Photodynamic therapy with 3‐(1′‐hexyloxyethyl) pyropheophorbide‐a for early‐stage cancer of the larynx: Phase Ib study

Abstract

BackgroundThe purpose of this study was for us to report results regarding the safety of 3‐(1′‐hexyloxyethyl) pyropheophorbide‐a (HPPH) mediated photodynamic therapy (PDT) in early laryngeal disease, and offer preliminary information on treatment responses.MethodsA single‐institution, phase Ib, open label, noncomparative study of HPPH‐PDT in patients with high‐risk dysplasia, carcinoma in situ, and T1 squamous cell carcinoma (SCC) of the larynx. The primary outcomes were safety and maximum tolerated dose (MTD), and the secondary outcome was response.ResultsTwenty‐nine patients and 30 lesions were treated. The most common adverse event (AE) was transient hoarseness of voice. Severe edema, requiring tracheostomy, was the most serious AE, which occurred in 2 patients within several hours of therapy. The MTD was 100 J/cm2. Patients with T1 SCC seemed to have good complete response rate (82%) to HPPH‐PDT at MTD.ConclusionHPPH‐PDT can be safely used to treat early‐stage laryngeal cancer, with potential efficacy. © 2015 The Authors Head & Neck Published by Wiley Periodicals, Inc. Head Neck 38: E377–E383, 2016

A Phase I Study of Light Dose for Photodynamic Therapy Using 2-[1-Hexyloxyethyl]-2 Devinyl Pyropheophorbide-a for the Treatment of Non–Small Cell Carcinoma In Situ or Non–Small Cell Microinvasive Bronchogenic Carcinoma: A Dose Ranging Study

“…Based on this and several other studies, an HPPH dose of 4 mg/m 2 appears effective 13–15 . A 2-day drug/light interval was allowed in this trial.…”

“…A 2-day drug/light interval was allowed in this trial. In more recently initiated studies the drug/light interval has been reduced to ~24 hours based on pharmacokinetic studies 25 yielding at least comparable effectiveness 14, 15 . Although a maximally tolerated light dose could not be firmly established, the one SAE/DLT that occurred at 150 J/cm 2 suggests that the light dose should not exceed 125 J/cm 2 .…”

“…The trial (NCI-2010-02114) was carried out at RPCI between August 2004 and April 2013. HPPH was used at a fixed, previously determined systemic dose of 4 mg/m 27, 13–15 . The study followed a conventional 3+3 dose escalation scheme, designed to determine the maximally tolerated light dose (MTD) 16 .…”

Current state and future of photodynamic therapy for the treatment of head and neck squamous cell carcinoma

“…A Phase Ib study carried out at Roswell Park Cancer Institute examined response of laryngeal T1 squamous cell carcinoma of the larynx to HPPH treatment as a secondary outcome, and observed an 82% complete response rate. 12 …”

Photodynamic therapy induces antifibrotic alterations in primary human vocal fold fibroblasts

“…Merrill A. Biel treated 115 patients with early laryngeal cancers, and concluded that PDT resulted in no glottic scarring as compared to conventional laser or surgical excision . Shafirstein et al reported that there was no damage to the mucosal wave of vocal folds after PDT in some patients with laryngeal carcinoma . Silbergleit et al reported that PDT yielded significant improvement in amplitude of vibration, mucosal wave, and nonvibrating portion of the vocal folds after treatment of laryngeal malignancies .…”