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Objective To evaluate the efficacy and safety of enzalutamide plus androgen deprivation therapy in Japanese men with metastatic hormone-sensitive prostate cancer. Methods A post-hoc analysis of the Japanese subgroup in the phase III, randomized, multinational ARCHES study (NCT02677896) was carried out. Patients with metastatic hormone-sensitive prostate cancer were randomized to receive enzalutamide or a placebo, plus androgen deprivation therapy, stratified by disease volume and prior docetaxel therapy. The primary end-point was radiographic progression-free survival. Secondary end-points included time to prostate-specific antigen progression and overall survival. Results Of 1150 patients, 92 Japanese patients were randomized to enzalutamide (n = 36) or a placebo (n = 56), plus androgen deprivation therapy; none received prior docetaxel. Enzalutamide plus androgen deprivation therapy reduced the risk of radiographic progression or death in Japanese patients by 61% versus the placebo, similar to the overall population. Similar results were observed with secondary end-points, showing clinical benefit of enzalutamide plus androgen deprivation therapy in Japanese patients. Overall survival data were immature. Grade 3-4 adverse events were reported in 47% and 25% of the enzalutamide and placebo groups, respectively. Nasopharyngitis, hypertension and abnormal hepatic function were reported more frequently in Japanese patients versus the overall population. Conclusions Enzalutamide plus androgen deprivation therapy has clinical benefit with a tolerable safety profile in Japanese men with metastatic hormone-sensitive prostate cancer, consistent with the overall population.

TPS782 Background: GN is a first-line treatment option for patients (pts) with mPC. Poor prognosis and low 5-year survival rate ( < 5%) with mPC highlight the need for new therapeutics. Claudin 18.2 (CLDN18.2), a tight junction protein expressed exclusively on normal gastric epithelial cells, is maintained during malignant transformation in gastric cancers and is frequently expressed in some carcinomas from organs that do not normally express it, such as pancreatic cancer. Zolbetuximab, a chimeric IgG1 monoclonal antibody, binds to CLDN18.2 and mediates tumor cell death through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. This phase 2 study (NCT03816163) will assess safety and efficacy of GN alone or with zolbetuximab in CLDN18.2-positive mPC. Methods: The study was expanded to enroll approximately 369 pts with histologically confirmed mPC and high CLDN18.2 expression (moderate-to-strong IHC staining intensity in ≥75% of tumor cells). The study included a safety lead-in that enrolled 3-12 pts to assess safety/tolerability of zolbetuximab (n = 3 at 1,000 mg/m2 on Cycle 1 Day 1 then 600 mg/m2 Q2W, then expand/de-escalate using a 3+3 design) plus GN. Dose-limiting toxicities (DLTs, defined as a specified zolbetuximab-related toxicity that occurs during DLT assessment period) will be assessed after Cycle 1 (28 days). Based on the recommended phase 2 dose (RP2D), confirmed during the safety lead-in, approximately 357 pts will be randomized 2:1 to zolbetuximab Q2W on Days 1 and 15 plus GN on Days 1, 8, and 15 of each cycle (Arm 1), or GN alone on Days 1, 8, and 15 of each cycle (Arm 2). Randomization will be stratified by ECOG performance status (0 or 1) and liver metastasis (yes or no). At sites in Japan, DLTs (assessed from Cycle 1 Day 1 to Cycle 2 Day 1) will be evaluated in ≤6 pts randomized to the RP2D in Arm 1. Pts will undergo imaging (CT/MRI) at baseline and Q8W until investigator-assessed disease progression (RECIST v1.1) or the start of another systemic anticancer treatment, whichever comes earlier. In addition to confirming the RP2D during the safety lead-in, primary objectives are to assess whether treatment with zolbetuximab plus GN, versus GN alone, improves overall survival (randomization phase) and to establish the safety/tolerability profile of zolbetuximab plus GN (across the study). Secondary endpoints include progression-free survival, objective response rate, disease control rate, duration of response, pharmacokinetics, and health-related quality of life (per protocol amendment). Descriptive statistics will be used for continuous endpoints and frequency and percentage for categorical endpoints. Original protocol enrollment completion was in October 2021. Under the expanded protocol amendment, 95 of ~140 sites in North America, Latin America, Europe, and Asia Pacific were activated. Clinical trial information: NCT03816163 .

TPS4186 Background: GN is a first-line treatment option for patients (pts) with mPC. Poor prognosis and low 5-year survival rate ( < 5%) of pts with mPC highlight the need for new therapeutics. Claudin 18.2 (CLDN18.2), a tight junction protein expressed exclusively on normal gastric epithelial cells, is maintained during malignant transformation in gastric cancers and is frequently expressed in some carcinomas from organs that do not normally express it, such as pancreatic cancer. Zolbetuximab, a chimeric IgG1 monoclonal antibody, binds to CLDN18.2 and mediates tumor cell death through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. Methods: This phase 2 study (NCT03816163), expanded to enroll approximately 369 pts, will assess safety and efficacy of GN alone or with zolbetuximab in pts with histologically confirmed mPC and high CLDN18.2 expression (moderate-to-strong IHC staining intensity in ≥75% of tumor cells). The study included a safety lead-in that enrolled 3-12 pts to assess safety/tolerability of zolbetuximab (n = 3 at 1,000 mg/m2 on Cycle 1 Day 1 then 600 mg/m2 Q2W, then expand/de-escalate using a 3+3 design) plus GN. Dose-limiting toxicities (DLTs, defined as a specified zolbetuximab-related toxicity that occurs during DLT assessment period) will be assessed after Cycle 1 (28 days). Based on the recommended phase 2 dose (RP2D), confirmed during the safety lead-in, approximately 357 pts will be randomized 2:1 to zolbetuximab Q2W on Days 1 and 15 plus GN on Days 1, 8, and 15 of each cycle (Arm 1), or GN alone on Days 1, 8, and 15 of each cycle (Arm 2). Randomization will be stratified by ECOG performance status (0 or 1) and liver metastasis (yes or no). At sites in Japan, DLTs (assessed from Cycle 1 Day 1 to Cycle 2 Day 1) will be evaluated in ≤6 pts randomized to the RP2D in Arm 1. Pts will undergo imaging (CT/MRI) at baseline and every 8 weeks until investigator-assessed disease progression (RECIST v1.1) or the start of another systemic anticancer treatment, whichever comes earlier. In addition to confirming the RP2D during the safety lead-in, primary objectives are to assess whether treatment with zolbetuximab plus GN, versus GN alone, improves overall survival (randomization phase) and to establish the safety/tolerability profile of zolbetuximab plus GN (across the study). Secondary endpoints include progression-free survival, objective response rate, disease control rate, duration of response, pharmacokinetics, and health-related quality of life (per protocol amendment). Data will be presented using descriptive statistics for continuous endpoints and frequency and percentage for categorical endpoints. At original protocol enrollment completion (October 2021), 84 sites were actively recruiting; sites are currently reopening for screening/enrollment pending protocol amendment approval. Clinical trial information: NCT03816163.

INTRODUCTION AND OBJECTIVES:Potent androgen receptor inhibitor enzalutamide (ENZA) provides benefit in men with castration-resistant prostate cancer (CRPC). ARCHES, a multinational, double-blind, p...

