Bayer Oncology Medical Affairs Department is interested in receiving and reviewing grant applications to support appropriate programs which cover the following area of interest:
Therapeutic Areas/Disease States:
Hepatocellular Carcinoma (HCC), Cholangiocarcinoma (CCA)
Intended Audience: Oncologists, Hepatologists, Interventional Radiologists, Surgeons, Endocrinologists, Nurses, Pharmacists, Patients/Caregivers
Bayer TA Rationale for Educational Support:
Areas of interest based on referenced literature:
- Treatment and management of unresectable HCC and CCA
- Role of systemic therapy in HCC and CCA multidisciplinary treatment algorithms
- Role of TRK-fusion and impact of TRK-fusion testing in CCA treatment algorithms
- Treatment and management of TRK fusion cancer
- Understanding of efficacy and safety profiles of approved NTRK inhibitors
- Sequential use of LRT and multiple systemic therapies in unresectable HCC
- Combination therapies
- Prevention and management of adverse events due to systemic therapies, such as TKIs, IOs and others
Proposal Requirements:
All submissions for CE/CME support must be consistent with the ACCME guidelines and contain supporting documents that should include:
- Needs assessment
- Educational design and rationale for selection (where applicable)
- Learning objectives
- Proposed faculty
- Participant recruitment plan (where applicable)
- Outcomes strategy/plan
- Detailed budget (please use the template available on the website)
Provider Justification:
- Copy of most recent accreditation letter and status
- Sample of other program(s) in similar therapeutic area
Process
Applications/proposals which are submitted and determined to be complete are reviewed monthly. Allow a minimum of 45 days from submission for response.
Acceptance of a Bayer educational grant indicates that you will:
- Reconcile grant funding within 60 days of completion of the educational program
- Permit a Bayer Medical Affairs representative to audit live programs
- Share activity data and outcomes metrics within 30 days of their availability
References
Management and treatment of HCC and CCA
- National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Hepatobilliary Cancers. Version 3.2019 – August 1, 2019 (link)
- Heimback J, Kulik LM, Finn R et al. AASLD Guidelines for the Treatment of Hepatocellular Carcinoma. Hepatology. 2018, vol 67, No 1: 358-380. (link)
- Zarrinpar A, Kaldas F, Busuttil RW. Liver transplantation for hepatocellular carcinoma: an update. Hepatobiliary Pancreat Dis Int. 2011 Jun;10(3):234-42. (link)
- Maggs JR, SuddleAR, Aluvihare V, Heneghan MA. Systematic review: the role of liver transplantation in the management of hepatocellular carcinoma. Aliment Pharmacol Ther. 2012 May;35(10): 1113-34. (link)
- Miksad, R et al. ASCO GI 2018 Poster - Acute and chronic deterioration in liver function after transarterial radioembolization (TARE) in US patients (pts) with hepatocellular carcinoma (HCC). J Clin Oncol 36, 2018 (suppl 4S; abstr 439).(link)
- Miksad et al. ASCO GI 2018 Poster - Changes in liver function following real-world transarterial chemoembolization (TACE) in US patients (pts) with hepatocellular carcinoma (HCC): The LiverT study. J Clin Oncol 36, 2018 (suppl 4S; abstr 441). (link)
- Xu, LX et al. Genomic and transcriptional heterogeneity of multifocal hepatocellular carcinoma. Ann Oncol. 2019 Mar 27. (Epub ahead of print) (link)
- Llovet, JM et al. Randomized trials and endpoints in advanced HCC: Role of PFS as a surrogate of survival. J Hepatol. 2019 Jun;70(6):1262-1277. (link)
- Marquardt, JU et al. The Changing Landscape of Systemic Treatment of Advanced Hepatocellular Carcinoma: New Targeted Agents and Immunotherapies. Target Oncol. 2019 Apr;14(2):115-123. (link)
- Kudo M. Targeted and immune therapies for hepatocellular carcinoma: Predictions for 2019 and beyond. World J Gastroenterol. 2019 Feb 21;25(7):789-807. (link)
Tyrosine Kinase Inhibitors in HCC treatment algorithms
