Phase II study of gemcitabine in combination with cisplatin in patients with locally advanced and/or metastatic pancreatic cancer.

The present phase II trial was performed to assess the efficacy and toxicity of polychemotherapy with gemcitabine and cisplatin in patients with locally advanced or metastatic carcinoma of the pancreas. Sixteen patients received six courses of an i.v. cytotoxic regimen consisting of gemcitabine (1000 mg/m2, days 1, 8 and 15) and cisplatin (35 mg/m2, days 1, 8 and 15) administered in 28-day intervals. Complete remission (CR) occurred in one patient (6%), partial remission (PR) in four patients (25%) and stable disease in seven patients (44%), whereas four patients (25%) developed progressive disease resulting in an overall response rate of 31%. Mean duration of responses (CR+PR) was 3.6 (range 0.7-8.5) months and mean time to progression was 7.4 (range 3.8-12.6) months. After a mean observation period of 11.5 months the overall survival was 9.6 months with 12 patients (75%) still being alive, which compares favorably with historical data of the administration of gemcitabine alone. The performance status improved in three (19%) and stabilized in eight (50%) out of 16 patients for 4 weeks or longer. Treatment-associated toxicity included alopecia of WHO grade III in all cases, leukopenia of WHO grades I and II in 10 patients (63%), grade III in five patients (31%), and thrombocytopenia grades I and II in four patients (25%), and grades III and IV in 10 patients (63%). We conclude that the administered dosage and schedule of gemcitabine and cisplatin in patients with locally advanced or metastatic cancer of the pancreas constitutes an active cytotoxic regimen associated with moderate toxicity.

Monotherapy with docetaxel in second- or third-line treatment of anthracycline-resistant metastatic breast cancer.

Nineteen breast cancer patients pretreated with one or two anthracycline-containing regimens for visceral metastases received i.v. docetaxel 100 mg/m2 on day 1, q 21d. Docetaxel was administered as second-line therapy in 11 patients, whereas eight patients received docetaxel in a third-line setting. In the second-line setting, complete response (CR) was achieved in two (18%), partial response (PR) in four (36%) and stable disease (SD) in three (27%) patients resulting in a response rate (RR) of 54%. In the third-line setting three (38%) patients experienced PR (RR 38%) and two (25%) SD. In the second-line setting, median time to progression was 6.5+/-3.9 months (range 2.1-15.8) versus 4.7+/-5.5 months (range 0.6-15.9) in the third-line setting. Median overall survival was 9.6+/-8.0 months (range 2.7-25.8) versus 11.2-6.1 months (range 4.8-18.7). Overall, no patient experienced treatment-limiting toxicities. We conclude that docetaxel induced responses in 48% of anthracycline-resistant patients enrolled into the present study. The safety profile of docetaxel was manageable and tolerable. Docetaxel represented efficacious treatment in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy.

Single-agent gemcitabine as second- and third-line treatment in metastatic breast cancer.

In the present study, 25 patients with breast cancer pretreated with one or two anthracycline-based regimens for visceral metastases were enrolled. Patients were treated with gemcitabine 1250 mg/m2 on days 1, 8 and 15, q28d. Nine patients received gemcitabine as second-line treatment, whereas 16 patients received gemcitabine as third-line cytotoxic treatment, respectively. In the second-line setting, two (22%) patients gained PR (RR 22%) and four (44%) patients experienced SD (P=0.2), respectively. In the third-line-setting, one (6%) patient gained CR, one patient PR (6%) and four patients (25%) SD, respectively, resulting in a response rate (RR) of 12%. In the second-line-setting, median time to progression was 5.1 +/- 4.0 months (range: 1.6-13.9) versus 3.5-2.5 months (range: 1.3-10.4) in the third-line-setting. Median overall survival was 12.6 +/- 9.1 months (range: 3.9-30.8) versus 7.5 +/- 6.7 months (range: 2.0-26.0), respectively. Overall, no patient experienced treatment limiting toxicities. We conclude from the present study that gemcitabine induced an overall RR of 16% following prior treatment with anthracyclines. However, median time to progression and median overall survival were limited. In the search for efficacious treatment of patients with metastatic breast cancer, gemcitabine constitutes a valid tool in anthracycline-resistant disease and thus might represent a valuable option for combination chemotherapy in controlled trials in this condition.

[Placental isoferritin (PLF): early predictor of fetal growth retardation]. / Früherkennung fetaler Wachstumsretardierung durch Bestimmung des plazentaren Isoferritins.

OBJECTIVE: Maternal immunoreaction against the embryo can be responsible for fetal growth retardation. The secretion of PLF during pregnancy could be reliable for a diminished immunoreaction of maternal lymphocytes against the embryo. The aim of the present study was to elucidate a possible correlation between PLF and fetal growth retardation. METHODS: In this study, blood samples of 402 pregnant women were obtained between the 12th and 16th weeks of gestation. The serum levels of PLF were compared with birth weight, percentile of birth weight, and gestational age. RESULTS: Women with children whose birth weight was below or equal to the 10th percentile for gestational age showed significantly lower PLF levels (11.4 U/ml, n = 107) as compared with women whose newborns were of normal weight (19.9 U/ml, n = 295; p < 0.004). CONCLUSION: Determination of the PLF level could serve to identify women at risk of having growth-retarded babies.

[Botulism in the Czech Republic]. / Botulismus v Ceské republice.

In a retrospective study the authors analyzed 76 cases of botulism reported in 1961-1989 in the Czech Republic. The analysis of descriptive data pertained to the annual incidence of botulism with a maximum of cases in 1966, 1973 and 1984 (11, 7 and 6 cases); geographical distribution with a maximum incidence in the South and Central Bohemian region (100,000 population); age distribution with a predominance in subjects above 15 years. The dominating vehicle of botulism was in 61% of the notified cases a home-prepared food; usually a galantine, aspic, liver paste, pork with vegetables, and smoked pork. In 1966 and 1973 a processed food predominated as vehicle: pickled herring and tomato, red peppers and sausage. The results of the retrospective study were compared in the discussion with the problem of botulism in other countries. The authors discuss the danger of undetected botulism and the necessity of an anti-botulin serum (Bossea).