ASP5878 is a selective small-molecule inhibitor of fibroblast growth factor receptors (FGFRs). This study investigated safety, tolerability, and antitumor effect of single and multiple oral doses of ASP5878 in patients with solid tumors. This phase 1, open label, first-in-human study comprised dose-escalation and dose-expansion parts. Primary objectives of the dose-escalation part were to identify the dose-limiting toxicity (DLT), maximum tolerated dose, and recommended dose of ASP5878 for the dose-expansion part. Nine dose cohorts of ASP5878 were evaluated (0.5─2 mg once daily; 2─40 mg twice daily [BID]). A single dose of ASP5878 was followed by a 2-day pharmacokinetic collection, and then either 28-day cycles of daily dosing (ASP5878 ≤ 10 mg BID) or 5-day dosing/2-day interruption (ASP5878 ≥ 20 mg BID). The primary objective of the dose-expansion part was to determine the safety of ASP5878 (16 mg BID) administered in 28-day cycles of 5-day dosing/2-day interruption in patients with urothelial carcinoma, hepatocellular carcinoma, or squamous cell lung carcinoma with FGFR genetic alterations. Safety was assessed by monitoring adverse events (AEs). Thirty-five patients were enrolled and 31 discontinued in the dose-escalation part; 51 patients were enrolled and 51 discontinued in the dose-expansion part. In the dose-escalation part, 66.7% of patients in the 20 mg BID 5-day dosing/2-day interruption group reported DLTs of hyperphosphatemia. The recommended dose for the dose-expansion part was 16 mg BID. Common AEs included retinal detachment, diarrhea, and increased alanine aminotransferase. One death occurred that was not related to ASP5878. ASP5878 was well tolerated with manageable toxicities including hyperphosphatemia.

TPS4667 Background: Combinations of folinic acid, fluorouracil (5-FU), irinotecan, and oxaliplatin (FOLFIRINOX) along with GN are standard first-line treatment options for mPC. Despite treatment advances, mPC has a poor prognosis with a 5-year survival rate of < 5%, emphasizing an urgent need for new targeted therapeutics. Claudin 18.2 (CLDN18.2) is a tight junction protein restricted to normal gastric mucosa cells; however, in the context of malignant transformation, CLDN18.2 is frequently expressed in carcinomas derived from organs that do not normally express it, such as pancreatic adenocarcinoma (50-70% express CLDN18.2). Zolbetuximab is a chimeric IgG1 monoclonal antibody that specifically binds to CLDN18.2, designed to mediate cancer cell death through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. Methods: This phase 2 study (NCT03816163) with a safety lead-in phase will assess safety and antitumor activity of zolbetuximab plus GN in patients (pts) with histologically confirmed mPC with high CLDN18.2 expression (≥75% of tumor cells demonstrate moderate-to-strong IHC staining). The safety lead-in will assess safety/tolerability of zolbetuximab (n = 3 at 1,000 mg/m2 on Cycle 1 Day 1 then 600 mg/m2 Q2W then expand/de-escalate using a 3+3 design) plus GN and confirm the recommended phase 2 dose (RP2D). Dose-limiting toxicities (DLTs), defined as a specified toxicity that occurs during the DLT assessment period and is related to zolbetuximab, will be assessed after Cycle 1 (28 days). After determining the RP2D, approximately 129 pts will be randomly assigned 2:1 to receive either zolbetuximab RP2D Q2W on Days 1 and 15 plus GN on Days 1, 8, and 15 of each cycle ( Arm 1), or GN alone on Days 1, 8, and 15 of each cycle ( Arm 2). Randomization will be stratified by ECOG performance status (0 or 1) and liver metastasis (yes or no). Imaging (CT/MRI) will be performed at baseline and every 8 weeks until investigator-assessed disease progression (per RECIST v1.1 criteria) or the start of other systemic anticancer treatment, whichever comes earlier. Primary objectives are to confirm RP2D (safety lead-in), to assess antitumor activity measured by overall survival (randomization phase), and to establish the safety/tolerability profile of zolbetuximab plus GN across the study. Key secondary endpoints in the randomization phase are progression-free survival and objective response rate. As of January 2020, this study is recruiting pts at 74 centers. Clinical trial information: NCT03816163 .

