Pirarubicin is a more lipophilic derivative of doxorubicin, with a higher uptake rate of cells, lower cardiotoxicity and better antitumor efficacy in preclinical models. Thirty-four patients with metastatic breast cancer were treated in a multicenter phase II study with pirarubicin (THP) using a dosage of 75 mg/m²/every 3 weeks. The patients had a median age of 56 years (range 41–73) and a performance status of WHO grade 0–2. Patients pretreated with anthracycli-nes, or who were older than 75 years and without sufficient bone marrow reserve were excluded. The 32 evaluable patients received a median number of 4 cycles (range 2–8). The myelosuppression was dose-limiting and led to infections (grades 1 and 2) in 5 patients. Twenty-eight patients developed leukocytopenia grade 3 and 4 toxicity and 7 patients experienced thrombocytopenia grade 1 and 2. The drug was subjectively well tolerated and nausea, vomiting and alopecia were mild. One complete remission with a duration of 15.4 months (67 weeks) and 7 partial remissions with a median duration of 9.3 months (40 weeks) were achieved, which resulted in an overall response rate of 25 %. Twenty-one patients were stable for 17 weeks (median) under the treatment with pirarubicin.

Background: The biochemical rationale for the use of folinic acid (FA) and interferon (IFN) to modulate and thereby enhance the antitumor activity of 5-fluorouracil (5-FU) in vitro has been well established. Based on randomized trials comparing 5-FU alone and 5-FU and FA, the combination has been recommended as standard treatment in patients with advanced colorectal carcinoma. Recently, phase II trials demonstrated higher response rates for 5-FU and IFN than those anticipated for 5-FU alone. The present investigation was therefore undertaken to compare efficacy, toxicity, and quality of life of IFN and FA as modulators of 5-FU in a multicenter randomized trial. Patients and Methods: 129 patients with advanced and measurable colorectal carcinoma previously unexposed to chemotherapy or cytokines were randomly assigned to treatment with either 5-FU administered at a dose of 600 mg/m2 as an i.v. 2-hour infusion and FA at a dose of 200 mg/m2 given by bolus weekly or 5-FU (in the same dose and schedule) and IFN α-2b at a dose of 5 million IU three times a week. We used the 52-item EORTC QLQ Core 30 questionnaire including a diagnosis-specific module to assess the patients’ quality of life before and during chemotherapy.c Results: The treatment arms were well balanced for prognostic criteria including performance status, age, metastatic sites and size. Median time to disease progression was 134 days in patients treated with 5-FU and FA and 105 days in those receiving 5-FU and IFN α-2b. Median survival was 255 days for patients in the 5-FU+FA arm and 185 days in the 5-FU+IFN ot-2b arm (p = 0.06). An analysis of the toxicities experienced by the patients of the two treatment groups showed significantly more flu-like syndrome (p = 0.004) in patients treated with 5-FU+IFN α-2b. Mucositis grade 3 or 4 did not occur and diarrhea was found in only 1% and 3%. Nausea and vomiting were reported in 9% and 8%, respectively. There was no drug-related death. The compliance with the EORTC QL assessment was high (92%) and the data received of high quality. Serial assessment of the qualitiy of life revealed a trend towards a higher quality of life in the 5-FU and FA group with regard to most items. Conclusions: The results of this interim analysis suggest that there is a trend towards an improved survival and better quality of life for FA as modulator of 5-FU so far. Moreover, we have shown that the EORTC QL questionnaire is a feasible instrument for measuring the quality of life in prospective randomized trials in patients with palliative cancer therapy.

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With the introduction of an ambulatory community-centered comprehensive cancer care system in Hamburg, based on private practice outpatient day clinics in 1976, it became obligatory to study the psychosocial consequences both for the patient and the relatives taking care of them and their impact on private and professional cancer nursing. In a common effort of qualified cancer nurses, medical psychologists and oncologists, we visited 59 surviving dependents who had cared for their relatives who had died from cancer four to twelve weeks before. In semi-structured interviews comprising 117 questions we studied the subjective and objective burden related to psychological, social, physical and nursing areas. In 85% the nursing service was predominantly supported by the spouses, in 15% by children or parents. The average duration of total dependence of the bed-ridden patient was 16 days. In 94%, gratitude for and acknowledgement of the deceased were the dominant motivation, in 44% the relations towards the patient grew more affectionate. Being responsible for the terminal care was experienced as too heavy a burden because of insufficient medical (39%) or nursing support (35%), 64% claimed an inadequate preparation for death as a sudden and frightening event. In retrospective, 76% of the caring relatives would again prefer terminal home care to hospital services. Following a discussion of problematic methodological aspects of the responses to our interviews, consequences are presented for an improved support of the terminally ill patient and his caring family, as well as for professional education and further development of the hospice system in Germany.

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