Significant activity of paclitaxel in advanced transitional-cell carcinoma of the urothelium: a phase II trial of the Eastern Cooperative Oncology Group.

Roth, Bruce J.; Dreicer, Robert; Einhorn, Lawrence H.; Neuberg, Donna; Johnson, David H.; Smith, Julia; Hudes, Gary R.; Schultz, Stephen; Loehrer, Patrick J.

doi:10.1200/jco.1994.12.11.2264

Cited by 310 publications

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“…Britsh Joumal of Cancer (1998) 78(8) (Loehrer et al 1994) and the MD Anderson study of M-VAC vs CISCA (Logothetis et al 1990). There are a number of possible explanations for this.…”

Section: Effects In Different Subgroupsmentioning

confidence: 99%

“…on the whole British Jourmal of Cancer (1998) 78(8) pro'ide poor palliation for a majority of patients. A number of studies have attempted to increase the dose intensity of M-VAC by simultaneous administration of orowth factors (Loehrer et al 1994: Logothetis et al 1985. The majoritv of these studies have concluded that this resulted in a modest increase in dose intensitv.…”

Section: Effects In Different Subgroupsmentioning

confidence: 99%

“…These agents include the taxanes. paclitaxel (Roth et al 1994) and docetaxel (McCaffrey et al 1995). g!emcitabine (Stadler et al 1995) ifosfamide (Witte et al 1997) and gallium (Seligman et al 1991 New prospective studies should therefore examine not only response rates and survival.…”

Section: Effects In Different Subgroupsmentioning

confidence: 99%

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A randomized trial comparing methotrexate and vinblastine (MV) with cisplatin, methotrexate and vinblastine (CMV) in advanced transitional cell carcinoma: results and a report on prognostic factors in a Medical Research Council study

Mead

Russell²,

Clark³

et al. 1998

Br J Cancer

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of CMV. This translates to an absolute improvement in 1-year survival of 13%, 16% in MV and 29% in CMV. The median survival for CMV and MV was 7 months and 4.5 months respectively. Two hundred and eight patients objectively progressed or died. The hazard ratio was 0.55 (95% Cl 0.41-0.73, P-value = 0.0001) in favour of CMV. Two hundred and nine patients symptomatically progressed or died. The hazard ratio was 0.48 (950°o Cl 0.36-0.64. P-value = 0.0001) in favour of CMV. The most important pretreatment factors influencing overall survival were WHO performance status and extent of disease. These two factors were used to derive a prognostic index which could be used to categorize patients into three prognostic groups. We conclude that the addition of cisplatin to methotrexate and vinblastine should be considered in patients with transitional cell carcinoma, taking into account the increased toxicity.Keywords: chemotherapy; transitional cell carcinoma: randomized Transitional cell carcinomas (TCCs) mav arise at anx site within the unrnarx tract and are a source of considerable morbiditx and mortalitv. In 1994. there A-ere 5300 deaths from this disease in the UK (Cancer Research Campaign. 1995). Approximately 90% of these cancers arise in the bladder. occumrng at a median ag,e of 65 Xears. Treatment of patient.s with disease confined to the bladder (1T2 or T3) w-ith radiotherapy or cystectomy results in cure in 30-40%7 of cases. Patients w-ith metastatic disease hax-e a much poorer prognosis. with less than 5%-alix-e at 5 vears (Saxman et al. 1997).During the last 15-20 years. chemotherapy. predominantly using the drugs methotrexate. Xinblastine. cisplatin and doxorubicin. has been w-idelx used to treat these cancers (Sternberg. 1995). Early randomized trials using combinations of these drugs. (Sternberg et al 1985(Sternberg et al . 1988(Sternberg et al . 1989). a drug combination incorporating all these drugs. and CMV (omittinc doxorubicin: Hark-er et al. 1985: Jeffern et al. 1992). large improvements in remission rate were reported in single-institution studies. with reports of longterm sunrival in 20'c of patients in one study (Sternberg et al. 1989). In a subsequent randomized trial. howex er. comparing single-agent cisplatin wxith M-VAC (Loehrer et al. 1992). the essentially palliative nature of these treatments w as demonstrated.W'hile M-VAC proxed capable of increasing median sun-ix al time from 8 months to 12 months. a 5-y ear progression-free surnival of only 4%/c wxas reported (Saxman et al. 1997 resulting in marked morbidity-for the majority of patients and treatment-related mortality in up to 4%,c of cases (Loehrer et al. 1992). Cisplatin itself is probably responsible for most of the impairment of quality of life. and the precise role of this drug in the management of these cancers has not been clearlv demonstrated. Cisplatin-based treatment can also be inconvenient to the patient. usually requirinc hospitalization for administration. In the trial comparing single-agent cisplatin with M-VAC (Loehre...

