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/
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
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.