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Significance of Ovarian Function Suppression in Endocrine Therapy for Breast Cancer in Pre-Menopausal Women.

ABSTRACT: Ovarian function suppression (OFS) for treating breast cancer in pre-menopausal women was introduced for the first time in the late 19th century as bilateral oophorectomy. It was not until the 1960s that the oestrogen receptor was identified and a test for detecting endocrine sensitivity of the breast cancer was developed. A weakness of early trials on OFS for breast cancer treatment is therefore their failure to take receptor sensitivity into account when selecting participants. A meta-analysis performed in the early 1990s first proved that adjuvant OFS significantly improved the cure rate of oestrogen receptor-positive breast cancer in pre-menopausal women regardless of whether it was carried out through oophorectomy, radiation-induced ablation or drug therapy. In the 1970s, tamoxifen was synthesized. It became one of the most important cancer drugs and today constitutes the gold standard for endocrine adjuvant therapy. Taking tamoxifen for a five-year period lowers mortality by 30?% over 15 years. Ten years of tamoxifen therapy reduces mortality even further, with increased side effects, however. Research over the past ten years has proven that for post-menopausal women, aromatase inhibitors have benefits over tamoxifen. Current trial results have rekindled the debate about the combination of OFS with tamoxifen or with aromatase inhibitors for adjuvant breast cancer treatment of pre-menopausal women. These trials have reported an improvement in disease-free survival in patients with a high risk of recurrence when they are treated with a combination of OFS plus tamoxifen or aromatase inhibitors, especially in women younger than 35. However, combination therapy causes significantly more side effects, which could negatively impact compliance. Endocrine treatments administered over a period of many years show waning compliance, which tends to be only around 50?% after five years. Inadequate compliance compromises efficacy and increases the risk of mortality. For this reason, when indicating and supporting endocrine adjuvant therapy, physicians must ensure that compliance will be good. To prevent recurrence in the long run, it is much more effective to prescribe a somewhat less effective therapy that will actually be carried out than to prescribe one that is theoretically more effective, but is not adhered to consistently.

SUBMITTER: Scharl A

PROVIDER: S-EPMC4873297 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Significance of Ovarian Function Suppression in Endocrine Therapy for Breast Cancer in Pre-Menopausal Women.

Scharl A A Salterberg A A

Geburtshilfe und Frauenheilkunde 20160501 5

Ovarian function suppression (OFS) for treating breast cancer in pre-menopausal women was introduced for the first time in the late 19th century as bilateral oophorectomy. It was not until the 1960s that the oestrogen receptor was identified and a test for detecting endocrine sensitivity of the breast cancer was developed. A weakness of early trials on OFS for breast cancer treatment is therefore their failure to take receptor sensitivity into account when selecting participants. A meta-analysis ...[more]

PMID: 27239060

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Project description:Background:Recent breast cancer treatment guidelines recommend that higher-risk premenopausal patients should receive ovarian function suppression (OFS) as part of adjuvant endocrine therapy. If chemotherapy is also given, it is uncertain whether to select concurrent or sequential OFS initiation. Design and methods:We analyzed 1872 patients enrolled in the randomized phase III TEXT and SOFT trials who received adjuvant chemotherapy for hormone receptor-positive, HER2-negative breast cancer and upon randomization to an OFS-containing adjuvant endocrine therapy, initiated gonadotropin-releasing-hormone-agonist triptorelin. Breast cancer-free interval (BCFI) was compared between patients who received OFS concurrently with chemotherapy in TEXT (n?=?1242) versus sequentially post-chemotherapy in SOFT (n?=?630). Because timing of trial enrollment relative to adjuvant chemotherapy differed, we implemented landmark analysis re-defining BCFI beginning 1?year after final dose of chemotherapy (median, 15.5 and 8.1?months from enrollment to landmark in TEXT and SOFT, respectively). As a non-randomized treatment comparison, we implemented comparative-effectiveness propensity score methodology with weighted Cox modeling. Results:Distributions of several clinico-pathologic characteristics differed between groups. Patients who were premenopausal post-chemotherapy in SOFT were younger on average. The median duration of adjuvant chemotherapy was 18?weeks in both groups. There were 231 (12%) BC events after post-landmark median follow-up of about 5?years. Concurrent use of triptorelin with chemotherapy was not associated with a significant difference in post-landmark BCFI compared with sequential triptorelin post-chemotherapy, either in the overall population (HR?=?1.11, 95% CI 0.72-1.72; P?=?0.72; 4-year BCFI 89% in both groups), or in the subgroup of 692 women?<40?years at diagnosis (HR?=?1.13, 95% CI 0.69-1.84) who are less likely to develop chemotherapy-induced amenorrhea. Conclusion:Based on comparative-effectiveness modeling of TEXT and SOFT after about 5?years median follow-up, with limited statistical power especially for the subgroup?<40?years, neither detrimental nor beneficial effect of concurrent administration of OFS with chemotherapy on the efficacy of adjuvant therapy that includes chemotherapy was detected. Clinicaltrials.gov:NCT00066690 and NCT00066703.

Project description:BACKGROUND:Anti-estrogen (ER) endocrine therapy is an effective treatment strategy in reducing breast cancer mortality. This therapy has a better therapeutic index than chemotherapy but can still affect patients' quality of life (QOL) over time. OBJECTIVE:The objectives of this systematic review were to (1) describe QOL instruments used in ER-positive (ER+) non-metastatic breast cancer trials and (2) document the longitudinal effects of adjuvant endocrine therapy on the QOL of post-menopausal women with ER+ non-metastatic breast cancer. METHODS:We searched three electronic bibliographic databases for articles published from inception to October 2017 that described (1) a randomized controlled trial (RCT) of non-metastatic breast cancer containing an adjuvant endocrine regimen in at least one arm; (2) the use of a patient self-report measure assessing general or breast cancer-specific QOL; and (3) QOL outcomes at multiple time points during follow-up of at least 5 years. All included trials were independently evaluated by two reviewers, and data were extracted using standardized forms. RESULTS:In total, 13 studies met our inclusion criteria and were assessed in this review. The quality of the trials was reasonably good. The top three most commonly used QOL instruments in the trials were the Functional Assessment of Cancer Therapy/Functional Assessment of Chronic Illness Therapy, the Short Form-36 and the Menopause-Specific Quality of Life. Most studies found no differences between tamoxifen and aromatase inhibitor groups in terms of global QOL. QOL data affected treatment regimen recommendations in a few cases. A meta-analysis was not feasible because the RCTs included in our review varied in terms of sample size, comparators, QOL instrument used, and timing of QOL measurement. Additionally, as no search strategy has perfect sensitivity, specificity and accuracy, there is always a chance that potentially relevant articles were missed. CONCLUSION:This systematic review suggests that the QOL of post-menopausal women is unlikely to be adversely affected by long-term use of adjuvant endocrine therapy. Efforts are needed to improve the quality of QOL reporting in clinical trials.

Dataset Information

Significance of Ovarian Function Suppression in Endocrine Therapy for Breast Cancer in Pre-Menopausal Women.

Publications

Significance of Ovarian Function Suppression in Endocrine Therapy for Breast Cancer in Pre-Menopausal Women.

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