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Toxicity and Patient-Reported Outcomes of a Phase 2 Randomized Trial of Prostate and Pelvic Lymph Node Versus Prostate only Radiotherapy in Advanced Localised Prostate Cancer (PIVOTAL).
Dearnaley, David; Griffin, Clare L; Lewis, Rebecca; Mayles, Philip; Mayles, Helen; Naismith, Olivia F; Harris, Victoria; Scrase, Christopher D; Staffurth, John; Syndikus, Isabel; Zarkar, Anjali; Ford, Daniel R; Rimmer, Yvonne L; Horan, Gail; Khoo, Vincent; Frew, John; Venkitaraman, Ramachandran; Hall, Emma.
Affiliation
  • Dearnaley D; The Institute of Cancer Research, London, United Kingdom; The Royal Marsden NHSFT, London, United Kingdom. Electronic address: david.dearnaley@icr.ac.uk.
  • Griffin CL; The Institute of Cancer Research, London, United Kingdom.
  • Lewis R; The Institute of Cancer Research, London, United Kingdom.
  • Mayles P; Clatterbridge Cancer Centre, Wirral, United Kingdom.
  • Mayles H; Clatterbridge Cancer Centre, Wirral, United Kingdom.
  • Naismith OF; The Royal Marsden NHSFT, London, United Kingdom; UK Radiotherapy Trials Quality Assurance Group, London, United Kingdom.
  • Harris V; The Institute of Cancer Research, London, United Kingdom; The Royal Marsden NHSFT, London, United Kingdom.
  • Scrase CD; Ipswich Hospital NHS Trust, Ipswich, United Kingdom.
  • Staffurth J; Division of Cancer and Genetics, Cardiff University and Velindre Cancer Centre, Cardiff, United Kingdom.
  • Syndikus I; Clatterbridge Cancer Centre, Wirral, United Kingdom.
  • Zarkar A; Queen Elizabeth Hospital, Birmingham, United Kingdom.
  • Ford DR; Queen Elizabeth Hospital, Birmingham, United Kingdom.
  • Rimmer YL; Addenbrooke's Hospital, Cambridge, United Kingdom; West Suffolk Hospital, Bury St. Edmunds, United Kingdom.
  • Horan G; Addenbrooke's Hospital, Cambridge, United Kingdom; West Suffolk Hospital, Bury St. Edmunds, United Kingdom.
  • Khoo V; The Institute of Cancer Research, London, United Kingdom; The Royal Marsden NHSFT, London, United Kingdom.
  • Frew J; Freeman Hospital, Newcastle upon Tyne, United Kingdom.
  • Venkitaraman R; Ipswich Hospital NHS Trust, Ipswich, United Kingdom.
  • Hall E; The Institute of Cancer Research, London, United Kingdom.
Int J Radiat Oncol Biol Phys ; 103(3): 605-617, 2019 03 01.
Article in En | MEDLINE | ID: mdl-30528653
PURPOSE: To establish the toxicity profile of high-dose pelvic lymph node intensity-modulated radiation therapy (IMRT) and to assess whether it is safely deliverable at multiple centers. METHODS AND MATERIALS: In this phase 2 noncomparative multicenter trial, 124 patients with locally advanced, high-risk prostate cancer were randomized between prostate-only IMRT (PO) (74 Gy/37 fractions) and prostate and pelvic lymph node IMRT (P&P; 74 Gy/37 fractions to prostate, 60 Gy/37 fractions to pelvis). The primary endpoint was acute lower gastrointestinal (GI) Radiation Therapy Oncology Group (RTOG) toxicity at week 18, aiming to exclude a grade 2 or greater (G2+) toxicity-free rate of 80% in the P&P group. Key secondary endpoints included patient-reported outcomes and late toxicity. RESULTS: One hundred twenty-four participants were randomized (62 PO, 62 P&P) from May 2011 to March 2013. Median follow-up was 37.6 months (interquartile range [IQR], 35.4-38.9 months). Participants had a median age of 69 years (IQR, 64-74 years) and median diagnostic prostate-specific androgen level of 21.6 ng/mL (IQR, 11.8-35.1 ng/mL). At week 18, G2+ lower GI toxicity-free rates were 59 of 61 (96.7%; 90% confidence interval [CI], 90.0-99.4) for the PO group and 59 of 62 (95.2%; 90% CI, 88.0-98.7) for the P&P group. Patients in both groups reported similarly low Inflammatory Bowel Disease Questionnaire symptoms and Vaizey incontinence scores. The largest difference occurred at week 6 with 4 of 61 (7%) and 16 of 61 (26%) PO and P&P patients, respectively, experiencing G2+ toxicity. At 2 years, the cumulative proportion of RTOG G2+ GI toxicity was 16.9% (95% CI, 8.9%-30.9%) for the PO group and 24.0% (95% CI, 8.4%-57.9%) for the P&P group; in addition, RTOG G2+ bladder toxicity was 5.1% (95% CI, 1.7%-14.9%) for the PO group and 5.6% (95% CI, 1.8%-16.7%) for the P&P group. CONCLUSIONS: PIVOTAL demonstrated that high-dose pelvic lymph node IMRT can be delivered at multiple centers with a modest side effect profile. Although safety data from the present study are encouraging, the impact of P&P IMRT on disease control remains to be established.
Subject(s)

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Prostate / Prostatic Neoplasms / Radiotherapy Dosage / Lymphatic Irradiation / Radiotherapy, Intensity-Modulated / Lymph Nodes / Lymphatic Metastasis Type of study: Clinical_trials Aspects: Patient_preference Limits: Aged / Humans / Male / Middle aged Language: En Journal: Int J Radiat Oncol Biol Phys Year: 2019 Document type: Article Country of publication: United States

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Prostate / Prostatic Neoplasms / Radiotherapy Dosage / Lymphatic Irradiation / Radiotherapy, Intensity-Modulated / Lymph Nodes / Lymphatic Metastasis Type of study: Clinical_trials Aspects: Patient_preference Limits: Aged / Humans / Male / Middle aged Language: En Journal: Int J Radiat Oncol Biol Phys Year: 2019 Document type: Article Country of publication: United States