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Article ; Online: Entrectinib approval by EMA reinforces options for ROS1 and tumour agnostic

Ardini, Elena / Siena, Salvatore

ESMO open

2020 Volume 5, Issue 5, Page(s) e000867

MeSH term(s)	Benzamides ; Humans ; Indazoles/therapeutic use ; Neoplasms/drug therapy ; Protein-Tyrosine Kinases ; Proto-Oncogene Proteins
Chemical Substances	Benzamides ; Indazoles ; Proto-Oncogene Proteins ; Protein-Tyrosine Kinases (EC 2.7.10.1) ; ROS1 protein, human (EC 2.7.10.1) ; entrectinib (L5ORF0AN1I)
Language	English
Publishing date	2020-08-25
Publishing country	England
Document type	Editorial ; Research Support, Non-U.S. Gov't
ISSN	2059-7029
ISSN (online)	2059-7029
DOI	10.1136/esmoopen-2020-000867
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Article ; Online: Characteristics and Survival Outcomes of Patients With Metastatic

Hackshaw, Allan / Fajardo, Otto / Dafni, Urania / Gelderblom, Hans / Garrido, Pilar / Siena, Salvatore / Taylor, Matthew H / Bordogna, Walter / Nikolaidis, Christos

JCO precision oncology

2024 Volume 8, Page(s) e2300334

Abstract: Purpose: RET: Methods: Data for RET TKI-naïve patients with metastatic solid tumors (excluding NSCLC) who had ≥one Foundation Medicine comprehensive genomic profiling test (January 1, 2011-March 31, 2022) were obtained from a deidentified nationwide ( ...

Abstract	Purpose: RET Methods: Data for RET TKI-naïve patients with metastatic solid tumors (excluding NSCLC) who had ≥one Foundation Medicine comprehensive genomic profiling test (January 1, 2011-March 31, 2022) were obtained from a deidentified nationwide (US-based) clinicogenomic database. The primary objective of this study was to compare the overall survival (OS) of patients with Results: The study population included 26 patients in the Conclusion: These data suggest that
MeSH term(s)	Humans ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; Carcinoma, Non-Small-Cell Lung/pathology ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Lung Neoplasms/pathology ; Proto-Oncogene Proteins c-ret/genetics ; Standard of Care ; Prognosis
Chemical Substances	Proto-Oncogene Proteins c-ret (EC 2.7.10.1) ; RET protein, human (EC 2.7.10.1)
Language	English
Publishing date	2024-01-25
Publishing country	United States
Document type	Journal Article
ISSN	2473-4284
ISSN (online)	2473-4284
DOI	10.1200/PO.23.00334
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Article ; Online: The role of anti-EGFR rechallenge in metastatic colorectal cancer, from available data to future developments: A systematic review.

Ciardiello, Davide / Mauri, Gianluca / Sartore-Bianchi, Andrea / Siena, Salvatore / Zampino, Maria Giulia / Fazio, Nicola / Cervantes, Andres

Cancer treatment reviews

2024 Volume 124, Page(s) 102683

Abstract: Despite recent molecular and immunological advancements, prognosis of metastatic colorectal cancer (mCRC) patients remains poor. In this context, several retrospective and phase II studies suggested that after failure of an upfront anti-EGFR based ... ...

