Toxicities and Early Outcomes in a Phase 1 Trial of Photodynamic Therapy For Premalignant and Early Stage Head and Neck Tumors

Simple item page
dc.contributor.authorAhn, Peter H.
dc.contributor.authorQuon, Harry
dc.contributor.authorO'Malley, Burt W.
dc.contributor.authorWeinstein, Gregory
dc.contributor.authorChalian, Ara
dc.contributor.authorMalloy, Kelly
dc.contributor.authorAtkins, Joshua H.
dc.contributor.authorSollecito, Thomas
dc.contributor.authorGreenberg, Martin
dc.contributor.authorMcNulty, Sally
dc.contributor.authorLin, Alexander
dc.contributor.authorZhu, Timothy C.
dc.contributor.authorFinlay, Jarod C.
dc.contributor.authorCengal, Keith
dc.contributor.authorLivolsi, Virginia
dc.contributor.authorFeldman, Michael
dc.contributor.authorMick, Rosemarie
dc.contributor.authorBusch, Theresa M.
dc.date2023-05-18T00:19:53.000
dc.date.accessioned2023-05-22T13:13:21Z
dc.date.available2023-05-22T13:13:21Z
dc.date.issued2016-04-01
dc.date.submitted2021-01-11T12:18:39-08:00
dc.description.abstractObjectives 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 (⩽1.5 mm depth) squamous cell carcinoma were enrolled. Cohorts of 3–6 patients were given escalating intraoperative light doses of 50–200 J/cm2 4–6 h after oral administration of 60 mg/kg ALA. Light at 629–635 nm 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 42 months, 10 patients (34%) developed local recurrence; 4 of these received 50 J/cm2 and two each received 100, 150, and 200 J/cm2. Ten (34%) patients developed recurrence adjacent to the treated field. There was a 69% complete response rate at 3 months. 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.
dc.identifier.urihttps://repository.upenn.edu/handle/20.500.14332/8906
dc.legacy.articleid1245
dc.legacy.fields10.1016/j.oraloncology.2016.01.013
dc.legacy.fulltexturlhttps://repository.upenn.edu/cgi/viewcontent.cgi?article=1245&context=dental_papers&unstamped=1
dc.rights<p>© <2016>. This manuscript version is made available under the CC-BY-NC-ND 4.0 license <a href="http://creativecommons.org/licenses/by-nc-nd/4.0/">http://creativecommons.org/licenses/by-nc-nd/4.0/</a></p>
dc.source.beginpage37
dc.source.endpage42
dc.source.issue194
dc.source.journalDepartmental Papers (Dental)
dc.source.journaltitleOral Oncology
dc.source.peerreviewedtrue
dc.source.statuspublished
dc.source.volume55
dc.subject.otherPhotodynamic therapy Levulan Head and neck cancer Severe dysplasia Carcinoma in situ ALA PDT Aminolevulinic acid Protoporphyrin IX
dc.subject.otherDentistry
dc.titleToxicities and Early Outcomes in a Phase 1 Trial of Photodynamic Therapy For Premalignant and Early Stage Head and Neck Tumors
dc.typeArticle
digcom.contributor.authorAhn, Peter H.
digcom.contributor.authorQuon, Harry
digcom.contributor.authorO'Malley, Burt W.
digcom.contributor.authorWeinstein, Gregory
digcom.contributor.authorChalian, Ara
digcom.contributor.authorMalloy, Kelly
digcom.contributor.authorAtkins, Joshua H.
digcom.contributor.authorSollecito, Thomas
digcom.contributor.authorGreenberg, Martin
digcom.contributor.authorMcNulty, Sally
digcom.contributor.authorLin, Alexander
digcom.contributor.authorZhu, Timothy C.
digcom.contributor.authorFinlay, Jarod C.
digcom.contributor.authorCengal, Keith
digcom.contributor.authorLivolsi, Virginia
digcom.contributor.authorFeldman, Michael
digcom.contributor.authorMick, Rosemarie
digcom.contributor.authorBusch, Theresa M.
digcom.identifierdental_papers/194
digcom.identifier.contextkey21041367
digcom.identifier.submissionpathdental_papers/194
digcom.typearticle
dspace.entity.typePublication
upenn.schoolDepartmentCenterDepartmental Papers (Dental)
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
Toxicities_.pdf
Size:
142.23 KB
Format:
Adobe Portable Document Format
Download
Collection
Articles