Phase II randomized trial of gallium nitrate plus fluorouracil versus methotrexate, vinblastine, doxorubicin, and cisplatin in patients with advanced transitional-cell carcinoma Journal Article
| Authors: | McCaffrey, J. A.; Hilton, S.; Mazumdar, M.; Sadan, S.; Heineman, M.; Hirsch, J.; Kelly, W. K.; Scher, H. I.; Bajorin, D. F. |
| Article Title: | Phase II randomized trial of gallium nitrate plus fluorouracil versus methotrexate, vinblastine, doxorubicin, and cisplatin in patients with advanced transitional-cell carcinoma |
| Abstract: | Purpose: A phase II randomized trial of gallium nitrate/fluorouracil (5- FU) versus dose-intense methotrexate, vinblastine, doxorubicin, and cisplatin (M-VAC) was performed in poor-risk patients with advanced urothelial tract tumors. The efficacy and toxicity of these regimens were compared. Assessment of dose-intense M-VAC as salvage treatment in patients who failed to respond to the gallium nitrate/5-FU regimen was also performed. Patients and Methods: Thirty-four patients who had not received prior systemic chemotherapy were randomized to either arm of the study. All patients had one or more clinical features predicting a low likelihood of durable complete response to standard chemotherapy, ie, weight loss, visceral metastases, and low performance status. Gallium nitrate and 5-FU were each administered by continuous 5-day infusions every 28 days. M-VAC was recycled every 21 days, with prophylactic recombinant human granulocyte colony-stimulating factor (rh-G-CSF). Results: Two of 17 patients (12%; 95% confidence interval[CI] 1.4% to 36.4%) had a major response to gallium nitrate/5-FU. Sixteen of 17 patients treated with M-VAC (94%; 95% CI, 71.3% to 99.8%) demonstrated a major response. Five of 12 patients who failed to respond to the gallium nitrate/5-FU combination responded to M-VAC as second-line therapy (42%; 95% CI, 15.2% to 72.3%). Median survival for the gallium nitrate and 5-FU arm was 19 versus 17 months for the M-VAC arm, with a median follow-up duration of 35 months (range, 2 to 51) for all patients. Dose-intense M-VAC was associated with a greater incidence of neutropenia and thrombocytopenia. Conclusion: Dose-intense M- VAC is superior to gallium nitrate/5-FU in poor-risk patients (P < .0001). Despite the overall high response rate, the median survival for patients with M-VAC remained unsatisfactory. Similar survival distributions were observed for patients who received investigational therapy followed by cisplatin based therapy and patients treated with initial cisplatin-based therapy. |
| Keywords: | adult; cancer survival; clinical article; controlled study; treatment outcome; aged; aged, 80 and over; middle aged; survival analysis; clinical trial; neutropenia; cisplatin; doxorubicin; fluorouracil; cancer combination chemotherapy; methotrexate; follow up; metastasis; controlled clinical trial; phase 2 clinical trial; mucosa inflammation; randomized controlled trial; thrombocytopenia; antineoplastic combined chemotherapy protocols; weight reduction; continuous infusion; urogenital tract cancer; vinblastine; urologic neoplasms; recombinant granulocyte colony stimulating factor; carcinoma, transitional cell; transitional cell carcinoma; intravenous drug administration; gallium; subcutaneous drug administration; gallium nitrate; humans; human; male; female; priority journal; article |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 15 |
| Issue: | 6 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 1997-06-01 |
| Start Page: | 2449 |
| End Page: | 2455 |
| Language: | English |
| PUBMED: | 9196161 |
| PROVIDER: | scopus |
| DOI: | 10.1200/JCO.1997.15.6.2449 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 17 March 2017 -- Source: Scopus |
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