A Randomized Trial of Progestogens in the Primary Treatment of Endometrial Carcinoma

Macdonald, R. R.; Thorogood, J.; Mason, M. K.

doi:10.1097/00006254-198811000-00022

Cited by 12 publications

(46 citation statements)

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“…In the nine trials identified, patients were randomized to either adjuvant progestogen therapy or to a control group with no adjuvant therapy [6][7][8][9][10][11][12][13][14] . In seven trials, patients in the control group received no further treatment [6][7][8][9][10][11][12] ; in two trials, patients in the control group received a placebo control.…”

Section: Literature Search Resultsmentioning

confidence: 99%

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Adjuvant Hormonal Therapy for Stage I Endometrial Cancer

et al. 2008

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QuestionWhat is the role of hormonal therapy as adjuvant therapy in patients with stage I endometrial cancer? PerspectivesThere is little consensus on the role of adjuvant treatment for patients with stage I endometrial cancer. Although the use of hormonal therapy has been established in advanced disease, less agreement has emerged concerning the benefits of adjuvant hormonal therapy for patients with early-stage disease. The objective of the present evidence series was to review the existing literature on the role of hormonal therapy as adjuvant therapy in patients with stage I endometrial cancer. OutcomesReports were sought that included at least one of the following outcomes: overall survival, disease-free survival, recurrence (local, or distant, or both), adverse effects, and quality of life. Because of the potential for long-term adverse effects with adjuvant hormonal treatment in this patient population, especially with regard to thromboembolic or cardiovascular events, the rates of non-cancer-related death were also of interest. MethodologyThe MEDLINE, EMBASE, and Cochrane Library databases were systematically searched for randomized controlled trials, practice guidelines, systematic reviews, and meta-analyses. The resulting evidence informed the development of the clinical practice guideline. The systematic review with meta-analyses and practice guideline were approved by the Report Approval Panel of the Program in Evidence-Based Care, and by the Gynecology Cancer Disease Site Group (DSG). ResultsNine randomized trials and one published meta-analysis comparing adjuvant hormonal therapy with no adjuvant therapy in women with stage I endometrial cancer constituted the evidence base. One trial reported a statistically significant survival benefit with adjuvant progestogen as compared with no further treatment (97% vs. 69%, p < 0.001). In that trial, the treatment group had a higher number of patients with less myometrial invasion, and a lower number of patients with advanced-stage disease. These differences in baseline characteristics between the randomized groups were considered to be clinically important. In addition, the results of that trial were not consistent with those of other trials, and the trial was a source of statistical heterogeneity when data were pooled across trials.In two of the nine randomized trials, statistically significant recurrence-free benefits were detected with adjuvant hormonal therapy as compared with no further therapy. In one trial, the difference between the rates of recurrence was 16%; however, the methodologic concerns related to that that trial limited its relevance. In the other trial, the difference between the rates of recurrence was 5%. In that trial, patients were at a high risk of recurrence. None of the remaining seven

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Section: Literature Search Resultsmentioning

confidence: 99%

“…In seven trials, patients in the control group received no further treatment [6][7][8][9][10][11][12] ; in two trials, patients in the control group received a placebo control. One trial also included a third group of patients randomized to receive tamoxifen 6 .…”

Section: Literature Search Resultsmentioning

confidence: 99%

Adjuvant Hormonal Therapy for Stage I Endometrial Cancer

et al. 2008

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“…Urbanski et al reported that the 5-year survival rate of patients with endometrial cancer was significantly higher following postoperative adjuvant therapy with progesterone (97%, n=100) as compared to the control group (68.6%, n=105) (16). However, McDonald et al (17) and Vergote et al (18) reported that progesterone therapy failed to improve the survival rate sufficiently, and De Palo et al (19) also reported the lack of survival rate improvement following progesterone treatment, adding that postoperative adjuvant therapy is not effective and hence is not recommendable. Thus, there is no definite conclusion as to the usefulness of postoperative adjuvant therapy as a means of preventing recurrence of endometrial cancer (20).…”

Section: Progestin Therapy For Endometrial Cancermentioning

confidence: 99%

Progestin therapy for endometrial cancer: The potential of fourth-generation progestin (Review)

et al. 2012

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Abstract. Progestin preparations are made of synthetic progesterone and have often been used for hormone therapy in gynecological patients with endometriosis or endometrial cancer. Hormone therapy using progestin is considered to be one of the effective means of treatment particularly when dealing with endometrial cancer (an estrogen-dependent tumor). Numerous reports have been published concerning its efficacy in advanced or recurrent cases of atypical endometrial hyperplasia or endometrial cancer. Dienogest has been developed as a fourth-generation progestin for hormone therapy for endometriosis that can be used with high safety for long periods of time. In Japan, dienogest has been recommended as a first-line drug for endometriosis-associated pain. However, its antitumor activity has also been attracting close attention following a report that this drug suppressed the proliferation in vitro of endometrial cancer-derived cell lines which failed to respond to other progestins such as medroxyprogesterine acetate (MPA). The mechanism for antitumor activity of dienogest is considered to differ from the mechanism for antitumor activity of conventional progestin preparations used for treatment of endometrial cancer. This drug is expected to be clinically applicable as a new drug for the treatment of endometrial cancer. Contents

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“…The role of hormone therapy in early stage endometrial cancer has been studied in different randomized trials (Table 6). Only patients with stage I endometrial cancer were included in four trials (Lewis et al 1974;Malkasian and Bures 1978;Macdonald et al 1988;De Palo et al 1993). Other trials also included patients with more advanced disease (COSA-NZ-UK Endometrial Cancer Study Group ; Vergote et al 1989;Urbanski et al 1993 …”

Section: Low-risk Patientsmentioning

confidence: 99%