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19 results on '"hedgehog pathway inhibitor"'

1. Researchers at Universita Cattolica del Sacro Cuore Report Research in Basal Cell Cancer (Trichoscopy and LC-OCT findings in sonidegib-induced alopecia in patients with advanced basal cell carcinoma).

Abstract

A recent report from researchers at Universita Cattolica del Sacro Cuore in Rome, Italy, discusses the findings of a study on sonidegib-induced alopecia in patients with advanced basal cell carcinoma (aBCC). Sonidegib is a Hedgehog pathway inhibitor used as a first-line systemic treatment for aBCC. The study found that alopecia, or hair loss, was a common side effect of sonidegib treatment, occurring in 49% of patients. Trichoscopy and LC-OCT examinations revealed specific features of sonidegib-induced alopecia, including yellow dots, black dots, exclamation mark hairs, and broken hairs. The researchers concluded that LC-OCT may provide additional insights into the early signs and clinical evolution of sonidegib-induced alopecia in patients with aBCC. [Extracted from the article]

Published
2024

2. Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas.

Abstract

This document provides information about a clinical trial (NCT06623201) that is testing the combination of blue-light photodynamic therapy and Sonidegib as a potential treatment for multiple basal cell carcinoma (BCC) lesions. BCC lesions are typically treated by freezing or surgically removing the lesion, which can cause scarring. Photodynamic therapy, on the other hand, uses light and a drug applied to the skin to kill cancer cells without causing scarring. The trial aims to evaluate the safety and efficacy of this treatment approach. The trial is being conducted in the United States and is expected to be completed by December 2026, with Nathalie Zeitouni, MD, from Medical Dermatology Specialists as the principal investigator. [Extracted from the article]

Published
2024

3. Findings in Basal Cell Cancer Reported from Istituto Nazionale Tumori (Survey of the impact of BOLT-trial data on oncologists' and dermatologists' decision-making in treating patients with locally advanced basal cell carcinoma).

Abstract

A recent study conducted by the Istituto Nazionale Tumori examined the impact of BOLT-trial data on the decision-making process of Italian clinicians treating patients with locally advanced basal cell carcinoma (BCC). Basal cell carcinoma is the most common malignant tumor in white populations. The study found that the overall response rate (ORR) and the duration of response (DoR) were the most important factors considered by dermatologists and oncologists when choosing a treatment for patients with locally advanced BCC. The study also highlighted the different toxicity profiles of the two Hedgehog inhibitors, Vismodegib and Sonidegib, and how this influenced the choice between the two drugs. [Extracted from the article]

Published
2024

4. Studies from Section of Dermatology Further Understanding of Basal Cell Cancer (Evaluation of the Tolerability of Hedgehog Pathway Inhibitors In the Treatment of Advanced Basal Cell Carcinoma: a Narrative Review of Treatment Strategies).

Abstract

A recent study conducted by investigators in Dallas, Texas, explores the use of Hedgehog pathway inhibitors (HHIs) in the treatment of advanced basal cell carcinoma (BCC). The study focuses on the safety and tolerability profiles of two oral HHIs, sonidegib and vismodegib, and discusses potential management strategies for treatment-emergent adverse events (AEs). The research highlights the importance of effective management strategies to avoid treatment discontinuation and optimize therapeutic response. Healthcare providers and patients with advanced BCC should be aware of the potential AEs associated with HHIs and plan accordingly. [Extracted from the article]

Published
2024

5. Efficacy, rate of tumor response, and safety of a short course (12-24 weeks) of oral vismodegib in various histologic subtypes (infiltrative, nodular, and superficial) of high-risk or locally advanced basal cell carcinoma, in an open-label,...

