Hainsworth John D, Litchy Sharlene, Lamb M Ray, Rodriguez Gladys I, Scroggin Carroll, Greco F Anthony
The Sarah Cannon Cancer Center and Tennessee Oncology, Nashville, 37203, USA.
Clin Lymphoma. 2003 Jun;4(1):36-42. doi: 10.3816/clm.2003.n.012.
This study was designed to evaluate the feasibility, toxicity, and efficacy of rituximab added to the VNCOP-B (etoposide/mitoxantrone/cyclophosphamide/vincristine/prednisone/bleomycin) combination regimen for the treatment of elderly patients with large B-cell lymphoma. Previously untreated patients > or = 65 years of age with stage II, III, or IV large B-cell non-Hodgkin's lymphoma were treated with a modified VNCOP-B regimen with weekly chemotherapy for 8 weeks. In addition, patients received rituximab 375 mg/m2 intravenously on weeks 1, 2, 3, 4, 6, and 8. All patients received prophylactic granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) during the 8 weeks of treatment. Between August 1999 and February 2002, 41 patients entered this multicenter phase II trial. The median age was 74 years, and 54% of patients had high-risk tumors (age-adjusted International Prognostic Index scores of 2 or 3). Sixty-eight percent of patients completed the 8 weeks of therapy. Overall response rate was 66%; actuarial progression-free survival rate at 2 years was 59%, with a 57% actuarial overall 2-year survival rate. Patients > or = 75 years of age had similar treatment outcomes compared with younger patients. Toxicity with this regimen was predominantly related to chemotherapy; rituximab was well tolerated. Grade 3/4 neutropenia occurred in 83% of patients even with routine use of prophylactic G-CSF or GM-CSF. Treatment-related death occurred in 4 patients (10%). VNCOP-B plus rituximab is efficacious, producing 2-year progression-free survival rates that compare favorably with those of other active regimens in this patient group. Hematologic toxicity was increased compared with previous reports with VNCOP-B alone, as evidenced by the treatment-related mortality rate of 10% in the present study. Differences in toxicity may have been caused by the addition of rituximab, the modified etoposide schedule, or the differences in patient characteristics. This regimen provides a treatment option for elderly patients who are not considered candidates for standard CHOP/rituximab chemotherapy.
本研究旨在评估利妥昔单抗联合VNCOP - B（依托泊苷/米托蒽醌/环磷酰胺/长春新碱/泼尼松/博来霉素）方案治疗老年大B细胞淋巴瘤患者的可行性、毒性及疗效。年龄≥65岁、先前未接受过治疗的II、III或IV期大B细胞非霍奇金淋巴瘤患者采用改良的VNCOP - B方案，每周化疗，共8周。此外，患者在第1、2、3、4、6和8周静脉注射利妥昔单抗375mg/m²。所有患者在8周治疗期间均接受预防性粒细胞集落刺激因子（G - CSF）或粒细胞巨噬细胞集落刺激因子（GM - CSF）。1999年8月至2002年2月，41例患者进入该多中心II期试验。中位年龄为74岁，54%的患者患有高危肿瘤（年龄校正国际预后指数评分为2或3）。68%的患者完成了8周治疗。总缓解率为66%；2年无进展生存率为59%，2年总生存率为57%。≥75岁的患者与年轻患者的治疗结果相似。该方案的毒性主要与化疗相关；利妥昔单抗耐受性良好。即使常规使用预防性G - CSF或GM - CSF，83%的患者仍发生3/4级中性粒细胞减少。4例患者（10%）发生治疗相关死亡。VNCOP - B加用利妥昔单抗有效，2年无进展生存率与该患者组其他有效方案相当。与既往单独使用VNCOP - B的报道相比，血液学毒性增加，本研究中治疗相关死亡率为10%可证明这一点。毒性差异可能由加用利妥昔单抗、改良的依托泊苷给药方案或患者特征差异所致。该方案为不适合标准CHOP/利妥昔单抗化疗的老年患者提供了一种治疗选择。
