Barbara Pistilli1, Chafika Mazouni2, Anna Zingarello3, Matthieu Faron4, Mahasti Saghatchian5, Michael Grynberg6, Marc Spielmann5, Paul Kerbrat7, Henri Roché8, Veronique Lorgis9, Thomas Bachelot10, Mario Campone11, Christelle Levy12, Anthony Gonçalves13, Anne Lesur14, Corinne Veyret15, Laurence Vanlemmens16, Jerome Lemonnier17, Suzette Delaloge5. 1. Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France. Electronic address: barbara.pistilli@gustaveroussy.fr. 2. Department of Surgical Oncology, Institut Gustave Roussy, Villejuif, France. 3. Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France; U.O. Oncologia Medica 2, IRCCS AOU San Martino-IST, Genova, Italy. 4. Department of Surgical Oncology, Institut Gustave Roussy, Villejuif, France; Department of Biostatistics and Epidemiology, Institut Gustave Roussy, Villejuif, France. 5. Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France. 6. Department of Reproductive Medicine and Fertility Preservation, Hopital Antoine Béclère, Clamart, and Université Paris Sud XI, Paris, France. 7. Department of Oncology, Centre Eugene Marquis, Rennes, France. 8. Department of Medical Oncology, Institut Claudius Regaud, IUCT Oncopole, Toulouse, France. 9. Department of Medical Oncology, Centre Georges François Leclerc, Dijon, France. 10. Department of Medical Oncology, Centre Léon Bérard, Lyon, France. 11. Department of Medical Oncology, Institut de Cancérologie de l'Ouest, Angers, France. 12. Department of Medical Oncology, Centre Franois Baclesse, Caen, France. 13. Department of Medical Oncology, Institut Paoli-Calmettes, Marseille, France. 14. Department of Medical Oncology, Institut de Cancérologie de Lorriane, Nancy, France. 15. Department of Medical Oncology, Centre Henri Becquerel, Rouen, France. 16. Department of Medical Oncology, Centre Oscar Lambret, Lille, France. 17. National Federation of French Cancer Centres, Paris, France.
Abstract
BACKGROUND: The likelihood of menses recovery varies greatly in premenopausal patients receiving adjuvant chemotherapy for breast cancer. Quantifying this probability for each patient could better inform the chemotherapy discussion and individualize fertility counseling. We performed a pooled analysis of the PACS04 and PACS05 adjuvant randomized trials to develop a nomogram to estimate the probability of menses recovery at 3, 6, and 18 months after the end of adjuvant chemotherapy. PATIENTS AND METHODS: Women who were premenopausal and aged ≤ 50 years at randomization in thePACS04 and PACS05 trials were included in the present analysis. The primary endpoint was the probability of menses recovery within 18 months of chemotherapy completion. Multivariable Cox proportional hazards regression was used to estimate the association of each variable with the likelihood of menses resumption. A nomogram was developed to predict menses recovery at different intervals. RESULTS: The factors associated with menses recovery were assessed for 1210 patients. At a median follow-up of 90 months (range, 3-189 months), 342 of 1210 patients (28.2%) had recovered menses. The probability of menses recovery at 18 months was 25.5% (range, 23.0%-27.9%). After backward elimination, age, final body mass index, type of chemotherapy, and hormone therapy were selected to build the nomogram to predict the probability of menstrual resumption at 3, 6, and 18 months after chemotherapy. CONCLUSION: An accurate and individualized prediction of menses recovery is feasible for premenopausal patients eligible for adjuvant chemotherapy for early-stage breast cancer. Our nomogram will be externally validated in a large prospective cohort.
RCT Entities:
BACKGROUND: The likelihood of menses recovery varies greatly in premenopausal patients receiving adjuvant chemotherapy for breast cancer. Quantifying this probability for each patient could better inform the chemotherapy discussion and individualize fertility counseling. We performed a pooled analysis of the PACS04 and PACS05 adjuvant randomized trials to develop a nomogram to estimate the probability of menses recovery at 3, 6, and 18 months after the end of adjuvant chemotherapy. PATIENTS AND METHODS: Women who were premenopausal and aged ≤ 50 years at randomization in the PACS04 and PACS05 trials were included in the present analysis. The primary endpoint was the probability of menses recovery within 18 months of chemotherapy completion. Multivariable Cox proportional hazards regression was used to estimate the association of each variable with the likelihood of menses resumption. A nomogram was developed to predict menses recovery at different intervals. RESULTS: The factors associated with menses recovery were assessed for 1210 patients. At a median follow-up of 90 months (range, 3-189 months), 342 of 1210 patients (28.2%) had recovered menses. The probability of menses recovery at 18 months was 25.5% (range, 23.0%-27.9%). After backward elimination, age, final body mass index, type of chemotherapy, and hormone therapy were selected to build the nomogram to predict the probability of menstrual resumption at 3, 6, and 18 months after chemotherapy. CONCLUSION: An accurate and individualized prediction of menses recovery is feasible for premenopausal patients eligible for adjuvant chemotherapy for early-stage breast cancer. Our nomogram will be externally validated in a large prospective cohort.
Authors: Zobaida Edib; Yasmin Jayasinghe; Martha Hickey; Lesley Stafford; Richard A Anderson; H Irene Su; Kate Stern; Christobel Saunders; Antoinette Anazodo; Mary Macheras-Magias; Shanton Chang; Patrick Pang; Franca Agresta; Laura Chin-Lenn; Wanyuan Cui; Sarah Pratt; Alex Gorelik; Michelle Peate Journal: BMJ Open Date: 2020-02-10 Impact factor: 2.692