Conservative management of advanced bladder cancer A sequential treatment approach to myoinvasive urothelial cancer: a phase II Southwest Oncology Group trial (S0219). The initial results in muscle-invading bladder cancer of RTOG 95-06: phase I/II trial of transurethral surgery plus radiation therapy with concurrent cisplatin and 5-fluorouracil followed by selective bladder preservation or cystectomy depending on the initial response. Can patient selection for bladder preservation be based on response to chemotherapy? Feasibility of radical transurethral resection as monotherapy for selected patients with muscle invasive bladder cancer. RTOG 97-06: initial report of a phase I-II trial of selective bladder conservation using TURBT, twice-daily accelerated irradiation sensitized with cisplatin, and adjuvant MCV combination chemotherapy. Organ-sparing treatment of invasive transitional cell bladder carcinoma. Phase II study of a new combined primary chemotherapy regimen, intravenous methotrexate and vincristine and intraarterial Adriamycin and cisplatin, for locally advanced urinary bladder cancer: preliminary results Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial. Validation of a combined comorbidity index. Outcome of patients who refuse cystectomy after receiving neoadjuvant chemotherapy for muscle-invasive bladder cancer. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. Phase I-II RTOG study (99-06) of patients with muscle-invasive bladder cancer undergoing transurethral surgery, paclitaxel, cisplatin, and twice-daily radiotherapy followed by selective bladder preservation or radical cystectomy and adjuvant chemotherapy. Bladder preservation in selected patients with muscle-invasive bladder cancer by complete transurethral resection of the bladder plus systemic chemotherapy: long-term follow-up of a phase 2 nonrandomized comparative trial with radical cystectomy.
Between January 1991 and October 1993 , 32 consecutive patients with documented primary bladder tumours invading muscle received 3 cycles of methotrexate , vinblastin , doxorubicin and cisplatin ( MVAC ) . The disease was re-staged by bimanual examination with the patient under anaesthesia , CT scanning and transurethral biopsy or resection . Of the 32 patients 2 underwent total or partial cystectomy and 30 did not , because re-staging showed no residual tumour in 8 ( 25 % ) , stage T1–2 in 12 ( 37.5 % ) and far-advanced tumour in 10 ( 31.2 % ) . The median follow-up was 2.8 years . Twelve patients with stage T1–2 tumour have required TUR , and cystectomy has not been necessary . Two patients who underwent total/partial cystectomy were all downstaged pathologically . Of the 10 failures 5 patients died of disease and 5 are alive with metastatic disease . The overall survival rate was 84.3 % ( 27 of 32 ) and was 96.8 % for patients with a functioning bladder . The data suggested that this active regimen can clinical ly induce down-staging in a significant number of patients with primary muscle-infiltrating bladder tumours .  Transurethral resection plus MVAC chemotherapy is important for increased curability in patients with advanced bladder cancer PURPOSE We conducted a phase II trial of neoadjuvant paclitaxel , carboplatin and gemcitabine as well as transurethral resection of bladder tumor to evaluate the clinical T0 ( cT0 ) rate with paclitaxel , carboplatin and gemcitabine , and to study cystoscopic surveillance or immediate cystectomy for patients with cT0 status following chemotherapy .  MATERIAL S AND METHODS Patients with T2-T4a chemotherapy and radiation naive urothelial cancer were eligible . T2 + tumor had to be diagnosed by transurethral bladder tumor resection followed by a second transurethral bladder tumor resection to confirm persistent disease within 16 weeks of the first resection . Three cycles of paclitaxel , carboplatin and gemcitabine were administered within 8 weeks of the second transurethral bladder tumor resection . Patients with cT0 status after paclitaxel , carboplatin and gemcitabine therapy could elect immediate cystectomy or cystoscopic surveillance , and those with greater than cT0 status were to undergo immediate cystectomy . RESULTS Of 77 patients 74 were assessable , and cT0 status after