A phase IIb trial of docetaxel concurrent with radiotherapy plus hormotherapy versus radio hormonotherapy in high-risk localized prostate cancer (QRT SOGUG trial): Preliminary report for design, tolerance, and toxicity.

Authors

Joan Carles

Joan Carles

Hosp Universitari de Vall d'Hebron

Joan Carles , Enrique Gallardo Diaz , Montserrat Domenech , Albert Font , Joaquim Bellmunt , Begoña Mellado , Cristina Suárez , Teresa Bonfill , M Isabel Saez , Marta Guix , Maria Jose Mendez , Pablo Maroto , Teresa de Portugal , Mariona Figols , Raquel Luque , Ramon Aldabo , Rafael Morales , Marta Bonet , Xavier Maldonado , Palmira Foro

Organizations

Hosp Universitari de Vall d'Hebron, Parc Taulí Sabadell Hospital Universitari, Sabadell, Spain, Hospital Althaia, Manresa, Spain, Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Barcelona, Spain, University Hospital del Mar, IMIM, Barcelona, Spain, Hospital Clinic University of Barcelona, Barcelona, Spain, Hospital Universitari Vall d’Hebron, Barcelona, Spain, Hospital de Sabadell, Corporació Sanitària Parc Taulí, Institut Universitari, Sabadell, Spain, Hospital Universitario Virgen de la Victoria, Malaga, Spain, Hospital del Mar, IMIM, Barcelona, Spain, Hospital Reina Sofia, Cordoba, Spain, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, Hospital Provincial de Zamora, Zamora, Spain, Medical Oncology Department, Hospital Universitario Virgen de las Nieves, Granada, Spain, Hospital Universitari Arnau de Vilanova., Lleida, Spain, Oncology Department, University Hospital Vall d'Hebron, Barcelona, Spain, Institut Oncologic del Valles, Consorci Sanitari de Terrasa, Terrasa, Spain, University Hospital Vall d'Hebron, Barcelona, Spain, Parc de Salut Mar, Barcelona, Spain

Research Funding

Other

Background: Docetaxel improves survival in patients (pts) with metastatic hormonosensitive prostate cancer (PC) and castration-resistant prostate cancer. The objective of this phase IIb trial was to assess the activity of low dose docetaxel concurrent with radiotherapy plus standard hormonal treatment in pts with high risk localized CaP. Methods: High-risk localized CaP was defined by ≥ 1 of the following criteria: T3-T4, Gleason score (GS) ≥ 8, PSA > 20 ng/mL, pN+. Pts were randomly assigned to either arm A (LH-RH analogs every 3 months for 3 years and radiotherapy 73.8 Gy [1.8 Gy x 41 fractions] or 74 Gy [2Gy x 37 fractions]) or arm B (LH-RH analogs every 3 months for 3 years, radiotherapy and concurrent weekly docetaxel at 20 mg/m2 for 9 weeks). Chemotherapy was started one week before of radiotherapy. Primary endpoint was PSA relapse according to the Phoenix definition. The planned number of pts was 130 to detect a 15% difference with a power of 80% and an alpha of 0.05 (two-sided). Results: From 12/2008 to 9/2012, 130 pts were accrued (Arm A: 64, Arm B: 66). Median age was 68 years (61-73). Patients had T3-T4 (82.6%), GS ≥ 8 (76.3%), PSA > 20 ng/mL (26.9%) and pN+ (18.9%). All characteristics were well-balanced between arms. Median dose of radiotherapy was 74 Gy (72–74.8) in arm A, and 73.8 Gy ( 72-75.6) in arm B. 75.7% of pts received the planned 9 treatments of docetaxel and median number of cycles delivered per patient was 9. After a median follow-up of 29.6 months (9.6-40.2), most common grade 1/2 toxicities (arm A and arm B) were: cystitis ( 12.5% vs 8.3%), diarrhea (35.9% vs 70%), proctitis (12.5% vs 13.3%), rectal tenesmus (3.1% vs 23.3%), asthenia (23.4% vs 61.6%) and dysuria ( 28.1% vs 30.0%). Toxicity G3/G4 diarrhea was reported in 8.3% of pts in arm B and 0% in arm A. G3/G4 lymphopenia occurred less often in arm A than in arm B (3.1% vs 23.3%). %). There was no toxicity-related death. Conclusions: The QRT SOGUG phase IIb trial met its accrual target and shows that concurrent weekly docetaxel can be administered with standard doses of radiotherapy and without increasing toxicity profile. Clinical trial information: 2008-003554-14.

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Abstract Details

Meeting

2015 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session A: Prostate Cancer

Track

Prostate Cancer

Sub Track

Prostate Cancer - Localized Disease

Clinical Trial Registration Number

2008-003554-14

Citation

J Clin Oncol 33, 2015 (suppl 7; abstr 15)

DOI

10.1200/jco.2015.33.7_suppl.15

Abstract #

15

Poster Bd #

B7

Abstract Disclosures

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