Bladder Preservation Strategies Research Articles

Multidisciplinary Management of Muscle-Invasive Bladder Cancer: Current Challenges and Future Directions.

The treatment of muscle-invasive bladder cancer (MIBC) is complex and requires a multidisciplinary collaboration among surgery, radiation, and medical oncology. Although neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) and lymph node dissection has been considered the standard treatment for MIBC, many patients are unfit for surgery or cisplatin-ineligible, and considerations for bladder-preservation strategies not only are increasingly recognized as optimal treatment alternatives, but also should feature in the range of management options presented to patients at the time of diagnosis. Apart from chemotherapy, immunotherapy has also been used with success in locally advanced and metastatic bladder cancer and is moving into the MIBC space. Prospective studies addressing trends in management that span systemic, surgical, and radiation options for patients are discussed in this article.

MP83-19 MITOMYCIN C (MMC) PLUS BACILLUS CALMETTE E GUERÌN (BCG) SEQUENTIAL THERAPY FOR RECURRENT NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)

You have accessJournal of UrologyBladder Cancer: Non-invasive II1 Apr 2018MP83-19 MITOMYCIN C (MMC) PLUS BACILLUS CALMETTE E GUERÌN (BCG) SEQUENTIAL THERAPY FOR RECURRENT NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) Mauro Ragonese, Luca Di Gianfrancesco, Niccolò Lenci, Salvatore Marco Recupero, Giuseppe Palermo, and Marco Racioppi Mauro RagoneseMauro Ragonese More articles by this author , Luca Di GianfrancescoLuca Di Gianfrancesco More articles by this author , Niccolò LenciNiccolò Lenci More articles by this author , Salvatore Marco RecuperoSalvatore Marco Recupero More articles by this author , Giuseppe PalermoGiuseppe Palermo More articles by this author , and Marco RacioppiMarco Racioppi More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.2767AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES BCG therapy represents the gold standard treatment in high grade NMIBC to prevent recurrence and reduce the risk of progression. In patients who do not respond to BCG the gold standard is radical cystectomy. For patients not suitable or not willing to undergo radical surgery there are some bladder preservation strategies: a second BCG induction therapy and chemo-immunotherapy with BCG and MMC are among these options. METHODS We retrospectively evaluated data from 200 patients treated in our Department for a recurrent high grade NMIBC. All the patients were not suitable for surgery or they do not want to undergo radical surgery and were treated with different endovesical regimen. A group of 120 patients (Group 1) was treated with a schedule of combined therapy with 4 weekly instillations of MMC followed by 4 weekly instillations of BCG and a second group of 80 patients (Group 2) was treated with a second induction therapy of BCG. Patients with a complete response after induction were treated with maintenance therapy. We evaluated the complete response after the induction cycle and after a median follow up of 18 months and we compared the rate of side effects evaluated with the Common Terminology Criteria for Adverse Events (CTCAE) RESULTS Complete response after the first evaluation at three months was similar for the two groups, 67.5 % (81 patients) in group 1 and 63.7 % (51 patients) in group 2 without a statistically significant difference. At the median follow-up of 18 months a recurrent disease was present in 76 patients (38 %), 37 (46.2 %) from group 2 and 39 (37.5%) from group 1 (p < 0.01). 7 patients (6%) in group 1 and 6 patients (7.5 %) in group 2 had a progression to muscle-invasive disease. The regimen was well tolerated with low treatment toxicity, only Grade 1 and Grade 2 events were reported and the overall rate of complications was 25 % in group 1 and 11.2 % in group 2 (p < 0.01). No severe adverse events (Grade 3, 4 or 5) were reported and all the patients with a response after the induction complete the maintenance therapy. CONCLUSIONS Recurrent NMIBC is a great challenge for urologist in particular in patients not suitable for radical cystectomy. Sequential therapy and repeat BCG therapy are among these options and our preliminary findings indicate a better efficacy for the combination treatment. Further prospective randomized trials are needed to find out if this regimen could really become a valid alternative for these patients. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e1123-e1124 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Mauro Ragonese More articles by this author Luca Di Gianfrancesco More articles by this author Niccolò Lenci More articles by this author Salvatore Marco Recupero More articles by this author Giuseppe Palermo More articles by this author Marco Racioppi More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

