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A prospective trial was initiated in 1972 utilizing Depo-Provera in women with metastatic or recurrent endometrial adenocarcinoma to evaluate if the objective response and survival would be significantly improved in comparison to patients previously treated with Delalutin at a similar dose. One hundred fourteen patients were included in the study: 70 received Delalutin and 44 Depo-Provera. There was no significant increase in the objective response or survival between the Delalutin or Depo-Provera patients. Of the 114 patients, 15.8% achieved an objective response, with 7.0% being complete responders. There was no significant increase in objective response to Delalutin or Depo-Provera in relationship to the size of the tumor masses, the number of metastases, site of metastases, histologic grade of the primary, histologic grade of recurrence or metastases, or prior radiation therapy. The only significant correlate was that patients whose disease recurred 3 or more years after the initial therapy had a significant (P = 0.01) increase in response (33.3%) compared to those with recurrence less than 3 years after their original treatment (8.3%).
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Piver et al. (1980) studied this question.
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