Wednesday, March 21, 2012

Outcomes after surgery for low-risk disease in men 65 years and ...

Data from the extensive series of patients with clinically localized prostate cancer treated by radical prostatectomy at Johns Hopkins over the past 30 years has shown that men > 65 years of age with low-risk disease had excellent survival after surgery, but we have no idea how well they might have done if managed conservatively (e.g., with active surveillance).

A paper by Mullins et al. in the Journal of Urology reports data from 1,560 men (8.1 percent) out of all the patients in the Johns Hopkins database who met the following criteria for analysis:

  • ? 65 years of age
  • Low-risk prostate cancer at diagnosis (i.e., clinical stage ? T2a; biopsy Gleason score ? 6; PSA < 10 ng/ml)
  • Treated with radical prostatectomy

It will immediately be recognized that these men represent only a small percentage of the 19,264 men treated surgically for prostate cancer at Johns Hopkins over the past 30 years.

Biochemical failure of surgery in these men was defined as a single PSA level of 0.2 ng/ml or higher. The authors evaluated the clinical, pathological, and survival data from these men in two groups: those who were 65 to 69 years old (Group A) and those who were 70 years old or older (Group B). The presence of unfavorable pathologic features at the time of surgery was defined by pathologic Gleason scores of ? 6 and/or by the presence of extra-prostatic extension of the cancer.

Here is a summary of the author?s first set of key findings:

  • Group A comprised 1,382/1,560 men aged between 65 and 69 years (median age, 66 years).
  • Group B comprised 178/1,560 men aged between 70 and 77 years (median age, 71).
  • A significant majority of the patients in both groups
    • Had a biopsy Gleason score of 6 (95.0 percent in Group A and 92.7 percent in Group B)
    • Were treated by open radical retropubic surgery (85.8 percent in Group A and 79.2 percent in Group B)
    • Had a pathologic Gleason score of 6 or less post-surgery (70.1 percent in Group A and 68 percent in Group B)
    • Had pathologically organ-confined disease post-surgery (75.3 percent in Group A and 71.3 percent in Group B)
  • There were no significant differences (other than age) between these two groups of men either before or immediately after their surgery.

And here are their findings related to longer-term outcomes:

  • Follow-up data were available for an average (median) of 4 years (range, 0 to 24 years).
  • 68/1,382 men (4.9 percent) in Group A and 12/178 men (6.7 percent) in Group B had biochemical recurrence.
  • 12/1,382 men (0.9 percent) in Group A and 3/178 men (1.7 percent) in Group B had evident metastasis.
  • 123/1,382 men (8.9 percent) in Group A and 20/178 men (11.2 percent) in Group B had died
  • Causes of death included
    • Prostate cancer (7/123 in Group A and 2/20 in Group B)
    • Cardiovascular problems (32/123 in Group A and 7/20 in Group B)
    • Non-prostate-related cancers (33/123 in Group A and 5/20 in Group B)
    • Other (51/123 in Group A and 6/20 in Group B)
  • For men in Group A
    • Actuarial rates of biochemical recurrence-free survival at 5, 10, and 15 years were 93.8, 90.1, and 82.7 percent, respectively.
    • Actuarial rates of prostate cancer-specific survival at 5, 10, and 15 years were 99.9, 98.9, and 97.5 percent, respectively.
    • Actuarial rates of overall survival at 5, 10, and 15 years were 96.8, 84.6, and 61.1 percent, respectively.
    • Actuarial rates of cardiovascular-specific survival at 5, 10, and 15 years were 98.8, 95.3, and 89.3 percent, respectively.
  • For men in Group B
    • Actuarial rates of biochemical recurrence-free survival at 5, 10, and 15 years were 88.0, 79.3, and 79.3 percent, respectively.
    • Actuarial rates of prostate cancer-specific survival at 5, 10, and 15 years were 98.4, 91.8, and 91.8 percent, respectively.
    • Actuarial rates of overall survival at 5, 10, and 15 years were 88.4, 70.1, and 49.6 percent, respectively.
    • Actuarial rates of cardiovascular-specific survival at 5, 10, and 15 years were 97.6, 92.5, and 82.2 percent, respectively.
  • There was no significant difference between men in Group A and Group B with respect to biochemical recurrence-free or cancer-specific survival.
  • Men in Group B had a lower overall and cardiovascular-specific survival than men in Group A.

Alas, this paper offers us no data on the complications and side effects of radical prostatectomy in these patients, stating only that, ?Data on recovery, erectile function and urinary continence were not consistently available.? (One has to remember that many men treated at Johns Hopkins do not get follow-up care at that institution since they come from all over the world to receive their surgery.)

The authors carefully make the following observations:

  • Men > 65 years of age in this carefully selected series ?experienced excellent prostate cancer-specific and overall survival? after their surgeries.
  • ?These outcomes do not ensure improved overall health outcomes for these older men.?
  • ?It is unknown whether [radical prostatectomy] or indolent disease biology is responsible for these results.?
  • These data are consistent with the data reported from the PIVOT trial.
  • ?Men must be counseled on the potential side effects of [radical prostatectomy] before undergoing a procedure that may have limited impact on cancer-specific survival.?

The ?New? Prostate Cancer InfoLink feels that this is an important (albeit retrospective) data analysis from one of the largest and most sophisticated prostate cancer surgery centers in the world. It very clearly acknowledges what we do not know about using surgical treatment in older men with localized, low-risk prostate cancer. It confirms data reported by others regarding the limited benefits of surgery for men > 65 years of age with low risk disease. And it also notes that about two-thirds of all men > 65 years of age with low-risk disease based on clinical data were confirmed to have low-risk disease based on their pathologic data post-surgery.

Are there particularly healthy men > 65 years of age and with a life expectancy of 15 or more years who may well benefit from surgical treatment of their prostate cancer? Certainly there are. However, these men are not the norm. And whether surgery is the most appropriate form of treatment for such men if treatment is indeed appropriate is still not known either.

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Source: http://prostatecancerinfolink.net/2012/03/20/outcomes-after-surgery-for-low-risk-disease-in-men-65-years-and-older-at-a-major-prostate-cancer-center/

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