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Phase III randomized placebo-controlled trial of two doses of megestrol acetate as treatment for menopausal symptoms in women with breast cancer: Southwest Oncology Group Study 9626.
J Clin Oncol. 2008 Apr 01; 26(10):1650-6.JC

Abstract

PURPOSE

Prior progestin studies treating hot flashes in women have been short duration and single dose. This study tests the progestin megestrol acetate (MA) at two doses versus placebo over 6 months.

PATIENTS AND METHODS

Patients with T1-3, N0-1, M0 breast cancer were eligible after completion of surgery and chemotherapy and at least 4 months of tamoxifen (if prescribed). Women were required to have at least 10 hot flashes of any severity or at least five severe episodes per week. Patients were randomly assigned to placebo, MA 20 mg, or MA 40 mg for 3 months. Success at 3 months was defined as completion of treatment with a >or= 75% reduction in hot flashes from baseline. If success was achieved, drug treatment for another 3 months was given on the same blinded arm; if not, open-label MA 20 mg was added to blinded study drug and continued for 3 months. Other menopausal symptoms were also assessed.

RESULTS

Two hundred eighty eight eligible women were randomly assigned (286 eligible), of whom 85% were on tamoxifen, 40% had over 63 hot flashes/week, and 75% had vasomotor symptoms for >or= 6 months. Success at 3 months was 14% on placebo, 65% on 20 mg, and 48% on 40 mg (both MA doses superior to placebo; P < .0001). Most successes at 3 months were maintained at 6 months (77% on 20 mg and 81% on 40 mg).

CONCLUSION

MA significantly reduced vasomotor symptoms with durable benefit over 6 months. MA 20 mg/d is the preferred dose. There was no significant impact on other menopausal symptoms.

Authors+Show Affiliations

Cancer Research for the Ozarks, 1730 E Republic Rd, Suite V, Springfield, MO 65804, USA. jgoodwin@sprg.mercy.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

18375894

Citation

Goodwin, J Wendall, et al. "Phase III Randomized Placebo-controlled Trial of Two Doses of Megestrol Acetate as Treatment for Menopausal Symptoms in Women With Breast Cancer: Southwest Oncology Group Study 9626." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 26, no. 10, 2008, pp. 1650-6.
Goodwin JW, Green SJ, Moinpour CM, et al. Phase III randomized placebo-controlled trial of two doses of megestrol acetate as treatment for menopausal symptoms in women with breast cancer: Southwest Oncology Group Study 9626. J Clin Oncol. 2008;26(10):1650-6.
Goodwin, J. W., Green, S. J., Moinpour, C. M., Bearden, J. D., Giguere, J. K., Jiang, C. S., Lippman, S. M., Martino, S., & Albain, K. S. (2008). Phase III randomized placebo-controlled trial of two doses of megestrol acetate as treatment for menopausal symptoms in women with breast cancer: Southwest Oncology Group Study 9626. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 26(10), 1650-6. https://doi.org/10.1200/JCO.2006.10.6179
Goodwin JW, et al. Phase III Randomized Placebo-controlled Trial of Two Doses of Megestrol Acetate as Treatment for Menopausal Symptoms in Women With Breast Cancer: Southwest Oncology Group Study 9626. J Clin Oncol. 2008 Apr 1;26(10):1650-6. PubMed PMID: 18375894.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase III randomized placebo-controlled trial of two doses of megestrol acetate as treatment for menopausal symptoms in women with breast cancer: Southwest Oncology Group Study 9626. AU - Goodwin,J Wendall, AU - Green,Stephanie J, AU - Moinpour,Carol M, AU - Bearden,James D,3rd AU - Giguere,Jeffrey K, AU - Jiang,Caroline S, AU - Lippman,Scott M, AU - Martino,Silvana, AU - Albain,Kathy S, PY - 2008/4/1/pubmed PY - 2008/5/14/medline PY - 2008/4/1/entrez SP - 1650 EP - 6 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J Clin Oncol VL - 26 IS - 10 N2 - PURPOSE: Prior progestin studies treating hot flashes in women have been short duration and single dose. This study tests the progestin megestrol acetate (MA) at two doses versus placebo over 6 months. PATIENTS AND METHODS: Patients with T1-3, N0-1, M0 breast cancer were eligible after completion of surgery and chemotherapy and at least 4 months of tamoxifen (if prescribed). Women were required to have at least 10 hot flashes of any severity or at least five severe episodes per week. Patients were randomly assigned to placebo, MA 20 mg, or MA 40 mg for 3 months. Success at 3 months was defined as completion of treatment with a >or= 75% reduction in hot flashes from baseline. If success was achieved, drug treatment for another 3 months was given on the same blinded arm; if not, open-label MA 20 mg was added to blinded study drug and continued for 3 months. Other menopausal symptoms were also assessed. RESULTS: Two hundred eighty eight eligible women were randomly assigned (286 eligible), of whom 85% were on tamoxifen, 40% had over 63 hot flashes/week, and 75% had vasomotor symptoms for >or= 6 months. Success at 3 months was 14% on placebo, 65% on 20 mg, and 48% on 40 mg (both MA doses superior to placebo; P < .0001). Most successes at 3 months were maintained at 6 months (77% on 20 mg and 81% on 40 mg). CONCLUSION: MA significantly reduced vasomotor symptoms with durable benefit over 6 months. MA 20 mg/d is the preferred dose. There was no significant impact on other menopausal symptoms. SN - 1527-7755 UR - https://www.unboundmedicine.com/medline/citation/18375894/Phase_III_randomized_placebo_controlled_trial_of_two_doses_of_megestrol_acetate_as_treatment_for_menopausal_symptoms_in_women_with_breast_cancer:_Southwest_Oncology_Group_Study_9626_ L2 - https://ascopubs.org/doi/10.1200/JCO.2006.10.6179?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -