精巣・前立腺

MRI-TRUS融合画像ガイド下前立腺生検の病理組織学的所見の臨床的予測因子に関する検討

演　　者：: 小路直¹，平岩真一郎², 花田いずみ¹, 小川貴博¹, 中野まゆら¹, 座光寺秀典¹, 長谷部光泉³, 田尻琢磨², 宮嶋哲⁴
所属機関：: ¹東海大学・八王子病院・泌尿器科, ²東海大学・八王子病院・病理診断科, ³東海大学・八王子病院・画像診断科, ⁴東海大学・泌尿器科

Objective: We evaluated predictive factors of significant cancer detection and pathological findings of target biopsy cores taken with MRI-TRUS elastic fusion image-guided prostate biopsy.
Methods: We prospectively recruited 500 patients with serum PSA level ≦ 20 ng/ml and multi-parametric MRI scans suggestive of prostate cancer. They each underwent MRI-TRUS fusion image-guided transperineal target prostate biopsies for each suspicious lesion with three-dimensional pre-biopsy needle simulation system and mechanical position-encoded stepper needle tracking (BioJet^® system, D&K Technologies GmbH, Barum, Germany). We analyzed predictive factors for significant cancer detection and pathological findings of target biopsy cores.
Results: The significant cancer detection rate was 49% for patients. In multivariate analysis, PSA density ≧ 0.23ng/ml/cm³ (risk ratio: 3.256, P=0.005), BMI ≧ 24kg/m² (risk ratio: 3.878, P <0.0001) and Prostate Imaging Reporting and Data System (PI-RADS) classification > 4 (risk ratio: 9.874, P <0.0001) were predictors of detecting significant cancer. By adding the factors of PSA density and BMI to the patients' selection, the significant cancer detection rates were significantly improved. In the analysis of the predictive factors for pathological findings of target biopsy cores, the PI-RADS classifications in Peripheral Zone (PZ) were related to WHO Gleason grades in target biopsy cores (r=0.418, p<0.0001). Maximum diameter of target lesion in apex-base axis on sagittal fusion image were related to cancer core lengths (r=0.876, P <0.0001) and biopsy core percentages of cancer (r=0.715, P <0.0001).
Conclusions: PSA density, BMI, and PI-RADS classification are potential predictors of significant prostate cancer detection in the patients. PI-RADS classification in PZ, and apex-base axis diameter on fusion image could be predictors of pathological findings in target biopsy cores.

高-超高リスク限局性前立腺癌に対する強度変調放射線治療の長期成績

演　　者：: 相澤理人¹，高山賢二¹, 中村清直¹, 井上貴博², 山崎俊成², 小林恭², 赤松秀輔², 小川修², 溝脇尚志¹
所属機関：: ¹京都大学・放射線腫瘍学・画像応用治療学, ²京都大学・泌尿器科

Background:
To evaluate long-term clinical outcomes of intensity-modulated radiation therapy (IMRT) combined with neoadjuvant (NA) hormonal therapy (HT) in Japanese patients with high- and very high-risk non-metastatic prostate cancer (NMPC).
Methods:
We retrospectively analyzed the data of 336 patients with high- and very high-risk NMPC consecutively treated with IMRT combined with NA-HT. Of these patients, 233 and 103 patients were categorized into the high- and very high-risk groups, respectively, according to the NCCN risk classification version 2.2017. NA-HT was basically administered for 6 months. In principle, 78 Gy in 2 Gy per-fraction were delivered to the prostate and seminal vesicles. Adjuvant HT (A-HT) was not administered for any patient following the completion of IMRT. Salvage HT (S-HT) commenced when prostate-specific antigen (PSA) values exceeded 4 ng/mL.
Results:
The median follow-up period was 110.0 months, and the median duration of NA-HT was 6.6 months. In the high-risk group, the 10-year overall survival, prostate cancer-specific survival, clinical failure-free survival, and biochemical failure-free survival rates were 82.3%, 97.6%, 73.9%, and 60.1%, respectively. In the very high-risk group, those were 83.0%, 92.1%, 65.3%, and 42.2%, respectively. The estimated 10-year cumulative incidence rates of late gastrointestinal and genitourinary (grades 2-3) toxicity were 7.1% and 26.0%, respectively. No grade 4 or higher toxicity was observed.
Conclusions:
High-dose IMRT, combined with NA-HT and without A-HT under the early S-HT policy, achieved excellent survival outcomes with acceptable morbidities for a Japanese cohort with high- and very high-risk NMPC. This approach could be a viable alternative to the uniform provision of long-term A-HT because more than the half of the patients maintained biochemical failure-free status long-term after IMRT. Prospective trials are warranted to validate the findings of this study.

