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Randomized Controlled Trial
. 2016 Jun:60:107-16.
doi: 10.1016/j.ejca.2016.03.011. Epub 2016 Apr 20.

Luteal versus follicular phase surgical oophorectomy plus tamoxifen in premenopausal women with metastatic hormone receptor-positive breast cancer

Richard R Love  1 , Syed Mozammel Hossain  2 , Md Margub Hussain  3 , Mohammad Golam Mostafa  4 , Adriano V Laudico  5 , Stephen Sixto S Siguan  6 , Clement Adebamowo  7 , Jing-Zhong Sun  8 , Fei Fei  9 , Zhi-Ming Shao  10 , Yunjiang Liu  11 , Syed Md Akram Hussain  12 , Baoning Zhang  13 , Lin Cheng  14 , Sonar Panigaro  15 , Fardiana Walta  16 , Jiang Hong Chuan  17 , Maria Rica Mirasol-Lumague  18 , Cheng-Har Yip  19 , Narciso S Navarro Jr  20 , Chiun-Sheng Huang  21 , Yen-Shen Lu  22 , Tahmina Ferdousy  23 , Reza Salim  24 , Chameli Akhter  25 , Shamsun Nahar  26 , Gemma Uy  27 , Gregory S Young  28 , Erinn M Hade  29 , David Jarjoura  30
Affiliations
Randomized Controlled Trial

Luteal versus follicular phase surgical oophorectomy plus tamoxifen in premenopausal women with metastatic hormone receptor-positive breast cancer

Richard R Love et al. Eur J Cancer. 2016 Jun.

Abstract

Purpose: 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.

Methods: 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.

Results: 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%.

Conclusions: 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.

Keywords: Acute effects; Anovulatory; Metastatic; Oophorectomy.

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Conflict of interest statement

statement The authors indicated no potential conflicts of interest.

Figures

Figure 1
Figure 1
CONSORT diagram
Figure 2
Figure 2
Kaplan-Meier curves for OS by randomized group (A- luteal phase surgery, B-follicular phase surgery). Number at risk indicated with events in parentheses. Log-rank p=0.36 and unadjusted Cox HR=0.87 (95% CI: 0.65–1.17).
Figure 3
Figure 3
Kaplan-Meier curves for OS for 154 cases categorized by menstrual cycle history and progesterone levels on the day of oophorectomy surgery (conf foll – confirmed follicular, conf lut – confirmed luteal, unconf lut – unconfirmed luteal)
See this image and copyright information in PMC

References

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