Tuesday, August 30, 2016

9-year SBRT outcomes

Katz and Kang have posted their 9-year SBRT outcomes on 515 patients. This represents the longest tracking of SBRT outcomes -- just one year short of the IMRT tracking reported by Alicikus et al. on a starting cohort of 170 patients treated at Memorial Sloan Kettering Cancer Center.

The patients were treated between 2006-2010 using the CyberKnife platform.
  • ·      324 were low risk, 139 intermediate risk, and 52 were high risk according to NCCN definitions.
  • ·      70 patients received adjuvant ADT for up to one year.
  • ·      158, all with Gleason score<4+3, received 35 Gy in 5 fractions.
  • ·      357 received 36.25 Gy in 5 fractions
  • ·      Median age was 69
  • ·      Median PSA was 6.5 ng/ml

After a median followup of 84 months:
  • ·      Oncological Control:

o   9-yr freedom from biochemical failure was:
§  95% for low-risk men
§  89% for intermediate risk men
§  66% for high-risk men
o   Median PSA nadir was .1 ng/ml
o   No difference in biochemical control for the lower vs. the higher radiation dose.
o   99.6% prostate cancer survival
o   86% overall survival
  • ·      Toxicity:

o   Late rectal toxicity:
§  Grade 2: 4%
o   Late urinary toxicity:,
§  Grade 2: 9.5%
§  Grade 3: 1.9%
§  Grade 2 or 3: 6.9% for the lower radiation dose vs. 13.2% for the higher dose.
o   Patient-reported bowel and urinary quality-of-life (EPIC questionnaire) declined at one month then returned to baseline by 2 years. Sexual quality-of-life declined by 29% at last followup.

These are clearly excellent results for any kind of radical therapy. The authors conclude:
These long-term results appear superior to standard IMRT with lower cost and are strikingly similar to HDR therapy.”

While it’s tempting to conclude that neither the higher dose of radiation, with its greater toxicity, nor the addition of ADT conferred any incremental benefit, that can only be proved with a randomized clinical trial. Until so proven, it must be understood as only a good hypothesis to be discussed by patients with their radiation oncologists. It is also worth noting that these reflect the outcomes of one very expert practitioner. There is an SBRT registry currently collecting data across many treatment centers.

The reported outcomes are nearly identical to those reported at 7 years (see this link and this link and this link), indicating very stable control and no additional late term toxicity with longer followup. In light of that, its low cost, convenience, and the fact that the standard of care, IMRT, has only one more year of follow-up on a much smaller sample size, it’s difficult to understand why some insurance companies still balk at covering SBRT for low and intermediate risk patients. Medicare does cover it.

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