Results Of Radiotherapy Quality Assurance In The Peace
10 May 2022
Quality assurance in radiotherapy is vital in ensuring the best possible performance from the equipment and personnel. In addition, it is valuable in improving the information obtained from images, lowering costs, and delivering the correct radiation dose. Since clinical trials aim to provide the best evidence that a treatment is beneficial to patients, it is essential to ensure that any treatment used in a trial is given appropriately and optimally.
The multi-centre EORTC PEACE-1 Phase 3 trial examines the effect of Abiraterone on men with metastatic hormone-naïve1 prostate cancer. Patients have been randomised into groups studying the impact of standard therapy with or without radiotherapy and standard treatment plus Abiraterone with or without radiotherapy. Presenting radiotherapy QA results from the trial to the ESTRO 2022 Congress in Copenhagen in May, Dr Najlaa Alyamani explained that 585 patients were enrolled in the radiotherapy arms where QA was carried out. After an internal EORTC quality control of individual plans, we submitted them to external reviewers for a case review of delineation and the radiotherapy dose and plan .
The PEACE trial is sponsored by Unicancer
Is Triple Therapy The New Standard For Metastatic Hormone
touchREVIEWS in Oncology & Haematology
Abstract:
Overview
The treatment of metastatic hormone-sensitive prostate cancer has rapidly changed over the last decade. Currently, standard of care options for first-line treatment are androgen deprivation therapy in combination with either docetaxel chemotherapy or an androgen receptor pathway inhibitor such as abiraterone, enzalutamide or apalutamide. Recent results from both the PEACE-1 and ARASENS trials show an overall survival and progression-free survival benefit from the addition of an androgen-receptor pathway inhibitor for patients in whom the SOC option of ADT plus docetaxel has been chosen in de novo metastatic hormone-sensitive prostate cancer, with a more pronounced benefit in those with high-volume metastatic disease. However, many clinicians now preferentially use ADT plus an androgen-receptor pathway inhibitor as SOC first-line treatment, and no prospective trial has addressed whether there is a benefit from the addition of docetaxel to this version of SOC combination therapy. The benefit of triplet combination therapy in those with recurrent or low-volume metastatic disease is less clear and longer follow-up is required before conclusions can be drawn about these patient groups.
Keywords
Abiraterone acetate, apalutamide, darolutamide, docetaxel, enzalutamide, metastatic hormone-sensitive prostate cancer, triplet combination therapy
Article:
Ravi A Madan Md Discusses The Significance Of The Peace
Ravi A. Madan, MD, discusses the potential impact of docetaxel, abiraterone acetate, androgen deprivation therapy, and radiotherapy on patients with metastatic castration-sensitive prostate cancer.
At the 2021 European Society for Medical Oncology Annual Congress, CancerNetwork® spoke with Ravi A. Madan, MD, clinical director of the genitourinary malignancies branch at the Center for Cancer Research, National Cancer Institute, about the significance of the phase 3 PEACE-1 trial with docetaxel, abiraterone acetate , androgen deprivation therapy , and radiotherapy for the treatment of metastatic castration-sensitive prostate cancer .
Madan explained how the studys regimen yielded promising data and may lead to superior outcomes in patients with mCSPC. However, he explained that investigators will need to ensure that the regimen is feasible so more patients are able to receive benefit from treatment.
Transcript:
this years meeting, we had some very interesting data presented in the PEACE-1 trial that highlighted the potential of docetaxel and abiraterone in combination with ADT, and potentially radiation, to have superior outcomes in . This represents the first data that have shown that combination of chemotherapy and an anti-androgen like abiraterone can improve outcomes . We have to figure out how we can get those data to our patients and make it feasible for more people to benefit.
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Triplet Regimen Reduced The Risk For Radiographic Progression Or Death But Os Data Await
byMike Bassett, Staff Writer, MedPage Today June 9, 2021
Hormonal therapies combined with chemotherapy significantly improved radiographic progression-free survival for men with de novo metastatic castration-sensitive prostate cancer , results from a phase III study showed.
In the PEACE-1 trial, the triplet therapy of abiraterone plus androgen-deprivation therapy and docetaxel extended rPFS by a median 2.5 years for these patients, and could be practice changing, reported Karim Fizazi, MD, PhD, of Institut Gustave Roussy in Villejuif, France.
“Regardless of overall survival results, this data question whether we should deny patients approximately 2 and a half years without radiographic progression or death, or whether combining ADT/docetaxel and abiraterone/prednisone should simply become the new standard of care,” Fizazi said during a presentation at the virtual American Society of Clinical Oncology annual meeting.
He noted that the standard of care for mCSPC has rapidly evolved over the last several years. For example, when the PEACE-1 trial began accruing patients in 2013, ADT alone was the standard of care . But in the time since, the trend has been to combine ADT with docetaxel, novel hormone therapies, or radiotherapy to the primary tumor , an approach that has increased survival and become the new standard.
