Abstract P4-10-02: Patient-reported outcomes in EA1131: A randomized phase III trial of platinum vs. capecitabine in patients with residual triple-negative breast cancer after neoadjuvant chemotherapy

Abstract Background: Understanding health-related quality of life (HRQOL), including side effects, is critical to guide supportive care during chemotherapy. The EA1131 trial demonstrated that Platinum (Plat) was unlikely to improve outcomes compared to capecitabine (Cape) in patients with stage II-I...

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Published in:	Cancer research (Chicago, Ill.) Ill.), 2022-02, Vol.82 (4_Supplement), p.P4-P4-10-02
Main Authors:	Smith, Karen L, Zhao, Fengmin, Mayer, Ingrid A, Tevaarwerk, Amye J, Garcia, Sofia F, Arteaga, Carlos L, Symmans, William F, Park, Ben H, Burnette, Brian L, Makower, Della F, Block, Margaret, Morley, Kimberly A, Jani, Chirag R, Mescher, Craig, Dewani, Shabana J, Brown-Glaberman, Ursa, Flaum, Lisa E, Mayer, Erica L, Sikov, William M, Rodler, Eve T, DeMichele, Angela M, Sparano, Joseph A, Wolff, Antonio C, Miller, Kathy D, Wagner, Lynne I
Format:	Article
Language:	eng
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Summary:	Abstract Background: Understanding health-related quality of life (HRQOL), including side effects, is critical to guide supportive care during chemotherapy. The EA1131 trial demonstrated that Platinum (Plat) was unlikely to improve outcomes compared to capecitabine (Cape) in patients with stage II-III triple-negative breast cancer (TNBC) of basal subtype and ≥1 cm residual disease after neoadjuvant chemotherapy (NAC), supporting Cape as the continued standard of care. Patient-reported outcomes (PRO) were administered as a sub-study to understand HRQOL and symptoms from the patient’s perspective. Methods: EA1131 was amended in 9/2017 to add PRO endpoints and all patients enrolled after this amendment were eligible for the PRO sub-study. The Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (FBSI) and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity Subscale (NtxS; Plat arm only) were administered at baseline (BL), cycle 3 day 1 (C3D1), and following treatment at 6 and 15 months. Due to early trial termination, the PRO sub-study target accrual (n=362) was not reached. It was hypothesized that HRQOL, assessed by the FBSI-Treatment Side Effect (TSE) subscale (range 0-16, higher score = less side effects, better HRQOL), would indicate fewer post-treatment side effects at 6 and 15 months following Plat compared to Cape. The Wilcoxon rank sum test was used to compare FBSI-TSE subscale scores and total FBSI scores (range 0-64, higher score = better overall HRQOL) between arms at BL, C3D1, 6 months and 15 months. Two-sample t-tests were used to compare change in FBSI-TSE subscale scores and total FBSI scores from BL to C3D1 between arms. Change in NtxS scores (range 0-44, higher score = less neurotoxicity) from BL to C3D1 was evaluated with the paired t-test. Analyses were exploratory and p-values
ISSN:	0008-5472 1538-7445