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HIGH DOSE RADIATION (HDR) IMPLANTS FOR BREAST CANCER
AT JOE ARRINGTON CANCER TREATMENT CENTER (JACC)

- Introduction
- HDR compared to External Radiation Therapy (XRT)
- HDR Procedure
- Side Effects and Complications
- Follow-up
- HDR Team
- References

Introduction :

The American Cancer Society estimated there would be 205,000 new cases of breast cancer diagnosed in the United States in 2002 [1]. Of these, 203,500 would occur in women, and 1,500 in men. The standard of care for most of the 20th century was complete removal of the breast, or Mastectomy (M). In the 1960s, the invention of high energy radiation treatment made it possible to preserve the breast. The technique developed to involve a limited surgery, or Lumpectomy (L) followed by a 6 week course of External Radiation Therapy (XRT). At least 6 major randomized trials have been conducted around the world, comparing M to L + XRT in Stage I/II breast cancer. All 6 of these studies have demonstrated that M offered no benefit over L + XRT, both in regard to cure and local-regional recurrence. With L alone, the NSABP-B6 reported 40% local recurrence rate at 10 years. The 6 randomized trials reported an aggregate rate of 7% chest wall and regional node recurrence after M, compared to 8% breast and regional node recurrence after L + XRT [2]. The NSABP recently reported the same conclusions with 20 year follow-up [3]. In interviews conducted by the National Cancer Institute, 90% of women who had undergone breast conservation, reported their cosmetic result as good to excellent [4]. In the same interviews, 98% of women stated they would still choose to undergo lumpectomy + radiation therapy if they had to choose again between mastectomy and breast conservation. Based on all of the preceding data, the National Institutes of Health convened an expert panel which discussed breast cancer in 1992. They issued the following consensus statement [5] : "Breast Conservation Treatment is an appropriate method of primary therapy for the majority of women with Stage I/II breast cancer, and is preferable because it provides survival equivalent to total mastectomy and axillary node dissection, while preserving the breast."

HDR compared to XRT :
The most common method of breast conservation has been L + XRT. Recent years have witnessed the use of HDR (High Dose Rate) radiation Implant instead of XRT. The advantage is that HDR Implant can be completed in 5 days, as opposed to 6 weeks with XRT. In addition, only part of the breast receives radiation with HDR, compared to the whole breast with XRT. The results so far indicate that HDR local recurrence rates are at least comparable to XRT, and maybe less. Multiple investigators have reported HDR local recurrence rates of less than 5% with follow-up ranging from 3 to 5 years [6-12]. We have done nearly 100 HDR Breast Implants in the past 3 years. There have been no recurrences.

HDR Procedure :
Before proceeding with HDR Implant, the patient is seen in consultation at JACC. All management options are discussed, with referenced outcome data for each option provided. Not all breast cancer patients are candidates for HDR Implant. If the patient elects to proceed with HDR Implant, the process involves placement of a Mammosite Balloon or interstitial catheters under Mammogram guidance into the breast. This is done under conscious sedation plus local anesthetic. The procedure can also be done under general anesthesia, but this method carries significantly more risk to the patient. With general anesthesia, there is a slight risk that the patient will not wake up. Local anesthesia is the safest method. Our Team has done more than 1,000 HDR Implants under local anesthesia, with no complications. On the day of the procedure, an i.v. is started to aid in the local anesthesia. Following placement of an i.v., in JACC, the patient is given low doses of Demerol and Versed. Implant placement under Mammographic guidance takes about 45 minutes. The patient is then sent for a CT Scan. The images are sent by fiberoptic link for 3-Dimensional Computer Radiation Treatment Planning. It is during this step that the radiation dose is "painted" on the breast tumor bed at risk. The Iridium HDR seed can spend as little or as much time as we direct in any given position along the needle pathway. This permits the most elegant tailoring of radiation dose delivery currently possible with any radiation technology. Following completion of Treatment Planning, HDR treatments are given twice a day for 5 days, for a total of 10 treatments. Each treatment lasts about 15 minutes.

Side Effects and Complications :
It is common for patients to develop a skin reaction in the implant region. The reaction consists of mild to moderate redness, which can occasionally peel like a sunburn. It is treated like a sunburn. Usually, this occurs about 1 week following implant removal. Within 1-3 months the skin should like the opposite breast. Much less commonly, patients can develop late effect problems after HDR Implant. These late effects can occur months to years after Implant. These reactions include fat necrosis and radiation mastitis. In rare cases, limited surgical repair of the implant bed might be necessary.

Follow-Up :
Patients should be seen 2 weeks after HDR Implant for evaluation of potential side effects and treatment as needed. Then, we recommend follow-up evaluation every 3 months for the 1st year, every 6 months for the 2nd year, and then annually. Mammograms should be done annually, or more frequently as needed.

HDR Experience :
Our HDR Team includes nurses, radiation oncologists, urologists, physicists, and radiation therapy technologists. We have performed nearly 100 HDR Breast Implants, under local anesthesia. Overall, we have done more than 1,000 HDR Implants for tumors of the Cervix, Vagina, Vulva, Breast, Lung, Oral Cavity, Esophagus, Anal Canal, Rectum, and Prostate since 1995. We are affiliated with numerous National Clinical Research Groups, including the Radiation Therapy Oncology Group (RTOG), National Surgical Adjuvant Breast and Bowel Project (NSABP), Gynecology Oncology Group (GOG), and Southwestern Oncology Group (SWOG). We currently have numerous active clinical trials.

References :
1. Cancer, 2002 ; 52[1] : 25.
2. NEJM, 1995 ; 332 : 907.
3. NEJM, 2002 ; 347[16] : 1233.
4. JNCI, 1992 ; 11 : 27.
5. JNCI Monograph, 1992 ; 11 : 1.
6. Int J Radiat Oncol Biol Phys, 2002 ; 53 [4] : 889.
7. J Surg Oncol, 2002 ; 80[3] : 121.
8. Int J Radiat Oncol Biol Phys, 2001 ; 50 [4] : 1003.
9. Int J Radiat Oncol Biol Phys, 2003 ; 56 [3] : 681.
10. J Natl Cancer Inst, 2003 ; 95 [16] : 1182.
11. J Surg Oncol, 1997 ; 65 : 263.
12. Int J Radiat Oncol Biol Phys, 1994 ; 30 [1] : 245.