He noted, however, that OS results at the time of presentation of the data were still immature and not able to be reported.
Disclosures
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Early Data From The Peace
The so-called PEACE-1 trial is an ongoing Phase III trial among men diagnosed with de novo metastatic castration-sensitive prostate cancer .The earliest results of this trial are to be presented by Fizazi et al. at the upcoming annual meeting of the American Society for Clinical Oncology .
The PEACE-1 trial is a complex four-arm trial, and there were added complexities during the course of the trial that we will try to explain below. Patients with newly diagnosed, mCSPC were randomly assigned to one of four arms of the trial as follows:
- Normal standard of care or SOC
- Normal SOC + abiraterone acetate + prednisone
- Normal SOC + radiotherapy
- Normal SOC + abiraterone acetate + prednisone + radiotherapy
However, initially, the normal SOC was androgen deprivation therapy alone. Then, after October 2015, the normal SOC was changed to ADT + docetaxel chemotherapy at the investigators discretion . Then after publication of the data from the STAMPEDE and the LATITUDE trials in 2017. accrual of patients was limited to men who were already previously treated with ADT + docetaxel.
Now we would point out with care that these changes in the trial protocol were almost certainly appropriate and necessary. However, they do complicate the interpretation of the preliminary results of the PEACE-1 trial .
The trial has two co-primary endpoints: radiographic progression-free survival and overall survival .
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Bimodal Vs Trimodal Therapy In Patients With Metastatic Hormone
Case-Based Roundtable Meetings Spotlight
During a case-based roundtable event, Ashley Evan Ross, MD, PhD, reviewing therapeutic options for a patient with metastatic hormone-sensitive prostate cancer.
Targeted OncologyTM: What therapeutic options would you consider for this patient with high-volume, hormone-naive metastatic prostate cancer?
ROSS: Based on the NCCN guidelines for prostate cancer, combination therapy for M1 disease is the preferred approach.1 So, ADT , plus abiraterone , ADT plus apalutamide , ADT plus enzalutamide , or ADT plus chemotherapy, which are all category 1 recommendations.
Now, ADT alone is not supported by category 1 evidence. Its a therapy than doing ADT plus an androgen axis inhibitor or plus chemotherapy, and so its a category 2A recommendation. Recent published results not included in the guidelines were from the PEACE1 trial and the ARASENS trial , which both had ADT plus chemotherapy plus either darolutamide , an androgen receptor blocker, or abiraterone.
Why do the NCCN guidelines have a category 1 recommendation for these options?
Both ADT plus 6 cycles of chemotherapy and ADT alone were in the CHAARTED trial and STAMPEDE trial that tested the strategy. There is an overall survival benefit if its newly diagnosed hormone-sensitive prostate cancer and you offer the gentleman 6 cycles of docetaxel plus ADT or ADT alone, and they extend their survival by about 1 year or so.
What data support the use of bimodal therapy vs ADT alone?
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Abiraterone Plus Prednisone Added To Androgen Deprivation Therapy And Docetaxel In De Novo Metastatic Castration
- Karim FizaziCorrespondenceCorrespondence to: Prof Karim Fizazi, Department of Cancer Medicine, Institut Gustave Roussy, University of Paris-Saclay, Villejuif 94805, France
- Department of Biostatistics and Epidemiology, Institut Gustave Roussy, University of Paris-Saclay, Villejuif, FranceOncostat U1018, Inserm, Ligue Contre le Cancer, Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France
- on behalf of thePEACE-1 investigators
- Members are listed in the appendix
Wise Summarizes Survival Data From Arasens And Peace
Dr. Wise highlights how intensified treatment with doublet or triplet therapy can lead to better long-term outcomes in prostate cancer, potential treatment sequencing options, and the importance of communication between patients and physicians.
Welcome to OncLive On Air®! Im your host today, Caroline Seymour.
OncLive On Air® is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.
In todays episode, we had the pleasure of speaking with David R. Wise, MD, PhD. Dr Wise is an assistant professor in the Department of Medicine and Department of Urology at the NYU Grossman School of Medicine, part of NYU Langone Health.
In our exclusive interview, Dr Wise discussed practice-changing findings from the phase 3 ARASENS and PEACE1 trials. The ARASENS study investigated darolutamide plus androgen deprivation therapy and docetaxel in metastatic castration-sensitive prostate cancer. The triplet resulted in a 32.5% reduction in the risk of death compared with docetaxel and ADT alone. Additionally, at a 36-week follow-up, this trial demonstrated a 63% reduction in the risk of death in patients with undetectable prostate-specific antigen levels who received the darolutamide combination.
Thanks again for listening to OncLive On Air®.
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