OncologyTube
Time 2021-11-03 06:03:59Web Name: OncologyTube
WebSite: http://www.oncologytube.com
ID:220334
Keywords:
OncologyTube,AVideo,videos,live,moviesDescription:
keywords:AVideo, videos, live, movies description:About Us and Privacy Policy - 40244 · About Us and Privacy Policy 0:09:02 Podcast - Sameek Roychowdhury, MD @OSUCCC_James #SameekRoychowdhuryLab #Cholangiocarcinoma #Cancer #Research Phase 2 Study - Mature Results From A Multicentre, Open-label, Single-arm - P...Sameek Roychowdhury, MD, Ph.D., a medical oncologist, and researcher with the OSUCCC – James Translational Therapeutics Research Program speaks about Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study.
Link to Study:
https://www.sciencedirect.com/science/article/abs/pii/S2468125321001965
Conclusion -
Brief history:
After advancement on first-line gemcitabine-based therapy, individuals with advanced cholangiocarcinoma have few treatment alternatives. In 10–16 percent of individuals with intrahepatic cholangiocarcinoma, FGFR2 fusions or rearrangements are found. Infigratinib is a fibroblast growth factor receptor inhibitor that is selective and ATP-competitive. The researchers wanted to see if infigratinib had an antitumor effect in patients with locally progressed or metastatic cholangiocarcinoma, FGFR2 mutations, and previous gemcitabine treatment.
Methodologies:
Patients were recruited from 18 academic centers and hospitals in the United States, Belgium, Spain, Germany, Singapore, Taiwan, and Thailand for this multicenter, open-label, single-arm phase 2 trial. Participants required to be at least 18 years old, have histologically or cytologically proven, locally progressed, or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements, and had received at least one gemcitabine-containing regimen previously. Patients were given 125 mg of oral infigratinib once a day for 21 days in 28-day cycles until disease progression, intolerance, consent withdrawal, or death. A CT or MRI of the chest, abdomen, and pelvis was used to evaluate the radiological tumor at baseline and every 8 weeks until disease progression. The primary endpoint was the objective response rate, which was defined as the percentage of patients who had a best overall response of a confirmed complete or partial response as determined by a blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors, version 1.1. The full analytic set, which included all patients who received at least one dosage of infigratinib, was used to look at the primary result and safety. This study has been registered with ClinicalTrials.gov with the number NCT02150967, and it is still running.
Observations:
122 patients were enrolled in our study between June 23, 2014, and March 31, 2020, with 108 having FGFR2 fusions or rearrangements receiving at least one dose of infigratinib and making up the whole analysis set. The BICR-assessed objective response rate was 231% (95 percent CI 156–322; 25 of 108 patients) after a median follow-up of 106 months (IQR 622–156) with one confirmed complete response in a patient who solely had non-target lesions diagnosed at baseline and 24 partial responses. Hyperphosphataemia (n=83), stomatitis (n=59), tiredness (n=43), and alopecia (n=41) were the most common treatment-emergent adverse events of any grade. Dry eyes were the most prevalent ocular toxicity (n=37). 18 (17%) patients had central serous retinopathy-like and retinal pigment epithelial detachment-like events, with ten (9%) having grade 1, seven (6%) having grade 2, and one (1%) having grade 3. There were no deaths as a result of the treatment.
Assessment:
In previously treated patients with locally advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions or rearrangements, infigratinib has shown to have good clinical activity and a manageable adverse event profile, and so represents a viable new therapeutic option in this situation.
Sameek Roychowdhury, MD, Ph.D., a medical oncologist, and researcher with the OSUCCC – James Translational Therapeutics Research Program speaks about Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study.
Link to Study:
https://www.sciencedirect.com/science/article/abs/pii/S2468125321001965
Conclusion -
Brief history:
After advancement on first-line gemcitabine-based therapy, individuals with advanced cholangiocarcinoma have few treatment alternatives. In 10–16 percent of individuals with intrahepatic cholangiocarcinoma, FGFR2 fusions or rearrangements are found. Infigratinib is a fibroblast growth factor receptor inhibitor that is selective and ATP-competitive. The researchers wanted to see if infigratinib had an antitumor effect in patients with locally progressed or metastatic cholangiocarcinoma, FGFR2 mutations, and previous gemcitabine treatment.