The Efficacy of Trimodal Chemoradiotherapy with Cisplatin as a Bladder-Preserving Strategy for the Treatment of Muscle-Invasive Bladder Cancer

Introduction: Open radical cystectomy (ORC) is currently the standard treatment for muscle-invasive bladder cancer (MIBC) without metastasis, while many patients with MIBC are not always appropriate candidates due to multiple comorbidities. To evaluate the bladder-preservation strategy, we compared the results with those obtained by ORC. Patients and Methods: We retrospectively analyzed the data of 50 patients with MIBC treated by trimodal chemoradiotherapy with cisplatin (CDDP-radiation [CDDP-R]). Transurethral resection of the bladder tumor (TURBT) was performed before treatment to confirm pathological stage ≥T2. Extensive TURBT was performed after chemoradiotherapy to evaluate the pathological response to treatment. We compared the survival outcomes of our CDDP-R with those of ORC (retrospective cohort, n = 205) by propensity score matching analysis. Results: The 2- and 5-year progression-free survival, bladder-intact survival, cancer-specific survival, and overall survival (OS) rates after treatment were 70.8 and 63.9%, 64.0 and 49.8%, 86.7 and 71.8%, and 84.3 and 64.8%, respectively. The 2- and 5-year OS rates after CDDP-R were 90.5 and 74.3%, respectively, and those after ORC were 71.8 and 59.9%, respectively, indicating a significant survival advantage conferred by CDDP-R over ORC (p < 0.05, HR 0.45, 95% CI 0.21-0.94). Conclusions: In selected patients, CDDP-R for MIBC may provide comparative oncological outcomes as ORC.

Lymphovascular invasion predicts poor prognosis in high-grade pT1 bladder cancer patients who underwent transurethral resection in one piece.

Lymphovascular invasion (LVI) in high-grade clinical T1 bladder cancer is usually considered a poor prognostic factor, but it is often difficult to achieve correct staging of T1 bladder cancer and diagnose the presence of LVI because of the inadequacy of conventional transurethral resection specimens. The aims of this study were to evaluate the prognostic value of LVI in patients with correctly staged high-grade pathological T1 (pT1) bladder cancer who initially underwent transurethral resection in one piece (TURBO). Eighty-six high-grade pT1 bladder cancer patients who underwent TURBO were enrolled. Risk of tumor understaging was avoided by examining the vertical resection margin of the TURBO specimen. Immunohistochemical staining using D2-40 and CD31 was performed to confirm LVI. We examined the association of LVI with other clinicopathological factors and the impact of LVI on progression-free survival and cancer-specific survival. The median follow-up period was 49 months (range, 6-142). In all patients, the tumors were accurately staged as pT1 at initial TURBO. LVI was detected in 15 patients (17%) and was significantly associated with tumor growth pattern (P = 0.001). Multivariate analysis identified LVI as the only independent predictor for reduced progression-free survival (HR, 4.48; 95% CI, 1.45-13.90; P = 0.009) and cancer-specific survival (HR, 4.35; 95% CI, 1.17-16.24; P = 0.029). The presence of LVI in TURBO specimens independently predicts poor clinical outcomes in patients with high-grade pT1 bladder cancer. This information may help urologists to counsel their patients when deciding whether to choose a bladder-preserving strategy or radical cystectomy.

ATM mediates DAB2IP-deficient bladder cancer cell resistance to ionizing radiation through the p38MAPK and NF-κB signaling pathway.

