Phase II Study of Vinorelbine and Estramustine in Combination With Conformational Radiotherapy for Patients With High-Risk Prostate Cancer

Journal Article · Mon Mar 15 04:00:00 EDT 2010 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2009.03.024· OSTI ID:21372164

Carles, Joan ^[1]; Nogue, Miguel ^[2]; Sole, Josep M ^[3]; Foro, Palmira ^[4]; Domenech, Montserrat ^[5]; Suarez, Marta ^[1]; Gallardo, Enrique ^[6]; Garcia, Dario ^[2]; Ferrer, Ferran ^[4]; Gelabert-Mas, Antoni ^[1]; Gayo, Javier ^[7]; Fabregat, Xavier ^[1]

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1. Hospital del Mar, Barcelona (Spain)
2. Hospital Parc Tauli, Barcelona (Spain)
3. Hospital General de Catalunya, Barcelona (Spain)
4. Hospital de la Esperanca, Barcelona (Spain)
5. Hospital General de Manresa, Barcelona (Spain)
6. Hospital de Terrasa, Barcelona (Spain)
7. Pierre Fabre Iberica, Barcelona (Spain)

Purpose: To evaluate the efficacy and safety profile of vinorelbine and estramustine in combination with three-dimensional conformational radiotherapy (3D-CRT) in patients with localized high-risk prostate cancer. Methods and Materials: Fifty patients received estramustine, 600 mg/m{sup 2} daily, and vinorelbine, 25 mg/m{sup 2}, on days 1 and 8 of a 21-day cycle for three cycles in combination with 8 weeks of 3D-CRT (total dose of 70.2 gray [Gy] at 1.8-Gy fractions or 70 Gy at 2.0-Gy fractions). Additionally, patients received luteinizing hormone-releasing hormone analogs for 3 years. Results: All patients were evaluated for response and toxicity. Progression-free survival at 5 years was 72% (95% confidence interval [CI]: 52-86). All patients who relapsed had only biochemical relapse. The most frequent severe toxicities were cystitis (16% of patients), leucopenia (10% of patients), diarrhea (10% of patients), neutropenia (8% of patients), and proctitis (8% of patients). Six patients (12%) did not complete study treatment due to the patient's decision (n = 1) and to adverse events such as hepatotoxicity, proctitis, paralytic ileus, and acute myocardial infarction. Conclusions: Vinorelbine and estramustine in combination with 3D-CRT is a safe and effective regimen for patients with localized high-risk prostate cancer. A randomized trial is needed to determine whether the results of this regimen are an improvement over the results obtained with radiotherapy and androgen ablation.

• OSTI ID: 21372164
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 4 Vol. 76; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
ABLATION
ANDROGENS
ANDROSTANES
ANTIMITOTIC DRUGS
ANTINEOPLASTIC DRUGS
BODY
CARBOHYDRATES
DISEASES
DRUGS
GLANDS
GLYCOPROTEINS
GONADOTROPINS
HORMONES
LIBERINS
LUTEINIZING HORMONE
MALE GENITALS
MEDICINE
NEOPLASMS
NUCLEAR MEDICINE
ORGANIC COMPOUNDS
ORGANS
PEPTIDE HORMONES
PITUITARY HORMONES
PROSTATE
PROTEINS
RADIOLOGY
RADIOTHERAPY
SACCHARIDES
STEROID HORMONES
STEROIDS
THERAPY
THREE-DIMENSIONAL CALCULATIONS
TOXICITY