Long-Term versus Short-Term Androgen Deprivation Combined with High-Dose Radiotherapy for Intermediate and High Risk Prostate Cancer: Preliminary Results.

Slides:

Advertisements

Similar presentations

Pulmonary Stereotactic Ablative Radiotherapy:

Advertisements

I I. B.- T R E A T M E N T P L A N: DOCETAXEL 75 mg/m2 40 mg/m2 THORACIC RT (66 Gys: 180 cGy/d) CISPLATIN 40 mg/m2 Days E V A L U A.

Efficacy and Safety of Three Bortezomib-Based Combinations in Elderly, Newly Diagnosed Multiple Myeloma Patients: Results from All Randomized Patients.

Controversies in Adjuvant Therapy for Pancreatic Cancer Parag Sanghvi M.D. Tasha McDonald M.D. Department of Radiation Medicine OHSU.

ANDREW NG PRINCE OF WALES HOSPITAL Role of primary chemoradiation in esophageal carcinoma.

Anal Cancer Rob Glynne-Jones Mount Vernon Cancer Centre on behalf of NCRI anal cancer subgroup.

Radiotherapy in prostate cancer Dr.Mina Tajvidi Radiation oncologist.

Final Study Results of the Phase III Dasatinib versus Imatinib in Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Trial (DASISION, CA )1.

The ONTARGET Trial Reference The ONTARGET investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med. 2008;358:15.

Postoperative Radiation for Oral Cavity Squamous Cell Carcinoma: The EP.

Neoadjuvant Adjuvant Curative Palliative Neoadjuvant Radiation therapy the results of a phase III study from Beijing demonstrated a survival benefit.

Prostate Cancer Int. 洪毓謙. Prostate cancer is the Second leading cause of death from cancer in the United States American male, the lifetime risk of:

Controversies in the management of PSA-only recurrent disease Stephen J. Freedland, MD Associate Professor of Urology and Pathology Durham VA Medical Center.

Phase III Study Comparing Gemcitabine plus Cetuximab versus Gemcitabine in Patients with Locally Advanced or Metastatic Pancreatic Adenocarcinoma Southwest.

Sequential vs. concurrent chemoradiotherapy for locally advanced non-small cell carcinoma.

Howard M. Sandler, MD University of Michigan Medical School

Effect of Age on Efficacy and Safety Outcomes in Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM) Receiving Lenalidomide and Low-Dose Dexamethasone.

Hormone Refractory Prostate Cancer A Regulatory Perspective of End Points to Measure Safety and Efficacy of Drugs Hormone Refractory Prostate Cancer Bhupinder.

RTOG1106: Randomized Phase IIR Trial of Personalized Adaptive Radiotherapy Based on Mid-treatment FDG-PET in Locally Advanced NSCLC P.I.: Feng-Ming (Spring)

Design of Clinical Trials for Select Patients With a Rising PSA following Primary Therapy Anthony V. D’Amico, MD, PhD Professor of Radiation Oncology Harvard.

Postoperative Radiotherapy for Patients with Stage II or III Nonsmall Cell Lung Cancer treated with Sublobar Resections: A SEER Registry Analysis Scott.

The Impact of Capecitabine and Oxaliplatin in the Preoperative Multimodality Treatment of Patients with Carcinoma of the Rectum: NSABP R-04 1 Capecitabine.

ENESTnd Update: Nilotinib (NIL) vs Imatinib (IM) in Patients (pts) with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP) and the Impact.

Targeted Intraoperative Radiotherapy versus Whole Breast Radiotherapy for Breast Cancer (TARGIT-A Trial): An International, Prospective, Randomised, Non-Inferiority.

Recent Advances in Head and Neck Cancer Robert I. Haddad, M.D., and Dong M. Shin, M.D. The NEW ENGLAND JOURNAL of MEDICINE N Engl J Med 2008;359:

Involved Field Radiotherapy versus No Further Treatment in Patients with Clinical Stages IA/IIA Hodgkin Lymphoma and a “Negative” PET Scan After 3 Cycles.

