PMID- 19036692
OWN - NLM
STAT- MEDLINE
DCOM- 20090210
LR  - 20181201
IS  - 1533-0028 (Print)
IS  - 1533-0028 (Linking)
VI  - 7
IP  - 6
DP  - 2008 Nov
TI  - Results of a phase II trial of cetuximab plus capecitabine/irinotecan as 
      first-line therapy for patients with advanced and/or metastatic colorectal 
      cancer.
PG  - 390-7
LID - 10.3816/CCC.2008.n.052 [doi]
AB  - BACKGROUND: XELIRI (capecitabine/irinotecan) is effective and well tolerated in 
      metastatic colorectal cancer (mCRC). Cetuximab is active in mCRC alone or with 
      chemotherapy. This study evaluated cetuximab plus XELIRI in first-line treatment 
      of mCRC. PATIENTS AND METHODS: Subjects had histologically confirmed unresectable 
      colorectal adenocarcinoma (with T4 lesions) after preoperative chemoradiation 
      and/or metastases. Treatment was capecitabine 1700 mg/m2 (850 mg/m2 orally twice 
      a day on days 1-14 for 3 weeks), irinotecan 200 mg/m2 intravenously (I.V.) on day 
      1 every 3 weeks, and weekly cetuximab (initially 400 mg/m2 I.V. [120 minutes], 
      subsequently 250 mg/m2 [30 minutes]). RESULTS: Baseline characteristics (N = 70): 
      43 men (61%); median age, 61.5 years; Eastern Cooperative Oncology Group 
      performance status 0/1 = 66%/34%; 94% adenocarcinoma. Previous therapy: surgery 
      (91%), chemotherapy (14%), or radiation therapy (7%). Responses (patients 
      completing > or = 2 cycles): complete response (5.7%), partial response (37.7%), 
      stable disease (43.4%), and progressive disease (PD; 13.2%); 16 patients 
      discontinued early (n = 4 allergic reaction, n = 2 withdrew consent, n = 2 death, 
      and n = 8 other adverse events [AEs]). The overall per-protocol response rate was 
      43.4% (34% intent to treat [ITT]; disease control rate, 86.8%; 69% ITT). The 
      median time to progression was 8.1 months (range, < 1-27.0 months), and the 
      median time to response was 1.6 months (range, 1.1-8.4 months). The median 
      survival was 20.5 months, and 45.7% of patients remain alive. Of the 38 deaths, 
      84% were because of PD. No death was treatment related. The most frequent grade 
      3/4 treatment-related AEs included diarrhea, neutropenia, and nausea/vomiting; 
      32% of patients required dose reductions. All patients are off the study 
      primarily because of PD (34.3%) or AEs (40.0%). CONCLUSION: In summary, XELIRI 
      plus cetuximab is a promising regimen that merits further study for first-line 
      mCRC.
FAU - Cartwright, Thomas
AU  - Cartwright T
AD  - US Oncology, Houston, TX, USA. thomas.cartwright@usoncology.com
FAU - Kuefler, Paul
AU  - Kuefler P
FAU - Cohn, Allen
AU  - Cohn A
FAU - Hyman, William
AU  - Hyman W
FAU - Berger, Maury
AU  - Berger M
FAU - Richards, Donald
AU  - Richards D
FAU - Vukelja, Svetislava
AU  - Vukelja S
FAU - Nugent, John E
AU  - Nugent JE
FAU - Ruxer, Robert L Jr
AU  - Ruxer RL Jr
FAU - Boehm, Kristi A
AU  - Boehm KA
FAU - Asmar, Lina
AU  - Asmar L
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Colorectal Cancer
JT  - Clinical colorectal cancer
JID - 101120693
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - 7673326042 (Irinotecan)
RN  - PQX0D8J21J (Cetuximab)
RN  - U3P01618RT (Fluorouracil)
RN  - XT3Z54Z28A (Camptothecin)
SB  - IM
MH  - Adenocarcinoma/*drug therapy/pathology
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/*administration & dosage
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Camptothecin/administration & dosage/*analogs & derivatives
MH  - Capecitabine
MH  - Cetuximab
MH  - Colorectal Neoplasms/*drug therapy/pathology
MH  - Deoxycytidine/administration & dosage/*analogs & derivatives
MH  - Disease Progression
MH  - Female
MH  - Fluorouracil/administration & dosage/*analogs & derivatives
MH  - Humans
MH  - Irinotecan
MH  - Male
MH  - Middle Aged
MH  - Quality of Life
MH  - Statistics, Nonparametric
MH  - Treatment Outcome
EDAT- 2008/11/28 09:00
MHDA- 2009/02/12 09:00
CRDT- 2008/11/28 09:00
PHST- 2008/11/28 09:00 [pubmed]
PHST- 2009/02/12 09:00 [medline]
PHST- 2008/11/28 09:00 [entrez]
AID - S1533-0028(11)70448-0 [pii]
AID - 10.3816/CCC.2008.n.052 [doi]
PST - ppublish
SO  - Clin Colorectal Cancer. 2008 Nov;7(6):390-7. doi: 10.3816/CCC.2008.n.052.