+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

Efficacies and safety of neoadjuvant gemcitabine plus carboplatin followed by immediate cystectomy in patients with muscle-invasive bladder cancer, including those unfit for cisplatin: a prospective single-arm study



Efficacies and safety of neoadjuvant gemcitabine plus carboplatin followed by immediate cystectomy in patients with muscle-invasive bladder cancer, including those unfit for cisplatin: a prospective single-arm study



International Journal of Clinical Oncology 18(4): 724-730



Neoadjuvant cisplatin-based chemotherapy for patients with muscle-invasive bladder cancer (BC) has better survival benefit than radical cystectomy (RC) alone. However, optimal dosing schedule, including drug selection, number of cycles, and interval between chemotherapy and cystectomy, as well as acceptable regimens remain to be established. We conducted a single-arm prospective study to evaluate efficacy and safety of neoadjuvant gemcitabine plus carboplatin (GCarbo) chemotherapy followed by immediate RC in patients with muscle-invasive BC, including cisplatin-unfit patients. Between March 2005 and June 2011, we enrolled 116 patients with histologically proven muscle-invasive BC, including 44 % of the patients who were identified as cisplatin-unfit. All participants received two courses of GCarbo therapy, gemcitabine 800 mg/m(2) administered on days 1, 8, and 15 and carboplatin with an area under the curve of four (AUC 4) administered on day 2. RC and bilateral pelvic lymphadenectomy were performed approximately within a month after cessation of chemotherapy. The primary endpoint was pT0 in the cystectomy specimen. Secondary endpoints were overall response rate, overall (OS) and disease-free survival (DFS), and toxicity. Survival after cystectomy was analyzed using the Kaplan-Meier method. The RC specimens of 28 (24.1 %) patients showed pT0. At a median follow-up period of 41 months, the OS and DFS rates were 89.7 and 86.3 %, respectively. No patients had grade 3/4 gastrointestinal toxicity or renal impairment. Neoadjuvant GCarbo therapy followed by immediate RC is safe, even in cisplatin-unfit patients, and provides a favorable pathological cancer-free state. The single-arm single-institution study design and relatively short observation period were limitations of this study.

Please choose payment method:






(PDF emailed within 0-6 h: $19.90)

Accession: 036596525

Download citation: RISBibTeXText

PMID: 23011100

DOI: 10.1007/s10147-012-0447-z


Related references

The utility of neoadjuvant gemcitabine plus carboplatin followed by immediate radical cystectomy in patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. International Journal of Clinical Oncology 22(1): 159-165, 2017

Neoadjuvant Gemcitabine Plus Carboplatin Followed By Immediate Radical Cystectomy In Patients With Muscle-Invasive Bladder Cancer: A Propensity Score Analysis. The Journal of Urology 187(4): e217-e218, 2012

Neoadjuvant chemotherapy with gemcitabine plus carboplatin followed by immediate radical cystectomy for muscle-invasive bladder cancer. International Journal of Urology 21(1): 3-4, 2014

Neoadjuvant sorafenib, gemcitabine, and cisplatin administration preceding cystectomy in patients with muscle-invasive urothelial bladder carcinoma: An open-label, single-arm, single-center, phase 2 study. Urologic Oncology 36(1): 8.E1-8.E8, 2018

Multicenter Prospective Phase II Trial of Neoadjuvant Dose-Dense Gemcitabine Plus Cisplatin in Patients With Muscle-Invasive Bladder Cancer. Journal of Clinical Oncology 36(19): 1949-1956, 2018

Retrospective analysis of the efficacy and safety of neoadjuvant gemcitabine and cisplatin in muscle-invasive bladder cancer. Journal of Oncology Pharmacy Practice 2019: 1078155219845434, 2019

Is neoadjuvant chemotherapy with gemcitabine plus cisplatin beneficial in patients with muscle-invasive bladder cancer?. Expert Review of Anticancer Therapy 9(6): 747-752, 2009

Cigarette smoking is associated with adverse pathological response and increased disease recurrence amongst patients with muscle-invasive bladder cancer treated with cisplatin-based neoadjuvant chemotherapy and radical cystectomy: a single-centre experience. Bju International 123(6): 1011-1019, 2019

Neoadjuvant gemcitabine and carboplatin followed by immediate cystectomy may be associated with a survival benefit in patients with clinical T2 bladder cancer. Medical Oncology 31(5): 949, 2014

Improving the outcome of patients with muscle invasive urothelial carcinoma of the bladder with neoadjuvant gemcitabine/cisplatin chemotherapy: A single institution experience. Canadian Urological Association Journal 8(3-4): E287-E293, 2014

Neoadjuvant gemcitabine plus cisplatin for muscle-invasive bladder cancer. Japanese Journal of Clinical Oncology 41(7): 908-914, 2011

Neoadjuvant induction dose-dense MVAC for muscle invasive bladder cancer: efficacy and safety compared with classic MVAC and gemcitabine/cisplatin. World Journal of Urology 34(2): 157-162, 2016

Short-term outcome of neoadjuvant gemcitabine-carboplatin therapy for muscle-invasive bladder cancer. Gan to Kagaku Ryoho. Cancer and ChemoTherapy 35(1): 83-86, 2008

Relative efficacy of neoadjuvant gemcitabine and cisplatin versus methotrexate, vinblastine, adriamycin, and cisplatin in the management for muscle-invasive bladder cancer. Hinyokika Kiyo. Acta Urologica Japonica 59(5): 277-281, 2013

Comparative effectiveness of gemcitabine plus cisplatin versus methotrexate, vinblastine, doxorubicin, plus cisplatin as neoadjuvant therapy for muscle-invasive bladder cancer. Cancer 121(15): 2586-2593, 2015