Since in Japan pegfilgrastim was approved as the first G-CSF indicated for prophylactic use in many cancers including breast cancer in September 2014, ddAC (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 on day 1 and pegfilgrastim 3.6 mg/body on day 2 every 2 weeks for 4 cycles) followed by T, one of the global standard regimens for early breast cancer, became available. The goal of this study is to examine the feasibility and efficacy of ddAC-T in Japanese women with early breast cancer.
We retrospectively reviewed data of consecutive patients with early breast cancer (stage I-III), who received ddAC-T or FEC-T (5-fluorouracil 500 mg/m2, epirubicin 100 mg/m2 and cyclophosphamide 500 mg/m2, every 3 weeks for 4 cycles followed by T) as neoadjuvant or adjuvant chemotherapy in our institute between January 2014 and August 2015. Primary endpoints were adverse events (AEs), and secondary endpoints were completion rate, relative dose intensity (RDI) and pathological complete response (pCR) rate.
Eighty-one patients were included in this analysis. Twenty-three patients received ddAC-T (mean age 45, range 36-68) and 58 patients received FEC-T (mean age 49, range 27-70). Stage I patients were 1 (4.3%) in ddAC group and 7 (12.1%) in FEC group, respectively, stage II patients were 14 (60.9%) and 36 (62.1%), respectively, and stage III patients were 8 (34.8%) and 15 (25.8%), respectively. The treatment-related AEs of grade 3 or 4 were as below: neutropenia (0 [0%] in ddAC group and 24 [41.4%] in FEC group), anemia (1 [4.3%] and 1 [1.7%], respectively), pneumonia (2 [8.7%] and 0 [0%], respectively), febrile neutropenia (FN) (0 [0%] and 2 [3.4%], respectively). The grade 1 or 2 fever occurred in 5 (21.7%) of ddAC group and 10 (17.2%) of FEC group. The completion rate was 91.3% in ddAC group, 93.1% in FEC group. RDI in ddAC group and FEC group was 97.8% and 96.6%, respectively. The grade 3 pneumonia in two patients in ddAC group was confirmed as bacterial pneumonia in one and Pneumocystis pneumonia in the other and improved with antibiotics. Updated feasibility and efficacy data will be presented at the meeting.
Dose-dense AC-T is feasible in Japanese women with early breast cancer.
Clinical trial identification
T. Takano: honoraria from Kyowa Hakko Kirin. All other authors have declared no conflicts of interest.