ABSTRACT
BACKGROUND: Neoadjuvant chemotherapy with methotrexate-vinblastine-doxorubicin-cisplatin (MVAC) is the standard of care for muscle-invasive urothelial bladder cancer. Gemcitabine plus cisplatin (GC) shows similar efficacy with less toxicity in the metastatic setting and has therefore often been used interchangeably with MVAC. We report on the efficacy and safety of neoadjuvant GC in patients with locally advanced urothelial cancer. MATERIALS AND METHODS: We prospectively evaluated 87 patients in 2 centers. Their median age was 68 years. Treatment consisted of 3× GC prior to radical cystectomy. The primary endpoint was pathologic response. The secondary endpoints were safety, progression-free survival (PFS), and overall survival (OS). RESULTS: In all, 83 patients finished chemotherapy; 80 patients were evaluable for the primary endpoint. Pathologic complete response (pCR) was achieved in 22.5% and near pCR was seen in 33.7% of the patients. The 1-year PFS rate was 79.5% among those patients achieving ≤pT2 versus 100% among those patients achieving pCR or near pCR (p = 0.041). Five-year OS was 61.8% (95% CI 67.6 to NA). GC was well tolerated. Grade 3/4 toxicities occurred in 38% of the patients. There was no grade 3/4 renal toxicity, febrile neutropenia, or death. CONCLUSION: Neoadjuvant GC is a well-tolerated regimen. Although the pathologic response is lower than that reported with MVAC, our data support GC as a feasible option in the absence of a prospective randomized comparison, particularly for older patients, since its toxicity is lower than that of MVAC.
Subject(s)
Carcinoma, Transitional Cell/drug therapy , Cisplatin/therapeutic use , Deoxycytidine/analogs & derivatives , Neoadjuvant Therapy , Urinary Bladder Neoplasms/drug therapy , Adult , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols , Carcinoma, Transitional Cell/pathology , Deoxycytidine/therapeutic use , Female , Humans , Male , Middle Aged , Prospective Studies , Treatment Outcome , Urinary Bladder Neoplasms/pathology , GemcitabineABSTRACT
BACKGROUND: To evaluate the reliability of sentinel lymphadenectomy compared to extended lymphadenectomy in men undergoing radical prostatectomy (RP). PATIENTS AND METHODS: A consecutive cohort of men with intermediate- to high-risk prostate cancer underwent RP with sentinel LA with intraoperative frozen section. In addition, extended LA was carried out in all cases. The endpoint was lymph node-positivity. RESULTS: In total, 54 men with a mean age of 65.3 (50.9-75.6) years were analyzed. The mean preoperative prostate-specific antigen was 10.6 (2.8-66.5) ng/ml, mean number of disease-positive cores was 5.8 (1-13), digital rectal examination was positive in 29 men (53.7%). In 12 men (22.2%), a positive lymph node was found (pN1). sLA was positive in 11 cases. One patient had a positive lymph node in eLA not found with sLA. The positive predictive value of frozen section was 50%; the respective figure for sLA compared to eLA was 91.6%. CONCLUSION: In this cohort, revealing a high prevalence of disease-positive lymph nodes, sLA was a reliable technique with a low rate of false negativity.
