[ad_1]
Action points
- Note that this study was published as a summary and presented at a conference. These data and conclusions should be considered as preliminary until they are published in a peer-reviewed journal.
SAN ANTONIO – The addition of hormone therapy and radiation therapy to pelvic lymph nodes has increased the progression rate of progression-free prostate cancer, revealed an interim badysis of the trial spport.
At 5 years, the FFP rate was 89.1% when this approach was added to prostate bed radiotherapy in patients with persistent or increasing PSA levels after prostatectomy, compared with 82.7% with PBR treatment plus hormone therapy and 71.7% with PBR treatment alone (P<0.0001), said Alan Pollack, MD, PhD, of the Sylvester Comprehensive Cancer Center in Miami.
At a press meeting held here at the meeting of the American Society of Radiation Oncology (ASTRO), Pollack described as "striking" the significant difference between the group receiving pelvic lymph node RT and anti-cancer treatment. -androgenic (ADT) and the group of PBRTs alone.
"The treatment of pelvic lymph nodes has a major effect that we have never seen before, and this is the first attempt to document this effect in the context of a rescue operation," he said. he declared.
The trial compared three treatment approaches:
- TEPB alone 64.8-70.2 Gy
- PBRT plus 4 to 6 months ADT
- PBRT and ADT plus 45 Gy RT to Pelvic Lymph Nodes
Among patients followed up to 8 years, the rate of distant metastases tended to be beneficial with triple therapy compared to PBRT alone (HR 0.52, 95% CI 0.32-0.85, P= 0.014) and PBRT plus ADT (HR 0.64, 95% CI 0.39-1.06, P= 0.28). There were 108 patients with distant metastases among the 1,800 patients.
But Daniel Spratt, MD, of the University of Michigan, said MedPage today Although this potential advantage has never been demonstrated before, the design of the three-arm test was necessary. P value less than 0.0125 to be significant.
Spratt, who was not involved in the study, also warned that early data did not indicate whether administration of this intensive treatment for low-risk patients would be necessary. "I really think we should wait longer to see if these more supportive patients benefit."
Eric Horwitz, MD, of the Fox Chase Cancer Center in Philadelphia, said MedPage today that SPPORT is a well-designed modern test that reflects and supports the number of patients treated in clinical practice. "It's a big problem," he said.
"We are cautious enough to use the data to support the way we treat a person or not, and that really fills part of the puzzle," said Horwitz, referring to the approach taken in his establishment. "It's actually a big piece of the puzzle."
"There is a group of men who benefit from the addition of short-term hormone therapy," he added. "And it now shows that with a well-designed radiation, some men actually benefit from a larger or wider field."
He also warned that although the data is not fully available, it is likely that the benefit is probably not for everyone. For patients with "super-low" PSA, the evidence suggests that the recurrence is probably confined to the prostate bed, he said. "So, it's probably a person where you can probably afford to treat the prostate bed."
ASTRO moderator, Neha Vapiwala, MD, of the University of Pennsylvania in Philadelphia, described the study as a "paradigm shift," explaining that radiation oncologists who treat patients with Prostate cancer have difficulty in determining whether to treat the lymph nodes. "It's a very controversial issue," Vapiwala said. "What has been presented here in this data is really Level 1 evidence that clearly shows the separation of the curves to the point that we look forward to what the additional follow-up will reveal."
From 2008 to 2015, the NRG Oncology / RTOG 0534 SPPORT trial randomized 1,792 prostate cancer patients with persistent or increasing PSA levels in the United States, Canada and Israel in one of the three treatment groups. The median age of the patients was 64 years and 87% were white. Almost all (93%) had an ECOG performance status of 0.
Gastrointestinal adverse events (GIs) were significantly higher with the treatment regimen of three treatments (grade ≥2: 6.9% versus 2.0% with PET alone), as did grades ≥2 (5, 1% vs. 2.3%, respectively) and grade ≥3 (2.6%). versus 0.5%) EI in the bone marrow.
Patients were stratified by Gleason score (≤7.8-9), PSA (≥0.1 to ≤ 1.0 ng / mL,> 1.0 to <2.0 ng / mL), and by stage ( pT2 and negative margin, all others). More than half of the patients had pT2 disease (54.3%) and positive margins (50.1%), while most had no seminal vesicle involvement (85.2%). The primary endpoint was PFC at 5 years, with failure being defined as an increase in PSA of 2.0 ng / mL, clinical progression, or death, regardless of the outcome. cause.
Pollack has revealed relationships with the Oncology Radiation Therapy Group (RTOG) and Varian Medical Systems.
2018-10-22T17: 30: 00-0400
Source link
