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Article: [ANTIBODY-DRUG CONJUGATES - A NOVEL APPROACH FOR THE TREATMENT OF METASTATIC UROTHELIAL CARCINOMA].

Sternschuss, Michal / Sarfaty, Michal

2022 Volume 161, Issue 1, Page(s) 49–54

Abstract: Aims: of this review: Metastatic urothelial carcinoma (mUC) is associated with poor prognosis despite advances in the treatment options in recent years. Antibody-drug conjugates (ADC) represent a novel class of drugs that allows selective transport of ... ...

Abstract	Aims: of this review: Metastatic urothelial carcinoma (mUC) is associated with poor prognosis despite advances in the treatment options in recent years. Antibody-drug conjugates (ADC) represent a novel class of drugs that allows selective transport of highly effective chemotherapy directly into the cancer cells by linkage to a monoclonal antibody which targets antigens overexpressed in the tumor cells as opposed to the normal tissue. In this review we will cover the current data and future perspectives for the use of ADCs in the treatment of mUC. Background: Several ADCs against different targets are currently in advanced development stages with encouraging efficacy results and manageable toxicity profiles. Two ADC drugs received FDA approval for advanced-line treatment of mUC, Enfortumab Vedotin and Sacituzumab Govitecan, which are currently being evaluated in earlier treatment settings as well as in combination with immune checkpoint inhibitors. These combinations are expected to enter clinical practice in the near future. Conclusions: ADCs have demonstrated efficacy in mUC and are expected to be incorporated in the treatment algorithm in the following years.
MeSH term(s)	Carcinoma, Transitional Cell ; Humans ; Immunoconjugates ; Urinary Bladder Neoplasms
Chemical Substances	Immunoconjugates
Language	Hebrew
Publishing date	2022-01-25
Publishing country	Israel
Document type	Journal Article ; Review
ZDB-ID	953872-0
ISSN	0017-7768
ISSN	0017-7768
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Article: Low Alanine Aminotransferase as a Marker for Sarcopenia and Frailty, Is Associated with Decreased Survival of Bladder Cancer Patients and Survivors-A Retrospective Data Analysis of 3075 Patients.

Laufer, Menachem / Perelman, Maxim / Segal, Gad / Sarfaty, Michal / Itelman, Edward

Cancers

2023 Volume 16, Issue 1

Abstract: Background: Sarcopenia is characterized by the loss of muscle mass and function and is associated with frailty, a syndrome linked to an increased likelihood of falls, fractures, and physical disability. Both frailty and sarcopenia are recognized as ... ...

Abstract	Background: Sarcopenia is characterized by the loss of muscle mass and function and is associated with frailty, a syndrome linked to an increased likelihood of falls, fractures, and physical disability. Both frailty and sarcopenia are recognized as markers for shortened survival in a number of medical conditions and in cancer patient populations. Low alanine aminotransferase (ALT) values, representing low muscle mass (sarcopenia), may be associated with increased frailty and subsequently shortened survival in cancer patients. In the current study, we aimed to assess the potential relationship between low ALT and shorter survival in bladder cancer patients and survivors. Patients and methods: This was a retrospective analysis of bladder cancer patients and survivors, both in and outpatients. We defined patients with sarcopenia as those presenting with ALT < 17 IU/L. Results: A total of 5769 bladder cancer patients' records were identified. After the exclusion of patients with no available ALT values or ALT levels above the upper normal limit, the final study cohort included 3075 patients (mean age 73.2 ± 12 years), of whom 80% were men and 1362 (53% had ALT ≤ 17 IU/L. The mean ALT value of patients within the low ALT group was 11.44 IU/L, while the mean value in the higher ALT level group was 24.32 IU/L ( Conclusions: Low ALT values, indicative of sarcopenia and frailty, are associated with decreased survival of bladder cancer patients and survivors and could potentially be applied for optimizing individual treatment decisions.
Language	English
Publishing date	2023-12-29
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers16010174
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Article ; Online: Low Alanine Aminotransferase, as a Marker of Sarcopenia and Frailty, Is Associated with Shorter Survival Among Prostate Cancer Patients and Survivors. A Retrospective Cohort Analysis of 4064 Patients.

