Clinical Research Of Bortezomib-based Combination Regimens For Multiple Myeloma

ObjectiveTo research the curative effect and adverse reaction of bortezomib-based combination regimens in the treatment of newly diagnosed and relapsed or refractory multiple myeloma(MM).MethodsCollecting42newly diagnosed and relapsed or refractory MM(RRMM) patients received treatment of bortezomib-based combination regimens in the first affiliated hospital of ZhengZhou university during Oct.1st,2008-Mar.1st,2013. All patients completed one cycle at least. Forty-two patients include30male and12female, age arrange from40to78years old, the median age was59years old, thirty newly diagnosed patients and twelve RRMM patients. Twenty-five patients were treated with BTD regimen, it consists of bortezomib(0.8-1.5mg/m2) by rapid intravenous injection on the lst,4th,8th and11th day, and dexamethasone4.5-13.5mg/m2by intravenous drip(day1-4) or4.5-13.5mg/m2by intravenous drip(day1-4, day9-12, day17-20) or4.5-13.5mg/m~2by intravenous drip(day1-2, day4-5, day8-9, day811-12), and oral thalidomide(50-200mg/d) was given for the whole course, every21days as one cycle. Fifteen patients received BD regimen, usage with the former. Two patients were treated with BT regimen, usage with the former. All regimen were repeated every21days as one cycle. Diagnosis and curative effect was assessed according to the criteria of 《Chinese Guideline for the Diagnosis and Treatment of Multiple Myeloma (2011Revised Edition)》, and adverse reaction were evaluated according to the criteria of National Cancer Institute Common Terminology Criteria for Adverse Events Version3.0. Data processing was completed by the software SPSS17.0, the compare of qualitative variable was analysed by Pearson chi-square test, continuity correction and Fisher’s exact test, the compare way of survival curve was Kaplan-Meier, and tested by Log-rank, correlation analysis completed with Spearman rank correlation, P＜0.05was significant.ResultsThe overall response rate(CR+nCR+VGPR+PR+MR), better response rate (CR+nCR+VGPR) and CR+nCR rate was85.71%,59.52%,52.38%respectively, the total CR, nCR, VGPR, PR, MR rate was23.81%,28.57%,7.14%,9.52%,16.67%separately. The overall response rate, better response rate and near complete response rate in newly diagnosed group and RRMM group separately was93.33%,66.67%;76.67%,16.67%;70.00%,8.33%, compared the two groups P=0.08, P＜0.01, P＜0.01. Grading the response rate, we found that the number of courses which contain bortezomib and response rank was positive correlation, age and response rank was negative correlation. The disease stage and type was not relative with curative effect. Patients with good early effects had better eventual effects than patients with bad early effects. The effects of Bortezomib-based combination regimens in renal inadequacy was also prominent, but has no significant difference with the normal renal function patients. Patients with complications of infection and others also had obvious effects. Survival analysis showed that the median OS was128.5weeks (9-248weeks) in all patients, compared each group, there was no significant difference, and median PFS was110.5weeks(4-217weeks), newly diagnosed group was longer than RRMM group. The major adverse events during treatment were leukopenia(40.48%), thrombocytopenia(47.62%) and anemia(33.33%), the mainly events were mild, and most were grade I and grade II, events in digestive system mainly were nausea or vomit(38.10%), diarrhea(30.95%) and constipation (42.86%), peripheral neuropathy(35.71%), infection was52.38%, included pulmonary infection(19.05%), upper respiratory tract infection(19.05%), herpes zoster(11.90%) and EB virus infection(2.38%) etc. Most events were grade I and grade II, gradeIII event was visible in peripheral neuropathy.ConclusionBortezomib-based combination regimens was effective both in newly diagnosed and RRMM patients, and newly diagnosed patients had better curative effect in better response rate and CR+nCR rate than RRMM patients. Patients received more courses which contain bortezomib had better effect, and younger patients had better effect than old ones. The stage and type was not relative with curative effect. The PFS of newly diagnosed group was longer than RRMM. The adverse events during treatment mainly appeared in hematologic system, digestive system, peripheral neuropathy and infection, most were mild and could be tolerant.