Kunos Charles, Simpkins Fiona, Gibbons Heidi, Tian Chunqiao, Homesley Howard
From the Department of Radiation Oncology, University Hospitals of Cleveland, Cleveland, Ohio; the Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Cleveland Clinic Foundation, Cleveland, Ohio; the Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University Hospitals of Cleveland, Cleveland, Ohio; the Gynecologic Oncology Group Statistical and Data Center; Roswell Park Cancer Institute, Buffalo, New York; and the Gynecologic Oncology Network/Brody School of Medicine, Greenville, North Carolina. Fiona Simpkins, MD, is currently at the Miller School of Medicine, University of Miami, Miami, Florida.
Obstet Gynecol. 2009 Sep;114(3):537-546. doi: 10.1097/AOG.0b013e3181b12f99.
To report long-term survival and toxicity of radiation compared with pelvic node resection for patients with groin node-positive vulvar cancer.
A Gynecologic Oncology Group protocol enrolled 114 patients randomly allocated to postoperative pelvic and groin radiation (45-50 Gy, n=59) or to ipsilateral pelvic node resection (n=55) after radical vulvectomy and inguinal lymphadenectomy. Retrospective analyses for 114 enrolled patients included both risk of progression and death after treatment and assessment of toxicity.
Median age was 70 years. Median survivor follow-up was 74 months. The relative risk of progression was 39% in radiation patients (95% confidence interval [CI] 0.17-0.88, P=.02). Fourteen intercurrent deaths occurred after radiation as compared with only two after pelvic node resection, narrowing 6-year overall survival (51% compared with 41%, hazard ratio 0.61 [95% CI 0.30-1.3], P=.18). However, the cancer-related death rate was significantly higher for pelvic node resection compared with radiation (51% compared with 29% at 6 years, hazard ratio 0.49 [95% CI 0.28-0.87], P=.015). Six-year overall survival benefit for radiation in patients with clinically suspected or fixed ulcerated groin nodes (P=.004) and two or more positive groin nodes (P<.001) persisted. A ratio of more than 20% positive ipsilateral groin nodes (number positive/number resected) was significantly associated with contralateral lymph node metastasis, relapse, and cancer-related death. Late chronic lymphedema (16% compared with 22%) and cutaneous desquamation (19% compared with 15%) were balanced after radiation and pelvic node resection.
Radiation after radical vulvectomy and inguinal lymphadenectomy significantly reduces local relapses and decreases cancer-related deaths. Late toxicities remained similar after radiation or pelvic node resection.
I.
报告腹股沟淋巴结阳性的外阴癌患者接受放疗与盆腔淋巴结切除术的长期生存率及毒性反应。
一项妇科肿瘤学组方案纳入了114例患者，这些患者在根治性外阴切除术和腹股沟淋巴结清扫术后被随机分配至术后盆腔及腹股沟放疗组（45-50 Gy，n = 59）或同侧盆腔淋巴结切除组（n = 55）。对114例入组患者进行回顾性分析，内容包括治疗后进展和死亡风险以及毒性评估。
中位年龄为70岁。中位生存随访时间为74个月。放疗患者的进展相对风险为39%（95%置信区间[CI] 0.17 - 0.88，P = 0.02）。放疗后发生14例并发死亡，而盆腔淋巴结切除术后仅2例，6年总生存率差距缩小（分别为51%和41%，风险比0.61 [95% CI 0.30 - 1.3]，P = 0.18）。然而，盆腔淋巴结切除术组的癌症相关死亡率显著高于放疗组（6年时分别为51%和29%，风险比0.49 [95% CI 0.28 - 0.87]，P = 0.015）。对于临床怀疑或固定溃疡的腹股沟淋巴结患者（P = 0.004）以及两个或更多阳性腹股沟淋巴结患者（P < 0.001），放疗的6年总生存获益持续存在。同侧腹股沟淋巴结阳性比例超过20%（阳性数/切除数）与对侧淋巴结转移、复发及癌症相关死亡显著相关。放疗和盆腔淋巴结切除术后晚期慢性淋巴水肿（分别为16%和22%）及皮肤脱屑（分别为19%和15%）情况相当。
根治性外阴切除术和腹股沟淋巴结清扫术后放疗可显著降低局部复发率并减少癌症相关死亡。放疗或盆腔淋巴结切除术后晚期毒性反应相似。
I级
