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Targeted Oncology Jul 2023In RELAY, a randomized, double-blind, phase III trial investigating the efficacy and safety of ramucirumab+erlotinib (RAM+ERL) or ERL+placebo (PBO) in patients with... (Randomized Controlled Trial)
Randomized Controlled Trial
Efficacy and Tolerability of Ramucirumab Plus Erlotinib in Taiwanese Patients with Untreated, Epidermal Growth Factor Receptor-Mutated, Stage IV Non-small Cell Lung Cancer in the RELAY Study.
BACKGROUND
In RELAY, a randomized, double-blind, phase III trial investigating the efficacy and safety of ramucirumab+erlotinib (RAM+ERL) or ERL+placebo (PBO) in patients with untreated, stage IV, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), RAM+ERL demonstrated superior progression-free survival (PFS) versus PBO+ERL, with no new safety signals.
OBJECTIVE
The aim of this paper was to report efficacy and tolerability findings for the Taiwanese participants of RELAY.
PATIENTS AND METHODS
Patients were randomized 1:1 to RAM+ERL or ERL+PBO. Primary endpoint was investigator-assessed PFS. Secondary endpoints included objective response rate (ORR), duration of response (DoR) and tolerability. Data for the current analysis are reported descriptively.
RESULTS
In RELAY, 56 Taiwanese patients were enrolled; 26 received RAM+ERL, 30 received ERL+PBO. The demographic profile of the Taiwanese subgroup was consistent with that of the overall RELAY population. Median PFS for RAM+ERL/ERL+PBO, respectively, was 22.05 months/13.40 months (unstratified hazard ratio 0.4; 95% confidence interval 0.2-0.9); ORR was 92%/60%; median DoR was 18.2 months/12.7 months. All patients experienced one or more treatment-emergent adverse events (TEAEs); those most commonly reported were diarrhea and dermatitis acneiform (58% each) for RAM+ERL and diarrhea (70%) and paronychia (63%) for PBO+ERL. Grade ≥ 3 TEAEs were experienced by 62%/30% of RAM+ERL/PBO+ERL patients, respectively, and included dermatitis acneiform (19%/7%), hypertension (12%/7%), and pneumonia (12%/0%).
CONCLUSIONS
PFS for the Taiwanese participants of RELAY receiving RAM+ERL versus ERL+PBO was consistent with that in the overall RELAY population. These results, together with no new safety signals and a manageable safety profile, may support first-line use of RAM+ERL in Taiwanese patients with untreated EGFR-mutant stage IV NSCLC.
TRIAL REGISTRATION
www.
CLINICALTRIALS
gov , NCT02411448.
Topics: Humans; Carcinoma, Non-Small-Cell Lung; Erlotinib Hydrochloride; Lung Neoplasms; Antineoplastic Combined Chemotherapy Protocols; ErbB Receptors; Diarrhea; Dermatitis; Mutation; Ramucirumab
PubMed: 37329423
DOI: 10.1007/s11523-023-00975-5 -
Indian Journal of Dermatology,... May 2023Nail cosmetics industry is growing at an enormous rate globally due to a surge in nail care all around the world. Various nail cosmetics are available, such as nail... (Review)
Review
Nail cosmetics industry is growing at an enormous rate globally due to a surge in nail care all around the world. Various nail cosmetics are available, such as nail polish along with its variants like shellacs, finishes, artificial nails, adornments, and nail polish removers. Nail cosmetics serve aesthetic as well as therapeutic purposes, with the end result being smooth, attractive nails. Nail grooming procedures have evolved from a basic manicure to many other advanced procedures like gel nails, nail tattooing, etc. Although a majority of nail cosmetics are considered safe, they may have potential complications, including allergic and irritant reactions, infections, and mechanical effects. The majority of the procedures related to nail enhancement are not performed by dermatologists but by beauticians with inadequate or no knowledge of the nail's anatomy and functions. The hygiene at the so-called nail-salons/beauty parlours is not standardized, leading to acute complications like paronychia and nail dystrophy following matrix injury. The use of nail cosmetics has become widespread, making it essential for dermatologists to be aware of the nail care products, aesthetic procedures pertaining to nails, and related adverse effects.
PubMed: 37317711
DOI: 10.25259/IJDVL_77_2023 -
International Journal of Infectious... Sep 2023We evaluated the burden of noninvasive group A Streptococcus (GAS) infections in ambulatory pediatrics before and during the COVID-19 pandemic in France.
Surveillance of noninvasive group A Streptococcus infections in French ambulatory pediatrics before and during the COVID-19 pandemic: a prospective multicenter study from 2018-2022.
OBJECTIVES
We evaluated the burden of noninvasive group A Streptococcus (GAS) infections in ambulatory pediatrics before and during the COVID-19 pandemic in France.