Result of Interim Analysis of Overall Survival in the GCIG ICON7 Phase III Randomized Trial of Bevacizumab in Women with Newly Diagnosed Ovarian Cancer.

Protocols for Advanced Prostate Cancer and/or Local Failure After Radical Prostatectomy Isaac Powell, MD.

1Bachelot T et al. Proc SABCS 2010;Abstract S1-6.

BASED ON PROTOCOL VERSION 1 SEPTEMBER 2012 A new study evaluating an investigational drug to treat patients with HER2-positive metastatic gastroesophageal.

ENESTnd 24-Month Update: Continued Superiority of Nilotinib versus Imatinib in Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

Trastuzumab plus Adjuvant Chemotherapy for HER2-Positive Breast Cancer: Final Planned Joint Analysis of Overall Survival from NSABP B-31 and NCCTG N9831.

A prospective randomized trial

Bortezomib Induction and Maintenance Treatment Improves Survival in Patients with Newly Diagnosed Multiple Myeloma: Extended Follow-Up of the HOVON-65/GMMG-HD4.

Bevacizumab continuation versus no continuation after first-line chemo-bevacizumab therapy in patients with metastatic colorectal cancer: a randomized.

Final Analysis of Overall Survival for the Phase III CONFIRM Trial: Fulvestrant 500 mg versus 250 mg Di Leo A et al. Proc SABCS 2012;Abstract S1-4.

Introduction/Aims There is less written about failure patterns after prostate brachytherapy (BT) alone or in combination with external beam radiotherapy.

Radiotherapy versus carboplatin for stage I seminoma: Updated analysis of the MRC/EORTC randomized trial Authors: Oliver et al,

Evidence for a Survival Benefit Conferred by Adjuvant Radiotherapy in a Cohort of 608 Women with Early-stage Endometrial Cancer O. Kenneth Macdonald 1,

FREEDOM FROM PROGRESSION FOR PATIENTS RECEIVING I 125 VERSUS Pd 103 FOR PROSTATE BRACHYTHERAPY Jane Cho, Carol Morgenstern, Barbara Napolitano, Lee Richstone,

Early Molecular and Cytogenic Response Is Predictive for Long-Term Progression-Free and Overall Survival in Chronic Myeloid Leukemia (CML) Hanfstein B.

Results of a Randomized Phase 2 Study of PD , a Cyclin ‐ Dependent Kinase (CDK) 4/6 Inhibitor, in Combination with Letrozole vs Letrozole Alone.

High Dose Rate Brachytherapy Boost for Prostate Cancer: Comparison of Two Different Fractionation Schemes Tania Kaprealian 1, Vivian Weinberg 3, Joycelyn.

Baselga J et al. Proc SABCS 2010;Abstract S3-3.

Switching to Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase with Suboptimal Cytogenetic Response on Imatinib: Results from the LASOR.

Continued Overall Survival Benefit After 5 Years’ Follow-Up with Bortezomib-Melphalan-Prednisone (VMP) versus Melphalan-Prednisone (MP) in Patients with.

S1207: Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients.

Combined Modality Treatment of Locally Advanced Prostate Cancer: Radiation Therapy (RT) with Concurrent Androgen Deprivation Therapy (ADT) Howard Sandler.

Lenalidomide Maintenance After Stem-Cell Transplantation for Multiple Myeloma: Follow-Up Analysis of the IFM Trial Attal M et al. Proc ASH 2013;Abstract.

HERA TRIAL: 2 Years versus 1 Year of Trastuzumab After Adjuvant Chemotherapy in Women with HER2-Positive Early Breast Cancer at 8 Years of Median Follow-Up.

Journal Club Dr. Eyad Al-Saeed Radiation Oncology 12 January, 2008.

Brentuximab Vedotin in Combination with RCHOP as Front-Line Therapy in Patients with DLBCL: Interim Results from a Phase 2 Study Yasenchak CA et al. Proc.

