晚期子宫内膜癌化疗添加放疗并没有改善生存率 (7/8/2023)
Adding radiation to chemotherapy not improving survival in advanced endometrial cancer
NRG Oncology GOG-258临床试验评估了III/IVA 期子宫内膜癌患者放化疗与单纯化疗的疗效。 经过近 10 年的中位随访后,总体生存率或无复发生存率没有差异。 接受单纯化疗患者局部复发较多,但接受放化疗患者远处复发较多。
在 813 名患者中,每组大约 75% 的患者患有 IIIC1 或 IIIC2 期疾病。 患者被随机分配接受放化疗或单独化疗。 实验组包括第 1 天和第 29 天的顺铂 50 毫克/平方米加上 45 Gy 的体积定向放射(有或没有近距离放射治疗),随后每 21 天接受卡铂曲线下面积 (AUC) 5 加紫杉醇 175 毫克/平方米四个周期。 单纯化疗组包括 AUC 6 的卡铂加紫杉醇 175 毫克/平方米,每 21 天一次,共六个周期。
先前报道的主要分析是在中位随访 47 个月时进行的。在 60 个月时,存活且未复发的患者百分比基本相同:接受放化疗的患者为 59%,接受单纯化疗的患者为 58%(风险比 HR = 0.90;90% 置信区间 [CI] = 0.74–1.10;P = .20)。 与单独化疗相比,放化疗的 5 年阴道复发率更低(2% 相对于 7%;HR = 0.36)以及更低的盆腔和主动脉旁淋巴结复发率(11% 相对于 20%;HR = 0.43;)较低,但 接受放化疗的女性中远处复发更为常见(27% 相对于 21%;HR = 1.36)。 最新分析显示,中位随访时间为 112 个月,放化疗组有 134 例死亡,单纯化疗组有 125 例死亡(HR = 1.05;95% CI = 0.82-1.34)。 与化疗相比,在任何亚组中,放化疗都没有改善总体生存率,包括分期, 组织学, 体重指数, 残留疾病的存在和年龄。
The NRG Oncology GOG-258 clinical trial evaluated chemoradiotherapy versus chemotherapy alone in patients with stage III/IVA endometrial cancer. After a median follow-up of nearly 10 years, there was no difference in overall survival or recurrence-free survival. Patients who received chemotherapy alone had more local recurrences, while patients who received chemotherapy and radiotherapy had more distant recurrences.
Of the 813 patients, approximately 75 percent in each group had stage IIIC1 or IIIC2 disease. Patients were randomly assigned to receive chemoradiotherapy or chemotherapy alone. The experimental arm consisted of cisplatin 50 mg/m2 on days 1 and 29, plus volume-directed radiation of 45 Gy with or without brachytherapy followed by carboplatin every 21 days (AUC=5) plus paclitaxel 175 mg/m2 for four cycles. The chemotherapy-alone arm consisted of carboplatin at AUC 6 plus paclitaxel 175 mg/m2 every 21 days for six cycles.
The previously reported primary analysis was performed at a median follow-up of 47 months. At 60 months, the percentages of patients alive and free of recurrence were essentially the same: 59% for those who received chemoradiation and 58% for those who received chemotherapy alone (hazard ratio, HR = 0.90; 90% confidence interval [CI] = 0.74– 1.10; P = .20). Chemoradiation was associated with lower 5-year vaginal recurrence rates (2% vs. 7%; HR = 0.36) and lower rates of pelvic and para-aortic nodal recurrence (11% vs. 20%; HR = 0.36) compared with chemotherapy alone. 0.43), while distant recurrence was more common in women who received chemoradiation (27% vs. 21%; HR = 1.36). The latest analysis showed that at a median follow-up of 112 months, there were 134 deaths in the chemoradiotherapy group and 125 deaths in the chemotherapy-alone group (HR = 1.05; 95% CI = 0.82-1.34). Chemoradiation did not improve overall survival compared with chemotherapy in any subgroup, including stage, histology, body mass index, presence of residual disease, and age.
参考文献 Reference
Matei DE et al. 2023 SGO Annual Meeting on Women’s Cancer. March 25, 2023.
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子宫肿瘤 (2018.2.11)
分类:
1)上皮细胞癌,包括纯子宫内膜癌,和高危性的(浆液性,透明细胞,未分化的和癌肉瘤[carcinosarcoma,也称为恶性混合中胚层肿瘤或恶性混合性穆勒氏瘤])
2)恶性间质肿瘤:间质肉瘤,子宫肉瘤和子宫平滑肌肉瘤。
手术:
凡是能够切除的,都须行子宫全切除,两侧输卵管和卵巢切除,以及手术分期。不能全部切除的,但能减灭(debulk)的,要侭可能切除,或先给予化疗然后再手术。
对子宫肉瘤要整块切除,要避免分碎切除(morcellation)。
术后治疗:
1)化疗:
A)对己切除的上皮细胞癌组合方案包括卡铂/紫杉醇(泰素),顺铂/阿霉素, 异环磷酰胺/紫杉醇(过去使用的,也是NCCN2018年对癌肉瘤的第一类建议),或顺铂/异环磷酰胺(癌肉瘤)。
B) 对不能切除或已转移的肉瘤,组合化疗包括阿霉素/异环磷酰胺,阿霉素/达卡巴嗪,吉西他滨/达卡巴嗪或吉西他滨/长春瑞滨。
2)放疗,包括外放射治疗(external beam radiation )和近距离放疗(brachytherapy )
其指征及方法视分期和肿瘤的类型有关。但高危病人(定义不完全一致,但多指分化3级和临床3期, 或4期但仅限于腹膜)愦例都接受放疗。放疗开始前必须做CT以排除它处转移。
A) 外放疗是针对盆腔,局部血管淋巴区(副作用主要为腹泻,可见于50%。
B) 术后近照射主要是针对阴道(它是早期子宫癌最常见的复发部位),它应在手术后6-8周后开始,且不应晚于术后12周。其副作用仅限于阴道(9%为1-2级),和轻微的泌尿道副反应。外照射结束后再给予近照射,用得很普遍,但还没有临床试验证明这样做可以带来多少额外的益处。
至于放疗和化疗的程序,有1)先是放化疗同时进行,然后化疗,该报道有98%的病人完成了治疗; 2)先放疗然后化疗; 3)化疗–>放疗–>化疗,或称为三明治法,其好处在于减少放疗延迟化疗的可能性,缺点是放疗开始得晚是否会导致局部复发的增加。
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