Onco Actu du 25 septembre 2018

	3.1.1 Prévention - Tabac - e-cigs
Potential Benefits and Risks of High-Nicotine e-Cigarettes [JAMA] Delays in enforcement action by the FDA as well as failure to enforce the full, premarket review process have created a climate in which products like JUUL devices can be marketed as smoking cessation to adults while ignoring the potential ramifications for adolescents and teenagers.
Special Report: High-nicotine e-cigarettes flood market despite FDA rule [Reuters] Start-ups and major tobacco firms have launched more than a dozen new high-nicotine devices with Juul-like designs since the FDA imposed the deadline, according to a Reuters review of the companies’ online advertisements, social media posts and public statements.
	4.12 Biopsies liquides
Foundation, Roche launch new 70-gene cancer blood test following June buyout [FierceBiotech] In April, the FDA granted a breakthrough device designation to Foundation’s liquid biopsy assay under development for measuring blood tumor mutational burden as a genomic biomarker. If approved, the test could be the first liquid biopsy to incorporate multiple companion diagnostics and biomarkers to guide cancer therapies, the company said.
	4.5 Dép., diag. & prono. - Colorectal
Colorectal cancer screening: Science should trump convenience [STAT] Ninety-five percent of colon cancers begin as polyps. Cologuard is not as good at finding pre-cancerous polyps and, unlike colonoscopy, it can’t remove them. According to the NEJM study, Cologuard misses more than 30 percent of polyps that will soon be cancer, and 57 percent of polyps that may become cancer.
	5.10 Traitements - Essais
Clinical trial investigators violate EU regulations: Entries in EU Register are incomplete [IQWIG] The fact that clinical trials are not registered and their results are not reported is not a trivial offence. Rather, ethical and scientific standards are being violated, because the benefit and harm of medical interventions can only be correctly assessed on the basis of complete data. Only then can physicians and patients decide on the best-possible alternative.
	5.12 Immunothérapies
Cancer cells evade immunotherapy by hiding telltale marker, suggesting how to stop relapse [Fred Hutch] A Nature Communications report explains why some Merkel cell carcinoma patients treated with immunotherapy see their cancers shrink at first but then come back.
	5.12.6 Immunothérapies - AMM
BLINCYTO® (blinatumomab) Approved In Japan For The Treatment Of Relapsed Or Refractory B-cell Acute Lymphoblastic Leukemia [Amgen] BLINCYTO is the First-and-Only Approved CD19-Directed CD3 Bispecific T Cell Engager (BiTE®) Immunotherapy.
European Commission approves Imfinzi for locally-advanced, unresectable NSCLC [AstraZeneca] Phase III PACIFIC trial demonstrated compelling overall survival benefit and progression-free survival of more than 11 months.
EU approves AstraZeneca immunotherapy drug for lung cancer [Reuters] The green light from the European Commission had been expected following a positive recommendation from experts at the European Medicines Agency in July.
	5.13 WCLC
IMpower132 Study Shows Atezolizumab in Combination With Carboplatin and Pemetrexed Reduced the Risk of Disease Worsening or Death (PFS) in Stage IV Non-Squamous NSCLC [IASLC] These IMpower132 study results are significant because it further supports the use of atezolizumab plus chemotherapy with or without Avastin (bevacizumab) in chemotherapy-naïve NSCLC.
Study Demonstrates Reliability of Trained Dogs in the Identification of Malignant Pulmonary Nodules [IASLC] The dog successfully identified malignant samples with a sensitivity of 0.97, a specificity of 0.99, a predictive positive value of 0.97 and a predictive negative value of 0.99. Twenty-seven of 30 nodules were correctly identified as lung cancer-positive, verified by the outcomes of pathology reports.
Roche Left Seeking a Niche as Merck Dominates Lung-Cancer Market [Bloomberg] Roche Holding AG is starting to look more like a niche player in the hottest new field in oncology, as lung-cancer study results unveiled on Monday failed to meet the benchmark set by U.S. rival Merck & Co.
Smoking Cessation Services Widely Accepted During Lung Cancer Screenings [IASLC] Of 1,241 individuals assessed for eligibility, 808 were eligible for screening and 63 percent were identified as current smokers. Of total current smokers, regardless of screen-eligibility, 83 percent accepted a referral to SCS.
Women With Non-Small Cell Lung Cancers Live Longer Than Men, WCLC Study Shows [IASLC] Albain and her SWOG team studied 981 patients newly diagnosed with Stage I, II or III NSCLC and grouped them into four cohorts based on sex and smoking history.
