Photodynamic Therapy In Patients Research Articles

Two Cases of Massive Subretinal Fluid Accumulation after Photodynamic Therapy for Age-related Macular Degeneration

Purpose: To report two cases of massive subretinal fluid accumulation at laser irradiated sites after photodynamic therapy in patients with age-related macular degeneration (ARMD).Case summary: (Case 1) A patient with bilateral polypoidal choroidal vasculopathy, who was treated with half-dose verteporfin photodynamic therapy (PDT), developed decreased visual acuity. On fundus examination, massive subretinal fluid accumulation was observed in the laser irradiated sites of both eyes. The subretinal fluid was reabsorbed without further treatment, and the patient's visual acuity has recovered. (Case 2) A patient with ARMD, accompanied by a choroidal neovascular membrane and accumulation of subretinal fluid in the right eye, developed decreased visual acuity on the treated eye a day after receiving half-dose PDT treatment. On fundus examination, the subretinal fluid in the right eye had increased more than 5-fold compared to pre-treatment levels. After one week, the amount of subretinal fluid decreased and the patient's visual acuity improved. However, since retinal exudate still remained, intravitreal bevacizumab treatment was administered. Thereafter, the patient’s fundus findings were unremarkable.Conclusions: In the case of photodynamic therapy for ARMD, a large amount of subretinal fluid may occur as a rare complication. The subretinal fluid was naturally absorbed, but close observation is needed with the possibility of developing subretinal fluid in the event of decreased vision after photodynamic therapy.

Texture and color enhancement imaging improve visibility in photodynamic therapy for patients with esophageal squamous cell carcinoma.

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Antimicrobial effect of indocyanine green-mediated photodynamic therapy in patients with periodontal disease: A systematic review

Abstract Aim: This systematic review assessed the antimicrobial effect of indocyanine green-mediated photodynamic therapy (ICG-PDT) in patients with periodontal disease. Materials and Methods: Four electronic databases that is, MEDLINE, MEDLINE-In-Process, EMBASE, and Cochrane Library were systematically searched from their inception until December 22, 2022. Randomized controlled trials (RCTs) reporting the antimicrobial effect of ICG-PDT in patients with periodontal disease and published in English were included. The Cochrane risk of bias tool was used to assess the quality of the included RCTs. Two independent reviewers performed all the steps involved in a systematic review (primary and secondary screening, data extraction, and quality assessment). As the data extracted was not suitable for meta-analysis, the evidence was synthesized qualitatively. Results: Overall, seven RCTs from seven publications were included. All included studies had PDT, laser, or photothermal with ICG as the test group while the control group included low-level laser therapy, root surface debridement, and scaling and root planning. The bacterial species assessed across the included studies included Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, Tannerella forsythia, Fusobacterium nucleatum, and Treponema denticola. With subtle exceptions, ICG-PDT in combination with root surface debridement and scaling and root planning significantly reduced the growth of periodontal pathogens from baseline. Conclusion: Based on the evidence from the limited studies, ICG-PDT seems to exhibit potent antimicrobial activity against an array of periodontal pathogens in patients with periodontal disease.

Effects of photodynamic therapy in patients with infected skin ulcers: A meta-analysis.

The purpose of the meta-analysis was to evaluate and compare the photodynamic therapy's effectiveness in treating infected skin wounds. The results of this meta-analysis were analysed, and the odds ratio (OR) and mean difference (MD) with 95% confidence intervals (CIs) were calculated using dichotomous or contentious random- or fixed-effect models. For the current meta-analysis, 6 examinations spanning from 2013 to 2021 were included, encompassing 154 patients with infected skin wounds were the used studies' starting point. Photodynamic therapy had a significantly lower wound ulcer size (MD, -4.42; 95% CI, -7.56--1.28, p = 0.006), better tissue repair (MD, -8.62; 95% CI, -16.76--0.48, p = 0.04) and lower microbial cell viability (OR, 0.13; 95% CI, 0.04-0.42, p < 0.001) compared with red light exposure in subjects with infected skin wounds. The examined data revealed that photodynamic therapy had a significantly lower wound ulcer size, better tissue repair and lower microbial cell viability compared with red light exposure in subjects with infected skin wounds. However, given that all examinations had a small sample size, consideration should be given to their values.

