完全手术切除后，区域高热与化疗联合治疗高危腹膜后和腹部软组织肉瘤的疗效：一项随机 III 期多中心研究的亚组分析。
Effectiveness of regional hyperthermia with chemotherapy for high-risk retroperitoneal and abdominal soft-tissue sarcoma after complete surgical resection: a subgroup analysis of a randomized phase-III multicenter study.
机构信息
*Department of General, Visceral, Transplantation, Vascular, and Thoracic Surgery and †Department of Internal Medicine III, University of Munich-Campus Grosshadern, Munich, Germany ‡Sarcoma Unit ITM-Interdisciplinary Tumor Center Mannheim, Mannheim University Medical Center, University of Heidelberg, Mannheim, Germany §Institute of Medical Informatics, Biometry, and Epidemiology, University of Munich-Campus Großhadern, Munich, Germany ¶Department of General, Visceral, and Vascular Surgery, University Hospital Magdeburg, University of Magdeburg, Magdeburg, Germany.
出版信息
Ann Surg. 2014 Nov;260(5):749-54; discussion 754-6. doi: 10.1097/SLA.0000000000000978.
OBJECTIVE
To determine whether regional hyperthermia (RHT) in addition to chemotherapy improves local tumor control after macroscopically complete resection of abdominal or retroperitoneal high-risk sarcomas.
BACKGROUND
Within the prospectively randomized EORTC 62961 phase-III trial, RHT and systemic chemotherapy significantly improved local progression-free survival (LPFS) and disease-free survival (DFS) in patients with abdominal and extremity sarcomas. That trial included macroscopically complete and R2 resections.
METHODS
A subgroup analysis of the EORTC trial was performed and long-term survival determined. From 341 patients, 149 (median age 52 years, 18-69) were identified with macroscopic complete resection (R0, R1) of abdominal and retroperitoneal soft-tissue sarcomas (median diameter 10 cm, G2 48.3%, G3 51.7%). Seventy-six patients were treated with EIA (etoposide, ifosfamide, doxorubicin)+RHT (≥5 cycles: 69.7%) versus 73 patients receiving EIA alone (≥5 cycles: 52.1%, P=0.027). LPFS and DFS as well as overall survival were determined.
RESULTS
RHT and systemic chemotherapy significantly improved LPFS (56% vs 45% after 5 years, P=0.044) and DFS (34% vs 27% after 5 years, P=0.040). Overall survival was not significantly improved in the RHT group (57% vs 55% after 5 years, P=0.82). Perioperative morbidity and mortality were not significantly different between groups.
CONCLUSIONS
In patients with macroscopically complete tumor resection, RHT in addition to chemotherapy resulted in significantly improved local tumor control and DFS without increasing surgical complications. Within a multimodal therapeutic concept for abdominal and retroperitoneal high-risk sarcomas, RHT is a treatment option beside radical surgery and should be further evaluated in future trials.
目的
确定在腹部或腹膜后高危肉瘤的大体完全切除术后，区域热疗（RHT）联合化疗是否能提高局部肿瘤控制。
背景
在 EORTC 62961 期 III 期前瞻性随机试验中，RHT 和全身化疗显著改善了腹部和肢体肉瘤患者的局部无进展生存期（LPFS）和无病生存期（DFS）。该试验纳入了大体完全和 R2 切除的患者。
方法
对 EORTC 试验进行了亚组分析，并确定了长期生存情况。从 341 例患者中，有 149 例（中位年龄 52 岁，18-69 岁）被确定为腹部和腹膜后软组织肉瘤的大体完全切除（R0、R1）（中位直径 10cm，G2 占 48.3%，G3 占 51.7%）。76 例患者接受 EIA（依托泊苷、异环磷酰胺、多柔比星）+RHT（≥5 个周期：69.7%）治疗，73 例患者单独接受 EIA 治疗（≥5 个周期：52.1%，P=0.027）。确定 LPFS、DFS 和总生存率。
结果
RHT 和全身化疗显著提高了 LPFS（5 年后 56% vs 45%，P=0.044）和 DFS（5 年后 34% vs 27%，P=0.040）。RHT 组的总生存率无显著改善（5 年后 57% vs 55%，P=0.82）。两组围手术期发病率和死亡率无显著差异。
结论
在大体完全切除肿瘤的患者中，RHT 联合化疗可显著提高局部肿瘤控制和 DFS，而不会增加手术并发症。在腹部和腹膜后高危肉瘤的多模式治疗概念中，RHT 是除根治性手术之外的一种治疗选择，应在未来的试验中进一步评估。
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