Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett's esophagus: international, partially blinded, randomized phase III trial

Overholt, Bergein F.; Lightdale, Charles J.; Wang, Kenneth K.; Canto, Marcia Irene; Burdick, Steven; Haggitt, Roger C.; Bronner, Mary P.; Taylor, Scott L.; Grace, Michael; Depot, Michelle

doi:10.1016/j.gie.2005.06.047

Cited by 483 publications

(346 citation statements)

References 48 publications

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“…However, the AIM-Dysplasia trial that randomized 127 patients with dysplasia to ablation therapy compared with surveillance reported a much higher yearly progression rate of 19% in the HGD surveillance arm ( 63 ). Th is rate is similar to a second randomized trial that also required confi rmation of HGD by a second expert pathologist, again suggesting that the rigor with which the histology is validated likely predicts the subsequent EAC risk ( 64 ).…”

Section: Summary Of Evidencementioning

confidence: 83%

“…Currently, level 1 evidence for prevention of cancer incidence exists in three clinical scenarios: photodynamic therapy in the setting of BE with HGD, radiofrequency ablation in the setting of HGD, and radiofrequency ablation in the setting of LGD ( 63,142,166 ). Given the costs and side-eff ect profi le of photodynamic therapy, as well as the large body of data supporting the safety and effi cacy of radiofrequency ablation, this modality appears to be the preferred therapy for most patients.…”

Section: Summary Of Evidencementioning

confidence: 99%

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ACG Clinical Guideline: Diagnosis and Management of Barrett’s Esophagus

Shaheen

Falk

Iyer

et al. 2016

American Journal of Gastroenterology

1,317

1,387

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Recent population studies suggest that gastroesophageal refl ux disease (GERD) is increasing in prevalence, both in the United States and worldwide ( 1,2 ). Th e diagnosis of GERD is associated with a 10-15% risk of Barrett's esophagus (BE), a change of the normal squamous epithelium of the distal esophagus to a columnar-lined intestinal metaplasia (IM). Risk factors associated with the development of BE include long-standing GERD, male gender, central obesity ( 3 ), and age over 50 years ( 4,5 ). Th e goal of a screening and surveillance program for BE is to identify individuals at risk for progression to esophageal adenocarcinoma (EAC), a malignancy that has been increasing in incidence since the 1970s ( 6,7 ).Th e purpose of this guideline is to review the defi nition and epidemiology of BE, available screening modalities for BE detection, rationale and methods for surveillance, and available treatment modalities including medical, endoscopic, and surgical techniques. In order to evaluate the level of evidence and strength of recommendations, we used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system ( 8 ). Th e level of evidence ranged from "high" (implying that further research was unlikely to change the authors' confi dence in the estimate of the eff ect) to "moderate" (further research would be likely to have an impact on the confi dence in the estimate of eff ect) to "low" (further research would be expected to have an important impact on the confi dence in the estimate of the eff ect and would be likely to change the estimate) or "very low" (any estimate of eff ect is very uncertain). Th e strength of a recommendation was graded as "strong" when the desirable eff ects of an intervention clearly outweighed the undesirable eff ects and as "conditional" when there was uncertainty about the tradeoff s. We used meta-analyses or systematic reviews when available, followed by clinical trials and cohort and case-control studies. In order to determine the level Barrett's esophagus (BE) is among the most common conditions encountered by the gastroenterologist. In this document, the American College of Gastroenterology updates its guidance for the best practices in caring for these patients. These guidelines continue to endorse screening of high-risk patients for BE; however, routine screening is limited to men with refl ux symptoms and multiple other risk factors. Acknowledging recent data on the low risk of malignant progression in patients with nondysplastic BE, endoscopic surveillance intervals are attenuated in this population; patients with nondysplastic BE should undergo endoscopic surveillance no more frequently than every 3-5 years. Neither routine use of biomarker panels nor advanced endoscopic imaging techniques (beyond high-defi nition endoscopy) is recommended at this time. Endoscopic ablative therapy is recommended for patients with BE and high-grade dysplasia, as well as T1a esophageal adenocarcinoma. Based on recent level 1 evidence, endoscopic ablative therapy is ...

