Leblond Véronique, Morel Pierre, Dilhuidy Marie-Sarah, Leleu Xavier, Soussain Carole, Leprête Stéphane, Dreyfus Brigitte, Dartigeas Caroline, Mahé Béatrice, Anglaret Bruno, Pégourié Brigitte, Besson Caroline, Aurran Thérèse, Vekhoff Anne, Tournilhac Olivier, Banos Anne, Oya Hervé, Lejeune Julie, Ouzegdouh Maya, Chevret Sylvie
a Service d?Hematologie, Hôpital Pitié Salpêtrière APHP GRC-11 UPMC , Paris , France.
b Service d'Hématologie Clinique , Centre Hospitalier Schaffner , Lens , France.
Leuk Lymphoma. 2017 Nov;58(11):2615-2623. doi: 10.1080/10428194.2017.1307357. Epub 2017 Apr 10.
In patients with advanced Waldenström macroglobulinemia (WM), overall response rate (ORR) and median progression-free survival (PFS) achieved with bortezomib alone and bortezomib rituximab combination were 27-85% and 7.9 months, and 81% and 16.4 months, respectively. We checked the role of dexamethasone in combination with bortezomib by enrolling in a phase II trial 34 patients with relapsed/refractory WM. Bortezomib (1.3 mg/m IV D1, 4, 8, and 11 every 21 days) was used for six cycles. In non-responding patients, dexamethasone (20 mg daily for two days) was added to each infusion after the second cycle. After two cycles, the Bayes estimated ORR was 43.2 (95% Credible Interval: 28.0-59.1%) using the informative prior. Two-year survival rate was 84.0% and the median PFS 15.3 months without difference between patients treated with or without dexamethasone. We conclude that dexamethasone must be associated to bortezomib-based regimen.
在晚期华氏巨球蛋白血症（WM）患者中，单独使用硼替佐米和硼替佐米联合利妥昔单抗治疗的总缓解率（ORR）及无进展生存期（PFS）中位数分别为27%-85%和7.9个月，以及81%和16.4个月。我们通过一项II期试验纳入34例复发/难治性WM患者，研究地塞米松联合硼替佐米的作用。硼替佐米（1.3mg/m²静脉注射，第1、4、8和11天，每21天一次）使用六个周期。在无反应的患者中，第二个周期后，每次输注时加入地塞米松（每日20mg，共两天）。两个周期后，使用信息先验，贝叶斯估计的ORR为43.2（95%可信区间：28.0-59.1%）。两年生存率为84.0%，PFS中位数为15.3个月，接受或未接受地塞米松治疗的患者之间无差异。我们得出结论，地塞米松必须与基于硼替佐米的方案联合使用。