Author

Fosko, Scott W., Chu, Melinda B., Armbrecht, Eric, Galperin, Tim, Potts, Geoffrey A., Mattox, Adam, Kurta, Anastasia, Polito, Kristen, Slutsky, Jordan B., Burkemper, Nicole M., and Hurley, M. Yadira

Abstract

Background: Vismodegib demonstrated 60% response rates in the ERIVANCE trial. Basal cell carcinoma has various histopathologies. Their effect on response is unclear.Objective: The purpose of this study was to determine whether basal cell carcinoma histopathology affected vismodegib response.Methods: This phase 2b, single-center, prospective case series study compared the efficacy of vismodegib in infiltrative, nodular, and superficial basal cell carcinomas treated for 12 or 24 weeks in 27 patients. Patients had 1 target lesion and up to 3 nontarget lesions.Results: Twenty-seven patients were enrolled, with 65 tumors (27 target lesions/38 nontarget lesions). At 24 weeks, most basal cell carcinomas achieved histologic clearance, with positive biopsy results in 10.5% of target lesions, 30.4% of nontarget lesions, and 21.4% overall. No statistical differences were observed between histopathologic subtypes. One hundred percent of patients experienced an adverse event, 94% grade 1 or 2. The most common adverse events were dysgeusia/loss of taste (86%), muscle spasms (82%), and alopecia (71%). Clinically progressive disease during treatment was low (1.5%). Two patients had recurrence within 1 year of treatment.Limitations: Limitations included sample size of basal cell carcinoma histopathologic subtypes, sampling punch biopsies, and short follow-up.Conclusions: Basal cell histopathologic subtype did not significantly affect response to vismodegib. Each subtype was observed to completely respond at 12 weeks of therapy, 24 weeks, or both. [ABSTRACT FROM AUTHOR]

Published
2020
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6. New Basosquamous Carcinoma Study Findings Recently Were Reported by Researchers at Universita Cattolica del Sacro Cuore (Real-Life Experience with Sonidegib for Locally Advanced Basosquamous Carcinoma: A Case Series).

Abstract

A recent report from researchers at Universita Cattolica del Sacro Cuore in Rome, Italy, discusses the use of hedgehog inhibitors (HHIs) as a potential treatment for locally advanced basosquamous carcinoma, a rare subtype of basal cell carcinoma. The study included five patients with skin lesions on the head and neck area, with three patients showing a clinical response to HHIs. However, further research and larger studies are needed to determine the efficacy of HHIs for basosquamous carcinoma. The full report can be accessed for free online. [Extracted from the article]

Published
2024

7. New Basal Cell Cancer Findings from Manipal Academy of Higher Education Described (Targeted Delivery of 5-Fluorouracil and Sonidegib via Surface-Modified ZIF-8 MOFs for Effective Basal Cell Carcinoma Therapy).

Abstract

Researchers from Manipal Academy of Higher Education in Karnataka, India have developed a topical gel formulation for the treatment of basal cell carcinoma (BCC) skin cancer. The gel contains a metal-organic framework (MOF) loaded with the anticancer drug 5-fluorouracil (5-FU) and a therapeutic agent called sonidegib (SDG). The MOFs were found to enhance skin deposition and permeation of the drugs, and showed strong cell growth inhibition in laboratory studies. The researchers concluded that the developed MOF gel has potential for targeted delivery of multifunctional MOFs in topical formulations for treating BCC cancer. [Extracted from the article]

Published
2023

8. University of Nevada Researchers Describe Research in Basal Cell Nevus Syndrome (Sustained Suppression of Gorlin Syndrome-Associated Basal Cell Carcinomas with Vismodegib or Sonidegib: A Case Series).

Abstract

Researchers from the University of Nevada have conducted a case series on the use of vismodegib or sonidegib in the treatment of basal cell nevus syndrome (Gorlin syndrome), a condition characterized by multiple cutaneous basal cell carcinomas. The study found that both drugs were effective in achieving complete remission and significantly reducing the number of new basal cell cancers. The treatment also showed potential in suppressing the progression of existing basal cell carcinomas. However, some patients experienced toxicity and required treatment modifications. The research suggests that sustained hedgehog inhibitor treatment can provide a prolonged response duration in managing basal cell nevus syndrome. [Extracted from the article]

Published
2023

9. University Hospital San Cecilio Researcher Targets Basal Cell Cancer (Multicenter Retrospective Andalusian Study of the Use of Sonidegib for the Treatment of Local Advanced Basal Cell Carcinoma in Real Clinical Practice).

