论文部分内容阅读
目的:观察DVD方案(脂质体阿霉素、长春新碱或长春地辛、地塞米松)和PAD方案(硼替佐米、脂质体阿霉素、地塞米松)治疗初治多发性骨髓瘤(MM)的近期疗效和不良反应。方法:初治MM患者50例,其中DVD组和PAD组各25例。DVD方案:D(脂质体阿霉素)40mg/m2,静脉滴注,第1天;V(长春新碱)2.0mg或(长春地辛)4.0mg,静脉注射,第1天;D(地塞米松)40mg/d,静脉或口服,连用4天;每4周为1个周期。PAD方案:P(硼替佐米,万珂)1.3mg/m2,静脉注射,第1、4、8、11天;A(脂质体阿霉素)20mg,静脉滴注,第1、4、8天;D(地塞米松)20mg/d,静脉滴注,第1、4、8、11天;每4周为1个周期。采用IMWG标准观察疗效,并按NCI CTCAE(第3版)标准判断不良反应。结果:DVD组患者接受平均4.5(2~8)个周期的治疗,完全缓解(CR)4例(16%),非常好的部分缓解(VGPR)3例(12%),部分缓解(PR)10例(40%),总反应(CR+VGPR+PR)率为68%。此外,疾病稳定(SD)5例(20%),疾病进展(PD)3例(12%),疾病控制(CR+VGPR+PR+SD)率为88%。初始疗效的中位时间为5(3~12)周,最佳疗效的中位时间为4(1~6)个月。最常见的不良反应为胃肠道症状,其中10例(40%)有轻微恶心,9例(36%)出现便秘。其次为血液学改变,中性粒细胞减少7例(28%),贫血6例(24%),血小板减少4例(16%)。手掌-脚底异常感觉、红斑4例(16%),黏膜炎2例(8%)。PAD组患者接受平均3.8(2~7)个周期的治疗,CR 13例(52%),VGPR 2例(8%),PR 7例(28%),总反应率为88%。此外,SD 3例(12%),疾病控制率为100%。初始疗效的中位时间为3(1~5)周,最佳疗效的中位时间为3(1~5)个月。最常见的不良反应为胃肠道症状,其中便秘9例(36%),腹泻2例(8%),恶心2例(8%),黏膜炎1例(4%)。其次为血液学改变,中性粒细胞减少7例(28%),贫血3例(12%),血小板减少6例(24%)。另外,周围神经病变较为多见,1/2级5例(20%),3级1例(4%)。5例(20%)出现手足综合征,3例(12%)出现乏力。2组比较,PAD组的总反应率和CR率明显高于DVD组(均P<0.01)。结论:PAD方案治疗初治MM近期疗效明显优于DVD方案,二者不良反应均较少,但PAD方案周围神经病变较为多见。
OBJECTIVE: To observe the effect of DVD regimen (liposomal doxorubicin, vincristine or vindesine, dexamethasone) and PAD regimen (bortezomib, liposomal doxorubicin and dexamethasone) in the treatment of initially treated multiple myeloma Short-term efficacy and adverse reactions of tumor (MM). Methods: 50 patients with newly diagnosed MM, including 25 cases in DVD group and PAD group. DVD regimen: D (liposomal doxorubicin) 40 mg / m2 intravenously on day 1; V (vincristine) 2.0 mg or vinblastine 4.0 mg iv on day 1; D Dexamethasone) 40mg / d, intravenously or orally, once every 4 days; every 4 weeks for a cycle. PAD program: P (bortezomib, Velcade) 1.3mg / m2 intravenous injection on the 1st, 4th, 8th and 11th days; A (liposomal doxorubicin) 20mg, 8 days; D (dexamethasone) 20mg / d, intravenous drip, 1,4,8,11 days; every 4 weeks for a cycle. Observed by IMWG standard efficacy, and according to NCI CTCAE (3rd edition) standard to determine adverse reactions. Results: The DVD group received an average of 4.5 (2-8) cycles of treatment, with complete remission (CR) in 4 patients (16%), very good partial response (VGPR) in 3 patients 10 cases (40%), the total response (CR + VGPR + PR) rate was 68%. In addition, disease stability (SD) was 5 (20%), disease progression (PD) 3 (12%) and disease control (CR + VGPR + PR + SD) was 88%. The median time to initial effect was 5 (3 to 12) weeks and the median time to optimal efficacy was 4 (1 to 6) months. The most common adverse reactions were gastrointestinal symptoms, with nausea in 10 (40%) and constipation in 9 (36%). Followed by hematological changes, neutropenia in 7 cases (28%), anemia in 6 cases (24%), thrombocytopenia in 4 cases (16%). Palms - abnormal feeling of the feet, erythema in 4 cases (16%), mucositis in 2 cases (8%). Patients in the PAD group were treated with an average of 3.8 (2-7) cycles. CR was 13 (52%), VGPR was 2 (8%) and PR was 7 (28%) with a total response rate of 88%. In addition, 3 (12%) SD patients had a disease control rate of 100%. The median time to initial effect was 3 (1-5 weeks) and the median time to optimal efficacy was 3 (1-5) months. The most common adverse reactions were gastrointestinal symptoms, including constipation in 9 (36%), diarrhea in 2 (8%), nausea in 2 (8%) and mucositis in 1 (4%). Followed by hematological changes, neutropenia in 7 cases (28%), anemia in 3 cases (12%), thrombocytopenia in 6 cases (24%). In addition, peripheral neuropathy is more common, 1/2 in 5 cases (20%), 3 cases in 1 case (4%). Five cases (20%) had hand-foot syndrome, and 3 (12%) developed fatigue. The total response rate and CR rate in PAD group were significantly higher than those in DVD group (all P <0.01). Conclusion: PAD regimen is superior to DVD regimen in the treatment of newly diagnosed MM. The adverse reactions of the two regimens are less, but peripheral neuropathy of PAD regimen is more common.