Photodynamic therapy in the treatment of vulvar lichen sclerosus et atrophicus

Lichen sclerosus (LS) is a chronic inflammatory disease that is 6–10 times more common in women than in men. LS affects between 1 in 1,000 and 1 in 300 people in the general population, but the exact prevalence is unknown since the disease is often asymptomatic. Objective: to evaluate the effectiveness of PDT in patients with LS in comparison with standard therapy methods. Material and methods: The study included 45 patients diagnosed with LS aged from 45 to 72 years (median age was 59 years). Depending on the therapy performed, the groups were divided into subgroups: Group 1A — patients with LS who were prescribed therapy with external glucocorticoids, Group 1B — patients with LS who were prescribed photodynamic therapy, Group 1C — patients with LS who were prescribed combined treatment: external glucocorticoids + PDT. Results: The study developed a special visual analogue scale to assess the objective condition of the vulva. VAS included the following parameters: pigmentation, skin pattern, turgor (skin fold straightening time), presence of cracks or erosions, and moisture. According to the data obtained, a complex treatment method using photodynamic therapy in patients with vulvar lichen sclerosus et atrophicus causes a higher effect than drug therapy and mono-PDT, which is confirmed by the dynamics of the total VAS index: 50.8 % compared with 28.2 % and 35.1 % in the comparison groups, respectively, therefore, it can be recommended for use in practical healthcare.

Aniseikonia after reduced-fluence photodynamic therapy in patients with central serous chorioretinopathy

This study investigated aniseikonia after reduced-fluence photodynamic therapy (RFPDT) for central serous chorioretinopathy (CSC). We examined 48 eyes of 48 patients (38 men; mean age, 49.2 ± 9.9 years) with CSC resolved after RFPDT. Horizontal and vertical aniseikonia were measured using the New Aniseikonia Test at baseline, 6 months, and 12 months after RFPDT. The maximum absolute value of the horizontal and vertical measurements indicated the aniseikonia score. The aniseikonia score was 2.2 ± 2.3 at 6 months and 2.2 ± 2.0 at 12 months after RFPDT, both of which improved significantly from the baseline score of 4.1 ± 2.9 (P < 0.05 and P < 0.01, respectively). The 12-month aniseikonia score significantly correlated with the baseline aniseikonia score (P = 0.047), outer nuclear thickness at baseline (P = 0.027) and 12 months after RFPDT (P = 0.014), baseline SRD area (P = 0.005), and ellipsoid zone disruption at 12 months after RFPDT (P = 0.021). In multivariate analysis, baseline serous retinal detachment (SRD) area (P = 0.034) was significantly associated with aniseikonia score at 12 months after RFPDT. Eyes with a larger SRD area might have higher aniseikonia scores even after SRD resolution following RFPDT.

Comparison between regular additional endobiliary radiofrequency ablation and photodynamic therapy in patients with advanced extrahepatic cholangiocarcinoma under systemic chemotherapy.

Extrahepatic cholangiocarcinoma (eCCA) remains a malignancy with a dismal prognosis. The first-line standard of care includes systemic chemotherapy (SC) and biliary drainage through stenting. Endobiliary ablative techniques, such as photodynamic therapy (ePDT) and radio-frequency ablation (eRFA), have demonstrated feasibility and favorable survival data. This study aimed to compare the oncologic outcome in patients treated with SC and concomitant eRFA or ePDT. All patients with eCCA were evaluated for study inclusion. Sixty-three patients receiving a combination of SC and at least one endobiliary treatment were retrospectively compared. Patients were stratified into three groups: SC + ePDT (n = 22), SC + eRFA (n = 28), and SC + ePDT + eRFA (n = 13). The median overall survival (OS) of the whole cohort was 14.2 months with no statistically significant difference between the three therapy groups but a trend to better survival for the group receiving ePDT as well as eRFA, during SC (ePDT + SC, 12.7 months; eRFA + SC, 13.8 months; ePDT + eRFA + SC, 20.2 months; p = 0.112). The multivariate Cox regression and subgroup analysis highlighted the beneficial effect of eRFA on OS. Overall, combined therapy was well tolerated. Only cholangitis occurred more often in the SC + eRFA group. Additional endobiliary ablative therapies in combination with SC were feasible. Both modalities, eRFA and ePDT, showed a similar benefit in terms of survival. Interestingly, patients receiving both regimes showed the best OS indicating a possible synergism between both ablative therapeutic techniques.

