First-trimester endocrinology is determined on the one hand by corpus luteum progesterone and estradiol biosynthesis and secretion and on the other hand by the time of onset and extent of progesterone and estradiol secretion by the placenta. This dual interplay is dominated by the corpus luteum placental shift, where a relative progesterone and estradiol deficiency can develop and may lead to early as well as late abortion. Measurements of serum progesterone and estradiol are mandatory in order to reveal such deficiencies and to treat them effectively with 17 alpha-hydroxyprogesterone caproate in combination with estradiol valerate or with progestins such as dydrogesterone.
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.
Short CommunicationDur resuIts suggest, that the crossreactivity of antisera against T 4-HSA conjugates to tyrosine and thyronine analogues was considerably less than the crossreactivity of thyroglobulin-antibodies used by Chopra (1972) and Beckers, Cornette and TIuz· lasso (1972).It may be possible that the high T 4 values in hyperthyroidism found by Becker, Cornette and Thalasso (1972) stern from the same reason. The radioimmunoassay described here is a specific, sensitive and reprodueible method for the measurement of total T4 in unextracted serum. The possibility to measure numerous sampies with a simple technique makes it practical for routine use in diagnostic procedures.
The effectiveness of therapy with cyproterone acetate and ethinyl estradiol was studied in 103 women. Acne and seborrhea responded best with 91.7 and 93.3% respectively, including complete and partial therapeutic success. For hirsutism complete remission and partial improvement were found in 75.3% of the treated women. Under therapy, body weight did not change in 51.9%, while 24.7% of the patients gained weight and 23.4% lost weight. The cycle length remained normal after therapy in 35.8%. Normalization or improvement was found in 54.7%. In 6.3% no improvement was noted after therapy and in 3.2% cycle irregularity developed in women with previous undisturbed pattern. According to BBT, improvement of the functional capacity of the reproductive system was found in 32.9% of the patients. Only 3% of the women studied demonstrated a deterioration. The 17-ketosteroid excretion was diminished in 35.3% after therapy and remained unchanged in 64.7%. The therapeutic regimen used for the study was well tolerated and good cycle control was obtained.
18 pregnancies occurred after treatment with bromoergocryptine in 17 patients who wished to conceive, but who suffered from anovulation of varying aetiology. The course of 15 pregnancies was uneventful. Three pregnancies ended in abortion. Nine of the 17 women had hyperprolactinemic amenorrhea. Furthermore, one woman had normoprolactinemic post-pill amenorrhea, another normoprolactinemic anovulatory oligomenorrhea and a third normoprolactinemic anovulatory regular menstruations. With the exception of one woman, all had galactorrhea. The courses of pregnancy were monitored by frequent ultrasound measurements of the fetal biparietal diameter, maternal urinary estriol excretion and radioimmunological measurements of plasma estrone, estradiol, unconjugated and immunoreactive estriol, progesterone, and HPL. All data were within the normal ranges and all babies were healthy at birth and had no teratogenic defects. The data prove the great value of bromoergocryptine in the treatment of hyperprolactinemic anovulation, sometimes even in the treatment of normoprolactinemic anovulation. Moreover, the results indicate no adverse effect on either the course or the outcome of pregnancy.
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