bluuebunny/crossref_metadata_2025 huggingface dataset:
A phase II randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of simtuzumab (GS-6624) combined with gemcitabine as first-line treatment for metastatic pancreatic adenocarcinoma.
Authors: Benson Al Bowen , Thai Zung , Hawkins Michael J. , Werner Douglas , Dong Hua , Lee Claudia , Bendell Johanna C.
Published: March 2020

TPS4149

Background: Lysyl oxidase-like molecule 2 (LOXL2) is an extracellular matrix enzyme that catalyzes the covalent cross-linking of collagen and is widely expressed across desmoplastic tumors. Simtuzumab (GS-6624) is a humanized antibody that specifically inhibits LOXL2 enzymatic activity. Inhibiting LOXL2 is expected to block formation of desmoplasia, which is thought to play an important role in tumor progression and metastasis. Methods: The primary objective and of the study is to compare the additive efficacy of simtuzumab vs. placebo in combination with gemcitabine as measured by improvement in progression free survival (PFS). The secondary objective is to compare the additive efficacy of simtuzumab vs. placebo as measured by overall survival (OS) and objective response rate. Study Design: The study is a randomized, double-blind, placebo controlled Phase 2 trial in subjects with metastatic pancreatic adenocarcinoma. A total of 234 subjects will be randomized to 200 mg simtuzumab, 700 mg simtuzumab, or placebo at a 1:1:1 ratio (78 subjects per treatment group) in combination with gemcitabine in cycles of 28 days. In each cycle, subjects will receive IV GS-6624 or placebo infused on Days 1 and 15, and IV gemcitabine (1000 mg/m2) on Days 1, 8, and 15. CT or MRI scans will be performed every 8 weeks to evaluate response to treatment. Subjects will continue courses of treatment every 28 days in the absence of disease progression or unacceptable toxicity. As of January 30, 2013, 162 subjects have been randomized. Clinical trial information: NCT01472198.
MetGastric: A randomized phase III study of onartuzumab (MetMAb) in combination with mFOLFOX6 in patients with metastatic HER2-negative and MET-positive adenocarcinoma of the stomach or gastroesophageal junction.
Authors: Cunningham David , Bang Yung-Jue , Tabernero Josep , Shah Manish A. , Lordick Florian , Hack Stephen Paul
Published: March 2020

TPS4155

Background: Dysregulation of the HGF/MET pathway in patients with gastroesophageal cancer (GEC) is associated with diminished survival and poor prognostic features, such as nodal and organ metastasis, disease stage and tumor invasiveness. Preclinical data suggest that inhibition of the HGF/MET axis may increase the anti-tumor properties of platinum agents by overcoming HGF-mediated resistance mechanisms. Overexpression and inappropriate activation of the MET pathway has been shown to promote peritoneal metastasis in murine models of GEC. Overexpression of HGF or MET has also been linked to metastatic spread to the liver and peritoneum in patients with GEC. Clinical studies suggest that antibody-based inhibitors of the HGF/MET pathway are active in GEC. Onartuzumab, a monovalent monoclonal antibody, specifically binds to the MET receptor preventing HGF binding thereby inhibiting signal transduction. The most commonly reported adverse events associated with onartuzumab are grade 1–3 peripheral edema, hypoalbuminemia and fatigue. Methods: MetGastric is a randomized placebo-controlled, international phase III study in patients with previously untreated metastatic GEC. Only patients with tumors classified as both HER2-negative and MET-positive (by IHC) are eligible. Patients will be randomized (1:1) to receive mFOLFOX6 plus onartuzumab or mFOLFOX6 plus placebo. A maximum of 12 cycles of mFOLFOX6 are permitted. Onartuzumab or placebo will be continued until disease progression. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, overall response rate, safety and correlative biomarker studies. Primary and secondary analyses will include all randomized patients, analyzed according to treatment arm assignment and MET IHC score. Safety will be assessed in all patients who receive at least one dose of study treatment. This study is open for accrual. Clinical trial information: NCT01662869.
ST03: A randomized trial of perioperative epirubicin, cisplatin plus capecitabine (ECX) with or without bevacizumab (B) in patients (pts) with operable gastric, esophagogastric junction (OGJ), or lower esophageal adenocarcinoma.
Authors: Smyth Elizabeth Catherine , Langley Ruth E. , Stenning Sally P. , Stevenson Laura , Robb Claire , Allum William H. , Grabsch Heike , Alderson Derek , Riddell Angela M. , Crosby Thomas , Mason Robert , Griffin Michael , Mansoor Wasat , Coxon Fareeda Y. , Falk Stephen , Furniss Debra , Middleton Gary William , Sumpter Katherine Anne , Blazeby Jane M. , Cunningham David
Published: March 2020

TPS4156

Background: Perioperative ECX chemotherapy is a standard of care for localised operable gastric/OGJ/lower oesophageal adenocarcinoma (Cunningham, NEJM 2006). In combination with chemotherapy B, a monoclonal antibody targeting VEGF-A, results in improved response rates (RR) and progression free survival in advanced gastric cancer (Ohtsu, JCO 2011). ST03 aims to assess the safety and feasibility (stage I, 200 pts) and efficacy (stage II) of the addition of B to perioperative ECX chemotherapy. Methods: ST03 is a multicentre, open-label, phase II/III randomised trial open at 106 UK centres. Eligibility criteria are histologically proven, untreated, resectable, lower oesophageal, OGJ or gastric adenocarcinoma; age ≥18 years; WHO PS 0-1; and adequate cardiac ejection fraction (EF). Exclusion criteria are TIA/CVA or MI ≤1 year; uncontrolled hypertension; ≥ Grade 2 NYHA heart failure; recent gastrointestinal inflammatory conditions or major surgery/trauma/open biopsy <28d of study entry. Pts receive 3 pre- and 3 postoperative ECX (epirubicin 50 mg/m2 iv D1, cisplatin 60 mg/m2 iv D1 and capecitabine 1250mg/m2/D1-21) +/- B 7.5mg/kg D1 q3wk during chemotherapy, then 6 B q3wk (investigational arm). Surgery is pre-specified and laparoscopic procedures allowed only after quality assurance review. All specimens undergo central pathology review; blood and tissue collection for translational studies is ongoing. Stage I Safety results including cardiac EF have been reported (Okines Ann Oncol 2012). The stage II primary outcome measure is overall survival. Secondary outcome measures are RR, resection rate, disease free survival, toxicity, and QoL. MRI and PET substudies are ongoing. 877 of 1,100 pts have been recruited, accrual expected to complete in Q4 2013. A pilot study within ST03 randomising HER2 positive pts to ECX ± lapatanib (L) opened Q1 2013 and will assess safety, HER2 positivity rate and feasibility in 40 pts randomised between standard ECX and modified ECX+L. Trial sponsored and co-ordinated by the MRC Clinical Trials Unit and funded by Cancer Research UK (CRUK06/025, NCT00450203). Clinical trial information: NCT00450203.
Open-label, phase I/randomized, phase II trial of the triple angiokinase inhibitor, nintedanib, versus sorafenib in previously untreated patients with advanced hepatocellular carcinoma (HCC).
Authors: Palmer Daniel H. , Peck-Radosavljevic Markus , Ma Yuk Ting , Graham Janet , Fartoux Laetitia , Hubner Richard , Loembe Arsene Bienvenu , Studeny Matus , Hocke Julia , Meyer Tim
Published: March 2020

