Surgery News - January 2008 - (Page 17) J A N U A RY 2 0 0 8 • SURGERY NEWS ONCOLOGY 17 Radioiodine Beneficial in Colorectal Metastases BY ERIK GOLDMAN Else vier Global Medical Ne ws N E W Y O R K — A humanized monoclonal antibody carrying radioactive iodine and targeting the carcinoembryonic antigen on the surfaces of colorectal cancer cells can prolong both disease-free and overall survival in colorectal cancer patients with liver metastases, Dr. David M. Goldenberg said at a symposium sponsored by the Chemotherapy Foundation. This experimental therapy, known as iodine-131–labeled labetuzumab, is given after complete surgical resection of hepatic metastases. It helps eliminate the microscopic foci of cancer cells that are inaccessible to surgical excision, explained Dr. Goldenberg, president of the Garden State Cancer Center and its Center for Molecular Medicine and Immunology in Belleville, N.J. “More than 90% of all liver metastases express the protein called carcinoembryonic antigen [CEA]. We can get to the micrometastases with a radioimmunoantibody specific to it,” he said. Radioimmunotherapy (RAIT) with 131Ilabetuzumab is being developed by Immunomedics Inc. in Morris Plains, N.J. Dr. vival advantage following adjuvant RAIT in colorectal cancer patients having salvage resection,” he said. Results of a second phase II trial assessing the impact of RAIT given at 6 weeks and at 4.5 months after surgery were even better, according to Dr. Goldenberg: “The early data suggest disease-free survival advantage that is two times higher in the RAIT versus non-RAIT patients. At five years out, we’re seeing a disease-free survival rate of 51% for RAIT, compared with 7.4% in the non-RAIT group.” A large-scale 131I-labetuzumab randomized trial comparing RAIT with to adjuvant chemotherapy is set to begin in 2008, he said. “It’s important to confirm the results in randomized, prospective trials that are balanced for the well-known prognostic variables that affect this group of patients,” said Dr. James Neifeld, who commented on the study. “Although it’s possible he has discovered the Holy Grail, I am very skeptical,” added Dr. Neifeld, chairman of the department of surgery at Virginia Commonwealth University. If the efficacy is confirmed in further studies, RAIT with 131I-labetuzumab may benefit many people. Dr. Goldenberg noted that roughly 60% of all people with colorectal cancer develop liver metastases. Surgical resection alone is seldom sufficient, as up to 75% of patients relapse within a few years. 131I-labetuzumab is being extremely efficient in reaching the CEA antigen, he explained. “After resection and RAIT, the CEA levels in the patients’ blood drop right down to normal levels,” he said. ■ AT OVER 6 YEARS, 47% OF THE PATIENTS TREATED WITH RADIOIMMUNOTHERAPY WERE STILL ALIVE, VERSUS ONLY 13% OF THE CONTROL GROUP. Goldenberg founded the company in 1982, and serves as chairman of its board of directors. In collaboration with oncologists at the University of Göttingen (Germany), he studied the outcomes of adjuvant RAIT with 131I-labetuzumab in 23 people undergoing resection of hepatic metastases from colorectal cancer. The treated patients received 40-60 mCi/m2 of the radioactive antibody; they were compared with 19 control patients who underwent the same surgery but without RAIT. At a median follow-up of 75 months, the RAIT patients showed a median overall survival of 68 months, compared with 31 months among the control patients. Median disease-free survival intervals also were extended in the RAIT group (18 months vs. 12 months). At over 6 years, 47% of the RAIT-treated patients were still alive; only 13% of the control group survived this long. Dr. Goldenberg said four of the surviving RAIT patients (21%) remain free from recurrent disease. He added that 13 of the 19 control patients were given 5-fluorouracil at some point during the follow-up period, but it did not substantially improve their survival. RAIT was beneficial regardless of bilobar hepatic involvement, size and number of liver metastases, or dimensions of the resection margins, he said. The only significant adverse effect from the treatment was transient myelosuppression. “This [was] the first evidence of a promising sur- The American College of Surgeons and the National Ultrasound Faculty have developed “Ultrasound for Surgeons: The Basic Course” for surgeons and surgical residents on CD-ROM. The objective of the course is to provide the practicing surgeon and surgical resident with a basic core of education and training in ultrasound imaging as a foundation for specific clinical applications. ^ Replaces the basic course offered by the American College of Surgeons. ^ A printable CME certificate is available upon successful completion. ^ CD will install the necessary software (PC or Mac). ^ The learner is offered two attempts to pass a multiple-choice exam with a minimum score of 80% at the completion of the program. ^ Residents must submit a letter from their director/chair to document residency status. ^ Only one user per CD is allowed. Online access is needed to register the CD and to take the exam. ^ ^ ^ ^ $300 for nonmembers $225 for Fellows of the College $125 for residents with letter proving status* $90 for Resident and Associate Society (RAS) members (Additional $16 for shipping and handling of international orders) *Non-RAS residents must supply a letter confirming status as a resident from a program director or administrator and are limited to one CD-ROM. The CD can be purchased online at http://www.acs-resource.org or by calling Customer Service at 312/202-5474. For additional information, contact Olivier Petinaux, MS, tel. 866/475-4696, e-mail elearning@facs.org The American College of Surgeons (ACS) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The ACS designates this educational activity for a maximum of four AMA PRA Category 1 Credits™ toward the AMA Physician’s Recognition Award. Each physician should claim only those credits that he/she actually spent in the activity. The American Medical Association has determined that physicians not licensed in the U.S. who participate in this CME activity are also eligible for AMA PRA Category 1 Credits.™ http://www.acs-resource.org http://www.acs-resource.org
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