Randomized Comparison of Three Palliative Regimens Including Brachytherapy, Photodynamic Therapy, and APC in Patients With Malignant Dysphagia (CONSORT 1a) (Revised II)

Abstract

Because most esophageal cancers are diagnosed at an advanced stage, a majority of patients require palliative dysphagia treatment. Dysphagia severity and the need for repeated re-canalization procedures signifi cantly affect patients ' quality of life (QoL). The aim of this study was to establish whether combining argon plasma coagulation (APC) of the neoplastic esophageal tissue with another re-canalization method results in a longer dysphagia-free period compared with APC alone. METHODS:We conducted a randomized trial in 93 patients with malignant dysphagia. Patients were followed until death. We compared three regimens of esophageal re-canalization; APC combined with high dose rate (HDR) brachytherapy, APC combined with photodynamic therapy (PDT), and APC alone. The primary outcome measure was the dysphagia-free period following randomization. Secondary measures were survival, QoL, treatment-associated complications, and treatment tolerance. A per-protocol analysis was carried out. RESULTS:The time to fi rst dysphagia recurrence was signifi cantly different between each combination treatment group and the control group (overall test: P = 0.006; HDR vs. control, log-rank P = 0.002, PDT vs. control, log-rank P = 0.036), but not different between the combination groups (HDR vs. PDT, log-rank P = 0.36). The median time to fi rst dysphagia recurrence was 88, 59, and 35 days in the HDR, PDT, and control groups, respectively. There was no difference in overall survival between the study groups ( P = 0.27). No deaths, perforations, hemorrhages, or fi stula formations were attributed to treatment. The only major complication was fever, occurring in three PDT patients. Minor complications were observed signifi cantly more often in the combination treatment groups and included pain in both groups, transient dysphagia worsening, and skin sensitivity in the PDT group. The QoL 30 days after treatment in the HDR group was signifi cantly better than in the other groups.CONCLUSIONS: In patients with inoperable esophageal cancer, palliative combination treatment of dysphagia with APC and HDR or PDT was signifi cantly more effi cient than APC alone, and was safe and well tolerated. APC combined with HDR resulted in fewer complications and better QoL than APC with PDT or APC alone (CONSORT 1b).SUPPLEMENTARY MATERIAL is linked to the online version of the paper at

The role of palliative interventional radiotherapy (brachytherapy) in esophageal cancer: An AIRO (Italian Association of Radiotherapy and Clinical Oncology) systematic review focused on dysphagia-free survival

“…There was no difference in overall survival between the study groups ( p 5 0.27). The QoL 30 days after treatment in the IRT group was significantly better than in the other groups (22). Despite these positive results, IRT is not always considered as treatment option in patients with symptomatic unresectable esophageal cancer.…”

“…Of these, 59 articles were excluded for various reasons such as being conference papers, surveys, letters, editorials, book chapters, not written in English or paper with insufficient data, leaving seven randomized studies assessing the clinical efficacy of BT in duration of dysphagia relief compared with other treatment. All studies were randomized prospective studies, two studies compared the sole IRT to IRT plus EBRT (20,21), two studies based on the same data compared the sole IRT to stent placement (16,23), other two studies compared IRT to laser (18,19), and finally one study compared IRT to PDT and argon plasma coagulation (22). Four are monocentric study and three multicentric studies.…”

“…There was no significant difference, and in particular, no deterioration, in LASA scores in the two groups until the end of the quality-of-life followup 10 weeks later. Rupinski (22) Spitzer quality of life index (SQLI)…”

“…Indeed, the only two randomized studies that compared IRT alone to IRT plus EBRT for the management of malignant dysphagia showed different results (20,21). One study did not report any significant difference regarding the disease-free survival (DFS) at 6 and 12 months, whereas the other one showed a significant improvement of the DFS in the group of patients treated by a combination therapy (22). The aim of this review was to examine efficacy of IRT in esophageal cancer compared with other treatment (PDT, stent, EBRT) in terms of dysphagia-free survival (DyFS) and safety.…”

Role of Photodynamic Therapy in the Palliation of Obstructing Esophageal Cancer

“…Surgical esophagectomy, while an effective means of palliating dysphagia, is accompanied by marked morbidity and mortality. Multimodality therapy, consisting of dilation [4], external beam irradiation [5], brachytherapy, argon plasma coagulation [6], esophageal prosthesis [7], chemotherapy [8], and photodynamic therapy (PDT) [9], has been used as a palliation therapy for esophageal cancer. Recently, PDT has emerged as a safe and effective technique for treating esophageal cancer.…”