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Clinical Cancer Research : An Official... Feb 2023On September 15, 2021, the FDA granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals USA, Inc.) for the treatment of adult patients with locally... (Clinical Trial)
Clinical Trial
On September 15, 2021, the FDA granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals USA, Inc.) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The approval was based on data from Study AP32788-15-101 (NCT02716116), an international, non-randomized, multi-cohort clinical trial that included patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. The overall response rate in 114 patients whose disease had progressed on or after platinum-based chemotherapy was 28% [95% confidence interval (CI), 20%-37%] with a median duration of response of 17.5 months (95% CI, 7.4-20.3). The most common adverse reactions (>20%) were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. Product labeling includes a Boxed Warning for QTc prolongation and torsades de pointes. This is the first approval of an oral targeted therapy for patients with advanced EGFR exon 20 insertion mutation-positive NSCLC.
Topics: Adult; Humans; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Mutagenesis, Insertional; Protein Kinase Inhibitors; ErbB Receptors; Exons; Mutation
PubMed: 36112541
DOI: 10.1158/1078-0432.CCR-22-2072 -
Frontiers in Medicine 2022Green nail syndrome (GNS) is a triad of green discoloration of the nail plate, proximal paronychia, and distal onycholysis. is known to be the most common causative...
Green nail syndrome (GNS) is a triad of green discoloration of the nail plate, proximal paronychia, and distal onycholysis. is known to be the most common causative agent; however, there is no unified standard for the diagnosis and treatment of GNS. Thus, treatment is challenging and often refractory. Here, we report three representative cases with different predisposing factors, including trauma-related, occupation-related, and onychosis-related GNS. Patients with GNS accompanied by onycholysis were instructed to undergo chemical nail avulsion combined with topical antibiotics, and favorable curative effects were observed in all cases. Chemical nail avulsion with urea powder as a conventional method may be an effective treatment for GNS and warrants clinical generalization.
PubMed: 36091683
DOI: 10.3389/fmed.2022.991918 -
Clinical Microbiology and Infection :... Feb 2023A global outbreak of monkeypox virus infections in human beings has been described since April 2022. The objectives of this study were to describe the clinical... (Observational Study)
Observational Study
OBJECTIVES
A global outbreak of monkeypox virus infections in human beings has been described since April 2022. The objectives of this study were to describe the clinical characteristics and complications of patients with a monkeypox infection.
METHODS
All consecutive patients with a polymerase chain reaction (PCR)-confirmed monkeypox infection seen in a French referral centre were included.
RESULTS
Between 21 May and 5 July 2022, 264 patients had a PCR-confirmed monkeypox infection. Among them, 262 (262/264, 99%) were men, 245 (245/259, 95%) were men who have sex with men, and 90 (90/216, 42%) practiced chemsex in the last 3 months. Seventy-three (73/256, 29%) patients were living with human immunodeficiency virus infection, and 120 (120/169, 71%) patients were taking pre-exposure prophylaxis against human immunodeficiency virus infection. Overall, 112 (112/236, 47%) patients had contact with a confirmed monkeypox case; it was of sexual nature for 95% of the contacts (86/91). Monkeypox virus PCR was positive on the skin in 252 patients, on the oropharyngeal sample in 150 patients, and on blood in eight patients. The majority of patients presented with fever (171/253, 68%) and adenopathy (174/251, 69%). Skin lesions mostly affected the genital (135/252, 54%) and perianal (100/251, 40%) areas. Overall, 17 (17/264, 6%) patients were hospitalized; none of them were immunocompromised. Complications requiring hospitalization included cellulitis (n = 4), paronychia (n = 3), severe anal and digestive involvement (n = 4), non-cardia angina with dysphagia (n = 4), blepharitis (n = 1), and keratitis (n = 1). Surgical management was required in four patients.
CONCLUSION
The current outbreak of monkeypox infections has specific characteristics: it occurs in the men who have sex with men community; known contact is mostly sexual; perineal and anal areas are frequently affected; and severe complications include superinfected skin lesions, paronychia, cellulitis, anal and digestive involvement, angina with dysphagia, and ocular involvement.