根治的前立腺全摘術後生化学的再発に対する救済放射線治療後二次再発の定義比較解析

演　　者：: 三宅牧人¹，田中宣道¹, 浅川勇雄², 中井靖¹, 井上剛志¹, 穴井智¹, 長谷川正俊², 藤井智美³, 小西登⁴, 藤本清秀¹
所属機関：: ¹奈良県立医科大学・泌尿器科, ²奈良県立医科大学・放射線治療科, ³奈良県立医科大学・病院病理部, ⁴高井病院・病理部

Background: Clinical management and follow-up strategy of recurrent prostate cancer after salvage radiotherapy has not been refined yet, especially in the definition of biochemical recurrence after radiotherapy. Two trials evaluating the potential benefit of this combination were recently published, RTOG 9601 and GETUG-AFU 16 trials. We compared the difference among the application of three different definitions to evaluate the impact of definitions on biochemical recurrence following salvage radiotherapy.
Methods: Data from 120 patients who had undergone salvage radiation monotherapy for biochemical recurrent disease after radical prostatectomy were reviewed. In all patients, salvage radiotherapy consisted of irradiation (70Gy/35fr) to the prostatic bed using three-dimensional conformal radiotherapy techniques. Treatment outcome including biochemical recurrence-free survival and prognostic factors was analyzed and compared among our Nara definition, RTOG 9601 definition, and GETUG-AFU 16 definition.
Results: The biochemical recurrence rate differed significantly among the applied definitions. Multivariate analyses revealed that both RTOG 9601 and GETUG -AFU 16 definitions found same four independent prognostic factors, whereas Nara definition found only two out of four factors. Although RTOG and GETUG definition showed similar results, prognostic values of four factors differed between two definitions. According to the RTOG 9601 definition of biochemical recurrence, negative resection margin on prostatectomy specimens and short PSA doubling time before salvage radiotherapy were associated with no response in prostate-specific antigen level.
Conclusions: The applied definition of biochemical recurrence after salvage radiotherapy can dramatically influence the reporting BCR-free rate and the potential prognostic factors. Our findings would raise a number of questions regarding decision-making for optimal treatment.

去勢抵抗性前立腺がんに対する20種混合ペプチドワクチンの有効性の検討

演　　者：: 野口正典¹，新井学², 頴川晋³, 大山力⁴, 内藤誠二⁵, 松本和将⁶, 植村天受⁷, 中川昌之⁸, 那須保友⁹, 江藤正俊¹⁰, 末金茂高¹¹, 笹田哲朗¹², 山田亮¹³, 角間辰之¹⁴, 伊東恭悟¹
所属機関：: ¹:久留米大学・がんワクチンセンター, ²:獨協医科大学埼玉医療センター・泌尿器科, ³:東京慈恵会医科大学・泌尿器科, ⁴:弘前大学・泌尿器科, ⁵:原三信病院,6:北里大学・泌尿器科, ⁷:近畿大学・泌尿器科, ⁸:鹿児島大学・泌尿器科, ⁹:岡山大学・泌尿器科, ¹⁰九州大学・泌尿器科, ¹¹久留米大学・泌尿器科, ¹²神奈川県立がんセンター, ¹³久留米大学・先端癌治療研究センター・がんワクチン, ¹⁴久留米大学・バイオ統計センター

Purpose: A novel cancer vaccine consisting of 20 mixed peptides (KRM-20) was designed to induce cytotoxic T lymphocytes (CTL) against twelve different tumor-associated antigens. The aim of this phase 2 trial was to examine whether KRM-20 in combination with docetaxel and dexamethasone enhances anti-tumor effects in patients with castration-resistant prostate cancer (CRPC).
Methods: In this double-blind, placebo-controlled, randomized, phase 2 study, we enrolled chemotherapy-naïve patients with progressive CRPC from 10 medical centers in Japan. Eligible patients were randomly assigned 1:1 centrally to either KRM-20 combined with docetaxel and dexamethasone or placebo with docetaxel and dexamethasone. Patients initially received 5 weekly subcutaneous KRM-20 (20 mg) or placebo injections with daily oral dexamethasone (1 mg) following 5 courses of docetaxel (70 mg/m²every 3 weeks). The primary endpoint was to compare each treatment for prostate-specific antigen (PSA) decline.
Results: Mean % PSA levels from baseline in the KRM-20 (n = 25) significantly decreased during the treatment compared with those in the placebo (n = 26) (P = 0.028, MANOVA). Human leukocyte antigen matched peptide-specific immunoglobulin G (P = 0.018) and CTL (P = 0.007) responses in the KRM-20 significantly increased after the treatment. The appearance of myeloid-derived suppressor cells in the KRM-20 significantly decreased after the treatment (P = 0.007). The addition of KRM-20 did not result in increased toxicity. There was no between-group differences in progression-free or overall survival.
Conclusions: Although these findings suggest potential immunological enhances for the combined use of KRM-20 with docetaxel and dexamethasone in patients with CRPC, there was no clinical benefits.

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