Prostate cancer surgery in high-risk patients can safely be delayed for as long as 6 months and should therefore be considered a low priority compared with other cancer and emergent surgeries when healthcare resources must be prioritized, a large U.S. database study found.
The analysis compared a surgical delay time of 31 to 60 days with longer delays in a large, contemporary cohort of high-risk localized prostate cancer patients who underwent radical prostatectomy within 180 days of diagnosis, and found that longer delays were not associated with adverse pathological outcomes (OR 0.95, 95% CI 0.80-1.12, P=0.53), reported Leilei Xia, MD, of the University of Pennsylvania Perelman School of Medicine in Philadelphia, and colleagues.
The study, published online in JAMA Network Open, also found that longer surgical delays of 151 to 180 days were not associated with the study’s secondary outcome of worse overall survival (OS) (HR 1.12, 95% C 0.79-1.59, P=0.53).
“Radical prostatectomy for high-risk prostate cancer could be safely delayed up to 6 months after diagnosis,” the researchers concluded, adding that the finding may be reassuring amid delays for surgery stemming from the need to divert usual resources during the COVID-19 pandemic.
The study involved 32,184 radical prostatectomy patients from the National Cancer Database (NCDB) with a mean age of 64 (range of 59-68). Of these, 25,548 (79.4%) were non-Hispanic white, and patients had high-risk (cT1-2cN0cM0) prostate adenocarcinoma diagnosed between 2006 and 2016.
Surgical delay time, defined as the number of days between initial cancer diagnosis and radical prostatectomy, was categorized according to five groups:
- 31-60 days
- 61-90 days
- 91-120 days
- 121-150 days
- 151-180 days
In the overall cohort, surgical delay times were as follows:
- 13,804 patients (42.9%), 31-60 days
- 11,750 (36.5%), 61-90 days
- 4,489 (14.0%), 91-120 days
- 504 (4.7%), 121-150 days
- 637 (2%), 151-180 days
Adverse pathological outcomes included pT3-T4 disease, pN-positive disease, and positive surgical margin. The adverse pathological score (APS) was defined as an accumulated score of the three outcomes (0-3), with an APS of 2 or higher considered a separate outcome to capture cases with more aggressive pathological features, the researchers explained.
Compared with delays of 31 to 60 days, longer surgical delays did not increase the risks of the following pathological outcome measures:
- pT3-T4 disease (OR 0.99, 95% CI 0.83-1.17, P=0.87)
- pN-positive disease (OR 0.79, 95% CI 0.59-1.06, P=0.12)
- Positive surgical margin (OR 0.88, 95% CI 0.74-1.05, P=0.17)
- APS of 2 or greater (OR 0.90, 95% CI, 0.74-1.05, P=0.17)
A total of 2,348 patients (7.3%) were determined to have very-high-risk disease, including 330 (1.0%) with a Gleason score of 5+3; 1,593 (5.0%) with a Gleason score of 5+4; and 425 (1.3%) with a Gleason score of 5+5. The findings were consistent even for this very high-rise group, Xia and co-authors reported.
They noted that Gupta et al. in 2018 similarly found that a 6-month delay in radical prostatectomy was not associated with adverse outcomes in intermediate- to very-high-risk patients, a finding paralleled recently in The Journal of Urology with reassuring implications for prostate cancer patients facing delays in the COVID-19 era.
Asked for his perspective, Eric A. Klein, MD, of the Glickman Urological and Kidney Institute at the Cleveland Clinic in Ohio, who was not involved with the study by Xia and co-authors, explained that prostate surgery may be delayed for a variety of reasons, including treatment toxicity and crisis situations such as the pandemic.
“Or a patient may want a second opinion or be a good candidate for neoadjuvant trials,” he told MedPage Today. “Understandably, there may be some hesitation among newly diagnosed patients about delaying surgery, even if it’s because they’re receiving other anticancer treatment. Patients are understandably scared when they learn they have high-grade cancer, but what we have seen anecdotally — and what the data suggest — is that a reasonable delay in treatment is not likely to affect outcomes in these patients.”
Study limitations, Xia and co-authors said, included the possible selection bias inherent in retrospective studies in general and in particular surgical waiting time studies. In addition, certain confounding factors were unknown, and bias could also have been introduced by excluding missing data. Also, since true long-term cancer-specific outcomes, such as biochemical recurrence, metastasis-free survival, and cancer-specific survival, were not available in the NCDB, pathological outcomes had to serve as surrogates. Moreover, because follow-up time for OS was short, results for this secondary outcome should be interpreted with caution, and only locally advanced cT1-T2 disease was included and it was unclear what staging method was used (digital rectal examination vs imaging), the researchers noted, cautioning that the results should not be used for decisions regarding locally advanced cancer or surgical delay times beyond 6 months and may not extend to patients who receive radiation therapy. Finally, the team said, because the NCDB is a hospital-based rather than a population-based system and patients were treated at Commission on Cancer–accredited facilities, the results may not be completely representative at the population level.
The National Cancer Database is a joint project of the Commission on Cancer of the American College of Surgeons and the American Cancer Society. The study was funded by the Department of Surgery of Penn Medicine.
The authors reported having no competing interests to disclose.
Klein reported having no competing interests to disclose.