Adjuvant endocrine treatment with medroxyprogesterone acetate or tamoxifen in stage I and II endometrial cancer—a multicentre, open, controlled, prospectively randomised trial

Minckwitz, Gϋnter von; Loibl, Sibylle; Brunnert, K.; Melchert, F.; Mösch, R.; Neises, Mechthild; Schermann, J; Seufert, R.; Stiglmayer, R.; Stosiek, U; Kaufmann, M.

doi:10.1016/s0959-8049(02)00378-7

Cited by 39 publications

(31 citation statements)

References 22 publications

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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%

“…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%

“…Only two of the nine randomized trials specifically described the randomization process 6,11 ; however, an additional two trials 9,14 were multicentric investigations that reported centralized randomization procedures. Thus, although randomization and allocation concealment techniques were not specifically reported, it can be inferred that adequate randomization occurred in the latter two trials.…”

Section: Study Qualitymentioning

confidence: 99%

“…Overall survival [6][7][8][9][10][11][13][14] or recurrence-free survival 12 were described or inferred as the primary outcomes of interest upon which power calculations were based. Only two trials specifically reported their power calculation 7,11 , but omission of that information may be a reflection of how reporting standards for clinical trial methodology have changed over time.…”

Section: Study Qualitymentioning

confidence: 99%

“…Only two trials specifically reported their power calculation 7,11 , but omission of that information may be a reflection of how reporting standards for clinical trial methodology have changed over time. Five trials randomized more than 200 patients per arm 7,9-11,14 , two trials 6,8 randomized fewer than 135 patients per arm, and two trials 12,13 randomized fewer than 30 patients per arm.…”

Section: Study Qualitymentioning

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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