paclitaxel , carboplatin and gemcitabine was achieved in 34 of 74 patients ( 46 % ) . Of the 34 patients with cT0 status 10 underwent immediate cystectomy , 6 of whom had persistent cancer . Persistent tumor at transurethral bladder tumor resection was seen in 28 patients ( 38 % ) and 21 underwent cystectomy . Thus , 35 of 74 patients underwent cystectomy . With a median followup of 22 months 2-year overall survival was 59 % ( 95 % CI 45 , 72 ) and among cT0 cases it was 75 % ( 95 % CI 57 , 93 ) . CONCLUSIONS Although neoadjuvant paclitaxel , carboplatin and gemcitabine had a promising 46 % cT0 rate , the study failed to meet the primary objective as there was an unacceptably high rate ( 60 % ) of persistent cancer at cystectomy in patients presumed to have pT0 status . Patients completing neoadjuvant chemotherapy should strongly consider definitive local therapy rather than cystoscopic surveillance regardless of post-chemotherapy cT0 status PURPOSE To assess the safety , tolerance , and efficacy of transurethral surgery plus concomitant cisplatin , 5-fluorouracil ( 5-FU ) , and radiation therapy in conjunction with selective bladder preservation in patients with muscle-invading bladder cancer . Patients and Methods . Thirty-four eligible patients with clinical stage T2-T4a , Nx M0 bladder cancer without hydronephrosis were entered into a protocol aim ed at selective bladder preservation . Treatment began with as complete a transurethral resection as possible followed by induction chemoradiation . This consisted of cisplatin 15 mg/m(2 ) i.v . and 5-fluorouracil ( 5-FU ) 400 mg/m(2 ) i.v . in the mornings on d 1 , 2 , 3 , 15 , 16 , and 17 . On d 1 , 3 , 15 , and 17 , radiation was given immediately following the chemotherapy using twice-a-day 3 Gy per fraction cores to the pelvis for a total radiation dose of 24 Gy . Response was evaluated by cystoscopy , cytology , and rebiopsy four weeks later . Patients with a complete response received consolidation therapy with the same drugs and doses on d 1 , 2 , 3 , 15 , 16 , and 17 combined with twice-daily radiation therapy to the bladder and bladder tumor volume of 2.5 Gy per fraction for a total consolidation dose of 20 Gy and a total induction plus consolidation dose to the bladder and bladder tumor of 44 Gy . Patients who did not achieve a complete response were advised to undergo prompt cystectomy , as were those with a subsequent invasive recurrence . The median follow up is 29 months . RESULTS Of the 34 eligible patients , 26 had a visibly complete transurethral resection . One patient did not complete induction treatment due to acute hematologic toxicity . After induction treatment , 22 ( 67 % ) of the 33 patients had no tumor detectable on urine cytology or rebiopsy . Of the 11 patients who still had detectable tumor , six underwent radical cystectomy and five underwent consolidation chemoradiation ( one because of refusal to have the recommended cystectomy and four because the treating institutions erroneously assigned them to receive consolidation chemoradiation rather than cystectomy ) . No patient has required a cystectomy for radiation toxicity . Six patients have died of bladder cancer . The actuarial overall survival at three years is 83 % . The probability of surviving with an intact bladder is 66 % at three years . A total of seven patients ( 21 % ) developed grade 3 or grade 4 hematologic toxicity in conjunction with this treatment . CONCLUSION This aggressive protocol comprising local surgery plus concurrent 5-FU , cisplatin , and high-dose hypofractionated radiation has been associated with moderately severe hematologic toxicity . Longer follow-up will be necessary to assess efficacy . Both the 67 % complete response rate to induction therapy and the 66 % three-year survival with an intact bladder are encouraging Neoadjuvant chemotherapy for patients with muscle‐invasive bladder carcinoma is given to treat micrometastases and to preserve the bladder . The objective of this study was to evaluate the possibility of bladder preservation in patients with muscle‐invasive bladder carcinoma who were treated with neoadjuvant methotrexate , vinblastine , doxorubicin , and cisplatin ( M‐VAC ) chemotherapy PURPOSE We proved the feasibility