Results of the Latin American Pediatric Oncology Group (GALOP-2011) Trial for Patients With Localized Ewing Sarcoma: A Multicentric Study of Interval-Compressed Multiagent Chemotherapy

IF 2.4 3区医学 Q2 HEMATOLOGY Pediatric Blood & Cancer Pub Date : 2025-01-21 DOI:10.1002/pbc.31554

Lauro José Gregianin, Adriana Rose, Milena Villarroel, Maria Tereza Almeida, Laurice Siqueira, Carmen Salgado, Gildene Alves da Costa, Luis Castillo, Julie Francine Cerutti Santos Pestilho, Algemir Lunardi Brunetto, GALOP Latin American Pediatric Oncology Group Ewing Sarcoma Investigators

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Abstract

Background

GALOP investigators developed a prospective cooperative protocol for localized Ewing sarcoma (ES) incorporating interval-compressed chemotherapy (VDC/IE, vincristine, doxorubicin, cyclophosphamide/ifosfamide and etoposide). After completing conventional treatment, patients were randomized to 1 year of metronomic chemotherapy (vinblastine and cyclophosphamide).

Methods

Phase III randomized prospective trial. Induction consisted of six alternating cycles of VDC/IE every 14 days, followed by local control, and eight cycles of consolidation every 21 days. After consolidation, patients were randomized 1:1 to metronomic chemotherapy or stop treatment, balanced by age (>/< 14 years-old), sex (M/F), site (pelvic/non-pelvic), and size (>/< 8 cm). The results of randomization will be published elsewhere with longer follow-up.

Results

Between 2011 and 2019, 315 patients (59.7% male, median age 11.0 years) were recruited across 34 centers in Argentina, Brazil, Chile, and Uruguay. The most frequent localizations were axial (45.1%), extremity (38.1%), and pelvic (16.8%). The median time interval between cycles was 19 and 22 days at induction and consolidation, respectively. There were no unexpected toxicity or toxic deaths related to interval compression. The overall response rate post-induction was 81.6%. Local treatment with surgery (50.8%), radiotherapy (19.7%), or a combination (26%) was performed in 304 (96.5%) patients. With a median follow-up of 50 months (range: 1.67–121.7), the 5-year overall and event-free survivals were 68.6% (SE: 0.030) and 63.7% (SE: 0.029), respectively.

Conclusion

Implementation of a multi-institutional protocol with the strategy of interval-compressed induction for ES in South America was feasible with favorable results. This success is attributed to rigorous protocol adherence, extensive educational efforts, and a strong emphasis on data quality maintenance, demonstrating a reproducible model for countries with similar resource limitations.

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拉丁美洲儿童肿瘤组（GALOP-2011）局部尤文氏肉瘤患者试验的结果：一项间隔压缩多药化疗的多中心研究。

背景：GALOP研究人员为局部尤文氏肉瘤（ES）制定了一项前瞻性合作方案，包括间隔压缩化疗（VDC/IE、长春新碱、阿霉素、环磷酰胺/异环磷酰胺和依托泊苷）。完成常规治疗后，患者随机接受1年的节律化疗（长春花碱和环磷酰胺）。方法：III期随机前瞻性试验。诱导为每14天6个VDC/IE交替周期，然后进行局部对照，每21天8个周期巩固。结果：2011年至2019年，在阿根廷、巴西、智利和乌拉圭的34个中心招募了315名患者（59.7%为男性，中位年龄11.0岁）。最常见的定位是轴位（45.1%）、四肢（38.1%）和骨盆（16.8%）。诱导期和巩固期的中位时间间隔分别为19天和22天。没有意外的毒性或与间隔受压相关的中毒性死亡。入职后总有效率为81.6%。304例（96.5%）患者进行了局部手术（50.8%）、放疗（19.7%）或联合治疗（26%）。中位随访50个月（1.67-121.7），5年总生存率和无事件生存率分别为68.6% （SE: 0.030）和63.7% （SE: 0.029）。结论：采用间隔压缩诱导策略的多机构协议在南美实施ES是可行的，效果良好。这一成功归功于严格遵守协议、广泛开展教育工作以及高度重视数据质量维护，为具有类似资源限制的国家展示了一种可复制的模式。

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来源期刊

Pediatric Blood & Cancer 医学-小儿科

CiteScore

4.90

自引率

9.40%

发文量

546

审稿时长

1.5 months

期刊介绍： Pediatric Blood & Cancer publishes the highest quality manuscripts describing basic and clinical investigations of blood disorders and malignant diseases of childhood including diagnosis, treatment, epidemiology, etiology, biology, and molecular and clinical genetics of these diseases as they affect children, adolescents, and young adults. Pediatric Blood & Cancer will also include studies on such treatment options as hematopoietic stem cell transplantation, immunology, and gene therapy.