Trastuzumab (Herceptin®, Roche) has become a mainstay in the treatment of pts with human epidermal growth factor receptor-2 (HER2)-overexpressing breast cancer in the adjuvant setting. Trastuzumab treatment consists in 21-day cycles during the last 3 cycles of FEC100-Docetaxel chemotherapy (CT) and 15 additional cycles thereafter. Although adjuvant CT was shown to have a deleterious effect on QoL and fatigue in BC pts, no data are available on experience of BC pts during this additional one-year treatment period by Trastuzumab. This case-control study assessed fatigue and QoL during and after Trastuzumab treatment as compared to age-matched BC pts receiving the same CT without Trastuzumab.
70 pts were included (35 pts in each group) on day 1 of last cycle of CT (first day of Trastuzumab for case group). The primary endpoint was severe fatigue (FACIT-F
No statistically significant differences were noted at baseline between groups: age (48 ± 10 y); marital status (87%); surgery (mastectomy, 42%); CT (all pts received complete FEC100-Docetaxel treatment except one pt who received only 1 cycle of Docetaxel; dose reduction for 12 pts); radiotherapy (84%); hormonotherapy (69%); anxiety (41%); depression (23%); severe fatigue at baseline (66%). At 9 mo post CT, proportion of pts with severe fatigue (39%) did not statistically significantly differ between groups and a significant reduction of severe fatigue from baseline was noted (p
Trastuzumab treatment was not shown to have a deleterious impact on fatigue and QoL in adjuvant setting as compared to CT with no indication to Trastuzumab treatment. CT-induced fatigue appears to improve similarly between women receiving or not Trastuzumab, despite a one-year longer duration of treatment.
Clinical trial identification
Clinical trial information: NCT01400438
Legal entity responsible for the study
Ligue contre le Cancer and Association “Le Cancer du Sein, Parlons-En !”, c/o Estée Lauder - Prix Ruban Rose
All authors have declared no conflicts of interest.