TPS4160

Background: While sorafenib is established as the standard first-line treatment for patients with advanced HCC, its use can be complicated by the occurrence of drug-related adverse events (AEs). Nintedanib, a potent, oral triple angiokinase inhibitor that targets VEGF, PDGF and FGF signaling (as well as Flt3 and RET), has demonstrated clinical activity in various advanced solid tumors with a relatively low incidence of AEs typically associated with angiogenesis inhibitors (e.g. skin toxicity, hypertension, hemorrhage, and hematologic toxicity) and is currently in phase III for non-small cell lung cancer and ovarian cancer. In the Phase I, dose-finding stage of this ongoing, multicenter, open-label Phase I/II trial (NCT01004003), 200mg twice daily (bid) was established as the maximum tolerated dose of nintedanib in previously untreated patients with advanced HCC (Palmer D, et al. Ann Oncol 2012;23(Suppl 9):ix245[Abs 740P]). Nintedanib had an acceptable liver AE profile; the most common AEs were mild/moderate gastrointestinal toxicities. Methods: The randomized Phase II stage of the trial aims to assess the efficacy, safety, and pharmacokinetics of nintedanib in comparison with sorafenib. Eligible patients have pathologically confirmed, measurable HCC that is not amenable to local therapy, ECOG Performance Status of ≤2, Child-Pugh score of 5–6 (Class A), AST/ALT levels ≤2× upper limit of normal, and no prior systemic therapy. Patients are being stratified by macrovascular invasion and/or extrahepatic spread and then randomized 2:1 to receive nintedanib 200mg bid or sorafenib 400mg bid in continuous 28-day cycles until progression or unacceptable toxicity. Overall, 93 patients were randomized between Sept 2011 and Nov 2012. The primary endpoint is time to progression (TTP) by independent review, according to RECIST 1.0. TTP will be estimated in the treated set by Kaplan–Meier methodology with treatment effects compared using a Cox proportional hazards model. Secondary endpoints include overall survival, tumor response, progression-free survival, safety and pharmacokinetics. Results are due late 2013. Clinical trial information: NCT01004003.
Phase II randomized study of dalantercept in combination with axitinib compared to axitinib alone as second-line treatment in patients with metastatic renal cell carcinoma.
Authors: Atkins Michael B. , Bhatt Rupal Satish , Voss Martin Henner , Rini Brian I. , Jonasch Eric , Plimack Elizabeth R. , Alter Robert , Barger Rachel , Wilson Dawn , McClure Ty , Kumar Ravi , Attie Kenneth M. , Sherman Matthew L. , Pandya Shuchi Sumant
Published: March 2020

TPS4595

Background: The treatment of metastatic renal cell cancer (mRCC) with therapies targeting the vascular endothelial growth factor (VEGF) pathway delays disease progression; however, overcoming tumor resistance to these agents remains a therapeutic challenge. Activin receptor-like kinase 1(ALK1) is a type 1 receptor in the TGF-ß superfamily and is selectively expressed on activated endothelial cells. While VEGF drives the proliferative stage of angiogenesis, ALK1 is primarily involved in the maturation phase. Dalantercept is a human ALK1-Fc receptor fusion protein that binds to bone morphogenetic proteins (BMP) 9 and 10 (ligands for ALK1) and acts as a ligand trap. Preclinically, dalantercept showed delayed tumor growth in solid tumor models, including RCC models alone and in combination with sunitinib. In RCC models, the addition of dalantercept to sunitinib enhanced the reduction in tumor blood flow compared to sunitinib alone. Dalantercept showed anti-tumor activity in a completed phase 1 study in 37 pts. with advanced solid tumors. Based on this promising data, we hypothesize that ALK1 inhibition may be synergistic with axitinib, a VEGFR tyrosine kinase inhibitor (TKI), in pts. with mRCC. Methods: A two-part, multi-center, open label phase 2 study to evaluate safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of dalantercept plus axitinib as second line therapy is ongoing. In Part 1, dose escalation using a 3+3 design will assess the safety and PK of dalantercept SC every 3 weeks plus axitinib 5 mg PO BID until disease progression or unacceptable toxicity. Once the maximum tolerated dose (MTD) has been determined, up to 20 pts. may be enrolled in an expansion cohort to establish safety for the recommended dose for Part 2. Part 2 will include 112 pts. randomized 1:1 to dalantercept plus axitinib vs. axitinib alone. Key eligibility criteria are one prior TKI in the first-line setting, ECOG </= 1, and measurable disease. The primary efficacy endpoint is PFS. Secondary endpoints are OS, TTP, ORR, DOR, DCR, and PD biomarkers on archived tumor and serum specimens including BMP9/10 and ALK1 expression. Clinical trial information: NCT01727336.
A phase I study of cabozantinib (Cabo) plus docetaxel (D) and prednisone (P) in metastatic castrate resistant prostate cancer (mCRPC).
Authors: Karzai Fatima H. , Madan Ravi Amrit , Apolo Andrea Borghese , Parnes Howard L. , Wright John Joseph , Trepel Jane B. , Beatson Melony A. , Harold Nancy , Couvillon Anna , Steinberg Seth M , Price Douglas K. , Gulley James L. , Figg William Douglas , Dahut William L.
Published: March 2020

