A PHASE-1 PHASE-2 STUDY OF EXTERNAL-BEAM RADIATION, BRACHYTHERAPY ANDCONCURRENT CHEMOTHERAPY IN LOCALIZED CANCER OF THE ESOPHAGUS (RTOG-92-07) - PRELIMINARY TOXICITY REPORT/

Citation
Le. Gaspar et al., A PHASE-1 PHASE-2 STUDY OF EXTERNAL-BEAM RADIATION, BRACHYTHERAPY ANDCONCURRENT CHEMOTHERAPY IN LOCALIZED CANCER OF THE ESOPHAGUS (RTOG-92-07) - PRELIMINARY TOXICITY REPORT/, International journal of radiation oncology, biology, physics, 37(3), 1997, pp. 593-599
Citations number
18
Categorie Soggetti
Oncology,"Radiology,Nuclear Medicine & Medical Imaging
ISSN journal
03603016
Volume
37
Issue
3
Year of publication
1997
Pages
593 - 599
Database
ISI
SICI code
0360-3016(1997)37:3<593:APPSOE>2.0.ZU;2-U
Abstract
Purpose: A multi-institutional, prospective study was designed to dete rmine the feasibility and tolerance of external beam irradiation plus concurrent chemotherapy and esophageal brachytherapy (EB) in a potenti ally curable group of patients with adenocarcinoma or squamous cell ca rcinoma of the esophagus. Methods and Materials: Planned treatment was 50 Gy external beam radiation (25 fractions/5 weeks) followed 2 weeks later by EB [either high dose rate (HDR) 5 Gy, weeks 8, 9, and 10, fo r a total of 15 Gy, or low dose rate (LDR) 20 Gy, week 8]. The protoco l was later revised to delete the LDR alternative, owing to poor accru al, and to decrease the HDR dose to 10 Gy (i.e. 5 Gy, weeks 8 and 9). Chemotherapy was given weeks 1, 5, 8, and 11 with cisplatin 75 mg/m(2) and 5-fluorouracil 1000 mg(2)/m per 24 h, 96-h infusion. The study cl osed in January 1995 after 56 patients had been entered on the HDR arm . Six patients were declared ineligible owing to tumor extension to th e gastroesophageal junction (three patients) or involved celiac lymph nodes (three patients). Of the 50 eligible patients, the planned EB do se was 15 and 10 Gy in 40 and 10 patients, respectively. Forty-six (92 %) of the eligible patients had squamous histology, and three (6%) ade nocarcinoma. Results: Life-threatening toxicity or treatment-related d eath occurred in 13 (26%) and 4 (8%) of the 50 eligible patients, resp ectively. Treatment-related esophageal fistulas occurred in three pati ents (12% overall, 14% of patients starting EB) at 0.5-6.2 months from the first day of brachytherapy, leading to death in three. The fourth death was secondary to renal toxicity and infection attributed to che motherapy. No correlation was found between the development of fistula and location of primary tumor, brachytherapy active length or applica tor diameter. So far, 5 of the 6 treatment-related fistulas have occur red following 15 Gy EB. The other fistula occurred after only 5 Gy of a planned 15 Gy was delivered. Conclusion: Thirty-five patients (70%) were able to complete external beam, FB, and at least two courses of c hemotherapy. Estimated survival rate at 12 months is 48%, with an esti mated 11-month median survival rate. Survival following external beam radiation plus concurrent chemotherapy and EB does not appear to be si gnificantly different from survival seen following external beam radia tion and chemotherapy only. The development of six fistulas in the 35 patients completing EB is of concern. Based on the high incidence of f istulas, we urge extreme caution in employing EB as a boost following concurrent external beam radiation and chemotherapy. (C) 1997 Elsevier Science Inc.