Abstract

Keywords: Basal Cell Cancer; Basal Cell Carcinoma; Cancer; Carcinomas; Drugs and Therapies; Epidemiology; Health and Medicine; Hedgehog Pathway Inhibitor; Oncology; Radiotherapy; Smoothened Receptor Antagonists; Surgery EN Basal Cell Cancer Basal Cell Carcinoma Cancer Carcinomas Drugs and Therapies Epidemiology Health and Medicine Hedgehog Pathway Inhibitor Oncology Radiotherapy Smoothened Receptor Antagonists Surgery 1603 1603 1 09/19/23 20230924 NES 230924 2023 SEP 18 (NewsRx) -- By a News Reporter-Staff News Editor at Medical Devices & Surgical Technology Week -- Investigators publish new report on basal cell cancer. Basal Cell Cancer, Basal Cell Carcinoma, Cancer, Carcinomas, Drugs and Therapies, Epidemiology, Health and Medicine, Hedgehog Pathway Inhibitor, Oncology, Radiotherapy, Smoothened Receptor Antagonists, Surgery. [Extracted from the article]

Published
2023

10. Findings in Basal Cell Cancer Reported from Dermatology Unit (Sonidegib in Locally Advanced Basal Cell Carcinoma: A Monocentric Retrospective Experience and a Review of Published Real-Life Data).

Abstract

Basal Cell Cancer, Basal Cell Carcinoma, Cancer, Carcinomas, Drugs and Therapies, Health and Medicine, Hedgehog Pathway Inhibitor, Oncology, Smoothened Receptor Antagonists Keywords: Basal Cell Cancer; Basal Cell Carcinoma; Cancer; Carcinomas; Drugs and Therapies; Health and Medicine; Hedgehog Pathway Inhibitor; Oncology; Smoothened Receptor Antagonists EN Basal Cell Cancer Basal Cell Carcinoma Cancer Carcinomas Drugs and Therapies Health and Medicine Hedgehog Pathway Inhibitor Oncology Smoothened Receptor Antagonists 336 336 1 07/31/23 20230804 NES 230804 2023 JUL 31 (NewsRx) -- By a News Reporter-Staff News Editor at Drug Week -- Current study results on basal cell cancer have been published. [Extracted from the article]

Published
2023

11. Data from La Spezia Advance Knowledge in Rhabdomyolysis (Sonidegib induced rhabdomyolysis in kidney transplant patient: a case report).

Abstract

Keywords: Biomedicine; Drugs and Therapies; Health and Medicine; Hedgehog Pathway Inhibitor; Kidney Transplants; Muscular Diseases and Conditions; Musculoskeletal Diseases and Conditions; Nephrology; Organ Transplants; Rhabdomyolysis; Risk and Prevention; Smoothened Receptor Antagonists; Surgery; Therapy; Transplant Medicine; Transplantation EN Biomedicine Drugs and Therapies Health and Medicine Hedgehog Pathway Inhibitor Kidney Transplants Muscular Diseases and Conditions Musculoskeletal Diseases and Conditions Nephrology Organ Transplants Rhabdomyolysis Risk and Prevention Smoothened Receptor Antagonists Surgery Therapy Transplant Medicine Transplantation 67 67 1 07/24/23 20230727 NES 230727 2023 JUL 27 (NewsRx) -- By a News Reporter-Staff News Editor at Blood Weekly -- Investigators publish new report on rhabdomyolysis. This paper reports the case of a kidney transplant patient, who developed severe acute kidney injury (AKI) due to rhabdomyolysis (RML) induced by sonidegib therapy which required renal replacement therapy (RRT).". [Extracted from the article]

Published
2023

12. Findings from Foundation Policlinico University A Gemelli IRCCS Yields New Data on Smoothened Receptor Antagonists (Clinical Characteristics of an Italian Patient Population With Advanced Bcc and Real-life Evaluation of Hhi Safety and...).

