Accelerated Partial Breast Irradiation (APBI)

Balloon radiotherapy for breast cancer, also known as intracavitary brachytherapy, can deliver a focused dose of radiation to part of the breast. The standard since the 1980s has been whole breast radiation therapy given over a period of a few weeks. With the balloon placed by the surgeon, radiation can be delivered twice a day for ten treatments to make treatment more focused and convenient.

This is one form of accelerated partial breast irradiation, or APBI. This technique is investigational but promising enough that it's reasonable to consider as an alternative to whole breast radiation therapy. Depending upon how conservative you are regarding medical evidence, it may be best done only on a clinical trial or there are guidelines for treatment off protocol in selected circumstances, which I have answered on TalkAboutHealth before: http://bit.ly/mZ2Fdg

I offer this treatment to selected women but tend to favor standard whole breast radiation. There's a fair amount of hype about APBI but it's still not proven to be equally effective. I'm not sure if this is the NY Times article you meant, but I'll discuss this: http://nyti.ms/wVW62K

Recent data presented at the San Antonio Breast Cancer Symposium showed that women receiving APBI were "about twice as likely to have a mastectomy in the following five years" after treatment compared to women receiving whole breast radiation. Sounds terrible, right? I call foul on the NY Times:

1. The failure rate almost doubled; 4% vs. 2.2%. Had the NY Times presented it based upon success rate, 96% vs 97.8%, it's not news.

2. It's a retrospective, broad stroke study. There can be all sorts of bias and no ability to account for quality control in how the treatment was done for APBI.

3. Presentations at academic meetings are interesting, but it's not finalized, peer-reviewed research until it's published.

I'm conservative regarding use of APBI. Don't believe the positive hype, but I don't put too much stock in the NY Times article. I hope that answers your question!


Balloon radiotherapy for breast cancer, also known as intracavitary brachytherapy, can deliver a focused dose of radiation to part of the breast. The standard since the 1980s has been whole breast radiation therapy given over a period of a few weeks. With the balloon placed by the surgeon, radiation can be delivered twice a day for ten treatments to make treatment more focused and convenient.

This is one form of accelerated partial breast irradiation, or APBI. This technique is investigational but promising enough that it's reasonable to consider as an alternative to whole breast radiation therapy. Depending upon how conservative you are regarding medical evidence, it may be best done only on a clinical trial or there are guidelines for treatment off protocol in selected circumstances, which I have answered on TalkAboutHealth before: http://bit.ly/mZ2Fdg

I offer this treatment to selected women but tend to favor standard whole breast radiation. There's a fair amount of hype about APBI but it's still not proven to be equally effective. I'm not sure if this is the NY Times article you meant, but I'll discuss this: http://nyti.ms/wVW62K

Recent data presented at the San Antonio Breast Cancer Symposium showed that women receiving APBI were "about twice as likely to have a mastectomy in the following five years" after treatment compared to women receiving whole breast radiation. Sounds terrible, right? I call foul on the NY Times:

1. The failure rate almost doubled; 4% vs. 2.2%. Had the NY Times presented it based upon success rate, 96% vs 97.8%, it's not news.

2. It's a retrospective, broad stroke study. There can be all sorts of bias and no ability to account for quality control in how the treatment was done for APBI.

3. Presentations at academic meetings are interesting, but it's not finalized, peer-reviewed research until it's published.

I'm conservative regarding use of APBI. Don't believe the positive hype, but I don't put too much stock in the NY Times article. I hope that answers your question!

The presentation by Dr. Smith at the San Antonio Breast Cancer Symposium entitled 'Partial breast brachytherapy is associated with inferior effectiveness and increased toxicity compared with whole breast irradiation in older patients' has garnered a tremendous amount of print and Internet media attention. After reading the abstract (paper not in press yet), seeing the talk live in San Antonio, and discussing the study with many colleagues in breast surgery and radiation oncology, I want to try to clarify the data on APBI, and discuss the “information” in the abstract and the hyperbole in the lay press that is distressing our patients.

First and unequivocally, accelerated partial breast irradiation is a safe and effective form of treating the breast after appropriately performed lumpectomy in patients over age 45-50 with early-stage invasive (typically <3cm primaries and lymph node negative) and non-invasive breast cancer. Numerous retrospective studies and two prospective randomized studies (the gold standard) have shown no difference in survival, local-regional cancer recurrence rates and complications between APBI and whole breast irradiation (WBI). The American Society of Breast Surgeons’ MammoSite Registry has published more than 16 papers showing the safety and efficacy (comparable to WBI) of Mammosite APBI.

