Paclitaxel in metastatic breast cancer: a trial of two doses by a 3-hour infusion in patients with disease recurrence after prior therapy with anthracyclines.

摘要: Background : To date, anthracyclines are the most active drugs against breast tumors, and taxane paclitaxel (Taxol) looks very promising. Both classes of affected by cellular multidrug-resistance mechanisms, therefore their sequential use raises possibility clinical cross-resistance. It is important to assess activity in patients with resistance anthracyclines. Purpose We assessed safety efficacy administered logistically convenient 3-hour infusion cancer who had disease progression within 12 months since prior therapy Methods Fifty-one metastatic all relapsed or whose progressed from completion an anthracycline-containing chemotherapy protocol (six receiving adjuvant therapy, 19 neoadjuvant 26 treatment for disease) were enrolled this phase II trial June 1992 May 1994. After medication prevent type I acute hypersensitivity reactions, was given intravenously over 3 hours at 175 mg/m 2 first 15 225 next 36 patients. The median age 50 years (range, 31-62 years), Eastern Cooperative Oncology Group performance status 0 0-2). Results Patients received a five cycles one 11 cycles). initial doses , could be increased 25 73% 58% cycles, respectively. Among assessable patients, seven achieved complete response partial (response rate, 38% [95% confidence interval = 25%-53%]). duration 7 4-16 months), time 5 months. Grade 4 neutropenia occurred 3% 12% never associated fever infection. Common toxic effects myalgia arthralgia (94% ; 4% grade 3), peripheral neuropathy (92% 8% alopecia (all patients). Pruritus significantly more frequent severe, respectively, higher dose (P<.01 χ test). Frequency severity other similar either starting dose. Ten symptoms neuro-optic toxicity. Only patient reaction. Conclusions Paclitaxel as can safely to, women has after There evidence toxicity but no suggestion better efficacy. Implication: combination doxorubicin should investigated cancer. Unless randomized trials demonstrate greater dose, it suggested that 175-200 schedule. [J Natl Cancer Inst 87 :1169-1175, 1995]