Abstract	Despite recent molecular and immunological advancements, prognosis of metastatic colorectal cancer (mCRC) patients remains poor. In this context, several retrospective and phase II studies suggested that after failure of an upfront anti-EGFR based regimen, a subset of patients can still benefit from further anti-EGFR blockade. Several translational studies involving circulating tumor DNA (ctDNA) analysis demonstrated that cancer clones harboring mutations driving anti-EGFR resistance, which can arise under anti-EGFR agents selective pressure, often decay after anti-EGFR discontinuation potentially restoring sensitivity to this therapeutic strategy. Accordingly, several retrospective analyses and a recent prospective trial demonstrated that ctDNA RAS and BRAF wild-type mCRC patients are those benefitting the most from anti-EGFR rechallenge. Indeed, in molecularly selected patients, anti-EGFR rechallenge strategy achieved up to 30 % response rate, with a progression free survival longer than 4 months and an overall survival longer than 1 year, which favorably compared with other standard therapeutic options available for heavily pretreated patients. Anti-EGFR is also well tolerated with no unexpected toxicities compared to the upfront setting. However, several open questions remain to be addressed towards a broader applicability of anti-EGFR strategy in the everyday clinical practice such as the identification of the best rechallenge regimen, the right placement in mCRC therapeutic algorithm, the best ctDNA screening panel. In our systematic review, we revised available data from clinical trials assessing anti-EGFR rechallenge activity in chemo-refractory mCRC patients, discussing as well potential future scenarios and development to implement this therapeutic approach. Particularly, we discussed the role of ctDNA as a safe, timely and comprehensive tool to refine patient's selection and the therapeutic index of anti-EGFR rechallenge.
MeSH term(s)	Humans ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/genetics ; Colorectal Neoplasms/pathology ; Retrospective Studies ; Antibodies, Monoclonal/therapeutic use ; Cetuximab ; Colonic Neoplasms/drug therapy ; Rectal Neoplasms/drug therapy ; Proto-Oncogene Proteins B-raf/genetics
Chemical Substances	Antibodies, Monoclonal ; Cetuximab (PQX0D8J21J) ; Proto-Oncogene Proteins B-raf (EC 2.7.11.1)
Language	English
Publishing date	2024-01-12
Publishing country	Netherlands
Document type	Systematic Review ; Journal Article ; Review
ZDB-ID	125102-8
ISSN	1532-1967 ; 0305-7372
ISSN (online)	1532-1967
ISSN	0305-7372
DOI	10.1016/j.ctrv.2024.102683
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Zs.A 1022: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 611: Show issues

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Article ; Online: Breaking Barriers in HER2+ Cancers.

Siena, Salvatore / Marsoni, Silvia / Sartore-Bianchi, Andrea

Cancer cell

2020 Volume 38, Issue 3, Page(s) 317–319

Abstract: Treatment with the immunoconjugate trastuzumab deruxtecan leads to unprecedented improvements in response and overall survival in patients with HER2-positive (HER2+) metastatic gastroesophageal carcinoma (GEA), according to a study published in the New ... ...

Abstract	Treatment with the immunoconjugate trastuzumab deruxtecan leads to unprecedented improvements in response and overall survival in patients with HER2-positive (HER2+) metastatic gastroesophageal carcinoma (GEA), according to a study published in the New England Journal of Medicine. Until now, no HER2-targeted drugs other than trastuzumab have shown significant benefit in patients with HER2+ GEA.
MeSH term(s)	Camptothecin/analogs & derivatives ; Humans ; Immunoconjugates ; Receptor, ErbB-2/genetics ; Stomach Neoplasms ; Trastuzumab/therapeutic use
Chemical Substances	Immunoconjugates ; trastuzumab deruxtecan (5384HK7574) ; Receptor, ErbB-2 (EC 2.7.10.1) ; Trastuzumab (P188ANX8CK) ; Camptothecin (XT3Z54Z28A)
Language	English
Publishing date	2020-08-27
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	2078448-X
ISSN	1878-3686 ; 1535-6108
ISSN (online)	1878-3686
ISSN	1535-6108
DOI	10.1016/j.ccell.2020.07.012
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Zs.A 5650: 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)
Zs.MG 104: Show issues

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Article: Indicators of guideline-concordant care in lung cancer defined with a modified Delphi method and piloted in a cohort of over 5,800 cases.

Andreano, Anita / Valsecchi, Maria Grazia / Russo, Antonio Giampiero / Siena, Salvatore

Archives of public health = Archives belges de sante publique

2021 Volume 79, Issue 1, Page(s) 12

Abstract: Background: To identify indicators of guideline-concordant care in lung cancer, to implement such indicators with cancer registry data linked to health databases, and to pilot them in a cohort of patients from the cancer registry of the Milan Province.!# ...