Although surgery remains the standard therapy for the treatment of bladder cancer (BCa), the data from previous clinical studies suggest that there is an increase in the number of patients with a preference for bladder preservation strategies, including radiotherapy, to improve their life quality. Our preliminary results showed that disabled homolog 2 interactive protein (DAB2IP), a putative tumor suppressor gene, is often downregulated in BCa with a radioresistant phenotype. Subsequent investigations revealed that elevated expression of ataxia-telangiectasia mutated (ATM) induced by DAB2IP-knockdown may be the key event in BCa cell resistance to ionizing radiation (IR). However, how ATM is involved in the survival of DAB2IP-deficient cells exposed to IR remains to be fully elucidated. The present study knocked down the expression of ATM in DAB2IP-deficient BCa cells using RNA interference technology. Activation of mitogen-activated protein kinase (MAPK) and nuclear factor-κB (NF-κB) signaling pathways were detected by western blot analysis and immunofluorescence assay, respectively. It was demonstrated that knockdown of ATM enhanced the response of DAB2IP-deficient BCa cells to IR, which may have resulted from delayed DNA double-strand break repair kinetics, compromised nuclear factor-κB translocation, inhibited phosphorylation of p38 and the induced activation of c-Jun N-terminal kinase. Taken together, these findings suggested that ATM may be an effective target in the radiotherapy of patients with DAB2IP-deficient BCa.

Absence of Tumor on Repeat Transurethral Resection of Bladder Tumor Does Not Predict Final Pathologic T0 Stage in Bladder Cancer Treated with Radical Cystectomy

BackgroundFor patients with bladder cancer (BC) receiving neoadjuvant chemotherapy (NAC), complete pathologic absence of tumor (pT0) at radical cystectomy (RC) is associated with better survival. It is unclear if pT0 status can be attributed to the absence of residual disease (cT0) on transurethral resection of bladder tumor (TURBT) or to the effects of NAC. ObjectiveTo determine how often cT0 is associated with pT0 and identify preoperative and postoperative factors associated with survival. Design, setting, and participantsBetween 1995 and 2011, 157 out of 1897 RC patients were identified as stage cT0 after at least two TURBT procedures at a single center. InterventionRC with or without NAC. Outcome measurements and statistical analysisInitial TURBT pathology and clinical staging were reviewed. The primary endpoint was pathologic stage at RC. Cox proportional hazards ratios identified factors associated with residual disease at RC, overall survival (OS), recurrence-free survival (RFS), and disease-specific survival (DSS). Results and limitationsOf the cT0 patients, 49.7% (n=78) underwent NAC. pT0 was found in 35.7% (n=56). Residual tumor was found at RC in 63.7% (n=101), of whom 24.8% (n=39) had advanced disease (≥pT3 or node-positive disease). Positive lymph nodes at RC were found in 12.7% (n=20) of the patients. There was no significant difference in achieving pT0 status between patients with and without NAC. The presence of advanced BC was most predictive of OS. NAC was associated with longer OS and RFS. During median follow-up of 6.3 yr, the 5-yr RFS was 81% for those with non-advanced disease and 46% for advanced BC (p<0.001). The 5-yr OS rate was 77% for non-advanced BC and 46% for invasive BC (p<0.001). Limitations include the retrospective design. ConclusionsComplete TURBT does not predict pT0 at RC. A notable fraction of patients with cT0 bladders have locally advanced and/or lymph node–positive disease. These findings may be of value when counseling patients on bladder preservation strategies for muscle-invasive BC. Patient summaryAmong patients thought to have had the entire tumor in their bladder removed via cystoscopy, a majority have persistent tumors when their bladders were removed. In a sizable proportion, these persistent tumors were even more invasive than initially thought.

