Arash Naeim1, Peter R Ward2, Hei-Jing Wang2, Richard Dichmann3, Andre K D Liem4, David Chan5, Ravi Patel6, Edward H L Hu7, Neres S Tchekmedyian8, Zev A Wainberg2, J Randolph Hecht2. 1. 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. 2. David Geffen School of Medicine at University of California at Los Angeles, 10945 LeConte, Suite 2333 PVUB, Los Angeles, CA 90095, USA. 3. Translational Oncology Research International (TORI), Central Coast Medical Oncology, 220 S Palisade Dr Suite 204, Santa Maria, CA 93454, USA. 4. TORI, Pacific Shores Medical Group, 1043 Elm Avenue, Suite #104, Long Beach, CA 90813, USA. 5. TORI, Cancer Care Associates Medical Group, Inc., 514 North Prospect Ave., 4th Floor, Redondo Beach, CA 90277, USA. 6. Pacific Care, Heritage Physician Network, 5925 Truxtun Extension Ste. A Bakersfield, CA 93309, USA. 7. Central Hematology Oncology, 707 S. Garfield Ave, Alhambra, CA 91801, USA. 8. Pacific Shores Med. Group, Long Beach Elm Office, 1043 Elm Avenue, Suite 104, Long Beach, CA 90813, USA.
Abstract
OBJECTIVES: 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. MATERIALS AND 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.
OBJECTIVES: 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. MATERIALS AND 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.