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初诊 IV 期乳腺癌患者局部肿瘤切除术的临床证据。

Clinical Evidence for Locoregional Surgery of the Primary Tumor in Patients with De Novo Stage IV Breast Cancer.

机构信息

Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Breast Tumor Center, Department of Medical Oncology, Phase I Clinical Trial Centre, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.

Department of Breast Oncology, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.

出版信息

Ann Surg Oncol. 2021 Sep;28(9):5059-5070. doi: 10.1245/s10434-021-09650-3. Epub 2021 Feb 3.

DOI:10.1245/s10434-021-09650-3
PMID:33534046
Abstract

BACKGROUND

Whether primary tumor surgery is better than no surgery in patients with de novo stage IV breast cancer remains controversial.

METHODS

This study combined prospective clinical trials and a multicenter cohort to evaluate the impact of locoregional surgery in de novo stage IV breast cancer. The GRADE approach was used to assess the quality of evidence in meta-analysis, and propensity score matching analysis was used in the cohort study. This study was registered with PROSPERO CRD42016043766 and ClinicalTrials.gov NCT04456855.

RESULTS

A total of 1110 patients from six trials and 353 patients from the cohort study were included. The meta-analysis showed that compared with no surgery, locoregional surgery did not prolong overall survival (hazard ratio [HR] = 0.90, P = 0.40; moderate-quality) but had a significantly longer locoregional progression-free survival (HR = 0.23, P < 0.001; moderate-quality). The subgroup analysis of solitary bone-only metastasis (HR = 0.47, P = 0.04; high-quality) resulted in prolonged overall survival. In the cohort study, locoregional surgery showed a survival benefit (HR = 0.63, P = 0.041) before matching, but not (HR = 0.84, P = 0.579) after matching. Patients with bone-only metastasis showed a survival advantage in surgery compared with no surgery before matching (HR = 0.36, P = 0.034) as well as after matching (HR = 0.18, P = 0.017).

CONCLUSIONS

This study indicated that locoregional surgery had a significantly longer locoregional progression-free survival than no surgery in de novo stage IV breast cancer, and patients with bone-only metastasis tended to show an overall survival benefit from surgery.

摘要

背景

新诊断为 IV 期乳腺癌患者中,原发肿瘤手术是否优于不手术仍存在争议。

方法

本研究结合前瞻性临床试验和多中心队列研究来评估局部区域手术对新诊断为 IV 期乳腺癌的影响。使用 GRADE 方法评估荟萃分析中证据的质量,并在队列研究中使用倾向评分匹配分析。本研究在 PROSPERO CRD42016043766 和 ClinicalTrials.gov NCT04456855 上注册。

结果

共有 6 项试验的 1110 例患者和队列研究的 353 例患者纳入研究。荟萃分析显示,与不手术相比,局部区域手术并未延长总生存(风险比 [HR] = 0.90,P = 0.40;中质量),但显著延长了局部区域无进展生存(HR = 0.23,P < 0.001;中质量)。仅骨转移亚组分析结果提示总生存延长(HR = 0.47,P = 0.04;高质量)。在队列研究中,局部区域手术在匹配前显示出生存获益(HR = 0.63,P = 0.041),但在匹配后则未显示(HR = 0.84,P = 0.579)。在匹配前,仅骨转移患者的手术治疗较不手术治疗有生存优势(HR = 0.36,P = 0.034),匹配后也有生存优势(HR = 0.18,P = 0.017)。

结论

本研究表明,新诊断为 IV 期乳腺癌患者中,局部区域手术较不手术有显著更长的局部区域无进展生存,仅骨转移患者的手术治疗有总生存获益的趋势。

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