scholarly journals Vismodegib-Induced Alopecia: Trichoscopic and Confocal Microscopy Evaluation

2020 ◽  
Vol 6 (6) ◽  
pp. 384-388
Author(s):  
Mariateresa Cantelli ◽  
Milena Cappello ◽  
Maria Vastarella ◽  
Angela Patrì ◽  
Massimiliano Scalvenzi ◽  
...  
Keyword(s):  
Adverse Event ◽  
Radiation Therapy ◽  
Confocal Microscopy ◽  
Adverse Events ◽  
Sonic Hedgehog ◽  
Locally Advanced ◽  
Sonic Hedgehog Pathway ◽  
Case Presentation ◽  
Metastatic Basal Cell Carcinoma ◽  
First Descriptions

<b><i>Introduction:</i></b> Vismodegib is the first-in-class inhibitor of the sonic hedgehog pathway useful in the treatment of locally advanced or metastatic basal cell carcinoma (BCC) that is not amenable to surgery and radiation therapy. Common adverse events of vismodegib, probably mechanism related, include alopecia (58%) as a reversible side effect. <b><i>Case Presentation:</i></b> We report 2 cases of patients receiving vismodegib for the treatment of locally advanced BCCs that developed alopecia during treatment and describe clinical, dermoscopic, and reflectance confocal microscopy (RCM) features of this adverse event. <b><i>Conclusion:</i></b> Alopecia is one of the most distressing adverse events leading to vismodegib discontinuations. To our knowledge, these are the first descriptions of RCM dermoscopy in vismodegib-induced alopecia. Trichoscopy and confocal microscopy are essential to monitoring vismodegib hair loss and the response to the treatment.

Long-term outcomes of locally advanced and borderline resectable esthesioneuroblastoma and sinonasal tumor with neuroendocrine differentiation treated with neoadjuvant chemotherapy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e18507-e18507
Author(s):  
Amit Kumar ◽  
Vanita Noronha ◽  
Vijay Maruti Patil ◽  
Amit Joshi ◽  
Nandini Sharrel Menon ◽  
...  
Keyword(s):  
Adverse Event ◽  
Neoadjuvant Chemotherapy ◽  
Adverse Events ◽  
Induction Chemotherapy ◽  
Locally Advanced ◽  
Neuroendocrine Differentiation ◽  
Local Therapy ◽  
Adjuvant Radiation ◽  
Cox Regression Analysis

e18507 Background: Sinonasal tumors are a rare subgroup of head and neck cancers. Locally advanced esthesioneuroblastoma and sinonasal neuroendocrine tumors (SNEC) are treated with a multidisciplinary approach with combination of surgery followed by adjuvant radiation or chemo radiation; but have unsatisfactory outcomes. Hence we devised the approach of administering neoadjuvant chemotherapy (platinum and etoposide) followed by surgery and adjuvant chemoradiation. This approach had the advantage of improved response rates, orbital preservation and improvement in short term outcomes. The present analysis was done to estimate the 5 year outcomes and late adverse events of locally advanced sinonasal tumors treated with induction chemotherapy followed by local therapy. Methods: Twenty five patients with locally advanced esthesioneuroblastoma or SNEC treated between August 2010 to August 2014 with induction chemotherapy followed by local therapy were selected. The 5 year outcomes and late adverse events (CTCAE version 4.02) were noted. Progression free survival (PFS) and overall survival (OS) were estimated using the Kaplan Meier method. COX regression analysis was used to identify factors impacting PFS and OS. Results: The median follow up was 5.15 years. The 5 year PFS in esthesioneuroblastoma cohort and in SNEC cohort was 63.5% (95%CI 28.9-84.7) and 34.6% (95%CI 10.1-61.1) respectively (p = 0.1). The only factor impacting PFS on multivariate analysis was response to neoadjuvant chemotherapy (p = 0.033). The 5 year OS in esthesioneuroblastoma cohort and in SNEC cohort were 91.7% (95%CI 53.9-98.9) and 46.2% (95%CI 19.2-69.6) respectively (p = 0.024). Any grade late adverse event was seen in 20 patients (80%). Metabolic late adverse events were seen in 19 patients (76%). Conclusions: Neoadjuvant chemotherapy in advanced sinonasal cancers is associated with improvement in 5 year outcomes. However late side effects especially metabolic are seen in these patients and should be evaluated during follow up. Keywords: Sinonasal; Adverse event; Esthesioneuroblastoma; SNEC; Induction; Neoadjuvant [Table: see text]

scholarly journals Dose-Painted Intensity Modulated Radiation Therapy Improves Local Control for Locally Advanced Pancreas Cancer