Objectifs L’enzalutamide (ENZA) apporte un benefice aux hommes atteints d’un cancer de la prostate resistant a la castration (CPRC). ARCHES, etude de phase III en double aveugle versus placebo (PBO), evalue l’efficacite d’ENZA associe a une suppression androgenique (TSA) dans le cancer de la prostate hormono-sensible metastatique (CPHSm). Les resultats rapportes ici portent sur le PSA, marqueur important du cancer de la prostate. Methodes Les patients (pts) CPHSm etaient randomises en deux groupes (1 :1) : ENZA + TSA ou PBO + TSA, stratifies selon le volume tumoral et la prise de docetaxel anterieure. Un TSA sans progression radiologique ou augmentation du PSA etait autorise jusqu’a trois mois avant j1 (≤ 6 mois si docetaxel prealable). Le critere principal etait la survie sans progression radiologique (rPFS) [lecture centralisee]. Les analyses pre-specifiees incluaient la rPFS globale et selon le PSA initial, le delai de progression biologique, le delai de resistance a la castration, le taux de PSA indetectable et la reponse du PSA. Le traitement etait continue jusqu’a progression ou toxicite non acceptable. Resultats Au total, 1150 pts furent randomises (ENZA + TSA, n = 574 ; PBO + TSA, n = 576). Les caracteristiques initiales etaient homogenes entre les groupes ; 91 % avaient recu un TSA anterieur. Le taux median de PSA etait 5,21 ng/mL ; le suivi median etait 14,4 mois. L’association ENZA + TSA a significativement ameliore la rPFS, quel que soit le PSA initial. L’association ENZA + TSA a significativement ameliore le delai de progression du PSA et le delai de resistance a la castration. Les proportions de pts avec un PSA indetectable ou une reponse du PSA ≥ 50 % ou ≥ 90 % pendant l’etude etaient plus importantes avec l’association ENZA + TSA. Des evenements indesirables ont ete rapportes chez 85,1 % sous ENZA + TSA vs 85,9 % sous PBO + TSA, sans survenue d’evenement indesirable inattendu ( Tableau 1 ). Conclusion ENZA + TSA a significativement ameliore la rPFS vs PBO + TSA au stade du CPHSm independamment du PSA initial, suggerant l’interet predictif limite du PSA initial chez ces patients dont la plupart avaient recu un TSA anterieur. ENZA + TSA a significativement ameliore les criteres dependants du PSA. L’analyse de tolerance est coherente avec le profil connu de ENZA issu des precedentes etudes.

A 55-year-old man who presented himself with gross hematuria and right back pain was found to have a right renal mass with evidence of metastasis to the lymph nodes, bone and lung (cT1bN1M1). He underwent a transperitoneal right nephrectomy. Tumor expressed markers of CD10, P504S and CK19 immunohistochemically, so histopathological examination revealed tubulocystic carcinoma of the right kidney (pT3a). After the patient received sunitinib therapy, computed tomography revealed reduction in the size of the metastatic lung nodule and lymph nodes, indicating a partial response. He is alive without disease progression at 12 months after nephrectomy. Tubulocystic carcinoma has been referred to by Amin et al as low-grade collecting duct carcinoma and is not yet included in the World Health Organization (WHO) 2004 classification of renal tumors. The cells lining the tumor range from cuboidal to columnar and have large nuclei with low-grade changes and abundant eosinophilic or amphophilic cytoplasm. Hobnail cells are commonly seen. Immunohistochemically, tubulocystic carcinomas are strongly positive for markers of the proximal nephron (CD10, P504S) and the distal nephron (parvalbumin, CK19). Despite a low nuclear grade, tubulocystic carcinomas occasionally show progressive behavior clinically. Although there is no established salvage therapy, sunitinib was found to be effective for this patient.

A non-randomized confirmatory trial was started in Japan to evaluate the efficacy of modified radical hysterectomy in patients with tumor diameter 2 cm or less FIGO Stage IB1 uterine cervical cancer, for which the current standard is radical hysterectomy. This study began in January 2013 and a total of 240 patients will be accrued from 37 institutions within 3 years. The primary endpoint is 5-year survival. The secondary endpoints are overall survival, relapse-free survival, local relapse-free survival, percent completion of modified radical hysterectomy, percent local relapse, percent pathological parametrial involvement, days until self-urination and residual urine disappearance, blood loss, operation time, percent post-operative radiation therapy, adverse events and severe adverse events. This trial was registered at the UMIN Clinical Trials Registry as UMIN 000009726 (http://www.umin.ac.jp/ctr/).