of radical transurethral bladder tumor resection in selected patients with muscle invasive bladder cancer with a minimum followup of more than 15 years and investigated the impact of patient age on survival . A followup schedule was developed based on progression and recurrence during this period . MATERIAL S AND METHODS A phase II nonr and omized trial was design ed including patients with muscle invasive bladder cancer with negative biopsies of tumor bed who were apparently healthy after undergoing complete transurethral bladder tumor resection . Patients with positive biopsies , or with macroscopically residual tumor , hydronephrosis or metastasis were excluded from study . In this trial 133 patients fulfilled the inclusion criteria and had a minimum followup of more than 15 years .  RESULTS Cancer specific survival was 81.9 % , 79.5 % and 76.7 % , and progression-free survival with bladder preservation was 75.5 % , 64.9 % and 57.8 % at 5 , 10 and 15 years , respectively . Patient age had a negative impact on overall survival on univariate ( HR 0.842 , p = 0.049 ) and multivariate analyses ( HR 1.062 , p = 0.000 ) , and according to median and quartile age stratifications ( p = 0.000 and p = 0.000 , respectively ) . However , age did not have a negative impact on cancer specific survival even when following the same stratifications . Although progression and recurrence were concentrated during the first 3 years ( 70 % and 65 % , respectively ) , both steadily increased afterward . A followup schedule was developed according to this sequence of events . CONCLUSIONS Radical transurethral bladder tumor resection is a reliable therapeutic approach for patients with muscle invasive bladder cancer after complete tumor resection and with negative biopsies of the tumor bed . These results are consistent in all age ranges To examine combination cisplatin and twice-daily accelerated irradiation ( RT ) after aggressive transurethral resection of bladder tumor ( TURBT ) in an attempt to preserve the bladder and to determine the likelihood that patients who complete this regimen could then complete three cycles of methotrexate , cisplatin , vinblastine ( MCV ) chemotherapy .  Between 1998 and 2000 , 52 patients with Stage T2-T4aN0M0 disease , from 17 institutions , were entered into the trial . Forty-seven patients were deemed eligible ; the planned accrual was 40 . Of the 46 patients , 68 % were > 60 years old , 70 % were men , and 96 % had a Karnofsky score > /=90 . The clinical T stage was T2 in 66 % , T3a in 25 % , and T3b in 9 % . The median follow-up at the time of analysis was 26 months . The protocol required TURBT within 6 weeks of the initiation of induction therapy . Induction treatment involved 13 days of concomitant boost RT , 1.8 Gy to the pelvis in the morning followed by 1.6 Gy to the tumor 4 - 6 h later . For sensitization , cisplatin ( 20 mg/m(2 ) ) was given on the first 3 days of each treatment week . Three to four weeks after induction , patients were evaluated cystoscopically for residual disease . Patients whose biopsies and cytologic evaluations showed no disease completed consolidation chemoirradiation . Patients with residual tumor went on to cystectomy . After either consolidation or cystectomy , patients were to complete three cycles of MCV chemotherapy . Of the 47 patients , 45 % completed all phases of the protocol treatment with minor , or no , deviations . Five patients refused either the postinduction evaluation or cystectomy and 6 refused adjuvant chemotherapy . The CR rate after induction therapy was 74 % . For 2 patients , residual disease after induction was limited to positive cytologic findings , and for 8 patients , biopsy of the primary site revealed persistence . Of the 8 cystectomy patients , 2 had no evidence of disease in the bladder at pathologic review of the surgery specimen . Grade 3 toxicity related to chemotherapy was observed in 11 % of patients during both induction and consolidation , and in 41 % during adjuvant chemotherapy . A total of 8 patients ( 36 % of those receiving adjuvant chemotherapy ) went on to develop Grade 4 neutropenia or thrombocytopenia during additional adjuvant chemotherapy .  