Phase II Trial of Weekly Paclitaxel in Patients With Previously Treated Advanced Urothelial Cancer

Vaughn, David J.; Broome, Catherine; Hussain, Maha; Gutheil, John; Markowitz, Avi B.

doi:10.1200/jco.20.4.937

Cited by 150 publications

(88 citation statements)

References 18 publications

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“…Paclitaxel alone yields a 42% response rate against urothelial carcinoma when used as a first-line treatment, 17 but yields only a 10% response rate in patients who were treated previously. 18 Considering the low response rate of paclitaxel alone when used as a second-line treatment, its combination with gemcitabine, cisplatin, carboplatin and ifosfamide have been investigated , and the response rate increased to 15-40%. 1,[9][10][11][12][13]18,19 In the present study, the response rate was 19.0% and overall disease control rate was 42.9%.…”

Section: Discussionmentioning

confidence: 99%

“…For previous chemotherapy, 18 patients received the GC regimen as the first-line and the M-VAC regimen as the second-line treatments, and three patients received M-VAC as the first-line and GC as the second-line treatments. The median treatment-free interval was 3.5 months (range [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20]. The response rate including complete remission (CR) and PR of the previous two regimens was 38.1%.…”

Section: Patient Characteristicsmentioning

confidence: 99%

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Paclitaxel and cisplatin chemotherapy for metastatic urothelial carcinoma after failure of two courses of platinum‐based regimens

et al. 2011

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Objectives:We investigated the outcomes of paclitaxel and cisplatin chemotherapy as an optional regimen for patients with metastatic urothelial carcinoma after failure of two consecutive platinum-based regimens. Methods: We retrospectively analyzed the data of 21 patients who had evidence of disease progression after two consecutive platinum-based regimens, gemcitabine and cisplatin (GC course), and methotrexate, vinblastine, doxorubicin and cisplatin (M-VAC course) as first-line and second-line treatments. As third-line chemotherapy, patients received paclitaxel (175 mg/m 2 ) and cisplatin (70 mg/m 2 ) every 3 weeks until disease progression. Results: Complete remission occurred in one patient (4.8%), partial remission occurred in three patients (14.3%) and stable disease occurred in five patients (23.8%). The overall response rate was 19.0% and the overall disease control rate, including stable disease, was 42.9%. The median progression-free survival (PFS) was 3 months (95% CI 3.0-5.0). The median overall survival was 9 months (95% CI 7.0-15.0). Grade 3 to 4 neutropenia appeared in 85.7% of patients. No life-threatening complications were observed. Conclusions: Paclitaxel and cisplatin chemotherapy could be an optional regimen for patients with metastatic urothelial carcinoma after the failure of two consecutive standard platinum-based regimens.

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Section: Discussionmentioning

confidence: 99%

Section: Patient Characteristicsmentioning

confidence: 99%

Paclitaxel and cisplatin chemotherapy for metastatic urothelial carcinoma after failure of two courses of platinum‐based regimens

et al. 2011

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“…The overall response rate was 69%, with 41% complete responses. Despite the encouraging activity, the authors recommended against further use of this dose and schedule given the high rate of pulmonary toxicity (14% grade [3][4][5]. This excessive rate of pulmonary toxicity was not encountered in the other trials of gemcitabine and paclitaxel using different doses and schedules.…”

Section: Paclitaxel Plus Gemcitabinementioning

confidence: 99%

“…Multiple trials have evaluated single-agent paclitaxel in metastatic TCC [2][3][4][5]. In an Eastern Cooperative Oncology Group (ECOG) trial, 26 previously untreated patients received paclitaxel 250 mg/m 2 by 24-hour continuous infusion every 21 days with granulocyte colony-stimulating factor (GCSF) support [4].…”

Section: Paclitaxelmentioning

confidence: 99%

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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“…In this setting, it has achieved an ORR of 22.5% and an mOS of 5 months [58]. Taxanes, including paclitaxel, nab-paclitaxel and docetaxel, have established activity for these patients, with ORRs ranging from 10 to 28% and including several durable responses [59][60][61][62]. The nontaxane microtubule modulator eribulin has more recently been evaluated in a single-arm, Phase II study that included treatment-naive patients as well, and showed an ORR of 32% with an mOS of 9.6 months (for second line or beyond and taxane-naive ORR was 28%, mOS 9.6 months) [63].…”

Section: Systemic Therapy For Metastatic Diseasementioning

confidence: 99%

Systemic Therapy for Bladder Cancer Finally Comes into a New Age

Zibelman

Plimack

2016

Future Oncol.

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Systemic therapy for bladder cancer, both localized muscle-invasive disease and metastatic disease, has seen minimal progress over the past two decades. Current approaches rely upon cytotoxic chemotherapy combinations aimed at increasing cure rates or achieving palliation and disease control, but these regimens are fraught with short-and long-term toxicities and outcomes remain suboptimal. The emergence of systemic immunotherapies that can provide durable remissions in subsets of patients with other malignancies has the potential to transform the field, and early phase trials have begun to demonstrate activity in some patients with metastatic bladder cancer. In this article, we review the current state of systemic therapy for bladder cancer and discuss the current literature and ongoing trials utilizing various immunotherapies. KEYWORDS• bladder cancerCancers of the urinary bladder are the sixth most commonly diagnosed malignancy in the USA and the most prevalent malignancy of the GI tract, with 74,000 new cases estimated from 2015 [1]. The predominant histologic subtype is urothelial carcinoma (UC), which accounts for more than 90% of diagnoses in the western world. For patients with muscle-invasive bladder cancer (MIBC) confined to the bladder and deemed surgical candidates, radical cystectomy (RC) with pelvic lymphadenectomy remains the gold standard, with bladder preservation techniques using combinations of radiation therapy (RT) and systemic therapy receiving increased attention [2][3][4][5]. Local therapy with surgery or radiation alone is suboptimal, with median overall survival (OS) ranging from 1.8 to 3.8 years and 5-year survival of only 43% after RC and less than 40% with RT, with the majority of deaths related to distant disease [6,7]. The addition of neoadjuvant chemotherapy (NAC) has significantly improved outcomes. For patients who present with metastatic disease, systemic chemotherapy with cisplatin-based regimens, long recognized as an active drug in this disease, is accepted as the standard of care. Thus, systemic therapy is an integral component of treatment for patients with UC, yet despite tremendous advances across a multitude of malignant conditions, no new therapies have entered the armamentarium in over decade. Fortunately, recent and ongoing research in the burgeoning field of cancer immunotherapy (IT) offers hope that new agents will finally demonstrate survival benefits in clinical trials. In this article, we review the definitive studies that have established the current standards of care for systemic treatment in UC, then focus on new and future trials aiming to bring the systemic treatment of UC into the IT age.For reprint orders, please contact: reprints@futuremedicine.com

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Phase II Trial of Weekly Paclitaxel in Patients With Previously Treated Advanced Urothelial Cancer

Abstract: Although the overall response rate to weekly paclitaxel in patients with previously treated advanced urothelial cancer was modest, the chemotherapy-refractory nature of the study population should be considered.

Cited by 150 publications

References 18 publications

Paclitaxel and cisplatin chemotherapy for metastatic urothelial carcinoma after failure of two courses of platinum‐based regimens

Paclitaxel and cisplatin chemotherapy for metastatic urothelial carcinoma after failure of two courses of platinum‐based regimens

The Role of Taxanes in the Management of Bladder Cancer

Systemic Therapy for Bladder Cancer Finally Comes into a New Age

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