Onco Actu du 29 mai 2017

	1. Biologie
Study provides better understanding of how brain tumors ‘feed’ [MD Anderson] New findings explain how the enzyme ACSS2 aids tumors in a nutrient-starved environment offering potential new treatment approaches.
	2.10 Etiologie - Alcool
Alcohol and breast cancer – how big is the risk? [Cancer Research UK] The report backs up previous research showing that drinking alcohol can cause 7 types of cancer including breast cancer. Even though it’s in the headlines, this is nothing new.
Just half a glass of wine a day may increase breast cancer risk [NHS Choices] “Drinking alcohol has a greater effect on the risks of several other cancers (such as cancers of the mouth, oesophagus and bowel) than it does on the risk of breast cancer, so there are other reasons to give up or cut down, but that just shows the importance of looking at the whole picture and not just at breast cancer."
	2.11 Etiologie - Alimentation
Red meat tied to higher risk of dying from many diseases [Reuters] Researchers examined data on almost 537,000 adults aged 50 to 71 and found the people who consumed the most red meat had 26 percent higher odds than those who ate the least of dying from a variety of causes.
	3.6 Prévention - Activité physique
Majority of time-pressed Brits walk less than a mile a day [Cancer Research UK] Around a third (32%) of adults said a lack of time puts them off walking more while a quarter (25%) are deterred by bad weather.
	3.8 Prévention - Alimentation
Drinking coffee may help prevent liver cancer, study suggests [The Guardian] People who drink more coffee – even decaffeinated – are less likely to develop liver cancer, an analysis of data from 26 studies has found.
	4. Dépistage, diagnostic et pronostic
Expanding waistline linked to an increased risk of cancer [NHS Choices] For women who hadn't used hormone therapy, this would increase to a risk of 2.7% if they had a BMI of 30 compared with 26, or a waist circumference of 95cm compared with 84cm. This accounts for only an extra 5 cases in every 1,000 women.
Where body fat is carried can predict cancer risk [Cancer Research UK] “To better reflect the underlying biology at play, we think it’s important to study more than just BMI when looking at cancer risk. And our research adds further understanding to how people’s body shape could increase their risk.”
Why your waist measurement can predict cancer risk [The Guardian] Study finds men with over 40in waist and women with over 35in waist are more at risk of cancer as waist size is as good at predicting cancer risk as BMI.
	4.9 Dép., diag. & prono. - Sein
Preventing unnecessary breast cancer treatment [Cancer Research UK] Changing clinical practice takes time – it’s like changing the direction of a big oil ship. With the Grand Challenge project we’ve got 5 years to make this happen and change the DCIS ship’s direction.
ASCO and the CAP Invite Comment on Focused Update to HER2 Testing Guideline in Breast Cancer [ASCO] Notably, this 2017 Focused Update will address uncommon clinical scenarios to improve clarity, particularly for infrequent HER2 test results that are of uncertain biologic or clinical significance.
	5. Traitements
Intensive Pre-Stem Cell Transplant Regimen May be Best for Younger Patients with AML, MDS [NCI] It was the trial's data safety monitoring board that, based on the substantial difference in relapse rates between the groups, called for the trial to be stopped early. The dramatically higher relapse rate in the reduced-intensity group caught the research team by surprise, Dr. Scott noted.
	5.12.2 Immunothérapies - CAR-T
Kite catches the inside track on the last leg of a race to the finish line with Novartis on a CAR-T first [EndPoints] The biotech announced this morning that the FDA is providing a priority review for their drug KTE-C19 (axicabtagene ciloleucel), which will cut the time it takes for regulators to complete their examination from 10 months down to 6.
	5.12.5 Immunothérapies - Pharma
U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Previously Treated Hepatocellular Carcinoma [BMS] Application is based on results from the Phase 1/2 CheckMate -040 trial.
Startup Tilos to develop cancer-fighting antibody that emerged from MS research [FierceBiotech] They were studying a population of the immune system’s T cells that normally prevent autoimmune diseases like MS, when they realized they could use the knowledge they were gaining to prompt the immune system to stop cancer.
Pierre Fabre buys up Igenica preclinical I-O meds [FierceBiotech] Igenica, which works on antibodies in the field of immuno-oncology and antibody-drug conjugates (ADCs) in cancer, was co-founded back in 2009 by Robert Schreiber.
	5.12.6 Immunothérapies - AMM
FDA Landmark Nod: Cancer Drug To Match Tumor Genes, Not Tissue Type [Xconomy] The FDA decision was based on five clinical trials enrolling 149 patients with MSI-H or dMMR solid tumors across 15 cancer types. Of the 149 patients, 39.6 percent had at least a partial response to treatment, meaning their tumors shrunk.
Immunotherapy drug opens a new era of precision medicine for cancer [LA Times] All told, scientists believe about 4% of advanced cancers bear the genetic signature that would make them treatable by Keytruda.
FDA Approves First Use for an Anticancer Therapeutic Based on Tumor Biomarker, Not Tumor Origin [Cancer Research Catalyst] The approval of pembrolizumab for unresectable or metastatic solid tumors found to be microsatellite instability–high or mismatch repair–deficient was based on response data, rather than overall survival data.
An Approval Like No Other [in the Pipeline] I would not be surprised if the way that we talk about cancer has just started to change, as of this week.
In Bold Move, FDA Approves Cancer Drug For Any Advanced Tumor With Genetic Changes [Forbes] A final concern I have is how cancer specimens were tested for MSI or DNA mismatch repair. The FDA notice refers to several methods of genetic analysis. Distinct ways of checking tumors for these abnormalities could yield variable results.
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Adult and Pediatric Patients with Unresectable or Metastatic, Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient Cancer [Merck] This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
FDA clears Merck's Keytruda based on cancer genetics, not location [Reuters] The approval marks a major step in so-called precision medicine, where genetic biomarkers may determine the course of therapy rather than the type of cancer.
FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indication [FDA] FDA granted this application priority review status and accelerated approval. Further studies are required to confirm clinical benefit of pembrolizumab for this indication.
Pioneering Merck makes another breakthrough with PD-1 star Keytruda, grabbing first OK for a cancer biomarker [EndPoints] Merck was able to draw on data from five studies showing Keytruda’s ability to shrink a significant number of tumors.
Tissue-independent cancer drug gets fast-track approval from US regulator [Nature] The approval of pembrolizumab for use in these patients is conditional, meaning that Merck must conduct additional trials. It also only applies to advanced cases of cancer. Still, the landmark approval opens doors to other companies betting on this approach.
Drug Is First to Treat Cancer Based on Genetics, Not Location [MIT Technology Review] The new approval only applies to patients for whom traditional treatment, like chemotherapy, has already failed. But genetic tests to identify patients with mismatch repair genes are widely available and cost $300 to $600, says Le. Keytruda itself costs around $150,000 a year.
	5.3 Traitements - FDA, EMA, NICE...
Novartis receives FDA approval for expanded use of Zykadia® in first-line ALK-positive metastatic non-small cell lung cancer (NSCLC) [Novartis] In ALK-positive metastatic NSCLC patients, Zykadia median progression-free survival (PFS) was 16.6 months, compared to 8.1 months with chemotherapy.
	5.3.4 Traitements - AMM (FDA, EMA)
ODAC votes 12-4 to recommend approval for kinase inhibitor used after completion of trastuzumab [The Cancer Letter] In the company’s registration trial, 2,840 women with early stage HER2-positive breast cancer who had previously received adjuvant treatment with trastuzumab were randomized 1:1 to receive either neratinib (n=1420) or placebo (n=1420). The primary endpoint was invasive disease-free survival (iDFS) within 2 years and 28 days.
Bullish Puma Investor Talks Neratinb FDA Panel Win, Next Steps and Takeout Potential [The Street] How is "clinically meaningful" defined? Basically, a two percentage point difference in DFS between the Perjeta and control arms. That's roughly the same DFS benefit shown by neratinib in Puma's EXTENET study.
FDA Panel Votes 12 To 4 to Approve Puma's Breast Cancer Drug [Forbes] Stan Lipkowicz from the National Cancer Institute, for instance, voted yes, but said: "I don't think I'd treat as broadly as the patients prescribed." Lori Minasian, also from the NCI, voted yes, but said: "The indication as stated is far too broad."
Puma wins a big round in fight for neratinib OK as experts offer a crucial thumbs up [EndPoints] “I do think that physicians will select patients very selectively for using this,” he noted, echoing a concern that the approval the company was seeking was too broad given the data available.
Puma Biotechnology Receives FDA Advisory Committee Support for Neratinib [Puma] The ODAC vote was based on a review of the clinical development program that included 11 trials in breast cancer and represented approximately 2,000 patient years’ experience.
U.S. FDA panel backs Puma Biotech's breast cancer drug [Reuters] The panel voted 12 to 4 in favor of the drug, neratinib, saying its benefits outweighed the risks, though panelists noted that the magnitude of the benefit was modest. The FDA is not obliged to follow the recommendations of its advisory panels, but typically does so.
	5.4 Traitements - Economie
Accelerated FDA approval and pricey drugs make a rotten combo, doctors argue [FiercePharma] “We see the value in getting products that qualify for accelerated approval to market for patients, but we believe the price paid by taxpayers should reflect the strength of the available evidence about the drug’s clinical impact.”
New FDA commissioner Gottlieb unveils price-fighting strategies [FiercePharma] Importantly, the FDA can’t regulate drug prices, but it can implement measures aimed at deterring the types of price hikes that have made so many headlines over more than a year.
Measuring Value Based On What Matters To Patients: A New Value Assessment Framework [Health Affairs Blog] The Avalere-FasterCures Patient-Perspective Value Framework (PPVF) version 1.0—developed in collaboration with a multistakeholder steering committee—has made significant progress in framing a new way to assess value from the patient perspective.
	5.5 ASCO
ASCO Launches CENTRA, a New Hub for Cancer Care Research, Data, and Analysis [ASCO] Through CENTRA, requests can be made for data from ASCO sources, such as ASCO’s quality programs; its annual census of oncology practices; and ASCO Scientific Meeting abstracts and presentations. CENTRA will also facilitate requests for data sets that will become available from ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) study.
	6. Lutte contre les cancers
Cancer Care in Low-Resource Areas: Cancer Treatment, Palliative Care, and Survivorship Care: Proceedings of a Workshop (2017) [NAP] The first workshop, held in October 2015, focused on cancer prevention and early detection. The second workshop was held in November 2016, and focused on cancer treatment, palliative care, and survivorship care in low-resource areas. This publication summarizes the presentations and discussions of this workshop.
	6.10 Politiques
World Health Organization gets first leader from Africa [Nature] In the new election, all member states have a single vote – giving small countries like the Pacific island nation of Tuvalu the same voting weight as China or the United States.
W.H.O. Elects Ethiopia’s Tedros as First Director General From Africa [NY Times] Dr. Tedros, 52, replaces Dr. Margaret Chan of China, who has held the post for a decade. He is best known for having drastically cut deaths from malaria, AIDS, tuberculosis and neonatal problems when he was Ethiopia’s health minister.
Ethiopia's Tedros wins WHO race, first African to get top job [Reuters] The former health minister and foreign minister, who vowed to make universal health care his priority, won over half the votes from 189 member states in the first round and prevailed in a third-round ballot against Britain's David Nabarro.
	6.10.1 Politiques (USA)
President’s Budget Threatens to Stall Nation’s Progress Against Cancer [ASCO] The President’s proposed budget is extremely disappointing, but we remain encouraged by bipartisan support from Congress that resulted in increased NIH and NCI funding in both FY 2016 and FY 2017.
Trump would cut over 20 percent of NIH, NCI budgets in new FY18 proposal [The Cancer Letter] In recent weeks, The Cancer Letter spoke with former NCI directors, scientists, advocates and legislators.
ASH President Responds to President Trump’s Proposal to Cut One in Five Dollars to NIH, Public Health Programs [ASH] President Trump’s proposal to cut NIH’s FY18 budget by over $7 billion is a devastating blow to the advancement of medical science. NIH is the largest global funder of biomedical research, and without adequate funding, advancement toward treatments and cures for many diseases and cancers will not happen.
What’s in Trump’s 2018 budget request for science? [Science] In a widely anticipated move that has already raised alarm bells at research institutes, a White House budget document states that “significant reductions” will come from slashing the overhead payments that NIH now pays to universities on top of the direct research costs for a project.
Trump budget would slash science programmes across government [Nature] Congressman Tom Cole (Republican, Oklahoma) who chairs the US House of Representatives spending subcommittee that funds the NIH, has said that he does not expect that Congress will support Trump’s proposed cuts.
Cancer research, public health and worker safety would all see steep cuts under Trump budget [LA Times] The detailed 2018 budget proposal for the Department of Health and Human Services includes substantial reductions in funds for cancer research, HIV/AIDS prevention, efforts to secure the food supply, and programs to improve environmental and occupational health and safety.
	6.5 Médecines alternatives
The Natural Cancer Cure Narrative [Science-Based Medicine] Julie Reason and her husband are producing a documentary about her cancer, and efforts to cure it. Based on their comments, they are drawing upon an established and false narrative about the causes and cures of cancer, one that can be dangerous to her, and all other cancer patients.
	6.6 Publications
Reproducible Research, Just Not Reproducible By You [The Scholarly Kitchen] At the very least, we need a new term for these works that are essentially irreproducible, but not invalid. Any suggestions for a term that is neutral and does not denigrate the validity of the work in question but that notes the difficulty of reproduction would be welcome.
	6.7 DMP, Big Data & applis
Big Data in Biomedicine panel examines data sharing difficulties [Stanford Medicine] The film is funny and thought provoking, touching on many of the all-too-familiar issues data users encounter on a regular basis. It’s well worth a look.
	6.8 Communication
Today’s alcohol and breast cancer headlines are wrong: Here’s how news reports could have done better [HealthNewsReview] All of these headlines are misleading and for a relatively simple reason: The evidence supporting the claims comes mainly from observational studies that can’t prove cause and effect.
	6.9 Controverses
Amy Reed, physician and patient who “moved mountains” to end widespread use of power morcellation, dies at 44 [The Cancer Letter] The final phase of her medical education began on Oct. 17, 2013, when Reed, then 41, checked in at Brigham & Women’s Hospital—her husband’s workplace at that time—to undergo a common gynecological procedure that would fundamentally redefine her career, and, ultimately, consume her life.