Photodynamic therapy of acne

Acne is one of the most common skin conditions in the world. A number of studies have shown that photodynamic therapy (PDT) is safe and effective for both inflammatory and non-inflammatory acne and can significantly improve skin conditions in this disease. The effectiveness of PDT against acne is mainly due to a decrease in the amount of sebum produced by the sebaceous glands due to a decrease in their activity as a result of direct photodynamic damage to the sebaceous glands, eradication of Cutibacterium acnes, and a decrease in the level of hyperkeratosis. Compared with systemic drug therapy, PDT treatment of severe acne has the following advantages: fast results, high efficiency, high selectivity, no systemic adverse reactions and drug resistance, and low recurrence rate. Most often for PDT in patients with acne, drugs based on 5-aminolevulinic acid (5-ALA) and its methyl ester (ME-ALA) are used. At the moment, there are no unified recommendations on PDT regimens for the treatment of this skin pathology. Various studies demonstrate the high efficiency of PDT with a wide range of doses of 5-ALA (3-20%) and ME-ALA (4-16%), light doses (15-120 J/cm2 ), and exposure time (30-90 min). The general trend in studies by different authors is that gentle low-intensity PDT regimens for acne demonstrate the same high efficiency with a significant reduction in pain during irradiation and local skin reactions (erythrema, edema, and hyperpigmentation).

Palliative surgical treatment using photodynamic therapy for biliary cancer complicated by obstructive jaundice

The article presents the results of a study of survival, markers of hemostasis, proteolysis, and tumor invasion after complex palliative treatment of patients with histologically verified malignant tumors of the bile ducts complicated by obstructive jaundice in two comparable groups of patients. The aim of the study was to evaluate the effectiveness of palliative surgical treatment using photodynamic therapy in patients with malignant tumors of the biliary system complicated by obstructive jaundice. In 10 patients of the main group, palliative surgical treatment was performed using photodynamic therapy; in 20 patients of the comparison group, palliative surgical treatment was performed without photodynamic therapy. In patients of the main group, a statistically significant increase in life expectancy by 104 days (p=0.033) was observed compared to the comparison group. At the same time, a statistically significant effect of tumor necrosis factor α, a marker of tumor invasion, on survival (p = 0.012) and a decrease in its level after photodynamic therapy by 15 pg/ml (p=0.041) was revealed. Thus, palliative treatment using photodynamic therapy of malignant tumors of the bile ducts, complicated by obstructive jaundice, can increase the survival rate of patients by reducing tumor invasion.

Novel Photodynamic Therapy for Esophageal Squamous Cell Carcinoma following Radiotherapy.

Radiotherapy (RT) or chemoradiotherapy (CRT) are frequently selected as treatments for esophageal squamous cell carcinoma (ESCC). However, salvage treatment remains challenging when endoscopic resection is not indicated for residual or recurrent ESCC following RT or CRT. Recently, owing to the emergence of second-generation photodynamic therapy (PDT) using talaporfin sodium, PDT can be performed with less phototoxicity and therefore has regained popularity in the treatment of ESCC. In this study, the effectiveness and safety of second-generation PDT in patients with residual or recurrent ESCC following RT or CRT were examined. Local complete response (L-CR) rates, procedure-related adverse events, and prognosis were evaluated. In 12 patients with 20 ESCC lesions, the L-CR rates were 95.0%. Perforation, postoperative bleeding, and photosensitivity were not observed. Esophageal stricture following PDT developed in one patient, but this could be addressed using balloon dilation. During a median follow-up period of 12 (range, 3-42) months, the 3-year cause-specific survival rate was 85.7%. Even in patients with a Charlson comorbidity index score ≥ 3, the 2-year overall survival rates were 100%. In conclusion, PDT was an efficacious and a safe salvage treatment in patients with local residual or recurrent ESCC following RT or CRT.

Photodynamic Therapy is an Effective Treatment of Facial Pigmented Actinic Keratosis.

