Randomized phase III trial of adjuvant radiation versus chemoradiation in intermediate-risk, early-stage cervical cancer following radical hysterectomy and lymphadenectomy: results from NRG Oncology/GOG-263/KGOG 1008.

Methods

Post-surgical patients with stage I-IIA cervical cancer with pathologically noted intermediate risk factors including combinations of capillary lymphatic space involvement, stromal invasion, and tumor size were randomly assigned in a 1 : 1 ratio to receive either adjuvant CRT or RT (NCT01101451).

对于I-IIA期宫颈癌术后患者，若病理显示存在中等风险因素，包括毛细淋巴管空间受累、间质浸润和肿瘤大小的组合，按照1:1的比例随机分配接受辅助CRT或RT治疗（NCT01101451）。

Patients received conformal RT, or intensity modulated radiation therapy.

患者接受了适形放射治疗或调强放射治疗。

In the CRT arm, 6 weekly cycles of cisplatin 40 mg/m2 were administered during RT.

在放化疗组中，RT期间每周一次共6个周期的顺铂40 mg/m2被施用。

RFS was the primary endpoint in randomized and eligible patients.

无病生存期（RFS）是随机化且符合条件患者的主要终点。

Secondary endpoints included overall survival(OS), quality of life (QoL), and adverse events (AEs).

次要终点包括总生存（OS）、生活质量（QoL）和不良事件（AEs）。

Results

Of the 340 randomized patients, 316 were eligible and most had Federation of Gynecology and Obstetrics (2009) stage IB1 and squamous cell carcinoma histology.

在340名随机患者中，316名符合入选标准，其中大多数为2009年国际妇产科联盟（Federation of Gynecology and Obstetrics，FIGO）IB1期和鳞状细胞癌组织学类型。

Out of 316 patients, 292 (92.4%) received 28 fractions of RT with a median dose of 50.4 Gy and a median treatment duration of 39 days.

在316名患者中，有292名（92.4%）接受了28次放疗（RT），中位剂量为50.4 Gy，中位治疗时间为39天。

Three-year RFS was 88.5% in the CRT arm and 85.4% in the RT arm.

在放化疗组中，三年无复发生存率为88.5%，而在单纯放疗组中为85.4%。

Both RFS [hazard ratio(HR) 0.698, 95% confidence interval(CI) 0.408-1.192, P = 0.09], as well as OS [HR 0.586, 95% CI 0.286-1.199, P = 0.07] favored CRT compared with RT alone.

无复发生存率（风险比[HR] 0.698, 95% 置信区间[CI] 0.408-1.192, P = 0.09）以及总生存率（HR 0.586, 95% CI 0.286-1.199, P = 0.07）均倾向于放化疗组，与单纯放疗组相比。

Grade 3 or 4 AEs occurred in 43% and 15% in the CRT and RT arms, respectively (P < 0.01).

CRT组和RT组分别有43%和15%的患者发生了3级或4级不良事件（P < 0.01）。

A transient decline in QoL occurred in the CRT arm compared with RT after starting treatments and recovered to pre-treatment level by 36 weeks.

与RT组相比，CRT组在开始治疗后QoL出现了短暂下降，并在36周内恢复到治疗前水平。

Conclusions

Although RFS and OS favored CRT, the addition of cisplatin during RT did not statistically improve RFS or OS in cervical cancer patients with intermediate pathological risk factors following radical hysterectomy and lymphadenectomy.

尽管无复发生存期（RFS）和总生存（OS）倾向于放化疗（CRT），但在接受根治性子宫切除术和淋巴结清扫术的宫颈癌患者中，放疗期间添加顺铂并未在统计学上显著改善具有中等病理风险因素患者的无复发生存期或总生存期。

CRT increased grade 3 and 4 AEs with a transient decline in QoL.

放化疗增加了3级和4级不良事件（AEs），并导致生活质量（QoL）的短暂下降。