Adjuvant progestogen therapy in the primary definitive treatment of endometrial cancer

Lewis, George Cornewall; Slack, Nelson H.; Mortel, Rodrique; Bross, Irwin D. J.

doi:10.1016/0090-8258(74)90028-6

Cited by 97 publications

(33 citation statements)

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“…In the trial by Urbanski et al 8 , the progestogen group had noticeably more patients with favourable characteristics in terms of stage and depth of myometrial invasion, a clinically relevant difference between groups. Conversely, in the trial by Lewis et al 14 , the placebo group had more patients with favourable characteristics with regard to depth of myometrial invasion.…”

Section: Study Qualitymentioning

confidence: 86%

“…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%

“…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%

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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: Study Qualitymentioning

confidence: 86%

Section: Literature Search Resultsmentioning

confidence: 99%

Section: Study Qualitymentioning

confidence: 99%

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Adjuvant Hormonal Therapy for Stage I Endometrial Cancer

et al. 2008

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“…In a recent study, no vaginal recurrences were reported in these patients after surgery alone (Straughn et al 2002). 1968-1974(Aalders et al 1980. All patients underwent surgery and subsequently received vaginal brachytherapy at the dose of 60 Gy.…”

Section: Low-risk Patientsmentioning

confidence: 99%

“…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%

Treatment Strategies and Prognosis of Endometrial Cancer

Garg¹,

Mutch²

2012

Cancer of the Uterine Endometrium - Advances and Controversies

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Perspectives on research in gynecologic oncology.Treatment protocols

DeVita

Wasserman

Young

et al. 1976

Cancer

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Gynecologic cancers present unusual opportunities to explore the fruits of well-designed clinical trials to assess the value of existing treatment using a combined modality approach soon after diagnosis. Cancers of the ovary and uterus have well-defined, familiar natural histories. Pathways of spread are clear and reasons for treatment failure are often blatantly obvious. In the case of ovarian cancer, regional treatment with surgery and radiotherapy has been relatively ineffective and generally has not improved the survival statistics in the last two decades. Spread of tumor cells widely throughout the abdominal cavity outside radiation or surgical fields, even in patients with apparently early disease, is the obvious reason. Studies are underway to assess the impact of long-term postoperative adjuvant chemotherapy with L-phenylalanine mustard, an alkylating agent effective in patients with advanced disease, in early stages of ovarian cancer following surgery and or x-irradiation. The search is on for more effective drugs, or combinations of drugs, that could subsequently serve as more effective adjuvant treatments. In carcinoma of the uterine cervix, chemotherapy as an adjunct to surgery and/or radiotherapy in patients with localized, or locally inoperable disease has been poorly evaluated; little data are available and the value of many established drugs in patients with metastatic cervical cancer is undermined. Some recent evidence suggests the use of hydroxyurea, a drug that by itself is not effective in controlling tumor, may enhance the effect of radiotherapy in patients with Stage II disease. Uterine fundal cancer is often successfully treated by surgery alone. The data for the use of pre- or postoperative radiotherapy are open to considerable question. While the relative nontoxic progesterone compounds are effective in a small but significant fraction of patients with advanced uterine cancer, no properly designed clinical trial has truly evaluated their role as postoperative adjuncts in patients who have resectable tumor but a definite high risk of recurrence. Systemic chemotherapy has been rarely used with any consistency against this tumor but, even so, some chemotherapeutic leads, such as the use of adriamycin, are worthy of exploration. The absence of useful information on systemic treatment of gynecologic malignancies can be traced to the excessive rigid compartmentalization of medical practice. Only recently have investigators of all persuasions begun to explore and exploit some of the therapeutic opportunities, which have been available for some time.

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Adjuvant progestogen therapy in the primary definitive treatment of endometrial cancer

Cited by 97 publications

References 4 publications

Adjuvant Hormonal Therapy for Stage I Endometrial Cancer

Adjuvant Hormonal Therapy for Stage I Endometrial Cancer

Treatment Strategies and Prognosis of Endometrial Cancer

Perspectives on research in gynecologic oncology.Treatment protocols

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