TPS5095

Background: In mCRPC, two randomized trials demonstrated an overall survival (OS) benefit with the chemotherapeutic agent D. However, the survival improvement is modest and new strategies are needed to enhance clinical response. D-based combinations have been evaluated as one alternative strategy. Cabo targets multiple tyrosine kinases including c-Met, vascular endothelial growth factor receptor 2 (VEGFR2) and RET. Cabo has shown activity in mCRPC, with resolution of bone lesions on bone scan, regression of soft tissue/visceral disease, and reductions in circulating tumor cells and bone biomarkers (Smith, et al, J Clin Oncol 30, 2012 [suppl; abstr 4513]). We hypothesize the addition of Cabo to D and P, in patients (pts) with mCRPC, will have an acceptable toxicity profile and could lead to improved survival by targeting different cellular pathways simultaneously. This combination therapy may represent a safe and effective strategy to improve the outcome of mCRPC pts treated with D-based chemotherapy. Methods: This is a phase I trial to determine the safety profile and the recommended phase II dose of Cabo in combination with D and P. Pts receive a fixed dose of D (75 mg/m2 IV day 1 of each 21 day cycle) and P (5 mg po q12 hours) in combination with Cabo at three escalating doses: dose level 1 is 20 mg, level 2 is 40 mg, and level 3 is 60 mg (all po qdaily). Using a standard 3 + 3 design, three patients will initially be treated at each dose level until the maximum tolerated dose (MTD) has been defined. An expansion cohort will then be enrolled at the MTD. The accrual ceiling for the study, including both the dose escalation and the expansion phases, is set at 24 pts. Secondary objectives include assessments of pharmacokinetics of each agent, evaluation of antitumor activity of the combination therapy, and assessment of changes in molecular biomarkers for receptor tyrosine kinase and angiogenesis pathways, as well as biomarkers for bone metabolism. Restaging with bone and CT scan will be undertaken every 3 cycles. Enrollment at dose level 1 has been completed without dose-limiting toxicity. Accrual is ongoing at the second dose level. Clinical trial information: NCT01683994.
Antiemetic efficacy of transcutaneous electrical nerve stimulation (TENS) at pericardium 6 acupuncture point (P6) in the treatment of chemotherapy-induced delayed nausea and vomiting (CINV) in stage I to III breast cancer patients during adjuvant/neoadjuvant chemotherapy (Ad/nAd).
Authors: Yared Jean , Hu Melody , Bao Ting , Chumsri Saranya , Bellavance Emily Catherine , Kesmodel Susan , Feigenberg Steven J. , Tait Nancy , Tkaczuk Katherine Hanna
Published: March 2020

TPS648

Background: CINV remain major adverse effects of highly emetic chemotherapy for breast cancer patients (BC). Patients (PT) rate nausea & vomiting as the most feared chemotherapy-related symptoms. There is substantial evidence that P6 (located in the region in the middle of the wrist 3 finger breaths from the juncture of the hand & wrist) acupuncture is an effective antiemetic treatment in a variety of PT including the post-anesthesia, obstetrical, and motion sickness PT. We hypothesized that application of TENS at P6 point will reduce:1) the overall incidence of CINV episodes in stage 1-3 BC PT, 2) the severity & duration of CINV, 3) the requirement for rescue antiemetics 4) & that TENS is well tolerated & feasible. Maxima III Transcutaneous Electrical Nerve Stimulation unit is utilized in this study & is self-administered by PT. Patients and Methods: We are conducting a prospective, randomized, double-blinded, controlled trial to determine if self-stimulating P6 may decrease the incidence and severity of delayed CINV in stage 1-3 BC treated with the initial dose of highly emetic Ad/nAd (AC, AC-T, TAC, TC, TCH) and reduce PT' need for rescue oral antiemetic medications. PT will be randomized in a 1:1 ratio to the active treatment group (TENS self-stimulation at P6) & the control group (TENS self-stimulation at a point on the lateral side of the elbow that does not conform to any known acupuncture points). The assignments are blinded to the PT & the investigators. Subjects self-administer TENS at home q4 hours for 20 minutes during days 2-5 postchemotherapy. The use of conventional antiemetic therapy (corticosteroids, setrons, aprepitant, phenergan & prochlorperazine) is similar for both treatment groups. The severity of nausea symptoms, episodes of emesis, use of rescue antiemetics, and compliance are recorded daily by the PT in diaries. A brief questionnaire is also administered to evaluate PT tolerability of TENS & their ability to comply with the treatment regimen. Twenty six out of 70 planned PT have been enrolled. Recruitment is ongoing.
Dovitinib plus fulvestrant in postmenopausal endocrine resistant HER2-/ HR+ breast cancer: A phase II, randomized, placebo-controlled study.
Authors: Andre Fabrice , Neven Patrick , Musolino Antonino , Latini Luciano , Campone Mario , Cortes Javier , Barrios Carlos H. , Squires Matthew , Zhang Yong , Deudon Stephanie , Yovine Alejandro Javier , Blackwell Kimberly L.
Published: March 2020

TPS651

Background: Overcoming endocrine resistance (ER) is a critical goal in the treatment of hormone receptor−positive (HR+) breast cancer (BC). Emerging in vitro evidence suggests that amplification and overexpression of fibroblast growth factor receptor 1 (FGFR1) is associated with ER. Up to 8% pts with HR+/ human epidermal growth factor receptor 2 negative (HER2–) BC have amplification of the FGFR1 gene. Dovitinib (DOV), a potent inhibitor of FGFR, vascular endothelial growth factor receptor, and platelet-derived growth factor receptor demonstrated antitumor activity in heavily pretreated BC pts with FGF-pathway amplification (FGFR1, FGFR2, or FGF3). The objective of this study is to determine if DOV plus fulvestrant (FUL) can improve outcomes in postmenopausal pts with endocrine resistant HER2-/HR+ BC. Methods: This multicenter, randomized, double-blind, placebo-controlled, ph II trial (NCT01528345) will enroll postmenopausal pts with HER2–/HR+ locally advanced or metastatic BC (N=150) progressing within 12 months of completion of adjuvant endocrine therapy or after ≤ 1 prior endocrine therapy in the advanced setting. Pts will be randomized 1:1 (stratified by FGF amplification and presence of visceral disease) to receive intramuscular FUL (500 mg q4w [with an additional dose 2 weeks after the initial dose]) plus oral DOV (500 mg, 5 days on/2 days off) or matching placebo until disease progression, unacceptable toxicity, death, or discontinuation (any reason). Crossover is not permitted. Primary endpoint is progression free survival (investigator’s assessment; RECIST v1.1). Secondary endpoints include overall response rate (investigator’s assessment; RECIST v1.1), duration of response, overall survival, time to deterioration of ECOG performance status, pt-reported outcome scores over time, safety, and assessment of plasma pharmacokinetic concentrations of FUL and DOV. Additionally, the pharmacodynamic effect of DOV on FGFR-associated angiogenic pathways in tumor specimens and potential predictive biomarkers of response to DOV will be explored. As of 21 Jan 2013, 128 pts had molecular screening; 73 pts are enrolled (of these 9 pts are FGF amplified). Clinical trial information: NCT01528345.
Overcoming health care disparities in cancer treatment by instituting a patient navigation program.
Authors: Elrafei Tarek N. , Castaldi Maria , Shaker Bassam , Stanise Tina , Marquez Mariaelena , Bodner William , Reed Louis Juden , Alexis Karenza M. , Strakhan Marianna , Gralla Richard J.
Published: March 2020

