| Objective To analyze bortezomib-based (Bortezomib, trade:Velcade) chemotherapy regimens in the treatment of multiple myeloma (Multiple Myeloma, MM) clinical efficacy and side effects, and compared different chemotherapy regimens containing bortezomib zolmitriptan of differences, comparison of different doses of bortezomib treatment of multiple myeloma differences.Methods A retrospective analysis of newly diagnosed and relapsed refractory multiple myeloma patients visit in Shandong University Qilu Hospital between March 2008 and July 2015, a total of 178 cases, containing all of the patients received bortezomib chemotherapy regimen. The diagnosis of all patients are in strict accordance with the NCCN multiple myeloma guidelines diagnostic criteria, classified according to IFE classification, and clinical stages according to ISS and IMWG risk stratification. Bortezomib-containing regimens:bortezomib intravenously or subcutaneously into 1.6mg/m2,1.0-1.3mg/m2, respectively, a chemotherapy cycle (day 1,day8,day 15, day22, every 35 days), a chemotherapy cycle (day 1, day 4, day 8, day 11, every 21 days). In addition, the domestic per capita surface area smaller than in other countries, the use of small doses of bortezomib treatment, for economic reasons and consider saving factors, combined with other one patient or two patients in combination with bortezomib treatment is more common. There is other esituation using 1.6mg/m2 intravenous bolus or subcutaneous injection every 21 days as a treatment cycle (day 1, day 8). After evaluating the efficacy of bortezomib in patients receiving chemotherapy, according to IWMG multiple myeloma standards were evaluated before treatment, after two cycles of chemotherapy, after four cycles of chemotherapy, six cycles of chemotherapy, the first assessed separately serum immunoglobulin, blood and urinary light chain, IFE, bone marrow morphology, renal function and hematologic remission, if the treatment cycle, disease progression or chemotherapy taboo, for the termination of the boron-containing adjuvant chemotherapy cycle after eight m chemotherapy treatment. For the use of boron-containing chemotherapy regimen bortezomib include PD, PTD, PAD, PCD program. Using International Myeloma Working Group IWMG criteria evaluated. In addition, we also observed the clinical efficacy and prognosisin elderly myeloma. During treatment, the patient’s condition may be needed to give support component transfusion, dialysis, anti-infective, G-CSF and other symptomatic and supportive treatment. According to the evaluation of adverse events observed CTCAE.V4.02, timely assessment of adverse events, and given symptomatic treatment, according to the disease to decide whether to give up bortezomib chemotherapy.Results In 178 patients newly diagnosed multiple myeloma patients 124 cases, relapsed or refractory multiple myeloma 54 cases. Wherein the IgG type 84 cases (47%), IgA 31 cases (17.4%), IgD 10 cases (5.6%), IgM type 1 cases, κ light chain 17 cases (9.6%), λlight chain 27 cases (15.2%), non-secretory 6 cases (3.4%). ISS stage I 47 cases, II of 56 cases of III 75 cases.Bortezomib treatment for multiple myeloma, the total effective rate (ORR) was 73% complete remission (CR) 45 cases (25.3%), very good partial response (VGPR) 29 patients (16.3%), partial remission (PR) 56 cases (31.5%), non-remission (NR) 37 patients (20.8%), progressive disease (PD) 11 patients (6.2%). In which newly diagnosed multiple myeloma 124 cases, relapsed or refractory multiple myeloma found in 54 cases, ORR was 67.7% and 85.2%(P= 0.016), complete response rate (CRR) was 25.8% and 24.1%, respectively (P= 0.807).Newly diagnosed MM patients received an average of 4.58 (2-16) cycles of chemotherapy, refractory and relapsed MM patients received an average of 4.57 (2-17) cycles of