| Objective:To evaluate the toxicity and therapeutic efficacyexternal-beam irradiation combined with Cf-252 intracavitaryradiation in the treatment of esophageal carcinoma in a clinicalrandomized trial.Methods: From January to December, 2004, fifty patientswho were eligible for the following selection critera wererandomized into two groups: external beam combined withCf-252 intracavitary twice group (EBIR-2) and external beamcombined with Cf-252 intracavitary three times group (EBIR-3).In EBIR-2 group, 22 patients were first treated with conventionalfractionated radiation to a dose of 40Gy over 4 weeks, then withexternal and intracavitary radiation concomitantly (5.0Gy perfraction, once a week to 10 Gy in 2 fractions), with externalirradiation skipped on the day of intracavitary radiation.The totaldose of external irradiation was 50Gy. In EBIR-3 group, 28patients were first treated with conventional fractionatedradiation to a dose of 30Gy over 3 weeks, then with external andintracavitary radiation concomitantly (3.5Gy per fraction, once aweek to 10.5 Gy in 3 fractions), with external irradiation skippedon the day of intracavitary radiation, and the total dose ofexternal irradiation also was 50Gy .The selection critera included histologically provensquamous cell carcinoma,tumor <10cm in length on bariumswallow; KPS ≥70, age 18-70 years, primary disease in theesophagus , no prior malignancy within the past 5 years, and noevidence of perforation or bleeding. All patients gave informedconsent to participate in the study.Both the external and intracavitary radiation fields weredesigned on the basis of the chest CT, barium and swallow.Six-MV linear accelerator was used as the X-ray source forexternal radiation therapy and the width of the external radiationfield was 5-8cm, the length covered the primary tumor with3-5cm margins from both ends of the primary lesion. For thehigh-dose-rate intracavitary irradiation, a Cf-252 source balloonapplicator 0.9 cm in diameter was used.A complete blood test was taken every week during thetreatment, and once at the end of treatment. A barium swallowwas done at the time of 30Gy and at the end of treatment. Theearly clinical effect of radiation was assessed by esophagographyat the end of treatment, and acute radiation esophagitis wasassessed twice a week during treatment, once a week in threemonths after radiotherapy, and once every month,subsequently.Acute and late toxicities were observed and graded according tothe RTOG criteria(1997).Results: The complete and partial response were observed50% and 50% in EBIR-2 group, 53.6% and 46.4% in EBIR-3group. The 1-year local tumor control is 78.75% in EBIR-2group and 86.79% in EBIR-3 group (P=0.595). The 1-yearsurvival rate is 85.56% in EBIR-2 group and 75.62%in EBIR-3group, but no significant difference was found between the twogroups (P=0.437). However, in the patients of the 50 patientswith 5 cm or less and more than 5cm tumor length the 1-yearsurvival rate was 100% and 77.92% in EBIR-2 group,55.6% and84.42% in EBIR-3 group. With 2cm or less and more than 2cmtumor depth, the survival rate at one year was 83.33% and85.71% in EBIR-2 group,87.50% and 61.71% in EBIR-3 group.There was no statistically significant difference both between twogroups. The 1-year survival rate in T1-2,T3 and T4 was 100%,82.50% and 71.11%,respectively and there were no statisticallysignificant difference(P=0.689).The acute esophagitis rate in EBIR-3 group was higher thanthat in EBIR-2 group, and the rate was 92.9%and 90.9%(P=0.666), respectively. The Table2 shows the detailed acuteesophagitis rate. During the treatment, one patient in EBIR-2group and two patients in EBIR-3 group were observed to havehoarseness, and one in EBIR-3 group was observed at 6 monthsafter therapy. There were no serious side-effects occurred such asnausea and vomiting.Up to the following-up day, 6 patients were found to haveradiation pneumonia in EBIR-2 group and 13 patients in EBIR-3group (P=0.445). The late reaction of esophagus was observed in16 patients in EBIR-2 group and 15 patients in EBIR-3 group,one was observed tracheo-esophageal fistula at 3 months after...
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