Abstract

Keywords: Rome; Italy; Europe; Drugs and Therapies; Hedgehog Pathway Inhibitor; Smoothened Receptor Antagonists EN Rome Italy Europe Drugs and Therapies Hedgehog Pathway Inhibitor Smoothened Receptor Antagonists 558 558 1 07/17/23 20230721 NES 230721 2023 JUL 21 (NewsRx) -- By a News Reporter-Staff News Editor at Drug Week -- Investigators publish new report on Drugs and Therapies - Smoothened Receptor Antagonists. Systemic therapy with hedgehog pathway inhibitors (HHI) changed the treatment landscape for this complex patient population." For HHI safety assessment, therapy-related adverse events (AEs) were reported and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. we enrolled 178 patients under treatment with HHI: 126 (70.8%) and 52 patients (29.2%) received sonidegib and vismodegib, respectively. [Extracted from the article]

Published
2023

13. Investigators at University Hospital Wurzburg Detail Findings in Acute Myeloid Leukemia (Phase 1/1b Study of Azacitidine and Hedgehog Pathway Inhibitor Sonidegib In Patients With Myeloid Neoplasms).

Abstract

Keywords: Wurzburg; Germany; Europe; Acute Myeloid Leukemia; Antineoplastics; Aza Compounds; Azacitidine; Azacitidine Therapy; Cancer; Drugs and Therapies; Health and Medicine; Hedgehog Pathway Inhibitor; Hematology; Leukemia; Neoplasms; Oncology; Pharmaceuticals; Smoothened Receptor Antagonists EN Wurzburg Germany Europe Acute Myeloid Leukemia Antineoplastics Aza Compounds Azacitidine Azacitidine Therapy Cancer Drugs and Therapies Health and Medicine Hedgehog Pathway Inhibitor Hematology Leukemia Neoplasms Oncology Pharmaceuticals Smoothened Receptor Antagonists 830 830 1 05/29/23 20230602 NES 230602 2023 JUN 2 (NewsRx) -- By a News Reporter-Staff News Editor at Drug Week -- Investigators discuss new findings in Oncology - Acute Myeloid Leukemia. Wurzburg, Germany, Europe, Acute Myeloid Leukemia, Antineoplastics, Aza Compounds, Azacitidine, Azacitidine Therapy, Cancer, Drugs and Therapies, Health and Medicine, Hedgehog Pathway Inhibitor, Hematology, Leukemia, Neoplasms, Oncology, Pharmaceuticals, Smoothened Receptor Antagonists. [Extracted from the article]

Published
2023

14. Research from Fondazione IRCCS Istituto Nazionale dei Tumori Provide New Insights into Basal Cell Cancer (The association of cemiplimab plus sonidegib for synchronous cutaneous squamous cell carcinoma and basal cell carcinoma of the head and...).

Abstract

Currently, Sonic Hedgehog inhibitors (i.e., vismodegib and sonidegib) have been approved for advanced BCC, while the PD-1 checkpoint inhibitor cemiplimab has been approved as a first-line treatment for cSCC and as a second-line treatment for BCC. Keywords: Basal Cell Cancer; Basal Cell Carcinoma; Cancer; Carcinomas; Cemiplimab Therapy; Drugs and Therapies; Health and Medicine; Hedgehog Pathway Inhibitor; Immunologic Agents; Monoclonal Antibodies; Oncology; Pharmaceuticals; Risk and Prevention; Smoothened Receptor Antagonists; Squamous Cell Carcinoma EN Basal Cell Cancer Basal Cell Carcinoma Cancer Carcinomas Cemiplimab Therapy Drugs and Therapies Health and Medicine Hedgehog Pathway Inhibitor Immunologic Agents Monoclonal Antibodies Oncology Pharmaceuticals Risk and Prevention Smoothened Receptor Antagonists Squamous Cell Carcinoma 1104 1104 1 03/23/23 20230314 NES 230314 2023 MAR 13 (NewsRx) -- By a News Reporter-Staff News Editor at Immunotherapy Weekly -- Investigators discuss new findings in basal cell cancer. Nevertheless, there is a clinical need for an effective and safe systemic therapies for advanced synchronous (syn) BCC/cSCC not amenable to local treatments. [Extracted from the article]