A Phase III clinical trial has been started in Japan to determine the optimal treatment strategy for patients with high-grade pT1 bladder cancer who have pT0 histology after second trans- urethral resection. The aim of this trial is to demonstrate the non-inferiority of relapse-free sur- vival (excluding Tis or Ta intravesical recurrence) for watchful waiting compared with intravesical bacillus Calmette-Guerin therapy for pT0 after second transurethral resection. Patients with high-grade pT1 bladder cancer at the first registration and pT0 after second transurethral resection at the second registration are randomized to either a watchful waiting arm or an intravesical bacillus Calmette-Guerin therapy arm. A total of 575 patients at the first registration and 260 patients at the second registration will be accrued for this study from 38 institutions over 5 years. The primary endpoint is relapse-free survival (excluding Tis or Ta intravesical recurrence), and the secondary endpoints are overall survival, metastasis-free survival with bladder preserved, annual proportion of intravesical relapse-free survival, annual proportion of T2 or deeper relapse-free survival, adverse events and serious adverse events.

Background: ASP5878 is an orally available, novel Fibroblast Growth Factor Receptor (FGFR) inhibitor against FGFR 1, 2, 3, and 4. It demonstrated potent in vitro and in vivo inhibitory effects on a variety of human tumor cell lines and xenograft models with FGFR alterations. Deregulated activation of FGFR signaling has been implicated in several human cancers. Method:This first-in-human phase I study consists of dose escalation (P1a) and expansion (P1b) stages. The primary objectives of P1a are to determine the safety and tolerability and to establish dose limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended P1b dose (RP1bD). The secondary objectives are to determine pharmacokinetics (PK) and pharmacodynamics (PD) of ASP5878. The exploratory objective is to determine antitumor activity of ASP5878. ASP5878 was orally administered on Cycle 0 (a single oral dose once daily followed by 2 days interruption), Cycle 1 and subsequent cycles (continuous daily dosing once (qd) or twice daily (bid)) consist of 28 days each. Dose escalation was planned in a step-wise manner, by using the Bayesian Continual Reassessment Method. Three to four patients (pts) with advanced solid tumors (unselected for FGFR alteration) were planned to be enrolled per cohort in P1a. Results: As of 12 March 2015, 25 pts with advanced solid tumors (lung cancer, hepatocellular carcinoma, etc.) had received at least 1 dose of ASP5878 in 7 dose cohorts (0.5 - 2.0 mg qd, 2.0 - 10.0 mg bid continuous dosing). Twenty three (92.0%) pts experienced at least a single AE. AEs reported by 20 (80%) pts were considered to be study-drug related by the investigators. SAEs were reported in 3 pts (grade 3 hepatic dysfunction in the 1.0 mg qd cohort, grade 3 dyspnea in the 2.0 mg bid cohort and grade 3 urinary tract infection (UTI) in the 2.0 mg bid cohort). Of these, only the UTI was considered to be possibly related to ASP5878 exposure. No DLT was observed, up to the 10 mg bid cohort. Common possibly or probably drug-related AEs (mostly grade 1/2) were hyperphosphatemia (HP) (12/25, 48%), serous retinal detachment (SRD) (8/25, 32%), and diarrhea (8/25, 32%). HP was transient and reversible, and was mostly manageable by appropriate measures (e.g.; low phosphate diet, oral phosphate adsorbent, and/or temporary study drug interruption). The vast majority of SRD did not cause any affect on visual perception and resolved after brief study drug interruption. Preliminary PK analyses revealed that plasma concentrations of ASP5878 were increased in a dose proportional manner with median tmax of 1-3 hr and median t1/2of 2-6 hr. Preliminary data on 3 pts enrolled at a 20mg bid dose indicate that HP was observed in all 3 pts with 2 of the 3 patient's HP considered a DLT by the investigators/sponsor. One partial response was observed in a bladder cancer patient with an FGFR gene alteration in the 20 mg bid cohort. In the presentation, further updates will be presented. Conclusions: ASP5878 was well tolerated with manageable, mostly grade 1/2 AEs. Tumor shrinkage was observed in a bladder cancer patient with an FGFR gene alteration. RP1bD has not yet been established. Further dose exploration is ongoing (NCT02038673). Citation Format: Toshio Shimizu, Toshihiko Doi, Noboru Yamamoto, Haruyasu Murakami, Junji Furuse, Koji Kawai, Hiroyuki Nishiyama, Satoshi Morita, Shunji Takahashi, Erkut Bahceci, Joyce Steinberg, Howard A. Ball, Futoshi Kunieda, Kentaro Takeda, Aya Kita, Shigeru Takeshita. Result of a phase 1 (dose-escalation stage), first-in-human study of ASP5878, an oral FGFR inhibitor, in patients with advanced solid tumors. [abstract]. In: Proceedings of the AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; 2015 Nov 5-9; Boston, MA. Philadelphia (PA): AACR; Mol Cancer Ther 2015;14(12 Suppl 2):Abstract nr A165.