Bladder Preservation Strategies in a Multicenter Community Setting Produces Outcomes Comparable to Prospective Radiation Therapy Oncology Group (RTOG) Protocols

Bladder Preservation Strategies in a Multicenter Community Setting Produces Outcomes Comparable to Prospective Radiation Therapy Oncology Group (RTOG) Protocols

Quality of life in patients with invasive bladder cancer who cannot undergo cystectomy

ABSTRACTBackground: To evaluate the quality of life in a bladder preservation strategy for patients with invasive bladder cancer, who are not eligible or refuse surgery.Methods: From January 2000 to February 2008 a total of 24 patients [mean age of 81 years - range 68 to 92] with muscle invasive bladder cancer, who had refused or had not been eligible for cystectomy, were followed up until their death.Results: 24 (21M/3F) patients were followed up for an average of 30.9 [range 10.4 - 73] months. All patients complained of frequency, urgency and severe nocturia. The second most frequent complication was bleeding, which required a salvage cystectomy in 11 cases. Other major complications were intestinal occlusion in five cases, four enterovesical fistulas, two brain metastases requiring neurosurgical intervention and radiation therapy of the brain, bone metastases in the cervical and thoracic spinal column with transient or permanent neurological impairment. The average re-admission rate was 11 times per pa...

Management of Bladder Cancer

Bladder cancer is the fourth most common cancer in men and the tenth most common in women. Patients commonly present with painless hematuria. Urinary frequency, urinary tract infection, upper tract obstruction, and pain are also possible; however, the physical examination of the patients is often unremarkable. Clinical diagnosis depends on urine cytology, bladder ultrasonography, and office cystoscopy. This review describes the epidemiology, pathology and natural history, clinical presentation and workup, staging and grading, non–muscle-invasive bladder cancer, bladder preservation strategies, nontraditional approaches, chemotherapy for metastatic disease, immunotherapy, and predictive factors of response to chemotherapy for bladder cancer. Figures show representative images of urothelial cell carcinoma, diagrams showing a cystoscopy for a man and bladder cancer staging, urinary diversion, and computed tomographic scans of a patient with hepatic metastases from bladder cancer before and after treatment with gemcitabine-cisplatin. Tables list the tumor-node-metastasis staging system for bladder cancer, the histologic classification of tumors of the urinary tract (WHO 1973 versus WHO 2004), risk group stratification based on the European Organization for Research and Treatment of Cancer Scoring System, types of bacillus Calmette-Guérin failure/recurrence and treatment recommendations, unfavorable factors for bladder preservation chemoradiation, consensus criteria for patients unfit for cisplatin-based regimens, and first-line combination chemotherapy regimens. This review contains 5 highly rendered figures, 7 tables, and 80 references.

Management of Bladder Cancer

Bladder cancer is the fourth most common cancer in men and the tenth most common in women. Patients commonly present with painless hematuria. Urinary frequency, urinary tract infection, upper tract obstruction, and pain are also possible; however, the physical examination of the patients is often unremarkable. Clinical diagnosis depends on urine cytology, bladder ultrasonography, and office cystoscopy. This review describes the epidemiology, pathology and natural history, clinical presentation and workup, staging and grading, non–muscle-invasive bladder cancer, bladder preservation strategies, nontraditional approaches, chemotherapy for metastatic disease, immunotherapy, and predictive factors of response to chemotherapy for bladder cancer. Figures show representative images of urothelial cell carcinoma, diagrams showing a cystoscopy for a man and bladder cancer staging, urinary diversion, and computed tomographic scans of a patient with hepatic metastases from bladder cancer before and after treatment with gemcitabine-cisplatin. Tables list the tumor-node-metastasis staging system for bladder cancer, the histologic classification of tumors of the urinary tract (WHO 1973 versus WHO 2004), risk group stratification based on the European Organization for Research and Treatment of Cancer Scoring System, types of bacillus Calmette-Guérin failure/recurrence and treatment recommendations, unfavorable factors for bladder preservation chemoradiation, consensus criteria for patients unfit for cisplatin-based regimens, and first-line combination chemotherapy regimens. This review contains 5 highly rendered figures, 7 tables, and 80 references.

Optimal management of muscle-invasive bladder cancer - a review.

Muscle-invasive bladder cancer is a complex disease requiring aggressive management. Patients are often older with comorbid conditions that impact treatment options. This review describes the available therapies for invasive urothelial carcinoma, including chemotherapy, radical extirpative surgery, and bladder-preserving strategies.

