REPLY: We thank the authors of the letter for their opinion piece, although we wish to rebut several erroneous points made and to resolve some confusion.
As stated clearly in the protocol (1), this interim analysis was scheduled for when 50% of the patient target was recruited. The intent was to assess initial clearance and treatment tolerance outcomes. A comprehensive dataset with 1- and 2-y follow-up is under way, although many in the study have 2–3 y of follow-up. Rhenium epidermal therapy has been used for approximately 20 y, with early studies following some patients beyond 5 y without serious toxicity. Unlike low- or high-energy photon-based therapy or traditional electrons, rhenium skin cancer therapy (Rhenium SCT) penetrates minimally into the skin while treating a reduced total tissue volume, allowing it to be delivered in a single session.
Details of the basal cell carcinoma subtype histology will be valuable in future decision-making, and these data will be included in primary endpoint publications along with longer-term full efficacy, safety, and patient-reported data as highlighted in the publication.
Determination of a quality-of-life improvement, or any metric for that matter, can indeed be assessed in a single-arm study provided baseline and follow-up assessments were performed—which they were, as stated clearly in the publication. Overall, patient quality of life after Rhenium SCT was significantly improved—the data are clear.
All patients in the study received surgical consultations for consideration. This was part of the study criteria. As Rhenium SCT requires initial referral by a skin specialist, determination of surgical suitability remains in their hands. We absolutely support advocating for dual surgery and radiation therapy/Rhenium SCT consultation, to aid in patient empowerment and reduce regrets about the decision.
In conclusion, we thank the authors for highlighting the elements of an interim analysis and look to forward to sharing follow-up outcomes in future EPIC-Skin publications that are under way.
DISCLOSURE
No potential conflict of interest relevant to this article was reported.
Gerhard Dahlhoff
OncoBeta International GmbH, Munich, Germany
E-mail: gerhard.dahlhoff{at}oncobeta.com
Footnotes
Published online Feb. 13, 2025.
- © 2025 by the Society of Nuclear Medicine and Molecular Imaging.
REFERENCE
- 1.↵
- Received for publication January 8, 2025.
- Accepted for publication January 13, 2025.