Published
2023

15. Les antinéoplasiques ciblés.

Author

Vuillet-A-Ciles, Hadrien and Buxeraud, Jacques

Abstract

Résumé Les antinéoplasiques qualifiés de « ciblés » constituent un groupe de médicaments qui sont capables de bloquer la croissance des cellules cancéreuses. Agissant en différents points stratégiques, les thérapies ciblées apportent une aide précieuse et novatrice au patient dans sa lutte contre la maladie. Summary Targeted antineoplastics. Antineoplastics qualified as “targeted” form a group of drugs which are able to block the growth of cancer cells. Acting at different strategic points, targeted therapies offer a valuable and innovative technique to help patients in their fight against the disease. [ABSTRACT FROM AUTHOR]

Published
2014
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16. Expanded access study of patients with advanced basal cell carcinoma treated with the Hedgehog pathway inhibitor, vismodegib.

Author

Chang, Anne Lynn S., Solomon, James A., Hainsworth, John D., Goldberg, Leonard, McKenna, Edward, Day, Bann-mo, Chen, Diana M., and Weiss, Glen J.

Abstract

Background: Vismodegib, a first-in-class Hedgehog pathway inhibitor, was US Food and Drug Administration (FDA) approved for advanced basal cell carcinomas (BCCs) based on a single, nonrandomized, phase-II trial. Consequently, additional clinical data are critical to confirm the efficacy and safety of vismodegib. Objective: We sought to assess efficacy and safety of vismodegib, while providing early drug access to patients with advanced BCC and limited treatment options. Methods: This was an open-label, multicenter study in patients with advanced BCC inappropriate for radiotherapy or surgery. Patients received 150 mg vismodegib daily until disease progression or intolerable toxicity. Tumor response was assessed via Response Evaluation Criteria in Solid Tumors version 1.0. Results: A total of 119 patients with advanced BCC took vismodegib for a median of 5.5 months. Objective responses occurred in 46.4% of locally advanced BCC and 30.8% of patients with metastatic BCC. Response was negatively associated with prior systemic therapy in patients with locally advanced BCC (P = .002). Mean follow-up for safety was 6.5 months, with muscle spasms (70.6%), dysgeusia (70.6%), alopecia (58.0%), and diarrhea (25.2%) as the most common adverse events. Limitations: Abbreviated follow-up time because of study termination upon FDA approval was a limitation. Conclusion: This study provides important clinical data supporting the efficacy and safety of vismodegib. Larger studies are underway to assess predictors of response and long-term outcomes. [Copyright &y& Elsevier]

Published
2014
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17. The 12-month analysis from Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT): A phase II, randomized, double-blind study of sonidegib in patients with advanced basal cell carcinoma.

Author

Dummer, Reinhard, Guminski, Alexander, Gutzmer, Ralf, Dirix, Luc, Lewis, Karl D., Combemale, Patrick, Herd, Robert M., Kaatz, Martin, Loquai, Carmen, Stratigos, Alexander J., Schulze, Hans-Joachim, Plummer, Ruth, Gogov, Sven, Pallaud, Celine, Yi, Tingting, Mone, Manisha, Chang, Anne Lynn S., Cornélis, Frank, Kudchadkar, Ragini, and Trefzer, Uwe

Abstract

Background: The hedgehog pathway inhibitor sonidegib demonstrated meaningful tumor shrinkage in more than 90% of patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC in the BCC Outcomes with LDE225 Treatment study.Objective: This report provides long-term follow-up data collected up to 12 months after the last patient was randomized.Methods: In this multicenter, randomized, double-blind phase II study, patients were randomized 1:2 to sonidegib 200 or 800 mg. The primary end point was objective response rate assessed by central review.Results: Objective response rates in the 200- and 800-mg arms were 57.6% and 43.8% in locally advanced BCC and 7.7% and 17.4% in metastatic BCC, respectively. Among the 94 patients with locally advanced BCC who responded, only 18 progressed or died and more than 50% had responses lasting longer than 6 months. In addition, 4 of 5 responders with metastatic BCC maintained an objective response. Grade 3/4 adverse events and those leading to discontinuation were less frequent with sonidegib 200 versus 800 mg (38.0% vs 59.3%; 27.8% vs 37.3%, respectively).Limitations: No placebo or comparator arms were used because sonidegib demonstrated efficacy in advanced BCC in a phase I study, and the hedgehog pathway inhibitor vismodegib was not yet approved.Conclusion: With longer follow-up, sonidegib demonstrated sustained tumor responses in patients with advanced BCC. [ABSTRACT FROM AUTHOR]

