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Cancer patients are at increased risk of venous thromboembolism (VTE).

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/m2on 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.

The present phase II trial was undertaken to assess the efficacy and toxicity of a combination of paclitaxel and carboplatin as first-line chemotherapy in patients with metastatic transitional cell carcinoma of the urothelium. Twenty patients (age range 50-79 years; inclusion criteria: WHO performance status 0-2, no previous cytotoxic treatment) with metastatic transitional cell carcinoma of the urothelium were recruited and received cytotoxic treatment with paclitaxel at a dosage of 175 mg m(-2) administered over a 3-h infusion and carboplatin given at an AUC of 5 mg ml(-1) min (according to creatinine clearance) administered every 21 days. A total of 65% of patients achieved remissions (CR+PR), with CR occurring in 40% of patients. A further 15% of patients experienced stable disease. Remissions occurred after 2.4 +/- 0.8 (mean +/- standard deviation; range two to four) treatment cycles. The mean duration of responses (CR+PR) was 8.5 +/- 5.5 months. After a mean observation period of 11.4 +/- 4.8 months, 16 patients (80%) are alive. Toxicity included alopecia of WHO grade 3 in all patients, leucopenia of WHO grades 1 and 2 in ten patients, grade 3 in eight and grade 4 in two patients and, finally, severe thrombocytopenia grade 3 in only three patients. Non-haematological toxicity consisted of polyneuropathy of WHO grade 1 in 13 patients and grade 2 in five patients. We thus conclude that a combination of paclitaxel and carboplatin at the given dosage and schedule constitutes an active, well-tolerated first-line cytotoxic treatment for patients with metastatic urothelial cancer.

The aim of the study was to investigate the therapeutic value of reinduction therapy with the same cytostatic treatment that had been used for induction treatment in patients with metastatic colorectal cancer. A total of 71 patients, all of whom had responded or achieved stable disease lasting > or = 12 weeks after six monthly courses of first-line treatment with 5-fluorouracil + racemic leucovorin (5-FU/LV; n = 35) or 5-FU plus the l-isomer of LV (LLV; n = 34) were entered in this study. At the time of relapse, the same treatment was used for initial therapy: racemic LV or LLV was administered at 100 mg m(-2) day(-1) by i.v. bolus injection, immediately followed by 5-FU 400 mg m(-2) day(-1) given as a 2-h infusion. Chemotherapeutic drugs were given on 5 consecutive days at 4-week intervals x 6 or until there was evidence of tumour progression. Among 49 evaluable patients, reinduction therapy that was initiated after a median treatment-free interval of 5.4 months (range 3-14.5) resulted in nine partial response (PR) (18%) and 26 stable disease (SD) (53%), yielding an overall tumour control rate of 69% (95% confidence interval, 54.6-81.7%). The median time to treatment failure from reinduction was 6.4 months, and the median survival duration from reinduction was 8.9 months (20.1 months as judged from the beginning of induction therapy). The toxicity associated with retreatment was generally mild to moderate; compared with initial treatment, there was no significant difference in terms of the overall rate (P = 0.33) or severity (P = 0.19) of adverse reactions. Our data suggest that in patients with advanced colorectal cancer an interrupted treatment strategy, i.e. retreatment with the same regimen in case of relapse > or = 3 months after discontinuation of 6 months of successful treatment with 5-FU/LV or 5-FU/LLV is an acceptable therapeutic concept.

