Levine A M, Wernz J C, Kaplan L, Rodman N, Cohen P, Metroka C, Bennett J M, Rarick M U, Walsh C, Kahn J
University of Southern California School of Medicine, Los Angeles 90033.
JAMA. 1991 Jul 3;266(1):84-8.
--To ascertain if low-dose multiagent chemotherapy, with central nervous system prophylaxis and antiretroviral therapy, might be associated with increased efficacy and decreased risk of intercurrent infection in patients with malignant lymphoma related to the acquired immunodeficiency syndrome (AIDS).
--A phase II prospective clinical trial, with median follow-up of 33 months.
--Eight university hospitals, within the context of the AIDS Clinical Trials Units, sponsored by the National Institute of Allergy and Infectious Diseases.
--Forty-two patients with AIDS-related malignant lymphoma. All were evaluable for toxicity assessment, and 35 for response.
--A low-dose modification of the M-BACOD regimen (day 1): cyclophosphamide, 300 mg/m2 intravenously (IV); doxorubicin, 25 mg/m2 IV; vincristine sulfate, 1.4 mg/m2 IV; bleomycin, 4 mg/m2 IV; dexamethasone, 3 mg/m2 orally on days 1 through 5; methotrexate, 500 mg/m2 IV on day 15, with leucovorin rescue. Intrathecal cytosine arabinoside (50 mg) to all on days 1, 8, 21, and 28, with radiation therapy to a helmet field to those with central nervous system involvement. Zidovudine for 12 months after completion of four to six cycles of chemotherapy.
--Response rate and number of opportunistic infections.
--Response rate was 51% with a complete response of 46%. Of 16 complete responses, relapse occurred in four, none isolated to the central nervous system. Opportunistic infections occurred in 21% of those receiving treatment. Median duration of survival among all 42 patients is 5.6 months, 6.5 months in 35 patients evaluable for response, and 15 months in patients with complete response. Lower concentration of CD4 cells, history of prior AIDS, bone marrow involvement, and stage IV disease were independently associated with decreased survival.
--Low-dose chemotherapy with central nervous system prophylaxis and zidovudine maintenance may be associated with durable remissions in AIDS-related lymphoma with fewer opportunistic infections than noted in prior reports.
确定低剂量多药化疗联合中枢神经系统预防和抗逆转录病毒治疗是否可能提高获得性免疫缺陷综合征（AIDS）相关恶性淋巴瘤患者的疗效并降低并发感染风险。
一项II期前瞻性临床试验，中位随访时间为33个月。
由美国国立过敏与传染病研究所资助的艾滋病临床试验单位网络内的8所大学医院。
42例AIDS相关恶性淋巴瘤患者。所有患者均可进行毒性评估，35例可进行疗效评估。
对M-BACOD方案进行低剂量调整（第1天）：环磷酰胺，300mg/m²静脉注射（IV）；阿霉素，25mg/m²静脉注射；硫酸长春新碱，1.4mg/m²静脉注射；博来霉素，4mg/m²静脉注射；地塞米松，第1至5天口服3mg/m²；甲氨蝶呤，第15天静脉注射500mg/m²，随后用亚叶酸钙解救。所有患者在第1、8、21和28天接受鞘内注射阿糖胞苷（50mg），中枢神经系统受累患者接受头盔野放射治疗。化疗四至六个周期完成后给予齐多夫定治疗12个月。
缓解率和机会性感染的发生次数。
缓解率为51%，完全缓解率为46%。16例完全缓解患者中，4例复发，均非孤立性中枢神经系统复发。接受治疗的患者中有21%发生机会性感染。42例患者的中位生存期为5.6个月，35例可评估疗效患者的中位生存期为6.5个月，完全缓解患者的中位生存期为15个月。较低的CD4细胞浓度、既往AIDS病史、骨髓受累和IV期疾病与生存期缩短独立相关。
低剂量化疗联合中枢神经系统预防和齐多夫定维持治疗可能使AIDS相关淋巴瘤获得持久缓解，且机会性感染少于既往报道。
