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Fumaric acid esters (FAEs) remain a widespread therapy option for moderate-to-severe psoriasis. However, drug survival of FAEs is limited by adverse events (AEs) or inadequate treatment response. Depressive disturbances are highly prevalent in psoriasis patients and are hypothesized to be associated with the reporting of AEs and therapy discontinuation. This study's aim was to analyze whether psoriasis patients with comorbid depressive symptomatology are more likely to discontinue treatment with FAEs due to AEs and/or inadequate treatment response. Data were retrospectively extracted from the records of patients starting therapy with FAEs in the Department of Dermatology, University Hospital Essen, Germany between 2017 and 2022, covering the first 52 weeks of treatment. Psoriasis severity and depressive symptomatology, as well as AEs and therapy discontinuation, were analyzed. Psoriasis patients (N = 95, 47.37% female) with depressive symptomatology (42.11%) were more likely to discontinue therapy due to patient-reported AEs, while the total number of reported AEs was not associated with depression. The results support the hypothesis that among psoriasis patients with depressive symptoms, the associated introspection and somatization may result in increased sensitivity for AEs and thus in quicker therapy discontinuation. In these patients, the occurrence of nocebo effects should be minimized, e.g. by special communication techniques.
Subject(s)
Dermatologic Agents , Psoriasis , Humans , Female , Male , Fumarates/adverse effects , Retrospective Studies , Dermatologic Agents/adverse effects , Psoriasis/diagnosis , Psoriasis/drug therapy , Psoriasis/chemically induced , Germany/epidemiology , Treatment OutcomeABSTRACT
BACKGROUND AND AIMS: Bacteria in wounds can lead to stagnation of wound healing as well as to local or even systemic wound infections up to potentially lethal sepsis. Consequently, the bacterial load should be reduced as part of wound treatment. Therefore, the efficacy of simple mechanical wound debridement should be investigated in terms of reducing bacterial colonisation. PATIENTS AND METHODS: Patients with acute or chronic wounds were assessed for bacterial colonisation with a fluorescence camera before and after mechanical wound debridement with sterile cotton pads. If bacterial colonisation persisted, a second, targeted wound debridement was performed. RESULTS: A total of 151 patients, 68 (45.0%) men and 83 (55.0%) women were included in this study. The male mean age was 71.0 years and the female 65.1 years. By establishing a new analysis method for the image files, we could document that the bacterial colonised areas were distributed 21.9% on the wound surfaces, 60.5% on the wound edges (up to 0.5 cm) and 17.6% on the wound surroundings (up to 1.5 cm). One mechanical debridement achieved a significant reduction of bacterial colonised areas by an average of 29.6% in the wounds, 18.9% in the wound edges and 11.8% in the wound surroundings and was increased by performing it a second time. CONCLUSIONS: It has been shown that even a simple mechanical debridement with cotton pads can significantly reduce bacterial colonisation without relevant side effects. In particular, the wound edges were the areas that were often most contaminated with bacteria and should be included in the debridement with special attention. Since bacteria remain in wounds after mechanical debridement, it cannot replace antimicrobial therapy strategies, but offer a complementary strategy to improve wound care. Thus, it could be shown that simple mechanical debridement is effective in reducing bacterial load and should be integrated into a therapeutic approach to wounds whenever appropriate.