Actinic keratosis (AK), or solar keratosis, is a precancerous condition of the skin, mainly caused by excessive and chronic exposure to ultraviolet radiation. Pigmented AK (pAK) is a rare variant of AK. Photodynamic therapy (PDT) is widely used to treat the classical variant of AK, but very limited data are available on the use of PDT in patients with pAK. The objective of this study was to assess the usefulness of PDT in the treatment of pAK. The study included 16 patients with 20 pAK lesions treated with PDT. All skin lesions were clinically and dermatoscopically assessed for typical features characteristic of pAK. Reflectance confocal microscopy (RCM) was also used to assess keratinocyte atypia, confirm pAK diagnosis, and rule out other disease entities. After three PDT sessions, the complete resolution of all clinical features of pAK was observed in 80% of the studied lesions. Dermatoscopically, 65% of the lesions achieved 100% response and no cellular atypia was seen in the follow-up RCM images of 85% of lesions. Photodynamic therapy is an effective treatment modality for pAK in fair-skinned individuals.

MP63-01 AN INTERIM ANALYSIS OF A PHASE II CLINICAL STUDY OF INTRAVESICAL PHOTO DYNAMIC THERAPY IN PATIENTS WITH BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) CARCINOMA IN-SITU (CIS)

You have accessJournal of UrologyCME1 Apr 2023MP63-01 AN INTERIM ANALYSIS OF A PHASE II CLINICAL STUDY OF INTRAVESICAL PHOTO DYNAMIC THERAPY IN PATIENTS WITH BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) CARCINOMA IN-SITU (CIS) Girish Kulkarni, Kyle Richards, Peter C. Black, Ricardo Rendon, Joseph Chin, Neal Shore, Gautam Jayram, Eugene Kramolowsky, Daniel Saltzstein, Piyush Agarwal, Laurence Belkoff, Michael O'Donnell, Ashish M. Kamat, Alexandre Zlotta, Michael A. S. Jewett, Donald Lamm, Victor DeGruttola, Arkady Mandel, Roger J. Dumoulin-White, and Wassim Kassouf Girish KulkarniGirish Kulkarni More articles by this author , Kyle RichardsKyle Richards More articles by this author , Peter C. BlackPeter C. Black More articles by this author , Ricardo RendonRicardo Rendon More articles by this author , Joseph ChinJoseph Chin More articles by this author , Neal ShoreNeal Shore More articles by this author , Gautam JayramGautam Jayram More articles by this author , Eugene KramolowskyEugene Kramolowsky More articles by this author , Daniel SaltzsteinDaniel Saltzstein More articles by this author , Piyush AgarwalPiyush Agarwal More articles by this author , Laurence BelkoffLaurence Belkoff More articles by this author , Michael O'DonnellMichael O'Donnell More articles by this author , Ashish M. KamatAshish M. Kamat More articles by this author , Alexandre ZlottaAlexandre Zlotta More articles by this author , Michael A. S. JewettMichael A. S. Jewett More articles by this author , Donald LammDonald Lamm More articles by this author , Victor DeGruttolaVictor DeGruttola More articles by this author , Arkady MandelArkady Mandel More articles by this author , Roger J. Dumoulin-WhiteRoger J. Dumoulin-White More articles by this author , and Wassim KassoufWassim Kassouf More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003321.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Novel therapies are required for BCG-unresponsive, high risk non-muscle invasive bladder cancer. We report the interim results of a Phase II Clinical Study of intravesical Photo Dynamic Therapy (PDT) in patients with BCG-unresponsive carcinoma in-situ (CIS) (+/- papillary disease). METHODS: 41 of planned 125 patients have been treated with two study treatments (Day 0 and Day 180) consisting of an intravesical instillation of the photosensitizer (TLD-1433 (0.70 mg/cm2)) followed by activation with a 520 nm intravesical laser under general anesthesia (Study Device TLC-3200) to a total of 90 J/cm2 of laser light. We have included 3 patients treated in a preceding Phase Ib NMIBC clinical study assessing the safety of TLD-1433 PDT, who were treated at the same parameters, for a total of 44 patients. The primary outcome was complete response (CR) at any point in time. The secondary outcome was duration of CR, after initial CR. A tertiary objective was safety, evaluated by the incidence and severity of grade ≥4 adverse events (AEs) that did not resolve within 450 days post treatment. All AEs were tracked for resolution to 450 days. Patients with a negative cystoscopy and positive cytology were defined as indeterminate response (IR), as these patients remain under investigation for lower and upper tract urothelial carcinoma. RESULTS: Primary and secondary outcomes for the first 41 patients plus the 3 Phase Ib patients (n=44) are listed in the table. For evaluable patients, a primary outcome of 55.3% CR at any point in time was achieved, with a secondary outcome of duration of response of 21% CR at 450 days. There have been eight serious adverse events (SAE) identified (2 grade II (tachycardia, hematuria), 3 grade III (acute kidney injury, cellulitis), 2 grade IV (urosepsis, depression/anxiety) and 1 grade V (cardiac arrest)). None of the SAEs were deemed to be directly related to PDT, per the Data Safety Monitoring Board. CONCLUSIONS: The interim data supports that PDT provides a viable treatment option for patients with BCG unresponsive CIS (±papillary disease) with an acceptable safety profile. Source of Funding: Theralase Technologies Inc © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e871 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Girish Kulkarni More articles by this author Kyle Richards More articles by this author Peter C. Black More articles by this author Ricardo Rendon More articles by this author Joseph Chin More articles by this author Neal Shore More articles by this author Gautam Jayram More articles by this author Eugene Kramolowsky More articles by this author Daniel Saltzstein More articles by this author Piyush Agarwal More articles by this author Laurence Belkoff More articles by this author Michael O'Donnell More articles by this author Ashish M. Kamat More articles by this author Alexandre Zlotta More articles by this author Michael A. S. Jewett More articles by this author Donald Lamm More articles by this author Victor DeGruttola More articles by this author Arkady Mandel More articles by this author Roger J. Dumoulin-White More articles by this author Wassim Kassouf More articles by this author Expand All Advertisement PDF downloadLoading ...

