P1-06-08: Effect of Treatment Emergent Symptoms on Relapse Free Survival: NCIC CTG MA.12 a Randomized Placebo-Controlled Trial of Tamoxifen after Adjuvant Chemotherapy in Pre-Menopausal Women in Early Breast Cancer.

Abstract Background: Evidence from the ATAC trial that vasomotor or joint symptomatology by 3 months is associated with reduced recurrence after 3 months led to an interest in examining this phenomenon in other aromatase inhibitor trials. We examined here whether there is such an association in the context of a placebo-controlled tamoxifen therapy trial. Methods: NCIC CTG MA.12 is a randomized placebo-controlled trial of tamoxifen (TAM) after adjuvant chemotherapy for pre-menopausal women with early breast cancer. Eligible patients were included if they received some protocol therapy, were alive and disease-free at 3 months: 1.) without prior grade 3/4 vasomotor or joint symptoms (N=293; only 3 patients had prior grade 1/2 vasomotor or joint symptoms); separately, 2.) all patients with/without prior vasomotor or joint symptoms (N=631). Vasomotor symptom at 3 months was adverse reporting of any grade of hot flashes and/or sweating, while joint symptom was any adverse event reporting of pain -joint, pain -muscle, pain -bone, arthritis, joint -function, or musculoskeletal —other. Exact Fisher tests were used to examine associations between baseline patient and tumour characteristics, treatment arm, and the development of symptomatology. Univariate testing of effect of symptomatology on relapse-free survival (RFS) was with a stratified Cox model, and multivariate was with stratified step-wise forward Cox modeling. Results: MA.12 accrued 672 patients, and the median follow-up for this investigation was 9.7 years. Excluding patients with prior vasomotor or joint symptoms, 27.3% of 293 patients reported vasomotor or joint symptoms by three months, all of which was vasomotor. Meanwhile, 20.8% of all 631 patients had symptomatology by 3 months: 19.2% reported vasomotor alone, 1.1% joint alone, and 0.5% both. With no prior symptoms, 23.4% on placebo (P) and 31.7% on TAM developed symptomatology; age was the only baseline factor with significant differences at 3 months (p=0.01), with under 40 years 18% of women on TAM and 8% on P, and 50 or older, 21% on TAM and 14% on P being symptomatic. For all patients, 20.1% on P and 21.4% on TAM reported symptomatology by 3 months, and there was weak evidence that those >50 on TAM had more symptoms (p=0.06). Vasomotor and joint symptoms did not exhibit significant univariate or multivariate effects on RFS (without prior symptoms, respectively, p=0.98 and p=0.90; for all patients, p=0.99 and p=0.93). Discussion: We did not observe any association of vasomotor or joint symptoms by 3 months and relapse-free survival after 3 months in the MA.12 placebo-controlled trial of tamoxifen therapy in premenopausal women. This mirrors the results we observed in our MA.27 trial of exemestane versus anastrozole in postmenopausal women, and points to the simple metric of early symptomatology not being a universal predictor of reduced relapse. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P1-06-08.

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