Bevacizumab in Stage II-III Colon Cancer: 5-Year Update of the National Surgical Adjuvant Breast and Bowel Project C-08 Trial

DOI Web Site 被引用文献1件
  • Carmen J. Allegra
    Carmen J. Allegraothers, Michael J. O'Connell, Saima Sharif, Nicholas J. Petrelli, Samia H. Lopa, Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project; Greg Yothers, Samia H. Lopa, University of Pittsburgh; Saima Sharif, Norman Wolmark, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA; Carmen J. Allegra, University of Florida, Gainesville, FL; Nicholas J. Petrelli, Helen F. Graham Cancer Center at Christiana Care, Newark, DE.
  • Greg Yothers
    Carmen J. Allegraothers, Michael J. O'Connell, Saima Sharif, Nicholas J. Petrelli, Samia H. Lopa, Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project; Greg Yothers, Samia H. Lopa, University of Pittsburgh; Saima Sharif, Norman Wolmark, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA; Carmen J. Allegra, University of Florida, Gainesville, FL; Nicholas J. Petrelli, Helen F. Graham Cancer Center at Christiana Care, Newark, DE.
  • Michael J. O'Connell
    Carmen J. Allegraothers, Michael J. O'Connell, Saima Sharif, Nicholas J. Petrelli, Samia H. Lopa, Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project; Greg Yothers, Samia H. Lopa, University of Pittsburgh; Saima Sharif, Norman Wolmark, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA; Carmen J. Allegra, University of Florida, Gainesville, FL; Nicholas J. Petrelli, Helen F. Graham Cancer Center at Christiana Care, Newark, DE.
  • Saima Sharif
    Carmen J. Allegraothers, Michael J. O'Connell, Saima Sharif, Nicholas J. Petrelli, Samia H. Lopa, Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project; Greg Yothers, Samia H. Lopa, University of Pittsburgh; Saima Sharif, Norman Wolmark, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA; Carmen J. Allegra, University of Florida, Gainesville, FL; Nicholas J. Petrelli, Helen F. Graham Cancer Center at Christiana Care, Newark, DE.
  • Nicholas J. Petrelli
    Carmen J. Allegraothers, Michael J. O'Connell, Saima Sharif, Nicholas J. Petrelli, Samia H. Lopa, Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project; Greg Yothers, Samia H. Lopa, University of Pittsburgh; Saima Sharif, Norman Wolmark, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA; Carmen J. Allegra, University of Florida, Gainesville, FL; Nicholas J. Petrelli, Helen F. Graham Cancer Center at Christiana Care, Newark, DE.
  • Samia H. Lopa
    Carmen J. Allegraothers, Michael J. O'Connell, Saima Sharif, Nicholas J. Petrelli, Samia H. Lopa, Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project; Greg Yothers, Samia H. Lopa, University of Pittsburgh; Saima Sharif, Norman Wolmark, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA; Carmen J. Allegra, University of Florida, Gainesville, FL; Nicholas J. Petrelli, Helen F. Graham Cancer Center at Christiana Care, Newark, DE.
  • Norman Wolmark
    Carmen J. Allegraothers, Michael J. O'Connell, Saima Sharif, Nicholas J. Petrelli, Samia H. Lopa, Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project; Greg Yothers, Samia H. Lopa, University of Pittsburgh; Saima Sharif, Norman Wolmark, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA; Carmen J. Allegra, University of Florida, Gainesville, FL; Nicholas J. Petrelli, Helen F. Graham Cancer Center at Christiana Care, Newark, DE.

抄録

<jats:sec><jats:title>Purpose</jats:title><jats:p>The National Surgical Adjuvant Breast and Bowel Project trial C-08 was designed to investigate the safety and efficacy of adding bevacizumab to fluorouracil, leucovorin, and oxaliplatin (FOLFOX6) for the adjuvant treatment of patients with stage 2-3 colon cancer. Our report summarizes the primary and secondary end points of disease-free and overall survival, respectively, with 5 years median follow-up time.</jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p>Patients received modified FOLFOX6 once every 2 weeks for a 6-month period (control group) or modified FOLFOX6 for 6 months plus bevacizumab (5 mg/kg) once every 2 weeks for a 12-month period (experimental group). The primary end point of the study was disease-free survival (DFS) and overall survival (OS) was a secondary end point.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 2,673 analyzed patients, demographic factors were well-balanced by treatment. With a median follow-up of 5 years, the addition of bevacizumab to mFOLFOX6 did not result in an overall significant increase in DFS (hazard ratio [HR], 0.93; 95% CI, 0.81 to 1.08; P = .35). Exploratory analyses found that the effect of bevacizumab on DFS was different before and after a 1.25-year landmark (time-by-treatment interaction P value <.0001). The secondary end point of OS was no different between the two study arms for all patients (HR, 0.95; 95% CI, 0.79 to 1.13; P = .56) and for those with stage 3 disease (HR, 1.0; 95% CI, 0.83 to 1.21; P = .99).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Bevacizumab for 1 year with modified FOLFOX6 does not significantly prolong DFS or OS in stage 2-3 colon cancer. We observed no evidence of a detrimental effect of exposure to bevacizumab. A transient effect on disease-free survival was observed during bevacizumab exposure in the study's experimental arm.</jats:p></jats:sec>

収録刊行物

被引用文献 (1)*注記

もっと見る

詳細情報 詳細情報について

問題の指摘

ページトップへ