Adriamycin-methotrexate high dose versus adriamycin-methotrexate moderate dose as adjuvant chemotherapy for osteosarcoma of the extremities: a randomized study |
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| Affiliation: | 1. Department of Internal Medicine and Oncology, Istituto Ortopedico Rizzoli, Bologna, Italy;2. Bone Tumor Center and 1st Orthopaedic Clinic, Istituto Ortopedico Rizzoli, University of Bologna, Bologna, Italy;3. St. Radboudziekenhuis, Nijmegen, Holland The Netherlands;4. M.D. Anderson Hospital, Houston, Texas, U.S.A.;1. Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400010, China;2. Department of Hepatobiliary Surgery, the First Affiliated Hospital of Chongqing Medical University, 400010, China;3. Department of Hepatobiliary Surgery, the Affiliated Hospital of Southwest Medical University, 646000, China;3. From the Department of Physiology and Pathophysiology, School of Basic Medical Sciences, Peking University, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, and Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing 100191, China,;4. Department of Endocrinology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020, China,;5. Department of General Surgery, Peking University Third Hospital, Beijing 100191, China;6. Department of Cardiometabolic Disease, Merck Research Laboratories, Merck & Co, Inc., Kenilworth, New Jersey 07033;1. Department of Orthopedic Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China;2. Molecular Oncology Laboratory, Department of Orthopaedic Surgery and Rehabilitation Medicine, The University of Chicago Medical Center, Chicago, IL 60637, USA;3. Department of Radiology, The University of Chicago, Chicago, IL 60637, USA;1. Department of Orthopedics, China-Japan Union Hospital of Jilin University, Changchun 130033, Jilin, China;2. Department of Orthopedics, The Second Hospital of Jilin University, Changchun 130033, Jilin, China;3. Department of Pain Medicine, China-Japan Union Hospital of Jilin University, Changchun 130033, Jilin, China;4. Department of Ophthalmology, The Second Hospital of Jilin University, ChangchCun 130033, Jilin, China;1. Université de Montréal, Département de biochimie, Montréal, Québec H3C 3J7, Canada;2. Division of Cancer Biology and Genetics, Queen’s University, Cancer Research Institute, Kingston, Ontario K7L 3N6, Canada;3. Department of Biochemistry, Queens University, Kingston, Ontario, Canada |
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| Abstract: | Adjuvant chemotherapy comprising Adriamycin (ADM) and Methotrexate (MTX) with Citrovorum Factor (CF) was administered on a randomization basis to 2 groups of patients with osteosarcoma after surgical ablation of the primary tumor. One group received high dose MTX (regimen I) and the other moderate dose MTX (regimen II). In both groups a short period of heparin treatment was also administered to prevent neoplastic emboli during surgery. All patients were free of metastasis at the beginning of therapy. The efficacy of therapy was determined by recording the percentage of continuously disease-free patients. This was compared to the disease-free survival in 132 patients previously treated with other ADM or ADM-MTX regimens and to a group of 39 patients treated during this period with amputation only. The latter did not receive adjuvant chemotherapy for a variety of reasons and are equated to a concurrent control group. Over the ensuing 27–66 months, 31 of 56 patients (55%) treated with regimen I and 25 of 50 (50%) treated with regimen II were disease-free. The overall disease-free survival in both regimens was 53%. This is similar to the 132 patients treated with previous adjuvant chemotherapy protocols (45–50%). However, the percentage of continuously disease-free patients treated with adjuvant chemotherapy was significantly better than the 39 patients (12%) treated contemporaneously with surgery only (P < 0.0005). Survival in the latter is similar to that of historical control patients. These results do not suggest any change in the natural history of osteosarcoma and reveal benefits which may accrue with adjuvant chemotherapy. These results also demonstrate that in adjuvant treatment of osteosarcoma performed with ADM and MTX the high and the moderate doses of MTX are equally efficacious. |
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