TY - JOUR
T1 - Phase II trial of preoperative chemoradiation with a hyperfractionated radiation boost in locally advanced rectal cancer
AU - Movsas, Benjamin
AU - Diratzouian, Hasmik
AU - Hanlon, Alexandra
AU - Cooper, Harry
AU - Freedman, Gary
AU - Konski, Andre
AU - Sigurdson, Elin
AU - Hoffman, John
AU - Meropol, Neal J.
AU - Weiner, Louis M.
AU - Coia, Lawrence
AU - Lanciano, Rachelle
AU - Stein, Joanne
AU - Kister, Debra
AU - Eisenberg, Burton
PY - 2006/10
Y1 - 2006/10
N2 - PURPOSE: The purpose of this phase II study was to prospectively determine the efficacy of preoperative chemoradiation with a hyperfractionated (Hfx) RT boost to 61.8 Gy in locally advanced rectal cancer. METHODS: Eligibility stipulated that the primary lesion had to be either T4; or T3 and >4 cm or 40% of the bowel circumference. Radiation (RT) consisted of 45 Gy to the pelvis (1.8 Gy per fraction) followed by 1.2 Gy twice daily (to the gross tumor volume) to a total RT dose of 61.8 Gy. There was 5-FU infused at 1 g/m/24 hours for 4 days during the 1st and 6th weeks of RT (concurrent with the Hfx boost). Surgical resection was planned 4 to 6 weeks later. Adjuvant chemotherapy (bolus 5-FU/leucovorin) was scheduled for 4 cycles at 28-day intervals. RESULTS: There were 22 patients, ages 22 to 81 years (median, 64) enrolled in the study. Of the 20 patients evaluable for response, 10 (50%) had evidence of clinical downstaging and 5 patients (25%) had ≥90% fibrosis in the resected specimen. With a median f/u of 40 months (7-158), the 4 years actuarial rate for all patients (n = 22) of OS was 64%, of DFS 62%, and of LC 84%. 3/21 patients (14%) had positive margins, all of whom developed a local failure (P < 0.001). CONCLUSION: This regimen of high dose preoperative chemoRT with a Hfx RT boost (to 61.8 Gy) in patients with bulky, locally advanced rectal cancer results in clinical downstaging in half of the patients with significant fibrosis in the operative specimen.
AB - PURPOSE: The purpose of this phase II study was to prospectively determine the efficacy of preoperative chemoradiation with a hyperfractionated (Hfx) RT boost to 61.8 Gy in locally advanced rectal cancer. METHODS: Eligibility stipulated that the primary lesion had to be either T4; or T3 and >4 cm or 40% of the bowel circumference. Radiation (RT) consisted of 45 Gy to the pelvis (1.8 Gy per fraction) followed by 1.2 Gy twice daily (to the gross tumor volume) to a total RT dose of 61.8 Gy. There was 5-FU infused at 1 g/m/24 hours for 4 days during the 1st and 6th weeks of RT (concurrent with the Hfx boost). Surgical resection was planned 4 to 6 weeks later. Adjuvant chemotherapy (bolus 5-FU/leucovorin) was scheduled for 4 cycles at 28-day intervals. RESULTS: There were 22 patients, ages 22 to 81 years (median, 64) enrolled in the study. Of the 20 patients evaluable for response, 10 (50%) had evidence of clinical downstaging and 5 patients (25%) had ≥90% fibrosis in the resected specimen. With a median f/u of 40 months (7-158), the 4 years actuarial rate for all patients (n = 22) of OS was 64%, of DFS 62%, and of LC 84%. 3/21 patients (14%) had positive margins, all of whom developed a local failure (P < 0.001). CONCLUSION: This regimen of high dose preoperative chemoRT with a Hfx RT boost (to 61.8 Gy) in patients with bulky, locally advanced rectal cancer results in clinical downstaging in half of the patients with significant fibrosis in the operative specimen.
KW - Adenocarcinoma/drug therapy
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antimetabolites, Antineoplastic/therapeutic use
KW - Combined Modality Therapy
KW - Dose Fractionation, Radiation
KW - Fluorouracil/therapeutic use
KW - Humans
KW - Middle Aged
KW - Prospective Studies
KW - Radiotherapy, High-Energy
KW - Rectal Neoplasms/drug therapy
KW - Survival Analysis
UR - http://www.scopus.com/inward/record.url?scp=33749557201&partnerID=8YFLogxK
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=purepublist2023&SrcAuth=WosAPI&KeyUT=WOS:000241431700003&DestLinkType=FullRecord&DestApp=WOS
U2 - 10.1097/01.coc.0000227480.41414.f2
DO - 10.1097/01.coc.0000227480.41414.f2
M3 - Article
C2 - 17023775
SN - 0277-3732
VL - 29
SP - 435
EP - 441
JO - American Journal of Clinical Oncology: Cancer Clinical Trials
JF - American Journal of Clinical Oncology: Cancer Clinical Trials
IS - 5
ER -