In a recently update article in their publication the American Society of Clinical Oncology, the ASCO came out in support of extending the time a woman might take adjuvant hormonal therapy up to as long as 10 years, following active treatment of hormone receptor-positive early breast cancer.
Pre-and peri-menopausal women who have completed 5 years of adjuvant tamoxifen should be offered an additional 5 years of the drug. Postmenopausal patients who have completed 5 years of adjuvant tamoxifen should have the option to continue tamoxifen for another 5 years or switch to an aromatase inhibitor (AI) for 5 years, wrote Harold J. Burstein, MD, PhD, of the Dana-Farber Cancer Institute in Boston, and colleagues.
The recommendations are based on recent data from long-term tamoxifen studies, showing a “modest” survival improvement and a lower risk of ipsilateral recurrence and contralateral breast cancer, the group reported online in the Journal of Clinical Oncology.
“The current update is in response to emerging data from multinational randomized studies that addressed the duration of endocrine therapy,” the authors noted. “This includes two randomized trials — one published and the other presented at the 2013 ASCO annual meeting — on extended durations of tamoxifen treatment. The 2010 guideline update referred to a historical standard of 5-year duration of tamoxifen monotherapy, because earlier studies of extended tamoxifen therapy had not shown clinical benefit for treatment beyond 5 years.”
The new information led to the following recommendations from the ASCO panel for women with hormone receptor-positive early breast cancer:
- Newly diagnosed: 5 years of tamoxifen as initial adjuvant therapy for pre- and perimenopausal women, plus 5 years of therapy determined by the patient’s menopausal status
- Continuation of tamoxifen for a total of 10 years for women with undetermined menopausal status
- Definitively postmenopausal women should be offered tamoxifen for a total of 10 years or a switch to an AI for 5 years after completion of 5 years of adjuvant tamoxifen
- Women who are intolerant of tamoxifen or an AI and discontinue before completing 5 years of initial therapy should be offered an alternative type of adjuvant endocrine therapy for as long as 5 years
- Postmenopausal patients who have completed 5 years of tamoxifen should be offered an additional 5 years or tamoxifen or an AI for 5 years, resulting in a total of 10 years of endocrine therapy
- Women who are pre- or perimenopausal — or whose menopausal status cannot be determined — and have completed 5 years of adjuvant tamoxifen should be offered an additional 5 years of tamoxifen
Finally, postmenopausal women with newly diagnosed hormone receptor-positive breast cancer may be offered 5 years of adjuvant treatment with an AI as initial therapy; 10 years of adjuvant tamoxifen; 5 years of adjuvant tamoxifen as initial therapy followed by an AI for an additional 5 years; 2 to 3 years of adjuvant tamoxifen followed by an AI for as long as 5 years, resulting in a total duration of adjuvant hormonal therapy of 7 to 8 years.
Note: Having taken tamoxifen for five years and weathered the side effects of bone pain, weight gain, night sweats, hot flashes, and mood swings, I can say the challenge for physicians will be to convince women that the possible extended protection will out way the continued discomfort and health-related problems from taking an extended course of tamoxifen or even switching to an aromatase inhibitor for five more years.