Bladder cancer: ESMO Practice Guidelines for diagnosis, treatment and follow-up

Bladder cancer: ESMO Practice Guidelines for diagnosis, treatment and follow-up

Novel Bladder Preservation Therapy with Osaka Medical College Regimen

We investigated the effect of balloon occluded arterial infusion of an anticancer agent (cisplatin/gemcitabine), used concomitantly with hemodialysis, which delivers an extremely high concentration of anticancer agent to the tumor site without systemic adverse effects, along with concurrent radiation (referred to as the Osaka Medical College regimen) in patients with advanced bladder cancer. A total of 329 patients (TisN0 16, T2N0 174, T3N0 77, T4N0 22 and TxN+ 40) were assigned to receive the Osaka Medical College regimen. Patients who did not achieve complete response underwent total cystectomy or secondary balloon occluded arterial infusion with an increased amount of cisplatin and/or gemcitabine. The Osaka Medical College regimen allowed 83.6% (276 of 329) of patients in total and 93.6% (250 of 267) of patients with organ confined disease (including T3b) to achieve complete response. Of the patients with a complete response 96% (240 of 250) survived with a functional bladder without evidence of recurrent disease within a mean followup of 159 weeks. Although lymph node involvement, especially N2 stage, was selected as a significant risk factor for treatment failure and survival, it was noteworthy that 61.9% of patients with N1 disease achieved complete response and that the 5-year overall survival rate was 72.2%. No patients had grade III or more severe toxicities. The Osaka Medical College regimen, a new bladder preservation strategy, can be curative not only in patients for whom cystectomy is indicated, but also in patients whose condition is not amenable to curative treatment because of disease stage, age or other factors, and for whom merely palliative therapy would otherwise seem the only option.

794 Bladder preservation strategy -CDDP radiation and GC (gemcitabine, CDDP) radiation-against muscle invasive bladder cancer

794 Bladder preservation strategy -CDDP radiation and GC (gemcitabine, CDDP) radiation-against muscle invasive bladder cancer

Bladder Cancer in Males: A Comprehensive Review of Urothelial Carcinoma of the Bladder

Bladder cancer is the second most common genitourinary malignancy after prostate cancer. It is a disease most commonly encountered in the elderly, particularly males, and has several well-established risk factors, including smoking and occupational exposures to certain chemical carcinogens. Roughly 90% of all bladder cancers are urothelial in origin; that is, they arise from the epithelial lining of the bladder. The remainder, including squamous cell carcinoma and adenocarcincoma, are nonurothelial. This review will focus solely on bladder cancer of urothelial origin, commonly referred to as urothelial carcinoma (UC) of the bladder. Bladder cancer can be divided into three distinct clinical entities: nonmuscle-invasive bladder cancer (NMIBC), muscle-invasive bladder cancer (MIBC), and metastatic bladder cancer. Each entity calls for different management. NMIBC, which accounts for roughly 70% of bladder cancer diagnoses, usually can be managed with transurethral resection, intravesical chemotherapy/immunotherapy, and aggressive surveillance protocols to monitor for recurrence and progression. MIBC calls for radical cystectomy (RC) with urinary diversion and bilateral pelvic lymph node dissection. Although it is often underutilized, neoadjuvant chemotherapy with platinum-based regimens improves survival. Data on adjuvant chemotherapy are less robust, but it remains an option for those who are medically fit and considered to be at high risk for recurrence and progression. Bladder-preserving strategies, including partial cystectomy and trimodality therapy, can provide adequate cancer control in appropriately selected patients with MIBC. Stringent surveillance is required. Metastatic bladder cancer is often lethal and the standard of care remains platinum-based chemotherapy regimens. Renal insufficiency is a common comorbidity that prevents patients from receiving chemotherapy in all settings. Currently, there are no recommended second-line chemotherapy regimens. Given the high rate of recurrence and progression, better prognostic variables should help to identify those who should be targeted in clinical trials. As bladder cancer affects a large number of men every year and significantly contributes to healthcare expenditures, prompt diagnosis and appropriate management are critical.

