Exemestane Improves DFS, but Not OS, vs Tamoxifen in Hormone Receptor-positive Breast Cancer

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Translating these findings into clinical practice will require careful conversations with patients to weigh toxicity and potential benefits for each individual.
Translating these findings into clinical practice will require careful conversations with patients to weigh toxicity and potential benefits for each individual.
The following article features coverage from the San Antonio Breast Cancer Symposium (SABCS) 2017 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.

Among women with hormone receptor–positive breast cancer, adjuvant exemestane plus ovarian function suppression (E + OFS) improves long-term disease free survival (DFS), but not overall survival (OS), vs tamoxifen (T) + OFS, according to findings presented at the 2017 San Antonio Breast Cancer Symposium.1

Ongoing follow-up will clarify the safety profile, late DFS, and OS effects of E + OFS, according to Prudence Francis, MD, of the International Breast Cancer Study Group.

The TEXT and SOFT trials (ClinicalTrials.gov Identifiers: NCT00066703, NCT00066690, respectively) enrolled premenopausal women with hormone receptor–positive early breast cancer between 2003 and 2011. In TEXT, patients were randomly assigned within 12 weeks of surgery to undergo 5 years of E + OFS vs T + OFS. Chemotherapy was optional and concurrent with OFS. In SOFT, patients were randomly assigned to receive 5 years of E + OFS vs T + OFS vs T alone within 12 weeks of surgery or within 8 months of neoadjuvant chemotherapy.

The 8-year DFS for the 2346 patients assigned E + OFS was superior to T + OFS (2344 patients; 86.8% vs 82.8%; hazard ratio [HR], 0.77; 95% CI: 0.67-0.90; P = .0006), Dr Francis said.

The 8-year distant recurrence-free interval was also higher with E + OFS (91.8% vs 89.7% with T + OFS; HR, 0.80; 95% CI: 0.66-0.96; P = .02).

OS was, however, similar for the 2 groups (8-year OS, E + OFS vs T + OFS: 93.4% vs 93.3%, respectively; P = .84).

Overall toxicity was not significantly different between E + OFS and T + OFS. The most frequent grade 3 or 4 adverse events were hot flashes, musculoskeletal symptoms, and hypertension.

Translating these findings into clinical practice will require careful conversations with patients to weigh toxicity and potential benefits for each individual, Dr Francis noted.

Read more of Cancer Therapy Advisor's coverage of the San Antonio Breast Cancer Symposium (SABCS) 2017 meeting by visiting the conference page.

Reference

  1. Pagani O, Regan MM, Fleming GF, et al. Randomized comparison of adjuvant aromatase inhibitor exemestane (E) plus ovarian function suppression (OFS) vs tamoxifen (T) plus OFS in premenopausal women with hormone receptor positive (HR+) early breast cancer (BC): update of the combined TEXT and SOFT trials. Oral presentation at: 2017 San Antonio Breast Cancer Symposium; December 5-9, 2017; San Antonio, TX.

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