scholarly journals Photodynamic Therapy in Refractory Mycosis Fungoides: A Prospective, Open-Label Study

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 32-32
Author(s):  
Caitlin M Brumfiel ◽  
Kevin J Severson ◽  
Meera H Patel ◽  
Helen J L Cumsky ◽  
Brenda F Ginos ◽  
...  

Background:Case reports suggest photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA) is an effective treatment for refractory mycosis fungoides (MF). No prospective trials have examined the use of ALA-PDT in MF. Objective:We aimed to assess the efficacy of ALA-PDT in refractory MF. Methods:This was a prospective study at Mayo Clinic in Scottsdale, Arizona in patients ≥ 18 years with plaque-stage treatment-refractory MF. Monthly sessions of ALA with blue light PDT were administered for up to six months. Responses were measured by Composite Assessment of Index Lesion Severity (CAILS) and Physician Global Assessment (PGA). Ad hoc analysis with modified CAILS (mCAILS) was performed, eliminating hyperpigmentation from scoring. Results:Eleven patients (30 total lesions) were treated. Six patients completed the trial per protocol. Objective response rates were 36.4% by PGA (10.9-69.2%), 18.2% by CAILS (2.3-51.8%), and 36.4% by mCAILS (10.9-69.2%). Limitations:Five patients did not complete all six PDT cycles per protocol, possibly accounting for reduced efficacy. Conclusion:ALA-PDT with blue light irradiation was moderately effective and well tolerated in refractory plaque stage MF. Lower response rates compared to similar trials may be partially explained by utilization of strict lesional assessment criteria and other variations in methodology. Disclosures Mangold: MiRagen:Research Funding;Sun Pharma:Research Funding;Elorac:Research Funding;Kirin:Membership on an entity's Board of Directors or advisory committees;Solagenix:Research Funding. OffLabel Disclosure: Photodynamic therapy is a two-step therapy in which a drug that acts as a photosensitizer is administered to target a diseased tissue, followed by illumination with visible light to activate the drug and destroy the target tissue. PDT has been used to treat internal cancers as well as treatment of cancer and precancer of the skin.

2020 ◽  
Vol 4 (4) ◽  
pp. 357-360
Author(s):  
Joan Paul ◽  
Alicia T. Dagrosa ◽  
Youdinghuan Chen ◽  
Pamela Gangar ◽  
Daniel Ressler ◽  
...  

ABSTRACTBackground:  Actinic cheilitis is a common precancerous disorder of the lower lip caused by ultraviolet radiation. Photodynamic therapy (PDT) is a potential treatment for actinic cheilitis, however controlled clinical trials regarding this treatment are needed.Objective:  To evaluate the safety and efficacy of PDT with blue light and topical δ-aminolevulinic acid (Levulan®) in the treatment of actinic cheilitis.Methods:  We conducted a single center, investigator-initiated, nonrandomized, open-label, proof of concept study of PDT with blue light for the treatment of actinic cheilitis. We enrolled 24 subjects, 20 meeting inclusion and exclusion criteria. One subject withdrew from the study prior to treatment. The study consisted of a screening visit, one to three scheduled treatments, and two follow-up visits. The primary outcome was clinical improvement in actinic cheilitis from baseline, estimated as no (0%), mild (25%), moderate (50%), marked (75%), or excellent improvement (100%). Post-treatment assessment of swelling, erythema, flaking/scaling, crusting, vesiculation/pustulation, and erosion/ulceration was also recorded. Subjects completed the Dermatological Life Quality Index questionnaire, subject global assessment of improvement, and pain assessment at each visit.Results:  65% of subjects achieved clinical improvement of 75% or greater and 20% achieved 100% improvement by the end of the study. Treatments were well tolerated with minimal discomfort. Subjects experienced transient mild adverse effects.Conclusion:  Overall, our study supports using PDT for the treatment of actinic cheilitis.


1998 ◽  
Vol 16 ◽  
pp. S208
Author(s):  
Edward Jeffes ◽  
Jerry McCullough ◽  
Gerald Weinstein ◽  
Toni Shull ◽  
Ross Kaplan ◽  
...  

2004 ◽  
Vol 140 (1) ◽  
Author(s):  
Daniel J. Piacquadio ◽  
Diana M. Chen ◽  
Harold F. Farber ◽  
Joseph F. Fowler, Jr ◽  
Scott D. Glazer ◽  
...  

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4542-4542
Author(s):  
Andrea Necchi ◽  
Arlene O. Siefker-Radtke ◽  
Bob Zhong ◽  
Parthiv Jasvant Mahadevia ◽  
Ademi E. Santiago-Walker ◽  
...  

4542 Background: FGFR-altered, advanced UC has predominantly a luminal 1 subtype, which is associated with lower response rates to immunotherapy and possibly also to chemotherapy. Objective response rates (ORR) for first-line cisplatin-based regimens, such as gemcitabine-cisplatin (gem/cis) and methotrexate-vinblastine-doxorubicin-cisplatin (MVAC), historically range between 45-60% and for gemcitabine-carboplatin (gem/carbo) 35-45%. However, the ORR on chemotherapy for the ~20% of patients with FGFR-altered tumors is unknown. Methods: BLC2001 (NCT02365597) is an ongoing global open-label phase 2 study of the pan-FGFR inhibitor erdafitinib in patients with locally advanced or metastatic UC with specific FGFR2/3 gene alterations. Patients who had received first-line (1L) or second-line (2L) chemotherapy for advanced UC were identified. Investigator-reported ORR (complete + partial responses) and median time to progression (TTP) on these pretreatments were analyzed. Results: Of 210 patients treated with erdafitinib in BLC2001, 191 had received prior systemic therapy including 184 and 83 patients who had received 1L and 2L chemotherapy, respectively. ORR were 29.3% (54/184; 95% CI 22.8%, 35.9%) to 1L chemotherapy and 24.1% (20/83; 95% CI 14.9%, 33.3%) to 2L chemotherapy. 1L therapy consisted of gem/cis in 94 patients, gem/carbo in 59 patients, and MVAC in 22 patients, with ORR (95% CI) of 35.1% (25.5%, 44.8%), 25.4% (14.3%, 36.5%), and 22.7% (5.2%, 40.2%), respectively. In the 2L setting, of 46 patients who had received a regimen containing a taxane (paclitaxel or docetaxel) or vinflunine, 8 patients (17.4%; 95% CI 6.4%, 28.3%) achieved an objective response. Median TTP was 7.16 mo (95% CI 6.18, 7.49) after 1L chemotherapy (7.6 mo for gem/cis, 6.3 mo for gem/carbo, and 5.3 mo for MVAC) and 4.35 mo (95% CI 3.3, 5.5) after 2L chemotherapy (3.6 mo for taxane or vinflunine). Conclusions: In this post-hoc analysis, the overall ORR to prior 1L chemotherapy was lower, but within the range expected based on historical data. Further investigation into the response to chemotherapy in FGFR alteration positive patients is warranted and may be useful for the development of 1L trials of combination therapy. Clinical trial information: NCT02365597.


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