Subject(s)
Sepsis , Wound Healing , Humans , Female , Male , Aged , Debridement , Prospective Studies , Bacterial LoadABSTRACT
BACKGROUND: Every medical treatment inevitably comprises not only physiological, but also psychological components, reflected by placebo and nocebo effects, which significantly affect treatment outcome. However, the extent of knowledge on the mechanisms steering placebo and nocebo effects in the dermatological community in Germany is currently unclear. OBJECTIVES: To assess the state of knowledge about placebo and nocebo effects in the German dermatological community, to evaluate whether this knowledge is already being used in clinical practice, and to investigate whether German dermatologists are interested in learning more about the topic. METHODS: German Dermatologists, the majority working in their own practice, were asked to fill in an online survey addressing the knowledge about placebo and nocebo effects and the feasibility of special techniques to enhance placebo and minimize nocebo effects within the clinical routine. RESULTS: N = 154 complete (79%) or partial (21%) responses to the survey were recorded in the online database and included in the analysis. All participants reported to know what the placebo effect is and 59.7% (74/124) indicated that they already had experience with prescribing or recommending a treatment without active substances. In contrast, only 62.0% (80/129) stated to know what the nocebo effect is. Participants showed a rather superficial knowledge regarding placebo and nocebo mechanisms. The majority of participants (76.7%, 99/129) expressed their willingness to be further educated about the underlying mechanisms mediating placebo and nocebo effects and the possible application in clinical practice. CONCLUSIONS: The current survey offers a so far unique insight into the state of knowledge of German dermatologists on placebo and nocebo effects. The results indicate a need for education about this topic. Encouragingly, however, German dermatologists considered communication strategies to maximize placebo and reduce nocebo effects and expressed motivation to be trained to implement these strategies in everyday clinical practice.
Subject(s)
Dermatologists , Nocebo Effect , Humans , Placebo Effect , Treatment Outcome , LearningABSTRACT
Psoriasis is an inflammatory, immune-mediated disease that is frequently associated with psychological comorbidities such as depression. The stigma patients feel because of the appearance of their skin may contribute to the high psycho-social burden of psoriasis. However, there is emerging evidence that overlapping biological mechanisms are, to a substantial degree, responsible for the close interaction between psoriasis and depression. Increased proinflammatory mediators, such as C-reactive protein or interleukin-6, are present in both psoriasis and depression, indicating that inflammation may represent a pathophysiological link between the diseases. Anti-inflammatory biologic therapies treat the clinical manifestations of psoriasis, but might also play a significant role in reducing associated depressive symptoms in patients with psoriasis. Comparison between single studies focusing on the change in depressive symptoms in psoriasis is limited by inconsistency in the depression screening tools applied.
Subject(s)
Depression , Psoriasis , Anti-Inflammatory Agents/therapeutic use , Depression/diagnosis , Depression/epidemiology , Humans , Inflammation , Psoriasis/diagnosis , Psoriasis/epidemiology , Psoriasis/therapy , SkinABSTRACT
Purpose: Psoriasis is a highly debilitating chronic inflammatory disease. Increased understanding of its pathophysiology has enabled development of targeted treatments such as biologics. Several medical treatments have been shown to be influenced by patients' experiences and expectations. However, only little is known about patients' experiences with and expectations towards biologics. Our objectives were to identify patients' treatment experiences and treatment expectations and assess their trajectories over the course of treatment with the IL-17A inhibitor secukinumab. Moreover, we aimed to document effects of psoriasis, factors that influence symptomatology, and prior treatment experiences. Patients and Methods: We conducted semi-structured interviews with n = 24 patients with moderate-to-severe plaque psoriasis and employed a qualitative content analysis to derive thematic and evaluative codes. Findings were validated via peer debriefings with experienced dermatologists. Results: Patients reported burdensome physical and psychological psoriasis symptoms and identified factors that can improve or worsen symptomatology, including stress and self-efficacy. Prior treatment experiences were mostly negative. Past barriers to effective treatment included time constraints or limited access. Concerning secukinumab, patients initially expected complete to partial remission of symptoms and occurrence or absence of side effects. Closer inspection of expectations and experiences revealed three trajectories. For most patients, initial expectations were met and future expectations remained unchanged. For the other patients, however, the experience did not match their initial expectation. One group then adapted their future expectations according to their experience, while the other group did not. Conclusion: To our knowledge, this is the first qualitative study to assess expectations towards treatment effectiveness and side effects, their trajectories, and interplay with experiences among psoriasis patients. Our findings highlight the value of further research on the subject in order to optimize care for psoriasis patients and to learn more about the trajectories and influence of treatment expectations in general.
