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肢体和体壁高危、高级别软组织肉瘤新辅助化疗和放疗的 2 期研究的长期结果:放射治疗肿瘤学组试验 9514。

Long-term results of a phase 2 study of neoadjuvant chemotherapy and radiotherapy in the management of high-risk, high-grade, soft tissue sarcomas of the extremities and body wall: Radiation Therapy Oncology Group Trial 9514.

机构信息

Department of Surgery, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute and Comprehensive Cancer Center, Ohio State University, Columbus, Ohio 43210, USA.

出版信息

Cancer. 2010 Oct 1;116(19):4613-21. doi: 10.1002/cncr.25350.

Abstract

BACKGROUND

The use of neoadjuvant and adjuvant chemotherapy in soft tissue sarcomas is controversial. This is a report of long-term (≥5 years) follow-up in patients with high-grade, high-risk soft tissue sarcomas treated with neoadjuvant chemotherapy, preoperative radiotherapy (RT), and adjuvant chemotherapy.

METHODS

Patients with high-grade soft tissue sarcoma≥8 cm in diameter of the extremities and body wall received 3 cycles of neoadjuvant chemotherapy (mesna, doxorubicin, ifosfamide, and dacarbazine) and preoperative RT (44 grays administered in split courses), and 3 cycles of postoperative chemotherapy (mesna, doxorubicin, ifosfamide, and dacarbazine).

RESULTS

Sixty-four of 66 patients were analyzed. After chemotherapy and RT, 61 patients had surgery; 58 had R0 resections (5 amputations), and 3 had R1 resections. Ninety-seven percent experienced grade 3 or higher toxicity, including 3 deaths. These toxicities were short term. With a median follow-up of 7.7 years in surviving patients, the 5-year rates of locoregional failure (including amputation), and distant metastasis were 22.2% (95% confidence interval [CI], 11.8-32.6) and 28.1% (95% CI, 17.0-39.2). The most common site of metastasis was lung. Estimated 5-year rates of disease-free survival, distant disease-free survival, and overall survival were 56.1% (95% CI, 43.9-68.3), 64.1% (95% CI, 52.3-75.8), and 71.2% (95% CI, 60.0-82.5), respectively.

CONCLUSIONS

Although the toxicity was significant, it was limited in its course and for the most part resolved by 1 year. The long-term outcome was better than might be expected in such high-risk tumors.

摘要

背景

新辅助化疗和辅助化疗在软组织肉瘤中的应用存在争议。这是一项关于接受新辅助化疗、术前放疗(RT)和辅助化疗的高危高级别软组织肉瘤患者进行长期(≥5 年)随访的报告。

方法

四肢和体壁直径≥8cm 的高级别软组织肉瘤患者接受 3 个周期的新辅助化疗(美司钠、阿霉素、异环磷酰胺和达卡巴嗪)和术前 RT(44 格雷分次给予),以及 3 个周期的术后化疗(美司钠、阿霉素、异环磷酰胺和达卡巴嗪)。

结果

66 例患者中有 64 例进行了分析。化疗和 RT 后,61 例患者接受了手术;58 例患者行 RO 切除(5 例截肢),3 例患者行 R1 切除。97%的患者发生 3 级或更高级别的毒性,包括 3 例死亡。这些毒性是短期的。在存活患者的中位随访 7.7 年后,局部区域复发(包括截肢)和远处转移的 5 年发生率分别为 22.2%(95%置信区间,11.8-32.6)和 28.1%(95%置信区间,17.0-39.2)。转移最常见的部位是肺部。估计 5 年无病生存率、无远处疾病生存率和总生存率分别为 56.1%(95%置信区间,43.9-68.3)、64.1%(95%置信区间,52.3-75.8)和 71.2%(95%置信区间,60.0-82.5)。

结论

尽管毒性显著,但在病程中是有限的,并且在很大程度上在 1 年内得到解决。长期结果优于此类高危肿瘤的预期结果。

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