araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Observational Study to Characterize the Incidence of EGFR Mutation Positive and Advanced NSCLC Patients

Summary: The present study has been designed in order to characterize the incidence of patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) positive mutations and their clinical management in Galicia.


Eligibility: Inclusion Criteria:
  Inclusion Criteria for patients´ screening:
  -  Patients of both sexes aged 18 or more.
  -  Histologically confirmed advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) (patients stage III B unsuitable for locoregional treatment, and stage IV).
  -  Chemo- naïve patients (Non-Small-Cell Lung Cancer patients who have not received first line systemic cytotoxic chemotherapy).
  -  Patients with available tumoral tissue (primary tumor or metastatic area) or cytological samples including fine needle aspirates (primary tumor or metastatic area), bronchial alveolar lavage or bronchial scrapings and pleural effusion.
  -  Patients who have granted their written informed consent.
  Patients must fulfill the inclusion criteria previously mentioned and the following one in order to be enrolled in the study (visit 1) for the follow-up until progression or until 9 months from the beginning of treatment have elapsed:
  Inclusion Criteria for patients´ follow-up
  -  Patients with documented positive mutation in epidermal growth factor receptor (EGFR) (M+).
  Exclusion Criteria:
  -  Combined histology of non-small cell and small cell lung cancer.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients

Summary: The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.

Detailed description: This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation，primary endpoint is progress-free survival，second endpoints include overall survival, time to progression, and so on.

Eligibility: Inclusion Criteria:
  -  Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
  -  Positive EGFR Mutation.
  -  No previous systemic anticancer therapy.
  -  Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
  -  Provision of written informed consent.
  Exclusion Criteria:
  -  Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
  -  Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
  -  Known severe hypersensitivity to icotinib or any of the excipients of this product.
  -  Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: A Study of ABT-414 in Subjects With Solid Tumors

Summary: A study of ABT-414 in subjects with solid tumors.


Eligibility: Inclusion Criteria:
  1. Subjects must have a solid tumor type likely to over-express Epidermal Growth Factor Receptor (EGFR) (Phase 1)
  2. Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  3. Subjects have available tumor tissue
  4. Subjects have adequate bone marrow, renal, and hepatic function as follows: Bone marrow: Absolute neutrophil count (ANC) >/= 1,500/mm3 Platelets >/= 100,000/mm3; Hemoglobin >/= 9.0 g/dL Renal function: Serum creatinine </= 1.5 times the upper limit of the institution's normal range Hepatic function: Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) </= 1.5 times the upper limit of the institution's normal range. Subjects with liver metastasis may have an AST and ALT of </= 5.0 x the upper limit of normal.
  5. Subjects in the Phase 2 portion must have squamous cell Non-Small Cell Lung Cancer (NSCLC)
  6. Eligibility is restricted to subjects with confirmed EGFR amplification in the EGFR amplified cohort
  Exclusion Criteria:
  1. The subject has uncontrolled metastases to the central nervous system (CNS). Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 28 days after definitive therapy and have not received prior whole brain radiation (Phase 1 only).
  2. The subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 28 days prior to the first dose of ABT-414.
  3. The subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
  4. The subject had had major surgery within 28 days prior to the first dose of ABT-414.
  5. The subject has a history of immunologic reaction to any Immunoglobulin G (IgG) containing agent.
  6. Phase 2 portion only: The subject has previous or concurrent cancer that is distinct in primary site or histology from NSCLC, except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Efficacy of EGFR TKIs in Patients With Rare EGFR-mutated NSCLC

