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:
Soft Tissue Sarcoma (STS), including Gastrointestinal Stromal Tumor (GIST)
Intended Audience: Medical Oncologists, Surgeons, Nurses, Pharmacists, Patients/Caregivers
Areas of interest based on referenced literature:
- Management and treatment of STS, including GIST
- Role of NTRK gene fusion and impact of NTRK gene fusion/TRK testing in STS treatment algorithms
- Treatment and management of TRK fusion cancer
- Understanding of efficacy and safety profiles of approved NTRK inhibitors
- Role of Tyrosine Kinase Inhibitors in STS treatment algorithms
- Prevention and management of adverse events
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 STS, including GIST
- National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Soft Tissue Sarcoma. Version 4.2019 – September 12, 2019 (link)
- Caram MV, Schuetze SM. Advanced or metastatic gastrointestinal stromal tumors: systemic treatment options. J Surg Oncol. 2011 Dec;104(8):888-95. (link)
Tyrosine Kinase Inhibitors in STS treatment algorithms
- Kim EJ and Zalupski MM. Systemic therapy for advanced gastrointestinal stromal tumors: Beyond imatinib. J. Surg. Oncol, 2011 Dec 104 (8): 901-906 (link)
- George S, Wang Q, Heinrich M, et al. Efficacy and Safety of Regorafenib in Patients with metastatic and/or Unresectable GI Stromal Tumor After Failure of Imatinib and Sunitinib: A Multicenter Phase II Trial. JCO. 2012 Jul 30 (19): 2401-2407 (link)
- Demetri G, Reichardt P, Kang YK, et al. Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumors after failure of imatinib and sunitinib (GRID): an international, multicenter, randomized, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):295-302 (link)
- Ben-Ami E et al. Long-term follow-up results of the multicenter phase II trial of regorafenib in patients with metastatic and/or unresectable GI stromal tumor after failure of standard tyrosine kinase inhibitor therapy. Ann Oncol. 2016 Sep;27(9):1794-9 (link)
- Call, JW et al. Survival in advanced GIST has improved over time and correlates with increased access to post-imatinib tyrosine kinase inhibitors: results from Life Raft Group Registry. Clin Sarcoma Res. 2019 Apr 2;9:4. (link)
- Mir O, Bradodwica T, Italiano, A, et al. Safety and efficacy of regorafenib in patients with advanced soft tissue sarcoma (REGOSARC): a randomized, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol 2016; 17:1732-42 (link)
- Riedel RF, Ballman KV, Lu Y, et al. A randomized, double-blind, placebo-controlled, Phase II study of regorafenib vs placebo in advanced/metastatic, treatment-refractory liposarcoma: results from the SARC04 study. J Clin Oncol 36, 2018 (suppl; abstr 11505). (link)
- Gounder MM, Mahoney, MR, Van Tine, BA, et al. Phase III, randomized, double blind, placebo-controlled trial of sorafenib in desmoid tumors (Alliance A091105). J Clin Oncol 36, 2018 (suppl; abstr 11500). (link)
- Penel, N et al. Prior exposure to pazopanib (PAZ) did not reduce efficacy of regorafenib (REG) in non-adipocytic soft tissue sarcoma patients (pts). Annals of Oncology 30(5), October 2019.(link)
- Penel, N et al. EREMISS: Efficacy of regorafenib (REG) as maintenance therapy in non-adipocytic soft tissue sarcomas (STS) having received 1st-line doxorubicin-based chemotherapy (Doxo-CT). Annals of Oncology 30(5), October 2019. (link)
- Duffaud, F et al. Efficacy and safety of regorafenib in adult patients with metastatic osteosarcoma: a non-comparative, randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2019 Jan;20(1):120-133. (link)
- Davis, LE et al. Randomized Double-Blind Phase II Study of Regorafenib in Patients With Metastatic Osteosarcoma. J Clin Oncol. 2019 Jun 1;37(16):1424-1431. (link)
- Pan, PJ et al. Protein Kinase B and Extracellular Signal-Regulated Kinase Inactivation is Associated with Regorafenib-Induced Inhibition of Osteosarcoma Progression In Vitro and In Vivo. J Clin Med. 2019 Jun 24;8(6). (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)
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)