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Original Articles: Bladder Cancer: Neoadjuvant Cisplatin Chemotherapy Before Radical Cystectomy in Invasive Transitional Cell Carcinoma of the Bladder: A Prospective Randomized Phase III Study

1995; Lippincott Williams & Wilkins; Volume: 153; Issue: 3S Linguagem: Inglês

10.1016/s0022-5347(01)67614-6

1527-3792

J A Martínez-Piñeiro, M. González Martín, Fernando Arocena, Nicolás Flores, Carlos Ramos Roncero, José Antonio Portillo, A Escudero, F. Jiménez Cruz, Santiago Isorna,

Viral-associated cancers and disorders

No AccessJournal of UrologyClinical Urology: Original Article1 Mar 1995Original Articles: Bladder Cancer: Neoadjuvant Cisplatin Chemotherapy Before Radical Cystectomy in Invasive Transitional Cell Carcinoma of the Bladder: A Prospective Randomized Phase III Study Jose A. Martinez-Pineiro, Marcelino Gonzalez Martin, Fernando Arocena, Nicolas Flores, Carlos Ramos Roncero, Jose A. Portillo, Angel Escudero, Fernando Jimenez Cruz, and Santiago. Isorna Jose A. Martinez-PineiroJose A. Martinez-Pineiro , Marcelino Gonzalez MartinMarcelino Gonzalez Martin , Fernando ArocenaFernando Arocena , Nicolas FloresNicolas Flores , Carlos Ramos RonceroCarlos Ramos Roncero , Jose A. PortilloJose A. Portillo , Angel EscuderoAngel Escudero , Fernando Jimenez CruzFernando Jimenez Cruz , and Santiago. IsornaSantiago. Isorna View All Author Informationhttps://doi.org/10.1016/S0022-5347(01)67614-6AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail From November 1984 to April 1989, 122 patients with clinical T2-4a Nx-2 M0 transitional cell carcinoma of the bladder were entered in a prospective randomized trial to compare survival between a control group of 60 patients treated only with radical cystectomy (arm A) and a group of 62 patients treated with 3 cycles of 100 mg./m2. neoadjuvant cisplatin before radical cystectomy (arm B). Secondary objectives of the trial were comparison of the disease-free interval and time to death, significance of response of the primary tumor to cisplatin, pattern of relapse and toxicity. As of April 1993 after a median followup of 78.2 months (range 48 to 101) no difference in survival between the control patients and those who received neoadjuvant cisplatin has been observed. The overall direct survival is 37.3% for arm A and 35.5% for arm B. The survival rate of the 109 patients who complied with the protocol is 38.2% for 55 patients of the control group and 40.7% for 54 patients of the cisplatin group. Survival rates of patients theoretically rendered free of disease by radical cystectomy (complete response pT0-4a, pN0-2, M0) is 43.7% for 40 control patients and 47.8% for 41 cisplatin treated patients. The time to relapse in complete response patients was significantly longer (p = 0.0298) for those who received cisplatin (arm A 13.1 months versus arm B 30.3 months). The time to death (cause specific) did not differ significantly between both groups overall (p = 0.1349) but it was significantly different between controls and responders (p = 0.0501). Preoperative cisplatin downstaged the primary tumor in 19 patients (33.9%), of whom 11 (19.6%) had no tumor in the cystectomy specimen (pT0) and 8 (14.3%) had superficial tumor (pTis pTa pT1). In 6 patients (9.7%) disease progressed during chemotherapy. The survival of the responders was significantly better than that of nonresponders (p = 0.0142), with specific death rate of 26.3% and 62.5%, respectively, and a median time to death of 43 months for responders and 30.5 months for nonresponders. Patients without nodal involvement (pN0) or with only 1 micrometastasis (pN1) fared significantly better (p = 0.0001) than those with major node invasion (pN2-4), irrespective of the treatment received. The survival rate is 48.6% for patients with pN0 disease, 37.5% for pN1 and 5% for pN2-4. Toxicity of cisplatin was minimal and there were no differences in perioperative morbidity between the arms. In conclusion, 3 cycles of neoadjuvant cisplatin did not improve the overall survival of patients undergoing cystectomy for muscle infiltrating transitional cell bladder cancer, although they did prolong significantly the disease-free interval (p = 0.0298). 