ASCO Endorsements Offer Guidance on Prostate Cancer Care

ASCO Endorsements Offer Guidance on Prostate Cancer Care

ASCO has published guidelines and endorsements in the last year addressing myriad aspects of prostate cancer care, from radiotherapy and hormone therapy to survivorship care. The recommendations aim to help physicians and patients navigate difficult and sometimes confusing treatment decisions, especially in the face of new chemotherapies and hormonal therapies.

Radiotherapy After Prostatectomy

In November 2014, ASCO endorsed a joint guideline from the American Urological Association (AUA) and the American Society for Radiation Oncology (ASTRO) on adjuvant and salvage radiotherapy in men after prostatectomy. The guideline recommends that physicians talk with patients about the risks and benefits of adjuvant therapy if they have adverse pathologic results at prostatectomy (seminal vesicle invasion, positive surgical margins, or extraprostatic extension). Physicians should also discuss salvage therapy with men experiencing PSA recurrence after prostatectomy.

The ASCO endorsement is consistent with the AUA/ASTRO recommendations, but it goes one step further by defining groups of men at particularly high risk of disease recurrence or progression based on specific pathologic findings (Gleason score 8-10, seminal vesicle invasion, detectable post-operative PSA, or extensive positive margins), as well as defining groups of men who may harbor lower risk for progression (focal positive margins or extraprostatic extension alone). Men at very high risk could potentially have the greatest reduction in absolute risk of progression from radiotherapy and may represent the group in whom the benefits associated with augmented disease control outweigh the quality-of-life implications of radiotherapy.

“For those patients who are at high risk but not very high risk, radiotherapy should still be discussed, but it’s a very different conversation. The benefit in terms of improving survival is less and the toxicity is the same, so it may not make sense, and that’s ultimately for the patient to decide,” said Stephen J. Freedland, MD, of Cedars-Sinai Medical Center in Los Angeles, co-chair of the ASCO endorsement, along with Howard M. Sandler, MD, also of Cedars-Sinai.

The guideline recommends that physicians monitor PSA levels after prostatectomy and explain to patients that recurrence of detectable PSA is associated with increased risk of developing metastatic prostate cancer. The ASCO endorsement agrees with the recommendation that men with PSA greater than 0.2 ng/mL and no evidence of distant metastatic disease should be offered salvage radiotherapy.

Hormone Therapy and Chemotherapy

ASCO and Cancer Care Ontario (CCO) recently published a joint guideline on the use of systemic therapy, along with continued androgen deprivation, for men with metastatic castration-resistant prostate cancer (mCRPC).1 The guideline summarizes the survival, quality-of-life benefits, and toxicity of 15 different therapies, many of which were not available in 2006 when the previous CCO guideline, endorsed by ASCO, was published.

“This guideline emphasizes quality-of-life benefits, as well as survival and treatment toxicities,” said Ethan M. Basch, MD, of the Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, and co-chair of the guideline along with Andrew Loblaw, MD, of the Odette Cancer Centre, Toronto.

“Men weigh various potential benefits and harms differently depending on their values, as well as where they are in their disease trajectory,” Dr. Basch said.

Among the recommendations, the guideline states that abiraterone acetate and prednisone, enzalutamide, radium-
223, and docetaxel plus prednisone have clear survival and quality-of-life benefits. The drugs should be offered to men with mCRPC along with continued androgen deprivation, although physicians should discuss with patients the toxicity risks of each—particularly for docetaxel plus prednisone. Although the guideline does not make recommendations about the sequence of therapies, it does state that cabazitaxel plus prednisone may be an option for men whose cancer has progressed on docetaxel. It recommends against offering bevacizumab, estramustine, or sunitinib for men with mCRPC. The guideline also has implications for future clinical research, Dr. Basch said.

“A subtext here is to encourage pharmaceutical companies to include rigorous evaluations of symptoms and quality of life, as well as of the harms of care, so we will better be able to write guidelines that enable high-quality decision making,” he said.

For men with non-metastatic CRPC, ASCO is working on a consensus guideline about management approaches. This patient subset is defined by having experienced PSA recurrence on androgen-deprivation therapy but having no radiographically visible metastases.

“This guideline tries to address questions about which approaches to use,” said Eric A. Singer, MD, MA, of the Rutgers Cancer Institute of New Jersey, and co-chair of the consensus guideline along with Katherine S. Virgo, PhD, of Emory University. “Recently there have been some new hormonal agents that have come out that work in a little bit different way than what we had previously. The emergence of these new drugs has really reinvigorated research and treatment for advanced prostate cancer.”

The guideline is the first developed using ASCO’s methodology for a systematic review-based consensus guideline, published in 2012.2 According to this approach, in areas where there was not high-quality evidence, the guideline is based on recommendations by a large group of experts, using a modified Delphi technique used by other guideline-development organizations such as CCO.

“It is very exciting for us to be able to say something that is clinically helpful to patients and providers, and not just that there is not enough evidence to make a level 1 assessment,” Dr. Singer said.

The guideline is expected to come out late 2015.

Survivorship Care

In February, ASCO endorsed a guideline by ACS regarding prostate cancer survivorship care. The guideline addresses five areas of care: health promotion, which discusses maintaining a healthy lifestyle; surveillance for prostate cancer recurrence, with recommendations on PSA testing and digital rectal examination; screening for second primary cancers, highlighting bladder and colorectal cancer risk associated with treatment; assessment and management of physical and psychosocial long-term and late effects of prostate cancer care; and care coordination and practice implications.

“This guideline offers a framework for prostate cancer survivorship care both for prostate cancer specialists and primary care doctors, and will help with transition of care between the two groups,” said Matthew J. Resnick, MD, of Vanderbilt University Medical Center, and co-chair of the endorsement along with David F. Penson, MD, MPH, also of Vanderbilt. Ultimately, this guideline may enhance the quality and comprehensiveness of care that we are able to deliver to prostate cancer survivors.”

The guideline could help reduce duplication of testing or inadequate testing for patients transitioning between prostate cancer specialists and primary care doctors. Although the endorsement agrees with the guideline recommendation to measure PSA every 6-12 months for the first 5 years followed by annual tests, it qualifies the recommendation by stating that prostate cancer specialists may advise more frequent tests in the early survivorship period for men with higher risk of recurrence.

Whereas previous ASCO guidelines on survivorship focused on specific symptom-based issues associated with cancer care in general, the characteristics of prostate cancer survivorship make a guideline for this cancer type particularly relevant.

“The survivorship experience for men with prostate cancer is very long and often fraught with unique challenges related to the considerable morbidity of available therapies,” Dr. Resnick said.

The ASCO endorsement underscores the ACS recommendation for clinicians to perform routine assessment of patients for stress, anxiety, and depression, which can be important prostate cancer comorbidities, and to identify patients who may benefit from behavioral or pharmacologic therapy. The endorsement added a reference to the ASCO guideline for screening, assessment, and care of anxiety and depressive symptoms in adults with cancer.