早期正电子发射断层扫描反应适应性治疗 I 期和 II 期霍奇金淋巴瘤：随机 EORTC/LYSA/FIL H10 试验的最终结果。
Early Positron Emission Tomography Response-Adapted Treatment in Stage I and II Hodgkin Lymphoma: Final Results of the Randomized EORTC/LYSA/FIL H10 Trial.
机构信息
Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
出版信息
J Clin Oncol. 2017 Jun 1;35(16):1786-1794. doi: 10.1200/JCO.2016.68.6394. Epub 2017 Mar 14.
Purpose Patients who receive combined modality treatment for stage I and II Hodgkin lymphoma (HL) have an excellent outcome. Early response evaluation with positron emission tomography (PET) scan may improve selection of patients who need reduced or more intensive treatments. Methods We performed a randomized trial to evaluate treatment adaptation on the basis of early PET (ePET) after two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) in previously untreated-according to European Organisation for Research and Treatment of Cancer criteria favorable (F) and unfavorable (U)-stage I and II HL. The standard arm consisted of ABVD followed by involved-node radiotherapy (INRT), regardless of ePET result. In the experimental arm, ePET-negative patients received ABVD only (noninferiority design), whereas ePET-positive patients switched to two cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) and INRT (superiority design). Primary end point was progression-free survival (PFS). Results Of 1,950 randomly assigned patients, 1,925 received an ePET-361 patients (18.8%) were positive. In ePET-positive patients, 5-year PFS improved from 77.4% for standard ABVD + INRT to 90.6% for intensification to BEACOPPesc + INRT (hazard ratio [HR], 0.42; 95% CI, 0.23 to 0.74; P = .002). In ePET-negative patients, 5-year PFS rates in the F group were 99.0% versus 87.1% (HR, 15.8; 95% CI, 3.8 to 66.1) in favor of ABVD + INRT; the U group, 92.1% versus 89.6% (HR, 1.45; 95% CI, 0.8 to 2.5) in favor of ABVD + INRT. For both F and U groups, noninferiority of ABVD only compared with combined modality treatment could not be demonstrated. Conclusion In stage I and II HL, PET response after two cycles of ABVD allows for early treatment adaptation. When ePET is positive after two cycles of ABVD, switching to BEACOPPesc + INRT significantly improved 5-year PFS. In ePET-negative patients, noninferiority of ABVD only could not be demonstrated: risk of relapse is increased when INRT is omitted, especially in patients in the F group.
目的
接受 I 期和 II 期霍奇金淋巴瘤（HL）联合治疗的患者预后良好。正电子发射断层扫描（PET）早期反应评估可能会改善需要减少或更强化治疗的患者的选择。
方法
我们进行了一项随机试验，以根据未经治疗的欧洲癌症研究与治疗组织（EORTC）标准的 I 期和 II 期 HL 的两个周期多柔比星、博来霉素、长春碱和达卡巴嗪（ABVD）后早期 PET（ePET）评估治疗适应性。标准臂由 ABVD 加受累淋巴结放疗（INRT）组成，无论 ePET 结果如何。在实验组中，ePET 阴性患者仅接受 ABVD（非劣效性设计），而 ePET 阳性患者改用两个周期博来霉素、依托泊苷、多柔比星、环磷酰胺、长春新碱、丙卡巴肼和泼尼松（BEACOPPesc）加 INRT（优效性设计）。主要终点是无进展生存期（PFS）。
结果
1950 名随机分配的患者中，1925 名接受了 ePET-361 名患者（18.8%）为阳性。在 ePET 阳性患者中，标准 ABVD+INRT 的 5 年 PFS 从 77.4%提高到强化 BEACOPPesc+INRT 的 90.6%（风险比[HR]，0.42；95%CI，0.23 至 0.74；P=0.002）。在 ePET 阴性患者中，F 组的 5 年 PFS 率为 99.0%，而 ABVD+INRT 为 87.1%（HR，15.8；95%CI，3.8 至 66.1）；U 组为 92.1%，而 ABVD+INRT 为 89.6%（HR，1.45；95%CI，0.8 至 2.5）。对于 F 组和 U 组，均不能证明 ABVD 单药治疗与联合治疗相比非劣效。
结论
在 I 期和 II 期 HL 中，ABVD 两个周期后的 PET 反应可进行早期治疗适应。当 ABVD 两个周期后 ePET 阳性时，切换至 BEACOPPesc+INRT 可显著提高 5 年 PFS。在 ePET 阴性患者中，不能证明 ABVD 单药治疗非劣效：当省略 INRT 时，复发风险增加，尤其是在 F 组患者中。
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