Adjuvant chemotherapy for adult soft tissue sarcomas of the extremities and girdles: Results of the Italian randomized cooperative trial
Adjuvant chemotherapy for adult soft tissue sarcomas of the extremities and girdles: Results of the Italian randomized cooperative trial
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DOI：
10.1200/jco.2001.19.5.1238
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发表时间：
2001-03-01
影响因子：
45.3
通讯作者：
Picci, P
中科院分区：
文献类型：
--
作者：
Frustaci, S;Gherlinzoni, F;Picci, P
目的：软组织肉瘤的辅助化疗是有争议的，因为以前的试验报道了相互矛盾的结果。患者和方法：18~65岁，肢体或环状梭形细胞肉瘤3~4级(原发直径大于或等于5 cm或任何大小的复发性肿瘤)，年龄18~65岁。根据原发肿瘤与复发肿瘤以及肿瘤直径大于或等于10厘米与小于10厘米进行分层。104例患者被随机分为两组，对照组51例，治疗组53例(4‘-表柔比星60 mg/m(2)d，异环磷酰胺1.8 g/m(2)d，1~5天，共5个周期)。结果：中位随访59个月，60例复发，48例死亡(治疗组28例，对照组20例，对照组32例，28例)。中位无病生存期(DFS)治疗组为48个月，对照组为16个月(P=0.04)；中位总生存期(QS)治疗组为75个月，未治疗组为46个月(P=0.03)。对于OS，化疗的绝对收益在2年时为13%，在4年时增加到19%(P=0.04)。结论：强化辅助化疗对高危肢体软组织肉瘤患者的DFS和OS有积极的影响，中位随访时间为59个月。因此，我们的数据支持对类似病例进行强化治疗。虽然治愈仍然很难实现，但考虑到治疗时间短和没有中毒死亡，显著推迟死亡是值得的。J Clin Oncol19：1238-1247。(C)2001年，由美国临床肿瘤学会主办。
Purpose: Adjuvant chemotherapy for soft tissue sarcoma is controversial because previous trials reported conflicting results. The present study wets designed with restricted selection criteria and high dose-intensities of the two most active chemotherapeutic agents.Patients and Methods: Patients between 18 and 65 years of age with grade 3 to 4 spindle-cell sarcomas (primary diameter greater than or equal to 5 cm or any size recurrent turner) in extremities or girdles were eligible. Stratification was by primary versus recurrent tumors and by tumor diameter greater than or equal to 10 cm versus less than 10 cm. One hundred four patients were randomized, 51 to the control group and 53 to the treatment group (five cycles of 4'-epidoxorubicin 60 mg/m(2) days 1 and 2 and ifosfamide 1.8 g/m(2) days 1 through 5, with hydration, mesna, and granulocyte colony-stimulating factor).Results: After a median follow-up of 59 months, 60 patients had relapsed and 48 died (28 and 20 in the treatment arm and 32 and 28 in the control arm, respectively). The median disease-free survival (DFS) was 48 months in the treatment group and 16 months in the control group (P = .04); and the median overall survival (QS) was 75 months for treated and 46 months for untreated patients (P = .03). For OS, the absolute benefit deriving from chemotherapy was 13% at 2 years and increased to 19% at 4 years (P = .04).Conclusion: Intensified adjuvant chemotherapy had a positive impact on the DFS and OS of patients with high-risk extremity soft tissue sarcomas at a median follow-up of 59 months. Therefore, our data favor an intensified treatment in similar cases. Although cure is still difficult to achieve, a significant delay in death is worthwhile, also considering the short duration of treatment and the absence of toxic deaths. J Clin Oncol 19:1238-1247. (C) 2001 by American Society of Clinical Oncology.