SUBJECT: Response to The Possibility of CMS Eliminating Payment for Proton Beam Radiation Therapy for Prostate Cancer

[PHI Redacted] received proton beam radiation therapy Gy 18 months ago to cure prostate cancer. [PHI Redacted] had daily treatments providing in total about 80 Gy to prostate. If given on whole body at one time, this would be about 10 times a lethal dose. The radiation to good tissue was so low that [PHI Redacted] had no significant negative side effects. Treatment was painless and there were no restrictions on physical activity. [PHI Redacted] PSA before treatment was 11 ng/ml and has continued going down. Today it is 1.5 ng/ml. About 100 other prostate cancer patients being treated at the same time had similar results.

The dose distribution with protons to the prostate is significantly better than treatment with neutrons or x-rays, permitting more radiation to the cancer and a better cure rate with no major adverse side effects in most cases. James Metz, MD at the Abramson Cancer Center of the University of Pennsylvania, compares the acute and long term side effects of protons, photons (x-rays), and prostatectomy in a report, dated June 29, 2006. His comparison is summarized below.

The acute complications of proton versus photon therapy are:
Grade 2 GU toxicity - Protons 0%, Photons 28%
Grade 2 GI toxicity - Protons 0%, Photons 35%
Either GU or GI morbidity - Protons 0%, Photons 53%

Acute complications of a prostatectomy are:
Hospitalization - 5 to 7 Days
Absence from work - 4 to 6 Weeks
Death - 0.3%
Pulmonary embolism/ DVT - 2.6%
Myocardial infarction or arrhythmia''s - 1.4%
Wound Complications - 1.3%
Lymphocele - 0.6%
Surgical Rectal Injury - 1.5%

Long term complications for protons, photons and prostatectomy are:
Impotence - Protons 30%, Photons 60%, prostatectomy 60%
Incontinence requiring a pad - Protons prostatectomy 32%
Bladder Neck contracture - Protons 0%, Photons 3%, prostatectomy 8%
Chronic Cystitis - Protons 0.4%, Photons 5%, prostatectomy n/a
Grade 3 GU toxicity severe frequency - Protons 0.3%, Photons 2%, prostatectomy 36%
Grade 3 GI toxicity rectal bleeding requiring transfusion severe pain - Protons 0%, Photons 7%, prostatectomy n/a
Rectal Stricture - Protons 0%, Photons 0.5%, prostatectomy n/a.

In addition to the above, the AMA in 2005 published a report stating that those patients having a prostatectomy will have a reoccurrence of cancer within 10 years.

Also, protons may treat tumors within 0.4 inches of nerves or vital organs without damage to these items. This is not possible when treatment is done with x-rays. This fact helps to confirm that proton beam therapy reduces radiation to good tissue for prostate treatment.

Yes, treating prostate cancer is more expensive with protons than treatment with x-rays. Conversely, cost for treatment of acute and long term complications with standard treatment are substantial. This may involve treatment with chemotherapy, radiation, hormones and more, plus a negative effect upon the patient’s quality of life, lost time, hospitalization and other complications. I do not know the cost of a prostatectomy, but based upon the cost of [PHI Redacted] one day in the hospital to place a stent in an artery ($40,000), the cost of a prostatectomy is probably at least as high as proton therapy.

Some claim that proton therapy is experimental. Over 55,000 cancer patients have been treated with protons. 25 facilities in the world now treat prostate cancer and about 50 other cancers with protons in a clinical environment, and at least 15 more are building or planned. About 200 insurance companies support proton therapy for cancer including prostate cancer.

Some claim that the 5 hospitals in the USA providing proton therapy are enough. Again, wrong. These facilities can treat, at most, 12,000 patients per year. As estimate for today indicates that about 300,000 cancer patients per year could benefit from proton therapy. An oncologist at a large hospital stated to me that due to the aging population, this number could reach 1,000,000 within 10 to 15 years.

Robert J. Marckini ([PHI Redacted]) published a book in 2006 entitled, “You Can Beat Prostate Cancer and You Don’t Need Surgery To Do It.” This book was written after studying proton and standard treatments and discussion with many doctors and patients. His book is now one of the best selling medical books on amazon.com. He also established a prostate cancer support group, now numbering over 3,500 patients.

In all due respect, if Medicare should eliminate payment for proton therapy for prostate cancer, it would be a disservice to patients, negatively effect their lives and in the long run, increase Medicare cost. With further technology improvements planned for existing and planned proton treatment facilities, its cost will decrease.

Sincerely,