Safety and Feasibility of Photodynamic Therapy for Ablation of Peripheral Lung Tumors.

Newer navigational bronchoscopy technologies render peripheral lung lesions accessible for biopsy and potential treatment. We investigated whether photodynamic therapy (PDT) delivered via navigational bronchoscopy is feasible and safe for ablation of peripheral lung tumors. Two studies evaluated PDT in patients with solid peripheral lung tumors followed by clinical follow-up (nonresection study, N=5) or lobectomy (resection study, N=10). Porfimer sodium injection was administered 40 to 50 hours before navigational bronchoscopy. Lesion location was confirmed by radial probe endobronchial ultrasonography. An optical fiber diffuser was placed within or adjacent to the tumor under fluoroscopic guidance; laser light (630nm wavelength) was applied at 200J/cm of diffuser length for 500 seconds. Tumor response was assessed by modified Response Evaluation Criteria in Solid Tumors at 3 and 6 months postprocedure (nonresection study) and pathologically (resection study). There were no deaths, discontinuations for adverse events, or serious or grade ≥3 adverse events related to study treatments. Photosensitivity reactions occurred in 8 of 15 patients: 6 mild, 1 moderate, 1 severe (elevated porphyrins noted in blood after treatment). Among 5 patients with clinical follow-up, 1 had complete response, 3 had stable disease, and 1 had progressive disease at 6 months follow-up. Among 10 patients who underwent lobectomy, 1 had no evidence of tumor at resection (complete response), 3 had 40% to 50% tumor cell necrosis, 2 had 20% to 35%, and 4 had 5% to 10%. PDT for nonthermal ablation of peripheral lung tumors was feasible and safe in this small study. Further study is warranted to evaluate efficacy and corroborate the safety profile.

Efficacy of 5-aminolevulinic acid-mediated photodynamic therapy in patients with nicotine stomatitis.