chemotherapy. Newly diagnosed MM patients CRR, ORR was after 2,4,6,8, ≥9 cycles of chemotherapy (4.1%,22.8%,34.8%,70%,30%) and (41.7%,70.2%, 78.2%,90%,70%). Refractory MM patients relapse after 2,4,6,8,≥9 cycles of chemotherapy CRR, ORR, respectively (0%,18.5%,38.5%,33.3%,50%) and (83.3%, 81.5%,92.3%,83.3%,100%). With the increase of the number of courses, the complete remission rate and overall response rate increased correspondingly.Newly diagnosed MM:large doses of bortezomib (1.6mg/m2) with a small dose (1.0-1.3mg/m2) of the CRR, ORR, respectively (36.4%and 21.9%, P= 0.106), (75.7%and 65.9%, P= 0.148); relapsed or refractory multiple myeloma:large doses of bortezomib (1.6mg/m2) with a small dose (1.0-1.3mg/m2) of the CRR, ORR, respectively (16.7%and 26.2%P= 0.49), (91.7%and 83.3%, P= 0.47). Overall high-dose and low-dose boron bortezomib of CRR, ORR rates (32.3% and 23.3%, P= 0.10), (85.3% and 71.4%, P= 0.07), peripheral neuropathy occurrence rate was (40% and 45.8%, P= 0.494).Different schemes PD, PAD, PCD, PTD total efficiency is 72.2%,58.8%,57.7%, 85.7%. The total PTD therapy more efficient than PCD therapy (85.7%,57.7%, P= 0.005), better than the PAD therapy (85.7%,58.8%, P= 0.004), with no significant difference in PD therapy (85.7%,72.2%, P= 0.131). Peripheral neuropathy PN incidence of PTD, PD, PCD, PAD were 52.1%,30.6%,35.3%,42.3%, PTD group were significantly different from the surrounding group PD of incidence of neuropathy (52.1% and 30.6%, P= 0.034).Elderly (> 65 years) patients with multiple myeloma is 45 cases (25.3%), median age 71 years (66-79 years old). ISS stage I 12 cases (26.7%),14 cases of stage II (31.1%) and 19 patients with stage Ⅲ (42.2%). It received an average of 4.67 chemotherapy cycle. After bortezomib-based chemotherapy, complete remission (CR) 11 Li (24.4%), ORR was 73.3%.All patients were followed up for a median time of 13.1 months, the mean follow-up time of 21.5 months. The overall median PFS was 30.1 months, the average PFS of 41.4 months. Naive patients with a median PFS of 39.1 months, the average is about 43.8 months PFS, refractory/relapsed patients with a median PFS of 20.7 months, the mean PFS was 36.3 months (P= 0.119). All elderly patients with a median PFS of 27.1 months, the average is about 32.8 months PFS, all non-elderly patients with a median PFS of 39.1 months, mean PFS of approximately 41.7 months (P= 0.965). Old early treatment with relapsed/refractory PFS (P= 0.394).The main adverse events due to drug-induced performance of digestive system diseases, peripheral neuropathy, shingles and bone marrow suppression, grade 3-4 adverse events accounted for 19.6%, and no cause bleeding and other life-threatening side effects, basically give symptomatic and supportive treatment after the better.Conclusions 1. bortezomib-based program for newly diagnosed, relapsed refractory elderly multiple myeloma valid.2. First diagnosed MM large doses of bortezomib (1.6mg/m) CRR with low-dose (1.0-1.3mg/m) of, ORR, respectively (36.4% and 21.9%, P= 0.106), (75.7% and 65.9%, P= 0.148); high dose relapsed or refractory MM with a small dose of CRR, ORR, respectively (16.7%and 26.2%, P= 0.49), (91.7% and 83.3%, P= 0.47). There is always more efficient than programs 3.PTD PCD program (85.7%,57.7%, P= 0.005), better than the PAD program (85.7%, 58.8%, P= 0.004), with no significant difference in PD programs (85.7%,72.2%, P= 0.131).4. The overall median PFS was 30.1 months, the average PFS of 41.4 months. Newly diagnosed with relapsed/refractory MM median PFS was 39.1 months and 20.7 months (P= 0.119). Non-elderly group and the elderly group MM median PFS was 39.1 months and 27.1 months (P= 0.965).5. Major adverse events are mostly reversible, no cause fatal side effects exist. |
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