Adverse Event Profile and Dose Modification of Everolimus for Advanced Renal Cell Carcinoma in Real-world Japanese Clinical Practice

被引：19

作者：

Nozawa, Masahiro ^{[1
]}

Nonomura, Norio ^{[2
]}

Ueda, Takeshi ^{[3
,4
]}

Nishimura, Kazuo ^{[5
]}

Kanayama, Hiro-Omi ^{[6
]}

Miki, Tsuneharu ^{[7
]}

Nakatani, Tatsuya ^{[8
]}

Tomita, Yoshihiko ^{[9
]}

Azuma, Haruhito ^{[10
]}

Yoshioka, Toshiaki ^{[11
]}

Tsujihata, Masao ^{[12
]}

Uemura, Hirotsugu ^{[1
]}

机构：

[1] Kinki Univ, Fac Med, Dept Urol, Osaka 5898511, Japan

[2] Osaka Univ, Grad Sch Med, Dept Urol, Suita, Osaka, Japan

[3] Chiba Canc Ctr, Prostate Ctr, Chiba 2608717, Japan

[4] Chiba Canc Ctr, Div Urol, Chiba 2608717, Japan

[5] Osaka Med Ctr Canc & Cardiovasc Dis, Dept Urol, Osaka, Japan

[6] Univ Tokushima, Grad Sch, Inst Hlth Biosci, Dept Urol, Tokushima 770, Japan

[7] Kyoto Prefectural Univ Med, Dept Urol, Kyoto, Japan

[8] Osaka City Univ, Grad Sch Med, Dept Urol, Osaka 558, Japan

[9] Yamagata Univ, Fac Med, Dept Urol, Yamagata 990, Japan

[10] Osaka Med Coll, Dept Urol, Takatsuki, Osaka 569, Japan

[11] Sumitomo Hosp, Dept Urol, Osaka, Japan

[12] Osaka Rosai Hosp, Dept Urol, Sakai, Osaka, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2013年 / 43卷 / 11期

关键词：

renal cell carcinoma; everolimus; adverse event; dose modification; dose reduction; PHASE-III TRIAL; LUNG-CANCER; ETHNIC-DIFFERENCES; SUBGROUP ANALYSIS; SUNITINIB; EFFICACY; TOXICITY; OUTCOMES; SURVIVAL; SAFETY;

D O I：

10.1093/jjco/hyt121

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Objective: The aim of the study was to assess the safety and efficacy of everolimus therapy for advanced renal cell carcinoma in Japanese patients receiving real-world care. Methods: Patients who had been treated with everolimus for advanced renal cell carcinoma at 39 Japanese medical centers between January 2010 and November 2011 were retrospectively investigated to assess adverse events and the time to treatment failure. Results: A total of 180 patients were identified. Their median age was 65 years (range 23-93). The median time to treatment failure was 2.9 months (95% confidence interval 2.4-3.4). The median time to treatment failure was significantly longer in patients with dose modification (4.2 months; 95% confidence interval 3.4-5.0) than in patients without dose modification (1.7 months; 95% confidence interval 1.0-2.3; P < 0.01) after experiencing adverse events. Stomatitis (44%) was the most frequent adverse event, followed by thrombocytopenia (31%), anemia (22%), interstitial pneumonia (22%) and hyperglycemia (17%). Interstitial pneumonia was the most frequent cause of discontinuation in patients who discontinued everolimus due to intolerability regardless of the dose modification status. None of the patients with dose modification of everolimus discontinued everolimus due to thrombocytopenia or leukopenia. Conclusions: The adverse event profile of everolimus may differ between Japanese and Caucasian patients. Dose modification of everolimus might be associated with longer treatment duration in patients with advanced renal cell carcinoma. Further studies are required to clarify this association. Interstitial pneumonia may be difficult to overcome by dose modification.

引用

页码：1132 / 1138

页数：7

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