Chest
Original ResearchA Randomized Trial of Different Docetaxel Schedules in Non-small Cell Lung Cancer Patients Who Failed Previous Platinum-Based Chemotherapy
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Materials and Methods
The study was conducted according to the existing rules for good clinical practice, and the study protocol was approved by the local ethics committee. Patients with NSCLC who had not responded to previous platinum-based chemotherapy, aged ≥ 18 years, were entered into the study after giving informed consent. The eligibility criteria were as follows: a histologic or cytologic diagnosis of stage IIIb or IV NSCLC in patients who had not responded to previous platinum-based chemotherapy; a
Results
Patients’ clinical characteristics are shown in Table 1. There was no statistical difference in the patients’ clinical characteristics among the different treatment arms. The mean age of patients was about 64 years, and more than half of the patients had a performance status of 2. All patients had been previously treated with platinum-based combination chemotherapy. In this study, docetaxel was the second-line chemotherapy in 146 patients and was third-line or greater chemotherapy in 15
Discussion
In phase II trials of NSCLC patients,15 single-agent docetaxel, 75 or 100 mg/m2, produced objective response rates of 14 to 25% in second-line treatment. Two phase III randomized trials45 revealed that single-agent docetaxel provided meaningful survival and clinical benefits in second-line NSCLC treatment, thus, establishing docetaxel as the standard second-line treatment for NSCLC. The dose recommended in this setting is 75 mg/m2 every 3 weeks.456 However, a dosage of 60 mg/m2 every 3 weeks
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