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.
Publisher Copyright:
© 2020 Informa UK Limited, trading as Taylor & Francis Group.
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 -