Identified Enrollment Challenges of Adolescent and Young Adult Patients on the Nonchemotherapy Arm of Children's Oncology Group Study ARST1321

Viswatej Avutu¹, Aaron R Weiss², Damon R Reed³, Safia K Ahmed⁴, Wendy A Allen-Rhoades⁵, Yen-Lin E Chen⁶, Lara E Davis⁷, Bree R Eaton⁸, Douglas S Hawkins⁹, Danny J Indelicato¹⁰, Shreyaskumar R Patel¹¹, R Lor Randall¹², Denise K Reinke¹³, Richard F Riedel¹⁴, Thomas J Scharschmidt¹⁵, Katherine A Thornton¹, Dian Wang¹⁶, Katherine A Janeway¹⁷, Lisa M Kopp¹⁸

Affiliations

¹ Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
² Department of Pediatrics, Maine Medical Center, Portland, Maine, USA.
³ Department of Individualized Cancer Management, Moffitt Cancer Center, Tampa, Florida, USA.
⁴ Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.
⁵ Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, Minnesota, USA.
⁶ Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.
⁷ Department of Medicine, Oregon Health & Science University, Portland, Oregon, USA.
⁸ Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia, USA.
⁹ Department of Pediatrics, Seattle Children's Hospital, Seattle, Washington, USA.
¹⁰ Department of Radiation Oncology, University of Florida, Jacksonville, Florida, USA.
¹¹ Department of Medicine, University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA.
¹² Department of Orthopaedic Surgery, UC Davis Health, Sacramento, California, USA.
¹³ Sarcoma Alliance for Research through Collaboration, Ann Arbor, Michigan, USA.
¹⁴ Department of Medicine, Duke Cancer Institute, Durham, North Carolina, USA.
¹⁵ Department of Orthopaedic Surgery, Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
¹⁶ Department of Radiation Oncology, Rush University Medical Center, Chicago, Illinois, USA.
¹⁷ Department of Pediatrics, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
¹⁸ Department of Epidemiology and Biostatistics, University of Arizona, Tucson, Arizona, USA.

PMID: 34515544
PMCID: PMC9354033
DOI: 10.1089/jayao.2021.0103

Identified Enrollment Challenges of Adolescent and Young Adult Patients on the Nonchemotherapy Arm of Children's Oncology Group Study ARST1321

Viswatej Avutu et al. J Adolesc Young Adult Oncol. 2022 Jun.

. 2022 Jun;11(3):328-332.

doi: 10.1089/jayao.2021.0103. Epub 2021 Sep 9.

Authors

Affiliations

¹ Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
² Department of Pediatrics, Maine Medical Center, Portland, Maine, USA.
³ Department of Individualized Cancer Management, Moffitt Cancer Center, Tampa, Florida, USA.
⁴ Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.
⁵ Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, Minnesota, USA.
⁶ Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.
⁷ Department of Medicine, Oregon Health & Science University, Portland, Oregon, USA.
⁸ Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia, USA.
⁹ Department of Pediatrics, Seattle Children's Hospital, Seattle, Washington, USA.
¹⁰ Department of Radiation Oncology, University of Florida, Jacksonville, Florida, USA.
¹¹ Department of Medicine, University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA.
¹² Department of Orthopaedic Surgery, UC Davis Health, Sacramento, California, USA.
¹³ Sarcoma Alliance for Research through Collaboration, Ann Arbor, Michigan, USA.
¹⁴ Department of Medicine, Duke Cancer Institute, Durham, North Carolina, USA.
¹⁵ Department of Orthopaedic Surgery, Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
¹⁶ Department of Radiation Oncology, Rush University Medical Center, Chicago, Illinois, USA.
¹⁷ Department of Pediatrics, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
¹⁸ Department of Epidemiology and Biostatistics, University of Arizona, Tucson, Arizona, USA.

PMID: 34515544
PMCID: PMC9354033
DOI: 10.1089/jayao.2021.0103

Abstract

ARST1321, a trial of patients with advanced soft tissue sarcoma, was the first National Clinical Trials Network study codeveloped by pediatric and adult consortia with two treatment cohorts. We report on the findings of a survey to identify barriers to enrolling adolescent and young adult patients (15-39 years) onto the nonchemotherapy arm. The survey response rate was 31% with a 70% completion rate. Common identified reasons for low accrual in order of decreasing frequency included insufficient funding, lack of study awareness or interest, competing trials, toxicity concerns, philosophical differences in the therapy backbone, and regulatory and infrastructure barriers. Clinical Trials.gov ID: NCT02180867.

Keywords: NCTN; clinical trials; cooperative groups; enrollment barriers; survey.

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Conflict of interest statement

A.R.W. is consultant/advisor for SpringWorks Therapeutics (travel only, no honoraria), BioAtla (honoraria); K.A.J. is consulting for Bayer and Ipsen and speaking honoraria from Foundation Medicine and Takeda. L.M.K. is employee of Arcus Biosciences. No competing financial interests exist for other authors. D.R.R., funding from Pfizer and Esiai and travel support from Salarius Pharmaceuticals. D.S.H., grants and nonfinancial support from Loxo Oncology, Bayer, and Bristol Myers Squibb, nonfinancial support from AstraZeneca and Celgene, and grants from Merck Sharpe Dohme, Lilly, Eisai, Glaxo Smith Kline, Novartis, Sanofi, Amgen, Seattle Genetics, Jazz Pharmaceuticals, and Incyte. R.L.R., grants and nonfinancial support from Balmora Medical, Daiichi Sankyo, OncLive, Onkos Surgical, and Zimmer. R.F.R., research support from AADi, AROG, Daiichi-Sankyo, GlaxoSmithKline, Karyopharm, Ignyta, Immune Design, Lilly, NanoCarrier, Novartis, Oncternal, Philogen, Plexxikon, Roche, SpringWorks, Threshold, and Tracon, and consulting for Bayer, Blueprint, Daiichi-Sankyo, Deciphera, EISAI, EMD Serono, Janssen, Lilly, Ignyta, NanoCarrier, and SpringWorks.

References

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Identified Enrollment Challenges of Adolescent and Young Adult Patients on the Nonchemotherapy Arm of Children's Oncology Group Study ARST1321

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Identified Enrollment Challenges of Adolescent and Young Adult Patients on the Nonchemotherapy Arm of Children's Oncology Group Study ARST1321

Authors

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Abstract

Conflict of interest statement

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