Patients' expectations towards a certain treatment can influence how well it will work and whether side effects occur or not. Such effects have been shown for a wide range of conditions, including dermatological ones. For patients suffering from psoriasis, a chronic inflammatory skin disease, modern biologics offer promising treatment options. Therefore, modern biologics are likely associated with high expectations by patients. Yet, the roles of treatment expectations and the experiences of patients undergoing biologic treatment have only received little attention to date. With this qualitative study, we aimed to understand patients' perspectives on these treatments, the symptoms they suffer from, expectations towards treatment effectiveness and side effects as well as treatment experiences in the past and over the course of treatment with a modern biologic. To this end, we conducted and transcribed interviews with 24 patients after several months of biologic treatment. We then analyzed interview transcripts to determine underlying categories and summarized these in a common framework. We found that patients' debilitating physical and psychological symptoms were often not well controlled in past treatments. Still, patients had positive expectations with regard to biologic treatment. For a large group of patients, their actual experiences met their expectations, leaving them with unchanged expectations for the future. Another important finding was the good understanding of factors influencing their symptomatology that patients had, like stress and self-efficacy. The reported findings may aid doctors in their clinical work, to further improve care for psoriasis patients.
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Visual clinical diagnosis of dermatoses in people of color (PoC) is a considerable challenge in daily clinical practice and a potential cause of misdiagnosis in this patient cohort. The study aimed to determine the difference in visual diagnostic skills of dermatologists practicing in Germany in patients with light skin (Ls) and patients with skin of color (SoC) to identify a potential need for further education. From April to June 2023, German dermatologists were invited to complete an online survey with 24 patient photographs depicting 12 skin diseases on both Ls and SoC. The study's primary outcomes were the number of correctly rated photographs and the participants' self-assessed certainty about the suspected visual diagnosis in Ls compared to SoC. The final analysis included surveys from a total of 129 dermatologists (47.8% female, mean age: 39.5 years). Participants were significantly more likely to correctly identify skin diseases by visual diagnostics in patients with Ls than in patients with SoC (72.1% vs. 52.8%, p ≤ 0.001, OR 2.28). Additionally, they expressed higher confidence in their diagnoses for Ls than for SoC (73.9 vs. 61.7, p ≤ 0.001). Therefore, further specialized training seems necessary to improve clinical care of dermatologic patients with SoC.
Subject(s)
Skin Diseases , Skin Pigmentation , Adult , Female , Humans , Male , Dermatologists , Germany , Skin Diseases/diagnosis , Surveys and Questionnaires , Ethnic and Racial MinoritiesABSTRACT
BACKGROUND: Effective treatment options are limited for patients with advanced melanoma who have progressed on immune checkpoint inhibitors (ICI) and targeted therapies (TT). Preclinical models support the combination of ICI with TT; however, clinical trials evaluating the efficacy of triplet combinations in first-line setting showed limited advantage compared to TT only. METHODS: We conducted a retrospective, multicenter study, that included patients with advanced melanoma who were treated with BRAF/MEK inhibitors in combination with an anti-PD-(L)1 antibody (triplet therapy) after failure of at least one anti-PD-(L)1-based therapy and one TT in seven major melanoma centers between February 2016 and July 2022. RESULTS: A total of 48 patients were included, of which 32 patients, 66.7% had brain metastases, 37 patients (77.1%) had three or more metastatic organs and 21 patients (43.8%) had three or more treatment lines. The median follow-up time was 31.4 months (IQR, 22.27-40.45 months). The treatment with triplet therapy resulted in an ORR of 35.4% (n = 17) and a DCR of 47.9% (n = 23). The median DOR was 5.9 months (range, 3.39-14.27 months). Patients treated with BRAF/MEK inhibitors as the last treatment line showed a slightly lower ORR (29.6%) compared to patients who received ICI or chemotherapy last (ORR: 42.9%). Grade 3-4 treatment-related adverse events occurred in 25% of patients (n = 12), with seven patients (14.6%) requiring discontinuation of treatment with both or either drug. CONCLUSIONS: Triplet therapy has shown activity in heavily pretreated patients with advanced melanoma and may represent a potential treatment regimen after failure of ICI and TT.
