Bladder Adjuvant Radiotherapy: Phase III Multicenter Randomized Controlled Trial of Adjuvant Radiotherapy or Observation for Postcystectomy Muscle-Invasive Bladder Cancer
Abstract
PURPOSE To report the primary analysis of a multicenter, phase III randomized trial of adjuvant radiotherapy (RT) after chemotherapy and radical cystectomy (RC) in patients with high-risk muscle-invasive bladder cancer (MIBC). METHODS Patients with nonmetastatic urothelial MIBC at high risk after RC (any one of: T3-4, N1-3, margin positive, ≤10 nodes dissected) were randomly assigned 1:1 to adjuvant RT or observation (Obs), stratified by nodal involvement (yes/no) and chemotherapy (neoadjuvant/adjuvant/none). Stoma-sparing IG-IMRT 50.4Gy in 28 fractions was prescribed to the cystectomy bed and pelvic nodes. The primary end point was 2-year locoregional recurrence–free survival (LRFS), and the secondary end points were disease-free survival (DFS), bladder cancer–specific survival (BCSS), and overall survival (OS). RESULTS From June 2016 to May 2024, 153 patients were randomly assigned (Obs = 76, RT = 77), with 62% and 41% of patients having pT3-T4 and pN+ stages, respectively. Over 90% of the patients received systemic chemotherapy (71% neoadjuvant and 20% adjuvant), and none received immunotherapy. After a median follow-up of 47 months, the 2-year LRFS was significantly higher with adjuvant RT versus observation (87.1% v 76.0%, hazard ratio [HR], 0.43 [95% CI, 0.20 to 0.96], P = .04). The DFS was 71.6% versus 58.7% (HR, 0.62 [95% CI, 0.36 to 1.05]), BCSS was 79.6% versus 65.0% (HR, 0.59 [95% CI, 0.33 to 1.10]), and OS was 70.4% versus 57.4% (HR, 0.78 [95% CI, 0.49 to 1.26]) for RT and Obs, respectively. CONCLUSION Adjuvant pelvic IMRT after radical cystectomy and perioperative chemotherapy suggests an improvement in locoregional control in patients with high risk urothelial MIBC with no additional severe toxicity.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (20)
Vedang Murthy
Tata Memorial Hospital and Advanced Center for Treatment Research and Education in Cancer Homi Bhabha National Institute Mumbai India
Priyamvada Maitre
Department of Radiation Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India
Mahendra Pal
Department of Surgery, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India
Amandeep Arora
Department of Surgery, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India
Reena Phurailatpam
Department of Medical Physics, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India
Rakesh Sharma
Deleep Gudipudi
Basavatarakam Indo-American Cancer Hospital and Research Institute, Hyderabad, India
Senthil Rajappa
Basavatarakam Indo-American Cancer Hospital and Research Institute, Hyderabad, India
Lincoln Pujari
Bhavesh Bandekar
Homi Bhabha Cancer Hospital & MPMMMC, Varanasi, India
Deepa Joseph
All India Institute of Medical Sciences (AIIMS), Rishikesh, India
Sadhana Kannan
5Tata Memorial Centre, Department of Biostatistics, Mumbai, India
Rahul Krishnatry
Department of Radiation Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India
Ankit Misra
Department of Surgery, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India
Amit Joshi
Sr. Specialist, Department of Forensic Medicine, Government Medical College, Kota, Rajasthan, India
Vanita Noronha
Kumar Prabhash, MD, DM, MBBS, Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India, Department of Medical Oncology, Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur, India; Vanita Noronha, MD, DM, MBBS, Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India; Akash Pawar, MSc, Department of Statistics, Advanced Centre for Treatment, Research and Education in Cancer, Homi Bhabha National Institute (HBNI), Mumbai, India, Ankush Shetake, MSc, Department of Statistics, Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur, India; and Rajendra Badwe, MS, Department of Surgical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India
Kumar Prabhash
Department of Medical Oncology, Division of Adult Solid Tumor Oncology, Tata Memorial Hospital, Mumbai, India
Santosh Menon
Department of Pathology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India
Ganesh Bakshi
Department of Surgery, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India
Gagan Prakash
Department of Surgery, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India