EA7375 (EC2M3 Research Team), Université Paris-Est Créteil (UPEC)-Val de Marne, Créteil, France; Department of Gastroenterology, APHP-Hôpital Henri Mondor, Créteil, France.
Department of Nuclear Medicine, APHP-Hôpital Henri Mondor, Créteil, France.
Ann Oncol. 2018 Apr 1;29(4):931-937. doi: 10.1093/annonc/mdy031.
[18F]2-fluoro-2-deoxy-d-glucose positron emission tomography/computed tomography (18FDG-PET/CT) has high sensitivity for detecting recurrences of colorectal cancer (CRC). Our objective was to determine whether adding routine 6-monthly 18FDG-PET/CT to our usual monitoring strategy improved patient outcomes and to assess the effect on costs.
In this open-label multicentre trial, patients in remission of CRC (stage II perforated, stage III, or stage IV) after curative surgery were randomly assigned (1 : 1) to usual monitoring alone (3-monthly physical and tumour marker assays, 6-monthly liver ultrasound and chest radiograph, and 6-monthly whole-body computed tomography) or with 6-monthly 18FDG-PET/CT, for 3 years. A multidisciplinary committee reviewed each patient's data every 3 months and classified the recurrence status as yes/no/doubtful. Recurrences were treated with curative surgery alone if feasible and with chemotherapy otherwise. The primary end point was treatment failure defined as unresectable recurrence or death. Relative risks were estimated, and survival was analysed using the Kaplan-Meier method, log-rank test, and Cox models. Direct costs were compared.
Of the 239 enrolled patients, 120 were in the intervention arm and 119 in the control arm. The failure rate was 29.2% (31 unresectable recurrences and 4 deaths) in the intervention group and 23.7% (27 unresectable recurrences and 1 death) in the control group (relative risk = 1.23; 95% confidence interval, 0.80-1.88; P = 0.34). The multivariate analysis also showed no significant difference (hazards ratio, 1.33; 95% confidence interval, 0.8-2.19; P = 0.27). Median time to diagnosis of unresectable recurrence (months) was significantly shorter in the intervention group [7 (3-20) versus 14.3 (7.3-27), P = 0.016]. Mean cost/patient was higher in the intervention group (18 192 ± 27 679 € versus 11 131 ± 13 €, P < 0.033).
18FDG-PET/CT, when added every 6 months, increased costs without decreasing treatment failure rates in patients in remission of CRC. The control group had very close follow-up, and any additional improvement (if present) would be small and hard to detect.
CLINICALTRIALS.GOV IDENTIFIER: NCT00624260.
[18F]2-氟-2-脱氧-D-葡萄糖正电子发射断层扫描/计算机断层扫描（18FDG-PET/CT）对结直肠癌（CRC）复发的检测具有很高的敏感性。我们的目的是确定在我们常规监测策略中添加常规的 6 个月 18FDG-PET/CT 是否可以改善患者的预后，并评估其对成本的影响。
在这项开放标签的多中心试验中，接受根治性手术后处于缓解期的 CRC（穿孔 II 期、III 期或 IV 期）患者被随机分配（1:1）至单独接受常规监测（每 3 个月进行一次体格检查和肿瘤标志物检测，每 6 个月进行一次肝脏超声和胸部 X 线检查，每 6 个月进行一次全身计算机断层扫描）或每 6 个月进行一次 18FDG-PET/CT，共 3 年。一个多学科委员会每 3 个月审查每位患者的数据，并将复发情况分类为是/否/可疑。如果可行，采用根治性手术治疗复发，否则采用化疗。主要终点是治疗失败，定义为不可切除的复发或死亡。采用相对风险估计，采用 Kaplan-Meier 方法、对数秩检验和 Cox 模型分析生存情况。比较直接成本。
在 239 名入组患者中，120 名患者在干预组，119 名患者在对照组。干预组的失败率为 29.2%（31 例不可切除的复发和 4 例死亡），对照组为 23.7%（27 例不可切除的复发和 1 例死亡）（相对风险=1.23；95%置信区间，0.80-1.88；P=0.34）。多变量分析也未显示出显著差异（风险比=1.33；95%置信区间，0.8-2.19；P=0.27）。干预组不可切除复发的中位诊断时间[7（3-20）个月]明显短于对照组[14.3（7.3-27）个月]（P=0.016）。干预组的平均每位患者成本较高（18192 欧元±27679 欧元），对照组的平均每位患者成本较低（11131 欧元±13131 欧元）（P<0.033）。
在 CRC 缓解期患者中，每 6 个月进行一次 18FDG-PET/CT 检查，增加了成本，但未降低治疗失败率。对照组的随访非常密切，任何额外的改善（如果存在）都很小，难以察觉。
临床试验.gov 标识符：NCT00624260。
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