Genitourinary Cancer

SS 28 - GU 3 - New Insights Into Treatment Intensification Strategies for Prostate Cancer

204 - A Phase IIB Trial of Docetaxel Concurrent With Radiation Therapy Plus Hormonotherapy Versus Radio Hormonotherapy in High-Risk Localized Prostate Cancer: Late Toxicity Analysis

Tuesday, October 23
3:45 PM - 3:55 PM
Location: Room 007 A/B

A Phase IIB Trial of Docetaxel Concurrent With Radiation Therapy Plus Hormonotherapy Versus Radio Hormonotherapy in High-Risk Localized Prostate Cancer: Late Toxicity Analysis
P. Foro1, J. Maldonado2, M. Bonet3, J. Jove-Teixido4, A. Rovirosa5, G. Sancho Pardo6, M. Mira Flores7, A. Bejar Luque8, and J. Carles9; 1Hospital del Mar. Parc de Salut Mar. Universitat Pompeu Fabra. Grup de Recerca d'Oncologia Radioterapica (GREOR), Barcelona, Spain, 2Hospital Universitari Vall d'Hebron, Barcelona, Spain, 3Consorci Sanitari de Terrassa – IOV,, Terrassa, Spain, 4Hospital Germans Trias i Pujol, Institud Catala d'Oncologia, Barcelona,, Spain, 5Hospital Clinic Universitari, Barcelona, Spain, 6Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, 7Hospital Universitari Arnau de Vilanova, Lleida, Spain, 8Hospital Reina Sofia, Cordoba, Spain, 9Oncology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain

Purpose/Objective(s): To analyze the late toxicity of concomitant radiation therapy with low doses of docetaxel plus standard hormonal treatment in patients with high-risk localized prostate cancer.

Materials/Methods: From 12/2008 to 9/2012, 130 patients were randomized to arm A(LH-RH analogues every 3 months for 3 years and to radiation therapy 74Gy [2Gy x 37 fractions]) or arm B (analogues of LH-RH every 3 months for 3 years, radiation therapy 73.8 Gy [1.8 Gy x 41 fractions]) and concurrent weekly docetaxel at 20 mg / m2 for 9 weeks). We have evaluated late toxicity using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A descriptive analysis was performed using median and standard deviations. Late toxicity was analyzed using the Chi square test.

Results: Median age was 68 years (61-73). Patients had T3-T4 (82.6%), Gleason Score ≥ 8 (76.3%), PSA> 20 ng / mL (26.9%) and pN + (18.9%). All clinical characteristics were well balanced between arms. Median dose of radiation therapy was 74 Gy (72-74.8) in arm A and 73.8 Gy (72-75.6) in arm B. 75.7% of patients received all 9 planned treatments of docetaxel and the median number of cycles administered per patient was 9. After median follow-up 58.3 months; (range 53.3-61.3) late toxicities reports are as follow: 27.9% in arm A and 22.4% of arm B presented grade ≥1 Genitourinary (GU) toxicity (p=0.532). Grade ≥1 Gastrointestinal (GI) toxicity, 18% in arm A and 10.3% in arm B (p=0.296). Most common grade ≥1 GU toxicity (Arm A /Arm B) were: increase in urinary frequency (8.2% “vs” 10.3%), hematuria (8.2% “vs” 5.1%) and urinary incontinence (6.5% “vs” 1.7%). In relation to grade ≥1 GI toxicity rectal bleeding (4.9% “vs”1.7%), proctitis (1.6 % “vs”3.4%) and fecal incontinence(3.3% “vs”1.7%) without differences between the arms. Toxicity grade 3 hematuria, urinary tract obstruction and rectal hemorrhage was reported in 3.3% of patients in Arm A and 0% in Arm B. There was no grade 4 toxicity.

Conclusion: Our study shows that standard doses of concurrent radiation therapy and weekly docetaxel can be administered safetly, without an increase in late toxicity. Clinical trial information: 2008-003554-14

Author Disclosure: P. Foro: None. J. Maldonado: None. M. Bonet: None. J. Jove-Teixido: None. A. Rovirosa: None. M. Mira Flores: None. J. Carles: None.

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204 - A Phase IIB Trial of Docetaxel Concurrent With Radiation Therapy Plus Hormonotherapy Versus Radio Hormonotherapy in High-Risk Localized Prostate Cancer: Late Toxicity Analysis



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