Lorenzen Sylvie, Quante Michael, Rauscher Isabel, Slotta-Huspenina Julia, Weichert Wilko, Feith Marcus, Friess Helmut, Combs Stefanie E, Weber Wolfgang A, Haller Bernhard, Angele Martin, Albertsmeier Markus, Blankenstein Christiane, Kasper Stefan, Schmid Roland M, Bassermann Florian, Schwaiger Markus, Liffers Sven-Thorsten, Siveke Jens T
Technical University of Munich, Klinikum rechts der Isar, III. Medizinische Klinik und Poliklinik, Munich, Germany.
Technical University Munich, Klinikum rechts der Isar, II. Medizinische Klinik und Poliklinik, Munich, Germany; Department of Internal Medicine II, University of Freiburg, Germany.
Eur J Cancer. 2022 Nov;175:99-106. doi: 10.1016/j.ejca.2022.07.027. Epub 2022 Sep 10.
Positron emission tomography (PET) may differentiate responding and non-responding tumours early in the treatment of locally advanced gastroesophageal junction adenocarcinomas. Early PET non-responders (P-NR) after induction CTX might benefit from changing to chemoradiation (CRT).
Patients underwent baseline F-FDG PET followed by 1 cycle of CTX. PET was repeated at day 14-21 and responders (P-R), defined as ≥35% decrease in SUV from baseline, continued with CTX. P-NR switched to CRT (CROSS). Patients underwent surgery 4-6 weeks post-CTX/CRT. The primary objective was an improvement in R0 resection rates in P-NR above a proportion of 70%.
In total, 160 patients with resectable gastroesophageal junction adenocarcinomas were prospectively investigated by PET scanning. Eighty-five patients (53%) were excluded. Seventy-five eligible patients were enrolled in the study. Based on PET criteria, 50 (67.6%)/24 (32.4%) were P-R and P-NR, respectively. Resection was performed on 46 responders, including one patient who withdrew the ICF, and 22 non-responders (per-protocol population). R0 resection rates were 95.6% (43/45) for P-R and 86.4% (19/22) for P-NR. No treatment related deaths occurred. With a median follow-up time of 24.5 months, estimated 18 months DFS was 75.4%/64.2% for P-R/P-NR, respectively. The estimated 18 months OS was 95.5% for P-R and 68.2% for P-NR.
The primary endpoint of the study to increase the R0 resection rate in metabolic NR was not met. PET response after induction CTX is prognostic for outcome with a prolonged OS and DFS in PET responders.
NCT00002014-000860-16.
在局部晚期胃食管交界腺癌的治疗中,正电子发射断层扫描(PET)可在早期区分有反应和无反应的肿瘤。诱导化疗(CTX)后早期PET无反应者(P-NR)可能从改为放化疗(CRT)中获益。
患者接受基线F-FDG PET检查,随后进行1个周期的CTX。在第14 - 21天重复PET检查,反应者(P-R)定义为SUV较基线下降≥35%,继续接受CTX治疗。P-NR改为CRT(CROSS方案)。患者在CTX/CRT后4 - 6周接受手术。主要目标是使P-NR的R0切除率提高至70%以上。
总共对160例可切除的胃食管交界腺癌患者进行了PET扫描的前瞻性研究。85例患者(53%)被排除。75例符合条件的患者纳入研究。根据PET标准,分别有50例(67.6%)/24例(32.4%)为P-R和P-NR。46例反应者接受了手术,其中1例患者撤回知情同意书,22例无反应者(符合方案人群)接受了手术。P-R的R0切除率为95.6%(43/45),P-NR为86.4%(19/22)。未发生与治疗相关的死亡。中位随访时间为24.5个月,估计18个月的无病生存率(DFS)P-R/P-NR分别为75.4%/64.2%。估计18个月的总生存率(OS)P-R为95.5%,P-NR为68.2%。
该研究提高代谢无反应者R0切除率的主要终点未达到。诱导CTX后的PET反应可预测预后,PET反应者的OS和DFS延长。
NCT00002014-000860-16。