Bortezomib in relapsed multiple myeloma: results of a non-interventional study by office-based haematologists.

BACKGROUND: In Germany, bortezomib is approved for the therapy of relapsed multiple myeloma since 2004. The data which had led to the approval were based on strictly selected patients. However, no data had been recorded on bortezomib in routine practice. MATERIALS AND METHODS: In this non-interventional study, bortezomib was studied under routine conditions by office-based haematologists. Data were obtained prospectively following a protocol approved by the responsible Ethics Committee. Treatment followed the prescribing information and was documented for a maximum of 8 cycles. Any therapeutic or diagnostic intervention was left to the discretion of the attending physician. The primary endpoints were efficacy and safety. RESULTS: Overall remission rate was 61% in patients evaluable for efficacy. Response rates were not significantly different between patients < or = 70 and >70 years of age, nor between patients with and without renal impairment. The median time to best response was 3 cycles. Serious adverse events included thrombocytopenia (grade 3: 6%; grade 4: 8%), peripheral neuropathy (grade 3: 8%), fatigue, and bone pain (grade 3: 6% each; grade 4: 2% each) and anaemia (grade 3: 4%). CONCLUSION: The efficacy and tolerability of bortezomib observed in daily practice are consistent with the results obtained in large-scale clinical trials.

Phase 2 study of a combined immunochemotherapy using rituximab and fludarabine in patients with chronic lymphocytic leukemia.

This multicenter phase 2 trial investigated safety and efficacy of a new immunochemotherapeutic regimen combining rituximab (R) and fludarabine (F) in patients with fludarabine- and anthracycline-naive chronic lymphocytic leukemia (CLL). The rationale for using R + F includes single-agent efficacy of both drugs, in vitro synergism of R and F, and no apparent overlapping toxicity. Of 31 eligible patients with B-CLL enrolled, 20 were previously untreated and 11 relapsed. Treatment consisted of fludarabine administered at standard doses (25 mg/m(2)/d; days 1-5, 29-33, 57-61, and 85-89) and rituximab (375 mg/m(2)/d) given on days 57, 85, 113, and 151. Side effects such as fever, chills, and exanthema were generally mild (National Cancer Institute Common Toxicity Criteria [NCI-CTC] grade 1/2 in 48% and grade 3 and/or 4 in 3% of patients). Fever and chills were mainly associated with the first rituximab infusion. Hematologic toxicity included neutropenia (grade 1 and/or 2 in 26%, grade 3 and/or 4 in 42%) and thrombocytopenia (grade 1 and/or 2 in 19%, grade 3 and/or 4 in 9%). One patient died of cerebral bleeding during prolonged thrombocytopenia after the second cycle of fludarabine. There were a total of 32 infections in 16 patients, none of which was fatal. The overall response rate (complete remission [CR] and partial remission [PR]) was 87% (27 of 31 evaluable patients). In 20 previously untreated patients, 17 (85%) responded. Ten of 31 patients achieved CR (5 of 20 untreated; 5 of 11 pretreated; 9 of 21 Binet stage B, 1 of 10 Binet stage C). The median duration of response was 75 weeks. We conclude that the combination of rituximab and fludarabine is feasible and effective in patients with B-CLL.