METHODS
We analyzed data from a national network of ambulatory pediatricians between 2018 and 2022. Clinicians evaluating children ≤15 years old for tonsillopharyngitis, perianal infections, paronychia/blistering dactylitis, and scarlet fever were invited to perform a rapid antigen detection test (RADT) for GAS. Monthly incidence of noninvasive GAS infections per 10,000 visits was modeled using time series analysis, considering two breakpoints: March 2020 (first national lockdown) and March 2022 (end of mandatory mask-wearing in schools).
RESULTS
Over the study period, 125 pediatricians recorded 271,084 infectious episodes. GAS-related illnesses represented 4.3% of all infections. In March 2020, the incidence of GAS diseases decreased by 84.5% (P <0.001), with no significant trend until March 2022. After March 2022, the incidence significantly increased (+23.8% per month, P <0.001), with similar patterns across all monitored GAS-related diseases.
CONCLUSION
By using routine clinical data and RADTs, we have monitored changes in the incidence of noninvasive GAS infections in ambulatory pediatrics. COVID-19 mitigation measures have had a major impact on the epidemiology of noninvasive GAS infections, but their relaxation was followed by a surge above baseline levels.
Topics: Child; Humans; Adolescent; Streptococcus pyogenes; Prospective Studies; Pandemics; COVID-19; Communicable Disease Control; Streptococcal Infections; Pediatrics
PubMed: 37290573
DOI: 10.1016/j.ijid.2023.06.003 -
Cancer Medicine Jul 2023Dacomitinib significantly improves progression-free survival and overall survival (OS) compared with gefitinib in patients with non-small-cell lung cancer (NSCLC)...
BACKGROUND
Dacomitinib significantly improves progression-free survival and overall survival (OS) compared with gefitinib in patients with non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR)-activating mutations. However, dacomitinib often causes skin toxicities, resulting in treatment discontinuation. We aimed to evaluate a prophylactic strategy for skin toxicity induced by dacomitinib.
METHODS
We performed a single-arm, prospective, open-label, multi-institutional phase II trial for comprehensive skin toxicity prophylaxis. Patients with NSCLC harboring EGFR-activating mutations were enrolled and received dacomitinib with comprehensive prophylaxis. The primary endpoint was the incidence of skin toxicity (Grade ≥2) in the initial 8 weeks.
RESULTS
In total, 41 Japanese patients participated between May 2019 and April 2021 from 14 institutions (median age 70 years; range: 32-83 years), 20 were male, and 36 had a performance status of 0-1. Nineteen patients had exon 19 deletions and L858R mutation. More than 90% of patients were perfectly compliant with prophylactic minocycline administration. Skin toxicities (Grade ≥2) occurred in 43.9% of patients (90% confidence interval [CI], 31.2%-56.7%). The most frequent skin toxicity was acneiform rash in 11 patients (26.8%), followed by paronychia in five patients (12.2%). Due to skin toxicities, eight patients (19.5%) received reduced doses of dacomitinib. The median progression-free survival was 6.8 months (95% CI, 4.0-8.6 months) and median OS was 21.6 months (95% CI, 17.0 months-not reached).
CONCLUSION
Although the prophylactic strategy was ineffective, the adherence to prophylactic medication was quite good. Patient education regarding prophylaxis is important and can lead to improved treatment continuity.
Topics: Humans; Male; Aged; Female; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Prospective Studies; Protein Kinase Inhibitors; ErbB Receptors; Mutation
PubMed: 37269194
DOI: 10.1002/cam4.6184 -
Cureus Apr 2023Pemphigus vulgaris (PV) is a rare disease that affects the skin and mucous membranes, causing blistering and erosions. Identifying and effectively managing atypical...
Pemphigus vulgaris (PV) is a rare disease that affects the skin and mucous membranes, causing blistering and erosions. Identifying and effectively managing atypical presentations of pemphigus vulgaris can be challenging due to its rarity. We describe a 32-year-old male patient with a medical history including prediabetes, moderate asthma, hyperlipidemia, coccidioidomycosis, and respiratory infections. He was evaluated via telehealth in the allergy and immunology clinic for uncontrolled asthma. Initially, he complained of a whitish film in the mouth while on treatment with fluticasone and salmeterol. He also noted new vesicular lesions on his scalp and body. When evaluated later in the clinic, he was found to have oral and periungual erosions as well as paronychia. After promptly referring to dermatology, histopathological examination and direct immunofluorescence testing were performed on the patient's lesions, revealing changes consistent with PV. Treatment with prednisone and rituximab resulted in the complete resolution of the patient's bullae and nail deformities over several months. This case highlights the importance of a thorough evaluation of complex medical histories and diagnostic testing in managing asthma and allergy symptoms. It also emphasizes the need for a multidisciplinary approach involving specialists such as immunologists, dermatologists, and infectious disease experts in the diagnosis and management of complex cases.
PubMed: 37261177
DOI: 10.7759/cureus.38334 -
Journal of Veterinary Dentistry Dec 2023Patellar fracture and dental anomaly syndrome (PADS) is a congenital bone disease of cats that is characterized by atraumatic bone fractures (most commonly the patella),...