Laufer, Menachem / Perelman, Maxim / Sarfaty, Michal / Itelman, Edward / Segal, Gad

European urology open science

2023 Volume 55, Page(s) 38–44

Abstract: Background: Sarcopenia is characterized by loss of muscle mass and function and is associated with frailty, a syndrome with higher likelihood of falls, fractures, physical disability, and mortality. Both frailty and sarcopenia are known markers of ... ...

Abstract	Background: Sarcopenia is characterized by loss of muscle mass and function and is associated with frailty, a syndrome with higher likelihood of falls, fractures, physical disability, and mortality. Both frailty and sarcopenia are known markers of shorter survival in various cancer patient populations. Low alanine aminotransferase (ALT), reflecting loss of muscle mass (sarcopenia), may be associated with greater frailty and shorter survival in multiple cancers. Objective: To assess the potential association between low ALT and shorter survival among prostate cancer (PCa) patients and survivors. Design setting and participants: This was a retrospective analysis of a historical cohort of PCa patients and survivors. Patients were defined as those still actively receiving PCa treatment, while those no longer receiving such treatment were classified as PCa survivors. Outcome measurements and statistical analysis: ALT data were obtained from results for basic biochemical blood testing carried out for patients on their first hospital admission. Patients were divided into two groups: those with ALT ≥17 IU/l and those with ALT <17 IU/l. Univariate and multivariable analyses were conducted for between-group survival comparisons. Results and limitations: We identified 9489 PCa records. The final study cohort with ALT data available included 4064 patients with ALT <40 IU/l. Of this cohort, 536 patients were actively receiving medical anticancer therapy for PCa. The mean age for the entire cohort was 74.6 yr (standard deviation 9.6) and the median ALT level was 19.28 IU/l; 1676 patients (41%) had low ALT (<17 IU/l). On univariate analysis, low ALT was associated with a 78% increase in mortality risk (95% confidence interval [CI] 1.62-1.97; Conclusions: Low ALT, which is indicative of sarcopenia and frailty, is associated with shorter survival among PCa patients and survivors and could potentially be used for treatment personalization. Patient summary: We compared survival for prostate cancer patients and survivors according to their blood level of the protein alanine aminotransferase (ALT). Low ALT levels in the general population are associated with loss of muscle mass. We found that in our group of prostate cancer patients and survivors, the risk of death from any cause was higher for those with low ALT levels.
Language	English
Publishing date	2023-08-22
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	3040546-4
ISSN	2666-1683 ; 2058-4881
ISSN (online)	2666-1683
ISSN	2058-4881
DOI	10.1016/j.euros.2023.07.007
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Article ; Online: Antibody-Drug Conjugates in Urothelial Carcinomas.

Sarfaty, Michal / Rosenberg, Jonathan E

Current oncology reports

2020 Volume 22, Issue 2, Page(s) 13

Abstract: Purpose of review: Urothelial carcinoma (UC) is a common malignancy with an urgent need for more effective and less toxic treatment strategies. Antibody-drug conjugate (ADC) represents a novel therapeutic approach, which combines the high specificity of ...

Abstract	Purpose of review: Urothelial carcinoma (UC) is a common malignancy with an urgent need for more effective and less toxic treatment strategies. Antibody-drug conjugate (ADC) represents a novel therapeutic approach, which combines the high specificity of monoclonal antibodies covalently linked with highly active cytotoxic agents. UC is an appropriate candidate for these drugs, as it expresses unique cell surface antigens that allow for specific targeting of these cells. We hereby present a review of the current literature and future perspectives of ADC treatment in early-stage and metastatic UC. Recent findings: Several ADCs are in advanced stages of development and approval, such as intravesical oportuzumab monatox in BCG-refractory non-muscle invasive bladder cancer and enfortumab vedotin and sacituzumab govitecan in pretreated metastatic UC. Other agents are in earlier stages of development, including some promising anti-Her2 agents. The favorable toxicity profile of these agents led to several combination strategies, especially with checkpoint inhibitors. In light of the encouraging results presented in this review and the recent FDA approval of enfortumab vedotin, ADCs will likely be incorporated in the management of UC in the near future.
MeSH term(s)	Antineoplastic Agents, Immunological/therapeutic use ; Carcinoma, Transitional Cell/drug therapy ; Humans ; Immunoconjugates/therapeutic use ; Urologic Neoplasms/drug therapy
Chemical Substances	Antineoplastic Agents, Immunological ; Immunoconjugates
Language	English
Publishing date	2020-02-01
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2057359-5
ISSN	1534-6269 ; 1523-3790
ISSN (online)	1534-6269
ISSN	1523-3790
DOI	10.1007/s11912-020-0879-y
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Zs.A 5521: Show issues

