Genitourinary Cancer

SS 08 - GU 2 - Long-Term Updates of Prospective Prostate Cancer Clinical Trials

64 - Results of a Phase III Trial of Optimal Sequencing of Dose Escalated Radiation (XRT) and 6 Months Androgen Deprivation Therapy (ADT) in Prostate Cancer

Monday, October 22
8:35 AM - 8:45 AM
Location: Room 214 C/D

Results of a Phase III Trial of Optimal Sequencing of Dose Escalated Radiation (XRT) and 6 Months Androgen Deprivation Therapy (ADT) in Prostate Cancer
S. Malone1, L. Eapen2, C. E1, W. S. Kendal3, R. M. MacRae4, G. Perry3, K. Malone3, J. Bowen5, J. Craig3, S. Grimes3, and S. C. Morgan1; 1The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada, 2University of Ottawa, Faculty of Medicine, Ottawa, ON, Canada, 3The Ottawa Hospital, Ottawa, ON, Canada, 4University of Ottawa, Division of Radiation Oncology, Ottawa, ON, Canada, 5Northeastern Ontario Regional Cancer Centre, Sudbury, ON, Canada

Purpose/Objective(s): The OTT0101 Phase III Trial evaluated the optimal sequencing of Dose Escalated XRT (76Gy) in combination with 6 mo ADT. Trial hypothesis was that early (day 1) XRT will improve PSA Disease Free Survival (DFS) compared to XRT after 4 months ADT.

Materials/Methods: 438 patients were entered on the Phase 3 trial evaluating optimal timing of XRT in combination with 6 mo ADT (goserelin + biclutamide). Inclusion criteria were cT1-T3, GL < 8, PSA < 30. Low risk prostate cancer patients were excluded. Patients were randomized to XRT after 4 months ADT (arm A) or to XRT day 1 of ADT (arm B). Overall Survival (OS), PSA DFS, Local DFS and Distant DFS were estimated using the Kaplan-Meier method. Treatment arms were compared using log rank tests.

Results: Clinical characteristics: mean age 69; 69 % cT1-T2A, 31 % cT2B-T3; 75 % Gleason 7; mean PSA = 10. Median follow-up is > 12 yrs. There was no stat sig difference between Rx arms. 5 & 10 yr PSA DFS (Arm A vs B): 89 vs 93% and 81% vs 86 %. There were no differences in local control, OS or distant metastases by Rx arm. The pooled 5 & 10 yr results are the following: PSA DFS 91 % & 83 %; Local DFS 96 % and 94 %; Distant DFS 99% & 96 %; OS 92 % & 72%.

Conclusion: The sequencing of XRT in combination with ADT did not influence clinical outcomes. The durable local control and PSA DFS support the benefit of ADT in combination with Dose Escalated XRT.

Author Disclosure: S. Malone: Honoraria; Janssen, Astellas, Astra Zeneca, AMGEN, Abbvie. Travel Expenses; TerSera, Sanofi. L. Eapen: Research Grant; Astra Zeneca, Abott, Paladin labs, Sanofi Aventis. Honoraria; Astra Zeneca, Abott, Paladin labs, Sanofi Aventis. C. E: None. W.S. Kendal: None. G. Perry: None. K. Malone: None. S.C. Morgan: Independent Contractor; The Ottawa Hospital Cancer Centre. Honoraria; Janssen, Bayer Healthcare, Sanofi, Amgen, Astellas. Advisory Board; Janssen, Bayer Healthcare.

Shawn Malone, MD

Disclosure:
Compensation
Abbvie: Honoraria; AMGEN: Honoraria; Astellas: Honoraria; Astra Zeneca: Honoraria; Janssen: Honoraria; Sanofi: Travel Expenses; TerSera: Travel Expenses

Presentation(s):

Send Email for Shawn Malone


Assets

64 - Results of a Phase III Trial of Optimal Sequencing of Dose Escalated Radiation (XRT) and 6 Months Androgen Deprivation Therapy (ADT) in Prostate Cancer



Attendees who have favorited this

Please enter your access key

The asset you are trying to access is locked. Please enter your access key to unlock.

Send Email for Results of a Phase III Trial of Optimal Sequencing of Dose Escalated Radiation (XRT) and 6 Months Androgen Deprivation Therapy (ADT) in Prostate Cancer