The extracellular domain of the HER-2/neu(c-erbB-2) oncogene protein can be found in soluble form in the sera of patients with breast cancer.We have analyzed serum levels of soluble HER-2/neuin 42 patients prior to any therapy and put it into relation to the overexpression and amplification of HER-2/neuin the primary tumor after surgical excision and to data obtained by patho histological staging. In addition, we have investigated the sera of 62 patients with stage IV breast cancer. We have further compared the possible prognostic value of serum HER-2/neuto two other Known serological tumor markers CEA and CA15–3 in both patient groups.We have observed an elevated serum HER-2/neulevel (20U/I) in 6/42 (14.2%) preoperative patients, out of whom those with HER2/neutissue expression/amplification showed elevated serum, levels in 42.8%. In contrast, 8.5% of patients without HER-2/neuexpression/amplification in the primary tumor presented with elevated serum levels. There was a significant difference in soluble HER-2/neuserum concentrations between patients with tumors of different size (p<0.0001) and various degrees of axillary lymph node involvement (p<0.0001), thus reflecting a close correlation of tumor load with serum concentrations of soluble HER-2/neu. In patients with stage IV disease, 27 out of 62 (43,5%) had elevated soluble HER-2/neuserum levels. A highly signiticant correlation of serum concentrations of HER-2/neuwith CA15–3 (p<0.002) was observed. We conclude that the measurement of serum HER-2/neulevels at diagnosis defines a small subgroup of breast cancer patients with a relatively advanced stage of disease. Its strong correlation with tumor load in patients with stage II disease and the high prevalence in patients with stage IV disease make it a promising tool for the assessment of disease activity and biologic behaviour in breast-cancer.

Numerous clinical studies showed efficacy of biological response modifiers (BRM) in the treatment of advanced RCC. In this phase II study, we investigated efficacy, toxicity, and feasibility of lFN-γ in combinalion with 1L-2 in patients with advanced RCC. One cycle of therapy consisted of 100 mcg lFN-γ sc 3x/week for two weeks, 4.5 MIU 1L-2 sc over four consecutive days for the next two weeks followed by a two week rest period. 3x500 mg/day paracetamol are given orally for the first two weeks of therapy to prevent or mitigate flu-like symptoms. To date 40 patients (25 males/15 females) with a median age of 59 years (range: 44– 81 years) have been accrued to the study. A median of 3 therapy cycles (range 1–9) have been given to these 40 patients (median time of observation: 5 months, range: 1–18 months) and all patients are eligible tor feasibilitv and toxicitv evaluation, and 31 patients for response documentation, respectively. 32 of the patients were trained in self-application of the cytokines und 8 patients preferred the application of therapy through their family doctor. No WHO-grade III or IV toxicity has been documented so far. Side effects consisted of flu-like syndrome grade I/II in 21 patients despite prophylactic paracetamol, local crythemas after 1L-2 application in 18 patients and hypotension grade I mainly after IL-2 application in 4 patients. Myelotoxicity was mild in general and consisted of grade I/ll leucopenia and thrombocylopenia only. No red cell transfusions had to be given. Response data of 32 patients after a median time of observation of 10 months (range: 5–16 months) are as lollows: CR: n = 2 (6%), PR: n = 3 (9%), SD: n = 14 (44%), PD: n=13 (41%). Our preliminary data show that a treatment with lFN-γ/IL-2 is not only associated with low toxicity, but also very practical lor out, patients, and offers therefore a good quality of life. The antitumor activity of this therapy in patients with advanced RCC is proven by the response rate (CR+PR+SD) of 59%.

PurposeThe rationale of the present study was to validate the hypothesis of a favorable influence of a perioperative start of adjuvant chemotherapy in patients with operable breast cancer of various prognostic groups, as suggested by results of experimental data.

Metastatic soft tissue sarcoma constitutes a major therapeutic problem potentiated by the development of drug resistance. The present pilot study was therefore undertaken in order to study the possibility of modulation of drug resistance by tamoxifen in patients with metastatic soft tissue sarcoma after the administration of combined cytostatic therapy consisting of ifosphamide (1.5 g/m2), adriblastin (50 mg/m2) and DTIC (200/m2), all on days 1-4; (IFADIC).12 patients with soft tissue sarcoma who experienced progression under or following treatment with IFADIC underwent second-line chemotherapy with Epirubicine 60 mg/m2(days 1 and 22). CCNU 80 mg/m2(day 1) (ECC) and high-dose Tamoxifen (480 mg/day. day -1 to +1) in an endeavour to modulate drug resistance. Under this very well tolerated, low toxic regimen. I patient with lung metastases experienced complete remission (duration: 5 months +) and 1 patient partial remission (duration: 6 months). 1 final patient experienced stable disease for 12 months thus resulting in an overall response rate of 3 out of 12 patients. We conclude that this low-toxicity regimen might be effective in heavily pretreated patients with soft tissue sarcoma thus making the use of high-dose tamoxifen a possible canditate for modulation of drug resistance in metastatic soft tissue sarcoma.