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Article ; Online: Cancer Drug Pricing and Reimbursement: Lessons for the United States From Around the World.

Goldstein, Daniel A / Sarfaty, Michal

The oncologist

2016 Volume 21, Issue 8, Page(s) 907–909

MeSH term(s)	Antineoplastic Agents/economics ; Drug Costs ; Humans ; Neoplasms/economics ; Neoplasms/epidemiology ; United States
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2016-07-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	1409038-7
ISSN	1549-490X ; 1083-7159
ISSN (online)	1549-490X
ISSN	1083-7159
DOI	10.1634/theoncologist.2016-0106
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Zs.A 4845: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article: The Cost of Enfortumab Vedotin Wastage Due to Vial Size-A Real-World Analysis.

Sarfaty, Michal / Moore, Assaf / Regazzi, Ashley M / Mitchell, Aaron P / Rosenberg, Jonathan E

Cancers

2021 Volume 13, Issue 23

Abstract: Enfortumab Vedotin (EV) is FDA-approved for advanced urothelial cancer in patients previously treated with platinum-based chemotherapy and a checkpoint inhibitor. We conducted a real-world study to determine the extent of EV wastage in a single ... ...

Abstract	Enfortumab Vedotin (EV) is FDA-approved for advanced urothelial cancer in patients previously treated with platinum-based chemotherapy and a checkpoint inhibitor. We conducted a real-world study to determine the extent of EV wastage in a single institution and assessed the financial impact of EV wastage annually in the United States. Systematic examination of the usage and wastage of all standard-of-care EV treatments administered to urothelial cancer patients at Memorial Sloan Kettering Cancer Center (MSKCC) between 1 January 2020 and 31 December 2020 was performed. Drug wastage was calculated by subtracting the actual administered dose from the total dose in an optimal set of vials. We built a pharmacoeconomic model to assess the financial impact of EV wastage annually in the US using the January 2021 Average Sales Prices from the Centers for Medicare and Medicaid Services. Sixty-four patients were treated with standard-of-care EV, with a median of 11 doses per patient (range 1-28). Wastage occurred in 46% of administered doses (367/793), with a mean waste per dose of 2.9% (0-18%). The average drug wastage cost per patient was $3127 ($252/dose). The annual cost of EV wastage in the US is estimated to be $15 million based on wastage data from a single center in the US. In summary, EV wastage due to available vial sizes was 2.9%, which falls under acceptable thresholds. While the percentage of EV wastage is relatively low, waste-minimizing practices may reduce the financial toxicity for the individual patient and for society.
Language	English
Publishing date	2021-11-27
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers13235977
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Article: Immune-Related Thyroiditis as a Predictor for Survival in Metastatic Renal Cell Carcinoma.

Sagie, Shira / Gadot, Moran / Levartovsky, Meital / Gantz Sorotsky, Hadas / Berger, Raanan / Sarfaty, Michal / Percik, Ruth

Cancers

2022 Volume 14, Issue 4

Abstract: Immune checkpoint inhibitors (CPI) are indicated for metastatic renal cell carcinoma (mRCC). Immune-related thyroiditis (irT), an immune-related adverse event (irAE), affects up to 30% of patients. We aimed to determine whether irT is associated with ... ...