4526 Background: Cisplatin-based NAC for patients (pts) with MIBC is considered to provide a 5–8% overall survival (OS) advantage, although several studies failed to prove the survival benefit of NAC. Methods: Eligibility criteria included histologically proven urothelial carcinoma, MIBC (T2-4aN0M0) within 8 weeks from TURBT, PS 0-1, and age 20-75 years old. Patients were randomized to receive 2 cycles of neoadjuvant MVAC followed by RC (NAC arm) or RC alone (RC arm). The primary endpoint was OS. Secondary endpoints were progression-free survival (PFS), surgery-related complications, adverse events during NAC, the percent with no residual tumor in the RC specimens (pT0), and QOL. The sample size was 180 pts in each arm with a one-sided alpha of 5% and a power of 80% to detect a 7% difference in 5-year OS, 45% in the RC arm, and 57% in the NAC arm. Results: From March 2003 to March 2009, 130 pts were randomized to the NAC arm (n=64) and RC arm (n=66). Fifty-nine patients in the NAC arm and 65 in the RC arm underwent cystectomy. The patient registration was terminated early because of slow accrual. At the 2nd interim analysis conducted after the completion of patient accrual, OS of the NAC arm was better than that of the RC arm, although the difference was not statistically significant (HR, 0.65; multiplicity adjusted 99.99%CI, 0.19-2.18; one-sided log-rank p = 0.07). Considering the current situation in which NAC with gemcitabine and cisplatin (GC) is widely used in clinical practice, the Data and Safety Monitoring Committee recommended early publication of the results. PFS of the NAC arm was better than that of the RC arm (HR, 0.61; 95% CI, 0.35-1.06, one-sided log-rank p=0.04). No differences in perioperative complications, other than lymph leakage, were observed between the arms. In the NAC arm and the RC arm, 34% and 9% of the patients had pT0, respectively (p

