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Real-world dosing of regorafenib and outcomes among patients with metastatic colorectal cancer: A retrospective analysis using US claims data
Background
Regorafenib is an oral multikinase inhibitor approved for advanced mCRC, advanced gastrointestinal stromal tumors, and advanced hepatocellular carcinoma. The phase 2 regorafenib dose-optimization study (ReDOS; Bekaii-Saab TS, et al., 2019) demonstrated that patients could initiate regorafenib at a dose of 80 mg/day and then subsequently escalate their dose depending on tolerability without compromising efficacy. In March 2018, the ReDOS strategy was included as a recommendation in US cancer guidelines. We conducted a retrospective analysis using a US claims database to assess whether inclusion of the regorafenib dose-escalation strategy in US cancer guidelines influenced the use of flexible dosing in the US.
Methods
This was a retrospective analysis of patients with metastatic colorectal cancer (mCRC) in the Optum Clinformatics claims database who initiated regorafenib between January 1, 2016, and June 30, 2020. Patients were stratified based on whether they initiated regorafenib before or after the inclusion of the dose-escalation strategy in US cancer guidelines (March 31, 2018) and the number of regorafenib tablets taken in their first 28-day treatment cycle (< 84 tablets or ≥84 tablets hereby defined as flexible dose or standard dose group, respectively). The proportion of patients who received the flexible dose, the proportion of patients who received standard dose in their first treatment cycle, the proportion of patients who initiated the third cycle of regorafenib, and the mean number of treatment cycles were analyzed.
Results
A total of 703 patients initiated regorafenib during the study period, of whom 310 (44%) initiated regorafenib prior to, and 393 (56%) initiated regorafenib after, the inclusion of the dose-escalation strategy in US guidelines. After the inclusion of the dose-escalation strategy in US guidelines, the proportion of patients who received the dose-escalation strategy increased from 21% (n=66/310) to 45% (n=178/393), the proportion of patients who received standard dose in their first treatment cycle decreased from 79% (n=244/310) to 55% (n=215/393), the proportion of patients who initiated the third cycle of regorafenib increased from 36% (n=113/310) to 46% (n=179/393), and the mean number of treatment cycles increased from 2.64 (standard deviation [SD] 2.93) to 3.20 (SD 3.11).
Conclusions
An increased uptake of the flexible dosing strategy (24%) was observed after inclusion of ReDOS in US cancer guidelines. Similarly, both the proportion of patients who reached the third cycle of treatment and mean number of treatment cycles increased by 10% and 21%, respectively. These results suggest that clinicians may have adopted a flexible dosing strategy in their clinical practice, which may improve tolerability and duration of regorafenib treatment.
Clinical trial identification
NCT02368886.
Legal entity responsible for the study
Bayer.
Funding
Bayer.
Disclosures
T. Bekaii-Saab: Honoraria (self): Royalties: Uptodate; Advisory / Consultancy: Consulting (to institution): Ipsen, Arcus, Pfizer, Seattle Genetics, Bayer, Genentech, Incyte, Eisai and Merck. , Consulting (to self): Stemline, AbbVie, Boehringer Ingelheim, Janssen, Daichii Sankyo, Natera, TreosBio, Celularity, Exact Science, Sobi, Beigene, Kanaph, Astra Zeneca, Deciphera, MJH Life Sciences, Aptitude Health, Illumina and Foundation Medicine, IDMC/DSMB: Fibrogen, Suzhou Kintor, Astra Zeneca, Exelixis, Merck/Eisai, PanCan and 1Globe. ; Research grant / Funding (institution): Agios, Arys, Arcus, Atreca, Boston Biomedical, Bayer, Eisai, Celgene, Lilly, Ipsen, Clovis, Seattle Genetics, Genentech, Novartis, Mirati, Merus, Abgenomics, Incyte, Pfizer, BMS.; Licensing / Royalties: WO/2018/183488: HUMAN PD1 PEPTIDE VACCINES AND USES THEREOF – Licensed to Imugene, WO/2019/055687: METHODS AND COMPOSITIONS FOR THE TREATMENT OF CANCER CACHEXIA – Licensed to Recursion. N. Khan: Full / Part-time employment: Bayer. H. Ostojic: Full / Part-time employment: Bayer Pharmaceuticals. X. Jiao: Full / Part-time employment: Bayer. G. Chen: Full / Part-time employment: Bayer. W. Lin: Full / Part-time employment: Bayer Healthcare. A. Bruno: Full / Part-time employment: Bayer.
