BREAST CANCER

Frequently Asked Questions

The Radixact System is cleared for the treatment of tumors anywhere in the body, including breast. The FDA provided clearance for the original TomoTherapy technology in 2002, and for the next-generation TomoTherapy technology – the Radixact System – in 2016. The efficacy of this technology is supported by many clinical studies including large numbers of patients.

The FDA provided clearance for the TomoTherapy technology in 2002 and in 2016 for the Radixact System, the next generation TomoTherapy platform, for the treatment of tumors anywhere in the body, including breast. The TomoTherapy technology included in the Radixact System is supported by published clinical follow-up with a large number of patients.

  • The TomoDirect treatment method provided uniform delivery of radiation dose to the breast tumor with minimal dose to nearby organs at risk. Patients experienced mild toxicity and no local recurrence of the cancer was reported at a mean follow-up of 12 months. Cosmesis – preservation of the normal appearance of the breast — was good/excellent in 91 percent of patients treated1.
  • A prospective single-center study of 30 patients using TomoHelical for irradiation of Stage III breast cancer found the treatments were very well tolerated with minimal acute or moderately late side effects. Cardiac and respiratory tests did not show evidence of significant treatment-related abnormalities. No local recurrence of the cancer had been recorded at the completion of the study2.
  • A retrospective single-center study of 136 patients with invasive breast cancer found that hypofractionated radiotherapy delivered with helical TomoTherapy was very well tolerated with minimal acute and late toxicities. Additionally, this treatment modality provided excellent three-year loco-regional failure free survival, meaning there was no local or regional recurrence or tumor progression, or death due to breast cancer, three years after treatment3.
  • A retrospective, single-center study evaluated the use of helical TomoTherapy to deliver radiation treatments post-surgery – either breast-conserving surgery (lumpectomy) or mastectomy – to 179 patients. The study showed that the TomoTherapy System optimized radiation delivery to the tumor site, while minimizing radiation delivery to nearby organs, including the lungs and heart. Treatment was well-tolerated and provided good local and distant disease control4


Studies support the use of the TomoTherapy System for the treatment of breast cancer and show evidence of very good tumor control2, 5, 6, 7 with minimal radiation delivered to surrounding organs at risk (heart, lungs, etc.) and healthy tissues, and low toxicity.8, 9 The treatment regimens described in the studies reinforce the benefits of the unique capabilities of the TomoTherapy platform and what clinicians and their patients could expect to see with the Radixact System.

Radixact treatment is available at many locations worldwide. TomoTherapy treatments are available at hundreds of locations worldwide.

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Treatment with the Radixact System is an outpatient procedure that does not require incisions or general anesthesia. Most patients will not require hospitalization or a long recovery period. Radiation therapy delivered with the Radixact System may be used to treat breast cancer at almost every stage and can be used after surgery, chemotherapy and other medications. It is commonly used to help reduce risk of breast cancer recurrence and also can be used to provide relief from symptoms, such as pain, associated with advanced breast cancer.

The helical design of the Radixact System — unique among radiation therapy systems — enables continuous 360-degree radiation dose delivery as the patient table moves. The Radixact System revolves around you while thousands of “beamlets” — more precise than the radiation beams of conventional systems — are delivered to the tumor. Each beamlet can deliver a different dose of radiation. Different doses go to different parts of each tumor, with less damage to surrounding healthy tissue. Integrated imaging and advanced dose-delivery capabilities enable your treatment team to create a more personalized treatment plan and confidently deliver the most precise dose of radiation, directly to the tumor. Radixact helical delivery also enables treatment of a full range of diseases, including larger, more complex tumors, multiple tumors and recurrent tumors.

Put simply, helical radiation delivery means that the Radixact System is continuously delivering image-guided, intensity-modulated radiation therapy (IG-IMRT) from a full 360 degrees around the patient as the treatment table also moves — providing greater control of the radiation dose so it conforms precisely to the tumor and minimizes dose to healthy tissue. Whereas conventional radiotherapy systems can only deliver radiation from a limited number of points, the helical delivery of the Radixact System gives your treatment team the ability to administer the accurate dose of radiation from thousands of independent locations, to provide the most personalized treatment delivery.

Radixact treatment eliminates the inconvenience and risk associated with radioactive seed implants.

Radiation therapy is a treatment that uses high-energy x-rays (photons) to kill, shrink or control the growth of tumors. Radiation therapy works by damaging cells, disabling them from growing and dividing. The goal of any radiation treatment is to destroy cancer cells while minimizing the side effects on healthy tissue. As imaging technologies have improved over the last several decades, radiation therapy has integrated those improvements to enhance dose delivery and minimize side effects.

Radiation may be recommended as an alternative to surgery or in addition to other therapies. Radiation therapy is constantly evolving with the introduction of new technologies to the market.. The Radixact System can deliver a type of radiation therapy known as image-guided intensity-modulated radiation therapy (IG-IMRT).

IMRT is a specialized form of external beam radiation therapy that varies the intensity of each radiation beam. IMRT can help clinicians shape the delivery of radiation to more accurately and precisely target the tumor — and can help minimize dose to surrounding organs and tissues.

IG-IMRT is a type of targeted external beam radiation therapy that enhances IMRT by using images acquired before each treatment.

With daily imaging, clinicians gain the confidence necessary to reduce margins and to accurately set-up patient on the table throughout the course of the treatment. And by modulating the intensity of the radiation beams/beamlets, IG-IMRT enables clinicians to carefully shape the radiation dose to fit the contours of the tumor, while minimizing dose to surrounding organs and healthy tissues. 

