Phase I Clinical Study of the Dietary Supplement, Agaricus blazei Murill, in Cancer Patients in Remission

Although many cancer patients use complementary and alternative medicine, including Agaricus blazei Murill (ABM), safety is not yet well understood. Cancer survivors took 1.8, 3.6, or 5.4 g ABM granulated powder (Kyowa Wellness Co., Ltd., Tokyo, Japan) per day orally for 6 months. Adverse events were defined by subjective/objective symptoms and laboratory data according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0). Seventy-eight patients were assessed for safety of ABM (30/24/24 subjects at 1/2/3 packs per day, resp.). Adverse events were observed in 9 patients (12%). Most were digestive in nature such as nausea and diarrhea, and one patient developed a liver dysfunction-related food allergy, drug lymphocyte product. However, none of these adverse events occurred in a dose-dependent manner. This study shows that ABM does not cause problems in most patients within laboratory parameters at the dosages tested over 6 months. This trial supports previous evidence that the ABM product is generally safe, excluding possible allergic reaction

The Efficacy of Neoadjuvant Androgen Deprivation Therapy as a Prostate Volume Reduction before Brachytherapy for Clinically Localized Prostate Cancer

From September 2003 to December 2005, 188 patients who visited our hospital and allied institutions for the purpose of prostate brachytherapy were administrated hormonal therapy for volume reductions before brachytherapy. The pretreatment and posttreatment of prostate volume using a transrectal ultrasound volumetric study and the types and duration of hormonal therapy were analyzed. We administered 91 patients with Luteinizing hormone-releasing hormone (LH-RH) agonist, 49 patients with anti-androgen (bicaltamide/flutamide), and 48 patients with maximum androgen blockade (MAB). The duration of the hormonal therapy was 1-3 months for 49 patients, 4-6 months for 59 patients, 7-9 months for 40 patients, 10-12 months for 32 patients, and over 13 months for 8 patients. Before the initiation of hormonal therapy, the mean prostate volume was 35.12 ml (11.04-78.71 ml), and the average of prostate volume before and after hormonal therapy was 36.79 ml and 24.79 ml, respectively (a 32.4% reduction). The prostate volume reduction rate was 32.0% for the LH-RH agonist only, 18.1% for the anti-androgen only and 41.2% for the MAB. No statistically significant difference was observed for the duration of hormonal therapy between 3 groups. A three-month course of the neoadjuvant LH-RH agonist indicated a sufficient volume reduction effectiveness for a large prostate volume.</p

Phase II clinical trial of sorafenib plus interferon-alpha treatment for patients with metastatic renal cell carcinoma in Japan

Comparison of the current study with other sorafenib-interferon combination studies and with single-agent sorafenib studies [25]. (XLSX 12 kb

Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): a randomised, double-blind, phase 3 trial

Few treatments with a distinct mechanism of action are available for patients with platinum-refractory advanced or metastatic urothelial carcinoma. We assessed the efficacy and safety of treatment with docetaxel plus either ramucirumab-a human IgG1 VEGFR-2 antagonist-or placebo in this patient population

ホルモン抵抗性前立腺癌に対するドセタキセル, プレドニゾロン併用療法

Between April 2004 and August 2005, we used docetaxel in combination with prednisolone to treat 14 patients with hormone-refractory prostate cancer (HRPC). Docetaxel was administered at a dose of 70 mg/m2 once every 21 days and oral prednisolone 5 mg was administered twice daily concurrently on days 1-21. The treatment was continued until disease progression or unacceptable adverse events occurred. Prostate specific antigen (PSA) was used as a tumor marker. PSA response was defined as a reduction from baseline of at least 50% that was maintained for 4 weeks. Five patients had measurable soft tissue lesions, which were nodal metastases in 4 and liver metastasis in 1. The median follow-up was 8.4 months. During follow-up, 5 patients died. The median treatment cycle was 7 cycles. Manifestations of hematologic toxicity included 11 patients (78%) with grade 3/4 neutropenia and only I with febrile neutropenia. Two patients with gastric hemorrhage and febrile neutropenia needed hospitalization. During follow-up, 8 patients (57%) achieved a PSA reduction from baseline of at least 50%. Three patients with nodal metastases and 1 patient with liver metastasis had partial response. Combined docetaxel and prednisolone was shown to be effective and feasible in Japanese patients.【目的】ホルモン抵抗性前立腺癌に対しドセタキセル+プレドニゾロン療法を行い, その有用性を検討した。【対象・方法】対象は2004年4月以降に再燃前立腺癌と診断された14例。観察期間は8.4ヵ月, 7コース(5.5コース)施行した。プレドニゾロン(10mg/日)連日投与を併用しドセタキセル70mg/m2を21日毎に点滴投与を繰り返した。全例, 転移巣を有しており, 測定可能病変は4例がリンパ節, 1例は肝臓であった。原則として外来通院治療とした。【結果】14例中8例(57%)で腫瘍マーカーが50%以上減少した。測定可能病変とでは肝臓の1例とリンパ節の2例がPRとなった。鎮痛剤を使用していた7例中4例が減量・中止可能であった。貧血が2例で改善し, 1例で発熱も改善した。血液有害事象では好中球減少ではgrade3/4が11例であった。PDのため4例, 高度の皮膚粘膜病変のため1例が中止し, ステロイドによる出血性胃潰瘍, 帯状疱疹のため1例ずつが休薬となった。発熱性好中球減少のため1例が入院を要した。【結語】好中球減少症を高頻度に認めるが外来治療が可能であり, また抗腫瘍効果, 疼痛の改善においても有用と思われた。(著者抄録

