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The addition of androgen deprivation therapy and pelvic lymph node treatment to prostate bed salvage radiotherapy (NRG Oncology/RTOG 0534 SPPORT): an international, multicentre, randomised phase 3 trial

Pollack, Alan ; Karrison, Theodore G ; Balogh, Alexander G ; Gomella, Leonard G ; Low, Daniel A ; Bruner, Deborah W ; Wefel, Jeffrey S ; Martin, Andre-Guy ; Michalski, Jeff M ; Angyalfi, Steve J ; Lukka, Himanshu ; Faria, Sergio L ; Rodrigues, George B ; Beauchemin, Marie-Claude ; Lee, R Jeffrey ; Seaward, Samantha A ; Allen, Aaron M ; Monitto, Drew C ; Seiferheld, Wendy ; Sartor, Oliver ; Feng, Felix ; Sandler, Howard M

The Lancet (British edition), 2022-05, Vol.399 (10338), p.1886-1901 [Periódico revisado por pares]

England: Elsevier Ltd

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  • Título:
    The addition of androgen deprivation therapy and pelvic lymph node treatment to prostate bed salvage radiotherapy (NRG Oncology/RTOG 0534 SPPORT): an international, multicentre, randomised phase 3 trial
  • Autor: Pollack, Alan ; Karrison, Theodore G ; Balogh, Alexander G ; Gomella, Leonard G ; Low, Daniel A ; Bruner, Deborah W ; Wefel, Jeffrey S ; Martin, Andre-Guy ; Michalski, Jeff M ; Angyalfi, Steve J ; Lukka, Himanshu ; Faria, Sergio L ; Rodrigues, George B ; Beauchemin, Marie-Claude ; Lee, R Jeffrey ; Seaward, Samantha A ; Allen, Aaron M ; Monitto, Drew C ; Seiferheld, Wendy ; Sartor, Oliver ; Feng, Felix ; Sandler, Howard M
  • Assuntos: Adenocarcinoma ; Adolescent ; Adult ; Adverse events ; Androgen Antagonists - therapeutic use ; Androgens ; Antigens ; Bone marrow ; Cancer therapies ; Criteria ; Deprivation ; Dosage ; Health services ; Humans ; Lymph nodes ; Lymph Nodes - pathology ; Lymphatic system ; Male ; Oncology ; Patients ; Prostate - pathology ; Prostate cancer ; Prostate-Specific Antigen ; Prostatectomy ; Prostatic Neoplasms - drug therapy ; Prostatic Neoplasms - radiotherapy ; Radiation ; Radiation Oncology ; Radiation therapy ; Regional planning ; Registration ; Salvage Therapy - adverse effects ; Toxicity
  • É parte de: The Lancet (British edition), 2022-05, Vol.399 (10338), p.1886-1901
  • Notas: Author Contribution: Dr. Pollack was involved in study design (all levels - endpoints, stratification, eligibility), monitoring of accrual, data consistency and verification (QA assessment during and after accrual; cause of death attribution), data interpretation, Table and Figure construction and formatting, and manuscript writing, editing and approval. Dr. Karrison was involved in data compilation, statistical oversight, data analysis, data interpretation, and writing, editing and approval of the manuscript. Dr. Low was the medical physicist on the RTOG 0534 and provided medical physics input, and was involved in the data interpretation, writing, and approval of final manuscript. Dr. Bruner was involved in the design of the trial and all aspects of the manuscript. Dr. Wefel was involved in data collection, data analysis, data interpretation, writing, and approval of final manuscript. Dr. Gomella was the Urology Co-PI on the protocol and was involved in protocol design, protocol updates, QA reviews, interpretation of data, and writing and approval of the manuscript. Drs. Michalski, Martin, and Sandler, as members of the GU steering committee of RTOG/NRG, were involved in trial arm design, endpoints, treatment approach. They also enrolled patients treated on the trial from their local institutions and were involved with data interpretation and manuscript writing and approval. Dr. Sandler was the NRG GU section chair during the implementation and enrollment period, and was involved in the cause of death attribution review. Dr. Feng is the current NRG GU section chair and was involved with data interpretation, and manuscript writing, editing and final approval. Dr. Angyalfi was involved in patient accrual to the study, manuscript editing and manuscript approval. Dr. Lukka was involved in the design of the study, interpretation of data, accrual and writing of the study. Dr. Faria was involved in data collection, data interpretation, manuscript editing and manuscript approval. Dr. Rodrigues was involved in the local accrual and data collection of patients as well as data interpretation and manuscript editing and approval of this work. Dr. Beauchemin was involved in data collection, manuscript editing and manuscript approval. Dr. Lee was involved in enrolling patients, patient management, and manuscript review, editing and approval of the manuscript. Dr. Seaward was involved in data collection, subject management, manuscript writing, editing, and final approval. Dr. Allen was involved in the recruitment of patients, and review, editing and final approval of the manuscript. Dr. Monitto was involved in patient accrual, and manuscript review, editing and final approval. Dr. Seiferheld was involved in programming data analysis, construction of tables, and figures, and manuscript review, editing, and final approval. Dr. Balogh was the study Co-PI and was involved in patient accrual, quality assurance of contouring for half of all cases, cause of death attribution, and manuscript writing, editing and final approval.
