Results of a randomized, prospective clinical trial evaluating metronomic chemotherapy in nonmetastatic patients with high-grade, operable osteosarcomas of the extremities: A report from the Latin American Group of Osteosarcoma Treatment
| Autor: | Carla Renata Pacheco Donato Macedo, Álvaro Nagib Atallah, J. H. Barreto, Sima Ferman, Walter Cacciavillano, Simone dos Santos Aguiar, Eduardo de Lima, Vera Lúcia Lins de Moraes, Tatiana El‐Jaick, Daniel Lustosa, Luis Castillo, Hugo Cogo-Moreira, Marcelo Scopinaro, Andreza Almeida Senerchia, Claudia T. de Oliveira, Maria Luisa Borsato, Maria Tereza Almeida, Guadalupe Rey, Lauro Greggiani, Erica Boldrini, Antonio Sergio Petrilli, Algemir Lunardi Brunetto |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Oncology Male Cancer Research medicine.medical_specialty Randomization Adolescent medicine.medical_treatment Bone Neoplasms 03 medical and health sciences 0302 clinical medicine Internal medicine Antineoplastic Combined Chemotherapy Protocols Clinical endpoint Medicine Humans Child Neoplasm Staging Proportional Hazards Models Chemotherapy Osteosarcoma business.industry Cancer Disease Management Extremities medicine.disease Metronomic Chemotherapy Primary tumor Combined Modality Therapy Surgery Tumor Burden Clinical trial 030104 developmental biology Treatment Outcome Amputation 030220 oncology & carcinogenesis Administration Metronomic Female Neoplasm Grading business |
| Zdroj: | Cancer. 123(6) |
| ISSN: | 1097-0142 |
| Popis: | BACKGROUND Metronomic chemotherapy (MC) consists of the administration of a low dose of chemotherapy on a daily or weekly basis without a long break to achieve an antitumoral effect through an antiangiogenic effect or stimulation of the immune system. The potential effect of MC with continuous oral cyclophosphamide and methotrexate in patients with high-grade operable osteosarcomas (OSTs) of the extremities was investigated. METHODS Patients with high-grade OSTs who were 30 years old or younger were eligible for registration at diagnosis. Eligibility for randomization included 1) nonmetastatic disease and 2) complete resection of the primary tumor. The study design included a backbone of 10 weeks of preoperative therapy with methotrexate, adriamycin, and platinum (MAP). After surgery, patients were randomized between 2 arms to complete 31 weeks of MAP or receive 73 weeks of MC after MAP. The primary endpoint was event-free survival (EFS) from randomization. RESULTS There were 422 nonmetastatic patients registered (May 2006 to July 2013) from 27 sites in 3 countries (Brazil, Argentina and Uruguay), and 296 were randomized to MAP plus MC (n = 139) or MAP alone (n = 157). At 5 years, the EFS cumulative proportions surviving in the MAP-MC group and the MAP-alone group were 61% (standard error [SE], 0.5%) and 64% (SE, 0.5%), respectively, and they were not statistically different (Wilcoxon [Gehan] statistic = 0.724; P =.395). The multivariate analysis showed that necrosis grades 1 and 2, tumor size, and amputation were associated with shorter EFS. CONCLUSIONS According to the current follow-up, EFS with MAP plus MC is not statistically superior to EFS with MAP alone in patients with high-grade, resectable OSTs of the extremities. Cancer 2017;123:1003–10. © 2016 American Cancer Society. |
| Databáze: | OpenAIRE |
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