Long-Term Survival in Metastatic Transitional-Cell Carcinoma and Prognostic Factors Predicting Outcome of Therapy

Bajorin, Dean F.; Dodd, Paul M.; Mazumdar, Madhu; Fazzari, Melissa; McCaffrey, John; Scher, Howard I.; Herr, Harry W.; Higgins, Geralyn; Boyle, Mary G.

doi:10.1200/jco.1999.17.10.3173

Cited by 674 publications

(402 citation statements)

References 19 publications

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“…methotrexate þ vinblastine, or doxorubicin þ cisplatin) is approximately 8 months (Sternberg et al, 1989). It is known that pretreatment prognostic features have an impact on individual patient outcome, thus the variation in reported survival in patients treated with chemotherapy may be biased by these features (Bajorin et al, 1999;Calabro and Sternberg, 2002).…”

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A phase I/II study of gemcitabine and fractionated cisplatin in an outpatient setting using a 21-day schedule in patients with advanced and metastatic bladder cancer

et al. 2004

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A randomised phase III trial of MVAC (methotrexate, vincristine, doxorubicin, cisplatin) vs gemcitabine and cisplatin (GC) (G 1000 mg m À2 days 1, 8, and 15 plus C 70 mg m À2 day 2, q 4 wks) indicated GC had similar efficacy and lower toxicity (JCO 2000). Significant haematologic toxicities in the GC arm occurred on day 15, necessitating dose adjustments in 37% of cycles. We conducted a phase I/II dose escalation trial using GC on a 21-day cycle, with G and C split between days 1 and 8. The objective of the study to define maximum-tolerated dose and dose-limiting toxicity (DLT), objective response rate, and overall survival. In all, 32 patients with locally advanced, relapsed, or metastatic disease received: dose level 1, G/C 1000/35; level 2, 1100/35; level 3, 1200/35; level 4, 1200/ 45 mg m À2 (G and C given on days 1 and 8 every 3 wks). A total of 19 patients had glomerular filtration rate o60 ml min À1 and 19 patients had metastatic disease. Dose-limiting toxicity was haematologic (grade 4 thrombocytopenia) at dose level 2. Of 151 cycles, at day 15, platelets were o100 in 61 cycles; neutrophils o0.5, platelets o50 in 26 cycles. Only seven cycles were deferred due to haematological toxicity; four for renal toxicity (chemotherapy instituted posthydration). Overall response rate was 65.5% on an intention-to-treat analysis (75% [21/28] for assessable patients), with four complete responses (12.5%) and 17 partial responses (53%). After the median follow-up of 17.2 months (range 13.1 -32.4 months), 12 patients remain alive. The overall median survival was 16 months (range 10.1 -26.6 months). G plus C every 3 weeks is active and well tolerated in an outpatient setting, even in patients receiving prior platinum-based regimens and with poor renal reserve.

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A phase I/II study of gemcitabine and fractionated cisplatin in an outpatient setting using a 21-day schedule in patients with advanced and metastatic bladder cancer

et al. 2004

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“…Currently, Karnofsky Performance scores and presence of visceral metastases are reported to correlate with outcome of treatment. 18 Given the molecular knowledge of urothelial tumorigenesis and chemosensitivity, more precise methods for predicting response to anticancer therapy seem possible.…”

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confidence: 99%

Personalized medicine in advanced urothelial cancer: when to treat, how to treat and who to treat

Ehdaie

Smith

Theodorescu

2013

CUAJ

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The past decade has provided an improved understanding of the molecular mechanism of bladder cancer by defining distinct pathways in tumorigenesis and progression. Advances in technologies, such as high-throughput transcript profiling, microarrays and proteomics, offer a systematic approach to identifying targets for bladder cancer diagnostics and drug discovery. This review presents a select outline of the advances in the development of biomarkers and targets for patient prognosis and therapy selection. This paper describes a representative cohort of recent studies that have the potential to significantly impact the management of muscle invasive and metastatic urothelial carcinoma of the bladder. Space constraints do not permit this review to be comprehensive and we apologize to the authors whose work we do not cite.

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“…It is interesting to note that 63% of the patients enrolled had received their initial chemotherapy in either the neoadjuvant or adjuvant settings. 16 Response rates in Phase II trials of patients with advanced bladder carcinoma can be influenced significantly by patient selection, as described by Bajorin et al 14 Their study concentrated on prognostic factors associated with response and identified performance status and the sites of metastatic disease as major response parameters. In the salvage setting, other factors in addition to those described the Bajorin et al 14 will likely influence response rates, including the time to disease progression, the drugs initially received by the patients, and the setting of initial chemotherapy (i.e., adjuvant/neoadjuvant versus therapy for metastatic disease).…”

Section: Discussionmentioning

confidence: 99%

“…16 Response rates in Phase II trials of patients with advanced bladder carcinoma can be influenced significantly by patient selection, as described by Bajorin et al 14 Their study concentrated on prognostic factors associated with response and identified performance status and the sites of metastatic disease as major response parameters. In the salvage setting, other factors in addition to those described the Bajorin et al 14 will likely influence response rates, including the time to disease progression, the drugs initially received by the patients, and the setting of initial chemotherapy (i.e., adjuvant/neoadjuvant versus therapy for metastatic disease). As is the case for many solid tumors, the therapeutic goals of salvage therapy need further characterization (i.e., palliation versus survival prolongation), given the limited impact of chemotherapy on survival in the initial treatment of patients with advanced urothelial carcinoma reported to date.…”

Section: Discussionmentioning

confidence: 99%

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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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Long-Term Survival in Metastatic Transitional-Cell Carcinoma and Prognostic Factors Predicting Outcome of Therapy

Cited by 674 publications

References 19 publications

A phase I/II study of gemcitabine and fractionated cisplatin in an outpatient setting using a 21-day schedule in patients with advanced and metastatic bladder cancer

A phase I/II study of gemcitabine and fractionated cisplatin in an outpatient setting using a 21-day schedule in patients with advanced and metastatic bladder cancer

Personalized medicine in advanced urothelial cancer: when to treat, how to treat and who to treat

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

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