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一项评价化疗治疗可切除高级别骨肉瘤患者的随机前瞻性临床试验的长期结果(>25 年)。

Long-term results (>25 years) of a randomized, prospective clinical trial evaluating chemotherapy in patients with high-grade, operable osteosarcoma.

机构信息

Department of Orthopedics, UCLA Orthopedic Hospital, David Geffen School of Medicine at UCLA, University of California-Los Angeles, Los Angeles, California 90095-1782, USA.

出版信息

Cancer. 2012 Dec 1;118(23):5888-93. doi: 10.1002/cncr.27651. Epub 2012 May 30.

DOI:10.1002/cncr.27651
PMID:22648705
Abstract

BACKGROUND

The authors present the long-term follow-up (>25 years) data from 1 of the original prospective, randomized trials that compared adjuvant chemotherapy with expectant management in patients with high-grade, localized osteosarcoma. In addition, the value of pathologic necrosis induced by a single cycle of neoadjuvant chemotherapy was analyzed as a predictive marker of disease-free and overall survival.

METHODS

Fifty-nine patients with high-grade, localized osteosarcoma were enrolled in a prospective trial that was performed between 1981 and 1984 at the University of California-Los Angeles (UCLA). Patients were randomized to receive either adjuvant chemotherapy or observation after surgical resection. Long-term outcomes, follow-up, and pathologic review of all available histologic sections were performed.

RESULTS

The 25-year disease-free survival rate was 28% for patients who received adjuvant chemotherapy compared with 15% for the untreated patients (P = .02). The overall survival rate at 25 years was also significantly higher for treated patients versus untreated patients (38% vs 15%; P = .02). Tumor necrosis >90% after a single round of chemotherapy was a statistically significant predictor of overall survival and disease-free survival for patients who received adjuvant therapy (164 months vs 65 months [P = .04] and 141 months vs 14 months [P < .01], respectively).

CONCLUSIONS

Patients with high-grade, localized osteosarcoma who received adjuvant chemotherapy after undergoing definitive surgical resection had a statistically significant benefit in disease-free and overall survival that was maintained through 25 years. Tumor necrosis after just 1 cycle of neoadjuvant chemotherapy and radiation was predictive of overall survival and disease-free survival in patients who received adjuvant chemotherapy.

摘要

背景

作者报告了其中 1 项原始前瞻性随机试验的长期随访(>25 年)数据,该试验比较了辅助化疗与高分级局部骨肉瘤患者的期待治疗。此外,还分析了新辅助化疗 1 周期诱导的病理坏死作为无病生存和总生存的预测标志物的价值。

方法

1981 年至 1984 年,加利福尼亚大学洛杉矶分校(UCLA)进行了一项前瞻性试验,纳入 59 例高分级局部骨肉瘤患者。患者被随机分配接受辅助化疗或手术后观察。对所有可用组织学切片进行长期结果、随访和病理复查。

结果

接受辅助化疗的患者 25 年无病生存率为 28%,未治疗患者为 15%(P=.02)。治疗组患者的 25 年总生存率也明显高于未治疗组(38%比 15%;P=.02)。接受辅助治疗的患者,化疗 1 周期后肿瘤坏死率>90%是总生存率和无病生存率的统计学显著预测因子(164 个月比 65 个月[P=.04]和 141 个月比 14 个月[P<.01])。

结论

接受确定性手术切除后接受辅助化疗的高分级局部骨肉瘤患者,在无病生存和总生存方面有显著获益,且维持 25 年。接受辅助化疗的患者,新辅助化疗和放疗 1 周期后的肿瘤坏死是总生存率和无病生存率的预测因子。

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Long-term results (>25 years) of a randomized, prospective clinical trial evaluating chemotherapy in patients with high-grade, operable osteosarcoma.一项评价化疗治疗可切除高级别骨肉瘤患者的随机前瞻性临床试验的长期结果(>25 年)。
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