Luteal versus follicular phase surgical oophorectomy plus tamoxifen in premenopausal women with metastatic hormone receptor-positive breast cancer.
In premenopausal women with metastatic hormone receptor-positive breast cancer, hormonal therapy is the first-line therapy. Gonadotropin-releasing hormone analogue + tamoxifen therapies have been found to be more effective. The pattern of recurrence risk over time after primary surgery suggests that peri-operative factors impact recurrence. Secondary analyses of an adjuvant trial suggested that the luteal phase timing of surgical oophorectomy in the menstrual cycle simultaneous with primary breast surgery favourably influenced long-term outcomes.



Two hundred forty-nine premenopausal women with incurable or metastatic hormone receptor-positive breast cancer entered a trial in which they were randomised to historical mid-luteal or mid-follicular phase surgical oophorectomy followed by oral tamoxifen treatment. Kaplan-Meier methods, the log-rank test, and multivariable Cox regression models were used to assess overall and progression-free survival (PFS) in the two randomised groups and by hormone-confirmed menstrual cycle phase.



Overall survival (OS) and PFS were not demonstrated to be different in the two randomised groups. In a secondary analysis, OS appeared worse in luteal phase surgery patients with progesterone levels <2 ng/ml (anovulatory patients; adjusted hazard ratio 1.46, 95% confidence interval [CI]: 0.89-2.41, p = 0.14) compared with those in luteal phase with progesterone level of 2 ng/ml or higher. Median OS was 2 years (95% CI: 1.7-2.3) and OS at 4 years was 26%.



The history-based timing of surgical oophorectomy in the menstrual cycle did not influence outcomes in this trial of metastatic patients. ClinicalTrials.gov number NCT00293540.
The International Breast Cancer Research Foundation, USA. Electronic address: richardibcrf@gmail.com.
Richard R
RR
Love
Khulna Medical College and Hospital, Khulna, Bangladesh. Electronic address: drsmozammel@yahoo.com.
Syed Mozammel
SM
Hossain
Dhaka Medical College and Hospital, Dhaka, Bangladesh. Electronic address: dr.margub@gmail.com.
Md Margub
MM
Hussain
National Cancer Research Institute and Hospital, Dhaka, Bangladesh. Electronic address: dr.mohammadgolammostafa@gmail.com.
Mohammad Golam
MG
Mostafa
Philippines General Hospital, Manila, Philippines. Electronic address: yago_md@yahoo.com.
Adriano V
AV
Laudico
Vicente Sotto Memorial Hospital, Cebu, Philippines. Electronic address: ssiguan@yahoo.com.
Stephen Sixto S
SS
Siguan
University College Hospital, Ibadan, Nigeria. Electronic address: cadebamo@yahoo.com.
Clement
C
Adebamowo
Qilu Hospital, Jinan, China. Electronic address: Doctor_sun@tom.com.
Jing-Zhong
JZ
Sun
Cancer Institute, Fudan University, Shanghai, China. Electronic address: fei.fei@eortc.be.
Fei
F
Fei
Cancer Institute, Fudan University, Shanghai, China. Electronic address: libin206@163.com.
Zhi-Ming
ZM
Shao
4th Hospital, Hebei, China. Electronic address: Lyj818326@126.com.
Yunjiang
Y
Liu
BSMMU Postgraduate Hospital, Dhaka, Bangladesh. Electronic address: syedmdakram@gmail.com.
Syed Md
SM
Akram Hussain
Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: cdb8891@126.com.
Baoning
B
Zhang
People's Hospital, Beijing, China. Electronic address: chenglin@pkuph.edu.cn.
Lin
L
Cheng
University of Indonesia General Hospital, Jakarta, Indonesia. Electronic address: sonarsp@yahoo.com.
Sonar
S
Panigaro
University of Indonesia General Hospital, Jakarta, Indonesia. Electronic address: fardiana_w@yahoo.com.
Fardiana
F
Walta
Chao Yang Hospital, Beijing, China. Electronic address: JHC2000@sohu.com.
Jiang Hong
JH
Chuan
Rizal Medical Center, Pasig City, Philippines. Electronic address: rdmsurgn@yahoo.com.
Maria Rica
MR
Mirasol-Lumague
University of Malaya Medical Center, Kuala Lumpur, Malaysia. Electronic address: chenghar.yip@gmail.com.
Cheng-Har
CH
Yip
Santo Thomas University Hospital, Manila, Philippines. Electronic address: nsnavarrojr@yahoo.com.
Narciso S
NS
Navarro
National Taiwan University Hospital, Taipei, Taiwan. Electronic address: huangcs@ntu.edu.tw.
Chiun-Sheng
CS
Huang
National Taiwan University Hospital, Taipei, Taiwan. Electronic address: yslu@ntu.edu.tw.
Yen-Shen
YS
Lu
Amader Gram, Khulna, Bangladesh. Electronic address: tahminaferdousy@yahoo.com.
Tahmina
T
Ferdousy
Amader Gram, Khulna, Bangladesh. Electronic address: rezasalim02@yahoo.com.
Reza
R
Salim
Amader Gram, Khulna, Bangladesh. Electronic address: chameli@agbreastcare.org.
Chameli
C
Akhter
BSMMU Postgraduate Hospital, Dhaka, Bangladesh. Electronic address: shamsunnahar73@yahoo.com.
Shamsun
S
Nahar
Philippine General Hospital, Manila, Philippines. Electronic address: gemmauymd@yahoo.com.
Gemma
G
Uy
The Ohio State University Center for Biostatistics, Columbus, Ohio, USA. Electronic address: gregory.young@osumc.edu.
Gregory S
GS
Young
The Ohio State University Center for Biostatistics, Columbus, Ohio, USA. Electronic address: erinn.hade@osumc.edu.
Erinn M
EM
Hade
The Ohio State University Center for Biostatistics, Columbus, Ohio, USA. Electronic address: davidjarjoura@gmail.com.
David
D
Jarjoura
D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000503:physiopathology / Q000628:therapy*; D003131:Combined Modality Therapy / Q000379:methods; D005260:Female; D005498:Follicular Phase / Q000502:physiology; D006801:Humans; D008183:Luteal Phase / Q000502:physiology; D010052:Ovariectomy / Q000379:methods*; D017697:Premenopause / Q000502:physiology; D013629:Tamoxifen / Q000627:therapeutic use*; D016896:Treatment Outcome
D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen
Acute effects; Anovulatory; Metastatic; Oophorectomy