TPS6644

Background: Cancer health disparities affecting low-income and minority patients are well documented. Causes of poor outcomes include treatment delays coupled with social and financial barriers. Navigation interventions have been more commonly applied in cancer screening and in early diagnosis programs than in improving adherence to treatment among those with barriers to care. This report examines the early impact of patient navigation on adherence to prescribed cancer treatment. Methods: We put into place a Patient Navigation Program as a pilot project (supported by an Avon Foundation grant) at our public safety net hospital. Health care coverage: 58% Medicaid, 23% uninsured or undocumented. Navigator duties included care coordination, appointment reminders, patient education materials, translation services, and transportation arrangement. During a 4 month period new medical oncology practice patients felt to be at high risk received navigated care. Data collected prospectively included patient characteristics, cancer type, time from referral to first RT, and compliance with visits; this was compared with usual care historical controls immediately prior to the 4 month period. Results: Patient Navigation Program patient characteristics: N = 52 patients (22 breast cancer, 6 prostate cancer, 5 lung cancer and 19 patients with other cancers). Mean age = 55; 48% Black, 38% Hispanic, 8% Asian, 6% White. Adherence to visits, and time to first RT results are seen in the Table. Conclusions: In the first 4 months of its initiation, this Patient Navigation Program has been associated with observed improvements in adherence to chemotherapy and follow up physician visits, but no impact on time to 1st RT to date. These results document that a Patient Navigation Program can help overcome barriers to good cancer care while identifying RT as an area for further improvement. [Table: see text]
Chemotherapy for malignancies in the post solid organ transplant (SOT) setting: A single institute experience.
Authors: Al Ustwani Omar , Gupta Neha , Chen Hongbin
Published: March 2020

TPS6646

Background: Management of advanced malignancies in SOT recipients is not well defined. These patients need immunosuppressive agents to avoid graft rejection. Simultaneous administration of chemotherapy and immunosuppressive agents may increase treatment toxicities. We reviewed data of SOT recipients treated at Roswell Park Cancer Institute (RPCI) for different malignancies to assess their tolerance to treatment and outcomes. Methods: Between 2000-2012, 126 SOT recipients were seen at RPCI for management of cancer. Patients with superficial skin cancer and PTLD or other malignancies not qualifying for therapy were excluded. Adverse events were documented per CTCAE 4.0. Results: 40 patients were included for the review. Median age was 61.5 (29-79) years, and 50% were male. Types of SOT were: 17 liver, 16 kidney, 4 heart, 2 lung and 1 liver/kidney. Types of cancers were: 12 GI, 9 breast, 6 lung, 4 AML/myeloma, 3 head & neck, 2 GYN, 2 skin requiring therapy and 2 GU. Median lag time between SOT and cancer diagnosis was 14.5 years (2m-39y). 13/36 (36%) of solid tumors were metastatic at diagnosis. At the time of analysis, 9/34 (26%) of patients with documented outcome were alive. Of all patients, median overall survival was 28.5m. 31/40 (78%) received chemotherapy and 9/40 (22%) had hormonal therapy alone. In the chemotherapy group, patients received a median of 1.8 lines of therapy (1-6), 4/31 (13%) were given definitive chemotherapy+RT and 8/31 (26%) received chemotherapy in the neoadjuvant/adjuvant setting. Treatment delays were necessary in 10/31 (32%), and dose omission or reduction in 13/31 (42%). The most common hematologic adverse events (AEs) were anemia (25/31, 80%) and thrombocytopenia (19/31, 61%). Febrile neutropenia (G3) occurred in 5/31(16%). The most common non-hematologic AEs were fatigue (23/31, 74%) and hepatic dysfunction (19/31, 61%). The most common G3/4 hematologic AEs were neutropenia (9/31, 29%) and leukopenia (7/31, 23%) while non-hematologic G3/4 AEs were diarrhea and fatigue (4/31 each, 13%). Conclusions: SOT patients tolerate chemotherapy relatively well but AEs, dose reductions and delays occur. Treating physicians should be careful when dosing chemotherapy in these cases.
A multicenter phase II randomized study of customized neoadjuvant therapy versus standard chemotherapy (CT) in non-small cell lung cancer (NSCLC) patients with resectable stage IIIA(N2) disease (CONTEST trial).
Authors: Grossi Francesco , Rijavec Erika , Barletta Giulia , Sini Claudio , Genova Carlo , Dal Bello Maria Giovanna , Ratto Giovanni Battista , Truini Mauro , Merlo Domenico Franco
Published: March 2020

