Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2-E2 Yamadaoka, Suita, Osaka, Japan,
Gastric Cancer. 2014;17(3):514-21. doi: 10.1007/s10120-013-0294-2. Epub 2013 Sep 3.
Neoadjuvant chemotherapy may improve outcomes in gastric cancer. Tumor responses can be evaluated with RECIST, Japanese Classification of Gastric Carcinoma (JCGC), and histological criteria. These approaches have not yet been compared.
We analyzed two phase II trials of neoadjuvant chemotherapy using S-1 plus cisplatin. JCOG0210 included patients with linitis plastica and large ulcero-invasive tumors, whereas JCOG0405 comprised those with para-aortic or bulky lymph node metastases. Radiologic evaluations were conducted using RECIST in JCOG0405 and JCGC criteria in JCOG0210, because the latter included many patients without measurable lesions. A histological responder was defined as a patient in whom one third or more of the tumor was affected. The hazard ratios (HR) for death between responders and non-responders and response rate differences between short- and long-term survivors were estimated.
In JCOG0210 (n = 49), HR was 0.54 in JCGC responders (P = 0.059) and 0.40 in histological responders (P = 0.005). The difference in response rates between short- and long-term survivors using histological criteria (34 %, P = 0.023) was greater than that using JCGC criteria (24 %, P = 0.15). In JCOG0405 (n = 51), HR was 0.67 in RECIST responders (P = 0.35) and 0.39 in histological responders (P = 0.030). In short- and long-term survivors, respectively, RECIST response rates were 62 and 67 % (P = 0.77), whereas histological response rates were 33 and 63 % (P = 0.048).
Histological criteria showed higher response assessment validity than RECIST or JCGC criteria and yielded the best surrogate endpoint for overall survival.
新辅助化疗可能改善胃癌患者的预后。肿瘤反应可以用 RECIST、日本胃癌分类（JCGC）和组织学标准进行评估。这些方法尚未进行比较。
我们分析了 S-1 联合顺铂新辅助化疗的两项 II 期临床试验。JCOG0210 纳入了固有型胃癌和大溃疡浸润型肿瘤患者，而 JCOG0405 纳入了腹主动脉旁或大块淋巴结转移患者。JCOG0405 采用 RECIST 进行放射学评估，JCOG0210 采用 JCGC 标准，因为后者纳入了许多无可测量病变的患者。组织学应答定义为肿瘤三分之一以上受累的患者。在应答者和无应答者之间以及短期和长期幸存者之间的应答率差异，估计了死亡的风险比（HR）。
在 JCOG0210 中（n=49），JCGC 应答者的 HR 为 0.54（P=0.059），组织学应答者的 HR 为 0.40（P=0.005）。使用组织学标准，短期和长期幸存者之间的反应率差异（34%，P=0.023）大于 JCGC 标准（24%，P=0.15）。在 JCOG0405 中（n=51），RECIST 应答者的 HR 为 0.67（P=0.35），组织学应答者的 HR 为 0.39（P=0.030）。分别在短期和长期幸存者中，RECIST 应答率分别为 62%和 67%（P=0.77），而组织学应答率分别为 33%和 63%（P=0.048）。
组织学标准比 RECIST 或 JCGC 标准具有更高的反应评估有效性，并为总生存期提供了最佳替代终点。
