Doubling of the epirubicin dosage within the 5-fluorouracil, epirubicin and cyclophosphamide regimen: a prospective, randomized, multicentric study on antitumor effect and quality of life in advanced breast cancer

In metastatic breast cancer (MBC) doubling the epirubicin (EPI) dose intens ity (DI) within the FEC (5-fluorouracil, EPI, cyclophosphamide) regimen cou ld increase the response rate (RR) and ameliorate the quality of life (QoL) over standard FEC. From May, 1995, 74 consecutive patients with MBC were r andomly treated with 6 courses of two FEC regimens containing 60 (60FEC) or 120 (120FEC, supported by primary G-CSF) mg/m(2) of EPI. Drugs were admins tered every 21 days. The QoL was assessed over and after treatment by the E ORTC QLQ-C30 (VER 2.0) and QLQ-BR23 questionnaires, compiled by the patient , and the Spitzer's QL-index, compiled by the physician. The study was prem aturely closed in May, 1997, due to RR and QoL data of 4th interim analysis . The delivered EPI DI was 20.0 and 37.9 mg/m(2)/week in 60- and in 120FEC, respectively. Among the two regimens, there was no statistically significa nt difference in RR or in improvement of baseline overall QoL. With respect to 60FEC patients, the 120FEC patients had longer time to progression (19. 2 vs 13.1 mos, p=0.04). Over baseline, the 120- but not the 60FEC patients had significantly greater pain decrease and lower deterioration of body ima ge. In MBC, both 60- and 120FEC regimens fournished the same RR and improve ment in overall baseline QoL. With respect to 60FEC patients, the 120FEC pa tients experienced longer time to progression. Over baseline, pain decrease and preservation of body image were also greater in these patients.