Docetaxel and cisplatin combination chemotherapy in advanced carcinoma of the urothelium: A multicenter phase II study of the Hellenic Cooperative Oncology Group

Dimopoulos, Meletios Α.; Bakoyannis, C.; Georgoulias, Vassilis; Papadimitriou, Christos; Moulopoulos, Lia A.; Deliveliotis, Ch.; Karayannis, A.; Varkarakis, Ioannis; Aravantinos, G.; Zervas, Anastasios; Pantazopoulos, D; Fountzilas, George; Bamias, Aristotelis; Kyriakakis, Zacharias; Anagnostopoulos, Αchilles; Γιαννόπουλος, Αθανάσιος; Kosmidis, P.

doi:10.1023/a:1008379500436

Cited by 64 publications

(26 citation statements)

References 12 publications

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“…The OR rate of 51.6% and a median overall survival of 15 months were similar to a series of rates achieved with combinations including cisplatin/gemcitabine (Moore et al, 1999;von der Maase et al, 1999;Kaufman et al, 2000a;Lorusso et al, 2000) or cisplatin/docetaxel (Sengelov et al, 1998;Dimopoulos et al, 1999).…”

Section: Discussionsupporting

confidence: 84%

Gemcitabine and docetaxel as first-line treatment for advanced urothelial carcinoma: a phase II study

et al. 2005

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The purpose of the study was to investigate the toxicity and efficacy of the combination of gemcitabine and docetaxel in untreated advanced urothelial carcinoma. Patients with previously untreated, locally advanced/recurrent or metastatic urothelial carcinoma stage-IV disease were eligible. Patients with Performance status: PS ECOG 43 or age 475 years or creatinine clearance o50 ml min À1 were excluded. Study treatment consisted of docetaxel 75 mg m À2 (day 8) and gemcitabine 1000 mg m À2 (days 1 þ 8), every 21 days for a total of six to nine cycles. A total of 31 patients with urothelial bladder cancer, 25 men and six women, aged 42 -74 (median 64) years were enrolled. The majority of patients had a good PS (51.6%; PS 0). In all, 15 (48.3%) patients had locally advanced or recurrent disease only and 16 (54.8%) presented with distant metastatic spread, with multiple site involvement in 22.5%. Toxicity was primarily haematologic, and the most frequent grade 3 -4 toxicities were anaemia 11 (6.7%) thrombocytopenia eight (4.9%), and neutropenia 45 (27.6%), with 10 (6.1%) episodes of febrile neutropenia. No toxic deaths occurred. A number of patients had some cardiovascular morbidity (38.7%). Nonhaematological toxicities except alopecia (29 patients) were mild. Overall response rate was 51.6%, including four complete responses (12.9%) and 12 partial responses (38.7%), while a further five patients had disease stabilisation (s.d. 16.1%). The median time to progression was 8 months (95% CI 5.1 -9.2 months) and the median overall survival was 15 months (95% CI 11.2 -18.5 months), with 1-year survival rate of 60%. In conclusion, this schedule of gemcitabine and docetaxel is very active and well tolerated as a first-line treatment for advanced/relapsing or metastatic urothelial carcinoma. Although its relative efficacy and tolerance as compared to classic MVAC should be assessed in a phase III setting, the favourable toxicity profile of this regimen may offer an interesting alternative, particularly in patients with compromised renal function or cardiovascular disease.

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Section: Discussionsupporting

confidence: 84%

Gemcitabine and docetaxel as first-line treatment for advanced urothelial carcinoma: a phase II study

et al. 2005

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“…Less common side effects included neuropathy and fluid retention. A third trial exploring the same DC regimen, given with GCSF support, yielded similar response proportions with slightly less hematologic toxicity [12].…”

Section: Docetaxel Plus Cisplatinmentioning

confidence: 89%

The Role of Taxanes in the Management of Bladder Cancer

Galsky

2005

The Oncologist

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Learning ObjectivesAfter completing this course, the reader will be able to:1. List the prognostic factors that are the best predictors of outcome for patients with metastatic bladder cancer.2. Interpret the results of the completed phase III trials comparing MVAC with taxane-based regimens in patients with metastatic bladder cancer.3. Describe the ongoing multinational phase III trial using taxane-based therapy in patients with metastatic bladder cancer.

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“…Recently, two studies that used the same regimen in bladder carcinoma have been reported (Sengelov et al, 1998;Dimopoulos et al, 1999) (Table 3). The results of these three studies confirm the efficacy of this regimen.…”

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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Docetaxel and cisplatin combination chemotherapy in advanced carcinoma of the urothelium: A multicenter phase II study of the Hellenic Cooperative Oncology Group

Abstract: The combination of docetaxel and cisplatin appeared relatively well tolerated and moderately active in patients with advanced urothelial cancer. The patients most likely to benefit were those without weight loss and without lung or liver metastases.

Cited by 64 publications

References 12 publications

Gemcitabine and docetaxel as first-line treatment for advanced urothelial carcinoma: a phase II study

Gemcitabine and docetaxel as first-line treatment for advanced urothelial carcinoma: a phase II study

The Role of Taxanes in the Management of Bladder Cancer

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

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