Summary: Lung cancer is the leading cause of cancer-related death worldwide and is well known to remain a major health problem. Non-small-cell lung cancer (NSCLC) constitutes more than 80% of all the cases of lung cancer.
  Today, NSCLC can be defined by various molecular criteria. Especially, somatic mutations within the epidermal growth factor receptor (EGFR) gene itself were discovered in a subset of NSCLC patients.
  Two activating EGFR mutations are in-frame deletion in exon 19 and the substitutions for L858R in exon 21, which account for 85% of all clinically important mutations related to EGFR TKI sensitivity.
  Besides two activating EGFR mutations, other EGFR mutations in NSCLC have been discovered. G719 and L861 are reported to have intermediate sensitivity to EGFR TKI. And in-frame insertions within exon 20 and T790, which are known to be resistant to EGFR TKIs.
  However, there are still other EGFR mutations such as E709 and S768 as well as doublet EGFR mutations are also observed. These rare mutations have not been fully described and data on their correlation with response to EGFR-TKIs are still unclear.
  Research hypothesis Rare EGFR mutations of unknown clinical significance in NSCLC patients, which are distinguish from mutations such as deletion in exon 19, L858 and insertion in exon 20, have some possibility of EGFR TKI sensitivity.
  Rationale for conducting this study It has an opportunity to be shown the efficacy of EGFR TKIs in patients with rare EGFR mutation in large number of patients in Korea (Asia) during the short period.


Eligibility: Inclusion Criteria:
  1. Histological confirmed non-small cell lung cancer (NSCLC), Stage IIIB or stage IV, between January 1, 2008 to December 31, 2011
  2. Confirmed EGFR rare mutations (EGFR mutation except both exon 19 deletion and exon 21 L858R) using direct DNA sequencing
  3. Experiences of treatment with EGFR TKIs.
  4. at least one measurable and/or evaluable lesion according to RECIST criteria (version 1.1)
  Exclusion Criteria:Subjects should not enter the study if any of the following exclusion criteria are fulfilled: EGFR wild type, EGFR exon 19 deletion alone, EGFR L858R alone

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis

Summary: To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR method.


Eligibility: Inclusion Criteria:
  -  1. Histologically confirmed NSCLC 2. Aged of or older than 20 years 3. ECOG performance status 0-2 4. Adequate hematological, renal, hepatic function 5. Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6. Patient who are about to be treated with EGFR TKI (gefitinib, erlotinib or other EGFR TKI) 7. At least more than one measurable disease 8. Informed consent
  Exclusion Criteria:
  -  1. Active infection 2. Active bleeding

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Retrospective Study in a NSCLC M+ p

Summary: This is a national, multicentre, non-interventional, retrospective study to be carried out in the oncology settings of approximately 15-20 Spanish hospitals.
  At each participant hospital, all patients recently diagnosed with advanced EGFR mutated NSCLC (both newly or with recurrent disease , without previous treatment for metastatic disease) from April 2010 to December 2011 will be included as study population. Information about the follow-up of the patients during a minimum of 12 months after diagnosis will be collected.

Detailed description: Observational retrospective study to describe the management of advanced or metastatic EGFR mutated non-small cell lung cancer patients in Spain

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed newly locally advanced or metastatic NSCLC (stage IIIB/IV)
  -  Confirmed EGFR mutation by a validated test
  -  Availability of medical record
  Exclusion Criteria:
  -  Participating on a blinded randomized clinical trial at any time during the study period
  -  Pregnant women (due to they do not reflect daily clinical practice)

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis

Summary: -  Saliva plays an important role in the homeostasis of the digestive tract mucosa.
  -  Salivary organic components, such as the Epidermal Growth Factor(EGF) have been found in defficient concentrations in patients with gastroesophageal reflux disease (GERD) and reflux related laryngitis (LPR).
  -  The epidermal growth factor receptor (EGFR) signaling pathway is one of the most important pathways that regulate growth, survival, proliferation, and differentiation in mammalian cells
  -  Eperdermal growth factor receptor (EGFR) overexpression has been linked to hyperproliferative diseases.
  -  It is unknown if the inflammatory process in GERD is realated to difficiencies in EGFR expression.
  -  The objective of the current study was to try to establish a correlation between the expression of EGFR in the laryngeal and esophageal mucosa and the severity of laryngitis in adults with GERD and LPR