Methodologies:
Patients were recruited from 18 academic centers and hospitals in the United States, Belgium, Spain, Germany, Singapore, Taiwan, and Thailand for this multicenter, open-label, single-arm phase 2 trial. Participants required to be at least 18 years old, have histologically or cytologically proven, locally progressed, or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements, and had received at least one gemcitabine-containing regimen previously. Patients were given 125 mg of oral infigratinib once a day for 21 days in 28-day cycles until disease progression, intolerance, consent withdrawal, or death. A CT or MRI of the chest, abdomen, and pelvis was used to evaluate the radiological tumor at baseline and every 8 weeks until disease progression. The primary endpoint was the objective response rate, which was defined as the percentage of patients who had a best overall response of a confirmed complete or partial response as determined by a blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors, version 1.1. The full analytic set, which included all patients who received at least one dosage of infigratinib, was used to look at the primary result and safety. This study has been registered with ClinicalTrials.gov with the number NCT02150967, and it is still running.
Observations:
122 patients were enrolled in our study between June 23, 2014, and March 31, 2020, with 108 having FGFR2 fusions or rearrangements receiving at least one dose of infigratinib and making up the whole analysis set. The BICR-assessed objective response rate was 231% (95 percent CI 156–322; 25 of 108 patients) after a median follow-up of 106 months (IQR 622–156) with one confirmed complete response in a patient who solely had non-target lesions diagnosed at baseline and 24 partial responses. Hyperphosphataemia (n=83), stomatitis (n=59), tiredness (n=43), and alopecia (n=41) were the most common treatment-emergent adverse events of any grade. Dry eyes were the most prevalent ocular toxicity (n=37). 18 (17%) patients had central serous retinopathy-like and retinal pigment epithelial detachment-like events, with ten (9%) having grade 1, seven (6%) having grade 2, and one (1%) having grade 3. There were no deaths as a result of the treatment.
Assessment:
In previously treated patients with locally advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions or rearrangements, infigratinib has shown to have good clinical activity and a manageable adverse event profile, and so represents a viable new therapeutic option in this situation.
Sudipto Mukherjee, MD, MPH, Ph.D., Director of Rare Cancers and Blood Diseases, at the Cleveland Clinic speaks about the Epidemiology and treatment patterns of idiopathic multicentric Castleman disease in the era of IL-6 directed therapy.
Link to Article:
https://doi.org/10.1182/bloodadvances.2021004441
Points to Remember:
* To calculate the incidence and prevalence of iMCD, a novel algorithm based on disease-specific ICD-10-CM codes and diagnostic criteria were developed.
* Despite being the only FDA-approved medication, siltuximab is rarely used in iMCD patients.
The epidemiology of HHV-8-deficient/idiopathic multicentric Castleman disease (iMCD) is still unknown. Due to a lack of uniform diagnostic criteria and a disease-specific International Classification of Diseases (ICD) code, previous epidemiologic studies of CD and iMCD have had difficulty accurately identifying cases. In this study, we use a novel claims-based algorithm to provide reliable estimates of CD and iMCD in the US, which includes a CD-specific ICD-10 diagnosis code (D47.Z2) and the presence of two claims codes corresponding to minor criteria from the international evidence-based diagnostic criteria for iMCD. We also looked at the different types of treatments and how they were used in the clinical course of iMCD patients. We identified 254 iMCD patients using an administrative claims database of 30.7 million people recruited between January 1, 2017, and December 31, 2018, with annual incidence and prevalence estimates of 3.4 (95 percent CI, 1.4 - 9.2) and 6.9 (95 percent CI, 3.7 - 13.3) cases per million, respectively. Patients with iMCD were given corticosteroid monotherapy in 39% of cases, no iMCD-directed medication in 33.1 percent of cases, and IL-6 targeted therapy with tocilizumab or siltuximab in 9.8% of cases. Only 8.7% of iMCD patients received siltuximab, the only FDA-approved medication and established first-line treatment prescription. This research presents the most up-to-date picture of the iMCD disease burden in the United States and shows a significant unmet therapeutic need for IL-6 focused therapy in this susceptible group.
