Icahn School of Medicine at Mount Sinai, New York, NY.
Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.
J Clin Oncol. 2021 Sep 1;39(25):2803-2815. doi: 10.1200/JCO.20.03611. Epub 2021 Jun 2.
To evaluate the use of early assessment of chemotherapy responsiveness by positron emission tomography (PET) imaging to tailor therapy in patients with esophageal and esophagogastric junction adenocarcinoma.
After baseline PET, patients were randomly assigned to an induction chemotherapy regimen: modified oxaliplatin, leucovorin, and fluorouracil (FOLFOX) or carboplatin-paclitaxel (CP). Repeat PET was performed after induction; change in maximum standardized uptake value (SUV) from baseline was assessed. PET nonresponders (< 35% decrease in SUV) crossed over to the alternative chemotherapy during chemoradiation (50.4 Gy/28 fractions). PET responders (≥ 35% decrease in SUV) continued on the same chemotherapy during chemoradiation. Patients underwent surgery at 6 weeks postchemoradiation. Primary end point was pathologic complete response (pCR) rate in nonresponders after switching chemotherapy.
Two hundred forty-one eligible patients received Protocol treatment, of whom 225 had an evaluable repeat PET. The pCR rates for PET nonresponders after induction FOLFOX who crossed over to CP (n = 39) or after induction CP who changed to FOLFOX (n = 50) was 18.0% (95% CI, 7.5 to 33.5) and 20% (95% CI, 10 to 33.7), respectively. The pCR rate in responders who received induction FOLFOX was 40.3% (95% CI, 28.9 to 52.5) and 14.1% (95% CI, 6.6 to 25.0) in responders to CP. With a median follow-up of 5.2 years, median overall survival was 48.8 months (95% CI, 33.2 months to not estimable) for PET responders and 27.4 months (95% CI, 19.4 months to not estimable) for nonresponders. For induction FOLFOX patients who were PET responders, median survival was not reached.
Early response assessment using PET imaging as a biomarker to individualize therapy for patients with esophageal and esophagogastric junction adenocarcinoma was effective, improving pCR rates in PET nonresponders. PET responders to induction FOLFOX who continued on FOLFOX during chemoradiation achieved a promising 5-year overall survival of 53%.
评估正电子发射断层扫描（PET）成像在食管和食管胃交界腺癌患者中用于通过早期评估化疗反应来调整治疗的效果。
基线 PET 后，患者被随机分配到诱导化疗方案：改良奥沙利铂、亚叶酸和氟尿嘧啶（FOLFOX）或卡铂紫杉醇（CP）。诱导后进行重复 PET；评估最大标准化摄取值（SUV）从基线的变化。PET 无反应者（SUV 降低<35%）在放化疗期间交叉到替代化疗（50.4 Gy/28 个剂量）。PET 有反应者（SUV 降低≥35%）在放化疗期间继续使用相同的化疗。患者在放化疗后 6 周接受手术。主要终点是无反应者在转换化疗后的病理完全缓解（pCR）率。
241 名符合条件的患者接受了协议治疗，其中 225 名有可评估的重复 PET。接受诱导 FOLFOX 后交叉到 CP（n=39）或诱导 CP 后改为 FOLFOX（n=50）的 PET 无反应者的 pCR 率分别为 18.0%（95%CI，7.5 至 33.5）和 20%（95%CI，10 至 33.7）。接受诱导 FOLFOX 的有反应者的 pCR 率为 40.3%（95%CI，28.9 至 52.5），而 CP 有反应者的 pCR 率为 14.1%（95%CI，6.6 至 25.0）。中位随访 5.2 年后，PET 有反应者的中位总生存期为 48.8 个月（95%CI，33.2 个月至无法估计），而无反应者为 27.4 个月（95%CI，19.4 个月至无法估计）。对于诱导 FOLFOX 患者中 PET 有反应者，中位生存期未达到。
使用 PET 成像作为生物标志物进行早期反应评估，为食管和食管胃交界腺癌患者进行个体化治疗是有效的，提高了 PET 无反应者的 pCR 率。接受诱导 FOLFOX 且在放化疗期间继续使用 FOLFOX 的 PET 有反应者，获得了有希望的 5 年总生存率为 53%。
