Nintedanib/capecitabine combination outperforms standard therapy, Roswell Park researchers report
- Colorectal cancer often detected at late stages and frequently persists/recurs
- Roswell Park team led a clinical study of nintedanib plus a standard therapy
- Results shared at ASCO Annual Meeting support further study of this approach
CHICAGO — Research from Roswell Park Comprehensive Cancer Center suggests that a new treatment combination can extend survival for many patients with advanced colorectal cancer. The findings from this study of the targeted drug nintedanib in combination with capecitabine, an approved standard therapy for colorectal cancer, will be shared during the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
Colorectal cancer is one of the most common cancers among men and women in both Europe and the United States. Up to half of patients with this type of cancer will be diagnosed with advanced disease or develop cancer that resists the effects of currently approved treatment strategies.
The phase I/II study was led by Patrick Boland, MD, Assistant Professor of Oncology in the Department of Medicine at Roswell Park. The research team sought to evaluate the recommended dose and efficacy of nintedanib, a tyrosine kinase inhibitor (TKI), plus capecitabine in patients with refractory metastatic colorectal cancer — those whose cancer progressed after they received standard chemotherapy.
The team, which includes researchers from City of Hope, reports that among 40 patients who received the new combination, progression-free survival at 4 months was 36%, compared to 25% in a historical comparison group receiving standard therapy alone — a statistically significant increase. The authors conclude that this treatment combination was well-tolerated and that its efficacy compares favorably to single-agent approaches.
“We’re encouraged by this evidence that we were able to improve outcomes, especially in a notoriously hard-to-treat disease like refractory colorectal cancer where there’s a pressing need for better options,” says Dr. Boland. “We will need to allow time for longer follow-up before we can draw firm conclusions about this combination, but this is clearly a treatment approach that warrants further examination.”
The researchers will also be sharing preliminary conclusions about biomarkers that may help clinicians to select the best therapy for particular patients. The study, “A phase I/II study of nintedanib and capecitabine in refractory metastatic colorectal cancer,” is abstract 3552 and will be presented Sunday, June 3, 8 to 11:30 a.m. in McCormick Place, Hall A, as part of the Gastrointestinal (Colorectal) Cancer poster session.
This study was approved and funded by the National Comprehensive Cancer Network (NCCN) Oncology Research Program from general research support provided by Boehringer Ingelheim Pharmaceuticals Inc.
Several Roswell Park clinical leaders were invited to play leadership roles at the meeting. Marc Ernstoff, MD, the Katherine Anne Gioia Chair of Medicine, will speak on management of immune-checkpoint toxicity during the “Where We Stand with Immunotherapy in Colorectal Cancer” education session Saturday, June 2, from 8:40 to 9 a.m. CDT in Hall D; Eunice Wang, MD, Chief of Leukemia, will lead a discussion on advances in treatment of acute myeloid leukemia and myelodysplastic syndromes Saturday, June 2, from 3:24 to 3:36 p.m. CDT during the “Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant” oral abstract session; and Kunle Odunsi, MD, PhD, Deputy Director, Chair of Gynecologic Oncology and Executive Director of the Center for Immunotherapy, is a co-chair of “Engaging the Immune System in Ovarian Cancer,” a clinical science symposium to be held Sunday, June 3, from 9:45 to 11:15 a.m. CDT in room S406.
Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer’s grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or ASKRoswell@roswellpark.org.
Annie Deck-Miller, Senior Media Relations Manager