| Prospective randomized trial of HDR brachytherapy as a sole modality in palliation of advanced esophageal carcinoma--an International Atomic Energy Agency study. | |
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MedLine Citation:
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PMID: 12007950 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Previous studies from South Africa have established that fractionated high-dose-rate (HDR) brachytherapy gives the best results in terms of palliation and survival in advanced esophageal cancer. A multicenter, prospective randomized study was therefore conducted under the auspices of the International Atomic Energy Agency to evaluate two HDR regimens. METHODS AND MATERIALS: Surgically inoperable patients with histologically proven squamous cell cancer of the esophagus, tumor >5 cm in length on barium swallow and/or endoscopy, Karnofsky performance score >50, age 17-70 years, primary disease in the thoracic esophagus, no prior malignancy within the past 5 years, and any N or M status were included in the study. Exclusion criteria included cervical esophagus location, tumor extending <1 cm from the gastroesophageal junction, tracheoesophageal fistula, Karnofsky performance score <50, altered mental status, and extension to great vessels on CT. Patients were randomized to receive 18 Gy in 3 fractions on alternate days (6 Gy per fraction, Group A) or 16 Gy in 2 fractions on alternate days (8 Gy per fraction, Group B). The HDR dose was prescribed at 1 cm from the center of the source axis after dose optimization. A margin of 2 cm was included proximally and distally. The respective hospital and university committees gave approval for the study, and all patients provided informed consent. RESULTS: A total of 232 patients were entered into the study (112 in Group A and 120 in Group B). There was no difference between the groups for any of the prognostic variables. All patients were followed until death. The dysphagia-free survival for the whole group was 7.1 months (Group A, 7.8 months; Group B, 6.3 months; p >0.05). The overall survival was 7.9 months for the whole group (Group A, 9.1 months; Group B, 6.9 months; p >0.05). On univariate analysis, the presenting weight (p = 0.0083), gender (p = 0.0038), race (p = 0.0105), the presenting dysphagia score (p = 0.0083), the treatment center (p = 0.0029), and tumor grade (p = 0.0029) had an impact on the dysphagia-free survival, and gender (p = 0.0011) and performance score (p = 0.0060) had an impact on dysphagia-free survival on multivariate analysis. Only age had an impact on overall survival on both univariate (p = 0.0430) and multivariate (p = 0.0331) analysis. The incidence of strictures (Group A, n = 12; Group B, n = 13; p >0.05) and fistulas (Group A, n = 11; Group B, n = 12; p >0.05) was similar in both groups. CONCLUSION: Fractionated HDR brachytherapy alone is an effective method of palliating advanced esophageal cancers, surpassing the results of any other modality of treatment presently available. Dose fractions of 6 Gy x 3 and 8 Gy x 2 give similar results for dysphagia-free survival, overall survival, strictures, and fistulas and are equally effective in palliation of advanced esophageal cancer. |
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Authors:
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Ranjan K Sur; C Victor Levin; Bernard Donde; Vinay Sharma; Leszek Miszczyk; Subir Nag |
Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: International journal of radiation oncology, biology, physics Volume: 53 ISSN: 0360-3016 ISO Abbreviation: Int. J. Radiat. Oncol. Biol. Phys. Publication Date: 2002 May |
Date Detail:
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Created Date: 2002-05-14 Completed Date: 2002-05-30 Revised Date: 2004-11-17 |
Medline Journal Info:
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Nlm Unique ID: 7603616 Medline TA: Int J Radiat Oncol Biol Phys Country: United States |
Other Details:
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Languages: eng Pagination: 127-33 Citation Subset: IM |
Affiliation:
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University of the Witwatersrand, Box 4280, Cresta 2118, Johannesburg, South Africa. rksur@global.co.za |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Analysis of Variance Brachytherapy / methods* Carcinoma, Squamous Cell / mortality, pathology, radiotherapy* Esophageal Neoplasms / mortality, pathology, radiotherapy* Female Humans Male Middle Aged Palliative Care Prognosis Prospective Studies Radiotherapy Dosage |
| Comments/Corrections | |
Comment In:
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Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):849-50; author reply 850
[PMID:
12573775
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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