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Alpelisib (Piqray) - Breast cancer Drug Approval Package: Piqray U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: Piqray Company: Novartis Pharmaceuticals Corporation Application Number: 212526 Approval Date: 05/24/2019 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF) FDA Application Review Files (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) Date created
Seaweed Consumption and Its Effect on Breast Cancer "Seaweed Consumption and Its Effect on Breast Cancer" by Alyssa MouaLee and Thanita Pradhanang < > > > > > Title Author Date of Graduation Summer 8-10-2019 Degree Type Capstone Project Degree Name Master of Science in Physician Assistant Studies Rights . Abstract Background: Breast cancer remains the most common cancer in women worldwide. Interestingly, breast cancer incidence varies dramatically among countries. Japan, in particular, has (...) relatively low breast cancer (BC) rates when compared to those in Western countries. Daily consumption of seaweed has been proposed as one of the factors in explaining the difference in incidence rates of BC. The high concentrations of polysaccharides in seaweed have been reported in many studies to have anti-cancer effects as well as chemoprotective effects. The aim for this review is to look at the potential benefits of seaweed consumption and its effect on breast cancer. Methods: Exhaustive search
Palbociclib (Ibrance) - hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer 1 Published 8 July 2019 1 SMC2149 palbociclib 75mg, 100mg, and 125mg hard capsules (Ibrance®) Pfizer Limited 7 June 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised (...) as follows: ADVICE: following a full submission considered under the end of life and orphan equivalent assessment process. palbociclib (Ibrance ® ) is accepted for use within NHSScotland. Indication under review: for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: - in combination with an aromatase inhibitor; - in combination with fulvestrant in women who have received prior endocrine therapy. In pre
Association Between Adjuvant Chemotherapy Duration and Survival Among Patients With Stage II and III Colon Cancer: A Systematic Review and Meta-analysis The results from the recent International Duration Evaluation of Adjuvant Therapy (IDEA) collaboration have led some clinicians to adopt shorter durations of adjuvant chemotherapy for patients with stage III colon cancer. The extent to which these findings are supported by other data is unknown.To conduct a systematic review and meta-analysis (...) of randomized and observational studies investigating the association between the duration of adjuvant chemotherapy and survival among individuals diagnosed as having stage II and III colon cancer (PROSPERO protocol CRD42018108711]).Abstracts published in English between 2003 and 2018 within the MEDLINE, Embase, CENTRAL, and CINAHL databases were reviewed by 2 authors. Also searched were conference proceedings and the indexes of high-impact oncology journals.Studies were excluded if they did not present
Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001): a randomised, double-blind, phase 3 trial Angiopoietin 1 and 2 regulate angiogenesis and vascular remodelling by interacting with the tyrosine kinase receptor Tie2, and inhibition of angiogenesis has shown promise in the treatment of ovarian cancer. We aimed to assess whether trebananib, a peptibody that inhibits binding of angiopoietin 1 and 2 to Tie2 (...) , improved progression-free survival when added to carboplatin and paclitaxel as first-line therapy in advanced epithelial ovarian, primary fallopian tube, or peritoneal cancer in a phase 3 clinical trial.TRINOVA-3, a multicentre, multinational, phase 3, double-blind study, was done at 206 investigational sites (hospitals and cancer centres) in 14 countries. Eligible patients were aged 18 years or older with biopsy-confirmed International Federation of Gynecology and Obstetrics (FIGO) stage III to IV
Accuracy of Detecting Residual Disease After Neoadjuvant Chemoradiotherapy for Esophageal Cancer: A Systematic Review and Meta-analysis The aim of this study was to perform a meta-analysis on the accuracy of endoscopic biopsies, EUS, and 18F-FDG PET(-CT) for detecting residual disease after neoadjuvant chemoradiotherapy (nCRT) for esophageal cancer.After nCRT, one-third of patients have a pathologically complete response in the resection specimen. Before an active surveillance strategy could (...) evaluated qualitative EUS with a pooled sensitivity and specificity of 68% and 57%, respectively. In subgroup analyses, sensitivity of PET-%ΔSUVmax and EUS for nodal disease was higher in squamous cell carcinoma than adenocarcinoma.Current literature suggests insufficient accuracy of endoscopic biopsies, EUS, and 18F-FDG PET(-CT) as single modalities for detecting residual disease after nCRT for esophageal cancer.