Roche’s Tecentriq in combination with pemetrexed and platinum-based chemotherapy reduced the risk of disease worsening or death in a type of previously untreated advanced lung cancer [Roche] While a numerical improvement of 4.5 months for the co-primary endpoint of overall survival (OS) was observed, at this interim analysis statistical significance has not yet been met.
Opening Plenary Speaker at World Conference on Lung Cancer Examines How Serious Illness Can Create Important Sense of Meaning for HCPs, Caregivers and Patients [IASLC] Lucy Kalanithi, M.D., Explores Themes in Late Husband’s New York Times’ Bestselling Memoir.
Study Shows Outdoor Air Pollution Exposure Significantly Higher in Women Non-Smokers With Lung Cancer Than Women Smokers With Lung Cancer [IASLC] The study enrolled 681 patients with newly diagnosed lung cancer, including 439 “ever-smokers” and 242 “never-smokers.”
Roche’s investigational medicine entrectinib showed a durable response of more than two years in people with a specific type of lung cancer [Roche] Entrectinib reduced tumours in people with ROS1-positive non-small cell lung cancer (NSCLC), including those whose disease had spread to the central nervous system (CNS).
	5.2 Pharma
FDA lifts hold on Epizyme cancer drug, shares surge [FierceBiotech] Tazemetostat ran into trouble in April when a pediatric cancer patient taking the drug developed a secondary T-cell lymphoblastic lymphoma. The adverse event was the first of its kind seen across the 750 people treated with tazemetostat to date.
Another Precision Step for Roche as Ignyta Drug Heads to Regulators [Xconomy] Entrectinib is one of an increasing number of cancer drugs being advanced toward a tissue-agnostic approval. Other tumor-agnostic drugs from Loxo, Eli Lilly, and more are advancing through clinical testing (here’s a look from Nature at the increasing pipeline of tumor-agnostic drugs).
	5.3 Traitements - FDA, EMA, NICE...
Companies stepping up efforts to ensure medicine supply post Brexit [EMA] Focus is now on 39 centrally authorised medicines, down from 108.
	5.3.4 Traitements - AMM (FDA, EMA,...)
Verastem Oncology Receives FDA Approval of COPIKTRA™ (duvelisib) Capsules [Verastem] COPIKTRA will be available in the U.S. market immediately.
Unwanted by AbbVie and Infinity, battered Verastem gets an OK for duvelisib and a second shot at success [EndPoints] Today, the FDA did its part, handing over an accelerated approval for the drug, which will now be sold as Copiktra, the only gamma/delta inhibitor on the market for third-line cases of chronic lymphocytic leukemia/small lymphocytic lymphoma. And the agency also offered up a tandem OK as a 3rd-line therapy for follicular lymphoma.
	5.5 ASCO
Three Studies Reveal Cancer Patients Face Serious Financial Hardship, Do Not Discuss Treatment Costs With Physicians [ASCO] Authors will present their findings at the American Society of Clinical Oncology’s (ASCO) upcoming Quality Care Symposium, taking place September 28–29, in at the JW Marriott Phoenix Desert Ridge in Phoenix.
	6. Lutte contre les cancers
Hope and Challenge: The NCI Annual Plan and Budget Proposal for Fiscal Year 2020 [NCI] I encourage you to take a look at the plan—the first during my term as NCI director—to learn more about key scientific areas of opportunity where additional support could fuel progress and improve the outlook for people with cancer and those at increased risk.
	6.5 Médecines alternatives/complémentaires
How online crowdfunding supports cancer quacks [Respectful Insolence] The problem is that the medical expert or the expression of doubt is usually used as the “token skeptic” and buried somewhere in the middle of the text. Sometimes, as Dvorak did after noting that the therapy has no evidence to support it, reporters even use consensus medical opinion as a foil, immediately pivoting to a “but…” and going on to portray what the family is doing as a brave gamble rather than what it is, an unfortunate desperate family being taken advantage of by quacks.
	6.8 Communication
Cancer In The News: Bias And Quality In Media Reporting Of Cancer Research. [bioRxiv] The main aim of this study was to investigate the nature and quality of cancer research covered in online news reports by four major news sources from USA, UK and Australia.
	6.9 Controverses
Scientific Advocacy and Biases of the Ideological and Industry Kinds [Absolutely Maybe] I think bias from non-financial interests is a big deal. But Bero and Grundy convinced me that if you go past clearly justified and objective commercial interests, you open up a door where anything goes, everyone can be dismissed as having a conflict, and no one is trusted. We’re seeing that happen with the Cochrane HPV vaccine review.