Southwest Oncology Group Study of Paclitaxel and Carboplatin for Advanced Transitional-Cell Carcinoma: The Importance of Survival as a Clinical Trial End Point

Small, Eric J.; Lew, Danika; Redman, Bruce G.; Petrylak, Daniel P.; Hammond, Neel; Gross, Howard M.; Eastham, James A.; Crawford, E. David

doi:10.1200/jco.2000.18.13.2537

Cited by 101 publications

(26 citation statements)

References 20 publications

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“…9,10,12 Poor prognostic risk factors in advanced urothelial carcinoma have been previously identified. In a recent study by Bajorin et al of 203 patients with advanced bladder carcinoma treated with M-VAC, the presence of lung, liver, or bone metastases and a baseline Karnofsky performance status less than 80% predicted independently for a poor outcome.…”

Section: Discussionmentioning

confidence: 99%

“…In this trial, a response rate of only 21% was seen, with median survival of 9 months. 12 Both studies by Pycha and SWOG required a creatinine clearance Ն 30 mL/ minutes for enrollment. The authors of the SWOG trial have suggested that differences in response rates in these trials may be linked to different patient characteristics, for example, the relative balance of patients with node only metastases versus visceral metastatic disease.…”

Section: Discussionmentioning

confidence: 99%

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Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2896)

Vaughn

Manola

Dreicer

et al. 2002

Cancer

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BACKGROUNDChemotherapy options for the patients with advanced urothelial carcinoma and renal dysfunction are limited. The authors performed a Phase II trial of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction.METHODSForty‐two patients were accrued; 37 eligible patients were treated. Patients received paclitaxel 225 mg/m2 over three hours followed by carboplatin targeted area under the concentration‐time curve = 6 mg/mL · minute every three weeks for up to six cycles.RESULTSThe median number of cycles received was four (range, one to six). The objective response rate was 24.3% (95% confidence interval, 11.9–41.7%). The median progression free survival was 3 months and the median overall survival was 7.1 months. The number of poor prognostic risk factors (Eastern Cooperative Oncology Group performance status > 1 or lung, liver, or bone metastases) significantly predicted for survival. The most common ≥ 1 Grade 3 toxicities included granulocytopenia (60%) and neurotoxicity (35%).CONCLUSIONSPaclitaxel/carboplatin is a chemotherapy option for patients with advanced urothelial carcinoma and renal dysfunction. Future trials in chemotherapy development for this patient population are warranted. Cancer 2002;95:1022–7. © 2002 American Cancer Society.DOI 10.1002/cncr.10782

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2896)

Vaughn

Manola

Dreicer

et al. 2002

Cancer

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“…However, those patients had a median survival of 9 months, similar to the survival observed in previous studies with the same regimen. 31 In another recently published study 32 that included 17 patients with poor prognostic features, carboplatin plus gemcitabine produced an overall response rate of 58.8%, a median time to disease progression of 4.6 months, and a median overall survival of 10.5 months. WHO Grade 3-4 granulocytopenia and thrombocytopenia were reported in 70% of patients and 47% of patients, respectively.…”

Section: Discussionmentioning

confidence: 97%

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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“…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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Southwest Oncology Group Study of Paclitaxel and Carboplatin for Advanced Transitional-Cell Carcinoma: The Importance of Survival as a Clinical Trial End Point

Cited by 101 publications

References 20 publications

Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2896)

Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2896)

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

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

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