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High-dose prednisone produced transient symptom improvement in radiation-associated lower cranial neuropathy

Prednisone 3 mg/kg improved symptoms in 3 of 5 survivors with late cranial neuropathy, but the benefit disappeared by 6–10 weeks.

RadOncToday · ·1 min read

KEY POINTS

  • STOP LCNP is a prospective single-institution phase I/II dose-finding trial testing corticosteroids for radiation-associated lower cranial neuropathy, a severe late complication causing progressive dysphagia, aspiration, dysarthria and loss of nutritional independence. This interim report includes 8 disease-free oropharyngeal cancer survivors with EMG-confirmed neuropathy at least 2 years after RT.
  • Patients received oral prednisone 1 mg/kg daily for 5 days followed by a 2-week taper (n=3) or 3 mg/kg daily for 5 days followed by the same taper (n=5). A planned intravenous methylprednisolone dose level had not yet been initiated.
  • The prespecified symptomatic response threshold was a ≥1.315-point decrease in the MDASI-HN Top 5 symptom score at 1–2 weeks after taper. At that time point, median change was only −0.2 with 1 mg/kg versus −1.6 with 3 mg/kg.
  • Three of five patients treated with 3 mg/kg reached the clinically meaningful symptom-response threshold, compared with none meeting the dose-progression criterion at 1 mg/kg. The early improvement was driven mainly by bulbar symptoms including swallowing, choking and voice/speech complaints.
  • The signal was not durable: by 6–10 weeks, median symptom change was 0.0 in the 3 mg/kg cohort, and neither dose produced consistent improvement in clinician-graded swallowing measures or electrophysiology.
  • Both regimens met feasibility and tolerability criteria with no treatment discontinuations or dose modifications. Grade 1 insomnia occurred in five patients; one patient receiving 3 mg/kg developed grade 3 worsening hypertension that was managed without stopping treatment.
  • The trial was explicitly not powered for statistical comparison between doses. Although 3 mg/kg met the prespecified criterion to progress to phase II, the transient patient-reported response without consistent objective improvement makes efficacy uncertain.

CLINICAL TAKEAWAY

There is currently no proven treatment for radiation-associated lower cranial neuropathy, so even a transient symptom signal is clinically interesting. Prednisone 3 mg/kg warrants further study, but these phase I data do not establish a durable treatment effect and do not justify routine high-dose corticosteroids outside individualized clinical decision-making.

SOURCE

International Journal of Radiation Oncology, Biology, Physics

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