Yamasaki Satoshi, Kada Akiko, Choi Ilseung, Iida Hiroatsu, Sekiguchi Naohiro, Harada Naoko, Sawamura Morio, Shimomura Takeshi, Komeno Takuya, Yano Takahiro, Yoshida Isao, Yoshida Shinichiro, Sunami Kazutaka, Hishita Terutoshi, Takatsuki Hiroshi, Ohshima Koichi, Takeshita Morishige, Saito Akiko M, Iwasaki Hiromi, Nagai Hirokazu
Department of Hematology and Clinical Research Institute National Hospital Organization Kyushu Medical Center Fukuoka Japan.
Clinical Research Center National Hospital Organization Nagoya Medical Center Nagoya Japan.
EJHaem. 2020 Oct 15;1(2):507-516. doi: 10.1002/jha2.111. eCollection 2020 Nov.
High-dose chemotherapy and autologous stem cell transplantation (ASCT) are too toxic for elderly patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Therefore, effective and tolerable regimens for elderly patients are urgently needed. The present phase II study assessed the efficacy and safety of dose-adjusted therapy with gemcitabine, dexamethasone, cisplatin, and rituximab (GDP-R) in this population. ASCT-ineligible elderly patients with relapsed or refractory DLBCL received dose-adjusted GDP-R in each 28-day cycle for up to six cycles. The primary endpoint was overall response rate (ORR), and secondary endpoints were complete response (CR) rate, progression-free survival (PFS), and safety. Thirty-three patients were enrolled and received dose-adjusted GDP-R. The median age was 75 years (range: 68-87 years). The ORR was 82.8% (90% confidence interval [CI], 67.1-93.0%), with a CR rate of 58.6% (90% CI, 41.7-74.1%). At a median follow-up of 20.9 months, the 2-year PFS rate was 46.8% (90% CI, 30.7-61.5%) and the 2-year overall survival rate was 63.2% (90% CI, 45.8-76.3%). The most frequently observed grade 4 adverse events were neutropenia (63.6%), thrombocytopenia (57.6%), and lymphocytopenia (39.4%). Dose-adjusted GDP-R is a promising salvage regimen for ASCT-ineligible elderly patients with relapsed DLBCL after rituximab-containing chemotherapy and warrants further investigation.
大剂量化疗和自体干细胞移植（ASCT）对复发或难治性弥漫性大B细胞淋巴瘤（DLBCL）老年患者毒性过大。因此，迫切需要针对老年患者的有效且可耐受的治疗方案。本II期研究评估了吉西他滨、地塞米松、顺铂和利妥昔单抗（GDP-R）剂量调整疗法在该人群中的疗效和安全性。不符合ASCT条件的复发或难治性DLBCL老年患者在每28天周期接受剂量调整的GDP-R治疗，最多六个周期。主要终点为总缓解率（ORR），次要终点为完全缓解（CR）率、无进展生存期（PFS）和安全性。33例患者入组并接受了剂量调整的GDP-R治疗。中位年龄为75岁（范围：68 - 87岁）。ORR为82.8%（90%置信区间[CI]，67.1 - 93.0%），CR率为58.6%（90%CI，41.7 - 74.1%）。中位随访20.9个月时，2年PFS率为46.8%（90%CI，30.7 - 61.5%），2年总生存率为63.2%（90%CI，45.8 - 76.3%）。最常观察到的4级不良事件为中性粒细胞减少（63.6%）、血小板减少（57.6%）和淋巴细胞减少（39.4%）。剂量调整的GDP-R对于接受含利妥昔单抗化疗后不符合ASCT条件的复发DLBCL老年患者是一种有前景的挽救方案，值得进一步研究。