- Abou-Alfa GK, Schwartz L, Ricci S, et al. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol 2006; 24:4293-4300. (link)
- Llovet J, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 2008;359:378-90. (link)
- Bruix et al. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Volume 389, No. 10064, p56–66. (link)
- Kaseb, AO et al. A phase II study of sorafenib and yttrium-90 glass microspheres for advanced hepatocellular carcinoma, BCLC stage C. Journal of Clinical Oncology 2017 35:15_suppl, 4083-4083
- Sun, W et al. Systemic Treatment of Patients with Advanced, Unresectable Hepatocellular Carcinoma: Emergence of Therapies. J Gastrointest Cancer. 2018 Feb 17. doi: 10.1007/s12029-018-0065-8. [Epub ahead of print]
- Drilon A, Laetsch TW, Kummar S et al. Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children. N Engl J Med 2018; 378: 731-9
- Iavarone, M et al. Preliminary experience on safety of regorafenib after sorafenib failure in recurrent hepatocellular carcinoma after liver transplantation. Am J Transplant. 2019 Jul 31. (Epub ahead of print) (link)
- Park, J et al. Relative Efficacy of Systemic Treatments for Patients with Advanced Hepatocellular Carcinoma According to Viral Status: A Systematic Review and Network Meta-Analysis. Target Oncol. 2019 Aug;14(4):395-403. (link)
- Iavarone, M et al. Preliminary experience on safety of regorafenib after sorafenib failure in recurrent hepatocellular carcinoma after liver transplantation. Am J Transplant. 2019 Jul 31. (Epub ahead of print) (link)
- Ogasawara, S et al. Sequential therapy with sorafenib and regorafenib for advanced hepatocellular carcinoma: a multicenter retrospective study in Japan. Invest New Drugs. 2019 Jun 6. (Epub ahead of print) (link)
- Zhu, AX et al. Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Feb;20(2):282-296. (link)
Prevention and management of adverse events due to TKIs
- Grothey, A et al. Exploration of efficacious alternative regorafenib regimens to manage hand-foot-skin-reaction (HFSR); Annals of Oncology 30 (5), October 2019 (link)
- Sato, J et al. Adherence to a topical moisturizing preparation for regorafenib-related hand-foot skin reaction. J Oncol Pharm Pract. 2019 May 19:1078155219849275. (link)
- Rimassa, L et al. Management of adverse events associated with tyrosine kinase inhibitors: Improving outcomes for patients with hepatocellular carcinoma. Cancer Treat Rev. 2019 Jul;77:20-28. (link)
Diagnosis, treatment and management of TRK fusion cancer
- Hong DS, Bauer TM, Lee JJ et al. Larotrectinib in adult patients with solid tumours: a multi-centre, open-label, phase I dose-escalation study. Ann Oncol. 2019 Feb 1;30(2):325-331. (link)
- Khotskaya YB, Holla VR, Farago AF, et al. Targeting TRK family protein in cancer. Pharmacol Ther 2017 (173), 58-66. (link)
- Drilon A, Laetsch TW, Kummar S et al. Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children. N Engl J Med 2018; 378: 731-9. (link)
- Cocco, E et al. NTRK fusion-positive cancers and TRK inhibitor therapy. Nat Rev Clin Oncol. 2018 Dec;15(12):731-747. (link)
- Hyman, DM et al. Durability of response with larotrectinib in adult and paediatric patients with TRK fusion cancer. Annals of Oncology 30 (5), October 2019 (link)
- Kummar, S et al. Patient-reported outcomes from two global multicenter clinical trials of children and adults with tropomyosin receptor kinase (TRK) fusion cancers receiving larotrectinib. Journal of Clinical Oncology 37, 2019 (suppl; abstr 6602) (link)
- Ricciuti, B et al. Antitumor activity of larotrectinib in tumors harboring NTRK gene fusions: a short review on the current evidence. Onco Targets Ther. 2019 Apr 30;12:3171-3179 (link)
- Solomon, JP et al. NTRK fusion detection across multiple assays and 33,997 cases: diagnostic implications and pitfalls. Mod Pathol. 2019 Aug 2. (Epub ahead of print) (link)
- Wong, D et al. Methods for Identifying Patients with Tropomyosin Receptor Kinase (TRK) Fusion Cancer. Pathol Oncol Res. 2019 Jun 29. (Epub ahead of print) (link)