Prospective trial to identify optimal bladder cancer surveillance protocol: reducing costs while maximizing sensitivity

Prospective trial to identify optimal bladder cancer surveillance protocol: reducing costs while maximizing sensitivity
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DOI:
10.1111/j.1464-410x.2010.10026.x
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发表时间:
2011-10-01
期刊:
影响因子:
4.5
通讯作者:
Dinney, Colin P.
Dinney, Colin P.
中科院分区:
医学2区
文献类型:
--
作者:
Kamat, Ashish M.;Karam, Jose A.;Dinney, Colin P.

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目的评估在膀胱镜检查的基础上使用细胞学检查、NMP22 BladderChek (R)和荧光原位杂交(FISH) UroVysion (R)对有膀胱癌复发监测史的患者的成本-效果。患者和方法在德克萨斯大学MD安德森癌症中心前瞻性地招募了200名连续的膀胱癌患者,这些患者均有未侵犯肌肉的膀胱癌病史。比较五种监测策略:(i)单独膀胱镜检查;(ii)膀胱镜检查和NMP22;(iii)膀胱镜检查和FISH;(iv)膀胱镜和细胞学检查;(v)经FISH阳性证实的膀胱镜检查和NMP22阳性。计算每个检测到的癌症的成本。对于最初检测呈阳性而膀胱镜检查呈阴性的患者,在第一次随访中发现的肿瘤被认为太小而无法在最初评估中可见,因此生物标志物被认为是早期发现的原因。结果13例患者在研究开始时检测到肿瘤。五种监测策略的检出率分别为:(i) 52%、(ii) 56%、(iii) 72%、(iv) 60%和(v) 56%。每个检测到的肿瘤(在初始标记物分析时)的成本为:(i) 7692美元;(ii) $ 12,000;(iii) 26 462美元;(iv) 11846美元;(v) 10292美元。如果将早期检测到的生物标志物考虑在内,CPTD就变成了:(i) 7692美元;(ii) 11143美元;19 111美元;(iv) 10 267美元;(v) $9557。首次随访时发现12例新发癌症(中位时间为4.1个月)。生物标志物检测而膀胱镜检查未检测到的肿瘤均无侵袭性。结论单纯膀胱镜检查仍是检测膀胱癌非侵袭性复发的最佳方法。尿液标记物的添加增加了成本,但没有改善对侵袭性疾病的检测。
OBJECTIVETo assess the cost-effectiveness of using cytological evaluation, NMP22 BladderChek (R), and fluorescence in situ hybridization (FISH) UroVysion (R) in addition to cystoscopy in patients with a history of bladder cancer undergoing surveillance for recurrence.PATIENTS AND METHODSIn all, 200 consecutive patients with a history of bladder cancer not invading the muscle were prospectively enrolled at The University of Texas MD Anderson Cancer Center.Five surveillance strategies were compared: (i) cystoscopy alone; (ii) cystoscopy and NMP22; (iii) cystoscopy and FISH; (iv) cystoscopy and cytology; and (v) cystoscopy and positive NMP22 confirmed by positive FISH.The cost per cancer detected was calculated. For patients with an initial positive test and negative cystoscopy, tumour detected at first follow-up was assumed to be too small to be visualized at the initial assessment and the biomarker was credited with early detection.RESULTSCancer was detected in 13 patients at study entry.Detection rates for the five surveillance strategies were: (i) 52%, (ii) 56%, (iii) 72%, (iv) 60%, and (v) 56%.The costs per tumour detected (at the time of initial marker analysis) were (i) $7692; (ii) $12 000; (iii) $26 462; (iv) $11 846; and (v) $10 292.When early detection of biomarkers was factored in, the CPTD became: (i) $7692; (ii) $11 143; (iii) $19 111; (iv) $10 267; and (v) $9557.There were 12 new cancers detected at first follow-up (median time, 4.1 months). None of the tumours detected by biomarkers but not by cystoscopy were invasive.CONCLUSIONSCystoscopy alone remains the most cost-effective strategy to detect recurrence of bladder cancer not invading the muscle.The addition of urinary markers adds to cost, without improved detection of invasive disease.