Feasibility and Tolerability of Chemoimmunotherapy Given During Induction for Treatment of Patients With High-Risk Neuroblastoma: A Report From the Children's Oncology Group
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: PURPOSE: The addition of the anti-GD2 antibody dinutuximab (DIN) to postconsolidation therapy led to improved event-free survival (EFS) for patients with high-risk neuroblastoma (HRNBL). The combination of DIN with chemotherapy (chemoimmunotherapy) results in objective responses in patients with recurrent/refractory neuroblastoma. We evaluated the feasibility of administering chemoimmunotherapy during induction for HRNBL in a multicenter trial. METHODS: Children's Oncology Group (COG) ANBL17P1 was a prospective, single-arm, limited institution pilot study to assess tolerability and feasibility of administering DIN and sargramostim with induction chemotherapy cycles 3-5. The primary end point of tolerability was assessed as the occurrence of a predefined unacceptable toxicity or toxic death during DIN-containing cycles. Feasibility was assessed as ability to receive ≥75% of planned DIN doses. Revised International Neuroblastoma Response Criteria were used to assess response. RESULTS: Forty eligible, evaluable patients with newly diagnosed HRNBL were enrolled at eight sites from January 2019 to June 2020. The most common DIN-related grade ≥3 toxicities during induction cycles 3-5 included fever (30.0%) and pain (7.5%). There were no unacceptable toxicities or toxic deaths during induction cycles 3-5. Patients received 92.0%-101.8% of intended induction DIN doses. This regimen was therefore deemed both feasible and tolerable. Thirty-seven patients completed all end-of-induction evaluations; 13 had complete response (CR), 22 partial response (PR), one minor response (MR), zero stable disease, and one progressive disease. The overall end of induction CR + PR rate was 87.5%. The 3-year EFS was 52.5% ± 7.9%. CONCLUSION: Administration of DIN with COG induction cycles 3-5 for patients with newly diagnosed HRNBL was tolerable and feasible. This approach is currently being evaluated in a COG randomized phase III trial.
Source: Journal of Clinical Oncology
DOI: 10.1200/jco-26-00810
Authors: Sara M. Federico, Arlene Naranjo, Fan F. Zhang, Paul Sondel, Ankita Shahi, Megan Lilley, Steve Braunstein, Christopher Tinkle, Gregory Yanik, Hiroyuki Shimada, Meredith S. Irwin, Alice L. Yu, Araz Marachelian, Shahab Asgharzadeh, Ami V. Desai, Jason Jarzembowski, Daphne Haas-Kogan, Tamarah J. Westmoreland, Marguerite T. Parisi, Barry Shulkin, Michael Acord, Wayne Furman, Steven G. DuBois, Rochelle Bagatell, Julie R. Park, Suzanne Shusterman
Institutions: St. Jude Children's Research Hospital, University of Florida, Children's Oncology Group, University of Wisconsin–Madison, UW Health University Hospital, University of Wisconsin Carbone Cancer Center, University of California, San Francisco, UCSF Benioff Children's Hospital, University of Michigan, Michigan Medicine, C. S. Mott Children's Hospital, Stanford Medicine, Stanford University, University of Toronto, Hospital for Sick Children, University of California San Diego, University of Southern California, Children's Hospital Los Angeles, University of Chicago, Medical College of Wisconsin, Brigham and Women's Hospital, Boston Children's Hospital, Harvard University, Dana-Farber Cancer Institute, Dana-Farber Brigham Cancer Center, Nemours Children's Clinic, Seattle Children's Hospital, University of Washington, Children's Hospital of Philadelphia, Dana-Farber/Boston Children's Cancer and Blood Disorders Center
Language: English
Subfield: Clinical Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W7225152289