早期滤泡性淋巴瘤患者受累野放疗后全身治疗的随机试验：TROG 99.03.
Randomized Trial of Systemic Therapy After Involved-Field Radiotherapy in Patients With Early-Stage Follicular Lymphoma: TROG 99.03.
机构信息
Michael MacManus, Richard Fisher, Bev McClure, and John F. Seymour, Peter MacCallum Cancer Centre; Michael MacManus and John F. Seymour, University of Melbourne; Melbourne; Sidney Davis, The Alfred Hospital, Prahran, Victoria; Daniel Roos, The Royal Adelaide Hospital and The University of Adelaide, Adelaide, South Australia; Peter O'Brien, Genesis Cancer Care, Newcastle; Jayasingham Jayamohan, Westmead Hospital, Sydney, New South Wales; David Christie, Genesis Cancer Care, Tugun, Queensland; David Joseph, Sir Charles Gairdner Hospital Perth, Perth, Western Australia, Austrailia; Andrew Macann, Auckland City Hospital, Auckland, New Zealand; and Richard Tsang, Princess Margaret Hospital, Toronto, Ontario, Canada.
出版信息
J Clin Oncol. 2018 Oct 10;36(29):2918-2925. doi: 10.1200/JCO.2018.77.9892. Epub 2018 Jul 5.
PURPOSE
Follicular lymphoma (FL) is curable by involved-field radiotherapy (IFRT) in < 50% of patients with stage I to II disease. We hypothesized that adding systemic therapy to IFRT would improve long-term progression-free survival (PFS).
PATIENTS AND METHODS
A multicenter randomized controlled trial enrolled patients with stage I to II low-grade FL after staging computed tomography scans and bone marrow biopsies. F-labeled fluorodeoxyglucose-positron emission tomography (PET) was not mandatory. Patients were randomly assigned to either arm A (30 Gy IFRT alone) or arm B (IFRT plus six cycles of cyclophosphamide, vincristine, and prednisolone [CVP]). From 2006, rituximab was added to arm B (R-CVP).
RESULTS
Between 2000 and 2012, 150 patients were enrolled, 75 per arm. In arm B, 44 patients were allocated to receive CVP and 31 were allocated to receive R-CVP. At randomization, 75% had stage I, the median age was 57 years, 52% were male, and 48% were PET staged. With a median follow-up of 9.6 years (range, 3.1 to 15.8 years), PFS was superior in arm B (hazard ratio, 0.57; 95% CI, 0.34 to 0.95; P = .033). Ten-year PFS rates were 59% (95% CI, 46% to 74%) and 41% (95% CI, 30% to 57%) for arms B and A, respectively. Patients in arm B who received R-CVP had markedly superior PFS compared with contemporaneous patients in arm A (hazard ratio, 0.26; 95% CI, 0.07 to 0.97; P = .045). Fewer involved regions ( P = .047) and PET staging ( P = .056) were associated with better PFS. Histologic transformation occurred in four and 10 patients in arms B and A, respectively ( P = .1). Ten deaths occurred in arm A versus five in arm B, but overall survival was not significantly different ( P = .40; 87% and 95% at 10 years, respectively).
CONCLUSION
Systemic therapy with R-CVP after IFRT reduced relapse outside radiation fields and significantly improved PFS. IFRT followed by immunochemotherapy is more effective than IFRT in early-stage FL.
目的
滤泡性淋巴瘤（FL）在 I 期至 II 期疾病患者中，通过累及野放疗（IFRT）可治愈的比例<50%。我们假设在 IFRT 中加入系统治疗会改善长期无进展生存期（PFS）。
方法
一项多中心随机对照试验纳入了接受 I 期至 II 期低级别 FL 分期后行 CT 扫描和骨髓活检的患者。F 标记的氟脱氧葡萄糖正电子发射断层扫描（PET）并非强制性。患者被随机分配至 A 组（30Gy IFRT 单独治疗）或 B 组（IFRT 加六周期环磷酰胺、长春新碱和泼尼松[CVP]）。从 2006 年开始，B 组加用利妥昔单抗（R-CVP）。
结果
在 2000 年至 2012 年期间，共纳入 150 例患者，每组 75 例。在 B 组中，44 例患者接受 CVP 治疗，31 例患者接受 R-CVP 治疗。在随机分组时，75%的患者为 I 期，中位年龄为 57 岁，52%为男性，48%为 PET 分期。中位随访 9.6 年（范围，3.1 至 15.8 年），B 组的 PFS 更优（风险比，0.57；95%CI，0.34 至 0.95；P=0.033）。10 年 PFS 率分别为 59%（95%CI，46%至 74%）和 41%（95%CI，30%至 57%），分别为 B 组和 A 组。B 组接受 R-CVP 的患者与同期 A 组患者相比，PFS 明显改善（风险比，0.26；95%CI，0.07 至 0.97；P=0.045）。累及区域较少（P=0.047）和 PET 分期（P=0.056）与更好的 PFS 相关。B 组和 A 组分别有 4 例和 10 例发生组织学转化（P=0.1）。A 组有 10 例死亡，B 组有 5 例，但总生存无显著差异（P=0.40；10 年分别为 87%和 95%）。
结论
在 IFRT 后应用 R-CVP 进行全身治疗可减少放疗野外的复发，并显著改善 PFS。IFRT 后加用免疫化疗比早期 FL 中的 IFRT 更有效。
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