Prof. Dr. med. Dirk Schadendorf, Universitätsklinikum Essen speaks about the ESMO 2021 Abstract - 1091TiP - STARBOARD: Randomized phase III study of encorafenib (enco) + binimetinib (bini) + pembrolizumab (pembro) for first-line treatment of metastatic or unresectable locally advanced BRAF V600-mutant melanoma.
Link to Abstract:
https://oncologypro.esmo.org/meeting-resources/esmo-congress-2021/starboard-randomized-phase-iii-study-of-encorafenib-enco-binimetinib-bini-pembrolizumab-pembro-for-first-line-treatment-of-metastatic-or
1091TiP -
Context:
BRAF V600 mutations are found in around half of all individuals with metastatic melanoma, and they accelerate melanoma progression by activating the MAPK pathway in a constant state. BRAF inhibitors (BRAFi) + MEK inhibitors (MEKi) (eg, enco + bini) and immune checkpoint inhibitors are now recommended treatments for metastatic or unresectable BRAF V600-mutant melanoma (CPIs; eg, pembro). BRAF V600-mutant tumors may be more sensitive to CPIs if BRAFi and MEKi are present. The goal of STARBOARD is to compare the effectiveness, safety, and tolerability of enco + bini + pembro vs pembro alone in the treatment of metastatic or unresectable locally advanced BRAF V600-mutant melanoma.
Design of the experiment:
STARBOARD is a phase III study with a safety lead-in that is randomized, double-blind, and placebo-controlled (SLI). In the SLI and phase III studies, about 24 and 600 patients will be included, respectively; phase III randomization will be stratified by past systemic adjuvant treatment and disease stage. Patients must have histologically proven metastatic or unresectable cutaneous melanoma with BRAF V600E/K mutation (by local laboratory assay); detectable disease (RECIST v1.1); ECOG performance level 0 or 1; and sufficient bone marrow, hepatic, and renal function. Patients must not have had first-line systemic therapy in the past. Prior adjuvant treatment with BRAFi and/or MEKi, as well as anti–PD-1 or anti–CTLA-4 antibodies, is allowed. Except for individuals with three brain lesions (either previously treated, asymptomatic, and stable for 28 days prior to inclusion; or untreated, asymptomatic, and each 5 mm), those with prior or present symptomatic brain metastases will be excluded. The table below lists the study's treatments and outcomes. Enrollment started on February 11, 2021.
Clinical trial identification
NCT04657991.
https://clinicaltrials.gov/ct2/show/NCT04657991
Sudipto Mukherjee, MD, MPH, Ph.D., Director of Rare Cancers and Blood Diseases, at the Cleveland Clinic speaks about the Epidemiology and treatment patterns of idiopathic multicentric Castleman disease in the era of IL-6 directed therapy.
Link to Article:
https://doi.org/10.1182/bloodadvances.2021004441
Points to Remember:
* To calculate the incidence and prevalence of iMCD, a novel algorithm based on disease-specific ICD-10-CM codes and diagnostic criteria were developed.
* Despite being the only FDA-approved medication, siltuximab is rarely used in iMCD patients.
The epidemiology of HHV-8-deficient/idiopathic multicentric Castleman disease (iMCD) is still unknown. Due to a lack of uniform diagnostic criteria and a disease-specific International Classification of Diseases (ICD) code, previous epidemiologic studies of CD and iMCD have had difficulty accurately identifying cases. In this study, we use a novel claims-based algorithm to provide reliable estimates of CD and iMCD in the US, which includes a CD-specific ICD-10 diagnosis code (D47.Z2) and the presence of two claims codes corresponding to minor criteria from the international evidence-based diagnostic criteria for iMCD. We also looked at the different types of treatments and how they were used in the clinical course of iMCD patients. We identified 254 iMCD patients using an administrative claims database of 30.7 million people recruited between January 1, 2017, and December 31, 2018, with annual incidence and prevalence estimates of 3.4 (95 percent CI, 1.4 - 9.2) and 6.9 (95 percent CI, 3.7 - 13.3) cases per million, respectively. Patients with iMCD were given corticosteroid monotherapy in 39% of cases, no iMCD-directed medication in 33.1 percent of cases, and IL-6 targeted therapy with tocilizumab or siltuximab in 9.8% of cases. Only 8.7% of iMCD patients received siltuximab, the only FDA-approved medication and established first-line treatment prescription. This research presents the most up-to-date picture of the iMCD disease burden in the United States and shows a significant unmet therapeutic need for IL-6 focused therapy in this susceptible group.
