Multiinstitutional phase II study of neoadjuvant chemotherapy for osteosarcoma (NECO study) in Japan: NECO-93J and NECO-95J
Multiinstitutional phase II study of neoadjuvant chemotherapy for osteosarcoma (NECO study) in Japan: NECO-93J and NECO-95J
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DOI：
10.1007/s00776-009-1347-6
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发表时间：
2009-07-01
影响因子：
1.7
通讯作者：
Yamawaki, Shinya
中科院分区：
文献类型：
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作者：
Iwamoto, Yukihide;Tanaka, Kazuhiro;Yamawaki, Shinya
骨肉瘤是最常见的原发性恶性骨肿瘤。在欧洲和美国，通过使用包括术前和术后化疗以及手术在内的多种治疗方式，其预后得到了极大的改善。然而，在日本，关于骨肉瘤的临床研究很少。为了评估新辅助化疗对发生在四肢的非转移性、可手术的骨肉瘤的疗效，进行了一项前瞻性的多机构II期试验，即新辅助化疗治疗骨肉瘤(NECO)研究。术前化疗包括大剂量甲氨蝶呤(HD-MTX)、顺铂(CDDP)和阿霉素(ADR)。如果诱导治疗被评估为无效，则在化疗方案中加入大剂量异环磷酰胺(IFO)。共有124名患者参加了这项试验，最终有113名患者符合条件。在NECO研究中，5年总生存率(OAS)和无事件生存率(EFS)分别为77.9%和65.5%。对诱导化疗的组织学反应良好，OAS良好(78.7%)。在诱导化疗后，被评估为组织学反应差的进展性疾病的患者结果相似(OAS 89.5%，EFS 68.2%)。两组患者对术前化疗的反应无明显差异。我们分析了日本骨肉瘤患者强化新辅助化疗的结果和加用IFO的效果。结果提示，在标准的三联化疗方案基础上加用大剂量异环磷酰胺是有效的。然而，需要一项随机的临床研究来确定IFO对骨肉瘤患者的真正影响。
Osteosarcoma is the most frequent primary malignant bone tumor. In Europe and the United States, its prognosis has been greatly improved by the use of multimodal treatment, including preoperative and postoperative chemotherapy as well as surgery. In Japan, however, only a few clinical studies on osteosarcoma have been carried out.To evaluate the efficacy of neoadjuvant chemotherapy on nonmetastatic, operable osteosarcoma arising in the extremities, a prospective multiinstitutional phase II trial, the Neoadjuvant Chemotherapy for Osteosarcoma (NECO) study, was conducted. Preoperative chemotherapy included high-dose methotrexate (HD-MTX), cisplatin (CDDP), and adriamycin (ADR). If the induction therapy was assessed as not effective, high-dose ifosfamide (IFO) was added to the chemotherapy regimen. A total of 124 patients were enrolled in this trial, and ultimately 113 patients were eligible.The 5-year overall survival (OAS) and event-free survival (EFS) rates in the NECO study were 77.9% and 65.5%, respectively. A good histological response to the induction chemotherapy resulted in favorable OAS (78.7%). The patients assessed as poor histological responders with progressive disease after the induction chemotherapy exhibited comparable outcomes (OAS 89.5%, EFS 68.2%). There were no significant differences between the OAS and EFS rates of the patients in terms of response to preoperative chemotherapy.We analyzed the results of the intensive neoadjuvant chemotherapy and the effects of adding IFO on patients with osteosarcoma in Japan. The results suggest efficacy of the high-dose IFO addition to the standard three-drug chemotherapy regimen. However, a randomized clinical study is needed to establish the true impact of IFO on patients with osteosarcoma.