The San Antonio abstract and presentation were drawn from the Medicare claims-SEER database, which is a large database with cancer-patient data linked to Medicare claims data. The database is managed by the National Cancer Institute and sold to institutions to do research. The linked database has information about cancer type and treatments, but it has no specific data on margin status, prognostic factors such as estrogen receptor/progesterone receptor (ER/PR) and HER2/Neu receptor -- or even local, regional or distant recurrence.

The study stated that “subsequent mastectomy” is a “validated surrogate for local failure,” but I am unaware of any literature that states this. The “two-fold increased risk for subsequent mastectomy” is misleading and inaccurate. (It s 4.0% for APBI vs. 2.2% for WBI in their study). Both of these rates are quite small, and it is questionable whether there is any clinical significance between the two. Not emphasized but equally important are the overall survival rates for APBI vs. WBI, which were equivalent.

The study also stated that infections were higher for APBI (not surprising since it involves the insertion of one or more catheters in the breast), but there is no statement regarding severity (were the APBI patients just placed on prophylactic antibiotics and is that how an infection was defined?). Fat necrosis and breast pain were also significantly higher in the APBI group, although there is absolutely no uniform definition of what fat necrosis is nor a statement about the severity of the fat necrosis or breast pain.

Lastly, the researchers state there was a 9.6% hospitalization rate for APBI patients vs. 5.7% for WBI patients. This is puzzling since no diagnosis was given for hospitalization nor was there information on the time period over which patients were hospitalized. Was hospitalization APBI-related (doubtful) or related to first chemotherapy cycle (perhaps) or other unrelated health issues? (It’s worth noting that APBI is often used in older, sicker patients who may not be candidates for six to seven weeks of WBI).

In summary, this retrospective study of an inherently inaccurate database (no data on tumor characteristics and margin status -- both known to be significant determiners of local recurrence), with questionable outcomes (admission rate) and non-validated “surrogate endpoints” (subsequent mastectomy=local recurrence) should be looked at with appropriate skepticism in the face of 20 years of retrospective studies and two prospective randomized trials to the contrary.
The presentation by Dr. Smith at the San Antonio Breast Cancer Symposium entitled 'Partial breast brachytherapy is associated with inferior effectiveness and increased toxicity compared with whole breast irradiation in older patients' has garnered a tremendous amount of print and Internet media attention. After reading the abstract (paper not in press yet), seeing the talk live in San Antonio, and discussing the study with many colleagues in breast surgery and radiation oncology, I want to try to clarify the data on APBI, and discuss the “information” in the abstract and the hyperbole in the lay press that is distressing our patients.

First and unequivocally, accelerated partial breast irradiation is a safe and effective form of treating the breast after appropriately performed lumpectomy in patients over age 45-50 with early-stage invasive (typically <3cm primaries and lymph node negative) and non-invasive breast cancer. Numerous retrospective studies and two prospective randomized studies (the gold standard) have shown no difference in survival, local-regional cancer recurrence rates and complications between APBI and whole breast irradiation (WBI). The American Society of Breast Surgeons’ MammoSite Registry has published more than 16 papers showing the safety and efficacy (comparable to WBI) of Mammosite APBI.

The San Antonio abstract and presentation were drawn from the Medicare claims-SEER database, which is a large database with cancer-patient data linked to Medicare claims data. The database is managed by the National Cancer Institute and sold to institutions to do research. The linked database has information about cancer type and treatments, but it has no specific data on margin status, prognostic factors such as estrogen receptor/progesterone receptor (ER/PR) and HER2/Neu receptor -- or even local, regional or distant recurrence.

The study stated that “subsequent mastectomy” is a “validated surrogate for local failure,” but I am unaware of any literature that states this. The “two-fold increased risk for subsequent mastectomy” is misleading and inaccurate. (It s 4.0% for APBI vs. 2.2% for WBI in their study). Both of these rates are quite small, and it is questionable whether there is any clinical significance between the two. Not emphasized but equally important are the overall survival rates for APBI vs. WBI, which were equivalent.

The study also stated that infections were higher for APBI (not surprising since it involves the insertion of one or more catheters in the breast), but there is no statement regarding severity (were the APBI patients just placed on prophylactic antibiotics and is that how an infection was defined?). Fat necrosis and breast pain were also significantly higher in the APBI group, although there is absolutely no uniform definition of what fat necrosis is nor a statement about the severity of the fat necrosis or breast pain.

