TY - JOUR
T1 - Retrospective study of capecitabine and celecoxib in metastatic colorectal cancer
T2 - Potential benefits and COX-2 as the common mediator in pain, toxicities and survival?
AU - Lin, Edward H.
AU - Curley, Steven A.
AU - Crane, Christopher C.
AU - Feig, Barry
AU - Skibber, John
AU - Delcos, Marc
AU - Vadhan, Saroj Raj
AU - Morris, Jeffrey
AU - Ayers, Gregory D.
AU - Ross, Alicia
AU - Brown, Thomas
AU - Rodriguez-Bigas, Miguel A.
AU - Janjan, Nora
N1 - Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2006/6
Y1 - 2006/6
N2 - OBJECTIVE: COX-2 activation may mediate capecitabine induced toxicities, eg, hand-foot syndrome (HFS) and colorectal cancer progression, both of which may be improved by concurrent celecoxib. PATIENTS AND METHODS: From October 2000 to December 2003, 66 patients with metastatic colorectal cancer received concurrent capecitabine at 1000 mg/m/d b.i.d. and celecoxib at 200 mg b.i.d. (XCEL). Twenty-four patients were chemo-naive, 42 patients were second-line; while 34 had XCEL with radiation. RESULTS: The median duration of XCEL was 7.2 months (range, 1.5-38 months). Ninety percent of Grade 2/3 HFS (17%) occurred after 6 months and incidence of grade 3/4 diarrheas was 8%. The overall response rate was 38% (95% confidence interval [CI], 26-51%), with 11 patients (17%) achieving complete responses and 2 patients (3%) with near complete responses. Six patients (9%) become resectable after sustaining treatment response. The median progression-free survival (PFS) and overall survival (OS) was 8.3 months (95% CI, 7.0-11.0 months) and 22 months (95% CI, 17.8-31.5 months), respectively. Improved median PFS of 14.5 months (P = 0.0001) and OS of 31.5 months (P = 0.005) were noted in patients with normal lactate dehydrogenase (LDH) levels (n = 37) than patients with high levels of LDH (n = 29). CONCLUSIONS: XCEL integrating radiation may improve response rate and survival and reduce toxicities, notably HFS for patients with metastatic colorectal cancer, leading to a randomized phase III study.
AB - OBJECTIVE: COX-2 activation may mediate capecitabine induced toxicities, eg, hand-foot syndrome (HFS) and colorectal cancer progression, both of which may be improved by concurrent celecoxib. PATIENTS AND METHODS: From October 2000 to December 2003, 66 patients with metastatic colorectal cancer received concurrent capecitabine at 1000 mg/m/d b.i.d. and celecoxib at 200 mg b.i.d. (XCEL). Twenty-four patients were chemo-naive, 42 patients were second-line; while 34 had XCEL with radiation. RESULTS: The median duration of XCEL was 7.2 months (range, 1.5-38 months). Ninety percent of Grade 2/3 HFS (17%) occurred after 6 months and incidence of grade 3/4 diarrheas was 8%. The overall response rate was 38% (95% confidence interval [CI], 26-51%), with 11 patients (17%) achieving complete responses and 2 patients (3%) with near complete responses. Six patients (9%) become resectable after sustaining treatment response. The median progression-free survival (PFS) and overall survival (OS) was 8.3 months (95% CI, 7.0-11.0 months) and 22 months (95% CI, 17.8-31.5 months), respectively. Improved median PFS of 14.5 months (P = 0.0001) and OS of 31.5 months (P = 0.005) were noted in patients with normal lactate dehydrogenase (LDH) levels (n = 37) than patients with high levels of LDH (n = 29). CONCLUSIONS: XCEL integrating radiation may improve response rate and survival and reduce toxicities, notably HFS for patients with metastatic colorectal cancer, leading to a randomized phase III study.
KW - Capecitabine
KW - Celecoxib
KW - Hand-foot syndrome
KW - Metastatic colorectal cancer
KW - Radiation
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U2 - 10.1097/01.coc.0000217818.07962.67
DO - 10.1097/01.coc.0000217818.07962.67
M3 - Article
C2 - 16755175
AN - SCOPUS:33744975683
SN - 0277-3732
VL - 29
SP - 232
EP - 239
JO - American Journal of Clinical Oncology: Cancer Clinical Trials
JF - American Journal of Clinical Oncology: Cancer Clinical Trials
IS - 3
ER -