Published
2016
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18. A phase II, multicenter, open-label, 3-cohort trial evaluating the efficacy and safety of vismodegib in operable basal cell carcinoma.

Author

Sofen, Howard, Gross, Kenneth G., Goldberg, Leonard H., Sharata, Harry, Hamilton, Tiffani K., Egbert, Barbara, Lyons, Benjamin, Hou, Jeannie, and Caro, Ivor

Abstract

Background Vismodegib is approved for treatment of advanced basal cell carcinoma. Objective We sought to characterize vismodegib efficacy and safety in operable basal cell carcinoma. Methods Patients with new, operable, nodular basal cell carcinoma received vismodegib (150 mg/d) followed by excision and Mohs micrographic surgery to ensure clear margins. Cohort 1 received vismodegib for 12 weeks; cohort 2 received vismodegib for 12 weeks, then 24 weeks of observation before excision; and cohort 3 received vismodegib for 8 weeks on/4 weeks off/8 weeks on. Results In all, 24 patients enrolled in cohort 1, and 25 in cohorts 2 and 3. Complete histologic clearance was achieved by 42%, 16%, and 44% of patients in cohorts 1, 2, and 3, respectively. Muscle spasms (76%), alopecia (58%), and dysgeusia (50%) were the most frequent adverse events (AEs). Five (7%) patients discontinued treatment because of an AE. AE reversibility was evaluated in cohort 2 with 24 weeks of observation after treatment discontinuation. Limitations Nonrandomized, small cohort sizes, and short observation durations for some patients are limitations. Conclusion Primary efficacy end points were not met (predefined complete histologic clearance rate: >50% in cohorts 1 and 3; >30% in cohort 2). Safety was comparable when dosed continuously versus intermittently. Posttreatment reversibility of vismodegib-related AEs was demonstrated. [ABSTRACT FROM AUTHOR]

Published
2015
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19. Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC.

Author

Sekulic, Aleksandar, Migden, Michael R., Lewis, Karl, Hainsworth, John D., Solomon, James A., Yoo, Simon, Arron, Sarah T., Friedlander, Philip A., Marmur, Ellen, Rudin, Charles M., Chang, Anne Lynn S., Dirix, Luc, Hou, Jeannie, Yue, Huibin, and Hauschild, Axel

Abstract

Background Primary analysis from the pivotal ERIVANCE BCC study resulted in approval of vismodegib, a Hedgehog pathway inhibitor indicated for treatment of adults with metastatic or locally advanced basal cell carcinoma (BCC) that has recurred after surgery or for patients who are not candidates for surgery or radiation. Objective An efficacy and safety analysis was conducted 12 months after primary analysis. Methods This was a multinational, multicenter, nonrandomized, 2-cohort study in patients with measurable and histologically confirmed locally advanced or metastatic BCC taking oral vismodegib (150 mg/d). Primary outcome measure was objective response rate (complete and partial responses) assessed by independent review facility. Results After 12 months of additional follow-up, median duration of exposure to vismodegib was 12.9 months. Objective response rate increased from 30.3% to 33.3% in patients with metastatic disease, and from 42.9% to 47.6% in patients with the locally advanced form. Median duration of response in patients with locally advanced BCC increased from 7.6 to 9.5 months. No new safety signals emerged with extended treatment duration. Limitations Limitations include low prevalence of advanced BCC and challenges of designing a study with heterogenous manifestations. Conclusion The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC. [ABSTRACT FROM AUTHOR]

Published
2015
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