Lastly, the researchers state there was a 9.6% hospitalization rate for APBI patients vs. 5.7% for WBI patients. This is puzzling since no diagnosis was given for hospitalization nor was there information on the time period over which patients were hospitalized. Was hospitalization APBI-related (doubtful) or related to first chemotherapy cycle (perhaps) or other unrelated health issues? (It’s worth noting that APBI is often used in older, sicker patients who may not be candidates for six to seven weeks of WBI).

In summary, this retrospective study of an inherently inaccurate database (no data on tumor characteristics and margin status -- both known to be significant determiners of local recurrence), with questionable outcomes (admission rate) and non-validated “surrogate endpoints” (subsequent mastectomy=local recurrence) should be looked at with appropriate skepticism in the face of 20 years of retrospective studies and two prospective randomized trials to the contrary.

Brachytherapy is radiation therapy delivered at a close distance - brachy means arm's length. Many cancers can be treated with brachytherapy including prostate cancer (implanted seeds), cervical cancer, and breast cancer. There any many techniques but most involve a shortened course (intra-operative single dose to two treatments per day for 5 days) and only treat the part of the breast at highest risk (the lumpectomy cavity). The term for this is Accelerated Partial Breast Irradiation (APBI) and is most commonly done with a device inserted into the lumpectomy cavity through a small skin nick. These devices (Contura, Mammosite Multi-Lumen, and SAVI) have multiple catheters bundled together that separate within the lumpectomy cavity (think egg beater). A small radiation seed (~size of a grain of rice) is inserted into each catheter and 'dwells' at a certain position for a certain amount of time to deliver the radiation dose prescribed by the radiation oncologist. Brachytherapy is radiation therapy delivered at a close distance - brachy means arm's length. Many cancers can be treated with brachytherapy including prostate cancer (implanted seeds), cervical cancer, and breast cancer. There any many techniques but most involve a shortened course (intra-operative single dose to two treatments per day for 5 days) and only treat the part of the breast at highest risk (the lumpectomy cavity). The term for this is Accelerated Partial Breast Irradiation (APBI) and is most commonly done with a device inserted into the lumpectomy cavity through a small skin nick. These devices (Contura, Mammosite Multi-Lumen, and SAVI) have multiple catheters bundled together that separate within the lumpectomy cavity (think egg beater). A small radiation seed (~size of a grain of rice) is inserted into each catheter and 'dwells' at a certain position for a certain amount of time to deliver the radiation dose prescribed by the radiation oncologist.

Let me start by saying that brachytherapy is safe and effective in properly selected patients. We have 20 years of studies that have analyzed patient outcome data and 2 prospective randomized trials (the true gold standard) that have shown that brachytherapy (accelerated partial breast irradiation [APBI]) is equally effective to whole breast irradiation (WBI).

There was a recent presentation at the San Antonio Breast Cancer Symposium from radiation oncologists from MDAnderson Cancer Center that has creasted some controversy. They retorspectively analyzed a large Medicare Claims-SEER database that showed equivalent survival rates between APBI and WBI. The controversial part of their presentation that they chose to emphasize was the slightly higher breast cancer local recurrence rate (as assessed by mastectomy rates) for APBI patients (4%) compared to WBI patients (2.2%). The difficulty with emphasizing this one point was that it struck fear in many patients. Frankly, both rates are very low and acceptible but to make a 'big deal' out of this clinically very small difference is unfair to APBI. Let me start by saying that brachytherapy is safe and effective in properly selected patients. We have 20 years of studies that have analyzed patient outcome data and 2 prospective randomized trials (the true gold standard) that have shown that brachytherapy (accelerated partial breast irradiation [APBI]) is equally effective to whole breast irradiation (WBI).

There was a recent presentation at the San Antonio Breast Cancer Symposium from radiation oncologists from MDAnderson Cancer Center that has creasted some controversy. They retorspectively analyzed a large Medicare Claims-SEER database that showed equivalent survival rates between APBI and WBI. The controversial part of their presentation that they chose to emphasize was the slightly higher breast cancer local recurrence rate (as assessed by mastectomy rates) for APBI patients (4%) compared to WBI patients (2.2%). The difficulty with emphasizing this one point was that it struck fear in many patients. Frankly, both rates are very low and acceptible but to make a 'big deal' out of this clinically very small difference is unfair to APBI.

