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Vinblastine and estramustine phosphate in metastatic renal cell carcinoma: a phase II trial of the Fox Chase Network
Naomi B Haas1, Bruce J Giantonio, Samuel Litwin
1Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, USA. nb_haas@fccc.edu
Background:
It is well known that metastatic renal cell carcinoma (RCC) exhibits constitutive resistance to chemotherapeutic agents. Antimicrotubule agents such as vinblastine are associated with low but reproducible response rates (approximately 12%) in patients with RCC. Estramustine has been shown to potentiate the antimicrotubule effects of vinblastine. The authors sought to increase the activity of vinblastine in RCC through the addition of estramustine.
Methods:
Twenty-one patients with metastatic RCC not previously treated with chemotherapy received oral estramustine phosphate, 600 mg/m(2), on Days 1, 2, and 3 weekly for 6 weeks, and intravenous vinblastine, 4 mg/m(2) on Day 2 weekly for 6 weeks, repeated every 8 weeks. Twenty-one patients received 31 cycles of therapy.
Results:
Two patients experienced Grade 3 and 4 hematologic toxicity, and three patients had Grade 3 nonhematologic toxicity consisting of neurologic toxicity, hepatic toxicity, or angioneurotic edema. One patient had a partial response with decreased liver metastases for 48 weeks; 9 patients had stable disease, for a median duration of 14 weeks (range, 11-31 weeks); and 11 patients demonstrated disease progression. The median overall time to progression was 8 weeks and the median overall survival period was 24 weeks.
Conclusions:
Although well tolerated, the combination of oral estramustine phosphate with vinblastine administered on this schedule had minimal activity in patients with metastatic RCC.
Insights
This study found that combining estramustine phosphate with vinblastine showed minimal activity in treating metastatic renal cell carcinoma (RCC). The combination was well-tolerated but did not significantly improve outcomes for advanced RCC patients.
Area of Science:
- Oncology
- Medical Research
Background:
- Metastatic renal cell carcinoma (RCC) demonstrates inherent resistance to chemotherapy.
- Antimicrotubule agents like vinblastine have limited efficacy in RCC.
- Estramustine can enhance the antimicrotubule effects of vinblastine.
Purpose of the Study:
- To evaluate if adding estramustine to vinblastine could increase treatment activity in metastatic RCC.
- To assess the efficacy and tolerability of this combination therapy.
Main Methods:
- A study involving 21 patients with previously untreated metastatic RCC.
- Patients received oral estramustine phosphate and intravenous vinblastine on a specific weekly schedule for 6 weeks, repeated every 8 weeks.
- The treatment cycles were administered over a defined period.
Main Results:
- The combination therapy was generally well-tolerated with manageable toxicity.
- One patient achieved a partial response, 9 had stable disease, and 11 showed disease progression.
- Median time to progression was 8 weeks, and median overall survival was 24 weeks.
Conclusions:
- The combination of oral estramustine phosphate and vinblastine demonstrated minimal clinical activity in metastatic RCC patients.
- Despite being well-tolerated, this regimen did not yield significant therapeutic benefits for this patient population.
