A randomized trial of progestogens in the primary treatment of endometrial carcinoma. Treatment of FIGO (1971) stage I endometrial carcinoma with intensive surgery, radiotherapy and hormonotherapy according to pathological prognostic groups. Long-term results of a randomised multicentre study. A randomized trial of adjuvant progestagen in early endometrial cancer Adjuvant progestogen therapy in the primary definitive treatment of endometrial cancer.
A r and omized trial was arranged in Yorkshire to assess whether progestogens would improve survival as part of the primary treatment of endometrial carcinoma , in conjunction with surgery and radiotherapy .  A total of 429 patients was r and omized on diagnosis to the progestogen or control group  and treated locally according to an agreed protocol . All the patients are now more than 1 year after operation and over half are more than 5 years after operation . The projected overall 5-year survival rate is 76 % but contrary to expectation there is no statistically significant difference in survival between the patients treated with progestogens and the control group even after statistical adjustment for known prognostic factors A multicentre trial on patients with apparent stage I endometrial carcinoma was conducted with the aims of defining a treatment plan on the basis of the pathological disease extension and of evaluating the effectiveness of adjuvant medroxyprogesterone acetate ( MPA ) . After surgery , patients with disease limited to the endometrium did not receive any further treatment . Patients with inner myometrial invasion and well or moderate differentiation were r and omised to no further treatment vs. MPA 100 mg orally twice a day for 12 months ; patients with moderate or deep myometrial invasion or undifferentiated grade were r and omised to radiotherapy on pelvis vs. radiotherapy plus MPA , and patients with node-positive disease ( N+ ) were su bmi tted to radiotherapy on pelvis and para-aortic nodes vs. radiotherapy plus MPA . At 84 months , analysis as intention to treat on 856 patients shows a high relapse-free survival , whereas it did not show any significant difference between the MPA-treated and untreated groups . The study indicates that relapse-free survival is influenced by a treatment based on the pathological extension of the disease and that adjuvant hormonotherapy does not improve the cure rate A r and omized , controlled trial was design ed to determine whether adjuvant progestagen therapy improves survival in patients with Stage I or Stage II endometrial cancer . After surgery , 1148 patients were r and omly assigned to adjuvant treatment with progesterone or were given no additional therapy . The duration of follow‐up ranged from 42 to 132 months ( median follow‐up , 72 months ) . Crude survival and relapse rates were similar for both groups . Death due to intercurrent disease was higher in the progesterone group ( P = 0.04 ) . The median survival of the group of patients with cancer‐related death was higher in the progestagen group than in the control group ( 30 and 22 months , respectively ; P = 0.03 ) . In 461 high‐risk patients , a tendency towards fewer cancer‐related deaths and a better disease‐free survival in the treatment group was observed , but crude survival was unchanged . We conclude that there is little to gain from adjuvant progestagen therapy in patients with low‐risk endometrial cancer , and that further studies are needed in high‐risk patients Abstract On the basis of reported successful hormone therapy for recurrent cancer of the endometrium , a multi-institutional program was established in 1963 and terminated in 1968 to study the adjuvant use of a progestogen in the primary definitive treatment of uterine carcinoma . The research protocol restricted entry to patients with disease limited to the uterine corpus as established by clinical evaluation , surgery , and pathology . Option of surgery alone or surgery plus irradiation was permitted . Depo-Provera and placebo given over 14 wk were r and omly assigned in such a way that 285 patients received hormone ; 287 served as controls .  Survival analysis at 4 yr indicated no significant contribution to results by the adjuvant therapy .  Overall excellent survival for treated patients and controls appeared to be the result of the high degree of patient selection incorporated in the protocol design . The influence of patient selection and of variations of disease-related parameters upon the results is discussed especially as it may affect future programs dealing with comparable patient material
BACKGROUND Endometrial cancer is the most common genital tract carcinoma among women in developed countries , with most women presenting with stage 1 disease .
Adjuvant progestagen therapy has been advocated following primary surgery to reduce the risk of recurrence of disease .
OBJECTIVES To evaluate the effectiveness and safety of adjuvant progestagen therapy for the treatment of endometrial cancer .