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Section: Summary Of Evidencementioning

confidence: 83%

Section: Summary Of Evidencementioning

confidence: 99%

ACG Clinical Guideline: Diagnosis and Management of Barrett’s Esophagus

Shaheen

Falk

Iyer

et al. 2016

American Journal of Gastroenterology

1,317

1,387

View full text Add to dashboard Cite

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“…We sought to examine the prevalence and sources of this problem, based on patients undergoing screening for an endoscopic ablation trial of Barrett's esophagus with high-grade dysplasia. 3,4 To help determine the validity of the trial diagnoses, the three study pathologists (SLT, MPB and late Dr Rodger C Haggitt) were evaluated for observer variability on a per endoscopy and per biopsy basis. The patients also underwent an additional protocol screening endoscopy with intensive biopsy sampling (fourquadrant jumbo biopsies every 2 cm throughout the Barrett's segment with additional biopsies of any visible lesions).…”

mentioning

confidence: 99%

Overdiagnosis of high-grade dysplasia in Barrett's esophagus: a multicenter, international study

et al. 2015

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Numerous histological mimics of high-grade dysplasia in Barrett's esophagus predispose to overdiagnosis and potential serious mismanagement, including unnecessary esophagectomy. This study investigates the prevalence and sources of this problem. Biopsies from 485 patients diagnosed with Barrett's high-grade dysplasia were screened for a multi-institutional, international Barrett's endoscopic ablation trial. Screening included review of the original diagnostic slides and an additional protocol endoscopy with an extensive biopsy sampling. Observer variability by the study pathologists was assessed through two blinded diagnostic rounds on 437 biopsies from 26 random study endoscopies. Study diagnostic reassessments revealed significantly lower rates of high-grade dysplasia. Only 248 patients (51%) were confirmed to have high-grade dysplasia. The remaining patients had inflamed gastric cardia without Barrett's (n ¼ 18; 7%), Barrett's without dysplasia (n ¼ 35; 15%), indefinite change (n ¼ 61; 26%), low-grade dysplasia (n ¼ 79; 33%), adenocarcinoma (n ¼ 43; 18%), and other (n ¼ 1; o1%), yielding an alarming total of 194 or 40% of patients who were overdiagnosed with Barrett's highgrade dysplasia. Study pathologists achieved a high-level agreement (90% three-way inter-observer agreement per biopsy, Kappa value 0.77) for high-grade dysplasia. Confounding factors promoting overdiagnosis included Barrett's inflammatory atypia (n ¼ 182), atypia limited to the basal metaplastic glands (n ¼ 147), imprecise criteria for low grade neoplasia (n ¼ 102), tangential sectioning artifact (n ¼ 59), and reactive gastric cardiac mucosa (n ¼ 38). A total of 194 patients (40%) were overdiagnosed with Barrett's high-grade dysplasia, as affirmed by the extensive screening process and high-level study pathologist agreement. The multiple diagnostic pitfalls uncovered should help raise pathologists' awareness of this problem and improve diagnostic accuracy.

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“…About 50% of all new esophageal cancers, which have very poor survival rates (see above), develop from Barrett's esophagus; therefore, effective treatment of Barrett's has major public health implications [84]. An international, multicenter prospective, randomized controlled trial using a blinded centralized pathology laboratory demonstrated that porfimer sodium PDT of Barrett's esophagus can ablate Barrett's high-grade dysplasia in 77%-96% of cases, compared with only 39% of cases for omeprazole therapy alone [85]. That study documented a significant reduction in the risk for esophageal cancer in patients treated with porfimer sodium PDT.…”

Section: Barrett's Esophagusmentioning

confidence: 99%

Photodynamic Therapy in Oncology

Triesscheijn¹,

et al. 2006

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Photodynamic therapy (PDT) is increasingly being recognized as an attractive, alternative treatment modality for superficial cancer. Treatment consists of two relatively simple procedures: the administration of a photosensitive drug and illumination of the tumor to activate the drug. Efficacy is high for small superficial tumors and, except for temporary skin photosensitization, there are no long-term side effects if appropriate protocols are followed. Healing occurs with little or no scarring and the procedure can be repeated without cumulative toxicity. Considering the efficacy and lack of long-term toxicity of PDT, and the fact that the first treatment of cancer with PDT was done more than 100 years ago, one might expect that this treatment had already become an established therapy. However, PDT is currently offered in only a few selected centers, although it is slowly gaining acceptance as an alternative to conventional cancer therapies. Here, we show the developmental steps PDT underwent and summarize the current clinical applications. The data show that, when properly used, PDT is an effective alternative treatment option in oncology. The

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Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett's esophagus: international, partially blinded, randomized phase III trial

Cited by 483 publications

References 48 publications

ACG Clinical Guideline: Diagnosis and Management of Barrett’s Esophagus

ACG Clinical Guideline: Diagnosis and Management of Barrett’s Esophagus

Overdiagnosis of high-grade dysplasia in Barrett's esophagus: a multicenter, international study

Photodynamic Therapy in Oncology

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