Randomized phase II trial of adjuvant hepatic arterial infusion and systemic chemotherapy with or without bevacizumab in patients with resected hepatic metastases from colorectal cancer Journal Article


Authors: Kemeny, N. E.; Jarnagin, W. R.; Capanu, M.; Fong, Y.; Gewirtz, A. N.; DeMatteo, R. P.; D'Angelica, M. I.
Article Title: Randomized phase II trial of adjuvant hepatic arterial infusion and systemic chemotherapy with or without bevacizumab in patients with resected hepatic metastases from colorectal cancer
Abstract: Purpose: Add systemic bevacizumab (Bev) to adjuvant hepatic arterial infusion (HAI) plus systemic therapy after liver resection to increase recurrence-free survival (RFS). Patients and Methods: Patients were randomly assigned to HAI plus systemic therapy with or without Bev. If 1-year RFS of ≥ 80% was obtained in Bev arm, then the regimen would be studied further. HAI with fluorodeoxyuridine plus dexamethasone was given on days 1 to 14 of a 5-week cycle. Systemic therapy and Bev 5 mg/kg was delivered on days 15 and 29: oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, and fluorouracil 2,000 mg/m2 infusion for 2 days (if patients received prior oxaliplatin, then irinotecan 150 mg/m2 was used). RFS and survival were estimated by using the Kaplan-Meier method and compared by using the log-rank test. Results: The two arms had similar characteristics: synchronous disease (66% v 63%), more than one metastasis (84% v 74%), and clinical risk score ≥ 3 (50% v 46%) for no Bev versus Bev arms, respectively. With a median follow-up of 30 months, 4-year survival was 85% and 81% (P = .5), and 4-year RFS was 46% versus 37%; 1-year RFS was 83% and 71% (P = .4) for no Bev versus Bev arms. Bilirubin > 3 mg/dL was seen in zero of 38 versus five of 35 patients (P = .02) and biliary stents were placed in zero versus four patients (P = .05) in no Bev versus Bev arms. Conclusion: The addition of Bev to adjuvant HAI plus systemic therapy after liver resection did not seem to increase RFS or survival but appeared to increase biliary toxicity. Four-year survival was 85% and 81% for no Bev and Bev arms, respectively. © 2010 by American Society of Clinical Oncology.
Keywords: adult; cancer survival; aged; disease-free survival; middle aged; survival analysis; cancer surgery; major clinical study; overall survival; bevacizumab; fluorouracil; cancer combination chemotherapy; cancer growth; diarrhea; side effect; systemic therapy; liver neoplasms; cancer adjuvant therapy; chemotherapy, adjuvant; adenocarcinoma; infection; multiple cycle treatment; randomized controlled trial; antineoplastic combined chemotherapy protocols; drug administration schedule; dexamethasone; dose-response relationship, drug; irinotecan; abdominal pain; colorectal carcinoma; fever; lung embolism; colorectal neoplasms; liver metastasis; antibodies, monoclonal; folinic acid; thrombosis; scoring system; heparin; infusions, intra-arterial; liver resection; stent; colitis; hepatectomy; alkaline phosphatase blood level; maximum tolerated dose; kaplan meier method; oxaliplatin; floxuridine; wound infection; infusions, intravenous; bilirubin blood level; allergic reaction; log rank test; recurrence free survival; colorectal adenocarcinoma; paralytic ileus
Journal Title: Journal of Clinical Oncology
Volume: 29
Issue: 7
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2011-03-01
Start Page: 884
End Page: 889
Language: English
DOI: 10.1200/jco.2010.32.5977
PUBMED: 21189384
PROVIDER: scopus
PMCID: PMC3646323
DOI/URL:
Notes: --- - "Export Date: 23 June 2011" - "CODEN: JCOND" - "Source: Scopus"
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MSK Authors
  1. Ronald P DeMatteo
    597 DeMatteo
  2. Marinela Capanu
    206 Capanu
  3. William R Jarnagin
    583 Jarnagin
  4. Yuman Fong
    741 Fong
  5. Nancy Kemeny
    347 Kemeny
  6. Alexandra Gewirtz
    16 Gewirtz