This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
Research Article
Masahiro Hatori
Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-10-6 Ariake, Koto-ku, Tokyo 135-8550, Japan
Corresponding Author
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: The association between regorafenib dosage in the treatment of metastatic colorectal cancer and efficacy is currently not well established. It was previously reported that the regorafenib dose as prescribed is associated with efficacy, but doses in actual clinical settings have not been analyzed. This study was to examine the association between the clinical significance of the cumulative dose of regorafenib in the early cycles and treatment efficacy in patients with metastatic colorectal cancer.
Methods: We retrospectively analyzed patients with metastatic colorectal cancer who had received regorafenib as third-line or later chemotherapy between May 2013 and June 2018. Patients who were not treated in the Pharmaceutical Outpatient Clinic for compliance assessment were excluded. Overall survival was calculated using the Kaplan-Meier method. Prognostic factors, including baseline demographics and adverse events, were evaluated using Cox proportional hazard models.
Results: A total of 176 patients were enrolled. By multivariate analysis, total dose until the second cycle <3180 mg (HR 1.71, 95% CI, 1.20-2.44, P = 0.003), age <65 years (HR 1.96, 95% CI, 1.36-2.86, P <0.001), PS 2 (HR 1.81, 95% CI, 1.28-2.57, P = 0.001), hepatic metastasis (HR 2.86, 95% CI, 1.90-4.30, P <0.001), and regorafenib initial dose ≤120 mg (HR 1.71, 95% CI, 1.14-2.58, P = 0.01) were independent negative predictors of overall survival. Median survival times of the lower dose group (<3180 mg) and higher dose group (≥3180 mg) were 5.8 and 7.6 months, respectively (P = 0.045).
Conclusion: The cumulative dose of regorafenib until the second cycle in patients with metastatic colorectal cancer was associated with survival. It is important to individualize regorafenib dose in metastatic colorectal cancer patients.
Keywords
Regorafenib, Cumulative dose, Real-world, Prognostic factor
Figure 1
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
Loading...
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Version 1
Posted 10 Dec, 2020
No community comments so far
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Cancer Biology
Learn more about our company.
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Research Article
Masahiro Hatori
Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-10-6 Ariake, Koto-ku, Tokyo 135-8550, Japan
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Version 1
Posted 10 Dec, 2020
No community comments so far
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Cancer Biology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: The association between regorafenib dosage in the treatment of metastatic colorectal cancer and efficacy is currently not well established. It was previously reported that the regorafenib dose as prescribed is associated with efficacy, but doses in actual clinical settings have not been analyzed. This study was to examine the association between the clinical significance of the cumulative dose of regorafenib in the early cycles and treatment efficacy in patients with metastatic colorectal cancer.
Methods: We retrospectively analyzed patients with metastatic colorectal cancer who had received regorafenib as third-line or later chemotherapy between May 2013 and June 2018. Patients who were not treated in the Pharmaceutical Outpatient Clinic for compliance assessment were excluded. Overall survival was calculated using the Kaplan-Meier method. Prognostic factors, including baseline demographics and adverse events, were evaluated using Cox proportional hazard models.
Results: A total of 176 patients were enrolled. By multivariate analysis, total dose until the second cycle <3180 mg (HR 1.71, 95% CI, 1.20-2.44, P = 0.003), age <65 years (HR 1.96, 95% CI, 1.36-2.86, P <0.001), PS 2 (HR 1.81, 95% CI, 1.28-2.57, P = 0.001), hepatic metastasis (HR 2.86, 95% CI, 1.90-4.30, P <0.001), and regorafenib initial dose ≤120 mg (HR 1.71, 95% CI, 1.14-2.58, P = 0.01) were independent negative predictors of overall survival. Median survival times of the lower dose group (<3180 mg) and higher dose group (≥3180 mg) were 5.8 and 7.6 months, respectively (P = 0.045).
Conclusion: The cumulative dose of regorafenib until the second cycle in patients with metastatic colorectal cancer was associated with survival. It is important to individualize regorafenib dose in metastatic colorectal cancer patients.
Figure 1
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
Loading...