Phase III study of docetaxel weekly (DW) versus every 3 weeks (D) in patients with metastatic breast cancer: Final results

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574 Background: D is a semi-synthetic taxane with significant activity in breast cancer. D is usually administered on an every 3-weeks schedule, however, studies have demonstrated drug efficacy and a different toxicity profile when administered on a weekly basis. In this study we compared the weekly schedule versus every 3-weeks to define the safest schedule with the highest efficacy. Methods: Patients (Pts) were enrolled if they had stage IV breast cancer and had received no more than one prior chemotherapy regimen for metastatic disease. Prior treatment with D was not allowed but adjuvant paclitaxel (P) was allowed if > 12 months since the last dose. Pts were randomized to receive D at a starting dose of 75mg/m2 on day 1 or DW at a dose of 35 mg/m2/week for 3 weeks followed by 1 week of rest every 28 days. Doses could be escalated to 100 mg/m2 and 40mg/m2, respectively at the discretion of the investigator. Premedication with dexamethasone was given with each regimen. Results: From 1/2001 until 9/2004, a total of 125 pts were enrolled, 63 in the DW arm and 62 in the D arm. Thirty-nine and 10 pts had received prior anthracycline (A) and P respectively in the D arm while 32 and 11 pts had A and P in the DW arm. Median ages were 56 and 54 years in the D and DW arm, respectively. 118 pts were eligible for an efficacy analysis with a response rate of 35.6%; (95% CI, 23.6%, 49.1%) for the D arm vs 20.3%; (95% CI, 11.0%, 32.8%) for DW. There was no difference between D and DW in median PFS and OS, 5.7 vs 5.5 months (p = 0.46) and 18.3 vs 18.6 months (p = 0.34), respectively. There was a higher overall toxicity rate (grade 3 and 4) in the D arm vs DW, 88.1% vs 55.9% (p = 0.0001). There were 48 (81%) and 6 (10%) pts with grade ¾ granulocytopenia with 6 (10%) and 2 (3%) episodes of neutropenic fever in D vs DW, respectively. Grade 3/4 fatigue and myalgias were reported more often in D than DW, 15 (25%) and 8 (13.5%), and 16 (27%) and 2 (3%), respectively. Grade 3 epiphora was similar in both arms, 4 (7%) and 5 (8%) for D and DW, respectively. Conclusions: D has a higher response rate compare to DW but with a more pronounced toxicity profile. This needs to be kept in mind when making a treatment recommendation for patients with metastatic breast cancer. No difference in PFS or OS was observed between both arms. No significant financial relationships to disclose.