Abstract	Background: To identify indicators of guideline-concordant care in lung cancer, to implement such indicators with cancer registry data linked to health databases, and to pilot them in a cohort of patients from the cancer registry of the Milan Province. Methods: Thirty-four indicators were selected by revision of main guidelines by cancer epidemiologists, and then evaluated by a multidisciplinary panel of clinicians involved in lung cancer care and working on the pathway of lung cancer diagnosis and treatment in the Lombardy region, Italy. With a modified Delphi method, they assessed for each indicator the content validity as a quality measure of the care pathway, the degree of modifiability from the health professional, and the relevance to the health professional. Feasibility was assessed using the cancer registry and the routine health records of the Lombardy region. Feasible indicators were then calculated in the cohort of lung cancer patients diagnosed in 2007-2012 derived from the cancer registry of the Milan Province. Criterion validity was assessed reviewing clinical records of a random sample of 114 patients (threshold for acceptable discordance ≤20%). Finally, reliability was evaluated at the provider level. Results: Initially, 34 indicators were proposed for evaluation in the first Delphi round. Of the finally 22 selected indicators, 3 were not feasible because the required information was actually not available. The remaining 19 were calculated on the pilot cohort. After assessment of criterion validity (3 eliminated), 16 indicators were retained in the final set and evaluated for reliability. Conclusion: The developed and piloted set of indicators is now available to implement and monitor, over time, quality initiatives for lung cancer care in the studied health system.
Language	English
Publishing date	2021-01-25
Publishing country	England
Document type	Journal Article
ZDB-ID	1117688-x
ISSN	2049-3258 ; 0778-7367 ; 0003-9578
ISSN (online)	2049-3258
ISSN	0778-7367 ; 0003-9578
DOI	10.1186/s13690-021-00528-0
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Zs.A 147: Show issues

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Article ; Online: Diagnosis and Treatment of ERBB2-Positive Metastatic Colorectal Cancer: A Review.

Strickler, John H / Yoshino, Takayuki / Graham, Rondell P / Siena, Salvatore / Bekaii-Saab, Tanios

JAMA oncology

2022 Volume 8, Issue 5, Page(s) 760–769

Abstract: Importance: Amplification of ERBB2 (formerly referred to as HER2) is present in nearly 3% of patients with metastatic colorectal cancer overall and 5% of patients with KRAS and NRAS wild-type tumors. Despite the availability of several ERBB2-targeted ... ...

Abstract	Importance: Amplification of ERBB2 (formerly referred to as HER2) is present in nearly 3% of patients with metastatic colorectal cancer overall and 5% of patients with KRAS and NRAS wild-type tumors. Despite the availability of several ERBB2-targeted therapeutic options for patients with ERBB2-positive breast and gastric/gastroesophageal tumors, to date, there are currently no approved therapies for patients with ERBB2-positive metastatic colorectal cancer, although ERBB2-targeted therapies are recommended in National Comprehensive Cancer Network guidelines. Recent evidence indicates that anti-ERBB2 therapeutic strategies are active in patients with ERBB2-positive metastatic colorectal cancer and could potentially represent a new standard-of-care. Observations: The protein ERBB2 is a member of a family of epidermal growth factor receptors that also includes epidermal growth factor receptor (ERBB1), ERBB3, and ERBB4. Amplification of ERBB2 leads to overexpression of the ERBB2 tyrosine kinase receptor, resulting in aberrant signaling and cell migration, growth, adhesion, and differentiation. Colorectal tumors that harbor ERBB2 amplification are more likely to originate on the left side of the colon, are associated with primary and acquired resistance to anti-epidermal growth factor receptor therapies, and have increased incidence of central nervous system metastases. Using immunohistochemistry, fluorescence in situ hybridization, next-generation sequencing, and liquid biopsy techniques, several randomized clinical trials have evaluated the efficacy of ERBB2-targeted therapies in patients with ERBB2-positive metastatic colorectal cancer. These therapies include monoclonal antibodies, antibody-drug conjugates, and tyrosine kinase inhibitors, many of which were associated with favorable efficacy and safety profiles when treating patients with ERBB2-positive metastatic colorectal cancer. Conclusions and relevance: The results of this review suggest the ERBB2 receptor is a promising target for patients with metastatic colorectal cancer; however, to date, no therapies are approved for use in this patient population. Therefore, it is imperative to continue to work to address this unmet need so that patients with ERBB2-positive metastatic colorectal cancer have therapeutic options should they become refractory to treatment with standard therapies.
MeSH term(s)	Colonic Neoplasms ; Colorectal Neoplasms/diagnosis ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/genetics ; Humans ; In Situ Hybridization, Fluorescence ; Receptor Protein-Tyrosine Kinases ; Receptor, ErbB-2/metabolism ; Trastuzumab/therapeutic use
Chemical Substances	ERBB2 protein, human (EC 2.7.10.1) ; Receptor Protein-Tyrosine Kinases (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1) ; Trastuzumab (P188ANX8CK)
Language	English
Publishing date	2022-02-25
Publishing country	United States
Document type	Journal Article ; Review
ISSN	2374-2445
ISSN (online)	2374-2445
DOI	10.1001/jamaoncol.2021.8196
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Article ; Online: Application of histology-agnostic treatments in metastatic colorectal cancer.