TPS7606

Background: Stage IIIA NSCLC constitutes 30% of all NSCLC patients (pts). The most powerful prognostic factor that has been identified in this stage is clearance of mediastinal lymph nodes and pathologic complete response (pCR). A pCR is obtained in 5-15% of pts with a significant survival prolongation. The identification of molecular biomarkers, such as excision repair cross-complementation 1 (ERCC1), ribonucleotide reductase subunit M1 (RRM1), and thymidylate synthase (TS), may predict response to CT. Similarly, EGFR mutations may predict response to EGFR inhibitors. Methods: CONTEST, a multicenter (19 Italian centers), randomized (2:1) 2-arm phase II study, recruits pts with resectable stage IIIA (N2) NSCLC. Pts will be randomized to receive before resection either standard CT with Cisplatin (CDDP) 75 mg/m2 + Docetaxel (Doc) 75 mg/m2 on day (d) 1 q 21 d for 3 cycles (cys) or customized therapy using predetermined values for ERCC1, RRM1, TS, and EGFR mutations. The choices of customized arms are as follows: -EGFR+: Gefitinib 250 mg/d for 8 weeks. -EGFR-/non-squamous (NS)/TS-/ERCC1-: CDDP 75 mg/m2 + Pemetrexed 500 mg/m2 d 1 q 21 d for 3 cys. -EGFR-/squamous (S) or NS TS+/ERCC1-/RRM1+: CDDP 75 mg/m2 + Doc 75 mg/m2 d 1 q 21 d for 3 cys. -EGFR-/S or NS TS+/ERCC1-/RRM1-: CDDP 75 mg/m2 d 1+ Gemcitabine (Gem) 1250 mg/m2 d 1,8 q 21 d for 3 cys. -EGFR-/S or NS TS+/ERCC1+/RRM1+: Doc 75 mg/m2 d 1 + Vinorelbine 20 mg/m2 d 1,8 q 21 d for 3 cys. -EGFR-/S or NS TS+/ERCC1+/RRM1-: Doc 40 mg/m2 y 1, 8 + Gem 1200 mg/m2 d 1,8 q 21 d for 3 cys. The primary end point will be obtained by comparing the pCR in all randomized pts based on treatment arm. Because pCR is a surrogate endpoint and given the expected proportion of pCR's in the control group pc= 5%, the minimal clinically worthwhile effect of this customized treatment is an increase in this proportion to 20%. To detect such an effect at the 0.05 (1-sided) significance level with 80% power, a total of 168 pts will be enrolled. This study is open for accrual; further details can be found on ClinicalTrials.gov (NCT01784549). Funded by Italian Ministry of Health – RF 2009-1530324. Clinical trial information: NCT01784549.
Baseline Plasma Aldosterone Level and Renin Activity Allowing Omission of Confirmatory Testing in Primary Aldosteronism
Authors: Kawashima Junji , Araki Eiichi , Naruse Mitsuhide , Kurihara Isao , Takahashi Katsutoshi , Tamura Kouichi , Kobayashi Hiroki , Okamura Shintaro , Miyauchi Shozo , Yamamoto Koichi , Izawa Shoichiro , Suzuki Tomoko , Tanabe Akiyo
Published: March 2020

Context

Previous studies have proposed cutoff value of baseline plasma aldosterone concentration (bPAC) under renin suppression that could diagnose primary aldosteronism (PA) without confirmatory testing. However, those studies are limited by selection bias due to a small number of patients and a single-center study design.

Objective

This study aimed to determine cutoff value of bPAC and baseline plasma renin activity (bPRA) for predicting positive results in confirmatory tests for PA.

Design

The multi-institutional, retrospective, cohort study was conducted using the PA registry in Japan (JPAS/JRAS). We compared bPAC in patients with PA who showed positive and negative captopril challenge test (CCT) or saline infusion test (SIT) results.

Patients

Patients with PA who underwent CCT (n = 2256) and/or SIT (n = 1184) were studied.

Main outcome measures

The main outcomes were cutoff value of bPAC (ng/dL) and bPRA (ng/mL/h) for predicting positive CCT and/or SIT results.

Results

In patients with renin suppression (bPRA ≤ 0.3), the cutoff value of bPAC that would give 100% specificity for predicting a positive SIT result was lower than that for predicting a positive CCT result (30.85 vs 56.35, respectively). Specificities of bPAC cutoff values ≥ 30.85 for predicting positive SIT and CCT results remained high (100.0% and 97.0%, respectively) in patients with bPRA ≤ 0.6. However, the specificities of bPAC cutoff values ≥ 30.85 for predicting positive SIT and CCT results decreased when patients with bPRA > 0.6 were included.

Conclusion

Confirmatory testing could be omitted in patients with bPAC ≥ 30.85 in the presence of bPRA ≤ 0.6.
Androgens Stimulate EPC-Mediated Neovascularization and Are Associated with Increased Coronary Collateralization
Authors: Lam Yuen Ting , Hsu Chi-Jen , Simpson Philippa J L , Dunn Louise L , Chow Renee W , Chan Kim H , Yong Andy S C , Yu Young , Sieveking Daniel P , Lecce Laura , Yuan Jun , Celermajer David S , Wise Steven G , Ng Martin K C
Published: March 2020

Endothelial progenitor cells (EPCs) play a key role in neovascularization and have been linked to improved cardiovascular outcomes. Although there is a well-established inverse relationship between androgen levels and cardiovascular mortality in men, the role of androgens in EPC function is not fully understood. In this study, we investigated the effects of androgens on 2 subpopulations of EPCs, early EPCs (EEPCs) and late outgrowth EPCs (OECs), and their relationships with coronary collateralization. Early EPCs and OECs were isolated from the peripheral blood of young healthy men and treated with dihydrotestosterone (DHT) with or without androgen receptor (AR) antagonist, hydroxyflutamide, in vitro. Dihydrotestosterone treatment enhanced AR-mediated proliferation, migration, and tubulogenesis of EEPCs and OECs in a dose-dependent manner. Furthermore, DHT augmented EPC sensitivity to extracellular stimulation by vascular endothelial growth factor (VEGF) via increased surface VEGF receptor expression and AKT activation. In vivo, xenotransplantation of DHT pretreated human EPCs augmented blood flow recovery and angiogenesis in BALB/c nude male mice, compared to mice receiving untreated EPCs, following hindlimb ischemia. In particular, DHT pretreated human OECs exhibited higher reparative potential than EEPCs in augmenting postischemic blood flow recovery in mice. Furthermore, whole blood was collected from the coronary sinus of men with single vessel coronary artery disease (CAD) who underwent elective percutaneous intervention (n = 23). Coronary collateralization was assessed using the collateral flow index. Serum testosterone and EPC levels were measured. In men with CAD, circulating testosterone was positively associated with the extent of coronary collateralization and the levels of OECs. In conclusion, androgens enhance EPC function and promote neovascularization after ischemia in mice and are associated with coronary collateralization in men.
Videolaryngoscope-Assisted Double-Lumen Endotracheal Tube Intubation in an Awake Patient With Known Difficult Airway and Bronchopleural Fistula: A Case Report
Authors: Goh Qing Yuan , Kong Andrew
Published: March 2020

