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斯坦福 V 试验(G4 和 G5 研究)中联合治疗早期非肿块性霍奇金淋巴瘤患者的长期结果。

Long-Term Outcomes of Patients With Early Stage Nonbulky Hodgkin Lymphoma Treated With Combined Modality Therapy in the Stanford V Trials (the G4 and G5 Studies).

机构信息

Division of Oncology, Stanford University, Stanford, California.

Department of Radiation Oncology, Stanford University, Stanford, California.

出版信息

Int J Radiat Oncol Biol Phys. 2021 Jun 1;110(2):444-451. doi: 10.1016/j.ijrobp.2020.12.039. Epub 2020 Dec 30.

Abstract

PURPOSE

Combined modality therapy (CMT) is standard therapy for early-stage Hodgkin lymphoma (ESHL). We previously reported excellent outcomes with the abbreviated Stanford V regimen. Herein we report updated results with median follow-up >10 years on survival, therapy-related late effects, and impact of disease risk factors on patient outcomes.

METHODS AND MATERIALS

The G4 and G5 studies enrolled patients with stage I-IIA nonbulky ESHL. Patients received 8 weeks of Stanford V chemotherapy followed by 30 Gy modified involved-field radiation therapy (mIFRT) (G4) or Stanford V-C + 20 Gy mIFRT (G5). Patients were categorized as favorable or unfavorable risk per German Hodgkin Study Group (GHSG) criteria and outcomes between groups compared.

RESULTS

A total of 129 patients were enrolled (68 favorable and 61 unfavorable risk). In the G4 study (n = 87), at median follow-up of 19.7 years, 5-, 10-, and 15-year progression-free survival (PFS) and overall survival (OS) were 95.4%/97.7%, 91.8%/96.5%, and 91.8%/95.3%, respectively. In the G5 study (n = 42), at median follow-up of 13.5 years, the 5-, 10-, and 15-year PFS and OS were 92.9%/100%, 92.9%/100%, and 88.4%/91.9%, respectively. PFS (P = .86) and OS (P = .86) were not significantly different between studies. There were also no significant differences between studies in patients with favorable or unfavorable risk for PFS (F: P = .53; U: P = .96), OS (F: P = .99; U: P = .78), secondary malignancies (F: P = .74; U: P = 1.0), and cardiovascular complications (F: no cases; U: P = 1.0).

CONCLUSIONS

The G4 and G5 studies achieve high rates of durable remission; 20 versus 30 Gy mIFRT and cyclophosphamide substituted for mechlorethamine did not compromise nodal control, PFS, or OS in both favorable and unfavorable risk disease. These results support the efficacy of CMT in early-stage disease and lower-dose radiation therapy in patients with favorable and nonbulky unfavorable ESHL.

摘要

目的

联合治疗(CMT)是早期霍奇金淋巴瘤(ESHL)的标准治疗方法。我们之前报道了使用斯坦福 V 方案的出色结果。在此,我们报告了更新的结果,中位随访时间超过 10 年,包括生存、治疗相关晚期效应以及疾病风险因素对患者结局的影响。

方法和材料

G4 和 G5 研究纳入了 I 期-IIA 期非肿块性 ESHL 患者。患者接受 8 周斯坦福 V 化疗,然后接受 30 Gy 改良累及野放疗(mIFRT)(G4)或斯坦福 V-C+20 Gy mIFRT(G5)。根据德国霍奇金研究组(GHSG)标准,患者被分为预后良好或不良风险组,并比较两组之间的结局。

结果

共纳入 129 例患者(68 例预后良好,61 例预后不良)。在 G4 研究(n=87)中,中位随访 19.7 年后,5 年、10 年和 15 年无进展生存率(PFS)和总生存率(OS)分别为 95.4%/97.7%、91.8%/96.5%和 91.8%/95.3%。在 G5 研究(n=42)中,中位随访 13.5 年后,5 年、10 年和 15 年 PFS 和 OS 分别为 92.9%/100%、92.9%/100%和 88.4%/91.9%。两组之间的 PFS(P=.86)和 OS(P=.86)无显著差异。对于预后良好或不良风险的患者,两组之间在 PFS(F:P=.53;U:P=.96)和 OS(F:P=.99;U:P=.78)、继发性恶性肿瘤(F:P=.74;U:P=1.0)和心血管并发症(F:无病例;U:P=1.0)方面也没有显著差异。

结论

G4 和 G5 研究达到了高持久缓解率;与 30 Gy mIFRT 相比,20 Gy mIFRT 和环磷酰胺替代美法仑并未影响淋巴结控制、PFS 或 OS,无论是在预后良好还是不良风险的疾病中。这些结果支持 CMT 在早期疾病中的疗效以及对预后良好和非肿块性不良 ESHL 患者进行低剂量放疗。

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