Department of Orthopaedic Surgery, Oita University, Idaigaoka 1-1, Hasama, Yufu City, Oita, 879-5593, Japan.
JCOG Data Center, National Cancer Center Hospital, Tokyo, 104-0045, Japan.
World J Surg Oncol. 2018 Aug 10;16(1):162. doi: 10.1186/s12957-018-1462-y.
Soft tissue sarcomas (STS) are rare malignant tumors. The efficacy of preoperative chemotherapy for STS is evaluated using various tumor size-based radiological response criteria. However, it is still unclear which set of criteria would show the best association with pathological response and survival of the patients with STS.
We compared radiological responses to preoperative chemotherapy for operable STS by the Response Evaluation Criteria in Solid Tumors (RECIST), modified RECIST, World Health Organization criteria, Japanese Orthopaedic Association criteria, and modified Choi criteria and analyzed the association with pathological response and survival using the data from the Japan Clinical Oncology Group (JCOG) study JCOG0304, a phase II clinical trial evaluating the efficacy of perioperative chemotherapy for STS in the extremities.
Seventy eligible patients in JCOG0304 were analyzed. The results demonstrated that none of the size-based radiological response criteria showed significant association with pathological response to preoperative chemotherapy for STS. The difference between overall survival of the patients assessed as partial response and stable disease/progressive disease by RECIST was not significant (hazard ratio 1.37, p = 0.63), and calculated C-index was 0.50. All other response criteria also could not exhibit significant association between radiological responses and survival.
In the present study, none of the radiological response criteria analyzed demonstrated association of response to preoperative chemotherapy with pathological response or survival of the patients with operable STS. Further prospective investigation is required to develop criteria to evaluate not only tumor shrinkage but biological effects of preoperative chemotherapy for the patients with localized STS.
UMIN Clinical Trials Registry C000000096. Registered 30 August, 2005 (retrospectively registered).
软组织肉瘤（STS）是一种罕见的恶性肿瘤。目前采用各种基于肿瘤大小的影像学反应标准来评估 STS 患者术前化疗的疗效。然而，哪种标准与 STS 患者的病理反应和生存的相关性最好，目前仍不清楚。
我们比较了实体瘤反应评估标准（RECIST）、改良 RECIST、世界卫生组织标准、日本矫形协会标准和改良 Choi 标准对可手术 STS 患者术前化疗的影像学反应，并分析了与病理反应和生存的相关性，数据来自日本临床肿瘤学组（JCOG）的 JCOG0304 研究，这是一项评估四肢 STS 围手术期化疗疗效的 II 期临床试验。
JCOG0304 中共有 70 名符合条件的患者纳入分析。结果表明，基于肿瘤大小的影像学反应标准均与 STS 患者术前化疗的病理反应无显著相关性。RECIST 评估的部分缓解和稳定/进展患者的总生存差异无统计学意义（危险比 1.37，p=0.63），计算的 C 指数为 0.50。其他反应标准也不能显示影像学反应与生存之间的显著相关性。
本研究中，分析的影像学反应标准均与可手术 STS 患者术前化疗的反应与病理反应或生存无相关性。需要进一步前瞻性研究以制定标准，不仅要评估肿瘤缩小，还要评估局部 STS 患者术前化疗的生物学效应。
UMIN 临床试验注册中心 C000000096。注册于 2005 年 8 月 30 日（回顾性注册）。