Awake endotracheal intubation is the technique of choice to secure the airway when both mask ventilation and intubation are anticipated to be difficult. We present a case of a patient with a known difficult airway, bronchopleural fistula (BPF), and acute respiratory distress syndrome (ARDS) who was intubated with a double-lumen endotracheal tube (DL ETT) under awake condition using a videolaryngoscope. Independent lung ventilation (ILV) was instituted because of the BPF. The patient was treated successfully for ARDS and discharged home. To our knowledge, this is the first reported case of successful videolaryngoscope-assisted DL ETT intubation in an awake patient.
Radical Care
Authors: Hobart Hi‘ilei Julia Kawehipuaakahaopulani , Kneese Tamara
Published: March 2020

This article introduces the topic of radical care by providing a genealogy of care as a vital but underexamined praxis of radical politics that provides spaces of hope in precarious times. Following recent theoretical interventions into the importance of self-care despite its susceptibility to neoliberal co-optation, the potentialities of self-care may be expanded outward to include other forms that push back against structural disadvantage. Care contains radical promise through a grounding in autonomous direct action and nonhierarchical collective work. However, because radical care is inseparable from systemic inequality and power structures, it can also be used to coerce subjects into new forms of surveillance and unpaid labor, to make up for institutional neglect, and even to position some groups against others, determining who is worthy of care and who is not. With care reentering the zeitgeist as a reaction to today’s political climate, radical care engages histories of grassroots community action and negotiates neoliberal models for self-care. Studies of care thereby prompt us to consider how and when care becomes visible, valued, and necessary within broader social movements. To that end, the articles in this collection locate and analyze the mediated boundaries of what it means for individuals and groups to feel and provide care, survive, and even dare to thrive in environments that challenge their very existence. As the traditionally undervalued labor of caring becomes recognized as a key element of individual and community resilience, radical care provides a roadmap for envisioning an otherwise.
Convergent Met and voltage-gated Ca2+ channel signaling drives hypermigration of Toxoplasma-infected dendritic cells
Authors: Ólafsson Einar B. , ten Hoeve Arne L. , Li Wang Xiaoze , Westermark Linda , Varas-Godoy Manuel , Barragan Antonio
Published: March 2020

Ras-Erk MAPK signaling controls many of the principal pathways involved in metazoan cell motility, drives metastasis of multiple cancer types and is targeted in chemotherapy. Yet, its putative roles in immune cell functions or in infections have remained elusive. Here, using primary dendritic cells (DCs) in an infection model with the protozoan Toxoplasma gondii, we show that two pathways activated by infection converge on Ras-Erk MAPK signaling to promote migration of parasitized DCs. We report that signaling through the receptor tyrosine kinase Met (also known as HGFR) contributes to T. gondii-induced DC hypermotility. Further, voltage-gated Ca2+ channel (VGCC, subtype CaV1.3) signaling impacted the migratory activation of DCs via calmodulin-calmodulin kinase II. We show that convergent VGCC signaling and Met signaling activate Ras GTPase to drive Erk1/2 phosphorylation and hypermotility of T. gondii-infected DCs. The data provide a molecular basis for the hypermigratory mesenchymal-to-amoeboid transition (MAT) of parasitized DCs. The emerging concept suggests that parasitized DCs acquire metastasis-like migratory properties to promote infection-related dissemination.
The Influence of Comorbidity on Health-Related Quality of Life After Esophageal Cancer Surgery
Authors: Backemar Lovisa , Johar Asif , Wikman Anna , Zylstra Janine , Gossage James , Davies Andrew , Lagergren Jesper , Lagergren Pernilla
Published: March 2020

Background

Esophageal cancer surgery reduces patients’ health-related quality of life (HRQoL). This study examined whether comorbidities influence HRQoL in these patients.

Methods

This prospective cohort study included esophageal cancer patients having undergone curatively intended esophagectomy at St Thomas’ Hospital London in 2011–2015. Clinical data were collected from patient reports and medical records. Well-validated cancer-specific and esophageal cancer-specific questionnaires (EORTC QLQ-C30 and QLQ-OG25) were used to assess HRQoL before and 6 months after esophagectomy. Number of comorbidities, American Society of Anesthesiologists physical status classification (ASA), and specific comorbidities were analyzed in relation to HRQoL aspects using multivariable linear regression models. Mean score differences with 95% confidence intervals were adjusted for potential confounders.

Results

Among 136 patients, those with three or more comorbidities at the time of surgery had poorer global quality of life and physical function and more fatigue compared with those with no comorbidity. Patients with ASA III–IV reported more problems with the above HRQoL aspects and worse social function and pain compared with those with ASA I–II. Cardiac comorbidity was associated with worse global quality of life and dyspnea, while pulmonary comorbidities were related to coughing. Patients assessed both before and 6 months after surgery (n = 80) deteriorated in most HRQoL aspects regardless of comorbidity status, but patients with several comorbidities had worse physical function and fatigue and more trouble with coughing compared with those with fewer comorbidities.

Conclusion

Comorbidity appears to negatively influence HRQoL before esophagectomy, but appears not to severely impact 6-month recovery of HRQoL.
Diagnostic analysis of abnormal increase of PASP in fetus in middle- and late-stage pregnancy by color Doppler echocardiography
Authors: Cui Hong , Su Juan , Liang Wen-Wen , Wang Hong-Ling , Wang Hui-Feng
Published: March 2020

Objective:

Our study was conducted with an attempt to investigate the diagnostic analysis of abnormal increase of fetal pulmonary artery systolic pressure (PASP) in middle and late pregnancy by color Doppler echocardiography.

Methods:

From August 2017 to January 2019, 52 fetuses with moderate or greater tricuspid high-speed regurgitation were retrospectively analyzed and selected as Group A. 88 fetuses with full-color blood flow of the two ventricles and symmetrical sizes of the cardiac cavities on both sides harboring tricuspid valve and mild regurgitation or a small amount of regurgitation were selected as Group B. The pulmonary artery blood flow acceleration time (AT) and right ventricular ejection time (ET) was measured, and the PASP was calculated.

Results:

The tricuspid regurgitation velocity, tricuspid regurgitation pressure difference and PASP in Group A were higher than those in Group B (p < 0.05), and the AT and AT/ET values in Group A were lower than those in Group B (p < 0.05). Gestational age, tricuspid regurgitation velocity and tricuspid regurgitation pressure difference were positively correlated with PASP. However, AT/ET and AT value were negatively correlated with PASP.

Conclusion:

The abnormal increase of pulmonary artery can be assessed by color Doppler echocardiography of fetal tricuspid regurgitation, which is worth popularizing and applying in clinic.

