Richard R Love1, Adriano V Laudico2, Nguyen Van Dinh2, D Craig Allred2, Gemma B Uy2, Le Hong Quang2, Jonathan Disraeli S Salvador2, Stephen Sixto S Siguan2, Maria Rica Mirasol-Lumague2, Nguyen Dinh Tung2, Noureddine Benjaafar2, Narciso S Navarro2, Tran Tu Quy2, Arturo S De La Peña2, Rodney B Dofitas2, Orlino C Bisquera2, Nguyen Dieu Linh2, Ta Van To2, Gregory S Young2, Erinn M Hade2, David Jarjoura2. 1. International Breast Cancer Research Foundation, Madison, WI (RRL); University of the Philippines Manila, Philippine General Hospital, Manila, Philippines (AL, GU, ADP, RD, OB); Hospital K, Hanoi, Vietnam (NVD, LHQ, NDL, TVT); Clarient Pathology Services, Aliso Viejo, CA (DCA); East Avenue Medical Center, Manila, Philippines (JS); Vicente Sotto Hospital, Cebu, Philippines (SSS); Rizal Medical Center, Manila, Philippines (RML, MHA); Hue Central Hospital, Hue, Vietnam (NDT); National Institute of Oncology, Rabat, Morocco (NB); Santo Tomas University Hospital, Manila, Philippines (NN); Danang General Hospital, Danang, Vietnam (TTQ); The Ohio State University Center for Biostatistics, Columbus, OH (GSY, EMH, DJ (ret.). richardibcrf@gmail.com. 2. International Breast Cancer Research Foundation, Madison, WI (RRL); University of the Philippines Manila, Philippine General Hospital, Manila, Philippines (AL, GU, ADP, RD, OB); Hospital K, Hanoi, Vietnam (NVD, LHQ, NDL, TVT); Clarient Pathology Services, Aliso Viejo, CA (DCA); East Avenue Medical Center, Manila, Philippines (JS); Vicente Sotto Hospital, Cebu, Philippines (SSS); Rizal Medical Center, Manila, Philippines (RML, MHA); Hue Central Hospital, Hue, Vietnam (NDT); National Institute of Oncology, Rabat, Morocco (NB); Santo Tomas University Hospital, Manila, Philippines (NN); Danang General Hospital, Danang, Vietnam (TTQ); The Ohio State University Center for Biostatistics, Columbus, OH (GSY, EMH, DJ (ret.).
Abstract
BACKGROUND: For women with hormone receptor-positive, operable breast cancer, surgicaloophorectomy plus tamoxifen is an effective adjuvant therapy. We conducted a phase III randomized clinical trial to test the hypothesis that oophorectomy surgery performed during the luteal phase of the menstrual cycle was associated with better outcomes. METHODS:Seven hundred forty premenopausal women entered a clinical trial in which those women estimated not to be in the luteal phase of their menstrual cycle for the next one to six days (n = 509) were randomly assigned to receive treatment with surgical oophorectomy either delayed to be during a five-day window in the history-estimated midluteal phase of the menstrual cycles, or in the next one to six days. Women who were estimated to be in the luteal phase of the menstrual cycle for the next one to six days (n = 231) were excluded from random assignment and receivedimmediate surgical treatments. All patients began tamoxifen within 6 days of surgery and continued this for 5 years. Kaplan-Meier methods, the log-rank test, and multivariable Cox regression models were used to assess differences in five-year disease-free survival (DFS) between the groups. All statistical tests were two-sided. RESULTS: The randomized midluteal phase surgery group had a five-year DFS of 64%, compared with 71% for the immediate surgery random assignment group (hazard ratio [HR] = 1.24, 95% confidence interval [CI] = 0.91 to 1.68, P = .18). Multivariable Cox regression models, which included important prognostic variables, gave similar results (aHR = 1.28, 95% CI = 0.94 to 1.76, P = .12). For overall survival, the univariate hazard ratio was 1.33 (95% CI = 0.94 to 1.89, P = .11) and the multivariable aHR was 1.43 (95% CI = 1.00 to 2.06, P = .05). Better DFS for follicular phase surgery, which was unanticipated, proved consistent across multiple exploratory analyses. CONCLUSIONS: The hypothesized benefit of adjuvant luteal phase oophorectomy was not shown in this large trial.
RCT Entities:
BACKGROUND: For women with hormone receptor-positive, operable breast cancer, surgical oophorectomy plus tamoxifen is an effective adjuvant therapy. We conducted a phase III randomized clinical trial to test the hypothesis that oophorectomy surgery performed during the luteal phase of the menstrual cycle was associated with better outcomes. METHODS: Seven hundred forty premenopausal women entered a clinical trial in which those women estimated not to be in the luteal phase of their menstrual cycle for the next one to six days (n = 509) were randomly assigned to receive treatment with surgical oophorectomy either delayed to be during a five-day window in the history-estimated midluteal phase of the menstrual cycles, or in the next one to six days. Women who were estimated to be in the luteal phase of the menstrual cycle for the next one to six days (n = 231) were excluded from random assignment and received immediate surgical treatments. All patients began tamoxifen within 6 days of surgery and continued this for 5 years. Kaplan-Meier methods, the log-rank test, and multivariable Cox regression models were used to assess differences in five-year disease-free survival (DFS) between the groups. All statistical tests were two-sided. RESULTS: The randomized midluteal phase surgery group had a five-year DFS of 64%, compared with 71% for the immediate surgery random assignment group (hazard ratio [HR] = 1.24, 95% confidence interval [CI] = 0.91 to 1.68, P = .18). Multivariable Cox regression models, which included important prognostic variables, gave similar results (aHR = 1.28, 95% CI = 0.94 to 1.76, P = .12). For overall survival, the univariate hazard ratio was 1.33 (95% CI = 0.94 to 1.89, P = .11) and the multivariable aHR was 1.43 (95% CI = 1.00 to 2.06, P = .05). Better DFS for follicular phase surgery, which was unanticipated, proved consistent across multiple exploratory analyses. CONCLUSIONS: The hypothesized benefit of adjuvant luteal phase oophorectomy was not shown in this large trial.
Authors: Richard R Love; Nguyen Ba Duc; Nguyen Van Dinh; Tian-Zhen Shen; Thomas C Havighurst; D Craig Allred; David L DeMets Journal: J Natl Cancer Inst Date: 2002-05-01 Impact factor: 13.506
Authors: Richard R Love; Gregory S Young; Adriano V Laudico; Nguyen Van Dinh; Gemma B Uy; Le Hong Quang; Arturo S De La Peña; Rodney B Dofitas; Orlino C Bisquera; Stephen S S Siguan; Jonathan D S Salvador; Maria Rica Mirasol-Lumague; Narciso S Navarro; Nguyen Dieu Linh; David Jarjoura Journal: Cancer Date: 2013-08-20 Impact factor: 6.860
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