Topics: Male; Humans; Female; Monkeypox virus; Mpox (monkeypox); Cellulitis; Deglutition Disorders; Homosexuality, Male; Paronychia; Sexual and Gender Minorities; Cohort Studies
PubMed: 36028090
DOI: 10.1016/j.cmi.2022.08.012 -
Pharmaceuticals (Basel, Switzerland) Jul 2022Trametinib has been used in neurofibromatosis type 1 (NF1) patients, especially those with unresectable nerve tumors, but no systematic review based on the latest... (Review)
Review
Trametinib has been used in neurofibromatosis type 1 (NF1) patients, especially those with unresectable nerve tumors, but no systematic review based on the latest studies has been published. We conducted this meta-analysis to evaluate the effectiveness and safety of trametinib in treating NF1-related nerve tumors. Original articles reporting the efficacy and safety of trametinib in NF1 patents were identified in PubMed, EMBASE, and Web of Science up to 1 June 2022. Using R software and the 'meta' package, the objective response rates (ORRs) and disease control rates (DCRs) were calculated to evaluate the efficacy, and the pooled proportion of adverse events (AEs) was calculated. The Grading of Recommendations, Assessment, Development and Evaluation system was used to assess the quality of evidence. Eight studies involving 92 patients were included, which had a very low to moderate quality of evidence. The pooled ORR was 45.3% (95% CI: 28.9-62.1%, I = 0%), and the DCR was 99.8% (95% CI: 95.5-100%, I = 0%). The most common AEs was paronychia, with a pooled rate of 60.7% (95% CI: 48.8-72.7%, I = 0%). Our results indicate the satisfactory ability to stabilize tumor progression but a more limited ability to shrink tumors of trametinib in NF1-related nerve tumors. The safety profile of trametinib is satisfactory.
PubMed: 36015104
DOI: 10.3390/ph15080956 -
Cureus Jul 2022Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor on T-cells and blocks its interaction with PD-L1 and PD-L2, releasing...
Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor on T-cells and blocks its interaction with PD-L1 and PD-L2, releasing the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response, resulting in decreased tumor growth. Here, we present a case of a 56-year-old lady with a diagnosis of squamous cell carcinoma (SCC) of the lip who presented with dystrophy of 20 nails, distal onycholysis, yellow-black discoloration of nail plates, painful paronychia with superimposed bacterial infection of big toes of both feet for three months. Few warty growths were also appreciated on big toes of both feet. She had undergone for her SCC 33 sessions of radiotherapy and 43 cycles of nivolumab 140mg for 60 minutes every two weeks. Following discontinuing this drug, the peri-ungual and nail bed inflammation improved, however nail plate dystrophy persisted. To our knowledge, the occurrence of nail dystrophy with nivolumab has never been reported before but it has been described with other targeted therapies.
PubMed: 35989738
DOI: 10.7759/cureus.26950 -
Zhongguo Fei Ai Za Zhi = Chinese... Jul 2022Epidermal growth factor receptor (EGFR) and cellular-mesenchymal to epithelial transition factor (c-Met) are widely expressed on cancer cells. There is a synergistic...
BACKGROUND
Epidermal growth factor receptor (EGFR) and cellular-mesenchymal to epithelial transition factor (c-Met) are widely expressed on cancer cells. There is a synergistic effect of EGFR and HGF/c-Met pathways on proliferation, downstream activation of signal transduction and an additive effect. Studies show that combination of both signaling pathways could potentially be targeted in a synergistic fashion. Amivantamab, a bispecific monoclonal antibody targeting EGFR and c-Met, yielded robust and durable responses in a variety of clinicals trials. However, few researches have reported its efficacy in Chinese non-small cell lung cancer (NSCLC) patients. This study was conducted to evaluate the effectiveness and tolerance of Amivantamab in NSCLC patients with EGFR/MET gene abnormalities at Peking University Cancer Hospital.
METHODS
The study enrolled NSCLC patients who received Amivantamab in our hospital between August 2020 and December 2021, and analyzed the response, survival, and treatment-related adverse events.
RESULTS
Fifteen patients were enrolled in this research, and six of them received Amivantamab treatment and the other nine patients received Amivantamab plus Lazertinib treatment. The rates of partial response (PR), stable disease (SD), and progressive disease (PD) were 46.7% (7/15), 46.7% (7/15) and 6.7% (1/15), respectively. The overall response rate (ORR) and disease control rate (DCR) were 28.6% (2/7) and 100.0% (7/7) in seven patients with EGFR exon 20 insertion, respectively. The ORR and DCR were 40.0% (2/5) and 100.0% (5/5) in five post-osimertinib EGFR-mutant patients, respectively. After a median follow-up of 8.7 months, the median progression-free survival and overall survival were not reached. The most common treatment-related adverse events were rash (86.7%), paronychia (80.0%), and infusion-related reactions (60.0%), and most of them were graded as 1 to 2. Grade 3 to 4 adverse events included rash (33.3%), alanine aminotransferase elevation (13.3%), gamma-glutamyl transpeptidase elevation (13.3%), peripheral edema (6.7%), thromboembolism (6.7%), interstitial lung disease (6.7%), and thrombocytopenia (6.7%).
CONCLUSIONS
Amivantamab was effective in Chinese NSCLC patients with EGFR exon 20 insertion and post-Osimertinib EGFR-mutant patients, similar to the results of clinical trials conducted in western countries. Amivantamab was well tolerated and emphases should be put on adverse events such as rash, paronychia, and infusion-related reactions.