Advances in knowledge:

It was suggested that the middle- and late-stage fetuses with moderate or greater tricuspid regurgitation and with >20 mmHg regurgitation pressure difference should be followed up in clinic. If PASP was ≥70 mmHg with symptoms of right heart failure, fetuses should be closely observed until 35–36 weeks old to ensure fetal safety and early delivery would be recommended.
Non-traumatic complications of a solitary rib osteochondroma; an unusual cause of hemoptysis and pneumothorax
Authors: Versteegh VE , Welvaart WN , Oberink-Gustafsson EEM , Lindenholz A , Staaks GHA , Schaefer-Prokop CM
Published: March 2020

Osteochondromas are a very common and usually asymptomatic entity which may originate anywhere in the appendicular and axial skeleton. However, the ribs are a rare site of origin and here they may prove symptomatic for mechanical reasons. In this case report, we describe an unusual case of a symptomatic osteochondroma of the rib secondary to its location and unique shape, ultimately requiring surgical intervention.
Η χαρισματική ηγεσία του Μουσταφά Κεμάλ στη μάχη του Σαγγαρίου
Authors: Αναγνωστοπούλου Βασιλική , Μητρόπουλος Γεώργιος Φ. , Μπαβέλη Γεωργία Α.
Published: March 2020

Η μελέτη χαρισματικών προσωπικοτήτων γίνεται με σκοπό τον εντοπισμό των στοιχείων εκείνων που δίνουν την ιδιαίτερη δυναμική τους. Ο χαρισματικός ηγέτης εμφανίζεται σε οριακές εποχές, στη διάρκεια των οποίων δημιουργείται ένα πολιτικό, κοινωνικό, οικονομικό ή και συνειδησιακό κενό που θα πρέπει να κατανοήσει προκειμένου να λυτρώσει το λαό του. Ο Κεμάλ συγκεντρώνει στο μέγιστο τον ιδεότυπο της χαρισματικής ηγεσίας. Οι αποφάσεις του κατά την διάρκεια των μαχών του Πολέμου της Ανεξαρτησίας (Kurtuluş Savaşı) και ιδιαίτερα του Σαγγαρίου έκαναν πολλούς να τον θεωρούν αθάνατο. Η εκκένωση του Εσκί Σεχίρ τον Ιούλιο του 1921 ήταν οδυνηρότατη. Ο Κεμάλ πρόβλεψε σωστά, η υποχώρηση ανατολικά του Σαγγαρίου ήταν η μόνη λύση. Οι Έλληνες πεπεισμένοι στην ανωτερότητά τους σχεδίαζαν να καταλάβουν την Άγκυρα. Ο Κεμάλ προβλέποντας επίθεση από τα αριστερά στηρίχθηκε στο γεωγραφικό πλεονέκτημα της θέσης σχεδιάζοντας την άμυνα. Στις 23 Αυγούστου ξεκίνησε η ελληνική επίθεση, οι δύο πλευρές έριξαν στη μάχη όλες τους τις δυνάμεις. Οι Έλληνες διέσπασαν σε πολλά σημεία την αμυντική γραμμή, όμως οι Τούρκοι δημιουργούσαν αμέσως νέα, ενώ διενεργούσαν απανωτές αντεπιθέσεις. Στις 13 Σεπτεμβρίου, ο ελληνικός στρατός υποχώρησε, τα δύο στρατόπεδα είχαν χάσει το ένα πέμπτο της δύναμής τους. Τιμώντας τον, η Εθνοσυνέλευση τον ονόμασε Νικητή (Gazi), η πρωτεύουσά του είχε σωθεί.
Στάσεις Εφήβων Μαθητών με και χωρίς Ειδικές Μαθησιακές Δυσκολίες απέναντι στην Παραγωγή Γραπτού Λόγου και τη χρήση των Τεχνολογιών της Πληροφορίας και της Επικοινωνίας
Authors: Βασιλείου Ηλίας , Πολυχρονοπούλου Σταυρούλα , Παπαδάτος Ιωάννης , Κουρουπέτρογλου Γεώργιος
Published: March 2020

Σκοπός της έρευνας ήταν να εξετάσει το υπόβαθρο των εφήβων μαθητών και τη συμπεριφορά τους όσον αφορά την παραγωγή γραπτού λόγου, τις ικανότητες, όπως τις αντιλαμβάνονται οι ίδιοι και τέλος τις στάσεις τους απέναντι σε αυτή την ακαδημαϊκή δεξιότητα. Για την καταγραφή της στάσης των μαθητών δευτεροβάθμιας εκπαίδευσης με και χωρίς Ειδικές Μαθησιακές Δυσκολίες (ΕΜΔ) απέναντι στο γράψιμο, χρησιμοποιήθηκε το ερωτηματολόγιο στάσεων των νέων απέναντι στην παραγωγή γραπτού λόγου “Young people’s attitude towards writing” του βρετανικού ιδρύματος National Literacy Trust το οποίο μεταφράστηκε και προσαρμόστηκε στην ελληνική πραγματικότητα με σκοπό να αξιολογηθούν: α) πόσο απολαμβάνουν το γράψιμο οι νέοι, β) με ποιες μορφές παραγωγής γραπτού καταπιάνονται και πόσο συχνά, γ) πόσο καλοί «συγγραφείς» νομίζουν ότι είναι και τι πιστεύουν για το γράψιμο και δ) ποιος είναι ο ρόλος της τεχνολογίας στην παραγωγή γραπτού λόγου των νέων. Στη διαδικασία συμμετείχαν 40 μαθητές γυμνασίων και λυκείων του νομού Αττικής με επίσημη διάγνωση ΕΜΔ και 20 χωρίς διάγνωση. Τα αποτελέσματα του ερωτηματολογίου συγκρίθηκαν με τα αντίστοιχα των μαθητών στην αντίστοιχη έρευνα του National Literacy Trust στην Αγγλία και εμφανίστηκαν ομοιότητες στις προτιμήσεις των μαθητών και από τις δύο χώρες κυρίως ως προς α) τις μορφές γραπτού που προτιμούν οι έφηβοι περισσότερο, β) τις μορφές γραπτού που αποφεύγουν οι έφηβοι περισσότερο, γ) γιατί θεωρούν ότι είναι «καλοί» στο γράψιμο δ) πόσο σημαντικό είναι το γράψιμο για τη ζωή κ.α.
Η μαθησιακή και εκπαιδευτική διαφορετικότητα στο νομικό πλαίσιο των Πειραματικών Σχολείων
Authors: Δρογγίτης Αναστάσιος
Published: March 2020

