A large-scale prospective registration study of the safety and efficacy of sorafenib tosylate in unresectable or metastatic renal cell carcinoma in Japan: results of over 3200 consecutive cases in post-marketing all-patient surveillance

Akaza, Hideyuki; Oya, Mototsugu; Iijima, Masafumi; Hyodo, Ichinosuke; Gemma, Akihiko; Itoh, Hiroshi; Adachi, Masatoshi; Okayama, Yutaka; Sunaya, Toshiyuki; Inuyama, Lyo

doi:10.1093/jjco/hyv099

Cited by 27 publications

(21 citation statements)

References 40 publications

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“…Hypertension of any grade according to CTCAE was reported with an incidence ranging from 17% to 49.6% in the reviewed randomized controlled trials (Table 2) [5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22]. …”

Section: Discussionmentioning

confidence: 99%

Influence of Tyrosine Kinase Inhibitors on Hypertension and Nephrotoxicity in Metastatic Renal Cell Cancer Patients

Semeniuk-Wojtaś

Lubas

Stec

et al. 2016

IJMS

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Renal cell carcinoma (RCC) is one of the most common kidney malignancies. An upgraded comprehension of the molecular biology implicated in the development of cancer has stimulated an increase in research and development of innovative antitumor therapies. The aim of the study was to analyze the medical literature for hypertension and renal toxicities as the adverse events of the vascular endothelial growth factor (VEGF) signaling pathway inhibitor (anti-VEGF) therapy. Relevant studies were identified in PubMed and ClinicalTrials.gov databases. Eligible studies were phase III and IV prospective clinical trials, meta-analyses and retrospective studies that had described events of hypertension or nephrotoxicity for patients who received anti-VEGF therapy. A total of 48 studies were included in the systematic review. The incidence of any grade hypertension ranged from 17% to 49.6%. Proteinuria and increased creatinine levels were ascertained in 8% to 73% and 5% to 65.6% of patients, respectively. These adverse events are most often mild in severity but may sometimes lead to treatment discontinuation. Nephrotoxicity and hypertension are related to multiple mechanisms; however, one of the main disturbances in those patients is VEGF inhibition. There is a significant risk of developing hypertension and renal dysfunction among patients receiving anti-VEGF treatment; however, there is also some evidence that these side effects may be used as biomarkers of response to antiangiogenic agents.

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Section: Discussionmentioning

confidence: 99%

Influence of Tyrosine Kinase Inhibitors on Hypertension and Nephrotoxicity in Metastatic Renal Cell Cancer Patients

Semeniuk-Wojtaś

Lubas

Stec

et al. 2016

IJMS

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“…However, the higher incidence of alopecia (17.8%) distinguishes sorafenib from other agents. Although rash was reported in 25% of the patients in the initial interim report, its incidence was reduced to 14% in the latest report, a reduction of more than 10% . The reduction might be as a result of reduced RDI in clinical settings, and by optimally administering reduced dosages and applying off‐periods as strategic modalities for managing AE, all of which were made possible by accumulating past clinical experiences.…”

Section: Management Of Pharmacotherapies In Clinical Practicementioning

confidence: 99%

“…According to the clinical algorithm by the Japanese Urological Association, which was revised in October 2011, cytokine therapy (IFN‐α therapy against pulmonary metastasis) is recommended as first‐line therapy, and there is no description on axitinib (Table ). The fact that axitinib became available after its publication can account for the absence of axitinib, and it definitely needs to be updated promptly . IFN‐α has shown limited efficacy against pulmonary metastases, and has prolonged survival when combined with low‐dose IL‐2; however, other than having empirical evidence, there have been no controlled trials comparing it with targeted agents.…”

