Clinical and pharmacological phase I study with accelerated titration design of a daily times five schedule of BBR3464, a novel cationic triplatinum complex.

Objectives: To define the maximum tolerated dose (MTD), the toxicity and pharmacokinetic profile of BBR3464, a novel triplatinum complex.

Patients And Methods: Fourteen patients with advanced solid tumors not responsive to previous antitumor treatments received BBR 3464 on a daily x 5 schedule every twenty-eighth day. The drug was given as a one-hour infusion with pre-and post-treatment hydration (500 ml in one hour) and no antiemetic prophylaxis.

Phase II studies of 4'-iodo-4'-deoxydoxorubicin in advanced non-small cell lung, colon and breast cancers.

The new anthracycline analogue, 4'-iodo-4'-deoxydoxorubicin (I-DOX), was administered at 70 mg/m2 as first chemotherapy in 61 patients with advanced NSCL (19), colon (20) and breast cancers (22). Treatment was repeated every 3 weeks; the dose was decreased to 60 mg/m2 (19% of the cycles) or increased to 80 mg/m2 (17% of the cycles) according to the granulocyte count nadir. Partial responses were observed in 6% of the patients with NSCL, in 5.

Smoking in pregnancy: a survey from northern Italy.

The prevalence of smoking in pregnancy was analyzed in a survey of women delivering between January and March 1989 in a large maternity clinic in Milan, Northern Italy. Out of the 528 women interviewed, 183 (35%) were current smokers before pregnancy and 99 stopped smoking during pregnancy. The probability of stopping smoking decreased with increasing age and was lower in less educated women, but these findings were not statistically significant.

Critical review of the quality and development of randomized clinical trials (RCTs) and their influence on the treatment of advanced epithelial ovarian cancer.

Trials on chemotherapy of advanced ovarian cancer published between 1975-88 were systematically reviewed for quality (according to the method of Chalmers) and consistency of tested hypotheses with a view to a meta-analysis of all published studies in the field. Median overall, internal and external validity scores were 47%, 43% and 53%, respectively. No association was found between scores and key features of trials, such as percentage studies with significant results in response or survival or percentage studies with high or low follow-up retention (withdrawal rates less than or greater than or equal to 15%).

[Assessment of the use of Pap test in a sample of pregnant women].

Four hundred and ninety-nine women were interviewed who gave birth in the "L. Mangiagali" Obstetrics-Gynaecological Clinic between March and April 1989. 22% of these women had never had a Pap-test, 37% reported having had 1-2 cervical smears and 41% 3 or more.