加拿大癌症试验组 LY.17：一项随机 II 期研究，评估复发/难治性弥漫性大 B 细胞淋巴瘤自体干细胞移植前的新型挽救疗法 - 利妥昔单抗剂量密集型环磷酰胺、依托泊苷、顺铂 (R-DICEP) 的结果) 与 R-GDP。
Canadian cancer trials group LY.17: A randomized phase II study evaluating novel salvage therapy pre-autologous stem cell transplant in relapsed/refractory diffuse large B-cell lymphoma-outcome of rituximab-dose-intensive cyclophosphamide, etoposide, cisplatin (R-DICEP) versus R-GDP.
发表日期：2024 May 27
作者：
Douglas A Stewart, John Kuruvilla, David Lee, Jill J Dudebout, Neil Chua, Jean-François Larouche, Tara Baetz, Mona Shafey, Nizar Abdel-Samad, Sue Robinson, Isabelle Fleury, Graeme Fraser, Pamela Skrabek, Vishal Kukreti, Jesse Kelly, Annette E Hay, Lois E Shepherd, Bingshu E Chen, Michael Crump
来源：
BRITISH JOURNAL OF HAEMATOLOGY
摘要：
加拿大癌症试验组 (CCTG) LY.17 是一项正在进行的多臂随机 II 期试验，在符合自体干细胞移植 (ASCT) 资格的患者中评估新型挽救疗法与 R-GDP（利妥昔单抗、吉西他滨、地塞米松和顺铂）的比较患有复发/难治性弥漫性大 B 细胞淋巴瘤 (RR-DLBCL)。 LY.17 试验的这一部分评估了使用单周期住院患者 R-DICEP（利妥昔单抗、剂量密集型环磷酰胺、依托泊苷和顺铂）的剂量密集型化疗方法，以实现淋巴瘤缓解和干细胞动员，从而缩短 ASCT 时间。本报告是对 67 名患者进行方案指定的第二次中期分析的结果，这些患者被随机分配至 1 个周期的 R-DICEP 或 3 个周期的 R-GDP。 R-DICEP 的总体缓解率 (ORR) 为 65.6%，R-GDP 的总体缓解率为 48.6%。 R-DICEP 与 R-GDP 的 ASCT 率分别为 71.9% 和 54.3%，1 年无进展生存率分别为 42% 和 32%。尽管 R-DICEP 与 R-GDP 相比，ORR 的改善超过了预先指定的 10% 阈值，以继续进行 64 名患者/组的完全累积，但 3-5 级毒性发生率较高，并且需要住院治疗，因此做出了决定停止这项研究。 CCTG LY.17 将继续评估包含新型药物的不同抢救方案。© 2024 作者。英国血液学杂志由英国血液学会和约翰·威利出版
The Canadian Cancer Trials Group (CCTG) LY.17 is an ongoing multi-arm randomized phase II trial evaluating novel salvage therapies compared with R-GDP (rituximab, gemcitabine, dexamethasone and cisplatin) in autologous stem cell transplantation (ASCT)-eligible patients with relapsed/refractory diffuse large B-cell lymphoma (RR-DLBCL). This component of the LY.17 trial evaluated a dose-intensive chemotherapy approach using a single cycle of inpatient R-DICEP (rituximab, dose-intensive cyclophosphamide, etoposide and cisplatin) to achieve both lymphoma response and stem cell mobilization, shortening time to ASCT. This report is the result of the protocol-specified second interim analysis of the 67 patients who were randomized to either 1 cycle of R-DICEP or to 3 cycles of R-GDP. The overall response rate (ORR) was 65.6% for R-DICEP and 48.6% for R-GDP. The ASCT rate was 71.9% versus 54.3%, and 1-year progression-free survival rate was 42% versus 32%, respectively, for R-DICEP versus R-GDP. Although the improvement in ORR for R-DICEP versus R-GDP exceeded the pre-specified 10% threshold to proceed to full accrual of 64 patients/arm, higher rates of grade 3-5 toxicities, and the need for hospitalization led to the decision to stop this arm of the study. CCTG LY.17 will continue to evaluate different salvage regimens that incorporate novel agents.© 2024 The Author(s). British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.