Subject(s)
Melanoma , Skin Neoplasms , Humans , Melanoma/pathology , Immune Checkpoint Inhibitors/adverse effects , Proto-Oncogene Proteins B-raf/genetics , Skin Neoplasms/therapy , Retrospective Studies , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Mitogen-Activated Protein Kinase Kinases , Protein Kinase Inhibitors/adverse effects , MutationABSTRACT
BACKGROUND: Psoriatic plaques at the distal lower extremities are notoriously treatment resistant. Medical compression therapy could potentially be a useful supplementary therapeutic measure at this site. However, there is concern that the Koebner phenomenon may cause a worsening of the skin condition. Therefore, the purpose of this study was to investigate the effects of compression therapy on psoriatic plaques in the presence of coexisting edema of the lower legs. PATIENTS AND METHODS: Compression therapy was performed in addition to standard of care on one lower leg for 4 weeks (half-side test) in patients with psoriatic plaques and edema on both lower legs. The primary endpoint of the study was clinical response of the psoriatic plaques on the lower legs measured with the lesion severity score (LSS) and the locally affected body surface area in a side-by-side comparison at week 4 compared with baseline. Secondary endpoints were related to patient-reported outcomes. RESULTS: Data from 30 patients were included in the analysis. In the descriptive analysis, the mean LSS results and the subjective pain reported by the patients showed a slightly greater improvement on the compressed lower leg compared with the non-compressed lower leg. None of the patients showed evidence of the Koebner phenomenon induced by compression therapy. CONCLUSION: This is the first clinical study that systematically investigated the impact of compression therapy on psoriatic plaques. During the study period of 4 weeks, there was no significant improvement in psoriatic plaques; however, there was also no evidence of worsening of the skin condition. Thus, anti-edematous compression therapy can be performed in psoriasis patients without causing complications if basic contraindications are considered.
Subject(s)
Leg , Psoriasis , Humans , Leg/pathology , Psoriasis/complications , Lower Extremity/pathology , Edema/therapyABSTRACT
Background: The rate of seroconversion after COVID-19 vaccination in patients with moderate to severe psoriasis requiring systemic treatment is poorly understood. Objectives: The aim of this prospective single-center cohort study performed between May 2020 and October 2021 was to determine the rate of seroconversion after COVID-19 vaccination in patients under active systemic treatment for moderate to severe psoriasis. Methods: Inclusion criteria were systemic treatment for moderate to severe psoriasis, known COVID-19 vaccination status, and repetitive anti-SARS-CoV-2-S IgG serum quantification. The primary outcome was the rate of anti-SARS-CoV-2-S IgG seroconversion after complete COVID-19 vaccination. Results: 77 patients with a median age of 55.9 years undergoing systemic treatment for moderate to severe psoriasis were included. The majority of patients received interleukin- (n=50, 64.9%) or tumor necrosis factor (TNF)-α inhibitors (n=16, 20.8%) as systemic treatment for psoriasis; nine patients (11.7%) were treated with methotrexate (MTX) monotherapy, and one patient each received dimethyl fumarate (1.3%), respectively apremilast (1.3%). All included patients completed COVID-19 vaccination with two doses over the course of the study. Serum testing revealed that 74 patients (96.1%) showed an anti-SARS-CoV-2-S IgG seroconversion. While all patients on IL-17A, -12 or -12/23 inhibitors (n=50) achieved seroconversion, three of 16 patients (18.8%) receiving MTX and/or a TNF-α inhibitor as main anti-psoriatic treatment did not. At follow-up, none of the patients had developed symptomatic COVID-19 or died from COVID-19. Conclusions: Anti-SARS-CoV-2-S IgG seroconversion rates following COVID-19 vaccination in psoriasis patients under systemic treatment were high. An impaired serological response, however, was observed in patients receiving MTX and/or TNF-α inhibitors, in particular infliximab.