Abstract	Immune checkpoint inhibitors (CPI) are indicated for metastatic renal cell carcinoma (mRCC). Immune-related thyroiditis (irT), an immune-related adverse event (irAE), affects up to 30% of patients. We aimed to determine whether irT is associated with overall survival in mRCC. A retrospective cohort study of 123 consecutive patients treated with CPI for mRCC in a single center between 2015 and 2020 was conducted. Disease risk stratification was assessed by two methods: Heng criteria and a novel dichotomic stratification system to "Low risk" versus "High risk" adding number of metastatic sites. Thirty-eight percent of patients developed irT. In the general cohort, irT was not associated with a survival benefit. However, irT was associated with better survival in the poor risk group per Heng criteria (
Language	English
Publishing date	2022-02-10
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers14040875
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Article: RCC Real-World Data: Prognostic Factors and Risk Stratification in the Immunotherapy Era.

Sagie, Shira / Sarfaty, Michal / Levartovsky, Meital / Gantz Sorotsky, Hadas / Berger, Raanan / Percik, Ruth / Gadot, Moran

Cancers

2022 Volume 14, Issue 13

Abstract: Immunotherapy has transformed the landscape of treatment in metastatic renal cell carcinoma (mRCC) in the last decade. Currently, prognostic risk stratification is based on the model developed in the era of vascular endothelial growth factor receptor ... ...

Abstract	Immunotherapy has transformed the landscape of treatment in metastatic renal cell carcinoma (mRCC) in the last decade. Currently, prognostic risk stratification is based on the model developed in the era of vascular endothelial growth factor receptor inhibitors (VEGFRi) by Heng in 2009. Our study aims to find the most relevant risk criteria for mRCC patients treated with checkpoint inhibitors (CPI). In a retrospective cohort study, laboratory, pathology, demographic, and clinical data were retrieved from electronic medical records of consecutive mRCC patients treated with CPI in a tertiary center between 2015 and 2020. An unbiased multivariate analysis was performed to define predictive variables with a bootstrap validation step. We analyzed data on 127 patients with a median follow-up of 60 months. The median overall survival (OS) since the diagnosis of metastatic disease was 57 months. The response rate for CPI was 39%. Five risk factors were correlated with worse OS: intact primary kidney tumor (HR 2.33, p = 0.012), liver metastasis (HR 3.33, p = 0.001), <one year to treatment start (HR 1.98, p = 0.029), elevated platelets (HR 3.06, p = 0.015), and Karnofsky performance status <80% (HR = 3.42, p = 0.001). The model received a C-index of 70.7 compared with a score of 62.0 for the Heng’s model. When dividing patients into “low-risk” (0−1 risk factors) and “high-risk” (2−5 risk factors), there was good separation between the groups, with an HR of 5.9 (p < 0.0001). This study presents a new prognostic model for mRCC in the immunotherapy era with improved accuracy. Further research is needed to validate this model in larger cohorts.<br />
Language	English
Publishing date	2022-06-26
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers14133127
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Article ; Online: Not only for melanoma. Subcutaneous pseudoprogression in lung squamous-cell carcinoma treated with nivolumab: A case report.

Sarfaty, Michal / Moore, Assaf / Dudnik, Elizabeth / Peled, Nir

Medicine

2017 Volume 96, Issue 4, Page(s) e5951

Abstract: Rationale: Pseudoprogression, that is, initial tumor growth followed by subsequent tumor regression, has been well described for immunomodulation therapy in melanoma patients. This phenomenon is not well defined in lung cancer. Nivolumab, an anti-PD-1 ... ...

