Call For Grant 5

TKI

Intended Audience: Veterans Affairs - Medical Oncologist, Nurse, Nurse Practitioner, Pharmacist

Total Budget - $150,000

Bayer TA Rationale for Educational Support:

• Optimal sequencing of 3L treatments for mCRC
• Using AEs from prior therapies to inform treatment selection in 3L
• Emerging Real World Evidence data, e.g. “STAR-T”, ESMO Data?
• Dosing strategies for targeted therapies for mCRC, i.e ReDOS
• Proactive AE management

Preferred Format:

• Enduring
• Downloadable slides
• Podcast
• Virtual

Proposal Requirements:

The proposal must be compliant with standards and guidelines for commercial support (e.g., ACCME).

The proposal should include:

• Needs assessment
• Educational design and rationale for selection (where applicable)
• Learning Objectives & Draft Agenda
• 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

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:

• Provide timely updates on changes in project timeline and event launch date
• 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

1. Hatori M, et al. “Association Between Regorafenib Dose and Efficacy Against Metastatic Colorectal Cancer in a Real-World Setting. Dose Response.” 2021 Oct 12;19(4):15593258211047658. (link)
2. Yeh KH, et al. “Real- world evidence of the safety and effectiveness of regorafenib in Taiwanese patients with metastatic colorectal cancer: CORRELATE Taiwan.” J Formos Med Assoc. 2021 Nov;120(11):2023-2031. Epub 2021 Jan 7. (link)
3. Hofheinz, R et al. “Effect of regorafenib in delaying definitive deterioration in health-related quality of life across three tumor types.” Annals of Oncology 30 (4), July 2019. (link)
4. Bekaii-Saab, TS et al. “Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study.” Lancet Oncology 2019 Aug;20(8):1070-1082. (link)
5. 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)
6. Røed Skårderud M, et al. “Efficacy and safety of regorafenib in the treatment of metastatic colorectal cancer: A systematic review.” Cancer Treat Rev. 2018 Jan;62:61-73. Epub 2017 Nov 10. (link)
7. Yoon SE, et al. “The use of regorafenib for patients with refractory metastatic colorectal cancer in clinical practice.” Onco Targets Ther. 2018 Dec 24;12:225-231. (link)
8. Grothey A, et al.  “Current Options for Third-Line Treatment of Metastatic Colorectal Cancer.” Clin Adv Hematol Oncol. 2016 Mar;14(3 Suppl 3):1-15. (link)
9. Grothey A. “Regorafenib in metastatic colorectal cancer: optimal dosing and patient selection recommendations.” Clin Adv Hematol Oncol. 2015 Aug;13(8):514-7. (link)
10. Rizzo A, et al. Dose reduction and discontinuation of standard-dose regorafenib associated with adverse drug events in cancer patients: a systematic review and meta-analysis. Ther Adv Med Oncol. 2020 Jul 7;12:1758835920936932. (link)
11. 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)
12. C. Signorelli, et al. Effectiveness and safety of regorafenib and trifluridine/ tipiracil in refractory metastatic colorectal cancer: A real world multicenter retrospective study with focus on sequential treatment; Annals of Oncology Volume 33- Issue S7- 2022. (link)
13. Sonbol, M.B., Benkhadra, R., Wang, Z., Firwana, B., Walden, D.J., Mody, K., Hubbard, J.M., Murad, M.H., Ahn, D.H. and Bekaii-Saab, T. (2019), A Systematic Review and Network Meta-Analysis of Regorafenib and TAS-102 in Refractory Metastatic Colorectal Cancer. The Oncol, 24: 1174-1179. (link)
14. Jatoi, A., Ou, F.-S., Ahn, D.H., Zemla, T.J., Le-Rademacher, J.G., Boland, P., Ciombor, K.K., Jacobs, N.L., Pasche, B., Cleary, J.M., McCune, J.S., Pedersen, K.S., Barzi, A., Chiorean, E.G., Heying, E.N., Lenz, H.-J., Sloan, J.A., Grothey, A., Lacouture, M.E. and Bekaii-Saab, T. (2021), Preemptive Versus Reactive Topical Clobetasol for Regorafenib-Induced Hand-Foot Reactions: A Preplanned Analysis of the ReDOS Trial. The Oncol, 26: 610-618. (link)
15. Deng YY, Zhang XY, Zhu PF, Lu HR, Liu Q, Pan SY, Chen ZL, Yang L. Comparison of the efficacy and safety of fruquintinib and regorafenib in the treatment of metastatic colorectal cancer: A real-world study. Front Oncol. 2023 Mar 3;13:1097911. (link)
16. Zhang Q, Chen M, Wang Z, Qi C, Cao Y, Zhang J, Peng Z, Wang X, Lu M, Shen L, Li J. Efficacy and Safety Comparison of Regorafenib and Fruquintinib in Metastatic Colorectal Cancer-An Observational Cohort Study in the Real World. Clin Colorectal Cancer. 2022 Sep;21(3):e152-e161. (link)
17. Akihiko Chida et al. Prospective observational study investigating the impact of treatment sequence using regorafenib and FTD/TPI for metastatic colorectal cancer on overall survival (OSERO study).. JCO 42, 103-103(2024). (link)
18. T. Bekaii-Saab, D. Ahn, C. Yuan, X. Jiao, M. Kurtinecz, X. Pan, Z. Vassilev, H. Ostojic. Sequential treatment with regorafenib (REG) and trifluridine/tipiracil (TAS) +/- bevacizumab (Bev) in refractory metastatic colorectal cancer (mCRC) in community clinical practice in the USA.. Annals of Oncology (2023) 34 (suppl_2): S410-S457. 10.1016/S0923-7534(23)01935-X.
19. Matsumoto T, Ikoma T, Yamamura S, Miura K, Tsuduki T, Watanabe T, Nagai H, Takatani M, Yasui H. Regorafenib is suitable for advanced colorectal cancer patients who have previously received trifluridine/tipiracil plus bevacizumab. Sci Rep. 2023 Feb 10;13(1):2433. doi: 10.1038/s41598-023-29706-6. Erratum in: Sci Rep. 2023 Jul 24;13(1):11935. (link)