ISRN Oncology ◽  
2012 ◽  
Vol 2012 ◽  
pp. 1-7
Author(s):  
Ahmet Tunceroglu ◽  
Joo Han Park ◽  
Sairam Balasubramanian ◽  
Matthew Poppe ◽  
Christopher J. Anker ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Adverse Events ◽  
Induction Chemotherapy ◽  
Local Control ◽  
Pancreas Cancer ◽  
Locally Advanced ◽  
Intensity Modulated Radiation Therapy ◽  
Intensity Modulated ◽  
Concomitant Boost ◽  
3D Crt

Background. To evaluate the outcomes, adverse events, and therapeutic role of Dose-Painted Intensity-Modulated Radiation Therapy (DP-IMRT) for locally advanced pancreas cancer (LAPC). Methods. Patients with LAPC were treated with induction chemotherapy (n=25) and those without metastasis (n=20) received DP-IMRT consisting of 45 Gy to Planning Treatment Volume 1 (PTV1) including regional lymph nodes with a concomitant boost to the PTV2 (gross tumor volume + 0.5 cm) to either 50.4 Gy (n=9) or 54 Gy (n=11) in 25 fractions. DP-IMRT cases were compared to three-dimensional conformal radiation therapy (3D-CRT) plans to assess the potential relationship of radiation dose to adverse events. Kaplan-Meier and Cox regression analyses were used to calculate survival probabilities. The Fisher exact test and t-test were utilized to investigate potential prognostic factors of toxicity and survival. Results. Median overall and progression-free survivals were 11.6 and 5.9 months, respectively. Local control was 90%. Post-RT CA-19-9 levels following RT were predictive of survival (P=0.02). Grade 2 and ≥grade 3 GI toxicity were 60% and 20%, respectively. In comparison to 3D-CRT, DP-IMRT plans demonstrated significantly lower V45 values of small bowel (P=0.0002), stomach (P=0.007), and mean liver doses (P=0.001). Conclusions. Dose-escalated DP-IMRT offers improved local control in patients treated with induction chemotherapy for LAPC. Radiation-related morbidity appears reduced with DP-IMRT compared to 3D-CRT techniques, likely due to reduction in RT doses to organs at risk.

THE ROLE OF SURGICAL STAGE IN COMBINATION THERAPY FOR PATIENTS WITH LOCALLY ADVANCED CERVICAL CANCER

2019 ◽  
Vol 65 (5) ◽  
pp. 749-755
Author(s):  
D. Reyes Santyago ◽  
Anzhella Khadzhimba ◽  
M. Smirnova ◽  
Sergey Maksimov
Keyword(s):  
Cervical Cancer ◽  
Radiation Therapy ◽  
Combination Therapy ◽  
Lymph Nodes ◽  
Locally Advanced ◽  
Advanced Cervical Cancer ◽  
Relapse Free Survival ◽  
Regional Lymph Nodes ◽  
Free Survival ◽  
Locally Advanced Cervical Cancer

Objective: to justify the expediency of the surgical stage as a part of the combination treatment for stage IIA-IIIB cervical cancer. Materials and methods. The study included 343 women with stage IIA-IIIB cervical cancer treated from 2013 to 2016 with mandatory follow-up for at least 2 years. Patients were divided into 2 groups. The first group included 214 patients who received a combination treatment. At the first stage, neoadjuvant chemoradiation therapy was performed (remote radiation therapy 5 days a week with radio modification with Cisplatin once a week at a dose of 40 mg/m2). After evaluating the effect, patients were subjected to surgical treatment or continued chemoradiotherapy. The second group (n = 129) received standard combined radiation therapy. Various schemes of combination and complex treatment and standard combined radiation therapy were evaluated using the indices of general and relapse-free survival. Results. The proposed scheme for the combination therapy for patients with locally advanced cervical cancer showed significantly higher survival rates at all the analyzed stages. For the combined treatment group with complete cytoreduction, the two-year overall and relapse-free survival with stage IIA is 94.1% vs. 82.4%, with IIB 90.8% vs. 80.3%, with IIB 87.5% vs. 75%, with IIB with metastatic lesion of regional lymph nodes 85% vs. 70%. For the second group, two-year overall and relapse-free survival with stage IIA 75% vs. 50%, with IIB 70.9% vs. 56.3%, with IIB 59.1% vs. 40.9%, with IIB with metastatic lesion of regional lymph nodes 62.2% and 40.5%. The advantages of this approach are most clearly seen within patients with metastatic lesions of regional lymph nodes (85% vs. 62% accordingly). Conclusion. Cytoreductive surgery in combination with the combination therapy allows to achieve a significant increase in overall and relapse-free survival for patients with locally advanced cervical cancer compared with standard treatment programs.

