Osteoradionecrosis of the jaw (ORNJ) is a radiation-induced late toxicity that can dramatically decrease patients’ quality of life. Recent increases in survival rates of head and neck cancers associated with human papillomavirus (HPV) infection have resulted in a higher frequency of radiation-induced toxicities, particularly ORNJ. Recent work with Normal Tissue Complication Probability (NTCP) models and a Weibull Accelerated Failure Time (WAFT) model have further developed our understanding of ORNJ clinical/dosimetric risk factors and longitudinal features, respectively. In this data descriptor, 1129 head and neck cancer (HNC) patients received curative intent radiotherapy (RT) at MD Anderson Cancer Center and were follow-up with clinical and radiological assessments at 3-6, 12, 18, 24 months, and then annually following the conclusion of RT for development of ORNJ. This data, in addition to the patients’ demographic, supplementary clinical, and dosimetric information was recorded in a comma-separated value file embedded within this data descriptor. This large, longitudinal dataset is a significant resource for further systematic analysis of post-RT normal tissue outcomes in HNC.

CDF has received unrelated grant support from Elekta AB and holds unrelated patents licensed to Kallisio, Inc. (US PTO 11730561) through the University of Texas, from which they receive patent royalties. CDF has also received unrelated travel and honoraria from Elekta AB, Philips Medical Systems, Siemens Healthineers/Varian, and Corewell Health. Additionally, CDF has served in an unpaid advisory capacity for Siemens Healthineers/Varian and has served on the guidelines/scientific committee for Osteoradionecrosis for the American Society of Clinical Oncology. VCS is a consultant and equity holder in Femtovox Inc and a consultant for PDS Biotechnology. KAW serves as an Associate Editor for Physics and Imaging in Radiation Oncology. The authors declare that no other competing interests exist.

NAW is supported by a training fellowship from UTHealth Houston Center for Clinical and Translational Sciences T32 Program (Grant No. T32 TR004905), a NIH National Institute of Dental and Craniofacial Research (NIDCR) Academic Industrial Partnership Grant (R01DE028290), and the American Legion Auxiliary Fellowship in Cancer Research. ZK is supported by a doctoral fellowship from the Cancer Prevention Research Institute of Texas grant RP210042. GEM acknowledges funding support from NIH UG3 TR004501, NSF CNS-2320261, the University Scholar Award from the University of Illinois System, and NIH/NCI R01CA258827. JR received salary support from the NIDCR Diversity Supplement Grant R01DE028290-02S1. KAW was supported by the Image-Guided Cancer Therapy T32 Training Program Fellowship from T32CA261856. KKB acknowledges support from the Image Guided Cancer Therapy Research Program at The University of Texas MD Anderson Cancer Center, which was partially funded by the National Institutes of Health/NCI under award number P30CA016672. MAN received funding from the National Institutes of Health/National Institute of Dental and Craniofacial Research (NIH/NIDCR) through grant R03DE033550. ASRM received funding from NIDCR (U01DE032168, 1R01DE028290-01A1) and NCI (R01CA258827). LVVD received funding and salary support from KWF Dutch Cancer Society through a Young Investigator Grant (KWF-13529) and from NWO ZonMw through the VENI grant (NWO-09150162010173). ACM receives funding from the NIH/NIDCR via grants K12CA088084, R21DE031082, and K01DE030524. CDF, SYL, and KAH receive related funding support from the NIH/NIDCR (U01DE032168). CDF and SYL also receive funding support from the NIH/NIDCR (R01DE025248). CDF also receives infrastructure and salary support through the NIH/NCI MD Anderson Cancer Center Core Support Grant (CCSG) Image-Driven Biologically-informed Therapy (IDBT) program (P30CA016672-47). SYL is supported through the CCSG Head and Neck Program (P30CA016672-48). This work was supported directly or in part by effort, funding, resources or infrastructure from the NIH NCI OPC SURVIVOR: Optimizing OroPharyngeal Cancer SURVIVORship Program Project Grant (NCI P01CA285249); and the Charles and Daneen MD Anderson Oropharyngeal Cancer Fund.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

After waiver of informed consent and study approval from institutional review board approval (RCR030800) at The University of Texas MD Anderson Cancer Center, data from a philanthropically funded observational cohort at The University of Texas MD Anderson Cancer Center (Stiefel Oropharynx Cancer Cohort, PA14-0947) were extracted for retrospective analysis.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

↵‡ MD Anderson Head and Neck Cancer Symptom Working Group

↵¶ Spatial-Non-spatial Multi-Dimensional Analysis of Radiotherapy Treatment/Toxicity Team (SMART3)

↵§ OPC-SURVIVOR Program

↵* Joint Supervision

Data sharing statement: In accordance with NOT-OD-21-013, Final NIH Policy for Data Management and Sharing, anonymized/de-identified data that support the findings of this study are openly available in an NIH-supported generalist scientific data repository (figshare) at https://doi.org/10.6084/m9.figshare.26240435.v1 no later than the time of an associated publication.

Public access policy compliance In accordance with NOT-OD-25-049, Supplemental Guidance to the 2024 NIH Public Access Policy: Government Use License and Rights: “This manuscript is the result of funding in whole or in part by the National Institutes of Health (NIH). It is subject to the NIH Public Access Policy. Through acceptance of this federal funding, NIH has been given a right to make this manuscript publicly available in PubMed Central upon the Official Date of Publication, as defined by NIH.”

Pre-print Statement Consistent with NOT-OD-17-050, Reporting Preprints and Other Interim Research Products, as “NIH encourages investigators to use interim research products, such as preprints, to speed the dissemination and enhance the rigor of their work”, a pre-peer reviewed deposition of the initial submission version of the manuscript has been deposited for public access at medRxiv with DOI available upon acceptance.

Reporting Guideline Compliance Statement In accordance with EQUATOR Network (Enhancing the QUAlity and Transparency Of health Research) guidance, we have utilized the RECORD Statement extended from the STROBE Statement; the completed checklist is attached as Supplementary file.

In accordance with NOT-OD-21-013, Final NIH Policy for Data Management and Sharing, anonymized/de-identified data that support the findings of this study are openly available in an NIH-supported generalist scientific data repository (figshare) at https://doi.org/10.6084/m9.figshare.26240435.v1 no later than the time of an associated publication. The script used for analyzing this dataset and training and testing the WAFT model can be found here in this repository: https://github.com/LaiaHV-MDACC/ORN-time-to-event-prediction-modelling.

https://doi.org/10.6084/m9.figshare.26240435.v1

https://github.com/LaiaHV-MDACC/ORN-time-to-event-prediction-modelling