Prostate-Only Versus Whole-Pelvic Radiation Therapy in High-Risk and Very High-Risk Prostate Cancer (POP-RT): Outcomes From Phase III Randomized Controlled Trial

被引:240
作者
Murthy, Vedang [1 ,2 ]
Maitre, Priyamvada [1 ,2 ]
Kannan, Sadhana [2 ,3 ]
Panigrahi, Gitanjali [1 ,2 ]
Krishnatry, Rahul [1 ,2 ]
Bakshi, Ganesh [2 ,4 ]
Prakash, Gagan [2 ,4 ]
Pal, Mahendra [2 ,4 ]
Menon, Santosh [2 ,5 ]
Phurailatpam, Reena [2 ,6 ]
Mokal, Smruti [2 ,3 ]
Chaurasiya, Dipika [1 ,2 ]
Popat, Palak [2 ,7 ]
Sable, Nilesh [2 ,7 ]
Agarwal, Archi [2 ,8 ]
Rangarajan, Venkatesh [2 ,8 ]
Joshi, Amit [2 ,9 ]
Noronha, Vanita [2 ,9 ]
Prabhash, Kumar [2 ,9 ]
Mahantshetty, Umesh [1 ,2 ]
机构
[1] Homi Bhabha Natl Inst HBNI, Tata Mem Hosp, Dept Radiat Oncol, Mumbai, Maharashtra, India
[2] Homi Bhabha Natl Inst HBNI, Adv Ctr Treatment Res & Educ Canc ACTREC, Mumbai, Maharashtra, India
[3] Homi Bhabha Natl Inst HBNI, Tata Mem Hosp, Clin Res Secretariat, Mumbai, Maharashtra, India
[4] Homi Bhabha Natl Inst HBNI, Tata Mem Hosp, Dept Surg, Mumbai, Maharashtra, India
[5] Homi Bhabha Natl Inst HBNI, Tata Mem Hosp, Dept Pathol, Mumbai, Maharashtra, India
[6] Homi Bhabha Natl Inst HBNI, Tata Mem Hosp, Dept Med Phys, Mumbai, Maharashtra, India
[7] Homi Bhabha Natl Inst HBNI, Tata Mem Hosp, Dept Radiodiag, Mumbai, Maharashtra, India
[8] Homi Bhabha Natl Inst HBNI, Tata Mem Hosp, Dept Nucl Med & Mol Imaging, Mumbai, Maharashtra, India
[9] Homi Bhabha Natl Inst HBNI, Tata Mem Hosp, Dept Med Oncol, Mumbai, Maharashtra, India
关键词
ANDROGEN SUPPRESSION; HORMONAL-THERAPY; RADIOTHERAPY; NEOADJUVANT; DEPRIVATION; CONSENSUS; SURVIVAL; FAILURE; UPDATE; TERM;
D O I
10.1200/JCO.20.03282
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
PURPOSEWe report the clinical outcomes of a randomized trial comparing prophylactic whole-pelvic nodal radiotherapy to prostate-only radiotherapy (PORT) in high-risk prostate cancer.METHODSThis phase III, single center, randomized controlled trial enrolled eligible patients undergoing radical radiotherapy for node-negative prostate adenocarcinoma, with estimated nodal risk >= 20%. Randomization was 1:1 to PORT (68 Gy/25# to prostate) or whole-pelvic radiotherapy (WPRT, 68 Gy/25# to prostate, 50 Gy/25# to pelvic nodes, including common iliac) using computerized stratified block randomization, stratified by Gleason score, type of androgen deprivation, prostate-specific antigen at diagnosis, and prior transurethral resection of the prostate. All patients received image-guided, intensity-modulated radiotherapy and minimum 2 years of androgen deprivation therapy. The primary end point was 5-year biochemical failure-free survival (BFFS), and secondary end points were disease-free survival (DFS) and overall survival (OS).RESULTSFrom November 2011 to August 2017, a total of 224 patients were randomly assigned (PORT = 114, WPRT = 110). At a median follow-up of 68 months, 36 biochemical failures (PORT = 25, WPRT = 7) and 24 deaths (PORT = 13, WPRT = 11) were recorded. Five-year BFFS was 95.0% (95% CI, 88.4 to 97.9) with WPRT versus 81.2% (95% CI, 71.6 to 87.8) with PORT, with an unadjusted hazard ratio (HR) of 0.23 (95% CI, 0.10 to 0.52; P < .0001). WPRT also showed higher 5-year DFS (89.5% v 77.2%; HR, 0.40; 95% CI, 0.22 to 0.73; P = .002), but 5-year OS did not appear to differ (92.5% v 90.8%; HR, 0.92; 95% CI, 0.41 to 2.05; P = .83). Distant metastasis-free survival was also higher with WPRT (95.9% v 89.2%; HR, 0.35; 95% CI, 0.15 to 0.82; P = .01). Benefit in BFFS and DFS was maintained across prognostic subgroups.CONCLUSIONProphylactic pelvic irradiation for high-risk, locally advanced prostate cancer improved BFFS and DFS as compared with PORT, but OS did not appear to differ.
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页码:1234 / +
页数:10
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