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早期转移性精原细胞瘤的手术治疗:局限于腹膜后淋巴结的精原细胞瘤行腹膜后淋巴结清扫术的 II 期临床试验。

Surgery in Early Metastatic Seminoma: A Phase II Trial of Retroperitoneal Lymph Node Dissection for Testicular Seminoma With Limited Retroperitoneal Lymphadenopathy.

机构信息

Department of Urology, USC/Norris Comprehensive Cancer Center, Los Angeles, CA.

Department of Urology, Indiana University, Indianapolis, IN.

出版信息

J Clin Oncol. 2023 Jun 1;41(16):3009-3018. doi: 10.1200/JCO.22.00624. Epub 2023 Mar 13.

Abstract

PURPOSE

The long-term toxicities of chemotherapy and radiotherapy can represent a significant burden to testicular cancer survivors. Retroperitoneal lymph node dissection (RPLND) is an established treatment for testicular germ cell tumors with minimal late morbidity although little data exist on its efficacy in early metastatic seminoma. Surgery in early metastatic seminoma is a prospective phase II single-arm, multi-institutional trial of RPLND as first-line treatment for testicular seminoma with clinically low-volume retroperitoneal lymphadenopathy.

PATIENTS AND METHODS

Twelve sites in the United States and Canada prospectively enrolled adult patients with testicular seminoma and isolated retroperitoneal lymphadenopathy (1-3 cm). Open RPLND was performed by certified surgeons with a primary end point of 2-year recurrence-free survival (RFS). Complication rates, pathologic up/downstaging, recurrence patterns, adjuvant therapies, and treatment-free survival were assessed.

RESULTS

A total of 55 patients were enrolled, with a median (IQR) largest clinical lymph node size of 1.6 cm (1.3-1.9). RPLND pathology demonstrated a median (IQR) largest lymph node size of 2.3 cm (0.9-3.5); nine patients (16%) were pN0, 12 (22%) pN1, 31 (56%) pN2, and 3 (5%) pN3. One patient received adjuvant chemotherapy. With a median (IQR) follow-up of 33 months (12.0-61.6), 12 patients experienced recurrence, with a 2-year RFS of 81% and a recurrence rate of 22%. Of the patients who experienced recurrence, 10 were treated with chemotherapy and two underwent additional surgery. At last follow-up, all patients who experienced a recurrence were disease-free and the 2-year overall survival was 100%. Four patients (7%) experienced short-term complications, and four patients experienced long-term complications including incisional hernia (1) and anejaculation (3).

CONCLUSION

RPLND is a treatment option for testicular seminoma with clinically low-volume retroperitoneal lymphadenopathy and is associated with low long-term morbidity.

摘要

目的

化疗和放疗的长期毒性可能会给睾丸癌幸存者带来严重负担。腹膜后淋巴结清扫术(RPLND)是治疗睾丸生殖细胞肿瘤的一种既定方法,其晚期发病率较低,尽管关于其在早期转移性精原细胞瘤中的疗效的数据很少。在早期转移性精原细胞瘤中,手术是一项前瞻性的 II 期、多中心、单臂临床试验,将 RPLND 作为具有临床低容量腹膜后淋巴结病的睾丸精原细胞瘤的一线治疗方法。

患者和方法

美国和加拿大的 12 个地点前瞻性地招募了患有睾丸精原细胞瘤和孤立性腹膜后淋巴结病(1-3cm)的成年患者。经认证的外科医生进行开放式 RPLND,主要终点为 2 年无复发生存率(RFS)。评估了并发症发生率、病理上下分期、复发模式、辅助治疗和无治疗生存。

结果

共纳入 55 例患者,最大临床淋巴结大小的中位数(IQR)为 1.6cm(1.3-1.9)。RPLND 病理学显示最大淋巴结大小的中位数(IQR)为 2.3cm(0.9-3.5);9 例(16%)患者为 pN0,12 例(22%)患者为 pN1,31 例(56%)患者为 pN2,3 例(5%)患者为 pN3。1 例患者接受辅助化疗。中位(IQR)随访 33 个月(12.0-61.6),12 例患者复发,2 年 RFS 为 81%,复发率为 22%。在复发的患者中,10 例接受化疗,2 例接受进一步手术。末次随访时,所有复发患者均无疾病,2 年总生存率为 100%。4 例(7%)患者出现短期并发症,4 例患者出现长期并发症,包括切口疝(1 例)和无精症(3 例)。

结论

对于具有临床低容量腹膜后淋巴结病的睾丸精原细胞瘤,RPLND 是一种治疗选择,且与较低的长期发病率相关。

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