Abstract
Abstract Background: Male breast cancer (MBC) is an uncommon malignancy with approximately 2000 American men diagnosed per year. It has been observed that the side effect profiles and tolerability with anti-hormonal treatments such as tamoxifen differ between women and men. There is a paucity of data specifically evaluating the side effect profiles of antihormonal treatments in MBC patients (pts). Objective: To specifically study the side effects of tamoxifen in a cohort of MBC pts and to determine toxicities in this population. Methods: We retrospectively reviewed all MBC pts evaluated at our institution from 1999-2009. Out of a total of 126 MBC pts, 64 met the following inclusion criteria: stage I-III, treated with tamoxifen, and at least one follow-up visit after starting tamoxifen. A descriptive analysis of side effects was performed on these 64 pts. Patient Characteristics and Results: Median follow-up time at our institution was 4.2 years (range 0.3-10.9). Median follow-up from the start of tamoxifen therapy was 4.0 years (range 0.3-19.4). The median age at diagnosis was 61 years (range 30-79). Breakdown by stage included: 29.7% Stage I, 54.7% stage II, and 15.6% stage III. Median initial tumor size was 2.0 cm (range 0.5-6.5). 100% were hormone-receptor positive and 7 tumors (11%) were HER2/neu-positive. Two pts had history of prior therapeutic radiation, and 11 pts (17%) had a prior or concomitant cancer diagnosis, including 6 pts with history of prostate cancer and 2 pts with history of renal cell carcinoma. Sixteen (25%) developed metastatic disease or recurrence. Thirty (47%) pts experienced at least one or more side effect while taking tamoxifen. There were a total of 101 documented side effects (more than one side effect in some pts). The most common toxicity was weight gain (14 out of 64 pts, 22%) and sexual dysfunction/loss of libido (14pts, 22%), followed by hot flashes (8pts, 13%), neurocognitive deficits (6 pts, 1%), thromboembolic events (4 pts, 1%) ocular events (3pts), mood alterations (2pts), depression (2 pts), GI disturbance(2 pts), insomnia (1) and leg cramps (1). Importantly, 13 out of the 64 (20.3%) pts discontinued tamoxifen due to toxicity: 1 for ocular, 2 for neurocognitive deficits, 4 for thromboembolic events, 2 for bone pain, 3 for loss of libido, and 1 for leg cramps. Conclusions: To our knowledge, this is the largest retrospective study specifically examining tamoxifen-related side effects among MBC pts. Among MBC pts, there is a high rate of discontinuation of tamoxifen. Further prospective work regarding better understanding of male hormonal biology as well as novel anti-hormonal drug development may be warranted in this unique population. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P1-16-02.
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