Elsevier

Radiotherapy and Oncology

Volume 148, July 2020, Pages 258-266
Radiotherapy and Oncology

Original Article
Patient-reported outcomes, physician-reported toxicities, and treatment outcomes in a modern cohort of patients with sinonasal cancer treated using proton beam therapy

https://doi.org/10.1016/j.radonc.2020.05.007Get rights and content

Highlights

  • Prospective toxicity analysis of patients treated using proton beam therapy (PBT).

  • PBT was associated with only one acute grade 3 neurologic toxicity that resolved.

  • There were no late grade 3–4 neurologic toxicities.

  • Patient-reported outcomes worsened from baseline to the acute and subacute period.

  • Patient-reported outcomes did not differ from baseline to chronic follow-up.

Abstract

Background and purpose

To report physician-assessed toxicities (PATs) and patient-reported outcomes (PROs) in a prospective cohort of patients treated using proton beam therapy (PBT).

Methods and materials

From 2011 to 2019, PBT-treated patients with a sinonasal malignancy were enrolled with a primary endpoint of toxicity assessment. PATs and PROs were assessed at baseline, acute (during PBT), subacute (within 90 days after PBT), and chronic time points. PATs were graded with the Common Terminology Criteria for Adverse Events V4.0. PROs were assessed with the Xerostomia-Related Quality-of-Life Scale (XeQoLS), MD Anderson Dysphagia Inventory (MDADI), and Functional Assessment of Cancer Therapy (FACT). PRO changes from baseline to follow-up were defined as significantly different based on a paired t-test plus a minimal clinically important difference.

Results

Sixty-four patients had a median follow-up time of 33 months (interquartile range: 10–52 months). The most common histology was olfactory neuroblastoma (28%) and most patients had T4 disease (46%). One acute G3 neurologic PAT (blurred vision) resolved, and no late G3–4 neurologic PATs were observed. Feeding tube placement occurred in 6% of patients. No significant changes were noted in PROs from baseline to the chronic period. Significant worsening from baseline was noted in the XeQoLS acute-subacute physical functioning, pain, personal/psychological distress, and social function; acute-subacute MDADI physical function; and acute-subacute FACT head/neck subscale. The 3-year local control, disease-free survival, and overall survival rates were 88%, 76%, and 82%, respectively.

Conclusions

We demonstrate low grade ≥3 toxicity and encouraging disease outcomes with PBT. PROs suggest significant changes in the acute-subacute period but no chronic sequelae.

Section snippets

Patient population

The institutional review board approved this prospective observational study, which was registered at ClinicalTrials.Gov (NCT01627093). Between 2011 and 2019, patients who had a sinus or sinonasal tumor were recruited to participate and informed consent was obtained. All patients underwent a multidisciplinary evaluation by surgical oncology, medical oncology, and radiation oncology. The primary site of disease was evaluated by using computed tomography (CT) and/or magnetic resonance imaging

Results

This prospective observational study included a total of 64 patients with a median follow-up time of 33 months (interquartile range: 10–52 months). Patients were predominantly Caucasian (77%), male (61%) never-smokers (61%), and a median 55 years years old (interquartile range: 15–89). Olfactory neuroblastoma (ONB; 28%), sinonasal undifferentiated carcinoma (SNUC; 22%), squamous cell carcinoma (SCC; 20%), and adenoid cystic carcinoma (ACC; 16%) were the most common histologic subtypes. Thirty

Discussion

This is the first study to prospectively report on PROs and PATs in patients with sinonasal malignancies treated using PBT, which can serve as a baseline for future study comparison and design of randomized controlled trials. Compared to historical XRT outcomes, acute and late PATs favor PBT. PROs suggest clinically significant changes from pre-treatment to the acute and subacute period, largely driven by PBT to the neck, followed by a gradual return to pre-treatment values in the chronic

Acknowledgement

Funding: Supported in part by Cancer Center Support (Core) Grant P30 CA016672 from the National Cancer Institute, National Institutes of Health, United States.

Disclosure/Conflict of interest:

Dr. Rosenthal serves on the scientific advisory board for Merck. Dr. Phan serves on the scientific advisor board for Cyberknife for Accuray, Inc. Dr. Ferrarotto has consulting/advisory role with Ayala Pharmaceuticals; research funding with OncoMed Pharmaceuticals, G1 Therapeutics, AstraZeneca-MedImmune, EMD

References (33)

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