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Google Scholar From the Hospital La Paz, Hospital 12 de Octubre, Hospital Ramon y Cajal, Madrid, Hospital Juan Canalejo, La Coruna, Hospital Virgen de Aranzazu, San Sebastian, Hospital Civil de Basurto, Bilbao, Hospital Marques deValdecilla, Santander, Hospital La Fe, Valencia and Hospital Nuestra Sra. del Pino, Las Palmas de Gran Canaria, Spain© 1995 by American Urological Association, Inc.FiguresReferencesRelatedDetailsCited byPugashetti N, Chandrasekar T, Lurvey R, Durbin-Johnson B, Dall'Era M, deVere White R, Evans C and Yap S (2016) Perioperative Outcomes following Neoadjuvant Chemotherapy and Radical Cystectomy—Is There Room for Improvement?Urology Practice, VOL. 3, NO. 5, (364-370), Online publication date: 1-Sep-2016.Traboulsi S and Kassouf W (2015) A Review of Neoadjuvant and Adjuvant Chemotherapy for Nonmetastatic Muscle Invasive Bladder CancerUrology Practice, VOL. 3, NO. 1, (41-49), Online publication date: 1-Jan-2016.Margel D, Tal R, Neuman A, Konichezky M, Sella A and Baniel J (2018) Prediction of Extravesical Disease by Preoperative Serum Markers in Patients With Clinically Organ Confined Invasive Bladder CancerJournal of Urology, VOL. 175, NO. 4, (1253-1257), Online publication date: 1-Apr-2006.ROSENBERG J, CARROLL P and SMALL E (2018) UPDATE ON CHEMOTHERAPY FOR ADVANCED BLADDER CANCERJournal of Urology, VOL. 174, NO. 1, (14-20), Online publication date: 1-Jul-2005.WINQUIST E, KIRCHNER T, SEGAL R, CHIN J and LUKKA H (2018) Neoadjuvant Chemotherapy for Transitional Cell Carcinoma of the Bladder: A Systematic Review and Meta-AnalysisJournal of Urology, VOL. 171, NO. 2, (561-569), Online publication date: 1-Feb-2004.ENNIS R, PETRYLAK D, SINGH P, BAGIELLA E, O'TOOLE K, BENSON M and OLSSON C (2018) THE EFFECT OF CYSTECTOMY, AND PERIOPERATIVE METHOTREXATE, VINBLASTINE, DOXORUBICIN AND CISPLATIN CHEMOTHERAPY ON THE RISK AND PATTERN OF RELAPSE IN PATIENTS WITH MUSCLE INVASIVE BLADDER CANCERJournal of Urology, VOL. 163, NO. 5, (1413-1418), Online publication date: 1-May-2000.SHIPLEY W, KAUFMAN D, HENEY N, ALTHAUSEN A and ZIETMAN A (2018) AN UPDATE OF COMBINED MODALITY THERAPY FOR PATIENTS WITH MUSCLE INVADING BLADDER CANCER USING SELECTIVE BLADDER PRESERVATION OR CYSTECTOMYJournal of Urology, VOL. 162, NO. 2, (445-450), Online publication date: 1-Aug-1999.SERRETTA V, LO GRECO G, PAVONE C and PAVONE-MACALUSO M (2018) THE FATE OF PATIENTS WITH LOCALLY ADVANCED BLADDER CANCER TREATED CONSERVATIVELY WITH NEOADJUVANT CHEMOTHERAPY, EXTENSIVE TRANSURETHRAL RESECTION AND RADIOTHERAPY: 10-YEAR EXPERIENCEJournal of Urology, VOL. 159, NO. 4, (1187-1191), Online publication date: 1-Apr-1998.Angulo J, Sanchez-Chapado M, Lopez J and Flores N (2018) Primary Cisplatin, Methotrexate and Vinblastine Aiming at Bladder Preservation in Invasive Bladder Cancer: Multivariate Analysis on Prognostic FactorsJournal of Urology, VOL. 155, NO. 6, (1897-1902), Online publication date: 1-Jun-1996. Volume 153Issue 3SMarch 1995Page: 964-973 Advertisement Copyright & Permissions© 1995 by American Urological Association, Inc.Metrics Author Information Jose A. Martinez-Pineiro More articles by this author Marcelino Gonzalez Martin More articles by this author Fernando Arocena More articles by this author Nicolas Flores More articles by this author Carlos Ramos Roncero More articles by this author Jose A. Portillo More articles by this author Angel Escudero More articles by this author Fernando Jimenez Cruz More articles by this author Santiago. Isorna More articles by this author Expand All Advertisement PDF downloadLoading ...