In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 4_suppl ( 2013-02-01), p. 487-487
Abstract:
487 Background: The goal of preoperative chemoradiation in rectal cancer is complete surgical resection without impairing sphincter function and to decrease local recurrence. The primary objective of the study was to determine complete pathological response rate (pCR) with capecitabine, oxaliplatin and celecoxib with concurrent radiation therapy. The secondary objectives were down staging rate, sphincter preservation rate, incidence and severity of adverse events. Methods: A total 37 out of 55 planned patients (pts) were enrolled by New Mexico cancer center consortium from 2005 to 2012. Inclusion criteria were: Resectable adenocarcinoma of the rectum within 12 cm of the anal verge, biopsy proven T3-4 N1-2 M0 based on endoscopic ultrasound, performance status of 0-2, adequate bone marrow reserve and liver functions. The neoadjuvant chemoradiation treatment was: capecitabine 850 mg/m2 bid Monday through Friday for 5 weeks, weekly oxaliplatin 50 mg/m2 IV, celecoxib 200 mg bid with concurrent 45 gray radiation therapy in 25 fractions over 5 weeks. Results: Only 21 of 37 pathology reports were assessable for the primary objective of pCR. 7/21 pts (33%, 95% CI, 0.14-0.56) had pCR and 4 had only microscopic residual disease. Thus, 11/21 pts (52%, 95% CI, 0.30-0.74) had an excellent response following chemoradiation. The secondary outcome analysis showed 19/21 pts (90%, 95% CI, 0.69-0.98) were down staged. Sphincter preservation rate was 71% (15/21) (95% CI, 0.47-0.88). Grade 3 and 4 toxicities were observed in 23% and included nausea, vomiting, diarrhea, dehydration, hypokalemia, lymphopenia and fatigue. Conclusions: We report the highest pathological CR so far in stage III rectal cancer with these early results. This could be due to anti-inflammatory activity of celecoxib leading to better tolerance of radiation therapy and possible synergistic anti-tumor activity. Final results will be reported upon completion of the trial. Clinical trial information: NCT00250835.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2013.31.4_suppl.487
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2013
detail.hit.zdb_id:
2005181-5
