The Influence of Patient-Provider Language Concordance in Cancer Care: Results of the Hispanic Outcomes by Language Approach (HOLA) Randomized Trial

Abstract

Pediatric malignancies are rare compared to adult cancers, and cooperative groups such as the Children's Oncology Group (COG) serve critical roles in testing key question in clinical trials. We sought to characterize the prevalence of off-study treatment of pediatric patients per Children's Oncology Group (COG) trials, as this approach may offer improved clinical outcomes but may also subject children to treatment with suboptimal, unproven regimens. Materials/Methods: We conducted a 12-question REDCap survey that was sent to 358 radiation oncologists listed as members of COG. Radiation oncologists were queried regarding their practice patterns for recent and ongoing COG protocols for medulloblastoma (ACNS0331, ACNS1422), ependymoma (ACNS0121), neuroblastoma (ANBL0532), Ewing sarcoma (AEWS1221), rhabdomyosarcoma (ARST1431), and Hodgkin lymphoma (AHOD1331). Data were collected anonymously through January 2020. Results: We received 97 responses (27.1%). The most common factor affecting consideration of immediate adoption of COG trial paradigms was improvement of clinical outcomes (n Z 70, 77.8%). Nine radiation oncologists treated average-risk medulloblastoma with 18 Gy craniospinal irradiation (CSI) off-study prior to publication of the ACNS0331 results (abstract, 2016). Eight physicians consider 18 Gy CSI for WNT-driven average-risk medulloblastoma, per the open ACNS1422. Of the 21 respondents who omitted radiation for grade II supratentorial ependymomas after gross total resection (GTR), 9 still consider this approach off-study since publication of ACNS0121 that showing 5 out of 11 patients recurring in the observation arm. Of the 50 radiation oncologists who treated highrisk neuroblastoma with boost to 36 Gy if GTR was not achieved, per ANBL0532, 10 still consider boost since publication of the ANBL0532 abstract (2019) that showed no benefit to the boost. Thirty-two respondents treated metastatic Ewing sarcoma with SBRT per AEWS1221, off-study. Twenty chose SBRT doses other than the AEWS1221-recommended 40 Gy in 5 fractions. Forty-one treated group 3 rhabdomyosarcoma with radiation tailored to chemotherapy-response per the open ARST1431 study. Fifty-four who treat high-risk Hodgkin lymphoma considered radiation to bulky mediastinal disease or sites with poor response to chemotherapy and 74 used involved site radiotherapy (ISRT) as prescribed by the open AHOD1331 study. Conclusion: Many pediatric radiation oncologists adopt COG trial treatment regimens before data are available in either abstract or final peer-reviewed form. This approach has the potential to offer patients state-of-the-art treatments, early in their development. However, given that some trials find no benefit and/or disclose detriment of tested radiation treatment paradigms, it is increasingly important to enroll patients on trial rather than follow regimens of open clinical trials, off-study, prior to availability of the results.