetaxel-induced pneumonitis in patients receiving treatment on the weekly schedule of treatment.

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