A Phase II Study Evaluating Bone Marrow-Sparing, Image-guided Pelvic Intensity-Modulated Radiotherapy (IMRT) With Cesium-131 Brachytherapy Boost, Adjuvant Chemotherapy, and Long-Term Hormonal Ablation in Patients With High Risk, Nonmetastatic Prostate Cancer

被引：7

作者：

Rice, Stephanie R. ^{[1
]}

Olexa, Gloribel ^{[1
]}

Hussain, Arif ^{[2
,3
]}

Mannuel, Heather ^{[2
,3
,5
]}

Naslund, Michael J. ^{[4
]}

Amin, Pradip ^{[1
]}

Kwok, Young ^{[1
]}

机构：

[1] Univ Maryland, Sch Med, Dept Radiat Oncol, Baltimore, MD 21201 USA

[2] Univ Maryland, Sch Med, Dept Med, Baltimore, MD 21201 USA

[3] Univ Maryland, Sch Med, Greenebaum Comprehens Canc Ctr, Baltimore, MD 21201 USA

[4] Univ Maryland, Sch Med, Dept Surg, Div Urol, Baltimore, MD 21201 USA

[5] Baltimore Vet Affairs Med Ctr, Baltimore, MD USA

来源：

AMERICAN JOURNAL OF CLINICAL ONCOLOGY-CANCER CLINICAL TRIALS | 2019年 / 42卷 / 03期

关键词：

prostate cancer; high risk; brachytherapy; Cs-131; external beam radiotherapy; docetaxel; chemotherapy; EXTERNAL-BEAM RADIOTHERAPY; NEOADJUVANT ANDROGEN DEPRIVATION; DOSE-ESCALATION TRIAL; RADIATION-THERAPY; RANDOMIZED-TRIAL; ASCENDE-RT; INTERMEDIATE; SUPPRESSION; SURVIVAL; MORBIDITY;

D O I：

10.1097/COC.0000000000000520

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose/Objective(s): Management of localized high-risk prostate cancer remains challenging. At our institution we performed a prospective phase II study of 2 years of androgen deprivation therapy (ADT), pelvic radiation, Cesium (Cs)-131 brachytherapy boost, and adjuvant docetaxel in high risk, localized prostate cancer with a primary endpoint of 3-year disease-free survival. Materials/Methods: Acute/chronic hematologic, gastrointestinal (GI) and genitourinary (GU) toxicities were scored based on the CTCAE v3.0/RTOG-EORTC criteria, respectively. Actuarial biochemical recurrence free survival (bRFS), bRFSdisease free survival (DFS) and overall survival (OS) were calculated. Patients had a median age of 62 years (range, 45 to 82), median Gleason score 8 (74% Gleason 8-10), median PSA of 11.2 (range, 2.8 to 96), and 47% cT2-T3a stage disease. Androgen deprivation was given for 2 years, 45 Gy whole-pelvis IMRT was followed by an 85 Gy Cs-131 boost to the prostate gland, and adjuvant docetaxel was given for 4 cycles. Results: In total 38 patients enrolled from 2006 to 2014, with 82% completing protocol specified treatment, and 84.2% completing 4 cycles of docetaxel. Median follow-up for the entire and alive cohorts were 44 months and 58 months (range, 3.4 to 118), respectively. Acute grade >= 2 GI and GU toxicity rates were 18.4% and 23.7%, respectively. Chronic grade >= 2 GI and GU toxicity rates were 2.6% and 2.6%, respectively. Twelve patients (31.6%) developed grade 4 hematologic toxicity, with no grade 5 toxicity. The 5-year DFS, bRFS and OS rates were 74.1%, 86.0%, and 80.3%, respectively. Conclusions: This aggressive pilot multimodal approach appears to be safe and well-tolerated, providing disease control in a significant proportion of patients with particularly high-risk prostate cancer.

引用

页码：285 / 291

页数：7

共 32 条

[1] UPDATE OF DUTCH MULTICENTER DOSE-ESCALATION TRIAL OF RADIOTHERAPY FOR LOCALIZED PROSTATE CANCER [J].

Al-Mamgani, Abrahim ;

van Putten, Wim L. J. ;

Heemsbergen, Wilma D. ;

van Leenders, Geert J. L. H. ;

Slot, Annerie ;

Dielwart, Michel F. H. ;

Incrocci, Luca ;

Lebesque, Joos V. .

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2008, 72 (04) :980-988

[2]

[Anonymous], 2015, J CLIN ONCOL

[3] 70 GY VERSUS 80 GY IN LOCALIZED PROSTATE CANCER: 5-YEAR RESULTS OF GETUG 06 RANDOMIZED TRIAL [J].

