Peter H Ahn1, Harry Quon2, Bert W O'Malley3, Gregory Weinstein3, Ara Chalian3, Kelly Malloy4, Joshua H Atkins5, Thomas Sollecito6, Martin Greenberg6, Sally McNulty7, Alexander Lin7, Timothy C Zhu7, Jarod C Finlay7, Keith Cengel7, Virginia Livolsi8, Michael Feldman8, Rosemarie Mick9, Theresa M Busch7. 1. Department of Radiation Oncology, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA 19104, United States. Electronic address: peter.ahn@uphs.upenn.edu. 2. Department of Radiation Oncology, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA 19104, United States; Department of Radiation Oncology, Johns Hopkins University, 401 N. Broadway, Baltimore, MA 21231, United States. 3. Department of Otolaryngology-Head and Neck Surgery, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, United States. 4. Department of Otolaryngology-Head and Neck Surgery, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, United States; Department of Otolaryngology, University of Michigan, 1500 E. Medical Center Dr, Ann Arbor, MI 48109, United States. 5. Department of Anesthesiology, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, United States. 6. Department of Oral Medicine, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA 19104, United States. 7. Department of Radiation Oncology, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA 19104, United States. 8. Department of Pathology, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, United States. 9. Department of Biostatistics and Epidemiology, University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA 19104, United States.
Abstract
OBJECTIVES: Management of early superficial lesions in the head and neck remains complex. We performed a phase 1 trial for high-grade premalignant and early superficial lesions of the head and neck using photodynamic therapy (PDT) with Levulan (ALA). MATERIALS AND METHODS: Thirty-five subjects with high grade dysplasia, carcinoma in situ, or microinvasive (⩽1.5mm depth) squamous cell carcinoma were enrolled. Cohorts of 3-6 patients were given escalating intraoperative light doses of 50-200J/cm(2) 4-6h after oral administration of 60mg/kg ALA. Light at 629-635nm was delivered in a continuous (unfractionated) or fractionated (two-part) schema. RESULTS: PDT was delivered to 30/35 subjects, with 29 evaluable. There was one death possibly due to the treatment. The regimen was otherwise tolerable, with a 52% rate of grade 3 mucositis which healed within several weeks. Other toxicities were generally grade 1 or 2, including odynophagia (one grade 4), voice alteration (one grade 3), and photosensitivity reactions. One patient developed grade 5 sepsis. With a median follow-up of 42months, 10 patients (34%) developed local recurrence; 4 of these received 50J/cm(2) and two each received 100, 150, and 200J/cm(2). Ten (34%) patients developed recurrence adjacent to the treated field. There was a 69% complete response rate at 3months. CONCLUSIONS: ALA-PDT is well tolerated. Maximum Tolerated Dose appears to be higher than the highest dose used in this study. Longer followup is required to analyze effect of light dose on local recurrence. High marginal recurrence rates suggest use of larger treatment fields.
OBJECTIVES: Management of early superficial lesions in the head and neck remains complex. We performed a phase 1 trial for high-grade premalignant and early superficial lesions of the head and neck using photodynamic therapy (PDT) with Levulan (ALA). MATERIALS AND METHODS: Thirty-five subjects with high grade dysplasia, carcinoma in situ, or microinvasive (⩽1.5mm depth) squamous cell carcinoma were enrolled. Cohorts of 3-6 patients were given escalating intraoperative light doses of 50-200J/cm(2) 4-6h after oral administration of 60mg/kg ALA. Light at 629-635nm was delivered in a continuous (unfractionated) or fractionated (two-part) schema. RESULTS: PDT was delivered to 30/35 subjects, with 29 evaluable. There was one death possibly due to the treatment. The regimen was otherwise tolerable, with a 52% rate of grade 3 mucositis which healed within several weeks. Other toxicities were generally grade 1 or 2, including odynophagia (one grade 4), voice alteration (one grade 3), and photosensitivity reactions. One patient developed grade 5 sepsis. With a median follow-up of 42months, 10 patients (34%) developed local recurrence; 4 of these received 50J/cm(2) and two each received 100, 150, and 200J/cm(2). Ten (34%) patients developed recurrence adjacent to the treated field. There was a 69% complete response rate at 3months. CONCLUSIONS:ALA-PDT is well tolerated. Maximum Tolerated Dose appears to be higher than the highest dose used in this study. Longer followup is required to analyze effect of light dose on local recurrence. High marginal recurrence rates suggest use of larger treatment fields.
Authors: Dennis M Sopka; Tianyu Li; Miriam N Lango; Ranee Mehra; Jeffrey Chang-Jen Liu; Barbara Burtness; Douglas B Flieder; John A Ridge; Thomas J Galloway Journal: Oral Oncol Date: 2013-09-17 Impact factor: 5.337
Authors: Joseph S Friedberg; Melissa J Culligan; Rosemarie Mick; James Stevenson; Stephen M Hahn; Daniel Sterman; Salman Punekar; Eli Glatstein; Keith Cengel Journal: Ann Thorac Surg Date: 2012-05 Impact factor: 4.330
Authors: B L Wenig; D M Kurtzman; L I Grossweiner; M F Mafee; D M Harris; R V Lobraico; R A Prycz; E L Appelbaum Journal: Arch Otolaryngol Head Neck Surg Date: 1990-11
Authors: K Furuse; M Fukuoka; H Kato; T Horai; K Kubota; N Kodama; Y Kusunoki; N Takifuji; T Okunaka; C Konaka Journal: J Clin Oncol Date: 1993-10 Impact factor: 44.544
Authors: Peter H Ahn; Jarod C Finlay; Shannon M Gallagher-Colombo; Harry Quon; Bert W O'Malley; Gregory S Weinstein; Ara Chalian; Kelly Malloy; Thomas Sollecito; Martin Greenberg; Charles B Simone; Sally McNulty; Alexander Lin; Timothy C Zhu; Virginia Livolsi; Michael Feldman; Rosemarie Mick; Keith A Cengel; Theresa M Busch Journal: Photodiagnosis Photodyn Ther Date: 2017-11-04 Impact factor: 3.631
Authors: Laura Mühleisen; Magdalena Alev; Harald Unterweger; Daniel Subatzus; Marina Pöttler; Ralf P Friedrich; Christoph Alexiou; Christina Janko Journal: Int J Mol Sci Date: 2017-06-29 Impact factor: 5.923