Weekly vinorelbine versus docetaxel for metastatic breast cancer after failing anthracycline treatment.

BACKGROUND: Vinorelbine and docetaxel are active in anthracycline-pretreated, metastatic breast cancer. We compared their efficacy. PATIENTS AND METHODS: Patients were randomized to receive weekly vinorelbine (VIN) or weekly docetaxel (DOC), 6 weekly doses per 8-week cycle, with optional crossover (X-DOC vs. X-VIN. The primary end point was time to progression (TTP) on initial treatment. Remission induction, survival, and quality of life were secondary end points. RESULTS: Among 122 poor risk patients, a non-significant trend for better TTP was seen for DOC, both on initial and on crossover treatment. Responses were seen on either treatment, but progression was more common with VIN than with DOC, while more patients had a response with X-DOC than with X-VIN. Survival was identical in those receiving only the initial VIN vs. DOC and in the subgroups receiving crossover treatments. Grade 3-4 toxicity, especially hematological toxicity resulting in treatment delay, was more common with VIN. Non-graded toxicity contributed to abandoning DOC. Quality of life scores reflected worse results in patients crossing treatment arms, in either direction. CONCLUSIONS: DOC showed marginally better activity but did not improve TTP or other endpoints over VIN in this poor risk population.

Rapid and sustained influence of intravenous zoledronic Acid on course of pain and analgesics consumption in patients with cancer with bone metastases: a multicenter open-label study over 1 year.

BACKGROUND: Bone metastases might lead to severe bone pain, pathologic fractures, and hypercalcemia. Osteolytic destruction is caused by the activation of osteoclasts by release of tumor-derived stimulating factors. Bisphosphonates are known to inhibit osteoclast function and, therefore, to alleviate the adverse effects of tumor-induced bone resorption. PATIENTS AND METHODS: We investigated the effects of zoledronic acid on bone pain and use of analgesic medication in 604 patients with cancer with bone metastases in an openlabel multicenter study over 1 year. Patients were treated with a maximum of 12 infusions (4 mg) every 3 or 4 weeks. RESULTS: During treatment, the mean visual analog score value for pain (mm) decreased by 13.9 +/- 32.3 from 37.1 +/- 28.2 to 23.3 +/- 24.2 (P < .0001, t test, intent-to-treat population, n = 410) and the mean analgesic score decreased by 0.56 +/- 1.42 from 1.84 +/- 1.53 to 1.28 +/- 1.63 (P < .0001, t test). A statistically significant reduction in visual analog score pain could be observed within 1 week after initiation of treatment. Application of zoledronic acid was safe and well tolerated. CONCLUSION: Treatment with zoledronic acid in patients with cancer with bone metastases in a broad range of tumor types provides substantial benefit in terms of pain relief.

[Late infectious complications after high-dose therapy and autologous blood stem cell transplantation]. / Späte infektiöse Komplikationen nach Hochdosistherapie und autologer Blutstammzelltransplantation.

AIM: Only a few data on frequency and character of late infectious complications after high-dose therapy (HDT) and autologous blood stem cell transplantation (ASCT) have been published. This prospective study was carried out to identify potential predictive factors for late infections (occurring after discharge following HDT) and to clarify the usefulness of prophylactic measures. PATIENTS AND METHODS: Clinical data of 192 consecutive patients treated with HDT and ASCT in a single hospital were analyzed on late infectious complications. After discharge following HDT, the 166 evaluable patients (84 with hematologic malignancies, 82 with solid tumors) had been examined and interviewed on infections every 4-12 weeks after ASCT. For Pneumocystis carinii prophylaxis, inhalation with pentamidine or oral cotrimoxazole was used for 3-4 months following ASCT. RESULTS: In the first 6 months following ASCT (after discharge) we saw on average one infectious episode per patient (median, range 0-6), usually light infections (mostly banal upper airway infections). 17 patients had to be treated in hospital for infectious (15 of whom with hematologic malignancies), three of whom (only with hematologic malignancies) died in spite of intensive care as a result of pneumonias due to opportunistic causative agents (mainly Pneumocystis carinii [PcP]). In the second half of the year after ASCT, five patients (with hematologic malignancies) had to be hospitalized due to infections. No further infection-related death occurred. Early documented infections (pneumonia, bacteremia or Clostridium difficile colitis) were associated with an increased risk for late serious infections. Zoster occurred in 18% of patients within 12 months, more frequently after increased pretreatment (25% vs. 11% after less pretreatment), most frequently in patients with relapsed lymphomas (32%). CONCLUSIONS: Significant late infectious complications after ASCT are uncommon. Patients with hematologic malignancies have a significantly increased risk of more serious infections and should be observed carefully. For risk patients with hematologic malignancies and possibly solid tumors, a strict PcP prophylaxis is required. Patients with relapsed lymphomas could possibly be treated preventively against zoster with low-dose aciclovir to reduce the extent of zoster disease. Each patient should be informed carefully that early signs of zoster require an effective zoster treatment as soon as possible.