Xoft
Xoft Intraoperative Radiation Therapy (IORT)
For over 100 years, radiation therapy has been widely used to help reduce the recurrence of cancer and improve survival, and more than 1 million cancer patients in the U.S. receive radiation every year.
However, despite a large body of research demonstrating that radiation therapy is an essential component of cancer treatment, many patients do not have access to this critical treatment. In fact, recent studies also show that many women opt out of receiving breast-sparing surgery with radiation therapy due to time, distance or difficulty accessing radiation therapy centers.
Issues of patient access, combined with other external factors that are expected to have dramatic impact on the industry (such as reimbursement levels; potential isotope shortages; and recent Nuclear Regulatory Commission recommendations to evaluate alternatives to radiation sources, such as isotopes, that may pose a national security risk) have generated interest in alternative treatment delivery methods, such as Electronic Brachytherapy (eBx™).
By eliminating the need for a high dose rate (HDR) afterloader device, heavy shielding, and regulations associated with radioisotope handling and disposal, the Axxent® eBx System offers a flexible platform for administering radiation therapy. The mobile nature of the system, as well as the limited shielding requirements has helped spur interest in the device as a modality in the delivery of IORT.
IORT delivers a concentrated beam of radiation to cancerous tumors during surgery. This technique allows doctors to administer high doses of radiation to tumors without exposing nearby healthy organs to radiation. A single dose of intraoperative radiation may have as much effect on the tumor as 10–20 daily radiation treatments.
Xoft electron Brachytherapy
For Breast
Delivers a prescribed, targeted dose of radiation directly to the site where cancer recurrence is most likely. Compared to traditional radiotherapy, eBx requires fewer treatments and minimizes exposure to healthy tissue and organs, such as the ribs, lungs, heart and opposite breast (Reduced Dose to Heart and Lungs). Patients also experience low rates of serious complications and favorable cosmetic outcomes.
Breast eBx — A Multi-disciplinary Approach
Communication between the breast surgeon and radiation oncologist is a key component of successful treatment. This physician-to-physician collaboration is particularly important in the treatment process, during which a joint effort can be made to ensure that the patient meets the treatment criteria and that a lumpectomy cavity is conducive to a successful eBx treatment.
Breast eBx Is a Two-stage Process:
- The surgeon places the balloon
- A radiation oncologist oversees delivery of radiation
After the surgeon performs the lumpectomy and receives the pathology report, an uninflated balloon — connected to a catheter — is placed inside the cavity. Once in place, the balloon is inflated with a sterile saline solution to fit snugly into the lumpectomy cavity. The balloon remains inflated for the entire time the patient is receiving radiation therapy.
The radiation oncologist determines the amount of radiation needed. This treatment is delivered on an outpatient basis twice a day for five days in a non-shielded room.
During radiation therapy, the portion of the catheter that remains outside the breast will be connected to an Axxent controller.
The patient is prepped with a flexible X-ray shield that is draped over the breast. A tiny X-ray source travels through the catheter into the inflated balloon inside the breast. The system then administers the therapy, with no additional shielding necessary. The X-ray source remains in the balloon and delivers radiation for about 10 minutes. The positioning of the X-ray source and the dosage required to effectively treat the cancer have already been determined in the treatment plan. The X-ray source is then turned off and withdrawn through the catheter. No radiation remains in the breast between treatments or after the final treatment. At the end of radiation treatment (usually on the same day as the final treatment), the balloon is deflated and easily removed.
For GYN
As an alternative to radionuclide-based HDR brachytherapy, the Xoft, Inc. technology will meet the standard of care set by Iridium 192. The standard of care begins with the surgical resection of the primary tumor through hysterectomy and bilateral salpingo-oophorectomy (TAH/BSO) (removal of the uterus, ovaries and tubes on both sides) whenever technically feasible. The procedure is often combined with complete surgical staging, including lymphnode removal or sampling to determine if the cancer has spread to pelvic or para-aortic lymphnodes. This additional surgical step can be performed when the health status of the patient allows a more invasive procedure and the facility can provide the extent of care postoperatively.
About 75% of endometrial cancer patients are considered early stage patients in which the cancer is still confined to the uterus and in which the majority of recurrences can be found in the vaginal cuff area (adjacent to the surgical site). Adjuvant radiotherapy has contributed to a three- to four-fold reduction in recurrence rates in early stage endometrial cancer patients. Postoperative radiotherapy typically consists of external beam radiation therapy, vaginal brachytherapy or a combination thereof.
If surgical staging reveals no involvement of lymphnodes or if the cancer is considered low-risk, the treatment regimen can be less aggressive and external radiation can be replaced by vaginal cuff brachytherapy in selected cases. Additionally, external beam radiation therapy requires daily doses over a course of 3–5 weeks, whereas vaginal brachytherapy consists of a total of 3–5 fractions, typically delivering 4–7 Gy once per week.
eBx is administered under the direction of a radiation oncologist who will determine the amount of radiation needed. It is delivered on an outpatient basis once a week for 3–5 weeks in a non-shielded room. During radiation therapy, the portion of the vaginal applicator that remains outside the vagina will be connected to an Axxent controller. The patient is prepared with a flexible X-ray shield that is draped over the abdomen. A miniaturized X-ray source will travel through the applicator into the vagina, administering radiation. The X-ray source will remain in the applicator and deliver radiation for about 3–10 minutes. The positioning of the X-ray source and the dose per fraction are determined in the treatment plan. The X-ray source can easily then be turned off and withdrawn. No radiation device will remain in the vagina between treatments or after the final treatment.
Xoft electron therapy
For Non-Melanoma Skin Lesions
Administered under the direction of a radiation oncologist. In cooperation with the dermatologist, the radiation oncologist will determine the amount of radiation needed and the physicist will ensure that the radiation is delivered as prescribed. eBx can be delivered on an outpatient basis in a room with reduced shielding requirements. Treatment regimen and prescription depend on tumor size, type, depth, patient age, prior treatments and other criteria. During radiation therapy, the surface applicator is connected to the Xoft Axxent Controller. The treatment site is prepared with a flexible shield that is cut to shape to surround the target area and protect the adjacent non-target tissues. A miniaturized X-ray source is placed in the applicator and energized to deliver radiation for a few minutes. At the completion of the treatment, the X-ray source is turned off. All devices are removed in between treatment fractions.
