Adaptive Neoadjuvant Chemotherapy Guided by (18)F-FDG PET in Resectable Non-Small Cell Lung Cancers: The NEOSCAN Trial.
Adaptive Neoadjuvant Chemotherapy Guided by (18)F-FDG PET in Resectable Non-Small Cell Lung Cancers: The NEOSCAN Trial.
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DOI：
10.1016/j.jtho.2015.12.104
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发表时间：
2016-04
期刊：
影响因子：
--
通讯作者：
Kris MG
中科院分区：
文献类型：
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作者：
Chaft JE;Dunphy M;Naidoo J;Travis WD;Hellmann M;Woo K;Downey R;Rusch V;Ginsberg MS;Azzoli CG;Kris MG
虽然围手术期化疗可以提高可切除肺癌患者的生存率，但全身复发仍然很常见。新辅助化疗允许反应评估和转换治疗方案的机会。通过氟脱氧葡萄糖PET测量的缓解与临床结局的相关性优于CT。NEOSCAN试验评估了2个周期新辅助化疗后PET应答欠佳的患者对替代化疗的PET测量应答率。这项II期研究入组了可切除的IB-IIIA期肺癌患者（原发性肿瘤≥ 2 cm且SUV峰值≥ 4.5）。患者在2个周期的顺铂（或卡铂）+吉西他滨（鳞状细胞癌）或培美曲塞（腺癌）治疗前接受了治疗前FDG PET/CT，然后重复PET/CT。如果原发肿瘤的SUV峰值下降≥ 35%，则患者继续初始化疗。PET应答<35%的患者转为长春瑞滨+多西他赛治疗。所有N2淋巴结阳性的患者均建议术后放疗。采用Simon最优两阶段设计评价了既往无应答患者中长春瑞滨+多西他赛的主要终点（PERCST定义的应答率）。入组了40例患者。15例患者（38%，95% CI：38 - 53%）SUV峰值下降<35%，13例接受长春瑞滨+多西他赛治疗。该研究达到了其主要终点，10/15（67%）的PET代谢对替代治疗有反应。化疗毒性从未排除手术探查。利用FDG PET/CT评估反应和改变无反应患者的术前化疗可以改善放射学反应指标。这种适应性方法也可用于测试新药，试图优化围手术期化疗，以实现更好的长期结果。
Although perioperative chemotherapy improves survival in patients with resectable lung cancers, systemic recurrence remains common. Neoadjuvant chemotherapy permits response assessment and opportunity to switch treatment regimens. Response measured by fluorodeoxyglucose PET correlates better than CT with clinical outcomes. The NEOSCAN trial assessed PET-measured response rate to alternative chemotherapy in patients with a suboptimal PET response after 2 cycles of neoadjuvant chemotherapy. This phase 2 study enrolled patients with resectable stage IB-IIIA lung cancers (primary tumor ≥2 cm and SUVpeak≥4.5). Patients had a pretreatment FDG PET/CT before 2 cycles of cisplatin (or carboplatin) + gemcitabine (squamous) or pemetrexed (adenocarcinomas) then repeat PET/CT. If SUVpeak in the primary tumor decreased by ≥35%, patients continued the initial chemotherapy. Individuals with <35% PET response were switched to vinorelbine + docetaxel. Post operative radiotherapy was recommended to all patients with positive N2 nodes. A Simon-optimal two stage design was used to evaluate the primary endpoint of a PERCIST-defined response rate to vinorelbine + docetaxel in previously non-responding patients. 40 patients were enrolled. 15 patients (38%, 95% CI: 38–53%) had <35% decrease in SUVpeak and 13 received vinorelbine + docetaxel. The study met its primary endpoint with 10/15 (67%) PET metabolic responses to alternate therapy. Chemotherapy toxicities never precluded surgical exploration. Utilizing FDG PET/CT to assess response and change preoperative chemotherapy in non-responding patients can improve radiographic measures of response. This adaptive approach can also be used to test new drugs, attempting to optimize perioperative chemotherapy to achieve better long term outcomes.