249 Background: Cisplatin-based NAC for patients (pts) with invasive BC is considered to provide a 5–8% overall survival (OS) advantage, although several studies failed to prove the survival benefit of NAC. Methods: Eligibility criteria included histologically proven urothelial carcinoma, invasive (T2-4aN0M0) bladder cancer within 8 weeks from TURBT, PS 0-1, age 20 to 75 years old. Patients were randomized to receive either 2 cycles of neoadjuvant MVAC followed by RC (NAC arm) or RC alone (RC arm). MVAC comprised M (30 mg/m2) on days 1, 15, and 22; V (3 mg/m2) on days 2, 15, and 22; A (30 mg/m2) on day 2; C (70 mg/m2) on day 2. The primary endpoint was OS. Secondary endpoints were progression-free survival (PFS), the surgery-related complication rate, adverse events during NAC, the rate of no residual tumor in the RC specimens (pT0), and quality of life. The sample size was 180 pts in each arm with a one-sided alpha of 5% and a power of 80% to detect a difference in 5-year OS from 45% in the RC arm to 57% in the NAC arm. Results: From March 2003 to March 2009, 130 pts were randomized to the NAC arm (n=64) and RC arm (n=66). The patient registration was terminated early because of slow accrual. At the second interim analysis conducted after the completion of patient accrual, the OS of the NAC arm was better than that of the RC arm (median, 102 and 81 months, respectively), although the difference was not statistically significant (HR, 0.65; multiplicity adjusted 99.99%CI, 0.19 - 2.18; one-sided log-rank p = 0.07). Considering the current situation in which NAC with gemcitabine and cisplatin (GC) is widely used in clinical practice, the Data and Safety Monitoring Committee recommended early publication of the results. The median PFS times in the RC arm and NAC arm were 78 and 99 months, respectively (p=0.04). No differences in perioperative complications, other than lymph leakage, were observed between the groups. pT0 in the NAC arm and RC arm was 34 % vs. 9 %, respectively (p

Plasma cell granuloma of the urinary bladder is a rare benign entity of the submucosal stroma that is difficult to distinguish from malignant neoplasm clinically. We report a case of plasma cell granuloma of the urinary bladder treated successfully with corticosteroid. A 78-year-old man was admitted to our hospital complaining of miction pain, pollakisuria and fever for a month. He had undergone surgery for a transverse colon tumor about 4 years previously, but the pathological diagnosis was plasma cell granuloma. Urinalysis showed microscopic hematuria. Urine cytology was class I. The urine culture was negative. Computed tomography (CT) showed diffuse thickness of the bladder wall (Fig. 1a). At this point, we made a diagnosis of invasive bladder cancer. Transurethral resection of bladder tumor (TUR-BT) was carried out. Histopathological examination demonstrated a proliferation of blood vessels and infiltration of many plasma cells. Histologically it was similar to that of the previous colon tumor and no malignant cell was identified. Thus, we made a diagnosis of plasma cell granuloma of the urinary bladder. The lesion occupied a large part of the bladder and it seemed difficult to carry out partial cystectomy. So we decided to carry out corticosteroid therapy according to some reports. We started 30 mg/day of oral prednisolone. The fever and the irritated bladder symptoms were dramatically improved from the next day. Bladder-wall thickening was significantly reduced in a CT after treatment in comparison with that before the treatment (Fig. 1a,b). The dose of prednisolone was gradually tapered down in an ambulatory setting. There has been no evidence of recurrence for 28 months. Many reports have dealt with similar lesions under various names including plasma cell granuloma, inflammatory myofibroblastic tumor, inflammatory pseudotumor, pseudosarcomatous fibromyxoid tumor, etc. The cause is not well resolved , but some reports describe that urinary tract infection, operation, and Crohn’s disease have some relations with the disease. Partial cystectomy is often carried out for treatment. Some cases are overtreated as total cystectomy. Some reports describe that corticosteroid was effective for inflammatory pseudotumor of the kidney and the upper urinary tract. Some reports describe that corticosteroid is effective for plasma cell granuloma of the lung, in which serum IgG4 level is high. Serum IgG4 of this case was within normal levels. This patient had a history of plasma cell granuloma of transverse colon about 4 years ago. The relation between plasma cell granuloma of transverse colon and urinary bladder is unknown but the histological appearance is very similar (Fig. 1c,d). To the best of our knowledge, this is a rare case of plasma cell granuloma of the urinary bladder that was dramatically reactive to corticosteroid. Futoshi Kunieda MD, Koji Inoue MD and Akito Terai MD PhD Department of Urology, Kurashiki Central Hospital, Kurashiki, Oyakama, Japan f kunieda@yahoo.co.jp