There are more options than ever for treating breast cancer, and the right option depends on your specific tumor location, cancer type and cancer aggressiveness — as well as your health, age and lifestyle. The Radixact System is routinely used to treat a variety of cancers — from routine to complex tumors, those located in hard-to-reach areas and recurrent tumors. The best way to determine if Radixact treatment is right for you is to find a Radixact treatment location and make an appointment to discuss your specific details.

Find a Treatment Center Near You

Most radiation side effects are minimal and last only a short time. Possible side effects could include but are not limited to:

  • Fatigue
  • Skin reactions
  • Swelling of the breast
  • Pain in the breast or chest area
  • Sore throat
  • Lymphoedema
  • Change in breast shape, size and colour
  • Tenderness over the ribs

 

Ask your doctor for more details about the side effects of your specific radiation therapy.

Learn More About Potential Side Effects

You can expect your Radixact treatment to require daily sessions over several weeks. Because the Radixact System can deliver radiation continuously, without requiring interruptions to reposition the patient, a treatment session typically lasts 10-20 minutes — including patient set-up time.

Treatment sessions are non-invasive outpatient procedures, and no anesthesia is required. Most patients resume normal activity immediately after treatment sessions.

No anesthesia is required for Radixact treatment and treatment sessions are completed on an outpatient basis.

The majority of patients can continue normal activity during and immediately following Radixact treatment — compared to the typical requirement to limit normal activity several weeks after traditional surgery. Just as important, the Radixact System is designed to minimize radiation dose to healthy tissues and reduce side effects, with the goal of improving patient quality of life both during and after treatment.

The majority of patients can continue normal activity during and immediately following Radixact treatment — compared to the typical requirement to limit normal activity for several weeks after traditional surgery.

Precisely delivering the prescribed radiation dose to the target is essential for optimizing cancer control. Additionally, precise dose delivery reduces irradiation of healthy tissues surrounding the target.

Because breast cancer tumors are located in close proximity to sensitive organs and tissues (i.e., heart, lungs, etc.), precise delivery is critically important for reducing the incidence and severity of side effects and protecting quality of life both during and after treatment.

Because the precise targeting of the Radixact System significantly reduces irradiation of surrounding healthy tissues, patients treated with the Radixact System could be candidates for re-irradiation, in the event of recurrence. Additionally, patients treated with the Radixact System may sometimes be candidates for surgical interventions, in the event of recurrence.

Because the precise targeting of the Radixact System significantly reduces irradiation of surrounding healthy tissues, patients treated with conventional radiotherapy systems may be candidates for re-irradiation with the Radixact System, in the event of recurrence. Each patient should consult his physician regarding his own specific case.

As of January 2020, IG-IMRT treatment for breast cancer is covered by Medicare in all 50 states and the District of Columbia. In addition, many private insurance payers cover IG-IMRT treatment for breast cancer. It is always best to check your insurance policy and if applicable, be sure to review your employee contract to determine if your insurance coverage benefits are limited. If you live outside of the United States, typically the Radixact Center that you would choose for treatment can answer coverage questions.

Not every patient’s breast cancer is effectively treated with IG-IMRT. Talk to your physician about your best options and come to a joint decision.

References:

1 Franco et al. “Intensity-modulated and hypofractionated simultaneous integrated boost adjuvant breast radiation employing statics ports of TomoTherapy (TomoDirect): a prospective phase II trial.” J Cancer Res Clin Oncol. 2014 Jan;140(1):167-77. doi: 10.1007/s00432-013-1560-8.

2 Caudrelier et al. “IMRT sparing of normal tissues in locoregional treatment of breast cancer.” Radiat Oncol. 2014 Jul 22;9:161. doi: 10.1186/1748-717X-9-161.

3 Chitapanarux I, Nobnop W, Tippanya D et al. “Clinical outcomes and dosimetric study of hypofractionated Helical tomotherapy in breast cancer patients.” PLoS One. 2019 Jan 31;14(1):e0211578.

4 Arsene-Henry A, Foy JP, Robilliard M et al. “The use of helical tomotherapy in the treatment of early stage breast cancer: indications, tolerance, efficacy-a single center experience.” Oncotarget. 2018 May 4;9(34):23608-23619.

5 O’Donnell et al. “Early Experience of TomoTherapy-based Intensity-modulated Radiotherapy for Breast Cancer Treatment.” Clinical Oncology 2009 21: 294-301.

6 Van Prijs et al. “Short course radiotherapy with simultaneous integrated boost for stage I-II breast cancer, early toxicities of a randomized clinical trial.” Radiation Oncology 2012, 7:80.

7 Michalski et al. “A dosimetric comparison of 3D-CRT, IMRT and static tomotherapy with an SIB for large and small breast volumes.” Medical Dosimetry. 2014 Summer;39(2):163-8. doi: 10.1016/j.meddos.2013.12.003.

8 Chitapanarux I, Nobnop W, Tippanya D et al. “Clinical outcomes and dosimetric study of hypofractionated Helical tomotherapy in breast cancer patients.” PLoS One. 2019 Jan 31;14(1):e0211578.

9 Arsene-Henry A, Foy JP, Robilliard M et al. “The use of helical tomotherapy in the treatment of early stage breast cancer: indications, tolerance, efficacy-a single center experience.” Oncotarget. 2018 May 4;9(34):23608-23619.