Section: Treatment Guidelines and Algorithmsmentioning

confidence: 99%

Pharmacotherapies for renal cell carcinoma in Japan

Yoshimura

Uemura

2015

Int J of Urology

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Abbreviations & Acronyms AE = adverse event ESMO = European Society for Medical Oncology FGFR = fibroblast growth factor receptor FLT-3 = Fms-like tyrosine kinase-3 HFS = hand-foot syndrome HR = hazard ratio IFN = interferon IL-2 = interleukin-2 ILD = interstitial lung disease mTOR = mammalian target of rapamycin NCCN = National Comprehensive Cancer Network ORR = objective response rate OS = overall survival PD = progressive disease PDGFR = platelet-derived growth factor receptor PFS = progression free survival RCC = renal cell carcinoma RCT = randomized controlled trial RDI = relative dose intensity TKI = tyrosine kinase inhibitor VEGF = vascular endothelial growth factor VEGFR = vascular endothelial growth factor receptor Abstract: The standard treatment for advanced renal cell carcinoma has changed dramatically in the past decade, from cytokine therapy to targeted therapy. Since sorafenib was approved in April 2008, four tyrosine kinase inhibitors and two mammalian target of rapamycin inhibitors have become available in Japan. Most Japanese renal cell carcinoma patients are treated by urologists who are involved in not only kidney surgeries, but also targeted therapy using tyrosine kinase inhibitors, as well as mammalian target of rapamycin inhibitors. Optimal treatment methods are selected from theoretically-based global recommendations, such as the National Comprehensive Cancer Network and European Society for Medical Oncology guidelines; however, realworld clinical practice might be different from that in non-Asian countries. This might be because of different practical conditions; for example, different adverse events and efficacy profiles, different healthcare system, and so on. In the present review, we examine current pharmacotherapy for renal cell carcinoma from evidence-based global data, and compare the reality of Japanese clinical practice to explore the importance of individualized patient therapy.

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“…In order to establish the position of these drugs in the clinical world in the future it will be necessary to engage in an accurate evaluation of the benefit/risk and cost/ effectiveness balance. With regard to sorafenib, sunitinib, everolimus and temsirolimus, which are the four drugs that have been newly approved for the treatment of renal cell carcinoma in Japan, the approval of these drugs was made contingent on the implementation of a survey of all cases of use after their market release, which has resulted in valuable clinical data on multiple cases being reported (13)(14)(15).…”

Section: Renal Cell Carcinomamentioning

confidence: 99%

Urologic cancer in Japan: role of Japan at the frontier of issues in Asia

Akaza

2015

Jpn. J. Clin. Oncol.

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The characteristics of urological cancer in Japan can be summarized in the following points. (i) As the onset of this type of cancer is typically seen in elderly patients, it is becoming a major social issue in Japan that has already become an aging society. (ii) Many diverse treatment methods are available and a response is required that prioritizes quality of life. (iii) Although vigorous research and development efforts into new drugs are being carried out on a global level, resulting in beneficial medical agents becoming more readily available, unless concepts relating to cost vs. effectiveness are further developed and there is a real risk that medical systems and structures in their current form will become unsustainable. (iv) Although at the current point there are no original large-scale clinical trials being conducted in Asia, Japan has a wealth of experience of participating in many international joint clinical trials and it is therefore an urgent and pressing challenge to organize joint clinical trials in Asia and amass a body of knowledge that is unique to Asia. In view of this current situation and given Japan's position at the frontier of issues, it is important for Japan to take the initiative in Asia in cooperating with other Asian nations in efforts to resolve and overcome various challenges.

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A large-scale prospective registration study of the safety and efficacy of sorafenib tosylate in unresectable or metastatic renal cell carcinoma in Japan: results of over 3200 consecutive cases in post-marketing all-patient surveillance

Cited by 27 publications

References 40 publications

Influence of Tyrosine Kinase Inhibitors on Hypertension and Nephrotoxicity in Metastatic Renal Cell Cancer Patients

Influence of Tyrosine Kinase Inhibitors on Hypertension and Nephrotoxicity in Metastatic Renal Cell Cancer Patients

Pharmacotherapies for renal cell carcinoma in Japan

Urologic cancer in Japan: role of Japan at the frontier of issues in Asia

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