Bladder Function Preservation With Brachytherapy, External Beam Radiation Therapy, and Limited Surger in Bladder Cancer Patients: Long-Term Results

To report long-term results of a bladder preservation strategy for muscle-invasive bladder cancer (MIBC) using external beam radiation therapy and brachytherapy/interstitial radiation therapy (IRT). Between May 1989 and October 2011, 192 selected patients with MIBC were treated with a combined regimen of preoperative external beam radiation therapy and subsequent surgical exploration with or without partial cystectomy and insertion of source carrier tubes for afterloading IRT using low dose rate and pulsed dose rate. Data for oncologic and functional outcomes were prospectively collected. The primary endpoints were local recurrence-free survival (LRFS), bladder function preservation survival, and salvage cystectomy-free survival. The endpoints were constructed according to the Kaplan-Meier method. The mean follow-up period was 105.5 months. The LRFS rate was 80% and 73% at 5 and 10 years, respectively. Salvage cystectomy-free survival at 5 and 10 years was 93% and 85%. The 5- and 10-year overall survival rates were 65% and 46%, whereas cancer-specific survival at 5 and 10 years was 75% and 67%. The distant metastases-free survival rate was 76% and 69% at 5 and 10 years. Multivariate analysis revealed no independent predictors of LRFS. Radiation Therapy Oncology Group grade ≥3 late bladder and rectum toxicity were recorded in 11 patients (5.7%) and 2 patients (1%), respectively. A multimodality bladder-sparing regimen using IRT offers excellent long-term oncologic outcome in selected patients with MIBC. The late toxicity rate is low, and the majority of patients preserve their functional bladder.

Editorial Comment from Dr Kitamura to Cystectomy and urinary diversion as management of treatment-refractory benign disease: The impact of preoperative urological conditions on perioperative outcomes

As removal of the bladder followed by urinary reconstruction impairs the quality of life (QOL) of patients, cystectomy should be indicated when the benefits surpass the loss of QOL. This means that the primary diseases requiring cystectomy must be severe and oppressive for patients; for example, radiation cystitis with uncontrollable hemorrhage, treatment-refractory vesicovaginal or rectovesical fistula, atrophic bladder and so on. It is possible that the procedures in cystectomy for such benign diseases require high technical skill levels compared with those in radical cystectomy for bladder cancer, but it might depend on the primary disease. There has been no report with a large series regarding morbidity and mortality of cystectomy for benign diseases because of their rarity. Cohn et al. evaluated early and late complications after cystectomy for patients with treatment-refractory benign disease, and attempted to determine associations between the preoperative condition, including the etiology, and such outcomes. All patients with radiation-induced fistula experienced complications within 30 days after the cystectomy, and half of them were Clavien grade III or more. At 90 days, 50% of the patients with radiation-induced fistula still had the preoperative problems, whereas 83% of the rest of the cohort experienced resolution. The authors commented that the morbidity of cystectomy for benign disease might be similar to that seen in radical cystectomy, and increased in particularly complex and comorbid patients with radiation-induced fistula. Although this article has the limitations of being a retrospective review with the probability of underestimation of complications and a small number of participants that do not allow multivariate analysis, it provides informative suggestions for clinical practice. According to recent reports regarding complications of radical cystectomy after radiation therapy, morbidity rates were acceptable and slightly higher than for non-irradiated participants. Unlike salvage cystectomy after radiotherapy as a bladder-preserving strategy, however, cystectomy for patients with uncontrollable radiation-induced fistula is a challenging operation, as shown in this paper. Should we, then, avoid carrying out cystectomy for patients with radiation-induced fistula? To answer this question, much longer follow up and outcome data should be analyzed. Whether the patients who underwent cystectomy for treatment of radiation-induced fistula finally received the real benefits of cystectomy with urinary diversion must be of interest to many urologists.

