TY - JOUR
T1 - Real-world use of sorafenib for advanced renal cell carcinoma patients with cardiovascular disease
T2 - nationwide survey in Japan
AU - Inamoto, Teruo
AU - Azuma, Haruhito
AU - Tatsugami, Katsunori
AU - Oya, Mototsugu
AU - Adachi, Masatoshi
AU - Okayama, Yutaka
AU - Sunaya, Toshiyuki
AU - Akaza, Hideyuki
N1 - Funding Information:
Professional medical writing/editorial support, under the guidance of the authors, was provided by DP Figgitt, Content Ed Net, with funding from Bayer Yakuhin Ltd, Japan.
Funding Information:
T Inamoto, H Azuma, K Tatsugami and M Oya received honoraria from Bayer Yakuhin, Ltd. M Adachi, Y Okayama and T Suyana are employees of Bayer Yakuhin, Ltd. H Akaza belongs to the endowed laboratory funded by Yakult Honsha, ONO Pharmaceutical and Takeda Pharmaceutical. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
PY - 2020/7/2
Y1 - 2020/7/2
N2 - Objectives: To assess whether the clinical outcome of advanced/metastatic renal cell carcinoma (mRCC) treated with sorafenib, in real-world conditions, differs in patients with cardiovascular disease (CVD). Methods: mRCC patients (n = 2256 before matching) were matched by propensity score into CVD (n = 560) and non-CVD groups (n = 560), followed by safety and effectiveness analyzes. Results: After matching, patients’ features used for matching were balanced between the CVD and non-CVD groups, except for age (p = 0.0049). Renal comorbidity occurred more frequently in the CVD group. Exposure to sorafenib and objective response rate (25.4% [CVD], 28.5% [non-CVD]) were comparable in both groups. Median progression-free survival (PFS; 7.1 months, 95% CI: 6.4–8.6 [CVD]; 6.7 months, 6.3–8.3 [non-CVD]), and hazard ratios for PFS (0.954, 0.821–1.108) and overall survival (0.889, 0.683–1.156), were similar in the matched population. The incidences of adverse drug reactions (ADR, ≥10%) were generally similar between groups, although hypertension (42.1% vs 34.5%), diarrhea (26.3% vs 19.6%), decreased appetite (11.3% vs 7.5%), and non-serious and serious renal failure/dysfunction (3.6% vs 1.4% and 1.8% vs 0.4%), occurred more frequently in the CVD group. Conclusion: This analyzes suggests that sorafenib has clinical benefit for mRCC patients regardless of baseline CVD. Serious ADRs increased for renal dysfunction. Clinical trial registration: www.clinicaltrials.gov identifier is NCT01411423.
AB - Objectives: To assess whether the clinical outcome of advanced/metastatic renal cell carcinoma (mRCC) treated with sorafenib, in real-world conditions, differs in patients with cardiovascular disease (CVD). Methods: mRCC patients (n = 2256 before matching) were matched by propensity score into CVD (n = 560) and non-CVD groups (n = 560), followed by safety and effectiveness analyzes. Results: After matching, patients’ features used for matching were balanced between the CVD and non-CVD groups, except for age (p = 0.0049). Renal comorbidity occurred more frequently in the CVD group. Exposure to sorafenib and objective response rate (25.4% [CVD], 28.5% [non-CVD]) were comparable in both groups. Median progression-free survival (PFS; 7.1 months, 95% CI: 6.4–8.6 [CVD]; 6.7 months, 6.3–8.3 [non-CVD]), and hazard ratios for PFS (0.954, 0.821–1.108) and overall survival (0.889, 0.683–1.156), were similar in the matched population. The incidences of adverse drug reactions (ADR, ≥10%) were generally similar between groups, although hypertension (42.1% vs 34.5%), diarrhea (26.3% vs 19.6%), decreased appetite (11.3% vs 7.5%), and non-serious and serious renal failure/dysfunction (3.6% vs 1.4% and 1.8% vs 0.4%), occurred more frequently in the CVD group. Conclusion: This analyzes suggests that sorafenib has clinical benefit for mRCC patients regardless of baseline CVD. Serious ADRs increased for renal dysfunction. Clinical trial registration: www.clinicaltrials.gov identifier is NCT01411423.
KW - Cardiovascular disease
KW - prognosis
KW - renal cell carcinoma
KW - sorafenib
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U2 - 10.1080/14737140.2020.1773805
DO - 10.1080/14737140.2020.1773805
M3 - Article
C2 - 32441582
AN - SCOPUS:85086948148
VL - 20
SP - 615
EP - 623
JO - Expert Review of Anticancer Therapy
JF - Expert Review of Anticancer Therapy
SN - 1473-7140
IS - 7
ER -