Detailed description: Objectives: The expression of the Epidermal Growth Factor receptor (EGFR) has been studied in a number of neoplastic and chronic diseases, but there are no reports in literature regarding its expression in chronic laryngitis associated to Gastroesophageal Reflux isease (GERD), also known as Laryngopharyngeal Reflux (LPR). The current study compared the expression of EGFR in the esophageal and laryngeal mucosa of adults with GERD and LPR. Study Design: Prospective based on imunohistochemical analysis of parafine embedded biopsy specimens and clinical data. Methods: From August, 2004 to February 2007 a total of 24 adults with confirmed diagnosis of LPR and no other clinical conditions or habits known to cause chronic laryngitis were studied at a University Hospital. Biopsies of the distal esophagus and the retrocrycoid laryngeal mucosa were obtained during upper digestive endoscopy. Data were analyzed statistically comparing samples in each individual and between individuals using the severity of histological signs of inflammation on hematoxacillin and eosinophillin (HE) stains to immunohistochemical analysis of the expression of EGFR. Other independent variables were severity of symptoms and signs, gender and age. Fishers´s exact test and multivariance ANOVA tests were used with significance level established at 95%.

Eligibility: Inclusion Criteria:
  -  Adults with reflux laryngitis diagnosed by clinical symptoms (Reflux Symptom -Index >13) and videolaryngoscopic signs (Reflux Finding Score >7)
  -  A positive 24-hour doube probe esophageal ph monitoring test
  Exclusion Criteria:
  -  Other known causes of chronic laryngitis or inflammatory conditions of the pharynx, larynx and upper digestive tract.
  -  Current or past history of Head and Neck or digestive tract tumors.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)

Summary: To study the safety and efficacy of the combination of LJM716 and BYL719 against currently available treatments of physician's choice in previously treated esophageal squamous cell carcinoma patients.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed esophageal squamous cell carcinoma (ESCC)
  -  No more than one prior chemotherapy regimen for recurrent or metastatic ESCC (for Phase II only).
  -  Progression during or after platinum-based therapy for recurrent or metastatic ESCC, or recurrence within 6 months of platinum-based chemotherapy or chemoradiotherapy for localized disease.
  Exclusion Criteria:
  -  Patients who received prior phosphoinositide-3-kinase (PI3K) inhibitor or anti-receptor tyrosine-protein kinase erbB-3 (ERBB3 or HER3) antibody treatment, including bi-specific antibodies with HER3 as one of the targets (patients with prior exposure to pertuzumab or epidermal growth factor receptor (EGFR)-targeted agents are eligible)
  -  Patients who do not have an archival or fresh tumor sample (or sections of it) available or readily obtainable.
  -  Patients with central nervous system (CNS) metastatic involvement.
  -  Patients who have received prior systemic anti-cancer treatment, such as cyclical chemotherapy or biological therapy within a period of time that is shorter than the cycle length used for that treatment (e.g. 6 weeks for nitrosourea, mitomycin-C) prior to starting study treatment.
  -  Patients who have received definitive radiotherapy ≤ 4 weeks prior to starting study drug, who have not recovered from side effects of such therapy and/or from whom ≥ 30% of the bone marrow was irradiated.
  -  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Study of S-1 in Combination With Radiotherapy in Esophageal Cancer

Summary: This trial aims to study the safety, the local control, and the overall survival of S-1 combined with radiotherapy for patients with esophageal squamous cell carcinoma. 105 patients will be recruited into this trial.


Eligibility: Inclusion Criteria:
  -  Joined the study voluntarily and signed informed consent form;
  -  Age ＞75 or age 18-75 who are intolerant of or reject intravenous chemotherapy
  -  Both genders
  -  Esophageal squamous cell carcinoma confirmed by pathology
  -  Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th)
  -  No radiotherapy, chemotherapy or other treatments prior to enrollment
  -  PS ECOG 0-2
  -  Life expectancy of more than 3 months
  -  Hemoglobin（Hb）≥9 g/dL
  -  WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L
  -  platelet count (Pt) ≥100x 109/L
  -  Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN
  -  Renal function: creatinine < 1.5 x ULN
  -  No immuno-deficiency
  -  Use of an effective contraceptive for adults to prevent pregnancy.
  Exclusion Criteria:
  -  Complete esophageal obstruction
  -  Deep esophageal ulcer
  -  Esophageal perforation
  -  Haematemesis
  -  After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
  -  Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
  -  Participation in other interventional clinical trials within 30 days
  -  Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
  -  Drug addiction
  -  Alcoholism or AIDS
  -  Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
  -  Patient who has metastasis such as lung, liver metastasis

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Second-line Treatment With Icotinib in Esophageal Carcinoma Patients With EGFR Overexpression (IHC 3+) or Positive FISH

Summary: This study is designed to evaluate the efficacy and safety of icotinib in treating advanced carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or positive FISH, the primary endpoint is objective response rates.

