An estimated 62,210 people in the United States will be diagnosed with pancreatic cancer this year. Most cases are diagnosed at an advanced stage, and current therapies only lead to a median overall survival benefit of approximately six to eight months. Mutations in the KRAS gene occur in between 70 to 90 percent of pancreatic ductal adenocarcinomas, of which KRAS wild-type is a distinct subtype. The five-year survival rate for this subtype is less than 10 percent. The findings, generated by a phase 3 study of 92 patients in China, found that participants who received nimotuzumab in addition to the standard treatment for the disease, gemcitabine (Gemzar), survived for 10.9 months compared with 8.5 months for those who got gemcitabine alone. Nimotuzumab, a type of therapy known as a monoclonal antibody, is the result of a collaboration between China and Cuba and is not yet approved by the FDA. The two-drug approach also resulted in a one-year survival rate of 43.6 percent, versus 13.9 percent among those who received gemcitabine alone. The three-year respective survival rate was 13.9 percent and 2.7 percent, respectively. Those who did not need surgery to remove blockage of the pancreatic bile duct fared even better on the treatment than those who would require or had undergone the procedure. The progression-free period — the time during which the disease did not advance — for those without a history of biliary surgery was 5.5 months in those who received combination treatment, versus 3.4 months in the gemcitabine alone group. Cathy Eng, MD, co-leader of VICC Gastrointestinal Cancer Research Program at Vanderbilt University, applauded the research for taking on a condition that, she noted, was “rarely investigated prospectively because … it represents less than 10 percent of all pancreatic cancer patients.” The study offers a “potential treatment option for patients with advanced pancreatic cancer for whom current standard-of-care dual chemotherapy options are not feasible and single-agent gemcitabine is being considered,” said Arif Kamal, MD, chief patient officer at the American Cancer Society, who was not involved in the research. He called for researchers to conduct larger studies to evaluate the “toxicity profile and quality of life benefits” needed to understand the role of nimotuzumab in the management of pancreatic cancer. .