Subject(s)
COVID-19 , Psoriasis , Humans , Middle Aged , COVID-19 Vaccines , Cohort Studies , Prospective Studies , Tumor Necrosis Factor-alpha , COVID-19/prevention & control , Psoriasis/drug therapy , Methotrexate , Antibodies, Viral , Immunoglobulin GABSTRACT
BACKGROUND: PD-1-based immune checkpoint inhibition (ICI) is the major backbone of current melanoma therapy. Tumor PD-L1 expression represents one of few biomarkers predicting ICI therapy outcome. The objective of the present study was to systematically investigate whether the type of tumor tissue examined for PD-L1 expression has an impact on the correlation with ICI therapy outcome. METHODS: Pre-treatment tumor tissue was collected within the prospective DeCOG cohort study ADOREG/TRIM (CA209-578; NCT05750511) between February 2014 and May 2020 from 448 consecutive patients who received PD-1-based ICI for non-resectable metastatic melanoma. The primary study endpoint was best overall response (BOR), secondary endpoints were progression-free (PFS) and overall survival (OS). All endpoints were correlated with tumor PD-L1 expression (quantified with clone 28-8; cutoff ≥5%) and stratified by tissue type. FINDINGS: Tumor PD-L1 was determined in 95 primary tumors (PT; 36.8% positivity), 153 skin/subcutaneous (34.0% positivity), 115 lymph node (LN; 50.4% positivity), and 85 organ (40.8% positivity) metastases. Tumor PD-L1 correlated with BOR if determined in LN (OR = 0.319; 95% CI = 0.138-0.762; P = 0.010), but not in skin/subcutaneous metastases (OR = 0.656; 95% CI = 0.311-1.341; P = 0.26). PD-L1 positivity determined on LN metastases was associated with favorable survival (PFS, HR = 0.490; 95% CI = 0.310-0.775; P = 0.002; OS, HR = 0.519; 95% CI = 0.307-0.880; P = 0.014). PD-L1 positivity determined in PT (PFS, HR = 0.757; 95% CI = 0.467-1.226; P = 0.27; OS; HR = 0.528; 95% CI = 0.305-0.913; P = 0.032) was correlated with survival to a lesser extent. No relevant survival differences were detected by PD-L1 determined in skin/subcutaneous metastases (PFS, HR = 0.825; 95% CI = 0.555-1.226; P = 0.35; OS, HR = 1.083; 95% CI = 0.698-1.681; P = 0.72). INTERPRETATION: For PD-1-based immunotherapy in melanoma, tumor PD-L1 determined in LN metastases was stronger correlated with therapy outcome than that assessed in PT or organ metastases. PD-L1 determined in skin/subcutaneous metastases showed no outcome correlation and therefore should be used with caution for clinical decision making. FUNDING: Bristol-Myers Squibb (ADOREG/TRIM, NCT05750511); German Research Foundation (DFG; Clinician Scientist Program UMEA); Else Kröner-Fresenius-Stiftung (EKFS; Medical Scientist Academy UMESciA).
Subject(s)
Immune Checkpoint Inhibitors , Melanoma , Skin Neoplasms , Humans , B7-H1 Antigen/metabolism , Cohort Studies , Immunotherapy , Melanoma/immunology , Melanoma/therapy , Prognosis , Programmed Cell Death 1 Receptor , Prospective Studies , Skin Neoplasms/immunology , Skin Neoplasms/therapy , Immune Checkpoint Inhibitors/therapeutic useABSTRACT
Patients suffering from chronic inflammatory diseases such as psoriasis are prone to develop depressive symptoms. However, within the time constraints of dermatological clinics, depressive symptoms in psoriasis patients are often overlooked and thus underdiagnosed. The Two Questions Test may serve as a quick screening tool for an initial assessment of depressive burden in these patients. We evaluated its usefulness in the clinical context analyzing the records of patients starting systemic treatment for psoriasis with a selective interleukin (IL)23- or IL17A-inhibitor. In a total sample of N = 139 patients, baseline Two Questions Test scores were analyzed together with measures of psoriatic and psychiatric symptoms. In addition, the development of the Two Questions Test scores over the course of the first 28 weeks of treatment was assessed. No association was found between the Two Questions Test scores and skin symptoms measured by the Psoriasis Area and Severity Index and the visibility of skin lesions. However, skin related quality of life analyzed with the Dermatology Life Quality Index was associated with the Two Questions Test scores. In addition, the longitudinal analysis revealed improvement in Two Questions Test outcomes over the course of patients' treatment. These results indicate the Two Questions Test's usefulness both as an initial screening tool of depressive symptoms, as well as in its use as a sensitive tool for the repeated assessment of depressive symptoms in psoriasis patients.
