Advances in hematopoietic stem cell transplantation in the Asia-Pacific region: the second report from APBMT 2005-2015.

Between 2005 and 2015, 138,165 hematopoietic stem cell transplantation (HSCT) were reported in 18 countries/regions in the Asia-Pacific region. In this report, we describe current trends in HSCT throughout the Asia-Pacific region and differences among nations in this region and various global registries. Since 2008, more than 10,000 HSCTs have been recorded each year by the Asia-Pacific Blood and Marrow Transplantation Group Data Center. Between 2005 and 2015, the greatest increase in the number of HSCTs was observed in Vietnam. Allogeneic HSCT was performed more frequently than autologous HSCT, and a majority of cases involved related donors. Regarding allogeneic HSCT, the use of cord blood has remained steady, especially in Japan, and the number of cases involving related HLA non-identical donors has increased rapidly, particularly in China. The incidence of hemoglobinopathy, a main indication for allogeneic HSCT in India, China, Iran, and Pakistan, increased nearly six-fold over the last decade. Among the 18 participating countries/regions, the transplant rate per population varied widely according to the absolute number of HSCTs and the national/regional population size. We believe that this report will not only benefit the AP region but will also provide information about HSCT to other regions worldwide.

Velcade® safety and effectiveness study: A case series of seven Filipino adult patients diagnosed with relapsed or refractory multiple myeloma

Multiple myeloma is the second most prevalent blood cancer after non-Hodgkin's Lymphoma. It represents only 1% of all cancers but contributes to 2% of all cancer deaths. Multiple myeloma is still classified as a non-curable disease and its management involves chemotherapy, radiotherapy and- bone marrow transplantation with the aim of prolonging survival. Bortezomib (Velcade®) is a new type of anti-myeloma drug and clinical trials show that patients under treatment have around 80% to 90% overall response rate. Hence bortezomib was placed on a monitored release status by the BFAD in June of 2005 and had required post-marketing surveillance study. It is therefore the objective of the study to describe the safety and effectiveness of bortezomib among Filipino patients with relapsed or refractory multiple myeloma. This is a case series study observing the effects of bortezomib use in seven adult Filipino diagnosed with multiple myeloma. Study participants were included if they were determined to have a relapsed multiple myeloma, who have received at least one prior therapy or have demonstrated disease progression during the last therapy. The 3 week treatment cycle for bortezomib (Velcade®) begun at recommended dose of 1.3 mg/m2 administered as an intravenous bolus injection twice weekly for two weeks (days 1,4, 8, and 11) followed by a 10-day rest period (days 12-21). It was administered as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with 0.9% sodium chloride solution for injection. Eight cycles of bortezomib (Velcade®) therapy were recommended for patients presenting response to treatment. Follow-up period lasted as long as the patient used bortezomib or if the patient has completed the 6 to 8 cycles of treatment. Overall, treatment responses to bortezomib (Velcade®) range from a stable disease (2 patients) to minimal or partial response (4 patients) based on EBMT classifications. Two non-serious and seven serious adverse events, similar to previous clinical trials were reported. Based on the analysis of the seven eligible case reports on clinical experience with bortezomib (Velcade®) in Filipinos with multiple myeloma, the effectiveness and safety profile is consistent with the previous studies conducted and the approved product label. The expected improvement in the activities of daily living was observed in this set of patients. No new safety signal is observed.

Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial.

BACKGROUND: Thalidomide has potent antimyeloma activity, but no prospective, randomized controlled trial has evaluated thalidomide monotherapy in patients with relapsed/refractory multiple myeloma. DESIGN AND METHODS: We conducted an international, randomized, open-label, four-arm, phase III trial to compare three different doses of thalidomide (100, 200, or 400 mg/day) with standard dexamethasone in patients who had received one to three prior therapies. The primary end-point was time to progression. RESULTS: In the intent-to-treat population (N=499), the median time to progression was 6.1, 7.0, 7.6, and 9.1 months in patients treated with dexamethasone, and thalidomide 100, 200, and 400 mg/day, respectively; the difference between treatment groups was not statistically significant. In the per-protocol population (n=465), the median time to progression was 6.0, 7.0, 8.0, and 9.1 months, respectively. In patients who had received two or three prior therapies, thalidomide significantly prolonged the time to progression at all dose levels compared to the result achieved with dexamethasone. Response rates and median survival were similar in all treatment groups, but the median duration of response was significantly longer in all thalidomide groups than in the dexamethasone group. Adverse events reported in the thalidomide groups, such as fatigue, constipation and neuropathy, confirmed the known safety profile of thalidomide. CONCLUSIONS: Although thalidomide was not superior to dexamethasone in this randomized trial, thalidomide monotherapy may be considered an effective salvage therapy option for patients with relapsed/refractory multiple myeloma, particularly those with a good prognosis and those who have received two or three prior therapies. The recommended starting dose of thalidomide monotherapy is 400 mg/day, which can be rapidly reduced for patients who do not tolerate this treatment. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00452569).