Prospective longitudinal outcomes of quality of life after laparoscopic radical prostatectomy compared with retropubic radical prostatectomy

Abstract Background There have been few reports on health-related quality of life (HRQOL) after laparoscopic radical prostatectomy (LRP) in Japanese patients. The aim of this study is to assess changes in HRQOL during 36 months after LRP compared with retropubic radical prostatectomy (RRP). Methods The subjects were 105 consecutive patients treated with LRP between 2011 and 2012. HRQOL was evaluated using the International Prostate Symptom Score (IPSS), Medical Outcome Study 8-Items Short Form Health Survey (SF-8), and Expanded Prostate Cancer Index Composite (EPIC) at baseline and 1, 3, 6, 12 and 36 months after surgery. These results were compared with data for 107 consecutive patients treated with RRP between 2005 and 2007. The comparison between LRP and RRP was examined at every time point by Mann-Whitney U-test and chi-square test. Multiple linear regression analysis was used to identify independent factors related to the urinary domain in EPIC. Results The IPSS change was similar in both groups. The LRP group had a better SF-8 mental component summary score at baseline and a better SF-8 physical component summary score at 1 month after surgery. In EPIC, urinary function and bother were worse after LRP, but improved at 12 months and did not differ significantly from those after RRP; however, these factors then worsened again at 36 months after LRP. Urinary incontinence was also worse at 36 months after LRP, compared to RRP. In patients treated with nerve-sparing surgery, urinary function and urinary incontinence were similar and good at 12 and 36 months in both groups. Bowel function and bother, and sexual function and bother were similar in both groups and showed no changes from 12 to 36 months. Age and salvage radiotherapy were independent predictors of incontinence (daily use of two or more pads) in multivariate analysis. Surgical procedure was not an independent factor for incontinence, but incontinence defined as use of one pad or more was associated with the surgical procedure. Conclusions Urinary function and bother at 36 months were worse after LRP than after RRP. Age, salvage radiotherapy and surgical procedure were associated with urinary incontinence after 36 months

腎クリーゼを起こした強皮症の1例

発症より10年後腎クリーゼにて急性腎不全を起こした進行性全身性硬化症の1例を経験した.急激な腎機能低下, コントロール不良な高血圧, 大量の消化管出血を認め, 治療開始約1カ月後死亡した.本症例では入院時すでにDICと腎不全が高度であったこと, 消化管出血によりアンギオテンシン変換酵素阻害剤であるenalaprilが経口投与できなかったことが予後不良であった原因と考えられた.剖検時の腎の光顕所見で動脈内膜の肥厚と軽度の腎硬化像が認められた.We report a case of progressive systemic sclerosis with scleroderma renal crisis 10 years after onset. The patient (female) had progressive renal dysfunction, hypertension which was difficult to control, and massive gastrointestinal bleeding. An angiotensin converting enzyme inhibitor (enalapril) could not control her hypertension. Only intravenous nicardipine had a slight effect on her hypertension. Hemodialysis and plasma exchange, did not reverse the renal crisis, and the patient died. Microscopic examination of her kidney showed thickening of the capillary walls and mild nephrosclerosis

Results of second transurethral resection for high-grade T1 bladder cancer

Background: The aim of this study was to examine the histological outcome and potential therapeutic benefit of second transurethral resection (TUR) for high-grade T1 bladder cancer. Patients and Methods: The subjects were 171 patients who underwent initial TUR between January 1993 and December 2013, and were diagnosed with high-grade T1 bladder cancer. Second TUR was performed within 4–6 weeks after the initial resection. Intravesical recurrence, invasive intravesical recurrence, and disease-free, progression-free, and overall survival were examined between second TUR group and no second TUR group. Results: Of the 171 patients, 79 (46.2%) underwent second TUR. Histological findings from second TUR were no cancer in 33 (41.8%), carcinoma in situ in 18 (22.9%), Ta in 15 (19.0%), T1 in 12 (15.2%), and muscle invasive bladder cancer (T2) in 1 case (1.3%). The 5- and 10-year intravesical recurrence-free survival rates were 72.0% and 57.4%, respectively, and the disease-free survival rates at these times were 69.7% and 49.6%, respectively. Second TUR had no influence on intravesical recurrence, regardless of the use of Bacillus Calmette–Guerin (BCG) therapy. No BCG therapy and recurrent cancer were significantly associated with intravesical recurrence in multivariate analysis. Recurrent cancer was also a significant risk factor for invasive intravesical recurrence. BCG therapy significantly improved disease-free survival. Second TUR was a significant factor in overall survival. In the histological results for second TUR, no cancer and Tis cases had reduced intravesical recurrence compared to Ta and T1 cases. Conclusion: Second TUR allows more accurate staging and pT0 cases in second TUR have a better outcome, indicating a possible therapeutic benefit of the procedure