Prof. Dr. med. Dirk Schadendorf, Universitätsklinikum Essen speaks about the ESMO 2021 Abstract - 1091TiP - STARBOARD: Randomized phase III study of encorafenib (enco) + binimetinib (bini) + pembrolizumab (pembro) for first-line treatment of metastatic or unresectable locally advanced BRAF V600-mutant melanoma.
Link to Abstract:
https://oncologypro.esmo.org/meeting-resources/esmo-congress-2021/starboard-randomized-phase-iii-study-of-encorafenib-enco-binimetinib-bini-pembrolizumab-pembro-for-first-line-treatment-of-metastatic-or
1091TiP -
Context:
BRAF V600 mutations are found in around half of all individuals with metastatic melanoma, and they accelerate melanoma progression by activating the MAPK pathway in a constant state. BRAF inhibitors (BRAFi) + MEK inhibitors (MEKi) (eg, enco + bini) and immune checkpoint inhibitors are now recommended treatments for metastatic or unresectable BRAF V600-mutant melanoma (CPIs; eg, pembro). BRAF V600-mutant tumors may be more sensitive to CPIs if BRAFi and MEKi are present. The goal of STARBOARD is to compare the effectiveness, safety, and tolerability of enco + bini + pembro vs pembro alone in the treatment of metastatic or unresectable locally advanced BRAF V600-mutant melanoma.
Design of the experiment:
STARBOARD is a phase III study with a safety lead-in that is randomized, double-blind, and placebo-controlled (SLI). In the SLI and phase III studies, about 24 and 600 patients will be included, respectively; phase III randomization will be stratified by past systemic adjuvant treatment and disease stage. Patients must have histologically proven metastatic or unresectable cutaneous melanoma with BRAF V600E/K mutation (by local laboratory assay); detectable disease (RECIST v1.1); ECOG performance level 0 or 1; and sufficient bone marrow, hepatic, and renal function. Patients must not have had first-line systemic therapy in the past. Prior adjuvant treatment with BRAFi and/or MEKi, as well as anti–PD-1 or anti–CTLA-4 antibodies, is allowed. Except for individuals with three brain lesions (either previously treated, asymptomatic, and stable for 28 days prior to inclusion; or untreated, asymptomatic, and each 5 mm), those with prior or present symptomatic brain metastases will be excluded. The table below lists the study's treatments and outcomes. Enrollment started on February 11, 2021.
Clinical trial identification
NCT04657991.
https://clinicaltrials.gov/ct2/show/NCT04657991
Erin Frances Cobain, MD, Clinical Lecturer, University of Michigan Rogel Cancer Center speaks about the ASCOPubs Article - Tumor/normal Genomic Profiling In Patients With Metastatic Solid Tumors Identifies Pathogenic Germline Variants Of Therapeutic Importance.
Link to Article:
https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.1501
Abstract:
Background:
Patients are frequently referred to clinical trials of targeted medicines based on tumor genetic profiling using next-generation sequencing (NGS). Incidental pathogenic germline variations (PGVs) are discovered during NGS testing of paired tumor/normal samples, which could have serious consequences for patients and their families.