Subject(s)
Psoriasis , Quality of Life , Chronic Disease , Depression/diagnosis , Depression/etiology , Depression/psychology , Humans , Psoriasis/complications , Psoriasis/diagnosis , Psoriasis/drug therapy , Severity of Illness IndexABSTRACT
(1) Background: Melanoma has the highest mortality of all cutaneous tumors, despite recent treatment advances. Many relevant genetic events have been identified in the last decade, including recurrent ARID1A mutations, which in various tumors have been associated with improved outcomes to immunotherapy. (2) Methods: Retrospective analysis of 116 melanoma samples harboring ARID1A mutations. Assessment of clinical and genetic characteristics was performed as well as correlations with treatment outcome applying Kaplan-Meier (log-rank test), Fisher's exact and Chi-squared tests. (3) Results: The majority of ARID1A mutations were in cutaneous and occult melanoma. ARID1A mutated samples had a higher number of mutations than ARID1A wild-type samples and harbored UV-mutations. A male predominance was observed. Many samples also harbored NF1 mutations. No apparent differences were noted between samples harboring genetically inactivating (frame-shift or nonsense) mutations and samples with other mutations. No differences in survival or response to immunotherapy of patients with ARID1A mutant melanoma were observed. (4) Conclusions: ARID1A mutations primarily occur in cutaneous melanomas with a higher mutation burden. In contrast to findings in other tumors, our data does not support ARID1A mutations being a biomarker of favorable response to immunotherapies in melanoma. Larger prospective studies would still be warranted.
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INTRODUCTION: Experimental and clinical data demonstrate that skin diseases like psoriasis are affected by psychological factors and can be modulated by interventions other than conventional drug therapy. The expectation of patients towards the benefit of a forthcoming treatment as well as treatment pre-experiences have been demonstrated as crucial factors mediating placebo responses in inflammatory skin diseases. However, it is unknown whether and to what extent treatment outcomes of psoriasis patients under therapy with monoclonal antibodies like secukinumab can be experimentally modulated at subjective and physiological levels by modifying the expectation of patients via verbal instruction or prior experience. METHODS AND ANALYSIS: Treatment expectations will be modulated in patients with moderate-to-severe psoriasis undergoing treatment with the anti-interleukin-17A monoclonal antibody secukinumab. Patients with a Psoriasis Area and Severity Index (PASI) >12 will be randomly allocated to one of three groups (N=40 each). As a standard schedule, patients in the pharmacological control group (group 1) will be treated weekly with 300 mg secukinumab, while patients in groups 2 and 3 will receive only 75 mg secukinumab (75% dose reduction) during all treatment weeks. In addition to the injections, patients in group 3 will ingest a novel tasting drink, with a cover story explaining that previous studies showed additional beneficial effects of this combination (drug and drink). Patients will be assessed and treated at nine visits over a 16-week period, during which the severity of pain and itch symptoms, skin lesions and quality of life will be analysed with standardised questionnaires and the PASI. ETHICS AND DISSEMINATION: This study was approved by the Ethics committee of the Medical Faculty of the University Duisburg-Essen. Study outcomes will be published in peer-reviewed scientific journals.