Abstract	Rationale: Pseudoprogression, that is, initial tumor growth followed by subsequent tumor regression, has been well described for immunomodulation therapy in melanoma patients. This phenomenon is not well defined in lung cancer. Nivolumab, an anti-PD-1 monoclonal antibody, was recently approved for nonsmall cell lung cancer (NSCLC) as a second-line therapy. Patient concerns and diagnosis: We present a patient with squamous NSCLC, suffering from multiple bone and subcutaneous metastases. Interventions: The patient was treated with nivolumab. Outcomes: A subcutaneous lesion in her upper back grew substantially after the first cycle of nivolumab, and later regressed, with marked improvement in all cancer sites. Lessons: Such pseudoprogression may serve to predict subsequent clinical response.
MeSH term(s)	Aged ; Antibodies, Monoclonal/therapeutic use ; Antineoplastic Agents/therapeutic use ; Bone Neoplasms/drug therapy ; Bone Neoplasms/secondary ; Carcinoma, Squamous Cell/drug therapy ; Carcinoma, Squamous Cell/secondary ; Fatal Outcome ; Female ; Humans ; Lung Neoplasms/drug therapy ; Lung Neoplasms/pathology ; Nivolumab ; Soft Tissue Neoplasms/drug therapy ; Soft Tissue Neoplasms/secondary
Chemical Substances	Antibodies, Monoclonal ; Antineoplastic Agents ; Nivolumab (31YO63LBSN)
Language	English
Publishing date	2017-01-20
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	80184-7
ISSN	1536-5964 ; 0025-7974
ISSN (online)	1536-5964
ISSN	0025-7974
DOI	10.1097/MD.0000000000005951
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Ua VI Zs.171: Show issues

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Article ; Online: Case Series of Men with the Germline APC I1307K variant and Treatment-Emergent Neuroendocrine Prostate Cancer.

Economides, Minas P / Nakazawa, Mari / Lee, Jonathan W / Li, Xiaochun / Hollifield, Lucas / Chambers, Rachelle / Sarfaty, Michal / Goldberg, Judith D / Antonarakis, Emmanuel S / Wise, David R

Clinical genitourinary cancer

2023 Volume 22, Issue 1, Page(s) e31–e37.e1

Abstract: Introduction: Somatic mutations in the Wnt signaling gene Adenomatous Polyposis Coli (APC) promote metastatic prostate cancer (PCa) progression. Less is known regarding the impact of germline APC mutations on PCa outcomes. We sought to investigate the ... ...

Abstract	Introduction: Somatic mutations in the Wnt signaling gene Adenomatous Polyposis Coli (APC) promote metastatic prostate cancer (PCa) progression. Less is known regarding the impact of germline APC mutations on PCa outcomes. We sought to investigate the prevalence of aggressive variant PCa (AVPC) and treatment-emergent neuroendocrine PCa (t-NEPC) in patients with the germline APC I1307K variant, an alteration found in 7% of Ashkenazi Jewish men. Materials and methods: We report a retrospective cohort study comparing patients with PCa and either APC I1307K germline mutation, APC somatic mutations, or unselected patients. Proportions of patients with AVPC among all the cases were estimated along with 95% Clopper-Pearson exact confidence intervals (CI). Odds ratios with 95% CI were provided for the prevalence of t-NEPC and AVPC in patients with germline APC I1307K compared to patients with frameshift alterations in APC. Results: From 2016-2022, 18 patients with PCa at 3 institutions with the germline APC (I1307K) mutation were identified. Clinically-defined AVPC was found in 8 of the 15 cases with metastatic disease (53%; 95% CI: 26%-79%). Combined somatic alterations in two or more of RB1, TP53 or PTEN (molecularly-defined AVPC) were found in 5/18 cases (28%; 95% CI: 10%-54%). When compared to 20 patients with APC somatic frameshift mutations, patients with the germline APC I1307K variant had a significantly increased risk of AVPC (OR 7.2; 95% CI 1.27, 40.68). Conclusion: PCa that develops in the presence of the germline APC I1307K mutation appear to be enriched for clinically-defined and molecularly-defined AVPC and in particular, for t-NEPC.
MeSH term(s)	Male ; Humans ; Germ-Line Mutation ; Colorectal Neoplasms/epidemiology ; Colorectal Neoplasms/genetics ; Retrospective Studies ; Adenomatous Polyposis Coli/genetics ; Prostatic Neoplasms/drug therapy ; Prostatic Neoplasms/genetics ; Prostatic Neoplasms/pathology ; Germ Cells/pathology
Language	English
Publishing date	2023-06-28
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	2225121-2
ISSN	1938-0682 ; 1558-7673
ISSN (online)	1938-0682
ISSN	1558-7673
DOI	10.1016/j.clgc.2023.06.013
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