Sartore-Bianchi, Andrea / Agostara, Alberto Giuseppe / Patelli, Giorgio / Mauri, Gianluca / Pizzutilo, Elio Gregory / Siena, Salvatore

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver

2022 Volume 54, Issue 10, Page(s) 1291–1303

Abstract: Cancer treatment is increasingly focused on targeting molecular alterations identified across different tumor histologies. While some oncogenic drivers such as microsatellite instability (MSI) and NTRK fusions are actionable with the very same approach ... ...

Abstract	Cancer treatment is increasingly focused on targeting molecular alterations identified across different tumor histologies. While some oncogenic drivers such as microsatellite instability (MSI) and NTRK fusions are actionable with the very same approach regardless of tumor type ("histology-agnostic"), others require histology-specific therapeutic adjustment ("histology-tuned") by means of adopting specific inhibitors and ad hoc combinations. Among histology-agnostic therapies, pembrolizumab or dostarlimab demonstrated comparable activity in MSI metastatic colorectal cancer (mCRC) as in other tumors with MSI status (ORR 38% vs 40% and 36% vs 39%, respectively), while entrectinib or larotrectinib proved effective in NTRK rearranged mCRC even though less dramatically than in the overall population (ORR 20% vs 57%, and 50% vs 78%, respectively). Histology-tuned approaches in mCRC are those targeting BRAF
MeSH term(s)	Antibodies, Monoclonal, Humanized ; Biomarkers, Tumor/genetics ; Colonic Neoplasms ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/genetics ; Colorectal Neoplasms/pathology ; Humans ; Microsatellite Instability ; Proto-Oncogene Proteins B-raf/genetics ; Rectal Neoplasms
Chemical Substances	Antibodies, Monoclonal, Humanized ; Biomarkers, Tumor ; dostarlimab ; Proto-Oncogene Proteins B-raf (EC 2.7.11.1)
Language	English
Publishing date	2022-06-11
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	1459373-7
ISSN	1878-3562 ; 1125-8055
ISSN (online)	1878-3562
ISSN	1125-8055
DOI	10.1016/j.dld.2022.05.013
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Zs.A 1134: Show issues

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Article: Plasticity of Resistance and Sensitivity to Anti-Epidermal Growth Factor Receptor Inhibitors in Metastatic Colorectal Cancer.

Sartore-Bianchi, Andrea / Siena, Salvatore

Handbook of experimental pharmacology

2017 Volume 249, Page(s) 145–159

Abstract: Colorectal cancer (CRC) is one of the most prevalent cancers and the second leading cause of cancer mortality worldwide. Survival in the metastatic setting has been gradually improved by the addition to cytotoxic chemotherapy of agents targeting the ... ...

