Assessment of Efficacy, Safety, and Quality of Life of 124 Patients Treated With Axitinib as Second-Line Therapy for Metastatic Renal-Cell Carcinoma: Experience in Real-World Clinical Practice in Japan.

PURPOSE: To comprehensively analyze the efficacy of axitinib for metastatic renal-cell carcinoma (mRCC) patients. PATIENTS AND METHODS: This study included 124 consecutive Japanese patients treated with axitinib as second-line systemic therapy for mRCC in a routine clinical setting. RESULTS: In addition to 4 indeterminate patients (3.2%), 0 (0%), 21 (16.9%), 87 (70.2%), and 12 (9.7%) were judged to show complete response, partial response, stable disease, and progressive disease, respectively, as the best responses to axitinib. The median progression-free survival (PFS) and overall survival (OS) after initiating treatment with axitinib were 9.3 and 27.0 months, respectively. Multivariate analyses of several parameters identified the following independent predictors of PFS and OS: Memorial Sloan Kettering Cancer Center (MSKCC) classification and C-reactive protein level for PFS; and MSKCC classification, C-reactive protein level, bone metastasis, and liver metastasis for OS. Common grade 3 or higher adverse events associated with axitinib were hypertension in 41 (33.1%), proteinuria in 14 (11.3%), and hand-foot syndrome in 14 (11.3%). Quality-of-life analysis using the Medical Outcomes Study 36-Item Short Form showed that 2 scores were significantly improved 12 weeks after the administration of axitinib, while there were no significant differences in the remaining 6 scores between surveys administered before and 12 weeks after the treatment with axitinib. CONCLUSION: Favorable disease control could be achieved with acceptable tolerability by introducing axitinib as second-line systemic therapy, resulting in improvement of the prognosis and quality of life of Japanese patients with mRCC.

Assessment of health-related quality of life in Japanese patients with metastatic renal cell carcinoma during treatment with tyrosine kinase inhibitors.

The objective of this study was to comprehensively analyze the health-related quality of life (HRQOL) in Japanese patients with metastatic renal cell carcinoma (mRCC) during treatment with tyrosine kinase inhibitors (TKIs). This study included 240 Japanese mRCC patients treated with TKIs. We conducted a total of 305 surveys assessing the HRQOL before and 3 months after the introduction of TKIs, including 150, 95 and 60 during treatment with sorafenib, sunitinib and axitinib, respectively, using the Medical Outcomes Study 36-Item Short Form, consisting of eight multi-item scales measuring the health status. There were no significant differences in any of the eight scale scores between these 305 surveys conducted before and 3 months after TKI treatment. Two scores in the surveys during axitinib treatment were significantly superior to those during sorafenib treatment; however, no significant differences were noted in any of the remaining scale scores among the surveys during treatment with the three TKIs. Multivariate analyses, which were performed to evaluate the contribution of several factors to each scale score, revealed that the therapeutic efficacy had independent impacts on two scale scores, despite the lack of an independent association between any scores and the remaining factors, including the age, gender, introduced TKI, timing of TKI introduction and degree of adverse events. Collectively, these findings suggest that treatment with TKIs did not result in a significant impairment of the HRQOL in Japanese patients with mRCC; however, patients with unfavorable disease control appeared to fail to achieve a satisfactory HRQOL during treatment with TKIs.

Assessment of efficacy, safety and quality of life of 110 patients treated with sunitinib as first-line therapy for metastatic renal cell carcinoma: experience in real-world clinical practice in Japan.