Topics: Antibodies, Bispecific; Carcinoma, Non-Small-Cell Lung; ErbB Receptors; Exanthema; Humans; Lung Neoplasms; Mutation; Paronychia; Protein Kinase Inhibitors
PubMed: 35899447
DOI: 10.3779/j.issn.1009-3419.2022.102.26 -
Scientific Reports Jul 2022Onycholysis and paronychia has been associated with chemotherapy treatment for women with breast cancer. Our primary aim was to investigate the effectiveness of... (Randomized Controlled Trial)
Randomized Controlled Trial
Onycholysis and paronychia has been associated with chemotherapy treatment for women with breast cancer. Our primary aim was to investigate the effectiveness of different topical interventions to ameliorate nail toxicity. Secondary aims were to explore the full range and severity of possible nail changes associated with taxane-based chemotherapy and the specific impact this had on quality of life, using two novel measures. This was an exploratory randomised controlled trial of three topical interventions (standard care, nail polish or specialist nail drops) for the prevention or reduction of nail changes induced by taxane-based chemotherapy. Outcomes included nail toxicity assessed at three time points (baseline, 3 weeks and 3 months post completion of chemotherapy) using two novel clinical tools (NToX-G12, NToX-QoL) and the Common Terminology Criteria for Adverse Events (CTCAE v3) and EQ-5D-5L. A total of 105 women were recruited (35 in each arm) and monitored up to three months post completion of chemotherapy. Almost 20% of patients were over the age of 60 years. There were 26 withdrawals, the majority from the nail polish arm. Residual Maximum Likelihood REML analysis indicated a significant arm, time and interaction effect for each intervention (p < 0.001). Less nail toxicity was observed in patients receiving specialist nail drops or standard care arms in comparison to those using nail polish. This study provides evidence to support clinicians' suggestions on nail care recommendations based on the patients' needs and preferences. Future investigations into comparing or combining cryotherapy and topical solutions that can support patient's decisions are warranted.
Topics: Breast Neoplasms; Female; Humans; Middle Aged; Nail Diseases; Onycholysis; Quality of Life; Taxoids
PubMed: 35798751
DOI: 10.1038/s41598-022-13327-6 -
Journal of Cutaneous and Aesthetic... 2022Paronychia refers to the inflammation of the tissue which immediately surrounds the nail and it can be acute (<6 weeks duration) or chronic (>6 weeks duration).... (Review)
Review
Paronychia refers to the inflammation of the tissue which immediately surrounds the nail and it can be acute (<6 weeks duration) or chronic (>6 weeks duration). Disruption of the protective barrier between the nail plate and the adjacent nail fold preceded by infectious or noninfectious etiologies results in the development of paronychia. A combination of general protective measures, and medical and/or surgical interventions are required for management. This review explores the pathogenesis, clinical features, differential diagnosis, medical, and surgical management of paronychia. For the purpose of this review, we searched the PubMed, Cochrane, and Scopus databases using the following keywords, titles, and medical subject headings (MeSH): acute paronychia, chronic paronychia, and paronychial surgeries. Relevant review articles, original articles, and case reports/series published till February 2020 were included in this study.
PubMed: 35655642
DOI: 10.4103/JCAS.JCAS_30_21 -
JPRAS Open Sep 2022is a rare encapsulated Gram-negative aerobic and facultative anaerobic rod belonging to the Enterobacteriaceae family. It tends to inhabit water and soil environments...
is a rare encapsulated Gram-negative aerobic and facultative anaerobic rod belonging to the Enterobacteriaceae family. It tends to inhabit water and soil environments and can be found on insects, fish, ticks, and termites, but can also found in the hospital environment. has been documented in respiratory, urinary, gastrointestinal, and biliary tract infections as well as bacteraemia and systemic infections but has rarely been documented in soft tissue infections. This case study describes a recurrent paronychia infection secondary to in a young woman not responding to antibiotics and successfully treated with surgical management.
PubMed: 35633992
DOI: 10.1016/j.jpra.2022.04.004 -
Dermatology and Therapy May 2022Erlotinib (Tarceva) is a drug used for the treatment of non-small cell lung cancer in patients with epidermal growth factor receptor (EGFR) mutations. Since EGFR is...
Erlotinib (Tarceva) is a drug used for the treatment of non-small cell lung cancer in patients with epidermal growth factor receptor (EGFR) mutations. Since EGFR is expressed in the skin, EGFR inhibitors commonly develop cutaneous side effects such as acneiform eruption, paronychia, telangiectasias, and abnormal eyelash growth. A 56-year-old man and a 46-year-old man visited the dermatology clinic complaining of yellowish papuloplaques and acneiform eruption on the face. They had been treated with erlotinib for lung cancer. Since patients using EGFR inhibitors are increasing, physicians should be aware that xanthomatous change can occur in severe acneiform eruptions after erlotinib treatment.
PubMed: 35508798
DOI: 10.1007/s13555-022-00739-5