Abstract Background: The multicenter, open-label, randomized phase III GEICAM/2003-02 study compared two regimens as adjuvant therapy for node-negative breast cancer (BC) patients: FAC (5-fluorouracil, doxorubicin, and cyclophosphamide) alone versus FAC plus weekly paclitaxel (FAC-wP). It demonstrated paclitaxel chemotherapy (CT) improved disease-free survival 1. This study aims to compare health-related quality of life (HRQoL) in these arms of treatment. Methods: Early-BC patients from the GEICAM/2003-02 study were selected (157 FAC arm and 141 FAC-wP arm). HRQoL was assessed using the EORTC QLQ-C30 version 3.0 questionnaire. Random intercept lineal model with two nested levels (hospital and subject) for repeated measures adjusted by patient and tumor characteristics at diagnosis (body mass, age, histopathological grade, surgery type, stage, tumor subtype and menopausal status) were used to assess changes in the global, functional and symptom QLQ-C30 summary scores from baseline to end of treatment and 6 months later. Stratified analyses were also performed by menopausal status and endocrine-therapy (ET) post-CT according to tumor subtype. Results: QLQ-C30 summary score significantly decreased from baseline to end of treatment (FAC: -2.08, 95% CI= -7.11, 2.94 and FAC-wP: -2.82, 95% CI: -7.76, 2.13) but slightly exceeded baseline scores 6 months post-treatment, with no significant differences between the two arms. Greater deterioration in post-treatment functional summary score was observed in the FAC-wP arm -4.15, 95%CI: -10.40, 2.11, compared to FAC -1.46, 95% CI= -7.78, 4.86. In postmenopausal patients, post-treatment QLQ-C30 summary score deterioration was greater in the FAC-wP arm -4.05, 95% CI= -9.96, 1.86. Hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+ HER2-) with ET post-CT patients showed more pronounced reductions in the QLQ-C30 summary score post-treatment (FAC: -3.58, 95% CI= -8.42, 1.27 and FAC-wP: -5.03, 95% CI: -9.77, -0.28) than triple-negative patients (FAC: -2.53, 95%CI= -7.43, 2.37 and FAC-wP: 1.05, 95% CI= -4.05, 6.16). Further details are shown in Table 1. Conclusions: Taxane-based regimens do not have a great impact on HRQoL recovery after 6 months of treatment: While temporary deterioration in functional and symptom scales was observed during treatment, patients in both arms recovered their baseline HRQoL scores 6 months later. These results also emphasize the importance of considering patient characteristics variables when evaluating HRQoL outcomes in BC survivors. References: 1. M. Martín et al., “Fluorouracil, Doxorubicin, and Cyclophosphamide (FAC) Versus FAC Followed by Weekly Paclitaxel AsAdjuvant Therapy for High-Risk, Node-Negative Breast Cancer: Results From the GEICAM/2003-02 Study,” JCO, vol. 31, no.20, Jul. 2013. Citation Format: A. Blasco, P. Zamora-Auñón, R. Pastor, M. Martín, C. Reboredo, A. Lahuerta-Martinez, I. Álvarez, S. Sonia, M. Marin, E. Martínez de Dueñas, J. López-Vega, A. Barnadas, Á. Rodríguez-Lescure, S. Salvador-Bofill, C. Jose Ignacio, V. Lope. Longitudinal changes in health-related quality of life of early-stage breast cancer patients treated with adjuvant chemotherapy: Data from geicam/2003-02 study abstract. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS1-04-29.
Blasco et al. (Tue,) studied this question.