Systematic review of outcomes after total neoadjuvant therapy for locally advanced rectal cancer Advances in surgical technique and the development of combined-modality therapy have led to significantly improved local control in rectal cancer. Distant failure rates however, remain high, ranging between 20 and 30 per cent. Additional systemic chemotherapy in the preoperative period has been proposed as a means of eradicating subclinical micrometastases and improving long-term survival (...) . The purpose of this systematic review was to evaluate the current evidence regarding induction chemotherapy in combination with standard neoadjuvant chemoradiotherapy, in terms of oncological outcomes, in patients with rectal cancer.A systematic review of the literature was performed to evaluate oncological outcomes and survival in patients with rectal cancer who underwent induction chemotherapy and neoadjuvant chemoradiotherapy, followed by surgical resection. Four major databases (PubMed, Embase, Scopus
Two-view digital breast tomosynthesis versus digital mammography in a population-based breast cancer screening programme (To-Be): a randomised, controlled trial Digital breast tomosynthesis is an advancement of mammography, and has the potential to overcome limitations of standard digital mammography. This study aimed to compare first-generation digital breast tomo-synthesis including two-dimensional (2D) synthetic mammograms versus digital mammography in a population-based screening (...) cancer, stratified by screening technique (ie, digital breast tomosynthesis and digital mammography). A log-binomial regression model was used to estimate the efficacy of digital breast tomosynthesis versus digital mammography, defined as the crude risk ratios (RRs) with 95% CIs for screen-detected breast cancer for women screened during the recruitment period. A per-protocol approach was used in the analyses. This trial is registered at ClinicalTrials.gov, number NCT02835625, and is closed
Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer. The use of adjuvant chemotherapy in patients with breast cancer may be guided by clinicopathological factors and a score based on a 21-gene assay to determine the risk of recurrence. Whether the level of clinical risk of breast cancer recurrence adds prognostic information to the recurrence score is not known.We performed a prospective trial involving 9427 women with hormone-receptor-positive, human epidermal (...) growth factor receptor 2-negative, axillary node-negative breast cancer, in whom an assay of 21 genes had been performed, and we classified the clinical risk of recurrence of breast cancer as low or high on the basis of the tumor size and histologic grade. The effect of clinical risk was evaluated by calculating hazard ratios for distant recurrence with the use of Cox proportional-hazards models. The initial endocrine therapy was tamoxifen alone in the majority of the premenopausal women who were 50
Risk of ovarian cancer in women treated with ovarian stimulating drugs for infertility. This is an updated version of the original Cochrane Review published in the Cochrane Library in 2013 (Issue 8) on the risk of ovarian cancer in women using infertility drugs when compared to the general population or to infertile women not treated. The link between fertility drugs and ovarian cancer remains controversial.To evaluate the risk of invasive ovarian cancer and borderline ovarian tumours in women (...) , we searched for randomised controlled trials (RCTs) and non-randomised studies and case series including more than 30 participants.At least two review authors independently conducted eligibility and 'Risk of bias' assessments and extracted data. We grouped studies based on the fertility drug used for two outcomes: borderline ovarian tumours and invasive ovarian cancer. We conducted no meta-analyses due to expected methodological and clinical heterogeneity.We included 13 case-control and 24 cohort
Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Hypofractionated radiotherapy for prostate cancer has gained increased attention due to its proposed high radiation-fraction sensitivity. Recent reports from studies comparing moderately hypofractionated and conventionally fractionated radiotherapy support the clinical use of moderate hypofractionation. To date (...) , there are no published randomised studies on ultra-hypofractionated radiotherapy. Here, we report the outcomes of the Scandinavian HYPO-RT-PC phase 3 trial with the aim to show non-inferiority of ultra-hypofractionation compared with conventional fractionation.In this open-label, randomised, phase 3 non-inferiority trial done in 12 centres in Sweden and Denmark, we recruited men up to 75 years of age with intermediate-to-high-risk prostate cancer and a WHO performance status between 0 and 2. Patients were randomly
Early versus deferred standard androgen suppression therapy for advanced hormone-sensitive prostate cancer. Standard androgen suppression therapy (AST) using surgical or medical castration is considered a mainstay of advanced hormone-sensitive prostate cancer treatment. AST can be initiated early when disease is asymptomatic or deferred when patients suffer symptoms of disseminated prostate cancer.To assess the effects of early versus deferred standard AST for advanced hormone-sensitive (...) AST. We excluded all other study designs. Participants included had advanced hormone-sensitive prostate cancer receiving surgical or medical castration.Two review authors independently classified studies and abstracted data. The primary outcomes were time to death of any cause and serious adverse events. Secondary outcomes were time to disease progression, time to death from prostate cancer, adverse events and quality of life. We performed statistical analyses using a random-effects model