  • Descrição: In men with a detectable prostate-specific antigen (PSA) level after prostatectomy for prostate cancer, salvage prostate bed radiotherapy (PBRT) results in about 70% of patients being free of progression at 5 years. A three-group randomised trial was designed to determine whether incremental gains in patient outcomes can be achieved by adding either 4–6 months of short-term androgen deprivation therapy (ADT) to PBRT, or both short-term ADT and pelvic lymph node radiotherapy (PLNRT) to PBRT. The international, multicentre, randomised, controlled SPPORT trial was done at 283 radiation oncology cancer treatment centres in the USA, Canada, and Israel. Eligible patients (aged ≥18 years) were those who after prostatectomy for adenocarcinoma of the prostate had a persistently detectable or an initially undetectable and rising PSA of between 0·1 and 2·0 ng/mL. Patients with and without lymphadenectomy (N0/Nx) were eligible if there was no clinical or pathological evidence of lymph node involvement. Other eligibility criteria included pT2 or pT3 disease, prostatectomy Gleason score of 9 or less, and a Zubrod performance status of 0–1. Eligible patients were randomly assigned to receive PBRT alone at a dose of 64·8–70·2 Gy at 1·8 Gy per fraction daily (group 1), PBRT plus short-term ADT (group 2), or PLNRT (45 Gy at 1·8 Gy per fraction, and then a volume reduction made to the planning target volume for the remaining 19·8–25 ·2 Gy) plus PBRT plus short-term ADT (group 3). The primary endpoint was freedom from progression, in which progression was defined as biochemical failure according to the Phoenix definition (PSA ≥2 ng/mL over the nadir PSA), clinical failure (local, regional, or distant), or death from any cause. A planned interim analysis of 1191 patents with minimum potential follow-up time of 5 years applied a Haybittle-Peto boundary of p<0·001 (one sided) for comparison of 5-year freedom from progression rates between the treatment groups. This trial is registered with ClinicalTrials.gov, NCT00567580. The primary objectives of the trial have been completed, although long-term follow-up is continuing. Between March 31, 2008, and March 30, 2015, 1792 eligible patients were enrolled and randomly assigned to the three treatment groups (592 to group 1 [PBRT alone], 602 to group 2 [PBRT plus short-term ADT], and 598 to group 3 [PLNRT plus PBRT plus short-term ADT]). 76 patients subsequently found to be ineligible were excluded from the analyses; thus, the evaluable patient population comprised 1716 patients. At the interim analysis (n=1191 patients; data cutoff May 23, 2018), the Haybittle-Peto boundary for 5-year freedom from progression was exceeded when group 1 was compared with group 3 (difference 17·9%, SE 2·9%; p<0·0001). The difference between groups 2 and 3 did not exceed the boundary (p=0·0063). With additional follow-up beyond the interim analysis (the final planned analysis; data cutoff May 26, 2021), at a median follow-up among survivors of 8·2 years (IQR 6·6–9·4), the 5-year freedom from progression rates in all 1716 eligible patients were 70·9% (95% CI 67·0–74·9) in group 1, 81·3% (78·0–84·6) in group 2, and 87·4% (84·7–90·2) in group 3. Per protocol criteria, freedom from progression in group 3 was superior to groups 1 and 2. Acute (≤3 months after radiotherapy) grade 2 or worse adverse events were significantly more common in group 3 (246 [44%] of 563 patients) than in group 2 (201 [36%] of 563; p=0·0034), which, in turn, were more common than in group 1 (98 [18%] of 547; p<0·0001). Similar findings were observed for grade 3 or worse adverse events. However, late toxicity (>3 months after radiotherapy) did not differ significantly between the groups, apart from more late grade 2 or worse blood or bone marrow events in group 3 versus group 2 (one-sided p=0·0060) attributable to the addition of PLNRT in this group. The results of this randomised trial establish the benefit of adding short-term ADT to PBRT to prevent progression in prostate cancer. To our knowledge, these are the first such findings to show that extending salvage radiotherapy to treat the pelvic lymph nodes when combined with short-term ADT results in meaningful reductions in progression after prostatectomy in patients with prostate cancer. National Cancer Institute.
  • Editor: England: Elsevier Ltd
  • Idioma: Inglês
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