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“…Britsh Joumal of Cancer (1998) 78(8) (Loehrer et al 1994) and the MD Anderson study of M-VAC vs CISCA (Logothetis et al 1990). There are a number of possible explanations for this.…”

Section: Effects In Different Subgroupsmentioning

confidence: 99%

Section: Effects In Different Subgroupsmentioning

confidence: 99%

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A randomized trial comparing methotrexate and vinblastine (MV) with cisplatin, methotrexate and vinblastine (CMV) in advanced transitional cell carcinoma: results and a report on prognostic factors in a Medical Research Council study

Mead

Russell²,

Clark³

et al. 1998

Br J Cancer

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“…Several of these agents, including paclitaxel, gemcitabine, and docetaxel, have exhibited significant activity against advanced transitional cell carcinoma. [2][3][4] Many doublet and triplet combinations of these agents in various Phase II trials have reported overall response rates in the range of 50 -80%, with some studies yielding intriguing, prolonged median survival rates compared with those obtained with the M-VAC regimen. 5 A Phase I study of gemcitabine and docetaxel evaluating a Day 1 and Day 8 schedule reported responses in two patients with bladder carcinoma, and a small Phase II trial using a different dose and schedule similarly demonstrated activity in patients with urothelial carcinoma, 6,7 prompting interest in a formal evaluation of this doublet.…”

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confidence: 99%

Phase II trial of gemcitabine and docetaxel in patients with advanced carcinoma of the urothelium

Dreicer

Manola

Schneider

et al. 2003

Cancer

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BACKGROUNDGemcitabine and docetaxel are active agents in advanced urothelial carcinoma. A Phase II trial of this combination was performed to determine the activity and toxicity of these agents in a multiinstitutional setting in patients previously treated with one prior chemotherapy regimen.METHODSTwenty‐nine eligible patients with advanced urothelial carcinoma were treated with docetaxel at a dose of 40 mg/m2 over 1 hour followed by gemcitabine, 800 mg/m2, over 30 minutes, both intravenously (i.v.) on Days 1 and 8. Cycles were repeated every 21 days until disease progression or a maximum of 6 cycles.RESULTSFive patients obtained an objective response for an overall response rate of 17% (90% confidence interval, 7–33%). One patient achieved a complete clinical response. The median overall survival of the group was 7.7 months. Toxicity was moderate with granulocytopenia, anorexia, and fatigue being the most commonly noted side effects.CONCLUSIONSGemcitabine and docetaxel is an active second‐line combination in patients with advanced urothelial carcinoma. Responses in visceral, lymph node, and soft tissues sites were observed. Granulocytopenia without fever, fatigue, and anorexia was common. Thromboembolic symptoms were reported and are of concern. The combination of gemcitabine and docetaxel has the potential to palliate a subset of previously treated patients with an adequate performance status. Cancer 2003;97:2743–7. © 2003 American Cancer Society.DOI 10.1002/cncr.11413

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“…However, very few patients are long-term survivors, 6 and the toxicities are significant: Grade 3-4 nausea and emesis, 12%; Grade 3-4 neutropenia, 24 -58% (with febrile neutropenia in 10 -25% of patients); severe mucositis, 13-17%; renal failure, 7%; and toxic deaths, 3%. 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.…”

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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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Significant activity of paclitaxel in advanced transitional-cell carcinoma of the urothelium: a phase II trial of the Eastern Cooperative Oncology Group.

Abstract: Single-agent paclitaxel at this dosage and schedule is one of the most active single agents in previously untreated patients with advanced urothelial carcinoma, and is well tolerated by this patient population when given with hematopoetic growth factor support.

Cited by 310 publications

References 0 publications

A randomized trial comparing methotrexate and vinblastine (MV) with cisplatin, methotrexate and vinblastine (CMV) in advanced transitional cell carcinoma: results and a report on prognostic factors in a Medical Research Council study

A randomized trial comparing methotrexate and vinblastine (MV) with cisplatin, methotrexate and vinblastine (CMV) in advanced transitional cell carcinoma: results and a report on prognostic factors in a Medical Research Council study

Phase II trial of gemcitabine and docetaxel in patients with advanced carcinoma of the urothelium

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

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