The objective of this study was to comprehensively evaluate the clinical outcomes of 110 consecutive Japanese patients who received at least two cycles of sunitinib as first-line therapy for metastatic renal cell carcinoma (mRCC) in a routine clinical setting. Initially, 50 mg of sunitinib was administered once daily on a 4 weeks on, followed by 2 weeks off dosing schedule; however, dose modification was required in 102 patients, and the relative dose intensity was 62.6 % throughout this series. As the best responses to sunitinib, 2, 28, 65 and 15 were judged to show a complete response, partial response, stable disease and progressive disease, respectively. The median progression-free survival (PFS) and overall survival (OS) following the treatment with sunitinib were 7.8 and 33.2 months, respectively. Multivariate analyses of several factors identified the following independent predictors of PFS and OS: Memorial Sloan Kettering Cancer Center (MSKCC) classification and C-reactive protein (CRP) level for PFS and liver metastasis, MSKCC classification and CRP level for OS. The common adverse events related to sunitinib corresponding to ≥grade 3 were thrombocytopenia in 59, leukopenia in 23, fatigue in 22, hand-foot syndrome in 15 and hypertension in 12. Quality of life (QOL) analysis using 36-Item Short Form revealed no significant differences in any scale scores between surveys performed before and 3 months after the treatment with sunitinib. Collectively, these findings suggest that the introduction of sunitinib as a first-line agent can lead to favorable disease control with acceptable tolerability, resulting in improvement in the prognosis and QOL of Japanese patients with mRCC.

Assessment of efficacy, safety and quality of life of 55 patients with metastatic renal cell carcinoma treated with temsirolimus: a single-center experience in Japan.

BACKGROUND: To evaluate experience of the use of temsirolimus for metastatic renal cell carcinoma (mRCC) in a single center in Japan. METHODS: This study included 55 consecutive patients with mRCC who received temsirolimus in a routine clinical setting, and retrospectively reviewed the comprehensive outcomes of these patients. RESULTS: Of the 55 patients, 20 had a Karnofsky performance status of ≤80, and 5, 41 and 9 were classified into favorable, intermediate and poor risk groups, respectively, according to the Memorial Sloan-Kettering Cancer Center model. Initially, 25 mg of temsirolimus was applied weekly; however, dose modification was required in 19 patients, resulting in a relative dose intensity of 90.5 % throughout this series. As the best responses to temsirolimus, 4, 44 and 7 were judged to have a partial response, stable disease and progressive disease, respectively. The median progression-free survival (PFS) and overall survival (OS) of these patients following the introduction of temsirolimus was 7.0 and 25.0 months, respectively. Of several factors examined, only the pretreatment C-reactive protein level was shown to be independently associated with both PFS and OS. The common adverse events related to temsirolimus corresponding to ≥grade 3 were anemia in 4, thrombocytopenia in 3, stomatitis in 3 and hyperglycemia in 3. Quality of life analysis using 36-Item Short Form showed that there were no significant differences in any scale scores between surveys performed before and 3 months after the introduction of temsirolimus. CONCLUSIONS: Temsirolimus was well tolerated and facilitated comparatively favorable cancer control in Japanese patients with mRCC.

Assessment of postoperative quality of life: comparative study between laparoscopic and minimum incision endoscopic radical prostatectomies.

BACKGROUND: To investigate the changes in postoperative quality of life (QOL) in patients with prostate cancer who underwent laparoscopic radical prostatectomy (LRP) or minimum incision endoscopic radical prostatectomy (MIE-RP). METHODS: This study included a total of 115 Japanese patients with clinically localized prostate cancer who underwent either LRP or MIE-RP and were subsequently followed for more than 12 months. Before and 12 months after surgery, health-related QOL and disease-specific QOL were assessed using the Medical Outcomes Study 8-item Short-Form Health Survey (SF-8) and the Expanded Prostate Index Composite (EPIC), respectively. RESULTS: LRP and MIE-RP were performed in 57 and 58 patients, respectively, and there were no significant differences in major clinicopathological parameters between these two groups. There were no significant differences in perioperative outcomes between the two groups except for the estimated blood loss, which was lower in the LRP group. There were no significant differences between the two groups in the preoperative and postoperative all-scale scores of the SF-8 survey. Of the fourteen scores evaluated by the EPIC survey, postoperative scores for urinary summary, sexual summary, urinary function, urinary incontinence and sexual function were significantly worse than these preoperative scores in both LRP and MIE-RP groups, while there were no significant differences between the two groups in the preoperative and postoperative all-scale scores of the EPIC survey. CONCLUSIONS: The postoperative QOL status in patients undergoing MIE-RP appeared to be equivalent to that in those undergoing LRP.