Grade 3 toxicity due to RT was seen in 4 % and 0 % of patients during induction and consolidation , respectively . One patient developed Grade 4 hydronephrosis during consolidation . The projected 36-month value for locoregional failure , distant metastasis , overall survival , and bladder-intact survival was 27 % , 29 % , 61 % , and 48 % , respectively . After aggressive TURBT , twice-daily accelerated RT initiated in concomitant-boost format is well tolerated and results in a rate of complete response ( 74 % ) similar to that in previous bladder-sparing trials . The projected 2-year values for locoregional control , bladder-intact survival , and overall survival were also consistent with previously reported trials of bladder-sparing treatment . With only 45 % of patients completing three cycles of MCV , this form of adjuvant chemotherapy appears to be poorly tolerated by most patients PURPOSE To assess the effectiveness of two approaches of organ-sparing treatment in patients with invasive transitional cell bladder carcinoma . PATIENTS AND METHODS During the period from June 1996 to June 2000 , 33 patients with invasive transitional cell carcinoma ( T2 - 4 ) of the bladder were treated . Patients were divided into two groups . Group A included 17 patients treated with CMV systemic chemotherapy ( methotrexate 30 mg/m(2 ) and vinblastine 3 mg/m(2 ) , day 1 ; and cisplatin 70 mg/ m(2 ) , day 2 ) repeated every 3 weeks for 3 courses , combined with intravesical BCG . Complete responders ( CR ) received maintenance intravesical BCG , while partial responders ( PR ) were subjected to transurethral bladder resection ( TURB ) or partial bladder resection . Group B included 16 patients treated with maximal TURB followed by 2 CMV courses and radiotherapy . RESULTS Group A patients have been followed-up for a period of 7 to 48 months ( median 21.6 months ) . After completing the 2nd chemotherapy course , 2 patients refused further treatment and were excluded from the group . On completing chemoimmunotherapy 11 ( 73 % ) patients showed objective response ( CR+PR ) and preservation of the bladder was achieved . Four ( 27 % ) patients were treatment failures . Group B patients have been followed for a period of 9 to 47 months ( median 27.5 months ) . On completing treatment 12 of 16 ( 75 % ) patients showed an objective response with preservation of the bladder . Treatment failure was diagnosed in 4 ( 25 % ) patients . The 2 groups differed significantly in terms of side-effects , which were more pronounced in Group B patients . Of the late complications in Group B a serious problem was the development of severe radiation-induced fibrosis leading to microcystis and a cystectomy was indispensable in one of the patients . CONCLUSION The applied 2 approaches of combined organ-sparing treatment of invasive bladder carcinoma seem equally effective . Future r and omized studies are needed to define reliable criteria for patient selection A phase II study of a new combination therapy was performed using intraarterial ( i.a . ) cisplatin and Adriamycin in combination with i.v . methotrexate and vincristine for 27 patients with invasive urinary bladder carcinoma of stages T2 - 3NOMO , and the therapeutic effects were assessed . Methotrexate ( 20 mg/ m2 ) was given i.v . on days 1,15 , and 22 , and vincristine ( 0.7 mg/m2 ) was injected i.v . on day 2 before i.a . infusion therapy and on days 15 and 22 . The i.a . chemotherapy was performed after both superior gluteal arteries had been embolized using 3- or 5-mm stainless-steel coils . A mixture of cisplatin ( 50–70 mg/m2 ) and Adriamycin ( 20 mg/m2 ) was infused i.a . via both internal iliac arteries over a period of 20–30 min . Angiotensin II ( mean dose , 21 μg ) was simultaneously infused i.a . in 15 of 27 patients . In 24 of the 27 patients , at least 2 cycles of full-dose chemotherapy were completed . The dose was decreased in the remaining 3 patients because of their poor health status and advanced age . Among the 27 patients , 9 and 14 had complete ( CR ) and partial responses ( PR ) , respectively ; 3 manifested no change ( NC ) , and 1 had progressive disease ( PD ) . The objective response rate ( CR + PR ) was 85.2 % . Among the 27 patients staged T2 - 3 NOMO , 6 ( CR , 1 ; PR , 5 ) underwent total