348 A phase II trial of docetaxel in patients (PTS) with anthracycline resistant (AR) metastatic breast cancer (MBC)

Abstract

51 females pts with AR MBC were treated with docetaxel (Taxotere®) at 100mg/m² as a 1-hour IV infusion every 3 week (wks). Oral steroids and antihistamines were given prior to docetaxel. AR was represented as follows: 5 pts has a metastatic relapse while on adjuvant, 25 pts had a progression as their best response in advance disease and 19 pts had stable disease after 4 cycles first line CT (16 pts had PD during anthracycline, 3 pts progressed off treatment); 2 pts were not AR. Median (med) age=47 years (27–72), WHO PS: 0–1=88%, 41% of pts had >2 organs involved, 67% had visceral involvement (liver: 43%). 38 pts were eligible and evaluable. The response rate (RR) in intent-to-treat analysis was 29.4%, 15 PRs (31.6% in evaluable pts). RR in pts with >2 organs involved=44% with visceral involvement=26%. Med duration of response=24 wks (12+−33), med survival time=10 months (0.2–11+). 258 cycles were given (med = 5, range=1–12); relative dose intensity=0.95 (0.66–1.02). Main toxicities (NCI grade): AGC gr 4=49 pts (81% of cycles) (med duration=7 days); febrile neutropenia=7% of cycles; neurosensory in 33 pts (only 3 pts gr 3, no gr 4), skin reaction in 19 pts (gr 3=2 pts: gr 4=1 pt), fluid retention (FR) in 30 pts (no severe cases; med cumulative dose to onset of FR=400mg/m² (100–1200+). Docetaxel is active in pts with AR MBC. Oral premeditation with steroids appears to reduce both the incidence and severity of FR and skin toxicities.