A randomized trial of adjuvant progestagen in early endometrial cancer.
A randomized, controlled trial was designed to determine whether adjuvant progestagen therapy improves survival in patients with Stage I or Stage II endometrial cancer. After surgery, 1148 patients were randomly 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.
Vergote
I
I
Department of Gynecologic Oncology, Norwegian Radium Hospital, Oslo.
Kjørstad
K
K
Abeler
V
V
Kolstad
P
P
D000077713:17 alpha-Hydroxyprogesterone Caproate; D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology / Q000628:therapy; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D004965:Estrogen Antagonists / Q000627:therapeutic use; D005260:Female; D006801:Humans; D006908:Hydroxyprogesterones / Q000627:therapeutic use*; D009364:Neoplasm Recurrence, Local; D045167:Progesterone Congeners / Q000627:therapeutic use; D011379:Prognosis; D011897:Random Allocation; D012307:Risk Factors; D014594:Uterine Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000628:therapy
D004965:Estrogen Antagonists; D006908:Hydroxyprogesterones; D045167:Progesterone Congeners; D000077713:17 alpha-Hydroxyprogesterone Caproate