Phase II Trial of Gemcitabine Plus Cisplatin in Patients With Metastatic Urothelial Cancer

Kaufman, Donald S.; Raghavan, Derek; Carducci, Michael A.; Levine, Ellis G.; Murphy, Barbara; Aisner, Joseph; Kuzel, Timothy M.; Nicol, Steven J.; Oh, William; Stadler, Walter M.

doi:10.1200/jco.2000.18.9.1921

Cited by 232 publications

(99 citation statements)

References 16 publications

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“…The objective has been to find combinations that demonstrate improved efficacy and a better toxicity profile compared with that of M-VAC. The most extensively studied drugs have been gemcitabine (Moore et al, 1999;Von der Maase et al, 1999;Kaufman et al, 2000) and paclitaxel (Redman et al, 1998;Vaughn et al, 1998;Zielinski et al, 1998;Dreicer et al, 2000;Small et al, 2000), each in combination with cisplatin or carboplatin. These studies have usually shown an elevated activity with a favourable toxicity profile (Table 3).…”

Section: Discussionmentioning

confidence: 99%

Phase II multicentre study of docetaxel plus cisplatin in patients with advanced urothelial cancer

Muro

Marcuello

Gumà³

et al. 2002

Br J Cancer

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A multicentre phase II trial was undertaken to evaluate the activity and toxicity of docetaxel plus cisplatin as first-line chemotherapy in patients with urothelial cancer. Thirty-eight patients with locally advanced or metastatic transitional-cell carcinoma of the bladder, renal pelvis or ureter received the combination of docetaxel 75 mg m 72 and cisplatin 75 mg m 72 on day 1 and repeated every 21 days, to a maximum of six cycles. The median delivered dose-intensity was 98% (range 79 -102%) of the planned dose for both drugs. There were seven complete responses and 15 partial responses, for and overall response rate of 58% (95% CI, 41 -74%). Responses were even seen in three patients with hepatic metastases. The median time to progression was 6.9 months, and the median overall survival was 10.4 months. Two patients who achieved CR status remain free of disease at 4 and 3 years respectively. Grade 3 -4 granulocytopenia occurred in 27 patients, resulting in five episodes of febrile neutropenia. There was one toxic death in a patient with grade 4 granulocytopenia who developed acute abdomen. Grade 3 -4 thrombocytopenia was rare (one patient). Other grade 3 -4 toxicities observed were anaemia (three patients), vomiting (five patients), diarrhoea (four patients), peripheral neuropathy (two patients) and non-neutropenic infections (seven patients). Docetaxel plus cisplatin is an effective and well-tolerated regimen for the treatment of advanced urothelial cancer, and warrants further investigation.

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Section: Discussionmentioning

confidence: 99%

Phase II multicentre study of docetaxel plus cisplatin in patients with advanced urothelial cancer

Muro

Marcuello

Gumà³

et al. 2002

Br J Cancer

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“…A number of studies using GC for treating urothelial cancer have been done. Kaufman et al (19), reported an overall response rate of 41% (CR: 22%, PR: 19%), a median time to treatment failure of 5.5 months and a median overall survival of 14.3 months for the metastatic urothelial cancer patients who were treated with GC. Moore et al (20), reported that using GC for advanced urothelial cancer produced an overall response rate and a median survival of 57% (CR: 21%, PR: 36%) and 13.2 months, respectively, which concurs with our findings of an overall response rate and a median survival of 36% (CR: 24%, PR: 12%) and 20 months, respectively.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of C ombined G emcitabine/Cisplatin C hemotherapy for Locally Advanced or Metastatic Urothelial Cancer