Detailed description: Epidermal growth factor receptor (EGFR) signaling is critical for cancer cell proliferation, invasion, metastasis, and resistance to apoptosis.EGFR is overexpressed in many epithelial malignancies and therefore makes an attractive therapeutic target.This study is designed to evaluate the efficacy and safety of icotinib in treating advanced carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or positive FISH, the primary endpoint is objective response rates. Secondary endpoints include progress-free survival, overall survival, safety and so on.

Eligibility: Inclusion Criteria:
  -  Patients with a histologic or cytologic diagnosis of carcinoma of the gastroesophageal junction or esophagus;
  -  Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria;
  -  Overexpression of EGFR defined by immunohistochemistry (3+) or gene amplification by fluorescence in-situ hybridisation;
  -  Have progressed after one chemotherapy regimen;
  -  Age 18-75 years old with performance status of 0 to 2
  Exclusion Criteria:
  -  Prior targeted therapy with erlotinib, gefitinib, and so on
  -  Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
  -  Known severe hypersensitivity to icotinib or any of the excipients of this product.
  -  Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

Relevance to patient case: possibly relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Circulating Tumor Cells as a Biomarker for Preoperative Prognostic Staging in Patients With Esophageal Cancer

Summary: Despite the availability of several preoperative diagnostic techniques, accurate pretreatment staging of esophageal cancer (EC) remains challenging. Therefore, The investigators evaluated the prognostic significance of circulating tumor cells (CTCs) in patients with EC.


Eligibility: Inclusion Criteria:
  -  > 18 years
  -  resectable esophageal cancer
  Exclusion Criteria:
  -  < 18 years
  -  esophageal cancer with preoperative distant metastases

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Analysis of Plasma Tumor DNA in Lung Cancer Patients

Summary: The presence of genetic alterations in the tyrosine kinase domain of the oncogene (eg. EGFR and ALK) is associated with the clinical response to tyrosine kinase inhibitors (TKIs) in patients with non-small cell lung cancers. Therefore, the detection of altered genetic alterations is useful for predicting the treatment response for TKIs in non-small cell lung cancer patients. However, good quality tumor tissues are available only in <50% of patients with inoperable lung cancer for mutation analysis. In this study, the investigators will detect and quantify the genetic alterations in plasma. the investigators will investigate if the serial measurement of cancer-derived genetic alterations in plasma can provide a means for monitoring disease progression, as well as treatment response. In addition the investigators will analysis the resistant mechanism of TKIs and chemotherapy with plasma tumor DNA.


Eligibility: Inclusion Criteria:
  -  Have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer
  -  Have molecular evidence of genetic alterations in tumor sample (eg. EGFR mutations, ALK fusions)
  -  Patients must have given written informed consent
  Exclusion Criteria:
  -  Patients who refuse the blood samplings

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: An Open-label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification

Summary: This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.

Detailed description: This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.
  The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 to 42 days after the last dose of neratinib and a survival follow-up period lasting for a maximum of 12 months for each patient after their last dose of neratinib or until initiation of additional anti -cancer therapy.
  Treatment will consist of neratinib alone 240 mg daily in all HER2 mutated cancers excluding hormone positive breast cancers and bladder cancers, or neratinib 240 mg daily and paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of every 4 week cycle in bladder cancers , or neratinib 240 mg daily and fulvestrant 500 mg on Days 1, 15 of the first month, then Day 1 of every 4 week cycle in hormone positive breast cancers.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed cancers for which no curative therapy exists.
  -  Documented HER2 mutation.
  Exclusion Criteria:
  -  Prior treatment with any pan-HER TKI (eg, lapatinib, afatinib, dacomitinib, neratinib).
  -  Patients who are receiving any other anticancer agents.
  -  Symptomatic or unstable brain metastases.
  -  Women who are pregnant or breast-feeding.
  Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Relevance to patient case: not relevant