Feasibility and Tolerability of Chemoimmunotherapy Given During Induction for Treatment of Patients With High-Risk Neuroblastoma: A Report From the Children's Oncology Group

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.

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Journal
Journal of Clinical Oncology
Published
2026-11-03
DOI
https://doi.org/10.1200/jco-26-00810
Primary Topic
Neuroblastoma Research and Treatments
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article
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article

Feasibility and Tolerability of Chemoimmunotherapy Given During Induction for Treatment of Patients With High-Risk Neuroblastoma: A Report From the Children's Oncology Group

Arlene H. Naranjo, Steven G. DuBois, Jason A. Jarzembowski, Hiroyuki Shimada et al.
Journal of Clinical Oncology
Neuroblastoma Research and Treatments
article

Feasibility and Tolerability of Chemoimmunotherapy Given During Induction for Treatment of Patients With High-Risk Neuroblastoma: A Report From the Children's Oncology Group

Arlene H. Naranjo, Steven G. DuBois, Jason A. Jarzembowski, Hiroyuki Shimada, Paul M. Sondel, Julie R. Park, Araz Marachelian, Wayne Lee Furman, Ami Vijay Desai, Rochelle Bagatell, Meredith S. Irwin, Marguerite T. Parisi, Sara Michele Federico, Megan M. Lilley, Ankita Shahi, Alice Lin-Tsing Yu, Christopher L. Tinkle, Barry Lynn Shulkin, Tamarah J. Westmoreland, Steve E. Braunstein, Suzanne Shusterman, Michael R. Acord, Fan F. Zhang, Gregory Anthony Yanik, Daphne Adele Haas-Kogan, Shahab Asgharzadeh
article en

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.

Journal of Clinical Oncology
Children's Oncology Group (CH), University of Southern California (US), Brigham and Women's Hospital (US), Boston Children's Hospital (US), Seattle Children's Hospital (US), St. Jude Children's Research Hospital (US), Children's Hospital of Philadelphia (US), Children's Hospital of Los Angeles (US), University of Wisconsin–Madison (US), Harvard University (US), University of Toronto (CA), University of Washington (US), Medical College of Wisconsin (US), University of Michigan (US), UW Health University Hospital (US), Hospital for Sick Children (CA), University of California San Diego (US), University of Chicago (US), University of Chicago Medical Center (US), University of Wisconsin Carbone Cancer Center (US), Michigan Medicine (US), Dana-Farber Cancer Institute (US), Children's Oncology Group (US), UCSF Benioff Children's Hospital (US), Stanford Medicine (US), C. S. Mott Children's Hospital (US), Nemours Children's Clinic (US), Dana-Farber Brigham Cancer Center (US), Dana-Farber/Boston Children's Cancer and Blood Disorders Center (US), Stanford University (US)
Openalex Percentile: Top 16%
Neuroblastoma Research and Treatments
DOISourceOpenAlex
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