Abstract	Colorectal cancer (CRC) is one of the most prevalent cancers and the second leading cause of cancer mortality worldwide. Survival in the metastatic setting has been gradually improved by the addition to cytotoxic chemotherapy of agents targeting the vascular endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR). Considerable heterogeneity exists within CRC due to the varied genetic and epigenetic mechanisms involved in differing pathways of carcinogenesis. The knowledge of molecular abnormalities underlying colorectal tumourigenesis and the progression of dysplastic precursors to invasive and ultimately metastatic lesions has advanced in recent years by comprehensive sequencing studies. From these genome-scale analyses, we know that a handful of genes are commonly affected by somatic mutations, whereas recurrent copy-number alterations and chromosomal translocations are rarer in this disease. Even though some of these molecular abnormalities make genes acting as drivers of cancer progression, translation of this recognition for therapeutic purposes is still limited, encompassing only as standard of care the exclusion of RAS-mutated cancers for better selecting patients to candidate to EGFR-targeted therapy with monoclonal antibodies. However, the effort of ameliorating molecular selection should not be considered exhausted by demonstration of RAS and BRAF-induced resistance, as the genomic landscape of response to EGFR blockade has been demonstrated to be wider and dynamically multifaceted. In this chapter we will review main molecular biomarkers of de novo (primary) and acquired (secondary) resistance to EGFR-targeted monoclonal antibodies in metastatic CRC and discuss therapeutic implications.
MeSH term(s)	Antibodies, Monoclonal/pharmacology ; Antineoplastic Agents/pharmacology ; Colorectal Neoplasms/drug therapy ; Drug Resistance, Neoplasm ; ErbB Receptors/antagonists & inhibitors ; Humans ; Mutation ; Neoplasm Metastasis ; Vascular Endothelial Growth Factor A/antagonists & inhibitors
Chemical Substances	Antibodies, Monoclonal ; Antineoplastic Agents ; Vascular Endothelial Growth Factor A ; ErbB Receptors (EC 2.7.10.1)
Language	English
Publishing date	2017-04-25
Publishing country	Germany
Document type	Journal Article
ISSN	0171-2004
ISSN	0171-2004
DOI	10.1007/164_2017_19
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Sign. bis Bd. 125 (1997): 1982 A 2146: Show issues
danach: Sign. bei den Einzelbänden: Show issues

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Article ; Online: Targeting HER2 heterogeneity in breast and gastrointestinal cancers.

Valenza, Carmine / Guidi, Lorenzo / Battaiotto, Elena / Trapani, Dario / Sartore Bianchi, Andrea / Siena, Salvatore / Curigliano, Giuseppe

Trends in cancer

2023 Volume 10, Issue 2, Page(s) 113–123

Abstract: About 20% of breast and gastric cancers and 3% of colorectal carcinomas overexpress the human epidermal growth factor receptor 2 (HER2) and are sensitive to HER2-directed agents. The expression of HER2 may differ within the same tumoral lesion (spatial ... ...

Abstract	About 20% of breast and gastric cancers and 3% of colorectal carcinomas overexpress the human epidermal growth factor receptor 2 (HER2) and are sensitive to HER2-directed agents. The expression of HER2 may differ within the same tumoral lesion (spatial intralesional heterogeneity), from different tumor locations (spatial interlesional heterogeneity), and throughout treatments (temporal heterogeneity). Spatial and temporal heterogeneity may impact on response and resistance to HER2-targeting agents and its prevalence and predictive role changes across HER2-overexpressing solid tumors. Therefore, the definition and the characterization of HER2 heterogeneity pose many challenges and its implementation as a reproducible predictive biomarker would help in guiding treatment modulation.
MeSH term(s)	Humans ; Gastrointestinal Neoplasms/drug therapy ; Gastrointestinal Neoplasms/genetics ; Breast/pathology ; Antineoplastic Agents ; Stomach Neoplasms/drug therapy ; Stomach Neoplasms/genetics
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2023-11-25
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2852626-0
ISSN	2405-8025 ; 2405-8033 ; 2405-8033
ISSN (online)	2405-8025 ; 2405-8033
ISSN	2405-8033
DOI	10.1016/j.trecan.2023.11.001
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Article ; Online: The Amount of Evidence Needed to Support ERBB2 as a Biomarker for Resistance to EGFR Inhibitors in Metastatic Colorectal Cancer.

Sartore-Bianchi, Andrea / Marsoni, Silvia / Siena, Salvatore

JAMA oncology

2019 Volume 5, Issue 10, Page(s) 1510–1511

Language	English
Publishing date	2019-08-09
Publishing country	United States
Document type	Journal Article
ISSN	2374-2445
ISSN (online)	2374-2445
DOI	10.1001/jamaoncol.2019.2982
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