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Immediate ADT offers little OS benefit for PSA-detected prostate cancer relapse
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Immediate initiation of androgen deprivation therapy did not substantially improve long-term survival among men with PSA-detected prostate cancer, according to results of a population-based, observational study.
The findings suggest the decision to defer initiation of ADT until clinical progression or at least 2 years after PSA relapse may be a safe approach that could considerably reduce costs and treatment-related adverse effects.
“The role of ADT therapy in asymptomatic patients is not clear,” Xabier Garcia-Albeniz, MD, research associate at Harvard University School of Public Health, said during a press conference. “NCCN guidelines say that this is a ‘therapeutic dilemma regarding the role of ADT’ in these patients, and the ASCO guidelines say that ‘the critical issue is to determine whether there is benefit and how large it is for starting ADT while patients are asymptomatic.’ In the present study, we tried to use PSA values and clinical events to personalize treatment initiation in patients who present with a PSA-only relapse.”
Garcia-Albeniz and colleagues used the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) registry to evaluate data from 2,012 men who experienced PSA-only relapse after radical prostatectomy or radiation therapy.
The median age of patients was 69 years (range, 63-74), and 33.8% of patients had a Gleason score >7. The median time to PSA relapse was 27 months (range, 14-51) after primary treatment.
Researchers then evaluated the timing of ADT for all patients.
Those who underwent ADT within 3 months of relapse were classified as receiving immediate treatment. Those who underwent ADT at least 2 years after PSA relapse — as well as those who underwent ADT after presenting with symptoms, metastasis or a short PSA doubling time — were classified as receiving deferred treatment.
During a median follow-up of 41 months, there were 176 death, 37 of which were due to prostate cancer.
Patients who underwent immediate ADT demonstrated no significant advantage in all-cause mortality (HR=0.94; 95% CI, 0.51-1.73) or prostate cancer-specific mortality (HR=1.15; 95% CI, 0.33-3.97). Researchers reported estimated 5-year OS rates of 85.1% in the immediate ADT arm and 87.2% in the deferred ADT arm, and estimated 10-year OS was 71.6% in both arms.
The decision to defer ADT could improve patients’ quality of life by avoiding or delaying the common treatment-related adverse effects, such as osteoporosis and risk for bone fracture, sexual dysfunction, hot flashes, decreased mental sharpness, fatigue, loss of muscle mass, increased cholesterol, weight gain and depression.
“Rising PSA levels trigger a lot of anxiety, and many men want to start treatment as soon as possible,” Garcia-Albeniz said in a press release. “These findings suggest that there may be no need to rush to ADT. If our results are confirmed in randomized trials, patients could feel more comfortable waiting until they develop symptoms or signs of cancer that are seen on a scan before initiating ADT.”
For more information:
Garcia-Albeniz X. Abstract #5003. Scheduled for presentation at: 2014 ASCO Annual Meeting; May 30-June 3, 2014; Chicago.
Disclosure: The researchers report funding from ASISA, NIH, the Spanish Society of Medical Oncology and the UCSF CaPSURE Program, which is partially funded by Abbott.
Perspective
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Clifford A. Hudis, MD, FACP
Simply put, this observational study provides really strong support for the randomization. It should strengthen the placement of the doctors and patients in the position of equipoise (ie, that they’re comfortable with either decision). And outside of clinical trials, it certainly does not provide evidence that you have to rush in with treatment, and it does provide comfort if you choose for any reason to withhold treatment, since you’re probably not risking much.
One other way to look at this, of course, is the hypothesis this study would generate; that there is not much of a difference one way or the other. And in that regard, I think it will provide some reassurance to doctors and patients who, for whatever reason, have to hold back on treatment for quality of life reasons, for example.
Perspective
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Peter P. Yu, MD, FASCO
There are about 60,000 men a year with prostate cancer who face this dilemma. The dilemma is that they were treated for prostate cancer with curative intent with either surgery or radiation therapy. Unfortunately, they now have heard the devastating news that there is a blood test that shows their prostate cancer is not cured and is starting to come back. But it happens at a time when there are no other signs of the cancer besides this blood test.
There is an emotional drive to seek therapy immediately, and very often that is hormone-based therapy. But it is therapy that has side effects, such as fatigue, anemia, loss of muscle mass and increased deterioration of cardiovascular and bone structure. So it comes at a real physical cost and the deterioration of the quality of life.
Hormone therapy is one of the oldest, most common and most effective treatment approaches in prostate cancer, and these findings will influence the treatment of thousands of patients worldwide. This study is also a great example of how less aggressive treatment can sometimes offer patients optimal outcomes while sparing them from side effects that impair their quality of life.
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