This study aimed to treat smoker's palate (SP) using 5-aminolevulinic acid (5-ALA)-mediated photodynamic therapy (PDT). A total of 24 patients with SP were divided into two groups: group-I (test group; n=12); and group-II (control group; n=12). Group-I patients were treated with 5-ALA-mediated PDT, while group-II patients were advised to cease the smoking habit during the entire duration of the study and later. PDT was repeated on days 3, 7, and 14 (i.e., a total of four sittings including day 0 [baseline]). Later, the participants were called for follow-up after week-4 (1st follow-up), week-6 (2nd follow-up), and week-8 (3rd follow-up) after the completion of the treatment. The SPSS version 22.0 was used for data analysis. Group-I patients showed a statistically significant improvement when all three time points were assessed (p<0.0001). Similarly, the same trend was observed in the group-II participants (p<0.001), however, the difference between both groups (i.e., group-I [test group] and group-II [control group]) was larger. The findings of this clinical trial indicated a promising and satisfactory decrease in the clinical features of the smoker's palate without any adverse impacts utilizing 5-aminolevulinic acid-mediated photodynamic therapy. Hence, 5-ALA-mediated PDT appeared to be a promising treatment option together with smoking cessation.

Fully automatic segmentation and monitoring of choriocapillaris flow voids in OCTA images.

Optical coherence tomography angiography (OCTA) is a non-invasive ophthalmic imaging modality that is widely used in clinical practice. Recent technological advances in OCTA allow imaging of blood flow deeper than the retinal layers, at the level of the choriocapillaris (CC), where a granular image is obtained showing a pattern of bright areas, representing blood flow, and a pattern of small dark regions, called flow voids (FVs). Several clinical studies have reported a close correlation between abnormal FVs distribution and multiple diseases, so quantifying changes in FVs distribution in CC has become an area of interest for many clinicians. However, CC OCTA images present very complex features that make it difficult to correctly compare FVs during the monitoring of a patient. In this work, we propose fully automatic approaches for the segmentation and monitoring of FVs in CC OCTA images. First, a baseline approach, in which a fully automatic segmentation methodology based on local contrast enhancement and global thresholding is proposed to segment FVs and measure changes in their distribution in a straightforward manner. Second, a robust approach in which, prior to the use of our segmentation methodology, an unsupervised trained neural network is used to perform a deformable registration that aligns inconsistencies between images acquired at different time instants. The proposed approaches were tested with CC OCTA images collected during a clinical study on the response to photodynamic therapy in patients affected by chronic central serous chorioretinopathy (CSC), demonstrating their clinical utility. The results showed that both approaches are accurate and robust, surpassing the state of the art, therefore improving the efficacy of FVs as a biomarker to monitor the patient treatments. This gives great potential for the clinical use of our methods, with the possibility of extending their use to other pathologies or treatments associated with this type of imaging.

The Impact of Surgically Induced Inflammation on Outcomes Following Intraoperative Photodynamic Therapy in Patients with Thoracic Malignancies

The Impact of Surgically Induced Inflammation on Outcomes Following Intraoperative Photodynamic Therapy in Patients with Thoracic Malignancies

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A chlorin e6 derivative‐mediated photodynamic therapy for patients with cervical and vaginal low‐grade squamous intraepithelial lesions: a retrospective analysis, by Hongxia Yao, Jia Yan, Zhongxia Zhou, Shuzhan Shen, Yun Wu, Pei Liu, Haiyan Zhang, and Xiuli Wang image

A phase II clinical study of intravesical photo dynamic therapy in patients with BCG-unresponsive NMIBC (interim analysis).