et al. 2006

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Purpose: W e wanted to determine and report on the outcome of combined gemcitabine/cisplatin chemotherapy for patients suffering with locally advanced or metastatic urothelial cancer.Materials and Methods: Between July 1999 and December 2004, 43 selected patients were enrolled in this study. Group 1 (the adjuvant chemotherapy group) had undergone radical surgery with removal of evident tumor from the following primary sites: bladder (n=8), renal pelvis (n=7) and ureter (n=3). Group 2 (the salvage chemotherapy group) had undergone palliative surgery with a remnant tumor at the following primary sites; bladder (n=23) and renal pelvis (n=2). All the patients were given gemcitabine/ciplatin and they evaluated for the therapeutic effect and toxicity. The patients were initially treated with gemcitabine 1000 mg/m 2 intravenously for 30 minutes on days 1, 8 and 15 of a 28-day cycle, and cisplatin 70 mg/m 2 was administered intravenously on day 1 using prehydration measures.Results: Group 1: The median follow-up period was 16.5 months. The mean age was 63 years (males: 15 cases, females: 3 cases), and eleven patients (61% ) remained alive. The estimated median relapse-free survival period and 2-year survival rate were 24 months and 63% , respectively. Group 2: the median follow-up period was 20 months, the mean patient age was 63.8 years (males: 22 cases, females: 3 cases), and nine patients (36% ) remained alive. The overall response and 2-year survival rates were 36% and 43%, respectively. Toxicities: Grade 3 toxicities developed in 14 cycles during the total 232 cycles. Grade 4 toxicity did not occur.Conclusions: The results of this study confirm that adjuvant and salvage chemotherapy with using gemcitabine and cisplatin is tolerable and safe.

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“…3,4 New agents, including gemcitabine, [7][8][9][10] paclitaxel, 11 and docetaxel, 12 have shown activity in patients with bladder and urinary tract transitional cell carcinomas. In Phase II trials, gemcitabine has been combined successfully with cisplatin, [13][14][15] paclitaxel, 16 and paclitaxel plus carboplatin, 17 producing interesting response rates and median survivals. A recently published multicenter, randomized study comparing M-VAC with gemcitabine plus cisplatin (GC) documented no differences in activity, progression free survival, and overall survival, with a tolerability profile favoring GC.…”

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confidence: 99%

Gemcitabine plus epirubicin in patients with advanced urothelial carcinoma who are not eligible for platinum‐based regimens

Ricci

Galli²,

Chioni³

et al. 2002

Cancer

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BACKGROUNDThe objective of this study was to evaluate the efficacy and toxicity of gemcitabine plus epirubicin in previously untreated patients with advanced urothelial carcinoma who were not eligible for cisplatin‐based regimens.METHODSPatients with advanced urothelial carcinoma and at least one of the following characteristics were eligible: impaired renal function (creatinine clearance < 60 mL per minute), an Eastern Cooperative Oncology Group performance status (PS) ≥ 2, and age ≥ 75 years. The treatment included epirubicin 70 mg/m2 as an intravenous bolus on Day 1 and gemcitabine 1000 mg/m2 over 30 minutes on Days 1 and 8 of a 21‐day cycle.RESULTSThirty‐eight patients entered the study, and a total of 152 cycles were administered, with a median of 4 cycles per patient (range, 1–6 cycles per patient). The following Grade 3–4 hematologic toxicities were reported (percent of cycles): neutropenia, 22.4%; anemia, 11.2%; and thrombocytopenia, 6.5%. No cardiac, renal, or hepatic toxicities were observed. Dose intensities of epirubicin and gemcitabine were 19.6 mg/m2 per week (84%) and 532.2 mg/m2 per week (80%), respectively. There were 2 complete responses (5.3%), 13 partial responses (34.2%), 11 patients with stable disease (28.9%), and 12 patients with progressive disease (31.6%), for an overall response rate of 39.5% (95% confidence interval, 25.1–55.1). The median progression free survival (PFS) and overall survival (OS) rates were 4.8 months and 8.0 months, respectively. The 1‐year survival rate was 38%, and the median PFS and OS were 6.4 months and 16.4 months, respectively, in patients with PS 0–1. Thirty patients were symptomatic: Seventeen patients (56.7%) achieved a complete response, and 5 patients (16.7%) achieved a partial symptomatic response.CONCLUSIONSAt the doses given in this study, gemcitabine and epirubicin had a good tolerability profile with interesting activity in patients with advanced urothelial carcinoma who were not fit for cisplatin‐based regimens. Cancer 2002;95:1444–50. © 2002 American Cancer Society.DOI 10.1002/cncr.10860

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Phase II Trial of Gemcitabine Plus Cisplatin in Patients With Metastatic Urothelial Cancer

Cited by 232 publications

References 16 publications

Phase II multicentre study of docetaxel plus cisplatin in patients with advanced urothelial cancer

Phase II multicentre study of docetaxel plus cisplatin in patients with advanced urothelial cancer

Efficacy of C ombined G emcitabine/Cisplatin C hemotherapy for Locally Advanced or Metastatic Urothelial Cancer

Gemcitabine plus epirubicin in patients with advanced urothelial carcinoma who are not eligible for platinum‐based regimens

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