Gemcitabine plus Cisplatin versus Gemcitabine plus Carboplatin as First-Line Chemotherapy in Advanced Transitional Cell Carcinoma of the Urothelium: Results of a Randomized Phase 2 Trial

Dogliotti, Luigi; Cartenì, Giacomo; Siena, Salvatore; Bertetto, Oscar; Martoni, Andrea; Bono, Aldo; Amadori, Dino; Onat, Haluk; Marini, Luca

doi:10.1016/j.eururo.2006.12.029

Cited by 303 publications

(195 citation statements)

References 26 publications

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“…Traditionally, MVAC or CMV is the regimen of choice.The regimen of GC has gained favor recently because it is easy to administer and has a less toxic profile. Both cisplatin and carboplatin have been used in the past, although a randomized phase II study showed carboplatin to be inferior to cisplatin in first-line treatment of metastatic transitional cell carcinoma of the urothelium [41]. Although the data were descriptive in nature without statistical comparisons and the trial was not designed with sufficient power to detect significant differences between arms in terms of efficacy, cisplatin was used preferentially over carboplatin in the neoadjuvant setting based on extrapolation of the previously mentioned data.…”

Section: Discussionmentioning

confidence: 99%

Neoadjuvant Chemotherapy for Muscle-Invasive Bladder Cancer: A Systematic Review and Two-Step Meta-Analysis

et al. 2016

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Background. Platinum-based neoadjuvant chemotherapy has been shown to improve survival outcomes in muscle-invasive bladder cancer patients.Weperformed a systematic review and meta-analysis to provide updated results of previous findings. We also summarized published data to compare clinical outcomes of methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) versus gemcitabine and cisplatin/carboplatin (GC) in the neoadjuvant setting. Methods. A meta-analysis of 15 randomized clinical trials was performed to compare neoadjuvant chemotherapy plus local treatment with the same local treatment alone. Because no randomized trials have investigated MVAC versus GC in the neoadjuvant setting, a meta-analysis of 13 retrospective studies was performed to compare MVAC with GC. Results. A total of 3,285 patients were included in 15 randomized clinical trials. There was a significant overall survival

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Section: Discussionmentioning

confidence: 99%

Neoadjuvant Chemotherapy for Muscle-Invasive Bladder Cancer: A Systematic Review and Two-Step Meta-Analysis

et al. 2016

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“…Similarly, a carboplatin regimen was investigated alongside gemcitabine in phase ii trials that did not exclude patients fit to receive cisplatin, resulting in ors of 56% and 59% and a median os of only 10 months [27][28][29] . In a phase ii randomized trial of gc versus gemcitabine with carboplatin, better response rates were observed with gc (66% vs. 35%) without significant differences in toxicity profile 30 . Based on the foregoing findings, it became evident that carboplatin is inferior to cisplatin.…”

Section: 21mentioning

confidence: 99%

First- and Second-Line Therapy for Metastatic Urothelial Carcinoma of the Bladder