2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial Aron Goldhirsch, Richard.

Ten Year Outcome of Coronary Artery Bypass Graft Surgery Versus Medical Therapy in Patients with Ischemic Cardiomyopathy Results of the Surgical Treatment.

J Clin Oncol 30: R2 윤경한 / Prof. 김시영 Huan Jin, Dongsheng Tu, Naiqing Zhao, Lois E. Shepherd, and Paul E. Goss.

SNDA ETHYOL FOR RADIATION INDUCED XEROSTOMIA.

Geisler C et al. Proc ASH 2011;Abstract 290.

A cura di Filippo de Marinis

STAMPEDE: Docetaxel Significantly Improves Survival in Men With Hormone-Naive Prostate Cancer CCO Independent Conference Highlights of the 2015 ASCO Annual.

CCO Independent Conference Coverage

Evaluation of biologically equivalent dose escalation, clinical outcome, and toxicity in prostate cancer radiotherapy: A meta-analysis of 12,000 patients.

Hormone Therapy for Prostate Cancer: Exploring Current Controversies

Coiffier B et al. Proc ASH 2010;Abstract 857.

Localised and Locally Advanced Prostate Cancer: Who to Treat and How?

Vitolo U et al. Proc ASH 2011;Abstract 777.

ACT II: The Second UK Phase III Anal Cancer Trial

Neoadjuvant Adjuvant Curative Palliative

Martin M et al. Proc SABCS 2012;Abstract S1-7.

HOPE-3 Trial design: Patients without known cardiovascular disease, and with an intermediate risk of cardiovascular events, were randomized in a 2 x 2.

Presentation transcript:

Long-Term versus Short-Term Androgen Deprivation Combined with High-Dose Radiotherapy for Intermediate and High Risk Prostate Cancer: Preliminary Results of a Phase III Randomized Trial - DART 01/05 A.Zapatero, A.Guerrero, X.Maldonado, A.Alvarez, C.González Sansegundo, A.Cabeza, V.Macías, F.Casas. A. Pedro-Olivé, S.Villa, A.Boladeras, M.L. Vazquez de la Torre, C. Martin de Vidales, F.A.Calvo. G.I.C.O.R. This study has been supported by Governmental Grant No. 04/2506 fron the FIS (National Health Investigation Fund – Fondo de Investigación Sanitaria)

Background 1.In locally advanced prostate cancer, randomized trials have shown a significant benefit in OS when androgen deprivation (AD) and conventional dose of radiotherapy (≤ Gy) are associated. 2. A GICOR study (JCO, 2005) showed and independent benefit of dose escalation combined with AD in high-risk disease. 3.The role and the optimal scheme of AD when associated to high-dose radiotherapy remains controversial.

Objectives / Purpose To determine whether long-term AD (LTAD) is superior to short -term AD (STAD) in intermediate and high-risk prostate cancer patients treated with high-dose RT. 1.Primary endpoint: Freedom from biochemical failure (FFBF). (Phoenix definition) 2.Secondary endpoints: Freedom from clinical failure (FFCF) Overall survival (OS) Toxicity (RTOG and CTC criteria)

- Study designed to detect a difference in FFBF of 15% in favor of LTAD with a statistical power of 80% and a unilateral significance level of 5%. -Sample size required including 15% loss: 358 patients

Limitations of the study  This study assumes the inherent limitations of an interim analysis report:  Short follow-up  Short number of events  Absence of a control arm with HDRT alone ?  FFBF less than optimal primary endpoint? Strenght of the study  This is a pioneering study to evaluate the role of AD combined with high- dose escalated RT (median 78 Gy) in prostate cancer.

Conclusion 1.Although preliminary, the results of the study suggest that LTAD could be superior to STAD in patients with unfavorable prostate cancer treated with high-dose external beam radiotherapy. 2.Relevant radiation toxicity remains acceptably low and not significantly different in both treatment arms. 3.Longer follow-up is required to confirm these trends.