A phase II trial of frontline capecitabine and bevacizumab in poor performance status and/or elderly patients with metastatic colorectal cancer.
OBJECTIVE
This study aims to determine the efficacy and tolerability of capecitabine (CAP) plus bevacizumab (BEV) as treatment for frontline metastatic colorectal cancer (mCRC) in frail and/or elderly patients.


METHODS
This was an open label, multi-site, single arm, phase II study in frontline mCRC. In this study, patients (pts) who were frail (ECOG 2) or older patients with ECOG 1 performance status (PS) received CAP (1000 mg/m(2) bid, 14 days of every 21 days) plus BEV (7.5mg/kg iv once every 21 days). The primary objective was progression free survival (PFS). Secondary objectives were overall response rate (ORR) and toxicity.


RESULTS
In terms of patients: 50 were enrolled; 5 withdrew consent prior to treatment; 45 were treated, and 41 were evaluable. The mean age was 75.9 (range 54-93) and 62% had an ECOG 2 PS. The median PFS was 6.87 months (95% CI, 5.1-11.5 months) and median overall survival was 12.7 months (95% CI, 6.9-12.7 months). The most common grades 3-4 toxicities were: diarrhea (17.8%), fatigue (13.3%), hand-foot syndrome (13.3%), dehydration (8.9%), hypertension (6.7%) and vomiting (6.7%).


CONCLUSIONS
The results of this trial support the use of CAP plus BEV as first-line treatment for frail/elderly patients with metastatic CRC. The ORR (40%) is comparable to pooled data in elderly on fluorouracil (5-FU)+BEV. The median PFS (7.2 months) in this study is slightly lower than that seen with 5-FU+BEV but this study had a high percentage of ECOG PS 2 patients. Side effects were manageable with no new safety signals.
David Geffen School of Medicine at University of California at Los Angeles, 10945 LeConte, Suite 2333 PVUB, Los Angeles, CA 90095, USA. Electronic address: anaeim@mednet.ucla.edu.
Arash
A
Naeim
David Geffen School of Medicine at University of California at Los Angeles, 10945 LeConte, Suite 2333 PVUB, Los Angeles, CA 90095, USA.
Peter R
PR
Ward
David Geffen School of Medicine at University of California at Los Angeles, 10945 LeConte, Suite 2333 PVUB, Los Angeles, CA 90095, USA.
Hei-Jing
HJ
Wang
Translational Oncology Research International (TORI), Central Coast Medical Oncology, 220 S Palisade Dr Suite 204, Santa Maria, CA 93454, USA.
Richard
R
Dichmann
TORI, Pacific Shores Medical Group, 1043 Elm Avenue, Suite #104, Long Beach, CA 90813, USA.
Andre K D
AK
Liem
TORI, Cancer Care Associates Medical Group, Inc., 514 North Prospect Ave., 4th Floor, Redondo Beach, CA 90277, USA.
David
D
Chan
Pacific Care, Heritage Physician Network, 5925 Truxtun Extension Ste. A Bakersfield, CA 93309, USA.
Ravi
R
Patel
Central Hematology Oncology, 707 S. Garfield Ave, Alhambra, CA 91801, USA.
Edward H L
EH
Hu
Pacific Shores Med. Group, Long Beach Elm Office, 1043 Elm Avenue, Suite 104, Long Beach, CA 90813, USA.
Neres S
NS
Tchekmedyian
David Geffen School of Medicine at University of California at Los Angeles, 10945 LeConte, Suite 2333 PVUB, Los Angeles, CA 90095, USA.
Zev A
ZA
Wainberg
David Geffen School of Medicine at University of California at Los Angeles, 10945 LeConte, Suite 2333 PVUB, Los Angeles, CA 90095, USA.
J Randolph
JR
Hecht
D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000068258:Bevacizumab; D000069287:Capecitabine; D005472:Fluorouracil
Chemotherapy; Colon cancer; Colorectal cancer; Efficacy; Elderly; Frail; Metastatic; Performance status; Response rate; Survival; Toxicity