Methods:
The Michigan Oncology Sequencing study sequenced the exome and transcriptome of matched tumor/normal samples for 1,015 patients with metastatic, resistant solid malignancies from 2011 to 2018. The treating oncologist was informed of any PGVs discovered that enhanced cancer risk or were linked to particular autosomal recessive disorders. Every three months, chart reviews were performed to see if the discovery of PGV had an impact on treatment decisions. PGVs were found in 160 different patients, yielding a total of 169 PGVs (15.8 percent of cohort). In the tumors of 69 PGVs (41%), there was an evident somatic second hit event. PGVs linked to abnormalities in double-strand DNA repair (BRCA1, BRCA2, ATM, PALB2, BRIP1) or DNA mismatch repair (MLH1, MSH2, and PMS2) were found in 49 individuals (5 percent of the cohort, 31% of patients with PGVs), 37 of whom had never been detected before. Cancer types not frequently associated with hereditary breast-ovarian cancer or Lynch syndromes, such as cancers of uncertain primary origin and sarcomas, were shown to have 14 PGVs in DNA double-strand repair and 7 PGVs in DNA mismatch repair. On the basis of a PGV in DNA repair, 7 patients received a PARP inhibitor (PARPi), 3 patients received an immune checkpoint inhibitor (ICI), and 1 patient received both PARPi and ICI therapy. Clinical effect was achieved in 6 patients with a treatment duration of fewer than 6 months. A patient with cancer of unclear primary etiology and PGV in MSH2 responded well to ICI therapy, with a full response that lasted 23 months.
Conclusions:
PGVs was discovered in roughly 1 in every 6 patients with metastatic solid tumors using targeted NGS of matched tumor/normal samples. PGVs are linked to a somatic second hit in the tumor in about 40% of cases, implying that they play a role in tumor etiology. In patients with a variety of cancer types, unexpected PGVs with therapeutic implications have been discovered, allowing for the adoption of targeted medicines with the potential for significant clinical benefit. Given this finding, all patients with metastatic solid tumor malignancies should be tested for PGVs in DNA repair genes.
Erin Frances Cobain, MD, Clinical Lecturer, University of Michigan Rogel Cancer Center speaks about the ASCOPubs Article - Tumor/normal Genomic Profiling In Patients With Metastatic Solid Tumors Identifies Pathogenic Germline Variants Of Therapeutic Importance.
Link to Article:
https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.1501
Abstract:
Background:
Patients are frequently referred to clinical trials of targeted medicines based on tumor genetic profiling using next-generation sequencing (NGS). Incidental pathogenic germline variations (PGVs) are discovered during NGS testing of paired tumor/normal samples, which could have serious consequences for patients and their families.
Methods:
The Michigan Oncology Sequencing study sequenced the exome and transcriptome of matched tumor/normal samples for 1,015 patients with metastatic, resistant solid malignancies from 2011 to 2018. The treating oncologist was informed of any PGVs discovered that enhanced cancer risk or were linked to particular autosomal recessive disorders. Every three months, chart reviews were performed to see if the discovery of PGV had an impact on treatment decisions. PGVs were found in 160 different patients, yielding a total of 169 PGVs (15.8 percent of cohort). In the tumors of 69 PGVs (41%), there was an evident somatic second hit event. PGVs linked to abnormalities in double-strand DNA repair (BRCA1, BRCA2, ATM, PALB2, BRIP1) or DNA mismatch repair (MLH1, MSH2, and PMS2) were found in 49 individuals (5 percent of the cohort, 31% of patients with PGVs), 37 of whom had never been detected before. Cancer types not frequently associated with hereditary breast-ovarian cancer or Lynch syndromes, such as cancers of uncertain primary origin and sarcomas, were shown to have 14 PGVs in DNA double-strand repair and 7 PGVs in DNA mismatch repair. On the basis of a PGV in DNA repair, 7 patients received a PARP inhibitor (PARPi), 3 patients received an immune checkpoint inhibitor (ICI), and 1 patient received both PARPi and ICI therapy. Clinical effect was achieved in 6 patients with a treatment duration of fewer than 6 months. A patient with cancer of unclear primary etiology and PGV in MSH2 responded well to ICI therapy, with a full response that lasted 23 months.
Conclusions:
PGVs was discovered in roughly 1 in every 6 patients with metastatic solid tumors using targeted NGS of matched tumor/normal samples. PGVs are linked to a somatic second hit in the tumor in about 40% of cases, implying that they play a role in tumor etiology. In patients with a variety of cancer types, unexpected PGVs with therapeutic implications have been discovered, allowing for the adoption of targeted medicines with the potential for significant clinical benefit. Given this finding, all patients with metastatic solid tumor malignancies should be tested for PGVs in DNA repair genes.
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