Di Fabio Francesca, Pinto Carmine, Rojas Llimpe Fabiola L, Fanti Stefano, Castellucci Paolo, Longobardi Ciro, Mutri Vita, Funaioli Chiara, Sperandi Francesca, Giaquinta Stefania, Martoni Andrea A
Medical Oncology Unit, S. Orsola-Malpighi Hospital, Via Albertoni, 15-40138, Bologna, Italy.
Gastric Cancer. 2007;10(4):221-7. doi: 10.1007/s10120-007-0438-3. Epub 2007 Dec 25.
The aim of the study was to evaluate whether the therapy-induced reduction of the (18)F-fluorodeoxyglucose positron emission tomography (18F-FDG-PET) maximum standardized uptake value in patients with advanced gastric adenocarcinoma treated with chemotherapy plus cetuximab could predict the objective response and outcome early during the treatment.
The study was performed as a part of a phase II trial evaluating cetuximab plus the leucovorin/5-fluorouracil/irinotecan (FOLFIRI) regimen. The objective response was evaluated according to the response evaluation criteria in solid tumors (RECIST) every 6 weeks. The early metabolic response evaluated by 18F-FDG-PET was assessed according to our own evaluated cutoff value (<35%) after receiver operating characteristic (ROC) analysis.
Twenty of 22 patients had positive baseline 18F-FDG-PET. The best RECIST response was: complete response (CR), 3; partial response (PR), 9; stable disease (SD), 8. Twelve patients (60%) were classified as metabolic responders and 8 (40%) as nonresponders. At the median follow-up time of 11 months, median time to disease progression (TTP) and overall survival (OS) for early metabolic responders versus nonresponders were 11 versus 5 months (P = 0.0016) and 16 versus 6 months (P = 0.1493), respectively.
The early metabolic response evaluated by 18F-FDG-PET predicted the clinical outcome in this series of patients with advanced gastric cancer treated with chemotherapy plus cetuximab.
本研究旨在评估化疗联合西妥昔单抗治疗的晚期胃腺癌患者经治疗后(18)F-氟脱氧葡萄糖正电子发射断层扫描(18F-FDG-PET)最大标准化摄取值的降低是否能在治疗早期预测客观缓解和预后。
本研究作为一项评估西妥昔单抗联合亚叶酸钙/5-氟尿嘧啶/伊立替康(FOLFIRI)方案的II期试验一部分进行。每6周根据实体瘤疗效评价标准(RECIST)评估客观缓解情况。在接受者操作特征(ROC)分析后,根据我们自己评估的临界值(<35%)评估18F-FDG-PET评估的早期代谢反应。
22例患者中有20例基线18F-FDG-PET呈阳性。最佳RECIST反应为:完全缓解(CR)3例;部分缓解(PR)9例;疾病稳定(SD)8例。12例患者(60%)被归类为代谢反应者,8例(40%)为无反应者。在11个月的中位随访时间,早期代谢反应者与无反应者的疾病进展中位时间(TTP)和总生存期(OS)分别为11个月对5个月(P = 0.0016)和16个月对6个月(P = 0.1493)。
在这一系列接受化疗联合西妥昔单抗治疗的晚期胃癌患者中,18F-FDG-PET评估的早期代谢反应可预测临床预后。