Tomokazu Sazuka

Combination of Gemcitabine and Paclitaxel as Second-line Chemotherapy for Advanced Urothelial Carcinoma

OBJECTIVE The aim of this study was to evaluate the efficacy and toxicities of the gemcitabine and paclitaxel combination regimen as second-line chemotherapy for patients with advanced or metastatic urothelial carcinoma (UC) who have previously been treated with platinum-based chemotherapy for the metastatic disease. METHODS Thirty-three patients with advanced or metastatic UC who had received platinum-based chemotherapy were treated with an outpatient gemcitabine and paclitaxel combination regimen. A dose of 180 mg/m(2) paclitaxel was administered by intravenous (IV) infusion on Day 1, and 1000 mg/m(2) gemcitabine was administered by IV on Days 1, 8 and 15.The course was repeated every 28 days. Patients were evaluated after every 2 cycles of therapy using computed tomography. RESULTS Of the 33 patients enrolled in this study, 30 could be evaluated to determine treatment efficacy; 10 had an objective response [overall response rate: 33.3%, 95% confidence interval (CI), 19.2-51.2%]. The median overall survival was 11.3 months (95% CI, 7.2-13.6 months). The chemotherapy sensitivity differed with disease site. The response rates of lung and bone metastases were 27% and 14%, and the progressive disease (PD) rates of lung and bone metastases were 13% and 14%, respectively. On the other hand, the response rate of liver metastasis was 14%, and its PD rate was 57%. None of the patients (n = 3) with adrenal metastasis responded to this regimen. Toxicities were mild, and no life-threatening complications occurred. CONCLUSIONS Gemcitabine and paclitaxel combination therapy is a tolerable and active regimen for patients with advanced UC after failure of platinum-based chemotherapy.

Treatment outcomes of sorafenib for first line or cytokinerefractory advanced renal cell carcinoma in Japanese patients

The objective of the present study was to document the treatment efficacy and safety of sorafenib in Japanese patients with advanced renal cell carcinoma (RCC). A retrospective analysis of 50 consecutive patients with metastatic RCC between January 2005 and December 2009 was carried out. Patients received sorafenib after failed cytokine therapy or first‐line sorafenib treatment. All received 400 mg of sorafenib orally twice daily. Five of 14 patients with bone metastases were also given bisphosphonates. Tumor response was evaluated every 1–2 months according to the Response Evaluation Criteria in Solid Tumors. Adverse events (AE) were evaluated at each visit during and after treatment, and were recorded according to the National Cancer Institutes Common Terminology Criteria for Adverse Events version 3.0. Dose modification of sorafenib was permitted if grade 3 or 4 AE occurred. Treatment continued until disease progression or treatment intolerance occurred. Partial response, and stable disease as best objective responses were observed in 11 (22%) and 23 (46%) patients, respectively. Median progression‐free survival was 7.3 months and median overall survival was 11.9 months. All patients experienced AE and one or more grade 3/4 AE occurred in 43 of 50 (86%) patients. Although it requires close monitoring, sorafenib treatment seemed to be effective in the present study population.

Development of a nomogram for predicting the stone-free rate after transurethral ureterolithotripsy using semi-rigid ureteroscope.

To develop and to internally validate a novel nomogram for predicting the stone‐free rate after transurethral ureterolithotripsy.

Validation of active surveillance criteria for pathologically insignificant prostate cancer in Asian men.

To validate the ability of contemporary active surveillance protocols to predict pathologically insignificant prostate cancer among Asian men undergoing radical prostatectomy.

Analysis of Preoperative Detection for Apex Prostate Cancer by Transrectal Biopsy

Background. The aim of this study was to determine concordance rates for prostatectomy specimens and transrectal needle biopsy samples in various areas of the prostate in order to assess diagnostic accuracy of the transrectal biopsy approach, especially for presurgical detection of cancer in the prostatic apex. Materials and Methods. From 2006 to 2011, 158 patients whose radical prostatectomy specimens had been evaluated were retrospectively enrolled in this study. Concordance rates for histopathology results of prostatectomy specimens and needle biopsy samples were evaluated in 8 prostatic sections (apex, middle, base, and transitional zones bilaterally) from 73 patients diagnosed at this institution, besides factors for detecting apex cancer in total 118 true positive and false negative apex cancers. Results. Prostate cancer was found most frequently (85%) in the apex of all patients. Of 584 histopathology sections, 153 (49%) from all areas were false negatives, as were 45% of apex biopsy samples. No readily available preoperative factors for detecting apex cancer were identified. Conclusions. In Japanese patients, the most frequent location of prostate cancer is in the apex. There is a high false negative rate for transrectal biopsy samples. To improve the detection rate, transperitoneal biopsy or more accurate imaging technology is needed.

