Randomized Phase II Study of PET Response-Adapted Combined Modality Therapy for Esophageal Cancer: Mature Results of the CALGB 80803 (Alliance) Trial
Randomized Phase II Study of PET Response-Adapted Combined Modality Therapy for Esophageal Cancer: Mature Results of the CALGB 80803 (Alliance) Trial
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DOI：
10.1200/jco.20.03611
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发表时间：
2021-09-01
影响因子：
45.3
通讯作者：
Ilson, David H.
中科院分区：
文献类型：
--
作者：
Goodman, Karyn A.;Ou, Fang-Shu;Ilson, David H.
目的评价正电子发射断层扫描（PET）成像早期评估食管和食管胃交界处腺癌患者化疗反应性的作用，以制定治疗方案。方法：在基线PET检查后，患者被随机分配至诱导化疗方案：改良奥沙利铂、亚叶酸钙和氟尿嘧啶（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）较基线的变化。PET无应答者（SUV下降< 35%）在放化疗期间交叉至替代化疗（50.4戈伊/28次）。PET应答者（SUV下降>= 35%）在放化疗期间继续接受相同的化疗。患者在放化疗后6周接受手术。主要终点是转换化疗后无应答者的病理完全缓解（pCR）率。结果241例符合条件的患者接受了方案治疗，其中225例接受了可评价的重复PET。诱导FOLFOX后交叉至CP（n = 39）或诱导CP后改为FOLFOX（n = 50）的PET无应答者的pCR率分别为18.0%（95% CI，7.5 - 33.5）和20%（95% CI，10 - 33.7）。接受诱导FOLFOX治疗的缓解者的pCR率为40.3%（95% CI，28.9 - 52.5），CP缓解者的pCR率为14.1%（95% CI，6.6 - 25.0）。中位随访时间为5.2年，PET应答者的中位总生存期为48.8个月（95% CI，33.2个月至无法估计），无应答者为27.4个月（95% CI，19.4个月至无法估计）。对于PET应答者的诱导FOLFOX患者，未达到中位生存期。结论：使用PET成像作为生物标志物对食管和食管胃结合部腺癌患者进行个体化治疗的早期反应评估是有效的，可提高PET无应答者的pCR率。诱导FOLFOX的PET应答者在放化疗期间继续接受FOLFOX治疗，5年总生存率为53%。
PURPOSE 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. METHODS 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. RESULTS 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. CONCLUSION 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%.