cystectomies and 18 ( CR , 8 ; PR , 8 ; NC , 2 ) had transurethral resection of a bladder tumor ( TUR-Bt ) or partial resections following chemotherapy . The remaining 3 diminished-dose patients had no surgery . Of the 27 patients , 22 were alive after a median follow-up period of 21 + ( range , 7–48 + ) months . No significant side effect was observed except for lower extremity paresthesias in 5 patients ( 18.5 % ) . These results point to the effectiveness of this therapy and to the possibility of urinary bladder preservation in patients with invasive , advanced urinary bladder cancers BACKGROUND Open radical cystectomy ( ORC ) and urinary diversion in patients with bladder cancer ( BCa ) are associated with significant perioperative complication risk . OBJECTIVE To compare perioperative complications between robot-assisted radical cystectomy ( RARC ) and ORC techniques . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve r and omized controlled trial was conducted during 2010 and 2013 in BCa patients scheduled for definitive treatment by radical cystectomy ( RC ) , pelvic lymph node dissection ( PLND ) , and urinary diversion . Patients were r and omized to ORC/PLND or RARC/PLND , both with open urinary diversion .  Patients were followed for 90 d postoperatively . INTERVENTION St and ard ORC or RARC with PLND ; all urinary diversions were performed via an open approach . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Primary outcomes were overall 90-d grade 2 - 5 complications defined by a modified Clavien system . Secondary outcomes included comparison of high- grade complications , estimated blood loss , operative time , pathologic outcomes , 3- and 6-mo patient-reported quality -of-life ( QOL ) outcomes , and total operative room and inpatient costs . Differences in binary outcomes were assessed with the chi-square test , with differences in continuous outcomes assessed by analysis of covariance with r and omization group as covariate and , for QOL end points , baseline score . RESULTS AND LIMITATIONS The trial enrolled 124 patients , of whom 118 were r and omized and underwent RC/PLND . Sixty were r and omized to RARC and 58 to ORC . At 90 d , grade 2 - 5 complications were observed in 62 % and 66 % of RARC and ORC patients , respectively ( 95 % confidence interval for difference , -21 % to -13 % ; p=0.7 ) . The similar rates of grade 2 - 5 complications at our m and ated interim analysis met futility criteria ; thus , early closure of the trial occurred . The RARC group had lower mean intraoperative blood loss ( p=0.027 ) but significantly longer operative time than the ORC group ( p<0.001 ) . Pathologic variables including positive surgical margins and lymph node yields were similar . Mean hospital stay was 8 d in both arms ( st and ard deviation , 3 and 5 d , respectively ; p=0.5 ) . Three- and 6-mo QOL outcomes were similar between arms . Cost analysis demonstrated an advantage to ORC compared with RARC . A limitation is the setting at a single high-volume , referral center ; our findings may not be generalizable to all setting s. CONCLUSIONS This trial failed to identify a large advantage for robot-assisted techniques over st and ard open surgery for patients undergoing RC/PLND and urinary diversion . Similar 90-d complication rates , hospital stay , pathologic outcomes , and 3- and 6-mo QOL outcomes were observed regardless of surgical technique . PATIENT SUMMARY Of 118 patients with bladder cancer who underwent radical cystectomy , pelvic lymph node dissection , and urinary diversion , half were r and omized to open surgery and half to robot-assisted laparoscopic surgery .  