One-month relative dose intensity of not less than 50% predicts favourable progression-free survival in sorafenib therapy for advanced renal cell carcinoma in Japanese patients

Kawashima, Atsunari; Takayama, Hitoshi; Arai, Yasuyuki; Tanigawa, Go; Nin, Mikio; Kajikawa, Jiro; Imazu, Tetsuo; Kinoshita, Tatsuya; Yasunaga, Yutaka; Inoue, Hitoshi; Nishimura, Kenji; Takada, Shingo; Nishimura, Kazuo; Tsujimura, Akira; Nonomura, Norio

doi:10.1016/j.ejca.2011.04.001

Cited by 29 publications

(24 citation statements)

References 14 publications

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“…The median PFS time was 9.0 months and disease control, defined as radiologically confirmed complete response, partial response or stable disease of more than 3 months was achieved in 59.9% of the patients in our study. Median PFS time in our study was longer than that of TARGET, although it was almost the same as that of other reports of Japanese patients (7,9) and those of Asian ethnicity (8). One of the possible reasons for the difference in treatment outcome is the difference in ethnicity.…”

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confidence: 44%

“…We previously found that 1M-RDI of not ,50% and favorable risk according to MSKCC factors were the prognostic factors for predicting favorable PFS but not overall survival in first-line therapy-refractory RCC patients (9). In overall metastatic RCC patients treated with sorafenib, our univariate and multivariate analysis results revealed that favorable prognosis according to MSKCC prognostic factors and a 1M-RDI of !50% were significant factors for predicting superior PFS with sorafenib treatment.…”

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confidence: 57%

“…The actual dose intensity (ADI) was defined as the cumulative dose received actually divided by the duration of the study therapy in weeks. Relative dose intensity (RDI) was defined as ADI divided by the dose prescribed for the duration of the study therapy (800 mg Â the number of days the patient received treatment) (9).…”

Section: Methodsmentioning

confidence: 99%

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Clinical Outcome and Prognostic Factors of Sorafenib in Japanese Patients with Advanced Renal Cell Carcinoma in General Clinical Practice

Tanigawa

Kawashima

Yamaguchi

et al. 2011

Japanese Journal of Clinical Oncology

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Objective: Effects of sorafenib in general clinical practice, especially those with patients of Asian ethnicity, have been rarely investigated. We assessed efficacy, safety and prognostic factors for progression-free survival in Japanese patients receiving sorafenib for advanced renal cell carcinoma. Methods: We performed a retrospective analysis of 159 Japanese patients with renal cell carcinoma. Progression-free survival was estimated by the Kaplan -Meier method. Objective response (per Response Evaluation Criteria in Solid Tumors) and safety were assessed. Cox proportional hazards model was used to identify independent prognostic factors for progression-free survival. Results: The median progression-free survival was 9.0 months (95% confidence interval, 7.5 -10.6 months). In 142 patients with measurable lesions, the objective response rate was 21.8%, and disease control was achieved in 85 (59.9%) patients. Adverse events of any grade occurred in 152 patients (95.6%). Most common adverse events causing discontinuation or interruption of sorafenib were hand-foot skin reaction (22%), rash (10.7%) and liver dysfunction (10.7%). Dose reduction or therapy interruption due to adverse events was required in 128 patients (80.5%). Univariate and multivariate analysis revealed that favorable prognosis according to Memorial Sloan-Kettering Cancer Center prognostic factors and relative dose intensity during the first month of treatment of !50% were significant factors for predicting superior progression-free survival with sorafenib treatment. Conclusions: Sorafenib was effective in Japanese patients with advanced renal cell carcinoma in general clinical practice and was tolerated although most patients required dose reduction or interruption of therapy. Future studies should establish new strategies for treatment without sacrificing both efficacy and patient quality of life.

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confidence: 44%

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confidence: 57%

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Clinical Outcome and Prognostic Factors of Sorafenib in Japanese Patients with Advanced Renal Cell Carcinoma in General Clinical Practice

Tanigawa

Kawashima

Yamaguchi

et al. 2011

Japanese Journal of Clinical Oncology

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“…A higher dose may be more effective as elevated concentrations result in greater inhibition of alternative target pathways as observed in RCC xenografts (20). It was also reported that a first one-month relative dose intensity (RDI) of not less than 50% predicted favorable PFS in sorafenib therapy for advanced RCC in Japanese patients (21). Considering these factors, when the initial dose was required to be reduced due to severe toxicities, we modified the daily dose from 800 mg to 600 mg instead of 400 mg, which had been widely recommended in the TARGET study and other follow-up studies.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of sorafenib in advanced renal cell carcinoma patients: Results from a long-term study

Yang

Shi

et al. 2012

Oncol Lett

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“…Although Kawashima and colleagues 28 suggested that 1M-RDI of ≥75% for the targeting agent was preferable for Asian patients, there is no evidence. In the present study, we could not determine the suitable initial dose of targeting agents.…”

Section: Prognostic Factors For Mrcc In Targeted Therapymentioning

confidence: 99%

Prognostic factors for overall survival with targeted therapy in Chinese patients with metastatic renal cell carcinoma

Zhao¹,

Huang²,

Sun³

et al. 2014

CUAJ

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Introduction: We wanted to identify the prognostic factors for overall survival (OS) in Chinese patients with metastatic renal cell carcinoma (mRCC) treated with first-line targeted therapy (sorafenib or sunitinib). Methods: We retrospectively reviewed clinical data from 119 mRCC patients administered sorafenib or sunitinib at the Ruijin Hospital since 2007. OS rates were calculated by the Kaplan-Meier method. Each variable was investigated univariately and then multivariately using a stepwise algorithm. A multivariate Cox regression model analyzed baseline variables for prognostic significance. Results: The mean patient age was 57 ± 12 years; 37 patients (31%) received sorafenib and 82 (69%) received sunitinib. The mean OS was 22.7 ± 15.6 months (range: 2.8-68.7). OS rates at year 1, 3 and 5 were 74%, 57%, and 36%, respectively. Univariate analysis identified significant negative prognostic factors (p < 0.05) as Eastern Cooperative Oncology Group (ECOG) performance status ≥2, symptoms, no prior nephrectomy, microscopic necrosis, ≥2 metastatic sites, presence of liver, bone, or pancreas metastasis, hemoglobin less than the lower limit of normal(female <115 g/L, male <130 g/L), and serum alkaline phosphatase greater than the upper limit of normal (126 IU/L) at baseline, as well as a relative dose intensity of targeting agents in the first month (1M-RDI) of <50%. Multivariate analysis of OS identified 4 independent predictors: no symptoms, no bone or pancreas metastasis, and 1M-RDI of targeting agents (≥50%). Conclusions: With targeted therapy, there is some change in the prognostic factors for mRCC and target drug therapies (1M-RDI ≥50%) play an important role in the prognosis of mRCC. Continued progress in the identification of patient-specific prognostic factors for mRCC will require further advances in the understanding of tumour biology.

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One-month relative dose intensity of not less than 50% predicts favourable progression-free survival in sorafenib therapy for advanced renal cell carcinoma in Japanese patients

Cited by 29 publications

References 14 publications

Clinical Outcome and Prognostic Factors of Sorafenib in Japanese Patients with Advanced Renal Cell Carcinoma in General Clinical Practice

Clinical Outcome and Prognostic Factors of Sorafenib in Japanese Patients with Advanced Renal Cell Carcinoma in General Clinical Practice

Efficacy and safety of sorafenib in advanced renal cell carcinoma patients: Results from a long-term study

Prognostic factors for overall survival with targeted therapy in Chinese patients with metastatic renal cell carcinoma

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