Prognostic models for renal cell carcinoma recurrence: External validation in a Japanese population

The aim of the present study was to compare the accuracy of three prognostic models in predicting recurrence‐free survival among Japanese patients who underwent nephrectomy for non‐metastatic renal cell carcinoma (RCC). Patients originated from two centers: Chiba University Hospital (n = 152) and Chiba Cancer Center (n = 65). The following data were collected: age, sex, clinical presentation, Eastern Cooperative Oncology Group performance status, surgical technique, 1997 tumor–node–metastasis stage, clinical and pathological tumor size, histological subtype, disease recurrence, and progression. Three western models, including Yaycioglus model, Cindolos model and Kattans nomogram, were used to predict recurrence‐free survival. Predictive accuracy of these models were validated by using Harrells concordance‐index. Concordance‐indexes were 0.795 and 0.745 for Kattans nomogram, 0.700 and 0.634 for Yaycioglus model, and 0.700 and 0.634 for Cindolos model, respectively. Furthermore, the constructed calibration plots of Kattans nomogram overestimated the predicted probability of recurrence‐free survival after 5 years compared with the actual probability. Our findings suggest that despite working better than other predictive tools, Kattans nomogram needs be used with caution when applied to Japanese patients who have undergone nephrectomy for non‐metastatic RCC.

External Validation of a Pre-operative Prognostic Nomogram for Renal Cell Carcinoma in Two Patient Populations: A Retrospective Cohort Study

The aim of this study was to establish the discriminating accuracy of Kanaos pre-operative nomogram for renal cell carcinoma in predicting cause-specific survival among representative patients who underwent nephrectomy. Patients originated from two centers: Chiba University Hospital (n= 151) and Chiba Cancer Center (n = 91). We validated the predictive accuracy, which was assessed using Harrells concordance-index. The concordance-index values were 0.692 and 0.834 for Chiba University Hospital and Chiba Cancer Center, respectively, although it was 0.822 for the combined data sets. Results of external validation were different at each cohort. We constructed calibration plots of Kanaos nomogram and confirmed the tendency at each institution. Inconsistency of results among two centers makes it difficult to reach a valid conclusion. Therefore, the predictive accuracy of Kanaos nomogram was not settled. Clinicians need to confirm the predictive accuracy of Kanaos nomogram and construct calibration plots when applying this nomogram to different patient populations.

Interferon treatment for Japanese patients with favorable-risk metastatic renal cell carcinoma in the era of targeted therapy

Purpose Single-agent interferon (IFN) is no longer regarded as a standard option for first-line systemic treatment of metastatic renal cell carcinoma (RCC) in Western countries. However, some patients with favorable-risk RCC may still achieve complete and long-lasting remission in response to IFN treatment. The present study compared favorable-risk Japanese patients with metastatic RCC Japanese patients who had been treated with IFN or tyrosine kinase inhibitor (TKI) therapy as a first-line systemic therapy. Materials and Methods From 1995 to 2014, a total of 48 patients with favorable risk as defined by the Memorial Sloan Kettering Cancer Center criteria who did not receive adjuvant systemic therapy were retrospectively enrolled in this study. We assessed the tumor response rate, progression-free survival (PFS), and overall survival (OS). Results The objective response rate for first-line therapy was 29% in the IFN group and 47% in the TKI group, but this difference did not reach the level of statistical significance. Median OS for IFN and TKI was 71 and 47 months, respectively (p=0.014). Median first-line PFS for IFN and TKI was 20 and 16 months, respectively (no significant difference). First-line IFN therapy did not prove inferior to TKI therapy in terms of OS according to metastatic sites. Conclusions IFN is associated with a survival benefit in Japanese patients with favorable-risk metastatic RCC in the era of targeted therapy. Further prospective study is needed.

Contralateral adrenal width predicts the duration of prolonged post‐surgical steroid replacement for subclinical Cushing syndrome

To identify pre‐treatment factors affecting the duration of post‐surgical steroid replacement in patients undergoing adrenalectomy for subclinical Cushing syndrome.

MP78-05 INTRAVESICAL IRRIGATION PREVENTS BLADDER CARCINOMA RECURRENCE AFTER NEPHROURETERECTOMY

Shinichi Yamashita*, Akihiro Ito, Koji Mitsuzuka, Masataka Aizawa, Naomasa Ioritani, Sendai, Japan; Shigeto Ishidoya, Sendai, Japan; Yoshihiro Ikeda, Osaki, Japan; Kenji Numahata, Yamagata, Japan; Kazuhiko Orikasa, Kesennuma, Japan; Tatsuo Tochigi, Natori, Japan; Fumihiko Soma, Hachinohe, Japan; Takashige Namima, Hideo Saito, Sendai, Japan; Makoto Sato, Rifu, Japan; Shinnosuke Katoh, Yuzawa, Japan; Shozo Ota, Sendai, Japan; Atsushi Kyan, Shirakawa, Japan; Atsushi Takeda, Ichinoseki, Japan; Yasuhiro Kaiho, Yoichi Arai, Sendai, Japan