Beckendorf, Veronique ;

Guerif, Stephane ;

Le Prise, Elisabeth ;

Cosset, Jean-Marc ;

Bougnoux, Agnes ;

Chauvet, Bruno ;

Salem, Naji ;

Chapet, Olivier ;

Bourdain, Sylvain ;

Bachaud, Jean-Marc ;

Maingon, Philippe ;

Hannoun-Levi, Jean-Michel ;

Malissard, Luc ;

Simon, Jean-Marc ;

Pommier, Pascal ;

Hay, Men ;

Dubray, Bernard ;

Lagrange, Jean-Leon ;

Luporsi, Elisabeth ;

Bey, Pierre .

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2011, 80 (04) :1056-1063

[4] Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial [J].

Bolla, M ;

Collette, L ;

Blank, L ;

Warde, P ;

Dubois, JB ;

Mirimanoff, RO ;

Storme, G ;

Bernier, J ;

Kuten, A ;

Sternberg, C ;

Mattelaer, J ;

Torecilla, JL ;

Pfeffer, JR ;

Cutajar, CL ;

Zurlo, A ;

Pierart, M .

LANCET, 2002, 360 (9327) :103-108

[5] Duration of Androgen Suppression in the Treatment of Prostate Cancer [J].

Bolla, Michel ;

de Reijke, Theodorus M. ;

Van Tienhoven, Geertjan ;

Van den Bergh, Alphonsus C. M. ;

Oddens, Jorg ;

Poortmans, Philip M. P. ;

Gez, Eliahu ;

Kil, Paul ;

Akdas, Atif ;

Soete, Guy ;

Kariakine, Oleg ;

Van der Steen-Banasik, Elsbietha M. ;

Musat, Elena ;

Pierart, Marianne ;

Mauer, Murielle E. ;

Collette, Laurence .

NEW ENGLAND JOURNAL OF MEDICINE, 2009, 360 (24) :2516-2527

[6] Impact of intensity-modulated radiotherapy on acute hematologic toxicity in women with gynecologic malignancies [J].

Brixey, CJ ;

Roeske, JC ;

Lujan, AE ;

Yamada, SD ;

Rotmensch, J ;

Mundt, AJ .

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2002, 54 (05) :1388-1396

[7] TOXICITY CRITERIA OF THE RADIATION-THERAPY ONCOLOGY GROUP (RTOG) AND THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER (EORTC) [J].

COX, JD ;

STETZ, J ;

PAJAK, TF .

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 1995, 31 (05) :1341-1346

[8] Escalated-dose versus control-dose conformal radiotherapy for prostate cancer: long-term results from the MRC RT01 randomised controlled trial [J].

Dearnaley, David P. ;

Jovic, Gordana ;

Syndikus, Isabel ;

Khoo, Vincent ;

Cowan, Richard A. ;

Graham, John D. ;

Aird, Edwin G. ;

Bottomley, David ;

Huddart, Robert A. ;

Jose, Chakiath C. ;

Matthews, John H. L. ;

Millar, Jeremy L. ;

Murphy, Claire ;

Russell, J. Martin ;

Scrase, Christopher D. ;

Parmar, Mahesh K. B. ;

Sydes, Matthew R. .

LANCET ONCOLOGY, 2014, 15 (04) :464-473

[9] Short-term neoadjuvant androgen deprivation and radiotherapy for locally advanced prostate cancer: 10-year data from the TROG 96.01 randomised trial [J].

Denham, James W. ;

Steigler, Allison ;

Lamb, David S. ;

Joseph, David ;

Turner, Sandra ;

Matthews, John ;

Atkinson, Chris ;

North, John ;

Christie, David ;

Spry, Nigel A. ;

Tai, Keen-Hun ;

Wynne, Chris ;

D'Este, Catherine .

LANCET ONCOLOGY, 2011, 12 (05) :451-459

[10] LONG-TERM RESULTS OF A PROSPECTIVE, PHASE II STUDY OF LONG-TERM ANDROGEN ABLATION, PELVIC RADIOTHERAPY, BRACHYTHERAPY BOOST, AND ADJUVANT DOCETAXEL IN PATIENTS WITH HIGH-RISK PROSTATE CANCER [J].

DiBiase, Steven J. ;

Hussain, Arif ;

Kataria, Ritesh ;

Amin, Pradip ;

Bassi, Sunakshi ;

Dawson, Nancy ;

Kwok, Young .

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2011, 81 (03) :732-736

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