We compared the rate of complications within 90 d after surgery for the open group versus the robotic group and found no significant difference between the two groups . TRIAL REGISTRATION Clinical Trials.gov identifier NCT01076387 , www . clinical trials.gov The basic objective of this paper is to evaluate an  age-comorbidity index  in a cohort of patients who were originally enrolled in a prospect i ve study to identify risk factors for peri-operative complications . Two-hundred and twenty-six patients were enrolled in the study . The participants were patients with hypertension or diabetes who underwent elective surgery between 1982 and 1985 and who survived to discharge . Two-hundred and eighteen patients survived until discharge . These patients were followed for at least five years post-operatively . The estimated relative risk of death for each comorbidity rank was 1.4 and for each decade of age was 1.4 . When age and comorbidity were modelled as a combined age-comorbidity score , the estimated relative risk for each combined age-comorbidity unit was 1.45 . Thus , the estimated relative risk of death from an increase of one in the comorbidity score proved approximately equal to that from an additional decade of age . The combined age-comorbidity score may be useful in some longitudinal studies to estimate relative risk of death from prognostic clinical covariates OBJECTIVES To determine the outcome of patients who refuse cystectomy after receiving neoadjuvant chemotherapy for muscle-invasive bladder cancer . METHODS Between 1995 and 2001 , 63 patients were evaluated who declined to undergo a planned cystectomy , because they achieved a complete clinical response to neoadjuvant cisplatin-based chemotherapy .  Patient , tumor , and treatment features were assessed prospect ively , and correlated in univariate and multivariate analyses with overall survival . The median follow-up was 86 mo and all patients were followed for more than 5 yr . RESULTS Forty patients ( 64 % ) survived , with 54 % of them having an intact functioning bladder . The number and size of invasive tumors were strongly associated with overall survival . The most significant treatment variable predicting better survival was complete resection of the invasive tumor on re-staging transurethral resection before starting chemotherapy . Of 23 patients ( 36 % ) who subsequently died of disease , 19 ( 30 % ) relapsed with invasive cancer in the bladder . Over 90 % of surviving patients had solitary , small , and low-stage invasive tumors completely resected , and 83 % survived without relapses in the bladder . CONCLUSIONS Selected patients with muscle-invasive bladder cancers may survive after transurethral resection and neoadjuvant chemotherapy , and tumor features can identify which patients responding completely to chemotherapy may survive without cystectomy BACKGROUND Despite aggressive local therapy , patients with locally advanced bladder cancer are at significant risk for metastases . We evaluated the ability of neoadjuvant chemotherapy to improve the outcome in patients with locally advanced bladder cancer who were treated with radical cystectomy .  METHODS Patients were enrolled if they had muscle-invasive bladder cancer ( stage T2 to T4a ) and were to be treated with radical cystectomy .  They were stratified according to age ( less than 65 years vs. 65 years or older ) and stage ( superficial muscle invasion vs. more extensive disease ) and were r and omly assigned to radical cystectomy alone or three cycles of methotrexate , vinblastine , doxorubicin , and cisplatin followed by radical cystectomy . RESULTS We enrolled 317 patients over an 11-year period , 10 of whom were found to be ineligible ; thus , 154 were assigned to receive surgery alone and 153 to receive combination therapy . According to an intention-to-treat analysis , the median survival among patients assigned to surgery alone was 46 months , as compared with 77 months among patients assigned to combination therapy ( P=0.06 by a two-sided stratified log-rank test ) . In both groups , improved survival was associated with the absence of residual cancer in the cystectomy specimen . Significantly more patients in the combination-therapy group had no residual disease than patients in the cystectomy group ( 38 percent vs. 15 percent , P<0.001 ) . CONCLUSIONS As compared with radical cystectomy alone , the use of neoadjuvant methotrexate , vinblastine , doxorubicin , and cisplatin followed by radical cystectomy increases the likelihood of eliminating residual cancer in the cystectomy specimen and is associated with improved survival among patients with locally advanced bladder cancer OBJECTIVES To evaluate the safety , tolerance , protocol completion rate , tumor response rate , and patient survival of chemoradiotherapy for patients with muscle-invasive operable bladder cancer . METHODS After transurethral resection of the tumor in patients with Stage T2-T4a bladder cancer , twice-daily radiotherapy with paclitaxel and cisplatin chemotherapy induction ( TCI ) was administered . If repeat biopsy showed less than Stage T1 disease , consolidation with TCI was given . If repeat biopsy showed greater than Stage T1 disease , cystectomy was recommended . Adjuvant gemcitabine and cisplatin were given to all patients . RESULTS A total of 80 patients met protocol eligibility .  