Novel Adverse Events of Iloperidone: A Disproportionality Analysis in US Food and Drug Administration Adverse Event Reporting System (FAERS) Database

2019 ◽  
Vol 14 (1) ◽  
pp. 21-26 ◽  
Author(s):  
Viswam Subeesh ◽  
Eswaran Maheswari ◽  
Hemendra Singh ◽  
Thomas Elsa Beulah ◽  
Ann Mary Swaroop
Keyword(s):  
Data Mining ◽  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Disproportionality Analysis ◽  
Positive Signal ◽  
Data Mining Algorithms ◽  
Mining Algorithms

Background: The signal is defined as “reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously”. Objective: To detect novel adverse events of iloperidone by disproportionality analysis in FDA database of Adverse Event Reporting System (FAERS) using Data Mining Algorithms (DMAs). Methodology: The US FAERS database consists of 1028 iloperidone associated Drug Event Combinations (DECs) which were reported from 2010 Q1 to 2016 Q3. We consider DECs for disproportionality analysis only if a minimum of ten reports are present in database for the given adverse event and which were not detected earlier (in clinical trials). Two data mining algorithms, namely, Reporting Odds Ratio (ROR) and Information Component (IC) were applied retrospectively in the aforementioned time period. A value of ROR-1.96SE>1 and IC- 2SD>0 were considered as the threshold for positive signal. Results: The mean age of the patients of iloperidone associated events was found to be 44years [95% CI: 36-51], nevertheless age was not mentioned in twenty-one reports. The data mining algorithms exhibited positive signal for akathisia (ROR-1.96SE=43.15, IC-2SD=2.99), dyskinesia (21.24, 3.06), peripheral oedema (6.67,1.08), priapism (425.7,9.09) and sexual dysfunction (26.6-1.5) upon analysis as those were well above the pre-set threshold. Conclusion: Iloperidone associated five potential signals were generated by data mining in the FDA AERS database. The result requires an integration of further clinical surveillance for the quantification and validation of possible risks for the adverse events reported of iloperidone.

Adverse Effects of Natural Products: A Brief Pre-Systematic Review

2020 ◽  
Vol 01 ◽  
Author(s):  
Carla Pires ◽  
Ana Fernandes
Keyword(s):  
Systematic Review ◽  
Adverse Event ◽  
Natural Products ◽  
Adverse Events ◽  
In Vitro Study ◽  
Google Scholar ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Meta Analyses

Background: Natural products are commonly used for treating health problems. These products may be associated with adverse events, which are defined as "noxious and unintended response to a medicinal product" by the European Medicine Agency. Objectives: To identify studies describing at least one adverse event (or with potential to promote an adverse event) related to the use of natural products, as well as to describe the involved product(s) and adverse event(s). Methods: A pre-systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria. Keywords: "natural product(s)" and ["adverse drug reaction(s)" or "adverse effect(s)"]. Screened databases: PubMed, SciELO, DOAJ and Google Scholar. Inclusion criteria: papers describing at least one adverse event associated with the use of natural products and published between 2017 and 2019. Exclusion criteria: Repeated studies, reviews and papers written in other languages than English, Portuguese, French or Spanish. Results: 104 studies were identified (20 PubMed; 0 SciELO; 2 DOAJ; 82 Google Scholar), but only 10 were selected (4 PubMed and 6 Google Scholar): 1 in-vitro study; 2 non-clinical studies, 1 study reporting in-vitro and clinical data and 5 studies were cases reports. Globally, 997 reports of adverse drug reactions with natural products were identified, mainly non-severe cases. Conclusion: Since a limited number of studies was found, we conclude that adverse events due to natural products may be underreported, or natural products may have a good safety profile. This review contributes for assuring the safety of natural products consumers, by evaluating the knowledge/information on the potential adverse events and interactions of these products.

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