Interventions for smoking cessation in people diagnosed with lung cancer. Lung cancer is one of the most common causes of death from cancer worldwide. Smoking induces and aggravates many health problems, including vascular diseases, respiratory illnesses and cancers. Tobacco smoking constitutes the most important risk factor for lung cancer. Most people with lung cancer are still active smokers at diagnosis or frequently relapse after smoking cessation. Quitting smoking is the most effective (...) way for smokers to reduce the risk of premature death and disability. People with lung cancer may benefit from stopping smoking. Whether smoking cessation interventions are effective for people with lung cancer and whether one method of quitting is more effective than any other has not been systematically reviewed.To determine the effectiveness of smoking cessation programmes for people with lung cancer.We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (accessed via
Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer. Enzalutamide, an androgen-receptor inhibitor, has been associated with improved overall survival in men with castration-resistant prostate cancer. It is not known whether adding enzalutamide to testosterone suppression, with or without early docetaxel, will improve survival in men with metastatic, hormone-sensitive prostate cancer.In this open-label, randomized, phase 3 trial, we assigned patients to receive (...) ). Treatment discontinuation due to adverse events was more frequent in the enzalutamide group than in the standard-care group (33 events and 14 events, respectively). Fatigue was more common in the enzalutamide group; seizures occurred in 7 patients in the enzalutamide group (1%) and in no patients in the standard-care group.Enzalutamide was associated with significantly longer progression-free and overall survival than standard care in men with metastatic, hormone-sensitive prostate cancer receiving
Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: ASCO Clinical Practice Guideline Update—Integration of Results From TAILORx | Journal of Clinical Oncology Search in: Menu Article Tools ASCO SPECIAL ARTICLES Article Tools OPTIONS & TOOLS COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO (...) .19.00945 Journal of Clinical Oncology - published online before print May 31, 2019 PMID: Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: ASCO Clinical Practice Guideline Update—Integration of Results From TAILORx , MD, PhD 1 x Fabrice Andre ; , MD 2 x Nofisat Ismaila ; , MD, PhD 3 x N. Lynn Henry ; , PhD 2 x Mark R. Somerfield ; , MD 4 x Robert C. Bast ; , PhD 5 x William Barlow ; 6 x Deborah E. Collyar ; , MD 7 x M. Elizabeth Hammond
Brigatinib (Alunbrig) - for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) Published 10 June 2019 1 SMC2147 brigatinib 30mg, 90mg and 180mg film-coated tablets (Alunbrig®) Takeda UK Ltd 10 May 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows (...) : ADVICE: following a full submission assessed under the end-of-life and ultra-orphan medicine process brigatinib (Alunbrig®) is accepted for use within NHSScotland. Indication under review: as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. Brigatinib was associated with an objective response rate of 56% in a single-arm, open- label, phase II study in patients with ALK
Durvalumab (Imfinzi) - for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) Published 10 June 2019 1 SMC2156 durvalumab 50mg/mL concentrate for solution for infusion (Imfinzi®) AstraZeneca 10 May 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission (...) considered under the ultra-orphan and end of life process durvalumab (Imfinzi®) is accepted for use within NHSScotland. Indication under review: as monotherapy for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 [programmed cell death ligand 1] on =1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy. Durvalumab, compared with placebo, improved progression-free survival and overall
Diagnosis and Treatment of Early Stage Testicular Cancer Diagnosis and Treatment of Early Stage Testicular Cancer: AUA Guideline (2019) - American Urological Association advertisement Toggle navigation About Us About the AUA Membership AUA Governance Industry Relations Education AUAUniversity Education Products & Resources Normal Histology and Important Histo-anatomic Structures Urinary Bladder Prostate Kidney Renovascular Diseases Andrenal Gland Testis Paratesticular Tumors Penis (...) and Reimbursement Practice Managers' Network (PMN) Patient Safety and Quality of Care Accreditations and Reporting Patient Education Diagnosis and Treatment of Early Stage Testicular Cancer: AUA Guideline (2019) AUA Guideline Published 2019 [pdf] [pdf] Panel Members Andrew Stephenson, MD; Scott E. Eggener, MD; Eric B. Bass, MD, MPH; David M. Chelnick, BS; Siamak Daneshmand, MD; Darren Feldman, MD; Timothy Gilligan, MD; Jose A. Karam, MD; Bradley Leibovich, MD, FACS; Stanley L. Liauw, MD; Timothy A. Masterson