2011

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but little improvement has been achieved in the outcomes of patients with advanced or metastatic disease. Almost 90% of those patients eventually succumb to their cancer.For patients who relapse after first-line chemotherapy, the prognosis is generally poor. To date, there is no real consensus on how to best treat these patients, and most of the available evidence stems from small phase ii trials that have mostly failed to show survival benefit over supportive care. The present review provides an update on the management of metastatic bc, with a focus on first-line and secondline therapies. FIRST-LINE THERAPY Single-Agent TherapySingle-agent therapy has generally failed to provide adequate results in patients with advanced bc. In a phase iii trial of patients randomized to receive either cisplatin alone or in combination [methotrexate, vinblastine, doxorubicin, and cisplatin (mvac)], the overall response rate (or) was only 12% in the cisplatin arm, with only 4 of 122 patients (3.3%) remaining alive at 3 years of follow-up 4 . Similar results were observed in phase ii trials with carboplatin [or: 18%; median duration of survival (mds): 16 months] 5 . In a phase iii trial examining the role of lobaplatin, 2 of 17 patients (12%) achieved a partial response (pr), but the study was terminated because of high toxicity rates 6 . Other drugs investigated in phase ii trials have manifested variable activity against advanced urothelial cancer: oral piritrexim (or: 23%; mds: 22 weeks) 7 , trimetrexate (or: 17%; mds not reported) 8 , and docetaxel (or: 13%; mds: 9 months) 9 . However, some improved results were obtained with other single agents such as paclitaxel and gemcitabine 10,11 . In a phase ii trial of 26 patients with advanced bc treated with paclitaxel, the or was 42%, and the mds, 8.4 months 10 . Similarly, in a phase ii trial of gemcitabine in 40 patients, an or of 28% was reported, with a mds of 54 weeks 11 . ABSTRACTUrothelial cancer of the bladder is the 4th most common malignancy in American men and the 9th most common in women. Although it is a chemosensitive disease, advanced bladder cancer seems to have reached a plateau with regard to median survival of patients. Standard first-line therapy remains gemcitabine plus cisplatin (gc) or methotrexate, vinblastine, doxorubicin, and cisplatin (mvac). In patients deemed unfit to receive cisplatin, gemcitabine plus carboplatin or gemcitabine plus paclitaxel can be considered. To date, no standard therapy has been established for patients who recur or are refractory to first-line therapy. Second-line vinflunine, by way of superiority over best supportive care, has shown promise in a phase iii trial. Cisplatin-based therapy (mvac or gc) can also be offered to patients previously treated with cisplatin, especially if they responded previously and are considered platinum-sensitive. Novel targeted therapies are sorely needed to further improve the delivery and efficacy of chemotherapy.

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“…Compared with GC, PGC is associated with a significant improvement in the OS among patients with primary bladder cancer (median, 16 vs. 12 months; hazard ratio, 0.80; 95% confidence intervals, 0.66-0.97), however, with increased incidence of serious grade III and IV toxicities (8). For patients with impaired renal function, carboplatin-based regimens can be used as the first-line for metastatic TCC, however, its efficacy remains to be evaluated with larger phase III trials (9). Non-platinum regimens, particularly those combining gemcitabine with either paclitaxel or docetaxel have also shown promising results in several phase II studies (10,11).…”

Section: Introductionmentioning

confidence: 99%

Efficacy of weekly paclitaxel treatment as a single agent chemotherapy following first-line cisplatin treatment in urothelial bladder cancer

Sideris

Aoun

Zanaty

et al. 2016

Molecular and Clinical Oncology

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Abstract. The aim of the present study was to investigate the efficacy of paclitaxel following a first-line cisplatin regimen in patients with metastatic bladder cancer. The present study retrospectively evaluated the clinical effects and toxicities of second-line paclitaxel regimens following first-line cisplatin treatment in metastatic bladder cancer. A total of 42 patients with progressing metastatic urothelial bladder cancer following cisplatin-based chemotherapy were enrolled. The patients received weekly treatment with paclitaxel (80 mg/m 2 ) with a median duration of 3 months. The overall response rate, disease control rate and median progression free survival were 9.5, 45.2 and 6.4 months, respectively. Weekly paclitaxel was well-tolerated with rare grade III or IV toxicities. Second-line weekly paclitaxel treatment following first-line cisplatin-based chemotherapy is an effective and well-tolerated regimen in urothelial metastatic bladder cancer.

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Gemcitabine plus Cisplatin versus Gemcitabine plus Carboplatin as First-Line Chemotherapy in Advanced Transitional Cell Carcinoma of the Urothelium: Results of a Randomized Phase 2 Trial

Cited by 303 publications

References 26 publications

Neoadjuvant Chemotherapy for Muscle-Invasive Bladder Cancer: A Systematic Review and Two-Step Meta-Analysis

Neoadjuvant Chemotherapy for Muscle-Invasive Bladder Cancer: A Systematic Review and Two-Step Meta-Analysis

First- and Second-Line Therapy for Metastatic Urothelial Carcinoma of the Bladder

Efficacy of weekly paclitaxel treatment as a single agent chemotherapy following first-line cisplatin treatment in urothelial bladder cancer

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