Department of Medicine, Division of Prevention Science, University of California San Francisco, San Francisco, California.
Orthopaedic Surgery, University of California San Francisco, San Francisco, California.
J Bone Joint Surg Am. 2023 Jul 19;105(Suppl 1):49-56. doi: 10.2106/JBJS.22.01077.
Although there is evidence suggesting that postoperative infection confers a survival benefit in osteosarcoma treated with resection and endoprosthetic reconstruction, there have been no prospective studies to date to support these findings. This secondary analysis of Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) study data examines the relationship between surgical site infection (SSI) and disease progression within 12 months after limb salvage surgery.
The PARITY trial was an international, multicenter, prospective randomized controlled trial of 604 patients who underwent resection of a lower-extremity bone tumor and endoprosthetic reconstruction. Our primary outcome was progression-free survival (PFS) at 1 year following surgery among the patients with osteosarcoma. Subgroup analyses by disease stage at presentation and infection severity were also performed. Cox proportional hazard models were employed to examine the association between clinical and tumor characteristics, SSI, and PFS. Kaplan-Meier analysis was used to determine the effect of SSI on PFS.
The 274 PARITY patients with osteosarcoma were included in this secondary analysis. Thirty-two (11.7%) of the patients presented with metastasis at baseline; 53 (19.3%) of the patients developed an SSI. There was no difference in 1-year PFS between patients with and without SSI. There was no decreased risk of disease progression at 1 year in patients with localized disease at baseline who developed an SSI (hazard ratio [HR] = 1.21; 95% confidence interval [CI] = 0.64 to 2.28). Infection was associated with increased disease progression at 1 year in patients with baseline metastases (HR = 4.26; 95% CI = 1.11 to 16.3).
No positive association was detected between postoperative infection and PFS at 1 year following surgery in this secondary analysis of prospective data. However, this analysis suggests infection could be a risk factor for early disease progression in patients with baseline metastases, and future investigations may better elucidate the association between disease burden and the host immune response to advance immunotherapeutic strategies for osteosarcoma.
Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
尽管有证据表明，在接受切除和内置假体重建治疗的骨肉瘤患者中，术后感染可带来生存获益，但迄今为止，尚无前瞻性研究支持这些发现。本研究对预防性抗生素治疗肿瘤手术（PARITY）研究数据进行了二次分析，以检查手术部位感染（SSI）与保肢手术后 12 个月内疾病进展之间的关系。
PARITY 试验是一项国际性、多中心、前瞻性随机对照试验，共纳入 604 例接受下肢骨肿瘤切除和内置假体重建的患者。我们的主要结局是手术治疗后 1 年的无进展生存（PFS）。此外，还对疾病分期和感染严重程度进行了亚组分析。采用 Cox 比例风险模型检查临床和肿瘤特征、SSI 与 PFS 之间的关系。Kaplan-Meier 分析用于确定 SSI 对 PFS 的影响。
本研究纳入了 274 例 PARITY 骨肉瘤患者。32 例（11.7%）患者基线时有转移；53 例（19.3%）患者发生 SSI。有无 SSI 的患者 1 年 PFS 无差异。基线时局限性疾病患者发生 SSI 并不会降低 1 年时疾病进展的风险（风险比 [HR] = 1.21；95%置信区间 [CI] = 0.64 至 2.28）。而基线时转移患者发生感染与 1 年时疾病进展增加相关（HR = 4.26；95% CI = 1.11 至 16.3）。
在这项对前瞻性数据的二次分析中，我们未发现术后感染与术后 1 年时 PFS 之间存在正相关关系。然而，本分析提示感染可能是基线转移患者早期疾病进展的危险因素，未来的研究可能会更好地阐明疾病负担与宿主免疫反应之间的关系，以推进骨肉瘤的免疫治疗策略。
预后 II 级。请参阅作者须知，以获得完整的证据水平描述。
