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Irradiation after radical prostatectomy improved PFS
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Conventional postoperative irradiation after radical prostatectomy significantly improved biochemical PFS and local control compared with a wait-and-see approach, according to results of a phase 3 study.
Michel Bolla, MD, of the department of radiation oncology at Centre Hospitalier Universitaire A Michallon in Grenoble, France, and colleagues enrolled 1,005 patients aged 75 years or younger with untreated cT0-3 prostate cancer from 37 institutions across Europe.
The researchers assigned eligible patients to postoperative irradiation (n=503), which consisted of 60 Gy of conventional irradiation to the surgical bed for 6 weeks, or to a wait-and-see approach (n=502) until biochemical progression. Median follow-up was 10.6 years (range, 2 months to 16.6 years).
Overall, 198 patients in the postoperative irradiation group had biochemical or clinical progression or died, compared with 311 patients in the wait-and-see group (HR=0.49; 95% CI, 0.41-0.59).
Patients in the postoperative irradiation group had more late adverse effects compared with those in the wait-and-see group. The 10-year cumulative incidence was 70.8% for the postoperative irradiation group vs. 59.7% for the wait-and-see group.
Exploratory analyses indicated that postoperative irradiation may improve clinical PFS in patients younger than 70 years and in patients with positive surgical margins; however, the treatment might have a possible detrimental effect in patients older than 70 years.
“Results of this long-term follow-up show that significantly more patients who received postoperative irradiation had biochemical progression-free survival than did those on the wait-and-see policy, supporting the 5-year follow-up results,” Bolla and colleagues wrote. “However, the between-group difference in clinical progression-free survival was not maintained after 10 years, and no effect on distant metastases or overall survival was seen.”
In an accompanying editorial, Jason A. Efstathiou, MD, DPhil, of the department of radiation oncology at Massachusetts General Hospital and Harvard Medical School, said novel imaging modalities currently under investigation may help clinicians determine which patients are most likely to benefit from postoperative radiation.
“Ultimately, the decision to treat needs multidisciplinary input,” Efstathiou said. “When surgery has probably not cured a patient, prospective data still support postoperative radiation. The onus is on the uro-oncology team (surgical, radiation and medical) to discuss postoperative radiation with the patient, address optimal timing of initiation when it is used, and to provide justification when it is not.”
Perspective
Back to TopDonald L. Trump, MD, FACP
Bolla and colleagues report 10-year follow-up of a trial designed to determine whether postoperative irradiation in men with prostate cancer ( stage pT2–3, N0 M0) improved biochemical progression. Clinical progression and OS also were examined. The report illustrates the challenges of long-term studies in a disease that occurs in older individuals and often progresses slowly.
The trial was designed in the pre-PSA era and took a long time to complete. Ten-year follow-up means we are about 20 years since the entry of patient No. 1. Accrual spanned from 1992 to 2001 in 37 institutions. Interestingly, twice as many patients entered on this trial died of another cancer as died of prostate cancer. This is not meant in any way as a criticism of the design or the investigators; it is just that “stuff happens” in large trials that take some time to accrue and for which long follow-up is needed.
The trial did show that post-op irradiation reduced the chances of PSA failure by about 50% and that neither clinical progression nor OS were different in the two groups. Thirty percent of patients had detectable PSA (>0.2 ng/ml) when entered on study and, at the present time, would not be suitable candidates in the opinion of many investigators for randomization to a no-treatment option.
As pointed out in the accompanying editorial by Jason A. Efstathiou, MD, DPhil, “results from the EORTC update still support the use of postoperative irradiation in patients younger than 70 years and those with positive margins (ie, those most likely to have persistent local disease) and who will live long enough to derive treatment benefits).” Irradiating patients at high risk of residual disease is now a widely applied oncologic practice. More work is required — quickly — to determine in which patients and when post-prostatectomy therapy improves survival and how we can improve outcomes through multidisciplinary approaches.
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