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Abstract
Anti-B4-blocked ricin (anti-B4-bR) is a potent immunotoxin directed against the CD19 antigen. Previous phase I and II studies suggested a possible role for anti-B4-bR as consolidation after high-dose chemotherapy and autologous stem cell transplant. Cancer and Leukemia Group B (CALGB) 9254 is a phase III study which randomized 157 patients with B-cell lymphoma in complete remission following autologous transplant to treatment with anti-B4-bR or observation. With a median follow-up time for patients of 5.8 years, the median event-free survival for protocol treatment and observation are 2.1 and 2.9 years, respectively (p = 0.275). The median overall survival for treatment and observation are 6.1 years and not reached, respectively (p = 0.063). Therefore, no differences were found in event-free survival and overall survival between protocol treatment and observation, although there was a trend toward improved survival with observation. These data fail to support a role for anti-B4-bR as consolidative therapy after bone marrow transplant in patients with B-cell lymphoma.
Acknowledgements
The following institutions participated in this study:
Dana-Farber Cancer Institute, Boston, MA—Harold J. Burstein, MD, PhD, supported by CA32291.
Dartmouth Medical School – Norris Cotton Cancer Center, Lebanon, NH—Konstantin Dragnev, MD, supported by CA04326.
Duke University Medical Center, Durham, NC—Jeffrey Crawford, MD, supported by CA47577.
Massachusetts General Hospital, Boston, MA—Jeffrey W. Clark, MD, supported by CA32291.
McGill University, Montreal, QC—Gerald Batist, MD.
Medical University of South Carolina, Charleston, SC—Mark Green, MD, supported by CA03927.
Mount Sinai School of Medicine, New York, NY—Lewis R. Silverman, MD, supported by CA04457.
North Shore University Health System CCOP, Evanston, IL—David L Grinblatt, MD, supported by CA35279.
Roswell Park Cancer Institute, Buffalo, NY—Ellis Levine, MD, supported by CA59518.
State University of New York Upstate Medical University, Syracuse, NY—Stephen L. Graziano, MD, supported by CA21060.
University of California at San Diego, San Diego, CA—Barbara A. Parker, MD, supported by CA11789.
University of California at San Francisco, San Francisco, CA—Charles J Ryan, MD, supported by CA60138.
University of Chicago, Chicago, IL—Hedy L Kindler, MD, supported by CA41287.
University of Iowa, Iowa City, IA—Daniel A. Vaena, MD, supported by CA47642.
University of Maryland Greenebaum Cancer Center, Baltimore, MD—Martin Edelman, MD, supported by CA31983.
University of Massachusetts Medical School, Worcester, MA—William V. Walsh, MD, supported by CA37135.
University of Missouri/Ellis Fischel Cancer Center, Columbia, MO—Michael C. Perry, MD, supported by CA12046.
University of North Carolina at Chapel Hill, Chapel Hill, NC—Thomas C. Shea, MD, supported by CA47559.
Wake Forest University School of Medicine, Winston-Salem, NC—David D. Hurd, MD, supported by CA03927.
Walter Reed Army Medical Center, Washington, DC—Brendan M. Weiss, MD, supported by CA26806.
Washington University School of Medicine, St. Louis, MO—Nancy Bartlett, MD, supported by CA77440.
Weill Medical College of Cornell University, New York, NY—John Leonard, MD, supported by CA07968.
Declaration of interest: The research for CALGB 9254 was supported, in part, by grants from the National Cancer Institute (CA31946) to the Cancer and Leukemia Group B (Richard L. Schilsky, MD, Chairman) and to the CALGB Statistical Center (Stephen George, PhD, CA33601). The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute.