Onco Actu du 8 juillet 2019

	5.10 TRAITEMENTS - ESSAIS
Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework [Trials] Decision aids, tools that have been shown in a treatment and screening context to support better-quality decisions, are emerging as a possible vehicle to support decision making about trial participation. However, information on how they should best be developed and evaluated in a clinical trial context is lacking.
	5.12.4 IMMUNOTHÉRAPIES - ESSAIS
Challenges and shifting paradigms in clinical trials in oncology: the case for immunological and targeted therapies [ecancer medical science] This review focuses on the different options pertaining to clinical trial design that have arisen in the field of immuno-oncology, as well as the challenges of accurately interpreting traditional survival analyses within this novel area of cancer medicine.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
EMA Recommends Extension of Indications for Ibrutinib [ESMO] New indications concern combination with obinutuzumab for CLL and with rituximab for Waldenström’s macroglobulinaemia.
	5.6.17 ESMO - FOIE
Ramucirumab Effective Irrespective of Prior TACE in Advanced HCC with Elevated AFP [ESMO] Overall, the results support the use of ramucirumab in patients with advanced HCC and elevated AFP regardless of prior TACE treatment, Dr Meyer concluded.
	5.6.20 ESMO - PANCRÉAS
Ipsen and Servier announce initial Phase 1/2 clinical data evaluating liposomal irinotecan (ONIVYDE®) as an investigational first-line treatment for metastatic pancreatic cancer at ESMO 21st World Congress on Gastrointestinal Cancer [Ipsen] ONIVYDE® is a topoisomerase inhibitor indicated in combination with 5-FU/LV for metastatic pancreatic cancer after disease progression following gemcitabine-based therapy.
Olaparib Maintenance Therapy Extends Survival in Patients With Metastatic Pancreatic Cancer [ESMO] “Our results are the first from a phase 3 trial to validate a targeted treatment in a bioselected population of pancreatic cancer, really highlighting the importance of germline BRCA testing for metastatic pancreatic cancer patients.”
Liposomal Irinotecan Added to FOLFOX Promising First-Line Therapy for Metastatic Pancreatic Cancer [ESMO] The primary end points of the phase 1/2, open-label trial were to assess the safety, tolerability, and dose-limiting toxicities of NAPOX in patients with metastatic pancreatic cancer to determine appropriate dosing for the phase 3 trial. The secondary end points were measures of efficacy and toxicity.
TYME Presents Updated Data at ESMO GI 2019 from TYME-88-Panc Phase II Study Demonstrating Encouraging Overall Survival Trends in Patients with Advanced Pancreatic Cancer [Tyme] SM-88 is an investigational modified proprietary tyrosine derivative that is hypothesized to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system.
	5.6.8 ESMO - CÔLON-RECTUM
New Trial Demonstrates the Efficacy of a More Flexible Dose of Regorafenib to Relieve Side-effects in Patients with Metastatic Colon Cancer [ESMO World GI Press Release] The investigators observed that flexible dosing showed numerical improvement on several parameters that improved tolerance, such as fatigue, hypertension or hand-foot syndrome (reaction due to redness, swelling and pain caused in the palms), although REARRANGE did not meet its primary endpoint of improving regorafenib global tolerability in the reduced and intermittent dose groups.
Targeted Therapy Combination Improves Survival in Patients with Advanced Bowel Cancer [ESMO World GI Press Release] “Colorectal cancer does not respond to BRAF therapy alone because tumour cells adapt through other mechanisms after initial treatment. With this triple targeted therapy, we are using a very scientifically logical combination to inhibit BRAF and these other mechanisms.”
Triplet-targeted therapy improves survival for patients with advanced colorectal cancer and BRAF mutations [MD Anderson Cancer Center] Phase III trial may change standard of care for up to 15 percent of colorectal cancer patients.
Pembrolizumab Fails to Achieve Goal Response Rate in Patients With Advanced Small Bowel Adenocarcinoma [ESMO] “This is the largest trial ever completed in small bowel adenocarcinoma to date. This is the first prospective immunotherapy trial also conducted in this population.”
Triplet Combo Regimen Defines New Standard of Care for Patients With BRAF V600E-Mutant Metastatic CRC [ESMO] The 3-arm, multi-center, open-label, phase 3 BEACON CRC trial evaluating ENCO plus CETUX with or without BINI (ie, triplet and doublet arms, respectively) versus investigator’s choice of irinotecan or FOLFIRI plus CETUX (control) in patients with BRAF V600E-mutant metastatic CRC that progressed after 1 or 2 previous regimens in the metastatic setting involved 665 patients.
Array shows off the positive BEACON CRC data that helped spur Pfizer's $11.4B buyout offer [EndPoints] They learned that the triplet scored a median overall survival rate of 9 months among drug resistant patients with BRAF V600E-mutated cases of colorectal cancer compared to 5.4 months for the standard of care.
	6.10.1 POLITIQUES (USA)
Trump plans drug pricing executive order aimed at ensuring U.S. pays less than other nations [STAT] At a June 2018 Senate hearing, Azar said that he looked at the idea of giving the U.S. “favored nation” status, but said “I don’t think it would be effective” because companies could simply raise prices abroad to gain leeway in setting prices here.
Trump Suggests Executive Order on Drug Prices, With a Scope That Is Unclear [NY Times] The administration is working on a plan that would use an index of international drug prices to set the price that Medicare pays for some drugs that are administered by doctors, such as cancer treatments.
	6.4 MÉDICO-ÉCO
Cancer deaths cost the U.S. $94 billion in lost earnings in a single year [STAT] But, the authors point out, there are opportunities to reduce the burden of cancer deaths — namely by improving cancer prevention. Many of the cancer types examined come with known risk factors, screening techniques, and effective treatments.
	6.6 PUBLICATIONS
Farewell authors, hello contributors [Nature] CRediT was created to allow quantification. Currently, it recognizes 14 types of contribution, including conceptualization, methodology, software, project administration and data curation. More than two dozen journal publishers — including Cell Press, Public Library of Science and Oxford University Press — are already using CRediT for at least some titles.
	6.7.3 DMP
EHR and physician burnout [Healthcare Economist] Designers of EHR will need to increasingly take into account the cost of alerts. For each individual alert, the benefits probably outweigh the cost. However, as the number of alerts increases, the cost to physicians–in terms of psychic burnout–increases in a non-linear fashion.
	6.8 COMMUNICATION
Organizing Online Health Content: Developing Hashtag Collections for Healthier Internet-Based People and Communities [JCO] Cancer-specific hashtags modeled on a breast cancer community, #bcsm, led to the development of a structured set of hashtags called the cancer tag ontology. In this article, we review how these hashtags have worked with the aim of describing our experience from 2011 to 2017.