Patellar fracture and dental anomaly syndrome (PADS) is a congenital bone disease of cats that is characterized by atraumatic bone fractures (most commonly the patella), the persistence of deciduous teeth, and impaction of permanent teeth. Jaw swelling due to osteomyelitis is often the reason that cats with PADS are presented for veterinary dental care. The clinical history, oral examination findings, dental radiological findings, and histopathology were evaluated for 13 cats with dental and skeletal pathology consistent with PADS, including 9 with osteomyelitis. Cats in this study were predominantly domestic shorthair (12 of 13 cats), and there was no apparent sex predilection. All cats had multiple persistent deciduous teeth and multiple impacted permanent teeth, although the number of persistent and impacted teeth varied. Osteomyelitis of the jaw typically occurred within the first 4 years of life. Osteomyelitis of the mandible was 4 times more common than osteomyelitis of the maxilla. Histologically, osteomyelitis was chronic, neutrophilic, and osteoproliferative. Necrotic bone was confirmed in 67% of osteomyelitis lesions. Histological evaluation of jaws without inflammation demonstrated abnormal amounts of unmodeled bone, abnormally dense bone, and retention of cartilage in the caudal mandible. Three cats in the study had mandibular distoclusion and 2 had concurrent paronychia. To obtain a favorable clinical outcome in PADS cats with jaw swelling, prompt and aggressive surgical treatment of osteomyelitis is required. Extraction of persistent deciduous teeth and impacted permanent teeth is recommended when there is associated periodontitis or osteomyelitis.
Topics: Cats; Animals; Pathology, Oral; Fractures, Bone; Tooth, Impacted; Maxilla; Osteomyelitis; Cat Diseases
PubMed: 37248965
DOI: 10.1177/08987564231175594 -
The Australasian Journal of Dermatology Aug 2023The cutaneous toxicity of MEK inhibitors may limit treatment adherence. The authors present a retrospective study of 41 paediatric patients with NF-1 undergoing therapy...
The cutaneous toxicity of MEK inhibitors may limit treatment adherence. The authors present a retrospective study of 41 paediatric patients with NF-1 undergoing therapy with selumetinib and propose a treatment algorithm.
Topics: Humans; Child; Retrospective Studies; Paronychia; Protein Kinase Inhibitors; Skin Diseases; Mitogen-Activated Protein Kinase Kinases
PubMed: 37224380
DOI: 10.1111/ajd.14079 -
Journal of Oncology Pharmacy Practice :... Mar 2024Despite the common occurrence of cetuximab (Cmab)-induced skin toxicity, management strategies are not well established. The traditional mainstay method consists of...
Efficacy and safety of adapalene gel as a reactive treatment for cetuximab-induced skin toxicity in recurrent or metastatic squamous cell carcinoma of the head and neck: A historical cohort comparison study.
INTRODUCTION
Despite the common occurrence of cetuximab (Cmab)-induced skin toxicity, management strategies are not well established. The traditional mainstay method consists of topical steroids, which, if used excessively, may give rise to other concerns. Alternatively, adapalene can activate epidermal growth factor receptor pathways to potentially alleviate these toxicities.
METHODS
We prospectively studied 31 patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who were eligible to use adapalene gel as a reactive treatment for topical steroid-refractory skin toxicity. For comparison, we retrospectively reviewed 99 patients with R/M SCCHN (historical control cohort) whose skin toxicity was mainly treated with topical steroids. We compared the frequency and severity of Cmab-induced skin toxicity, Cmab therapy status (e.g., dose modification), side effects caused by topical steroids and adapalene gel itself, and other medical interventions.
RESULTS
Adapalene gel was used by eight patients (25.8%) in the prospective cohort. Patients in the historical control cohort more frequently required escalation of topical steroid potency (34.3% vs. 12.9%, = 0.022). Although there was no statistically significant difference in the frequency of grade ≥3 facial skin rash and paronychia between the two cohorts, the prospective cohort showed a significantly shorter time to complete recovery from grade 2/3 paronychia (16 vs. 47 days, = 0.017). Further, while no skin infections were observed in the prospective cohort, 13 patients in the historical control cohort developed skin infections, especially periungual infection (0% vs. 13.1%, = 0.024). In addition, no patients in the prospective cohort received a dose reduction of Cmab due to skin toxicities, compared to 20 patients in the historical control cohort (0% vs. 20.2%, = 0.003). No apparent adapalene gel-related side effects were observed.
CONCLUSIONS
Adapalene gel may be an effective management option for topical steroid-refractory Cmab-induced skin toxicities and could improve compliance with Cmab therapy.
Topics: Humans; Cetuximab; Adapalene; Squamous Cell Carcinoma of Head and Neck; Prospective Studies; Retrospective Studies; Paronychia; Neoplasm Recurrence, Local; Skin Diseases; Head and Neck Neoplasms; Steroids; Antineoplastic Combined Chemotherapy Protocols
PubMed: 37098185
DOI: 10.1177/10781552231171699