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Titolo:
PHASE-I DOSE ESCALATING TRIAL OF HYPERFRACTIONATED PREOPERATIVE CHEMORADIATION FOR LOCALLY ADVANCED RECTAL-CANCER
Autore:
MOVSAS B; HANLON AL; LANCIANO R; SCHER RM; WEINER LM; SIGURDSON ER; HOFFMAN JP; EISENBERG BL; COOPER HS; PROVINS S; COIA LR;
Indirizzi:
FOX CHASE CANC CTR,DEPT RADIAT ONCOL,7701 BURHOLME AVE PHILADELPHIA PA 19111 DELAWARE CTY MEM HOSP,DEPT RADIAT ONCOL DREXEL HILL PA 00000 FOX CHASE CANC CTR,DEPT MED ONCOL PHILADELPHIA PA 19111 FOX CHASE CANC CTR,DEPT SURG ONCOL PHILADELPHIA PA 19111 FOX CHASE CANC CTR,DEPT PATHOL PHILADELPHIA PA 19111 COMMUNITY MED CTR,DEPT RADIAT ONCOL TOMS RIVER NJ 00000
Titolo Testata:
International journal of radiation oncology, biology, physics
fascicolo: 1, volume: 42, anno: 1998,
pagine: 43 - 50
SICI:
0360-3016(1998)42:1<43:PDETOH>2.0.ZU;2-1
Fonte:
ISI
Lingua:
ENG
Soggetto:
PREOPERATIVE RADIATION-THERAPY; RESECTABLE ADENOCARCINOMA; RECTOSIGMOID CARCINOMA; IRRADIATION; CHEMOTHERAPY; LEUCOVORIN; AGE;
Keywords:
RECTAL CANCER; RADIATION/CHEMOTHERAPY; PREOPERATIVE THERAPY; DOWNSTAGING;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
28
Recensione:
Indirizzi per estratti:
Citazione:
B. Movsas et al., "PHASE-I DOSE ESCALATING TRIAL OF HYPERFRACTIONATED PREOPERATIVE CHEMORADIATION FOR LOCALLY ADVANCED RECTAL-CANCER", International journal of radiation oncology, biology, physics, 42(1), 1998, pp. 43-50

Abstract

Purpose: To determine the acute toxicity, post-operative complications, pathologic response and extent of downstaging to high dose pre-operative radiation using a hyperfractionated radiation boost and concurrent chemotherapy in a prospective Phase I trial. Materials & Methods: To be eligible for this study, patients had to have adenocarcinoma of the rectum less than 12 cm from the anal verge with either Stage T4 or T3 but greater than 4 cm or greater than 40% of the bowel circumference. All patients received 45 Gy pelvic radiation (1.8 Gy per fraction). Subsequent radiation was given to the region of the gross tumor with a 2 cm margin. This ''boost'' treatment,vas given at 1.2 Gy twice daily to a total dose of 54.6 Gy for Level I, 57 Gy for Level II, and 61.8Gy for Level III. 5-FU was given at 1g/m2 over 24 hours for a four day infusion during the first and sixth weeks of radiation, with the second course concurrent with the hyperfractionated radiation. Surgical resection was carried out 4-6 weeks following completion of chemoradiation (in curative cases) and additional adjuvant chemotherapy consisting of 5-FU and Leucovorin was given for an additional 4 monthly cycles Days I through 5 beginning four weeks post surgery. Results: Twenty-seven patients, age 40-82 (median 61), completed the initial course of chemoradiation and are included in the analysis of toxicity. The medianfollow-up is 27 months (range 8-68). Eleven patients were treated to a dose of 54.6 Gy, nine patients to 57 Gy, and seven patients to 61.8 Gy. Twenty-one patients had T3 tumors, and six patients T4 tumors. Grade III acute toxicity from chemoradiation included proctitis (5 patients), dermatitis (9), diarrhea (five), leukopenia (1), cardiac (1). Grade IV toxicities included one patient with diarrhea (on dose Level I) and one patient (on dose Level III) with cardiac toxicity (unrelated to radiation). Surgical resection consisted of abdominal perineal resection in 16 and low anterior resection in 7. Four patients did not undergo a curative resection; three initially presented with metastases and one developed metastasis during the pre-operative regimen. Post-operative complications included pelvic or perineal abscess in two (on dose Levels I & II), and delayed wound healing in two (one of whom, on dose Level III, developed perineal wound dehiscence requiring surgical reconstruction). Of the 23 patients who had a curative resection, four manifested pathologic complete responses (17.4%). Thirteen of 23 patients (57%) had evidence of pathologic downstaging and only 1/23 patients (on dose Level I) had a positive resection margin. Of these 23 patients (with a minimum follow-up of 8 months), the patient with positive margins was the only one who developed a local failure (Fisher's Exactp = .04). The 3-year actuarial OS, DFS and LC rates are 82%, 72% and 96%, respectively. Twelve of 13 patients (92% at 3 years) greater thanor equal to 61 years vs. 5/10 patients (45% at 3 years) < 61 years remained disease-free (log-rank p = 0.017). Conclusion: This regimen of high dose pre-operative chemoradiation employing a hyperfractionated radiation boost is feasible and tolerable and results in significant downstaging in locally advanced rectal cancer. The vast majority of patients (96%) achieved negative margins, which appears to be a prerequisite for local control (p = 0.04). Older age (greater than or equal to 61 years) was a significant predictor for improved DFS. This regimen (at dose Level III, 61.8 Gy) is currently being tested in a Phase II setting. (C) 1998 Elsevier Science Inc.

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Documento generato il 27/09/20 alle ore 18:27:02