Subject(s)
Psoriasis , Quality of Life , Double-Blind Method , Humans , Motivation , Pain/drug therapy , Psoriasis/drug therapy , Randomized Controlled Trials as Topic , Severity of Illness Index , Treatment OutcomeABSTRACT
Fixed-dose pembrolizumab (200 mg absolute, day 1, every 3 wk) for the treatment of malignant pleural mesothelioma did not result in survival benefit in the phase 3 PROMISE-meso trial compared with second-line chemotherapy. Because of lack of validated imaging response criteria, responder subgroups with potential survival benefit have not yet been identified. Here, we administered high-dose pembrolizumab (10 mg/kg, day 1, every 2 wk) considering the KEYNOTE-028 trial and assessed the prognostic value of PET metabolic response in patients with chemotherapy-resistant malignant mesothelioma of the pleura or peritoneum. Methods: Data from 27 patients with baseline and follow-up 18F-FDG PET/CT imaging were retrospectively analyzed. RECIST, version 1.1; modified RECIST; and PERCIST using both tumor lesion metabolic activity in a 1 cm3 spheric region of interest of up to 5 target lesions (PERCISTSULpeak) and metabolic tumor volume PERCIST (PERCISTMTV) were applied separately to categorize responders in CT and PET imaging studies. Progression-free survival (PFS) and overall survival (OS) were compared between responders and nonresponders using Kaplan-Meier and log-rank analyses. Programmed cell death protein 1 ligand expression status was assessed, and its association with outcome was investigated. Results: Twenty-seven patients had 18F-FDG PET/CT imaging at baseline and after at least 4 cycles pembrolizumab. Median PFS and OS were 3.4 and 15.1 mo, respectively. Response rates were 7%, 7%, 30%, and 30% based on RECIST, modified RECIST, PERCISTSULpeak, and PERCISTMTV response criteria, respectively. Response according to PERCISTMTV predicted prolonged OS or PFS (P < 0.01), whereas all other imaging criteria and programmed cell death protein 1 ligand expression did not. Conclusion:18F-FDG PET metabolic volume response predicts survival in patients with malignant mesothelioma receiving high-dose pembrolizumab. These results should prompt inclusion of PET response assessment in future phase 3 clinical trials.
Subject(s)
Antibodies, Monoclonal, Humanized/pharmacology , Mesothelioma, Malignant/diagnostic imaging , Mesothelioma, Malignant/drug therapy , Positron Emission Tomography Computed Tomography , Aged , Aged, 80 and over , Antibodies, Monoclonal, Humanized/therapeutic use , Dose-Response Relationship, Drug , Female , Fluorodeoxyglucose F18 , Humans , Male , Middle Aged , Natriuretic Peptide, Brain , Peptide Fragments , Retrospective Studies , Treatment OutcomeABSTRACT
BACKGROUND: Anti-PD1 monoclonal antibody nivolumab is an approved therapy option for the treatment of advanced squamous cell non-small cell lung cancer (SQ-NSCLC) patients. Data outside clinical trials about therapy efficacy and safety in later therapy line treatments have rarely been described until now. METHODS: We performed a retrospective data analysis of patients who were enrolled into the nivolu-mab Compassionate Use Program (CUP) in Germany. Sufficient clinical data of 40 patients were available for efficacy and safety analysis. RESULTS: Overall, 47.5% of all treated patients were not affected by any adverse events (AEs); 17.5% of patients suffered from severe AEs. The 1-year survival rate was 61.3%. Estimated median progression-free survival (PFS) was 5.3 months. Patients who received nivolumab as third or later therapy line treatment (77.5%) achieved similar median PFS and 12-month overall survival rate of 52%. CONCLUSION: Our findings of immunotherapy treatment outside clinical trials support the results of studies in the past and confirm the efficacy and favorable toxicity profile of nivolumab treatment in advanced SQ-NSCLC patients. In addition, we can present some rarely described information about nivolumab treatment of heavily pretreated patients, which provides some evidence that immunotherapy could also be useful in later therapy lines.