| Objective1. To compare the efficacy and safety of bortezomib-based combination regimens and conventional chemotherapy in patients with newly diagnosed multiple myeloma. To evaluate the prognostic factors of the efficacy and survival for the patients who accepted bortezomib-based combination regimens.2. To research the effect and survival of bortezomib-based combination regimens in the treatment of relapsed or refractory multiple myeloma.3. To research the overall survival of autologous stem cell transplantation for patients treated with bortezomib.Methods191 MM patients who were newly diagnosed and accepted at least 2 courses of treatment from June 1 2010 to June 30 2015 in Fujian Medical University Union Hospital were retrospectively analyzed. It contains 108 patients who accepted at least 2courses of bortezomib-based combination regimens as inductive treatment(bortezomib group) and 68 patients who accepted at least 2 courses of conventional chemotherapy(conventional group).38 patients accepted at least 2 courses regimens as reinductive treatment after relapse or progression. Response were assessed according to the criteria of the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in Oncology: Multiple Myeloma(2015.V2).Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE) Version 4.0. The compare of clinical features、laboratory index、efficacy and adverse events was analysed by pearson chi-square test and Fisher,s exact test, single factor analysis was tested by Log-rank test and multiple-factor analysis was tested by COX proportional hazards model,the compare way of survival curve was Kaplan-Meier.Results With a median follow-up time of 21.0 moths for all patients, the overall response rate(ORR) in bortezomib group and conventional group were 82.7% 、 71.8%( P=0.103),respectively. The complete remission(CR) rate were 20.2% and2.6%(P=0.000),respectively. The median time to progression one(TTP1) in the two groups were 12.8 months( 1.2-54.4 months) and 17.5months(0.9-46.9 months)(P=0.166); The median progression free survival one(PFS1)were 23.9 months(1.2-67.3months)and 22.3 months(0.1-64.5 months)(P=0.458); The median overall survival times(OS) were′t reached(1.6-67.3months)and 45.9months(0.1-65.4months)(P=0.491).With the extension of time, PFS1 and OS show the tendency of separation. The major adverse events of the two groups during treatment were hematologic toxicities 、 infection 、gastrointestinal symptoms 、 peripheral neuropathy.The incidences of hematologic toxicities were 72.1% and 50.6%(P=0.011),respectively.The incidences of peripheral neuropathy were 22.2% and 8.4%,( P=0.007),respectively.Investigated the dependence in different cumulative bortezomib and the efficacy:The ORR were 66.7%、88.3%(P=0.017), respectively. The median time to progression one(TTP1) in the two groups were 17.6(1.2-34.2) months and 10.5(3.2-54.4) months(P=0.511); The median progression free survival one(PFS1)were 20.4( 1.2-56.9)months and 32.5(1.6-59.2)months(P=0.024); The median overall survival times(OS)were29.5(1.6-59.2)months and not reached(P=0.003).Analysis of the effect and survival of bortezomib-based combination related factors, the results show as follow: ISS III(P=0.010) 、 β2-MG≥5.5umol/L(P=0.013) 、Ca≥2.75mmol/L(P=0.019)、Scr≥177umol/L(P=0.000)、Alb<35g/L(P=0.015)、Hb<100g/L(P=0.006)、ECOG 2-4 score(P=0.022)、Ig G type(P=0.001)were prognostic factors for PFS, and Scr≥177umol/L(P=0.000)、Ig G type(P=0.000)、ECOG2-4score(P=0.018)were the independent prognostic factor for PFS. Age≥65years( P=0.001)、 ISS III(P=0.000) 、 β2-MG≥5.5umol/L(P=0.000) 、 Scr≥177umol/L(P=0.000)、Ca≥2.75mmol/L(P=0.013)、LDH≥245IU/L(P=0.011)、Alb<35g/L(P=0.019)、Hb<100g/L(P=0.001)、ECOG 2-4 score(P=0.013)were prognostic factors for OS, and age≥65 years(P=0.015)、Scr≥177umol/L(P=0.001)were the independent prognostic factors for OS.The ORR rate in patients who accepted brotezomib-based combination regimens and conventional chemotherapy as reinductive treatment after relapse or progression were78.6% and 38.9%(P=0.036), respectively. The median progression free survival two(PFS2) were 17.4 months(0.4-56.1 months)and 15.3 months(1.7-61.4months)(P=0.740);The median time to progression two(TTP2)in the two groups were34 months(1.7-56.1 months)and 30 months(0.4-48.8 months)(P=0.911); The median overall survival times(OS) were not reached(17.9-64.7 months) and not reached(12.4-61.4 months)(P=0.520), but OS times in bortezomib group were longer than conventional chemotherapy.The overall survival(OS) times of patients in the bortezomib group who accepted autologous stem cell transplantation were longer than those who did not(P=0.016).Conclusion1. Bortezomib-based combination therapy is more effective than conventional chemotherapy therapy in patients with newly diagnosed MM. Although the incidences of hematologic toxicities and peripheral neuropathy were higher in bortezomib group, after treatment most patients could tolerate or improve.2. The PFS and OS in those newly diagnosed MM patients who accepted at less 20.8mg/m2 cumulative bortezomib dose were prolonged.3. Scr≥177umol/L(P=0.000)、Ig G type(P=0.000)、ECOG 2-4score(P=0.018)were the independent prognostic factor for PFS. age≥65 years( P=0.015)、Scr≥177umol/L(P=0.001)were the independent prognostic factors for OS.4. As reinductive treatment, bortezomib-based combination therapy is more effective than conventional chemotherapy therapy in patients after relapse or progression5. Patients in the bortezmib group who accepted ASCT had a longer OS than those who did not. |
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