Hypofractionation IMRT in Combined Modality Treatment for Bladder Preservation in Elderly Patients With Invasive Bladder Cancer

Hypofractionation IMRT in Combined Modality Treatment for Bladder Preservation in Elderly Patients With Invasive Bladder Cancer

A great option for elderly patients with locally invasive bladder cancer, BOAI-CDDP-radiation (OMC regimen)

We have developed a novel bladder preservation therapy, balloon-occluded arterial infusion (BOAI) of cisplatin/gemcitabine, concomitantly with hemodialysis, along with concurrent irradiation [the so-called 'OMC (Osaka Medical College) regimen']. The OMC regimen delivers an extremely high concentration of anticancer agent to the site of a tumor without systemic adverse effects, since more than 95% of free Pt was efficiently eliminated by hemodialysis, which enables short hospital stay. In this study, we investigated the efficiency of OMC regimen in patients aged over 70 years with muscle-invasive bladder cancer without metastasis. A total of 134 such patients were assigned to receive either the OMC regimen (n=89) or cystectomy (n=45). OMC regimen patients who failed to achieve CR underwent cystectomy, or secondary BOAI with gemcitabine (1,600 mg). The OMC regimen, which delivers an extremely high concentration of anticancer agent to the tumor site without systemic adverse effects, yielded CR in >91% (81/89) of patients. More than 96% (78/81) of the CR patients survived without recurrence with intact bladder after a mean follow-up of 164 (range 16-818) weeks. The 5- and 10-year bladder intact survival rates were 87.2 and 69.8%, and overall survival rates were 88.4 and 70.7% (vs. 59.9 and 33.3% for cystectomy, p=0.0002), respectively, although the median age in the OMC regimen group was significantly greater than in the cystectomy group (median, range = 77, 70-98 vs. 74, 70-89; p=0.0003). No patients suffered grade II or more severe toxicities; the oldest patient, aged 91 years, successfully completed this therapy. In conclusion, the OMC regimen is a useful bladder preservation strategy for elderly patients with locally invasive bladder cancer, not only in those for whom cystectomy is indicated, but also in patients whose condition is not amenable to curative treatment and for whom palliation would otherwise seem the only option.

Effect of a novel bladder preservation therapy, BOAI-CDDP-radiation (OMC-regimen)

We have developed a novel form of bladder preservation therapy [OMC (Osaka Medical College)-regimen] involving balloon-occluded-arterial-infusion (BOAI) of an anticancer agent (cisplatin/gemcitabine), used concomitantly with hemodialysis, which delivers an extremely high concentration of anticancer agent to the site of a tumor without systemic adverse effects, along with concurrent radiation. We previously reported that the OMC-regimen elicited a complete response (CR) in >90% of patients with organ confined tumors, while LN(+), T4 tumors and a non-UC histological type were statistically significant risk factors for treatment failure and patient survival. In this study, we investigated the effects of the OMC-regimen in patients with organ confined urothelial cancer tumors and the outcomes were compared to those with total cystectomy. Three hundred and one patients were assigned to receive either the OMC-regimen (n=162) or total cystectomy (n=139). Patients in the OMC-regimen group who failed to achieve CR underwent cystectomy, or secondary BOAI with an increased amount of CDDP or gemcitabine (1600 mg). The OMC-regimen yielded 98.1% of clinical response; CR in 93.8% (152/162) of patients; PR in 4.3% (7/162). More than 96% of the CR patients (146/152) were alive with no evidence of recurrence after a mean follow-up of 166 (range 23-960) weeks. No patients suffered grade III toxicity; all patients successfully completed this therapy. The patient survival was significantly better compared to the cystectomy group; the overall 5-, 10- and 15-year survival rates were 87.3, 79.6 and 59.7%, respectively. Moreover, the 5-, 10- and 15-year bladder intact survival rates, the most important issue for bladder preservation therapy, were 85.7, 78.4 and 58.8%, respectively. In conclusion, the OMC-regimen is a useful bladder-preservation strategy, not only in those for whom cystectomy is indicated, but also in patients whose condition is not amenable to curative treatment and for whom palliation would otherwise seem the only option.