Long-term (up to 16 months) health-related quality of life after adjuvant tailored dose-dense chemotherapy vs. standard three-weekly chemotherapy in women with high-risk early breast cancer

Abstract

Purpose: To prospectively compare HRQoL effects of two modern adjuvant chemotherapy breast cancer treatment regimens at six time-points up to 16 months after random assignment.

Methods: The open-label, randomized, Phase 3 "Panther trial" was conducted between February 2007 and September 2011. 760 women, aged 65 years and younger, after surgery for non-metastatic node-positive or high-risk node-negative breast cancer were randomized 1:1 to the experimental group (four cycles of tailored and dose-dense adjuvant epirubicin and cyclophosphamide/2 weeks followed by four cycles of tailored dose-dense docetaxel/2 weeks) or standard group (three cycles of fluorouracil and epirubicin-cyclophosphamide/3 weeks followed by three cycles of docetaxel/3 weeks). HRQoL was assessed at all Swedish centres using EORTC QLQ-C30 and EORTC QLQ-BR23 at six points during 16 months before randomization.

Results: Response rates to questionnaires were highest at baseline 728/780 (93%) and lowest 16 months after randomization, 557/750 (74%). HRQoL declined during treatment in both groups. At the end of treatment, the experimental group reported statistically significantly lower HRQoL (P < 0.001) than the standard group on global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects. No differences were found for emotional functioning, body image, and arm and breast symptoms. There were no statistically significant differences between the groups at the first follow-up and at subsequent assessments. HRQoL levels at the 16-month follow-up were similar to baseline values.

Conclusions: Negative HRQoL impact of the dose-dense and tailored strategy appears to be prominent during treatment, but HRQoL recover once treatment ends.

Trial registration: clinicaltrials.gov Identifier: NCT00798070; isrctn.org Identifier: ISRCTN39017665.

Keywords: Adjuvant; Breast cancer; Dose dense; Health-related quality of life; Randomized trial.

Conflict of interest statement

Six of the authors declare that they have no conflict of interest. Professor Volker Möbus declare remuneration from Klinikum Frankfurt Höcht and advisory roles for Amgen, Roche and Tesaro. Professor Richard Greil declare remuneration from MSD, Abbvie and Sandos, advisory roles for Celgene, Roche, Takeda, Merck, Astra Zeneca, Novarits, BMS, Daischi and Sitead, Abbvie and Jansen. He has also been funded by Celgene, Merck, Takeda, Astra Zeneca, Novarits, Amgen, BMS, Sandoz and Roche.

Figures

Fig. 1

Mean baseline score (SD) for selected EORTC QLQ-C30 and EORTC QLQ-BR23 scales

Fig. 2

Mean scale scores for pre-selected EORTC QLQ-C30 and EORTC QLQ-BR23 scales at six points of assessment