Τα τελευταία χρόνια, όλο και περισσότερο, υπάρχει η συζήτηση σχετικά με το ρόλο και τη λειτουργία των Πειραματικών Σχολείων. Διαμορφώνονται δυο αντίρροπες τάσεις, αυτή που δίνει έμφαση στην επιλογή των μαθητών και στις υψηλές αποδόσεις και αυτή που αναφέρεται στην αντιπροσωπευτικότητα του μαθητικού πληθυσμού και στην ψυχοπαιδαγωγική έρευνα.Στο πλαίσιο αυτό διαμορφώθηκε το νομικό πλαίσιο λειτουργίας των Πειραματικών Σχολείων και, πιο συγκεκριμένα, ειδικές διατάξεις που αφορούν την μαθησιακή διαφορετικότητα σε ότι αφορά την επιλογή των μαθητών, την λειτουργία των μαθητικών ομίλων και τους χαρισματικούς μαθητές, αλλά την και την εκπαιδευτική διαφορετικότητα μέσα από την επιλογή και αξιολόγηση των εκπαιδευτικών και την προώθηση της αριστείας. Σκοπός της παρούσας εργασίας είναι η ανάδειξη των ρυθμίσεων αυτών και του τρόπου που εφαρμόζονται στην πράξη.Μέσα από την κατανόηση του νομικού πλαισίου, οδηγούμαστε στην διατύπωση προτάσεων, για την εισαγωγή και εφαρμογή και αξιολόγηση νέων δρόμων και καινοτομιών στη σκοποθεσία και τη λειτουργία των Πειραματικών Σχολείων, με σκοπό τη διάχυσή τους.
«Χαρισματικότητα: διδάσκεται/καλλιεργείται;»
Authors: Ζάλη Ελένη , Λώλη Αθηνά
Published: March 2020

Η χαρισματικότητα θα μπορούσε να οριστεί ως το δυναμικό ενός ατόμου για ασυνήθιστες επιδόσεις σε έναν ή περισσότερους ειδικούς τομείς. Θεωρείται πολυπαραγοντική έννοια και οι σύγχρονες θεωρίες της χαρισματικότητας εστιάζονται στο μοντέλο των πολλαπλών-διαστάσεων (Heller, 1992) και στην αλληλεπίδραση τριών βασικών ομάδων ανθρώπινων χαρακτηριστικών: γενικών ικανοτήτων άνω του μέσου όρου, υψηλών επιπέδων αφοσίωσης στην εργασία και υψηλών επιπέδων δημιουργικότητας (Renzulli, 1986). Σκοπός της παρούσας εργασίας, μέσω της μελέτης εννοιών, οι οποίες εμπλέκονται στη χαρισματικότητα, όπως το ταλέντο, η ευφυΐα και η δημιουργικότητα, είναι να καταρρίψει μύθους και να εστιάσει στο ερώτημα, αν η χαρισματικότητα είναι αντικείμενο καλλιέργειας και διδασκαλίας. Η διερεύνηση του παραπάνω ερωτήματος πραγματοποιείται μέσω επεξεργασίας των πρακτικών, οι οποίες μπορούν να εξυπηρετήσουν τις ανάγκες των χαρισματικών παιδιών, λαμβάνοντας υπόψη ότι, τα χαρισματικά άτομα δε συγκροτούν μια φυσική πληθυσμιακή ομάδα, αλλά μια κοινωνικώς προσδιορισμένη κατηγορία προσώπων.
Οι ψυχοκοινωνικες επιπτωσεις της αναπηριας στην οικογενεια και ο ρολος της συμβουλευτικης
Authors: Καραβασίλη Μαργαρίτα , Σκορδιαλός Εμμανουήλ
Published: March 2020

Η παρούσα εργασία διερευνά το πώς διαχειρίζονται οι γονείς τις ψυχοκοινωνικές επιπτώσεις της ύπαρξης παιδιού με αναπηρία στην οικογένεια, καθώς και κατά πόσο κρίνεται αναγκαία η συμβουλευτική υποστήριξή τους. Συγκεκριμένα, πρόκειται για μία βιβλιογραφική ανασκόπηση η οποία εστιάζει στον βαρυσήμαντο ρόλο που κατέχει η οικογένεια, ο ειδικός παιδαγωγός, καθώς και η οικογενειακή συμβουλευτική στην εκπαίδευση των παιδιών με αναπηρία. Σκιαγραφούνται όλες οι ψυχολογικές και κοινωνικές επιπτώσεις που υφίστανται οι γονείς, καθώς και η αναγκαιότητα της συμβουλευτικής και της ανάπτυξης της συναισθηματικής νοημοσύνης στα παιδιά. Έτσι, δημιουργείται ένα δίκτυο συνεργασίας μεταξύ των εκπαιδευτικών και της οικογένειας του παιδιού με πολλαπλά οφέλη τόσο για το παιδί, όσο και για την οικογένεια εν γένει. Σύμφωνα με τα αποτελέσματα της έρευνας, γίνεται φανερό ότι οι γονείς αισθάνονται μόνοι, αβοήθητοι, με συναισθήματα ελπίδας και απελπισίας, ματαίωσης και δικαίωσης, πραγματικότητας και φαντασίας, αποδοχής και πάλης, άγχους και απαισιοδοξίας. Ταυτόχρονα, παλεύουν να νιώσουν φυσιολογικοί μέσα σε μία κοινωνία- μία κοινωνία που ενώ έχει κάνει βήματα για την αλλαγή, δεν έχει προσαρμοστεί ακόμη στις απαιτήσεις των παιδιών. Επίσης, η συμβουλευτική γονέων στοχεύει στη διαρκή υπενθύμιση των θετικών χαρακτηριστικών της οικογένειας του παιδιού με αναπηρία αλλά και του ίδιου του παιδιού. Έτσι, μέσα από τη συνεργασία συμβούλου-γονέα η οικογένεια παραμένει δυνατή, αλώβητη και δεν χάνει την εμπιστοσύνη στον εαυτό της. Τέλος, αναλύεται η αναγκαιότητα ύπαρξης συμβουλευτικών δεξιοτήτων από την πλευρά των εκπαιδευτικών προκειμένου να καταστεί δυνατή η αποτελεσματική συνεργασία με τους γονείς ,η οποία θα επιφέρει μία νέα παιδαγωγική προσέγγιση και θα χτίσει γέφυρες με απώτερο σκοπό την προσήλωση στη μοναδικότητα του κάθε παιδιού με ειδικές ανάγκες.