528 Background: Novel therapies are required for BCG-unresponsive, high risk non-muscle invasive bladder cancer. We report the interim results of a Phase II Clinical Study of Intravesical Photo Dynamic Therapy (PDT) in patients with BCG-Unresponsive Carcinoma In-Situ (CIS) with or without papillary disease. Methods: Out of a planned 125 patients, 42 patients have been enrolled and treated with two Study Treatments (Day 0 and Day 180) consisting of an intravesical instillation of the photosensitizer TLD-1433 (0.70 mg/cm2) followed by activation with a 520 nm intravesical laser under general anesthesia (Study Device TLC-3200) to a total of 90 J/cm2 of laser light. The primary outcome assessed was efficacy, evaluated by Complete Response (CR), at any point in time. The secondary outcome was duration of CR at 12 months, post initial CR. A tertiary objective is safety, evaluated by the incidence and severity of Adverse Events, Grade 4 or higher that do not resolve within 450 days post treatment. Patients with a negative cystoscopy and positive cytology have been defined as indeterminate response (IR), as these patients remain under investigation for lower and upper tract urothelial carcinoma. Results: Interim analyses included the first 42 patients, along with 3 patients treated in a preceding Phase Ib NMIBC clinical study assessing the safety of TLD-1433 PDT who weretreated at the same parameters, for a total of 45 patients. Data for the primary and secondary outcomes are listed in the table.The interim clinical data demonstrates a 90 day CR of 50% and a duration of response at 360 and 450 days of 35% and 21%, respectively.There have been eight Serious Adverse Events (SAE) identified (2 Grade II (tachycardia, hematuria), 3 Grade III (acute kidney injury, cellulitis), 2 Grade IV (urosepsis, depression/anxiety) and 1 Grade V). None of the SAEs were deemed to be directly related to the PDT. Conclusions: The interim data support that treatment with Photo Dynamic Therapy provides a viable treatment option for patients with BCG unresponsive CIS (+/- papillary disease) with an acceptable ongoing safety profile. Clinical trial information: NCT03945162 . [Table: see text]

Photodynamic therapy treatment of oral cavity cancer in patients with comorbidities

We report the experience of radical treatment by photodynamic therapy of patients with squamous cell carcinoma of oral cavity with serious side diseases. Completed treatment of two patients with serious side diseases (HIV infection with associated pulmonary hypertension of high degree and cardiac pathology) suffered from cancer of oral cavity. Extensive surgical treatment and/or aggressive course of chemoradiation therapy were not indicated to them due to concomitant pathology. Both patients were diagnosed with squamous cell carcinoma of oral cavity, with appropriate stage Ist. сT1N0M0. Patients received treatment by photodynamic therapy with chorine photosensitizer in dose 1 mg/kg. Options of photodynamic were: output power – 1.5W, power density – 0.31 W/cm2, light dose – 300 J/cm2. After one time session of photodynamic therapy, in both cases full response was diagnosed (according to RECIST 1.1). In one case the second session of photodynamic therapy was performed due to concomitant disease of oral cavity – multiply lesions of leukoplakia and after was diagnosed full remission of all lesions. Major adverse event was pain during the first 5-7 days after treatment, curable by painkillers. Follow-up (IQR) was 12 and 18 month respectively with no evidence of progression. It is available to avoid extensive surgical treatment and aggressive course of chemoradiation therapy (as an alternative) with the use of photodynamic therapy. Photodynamic therapy is minimally invasive method of radical treatment of localized squamous cell carcinoma of oral cavity with minimal adverse events, and could be especially relevant in patients with serious concomitant diseases.

Photodynamic therapy improves the clinical efficacy of advanced colorectal cancer and recruits immune cells into the tumor immune microenvironment.

Although photodynamic therapy (PDT) has been proven effective in various tumors, it has not been widely used as a routine treatment for colorectal cancer (CRC), and the characteristics of changes in the tumor microenvironment (TME) after PDT have not been fully elucidated. This study evaluated the efficacy of PDT in patients with advanced CRC and the changes in systemic and local immune function after PDT. Patients with stage III-IV CRC diagnosed in our hospital from November 2020 to July 2021 were retrospectively analyzed to compare the survival outcomes among each group. Subsequently, short-term efficacy, systemic and local immune function changes, and adverse reactions were assessed in CRC patients treated with PDT. A total of 52 CRC patients were enrolled in this retrospective study from November 2020 to July 2021, and the follow-up period ended in March 2022. The overall survival (OS) of the PDT group was significantly longer than that of the non-PDT group (p=0.006). The objective response rate (ORR) and disease control rate two months after PDT were 44.4% and 88.9%, respectively. Differentiation degree (p=0.020) and necrosis (p=0.039) are two crucial factors affecting the short-term efficacy of PDT. The systemic immune function of stage III patients after PDT decreased, whereas that of stage IV patients increased. Local infiltration of various immune cells such as CD3+ T cells, CD4+ T cells, CD8+ T cells, CD20+ B cells and macrophages in the tumor tissue were significantly increased. No severe adverse reactions associated with PDT were observed. PDT is effective for CRC without significant side effects according to the available data. It alters the TME by recruiting immune cells into tumor tissues.