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SAN ANTONIO, November 1, 2018 / PRNewswire / – The first report of a large international clinical trial shows that in men with signs of prostate cancer after surgical removal of the prostate, the extension of radiotherapy to the pelvic lymph nodes combined with the addition of a short-term hormone treatment to standard treatment the treatment can prolong the delay of cancer spread. The results, presented last week at the 60th annual meeting of the American Society of Radiation Oncology (ASTRO), were so encouraging – exceeding the stringent threshold criteria – that the results were released by the research team more early than expected.
Men with prostate cancer who are initially treated with prostatectomy, that is, surgical removal of the prostate, often face signs of recurrence, usually reported by an increase in the rate of prostate specific antigen (PSA) in the blood. Radiation therapy in the area of prior prostate surgery (surgical bed) is standard, but only effective in keeping the PSA down more than five years or more in 60 to 70% of patients, said the main author of l & # 39; study Alan Pollack, MD, PhD, Chair of Radiation Oncology at University of Miami and Deputy Director of the Sylvester Comprehensive Cancer Center.
Although an increase in PSA after a prostatectomy indicates that cancer is still present, this does not indicate where the cancer is located. The NRG Oncology / RTOG 0534 SPORRT Clinical Trial is the first randomized trial to show that radiotherapy to treat pelvic lymph nodes in addition to the standard prostate bed results in significant incremental gains for these patients.
"We specifically examined men with prostate cancer who began to show signs that the cancer had not been completely eradicated after a prostatectomy," said Dr. Pollack. "The addition of hormonal treatment and treatment of pelvic lymph nodes has significantly increased the proportion of patients remaining unaffected by disease progression, to the point that we could report the data after a first Intermediate badysis The degree of effectiveness of the combination is surprising, but makes When you consider other more contemporary evidence using new PET methods, pelvic ganglia recurrences are more common than had already believed.
The SPPORT trial recruited 1,792 men from centers in the United States, Canada and Israel from 2008 to 2015. Eligible patients had persistent or detectable PSA levels, as well as evidence of the survival of certain cancer cells after prostatectomy in the prostate bed, pelvic lymph nodes or elsewhere in the body. after prostatectomy. The median age of patients was 64 years (range 39 to 84 years), most patients (87%) were Caucasian and men had generally favorable performance status.
Patients in the SPPORT trial were randomly badigned to three treatment groups: Prostate Lithotriptive Radiotherapy (PET) alone, TEPV, Short-Term Hormone Therapy (hormone) (STAD), and PET. plus Pelvic Lymph Node Radiotherapy (PLNRT) and STAD. The hormone therapy consisted of androgen deprivation for four to six months aimed at reducing testosterone levels, one of the engines of prostate cancer.
The trial evaluated the absence of disease progression five years after treatment. The results of a planned interim badysis with 1,191 patients followed for five years triggered the rapid release of these results, said Dr. Pollack. "The degree of importance reached at this stage was considerable, so that it is unlikely that the results will change significantly with longer follow-up, although results such as distant metastasis rates and survival require much longer patient follow-up, "he said. "Data release at this stage is important for physicians who treat patients with increased PSA following prostatectomy.The strategy of combining radiation therapy from the prostate bed and pelvic lymph nodes with short-term hormone therapy should be considered. to be much more strongly taken into account in current clinical practice is currently. "
Five years after treatment, the rates of no progression in the interim badysis group were 71.7% for the TRBP alone, 82.7% for the TRBP + ADT and 89.1%. % for the PLNRT + PBRT + ADT. The FFP rate was highest for the combination arm of the three treatments (p <0.0001). The lack of progression was defined as a nadir PSA of +2, clinical failure or death, whatever the cause.
Rates of cancer spread were also significantly different between treatment groups. In all eligible patients followed up to eight years, distant metastases were found in 45 patients in the PBRT group, 38 in the PBRT + ADT group and 25 in the PLNRT + PBRT + ADT group. Rates of distant metastases were significantly lower after the three-treatment approach compared to PBRT alone (Hazard Ratio: 0.52, 95% CI: 0.32-0.85) and TRBP + ADT (HR 0.64, 95% CI: 0.39-1.06).
"While it is common to treat lymph nodes in men with high-risk prostate cancer, treated without prostatectomy in the first place, this study constitutes the most convincing Level I evidence for demonstrate a profit, "said Dr. Pollack. "Seeing the differences in distant metastases with relatively short follow-up demonstrates the robustness of the impact, suggesting that the results will be maintained with longer follow-up."
Another key finding of the SPPORT study is that short-term hormone therapy (also known as androgen deprivation therapy or ADT) is a key element in the management of patients with signs of recurrence after prostatectomy. SPPORT is only the second try to specifically study the addition of a short-term hormone therapy to radiation therapy in men after prostatectomy, Dr Pollack added. "There is a lot of data showing the benefit of adding a short-term hormone treatment in men whose prostate has not been removed, although only one patient Another randomized trial – GETUG 16 – has shown significant improvements after prostatectomy.Our study confirms that the addition of STAD to PET after surgery prolongs the time to progression. "
Serious adverse event rates (grade 3 or higher with CTCAEv3.0) were low in all treatment groups. During treatment, the other major serious effects related to TRPN were related to blood / spinal events. For long-term effects, blood / bone marrow episodes were also slightly higher in the PLNRT group, but only for Grade 2+ (4.1%) and not Grade 3+ (1.1%) episodes. ).
Additional badyzes of the SPPORT trial will address the magnitude of the difference between the experimental treatment groups to isolate the impact of pelvic lymph node treatment compared to androgen deprivation treatment. . The research team also described preliminary data indicating that, for those whose PSA was very low at the start of the study, there was no improvement from PLNRT + PBRT + STAD to PBRT + STAD; although it is an unplanned badysis.
"It's now a question of management, whether a threshold of PSA or other factors can be used to identify a group of patients in which treatment of pelvic lymph nodes is not as beneficial, "concluded Dr. Pollack. "In addition, the role of new PET tracers identifying pelvic ganglia involvement earlier in this decision-making process remains a key issue, and we still need data, but we have reached a milestone with this study."
The abstract "Short-term treatment with androgens without or with treatment of pelvic lymph nodes added to the recovery radiotherapy of the prostate bed: the study NRG Oncology / RTOG 0534 SPPORT" was presented in detail during a press briefing and an oral summary session at the ASTRO 60th Annual Meeting at San Antonio. To schedule an interview with Dr. Pollack and / or outside experts in prostate cancer, contact the ASTRO Media Relations team at 703-286-1600 or [email protected].
Awarded to the annual meeting of the American Society of Radiation Oncology (ASTRO) requested for all coverage.
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The American Radiation Oncology Society (ASTRO) is the largest radiation oncology company in the world. It has more than 10,000 members: doctors, nurses, biologists, physicists, radiation therapists, dosimetrists and other health professionals specializing in the treatment of patients by radiotherapy. The Company is dedicated to improving patient care through professional education and training, support to clinical practice and health policy. standards, progress in science and research, and advocacy. ASTRO publishes three medical journals, International Journal of Radiation Oncology • Biology • Physics, Practical Radiation Oncology and advances in radiation oncology; developed and maintains a comprehensive website for patients, RT Answers; and created the non-profit foundation Radiation Oncology Institute. To learn more about ASTRO, visit astro.org or RTanswers.org, sign up for receive our news and follow us on our blog, Facebook and Twitter.
Liz Gardner, 703-286-1600
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Jeff White703-839-7392
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SOURCE American Society of Radiation Oncology
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