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

1. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Hepatobilliary Cancers. Version 3.2019 – August 1, 2019 (link)
2. 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)
3. Zarrinpar A, Kaldas F, Busuttil RW. Liver transplantation for hepatocellular carcinoma: an update. Hepatobiliary Pancreat Dis Int. 2011 Jun;10(3):234-42. (link)
4. 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)
5. 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)
6. 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)
7. Xu, LX et al. Genomic and transcriptional heterogeneity of multifocal hepatocellular carcinoma. Ann Oncol. 2019 Mar 27. (Epub ahead of print) (link)
8. 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)
9. 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)
10. 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

11. 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)
12. Llovet J, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 2008;359:378-90. (link)
13. 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)
14. 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
15. 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]
16. 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
17. 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)
18. 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)
19. 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)
20. 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)
21. 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

22. 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)
23. 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)
24. 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

25. 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)
26. Khotskaya YB, Holla VR, Farago AF, et al. Targeting TRK family protein in cancer. Pharmacol Ther 2017 (173), 58-66. (link)
27. 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)
28. Cocco, E et al. NTRK fusion-positive cancers and TRK inhibitor therapy. Nat Rev Clin Oncol. 2018 Dec;15(12):731-747. (link)
29. 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)
30. 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)
31. 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)
32. 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)
33. 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)