TCI result ed in 26 % developing grade 3 - 4 acute toxicity , mainly gastrointestinal ( 25 % ) . During consolidation TCI , grade 3 - 4 acute toxicity , all transient , was reported in 8 % . Four cycles of adjuvant chemotherapy were completed per protocol or with minor deviations in 70 % of the patients . Adjuvant treatment was associated with grade 3 toxicity in 46 % and grade 4 in 26 % . One patient had a fatal hemorrhagic stroke . Late bladder radiation toxicity was evaluated in 53 patients with > or = 2 years of follow-up . Of these 53 patients , 3 experienced self-limited , late grade 3 bladder toxicity . The postinduction complete response rate was 81 % ( 65/80 ) , 36 of the 80 patients died ( 22 of bladder cancer ) . At a median follow-up of 49.4 months , the actuarial 5-year overall and disease-specific survival rate was 56 % and 71 % , respectively . CONCLUSIONS These favorable tumor response rates with possible increased bladder preservation rates suggest that this treatment regimen deserves further study BACKGROUND Many phase 2 bladder-sparing programmes using transurethral resection of the bladder ( TURB ) plus chemotherapy or radio-chemotherapy have been undertaken , but some controversies remain . OBJECTIVE To determine the efficacy of complete TURB plus three cycles of cisplatin-based chemotherapy in selected patients with muscle-invasive bladder cancer ( MIBC ) . DESIGN , SETTING , AND PARTICIPANTS A phase 2 nonr and omized trial was design ed that included patients with MIBC who underwent complete TURB with positive biopsies of the tumour bed . Patients with negative biopsies of the tumour bed , with macroscopically residual tumour , with hydronephrosis , or with distant metastasis were excluded from this trial . Patients included in this trial were offered three cycles of systemic chemotherapy or radical cystectomy ( RC ) . Clinical response ( cR ) was denoted by either no tumour or the presence of Ta1-Tis bladder tumour at 3-mo evaluation ; clinical non-response ( cNR ) was denoted by cases of muscle-invasive tumour or distant metastasis . Of 146 patients who entered this trial , 75 choose the bladder-sparing programme and 71 chose RC . MEASUREMENTS At 5 yr and 10 yr , the cancer-specific survival ( CSS ) rate was 64.5 % and 59.8 % , respectively , with no significant difference compared to the RC arm ( p=0.544 ) . The progression-free survival with bladder preserved was 52.6 % and 34.5 % , respectively . In multivariate analysis , cR was the only predictive factor for survival ( p=0.001 ) and bladder preservation ( p=0.000 ) . RESULTS AND LIMITATIONS This was not a r and omized trial , and patients were included over 16 yr . However , no modifications were made to the therapy schedule except from chemotherapy schemes considered st and ard at the time . CONCLUSIONS Patients with microscopic residual cancer after complete TURB seem to be good c and i date s for the bladder-sparing programme using three cycles of systemic chemotherapy , with CSS comparable to RC
Background Bladder-sparing treatment of muscle invasive bladder cancer ( MIBC ) with systemic chemotherapy plus transurethral resection of bladder tumors ( TURBT ) is increasingly seen in the literature -both in case series and subanalyses of patients who opt out of or are unfit for radical cystectomy ( RC ) .
Survival outcomes among these patients are often impressive , but these are typically small retrospective studies from single institutions and therefore of limited clinical value .
Objectives Our aim is to summarize the literature regarding definitive treatment of MIBC with systemic chemotherapy plus TURBT and provide a meta- analysis of survival outcomes for patients who received this treatment .