Phase II study of paclitaxel in pretreated patients with locally advanced/metastatic cancer of the bladder and ureter

Papamichael, D.; Gallagher, Chris; Oliver, R. T. D.; Johnson, P. W. M.; Waxman, Jacob

doi:10.1038/bjc.1997.106

Cited by 115 publications

(48 citation statements)

References 7 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In a cohort of 31 pretreated patients, or and pr rates of 10% were observed, with a mds of 7.2 months 56 . However, in the other two trials, lower response rates of 5%-7% were achieved, with a mds of 6.5 months 47,58 . Similarly, docetaxel was investigated in 31 cisplatin-refractory patients.…”

Section: Single-agent Second-line Therapymentioning

confidence: 99%

First- and Second-Line Therapy for Metastatic Urothelial Carcinoma of the Bladder

2011

View full text Add to dashboard Cite

but little improvement has been achieved in the outcomes of patients with advanced or metastatic disease. Almost 90% of those patients eventually succumb to their cancer.For patients who relapse after first-line chemotherapy, the prognosis is generally poor. To date, there is no real consensus on how to best treat these patients, and most of the available evidence stems from small phase ii trials that have mostly failed to show survival benefit over supportive care. The present review provides an update on the management of metastatic bc, with a focus on first-line and secondline therapies. FIRST-LINE THERAPY Single-Agent TherapySingle-agent therapy has generally failed to provide adequate results in patients with advanced bc. In a phase iii trial of patients randomized to receive either cisplatin alone or in combination [methotrexate, vinblastine, doxorubicin, and cisplatin (mvac)], the overall response rate (or) was only 12% in the cisplatin arm, with only 4 of 122 patients (3.3%) remaining alive at 3 years of follow-up 4 . Similar results were observed in phase ii trials with carboplatin [or: 18%; median duration of survival (mds): 16 months] 5 . In a phase iii trial examining the role of lobaplatin, 2 of 17 patients (12%) achieved a partial response (pr), but the study was terminated because of high toxicity rates 6 . Other drugs investigated in phase ii trials have manifested variable activity against advanced urothelial cancer: oral piritrexim (or: 23%; mds: 22 weeks) 7 , trimetrexate (or: 17%; mds not reported) 8 , and docetaxel (or: 13%; mds: 9 months) 9 . However, some improved results were obtained with other single agents such as paclitaxel and gemcitabine 10,11 . In a phase ii trial of 26 patients with advanced bc treated with paclitaxel, the or was 42%, and the mds, 8.4 months 10 . Similarly, in a phase ii trial of gemcitabine in 40 patients, an or of 28% was reported, with a mds of 54 weeks 11 . ABSTRACTUrothelial cancer of the bladder is the 4th most common malignancy in American men and the 9th most common in women. Although it is a chemosensitive disease, advanced bladder cancer seems to have reached a plateau with regard to median survival of patients. Standard first-line therapy remains gemcitabine plus cisplatin (gc) or methotrexate, vinblastine, doxorubicin, and cisplatin (mvac). In patients deemed unfit to receive cisplatin, gemcitabine plus carboplatin or gemcitabine plus paclitaxel can be considered. To date, no standard therapy has been established for patients who recur or are refractory to first-line therapy. Second-line vinflunine, by way of superiority over best supportive care, has shown promise in a phase iii trial. Cisplatin-based therapy (mvac or gc) can also be offered to patients previously treated with cisplatin, especially if they responded previously and are considered platinum-sensitive. Novel targeted therapies are sorely needed to further improve the delivery and efficacy of chemotherapy.

show abstract

Section: Single-agent Second-line Therapymentioning

confidence: 99%

First- and Second-Line Therapy for Metastatic Urothelial Carcinoma of the Bladder

2011

View full text Add to dashboard Cite

show abstract

“…Given that MVAC or gemcitabine-based combinations are often used as first-line chemotherapy in advanced TCC, several trials have explored the activity of the taxanes in the second-line setting. In a small phase II trial (14 patients) involving paclitaxel 200 mg/m 2 administered every 21 days, there was only one partial response (7%) and no complete responses [3]. A trial of 31 previously treated patients exploring weekly paclitaxel (80 mg/m 2 ) yielded a similarly modest response rate of 10% [5].…”

Section: Role Of Taxanes As Second-line Therapy For Advanced Tccmentioning

confidence: 99%

“…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%

See 1 more Smart Citation

The Role of Taxanes in the Management of Bladder Cancer

Galsky

2005

The Oncologist

View full text Add to dashboard Cite

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.

show abstract

“…The Eastern Co-operative Oncology Group demonstrated a 42% response rate in a Phase II study of 26 patients (Roth et al, 1994), although in a group of 14 previously treated patients Papamichael et al found only 1 partial response for a response rate of 7% (Papamichael et al, 1997). Prompted by these observations our study substituted paclitaxel for methotrexate in the CMV regimen, investigating the combination of paclitaxel with vinblastine and cisplatin in previously untreated patients.…”

mentioning

confidence: 99%

Evidence for a schedule-dependent deleterious interaction between paclitaxel, vinblastine and cisplatin (PVC) in the treatment of advanced transitional cell carcinoma

et al. 2000

View full text Add to dashboard Cite

A phase II study to evaluate the efficacy and toxicity of the combination of vinblastine, paclitaxel and cisplatin (PVC) in previously untreated patients with advanced transitional cell carcinoma. Chemotherapy naive patients with locally advanced or metastatic transitional cell carcinoma received the intravenous combination of paclitaxel 175 mg/m 2 over three hours followed by cisplatin 70 mg/m 2 over 3 hours on day 1 and vinblastine 3 mg/m 2 as a bolus on days 1 and 8 on a 21-day cycle, to a maximum of 6 cycles. The day 8 vinblastine was omitted if the total neutrophil count was <1.0. 15 patients (13 M, 2 F) of median age 66 (54–75) received a median of 5 cycles of treatment. There were two complete responses (13%; 95% CI 2–40%) and five partial responses (33%; 95% CI 12–62%), for an overall response rate of 46% (95% CI 21–73%). Responses occurred only in those with locally recurrent tumours and/or lymph nodes involved. Neutropenia at Grade 3–4 occurred in 14 of 67 cycles (21%) resulting in 7 episodes of neutropenic sepsis. Grade 3–4 thrombocytopenia was not observed. Other Grade 3 toxicity included alopecia (10 pts), diarrhoea (2 pts), constipation resulting in bowel obstruction (2 pts), nephrotoxicity (1 pt), myalgic pain (1 pt) and peripheral neuropathy (1 pt). Six patients developed Grade 2 paraesthesia. The median time to progression was 6 months and the median survival was 11 months. The regimen PVC was both less effective against transitional cell carcinoma and less toxic than expected. This may reflect an inhibitory interaction between vinblastine and paclitaxel and this schedule cannot be recommended for further investigation. © 2000 Cancer Research Campaign http://www.bjcancer.com

show abstract

Phase II study of paclitaxel in pretreated patients with locally advanced/metastatic cancer of the bladder and ureter

Cited by 115 publications

References 7 publications

First- and Second-Line Therapy for Metastatic Urothelial Carcinoma of the Bladder

First- and Second-Line Therapy for Metastatic Urothelial Carcinoma of the Bladder

The Role of Taxanes in the Management of Bladder Cancer

Evidence for a schedule-dependent deleterious interaction between paclitaxel, vinblastine and cisplatin (PVC) in the treatment of advanced transitional cell carcinoma

Contact Info

Product

Resources

About