title: Randomized comparison of three palliative regimens including brachytherapy, photodynamic therapy, and APC in patients with malignant dysphagia (CONSORT 1a) (Revised II).
abstract: OBJECTIVE
  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 significantly 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 first dysphagia recurrence was significantly 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 first 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 fistula formations were attributed to treatment. The only major complication was fever, occurring in three PDT patients. Minor complications were observed significantly 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 significantly 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 significantly more efficient 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).
authors.affiliation: Gastroenterology Department, Medical Center for Postgraduate Education and Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland.
authors.forename: Maciej
authors.initials: M
authors.lastname: Rupinski
authors.forename: Edyta
authors.initials: E
authors.lastname: Zagorowicz
authors.forename: Jaroslaw
authors.initials: J
authors.lastname: Regula
authors.forename: Jacek
authors.initials: J
authors.lastname: Fijuth
authors.forename: Ewa
authors.initials: E
authors.lastname: Kraszewska
authors.forename: Marcin
authors.initials: M
authors.lastname: Polkowski
authors.forename: Ewa
authors.initials: E
authors.lastname: Wronska
authors.forename: Eugeniusz
authors.initials: E
authors.lastname: Butruk
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D057908:Argon Plasma Coagulation / Q000009:adverse effects; D001918:Brachytherapy / Q000009:adverse effects; D003131:Combined Modality Therapy; D003680:Deglutition Disorders / Q000209:etiology / Q000628:therapy*; D018572:Disease-Free Survival; D004938:Esophageal Neoplasms / Q000150:complications / Q000401:mortality / Q000628:therapy*; D005260:Female; D006415:Hematoporphyrins / Q000627:therapeutic use; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010166:Palliative Care / Q000379:methods*; D010778:Photochemotherapy / Q000009:adverse effects; D011788:Quality of Life; D011829:Radiation Dosage; D012008:Recurrence
chemical_list: D006415:Hematoporphyrins; C071875:photosan III