The purpose of this randomized phase III trial was to study whether medroxyprogesterone acetate (MPA) maintenance treatment prolongs the time to progression in advanced breast cancer patients responding to an induction chemotherapy. Patients with progressive advanced breast cancer previously untreated with anthracylines and progestins were given epirubicin (30 mg/m2) and ifosfamide (2 g/m2) on days 1 and 8 at 3-weekly intervals. Patients without disease progression after 6 cycles of chemotherapy were randomly assigned to receive, until progression, either no treatment or MPA at a daily total dose of 500 mg. Ninety patients were randomized: 46 to the MPA arm and 44 to the observation arm. Median time to progression was longer in the MPA arm: 4.9 months versus 3.7 months in the intent-to-treat analysis (p = 0.02), and 4.9 months versus 3.0 months in the secondary efficacy analysis (p = 0.012). Seven patients were removed from MPA due to side effects. The changes in patient-rated quality of life scores were similar in both groups. The median length of survival from randomization was 17.4 months for patients receiving MPA and 18.3 months for patients randomized to observation (p = 0.39). In conclusion, in patients with advanced breast cancer achieving remission or non-progression with 6 cycles of epirubicin and ifosfamide chemotherapy, MPA maintenance treatment led to a significant, though modest, prolongation of the time to progression without affecting overall survival of the study patients.
Between 1967 and 1973 15 women with ulcerative colitis had 20 pregnancies. 14 ended with normal deliveries, 4 with spontaneous abortions, and 2 with therapeutic abortions. Fertility was normal. Malformations in the children were not observed. In the case of conception during remission or a latent phase of the disease in general a normal pregnancy is to be expected (12 out of 14). On the other hand conception during an active phase can lead to an unpredictable threat to the life of mother and child. Therapeutic abortion should be seriously considered when ulcerative colitis and pregnancy begin simultaneously. In the same period of time in 15 comparable patients with Crohn's disease (12 with ileo-colitis and 3 with terminal ileitis) who were not taking ovulation inhibitors 4 pregnancies were observed. Fertility is not significantly reduced in terminal ileitis whereas in ileo-colitis it is highly significantly reduced (bilateral tubal irritation). As in ulcerative colitis a normal pregnancy can be expected after conception in an inactive phase (2 out of 4).
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