Brachytherapy is a more inclusive name for radiation that is delivered at a 'short distance' (the name 'brachy' means arm's length). Brachytherapy techniques include the Mammosite balloon technique. Mammosite is a balloon with a single catheter running down the middle. http://www.mammosite.com/ A small radiation seed (about the size of a grain of rice) is then run down the catheter and stops at various positions along the way to deliver the prescribed radiation dose. Other brachytherapy techniques include using multiple catheters that pierce the skin (interstial brachytherapy - used rarely now but was the original technique pioneered by Robert Kuske, MD) and single entry/multiple catheter devices (SAVI, Mammosite Multi-Lumen, and Contura). The radiation seed goes down each catheter (just as in the single catheter Mammosite) for a set time to deliver the prescribed dose.

I feel very comfortable offering properly selected patients - accelerated partial breast irradiation (5 days instead of 6-7 weeks) usually with one of the single entry/multicatheter devices. Brachytherapy is a more inclusive name for radiation that is delivered at a 'short distance' (the name 'brachy' means arm's length). Brachytherapy techniques include the Mammosite balloon technique. Mammosite is a balloon with a single catheter running down the middle. http://www.mammosite.com/ A small radiation seed (about the size of a grain of rice) is then run down the catheter and stops at various positions along the way to deliver the prescribed radiation dose. Other brachytherapy techniques include using multiple catheters that pierce the skin (interstial brachytherapy - used rarely now but was the original technique pioneered by Robert Kuske, MD) and single entry/multiple catheter devices (SAVI, Mammosite Multi-Lumen, and Contura). The radiation seed goes down each catheter (just as in the single catheter Mammosite) for a set time to deliver the prescribed dose.

I feel very comfortable offering properly selected patients - accelerated partial breast irradiation (5 days instead of 6-7 weeks) usually with one of the single entry/multicatheter devices.

There is always some leeway in these criteria including discussing all radiation options with the patient but generally
age >45
tumor size < 3 cm
Margins - neg
Lymph nodes - neg

Here is the link to the American Society of Breast Surgeons Offical Statment.
https://www.breastsurgeons.org/statements/PDF_Statements/APBI.pdf There is always some leeway in these criteria including discussing all radiation options with the patient but generally
age >45
tumor size < 3 cm
Margins - neg
Lymph nodes - neg

Here is the link to the American Society of Breast Surgeons Offical Statment.
https://www.breastsurgeons.org/statements/PDF_Statements/APBI.pdf

The study presented by Dr. Grace Smith at the San Antonio Breast Cancer Symposium entitled Partial Breast Brachytherapy is Associated with Inferior Effectiveness and Increased Toxicity Compared with Whole Breast Irradiation in Older Patients has garnered a tremendous amount of print and internet media attention. After reading the abstract (paper not in press yet), seeing the talk live in San Antonio, and discussing the study with many colleagues in the breast surgery and radiation oncology fields, it has become necessary to try to clarify the data on APBI, discuss the 'information' in the abstract and the hyperbole in the lay press that is distressing our patients.

First and unequivocally, Acellerated Partial Breast Irradiation is a safe and effective form of treating the breast after appropriately performed lumpectomy in patients over age 45-50 with early stage invasive (typically <3cm primaries and lymph node negative) and non-invasive breast cancer. Numerous retrospective studies and 2 prospective randomized (the gold standard) studies have shown no difference in survival, local-regional recurrence rates or complications between APBI and Whole Breast Irradiation (WBI). The American Society of Breast Surgeons Mammosite Registry has published more than 16 papes showing the safety and efficacy (comparable to WBI) of Mammosite APBI.

The abstract and presentation is drawn from the Medicare claims-SEER database which is a large database with cancer patient data linked to Medicare claims data. The database is managed by the NCI and sold to institutions to do research. The linked database has information about cancer type and treatments but no specific data on margin status, prognostic factors such as ER/PR and Her2Neu, or even local, regional or distant recurrence. The study stated that 'subsequent mastectomy' is a 'validated surrogate for local failure' although I am unaware of any literature that states this. The 'two-fold increased risk for subsequent mastectomy' is misleading (and inaccurate - it's 4.0% for APBI vs. 2.2% for Whole Breast Irradiation in their study). Both of these rates are quite small and questionable whether there is any clinical significance between the two. Not emphasized but equally (?more) important is the overall survival rates which were equivalent. The study also stated that infections were higher for APBI (not surprising since it involves the insertion of one or more catheters in the breast) but there is no statement regarding severity (were the APBI patients just placed on prophylactic antiobiotics and that is how an infection was defined?). Fat necrosis and breast pain were also significantly higher in the APBI group although there is absolutely no uniform definition of what fat necrosis is nor a statement about the severity or the fat necrosis or breast pain. Lastly, they state there was a 9.6% hospitalization rate for APBI patients vs 5.7% for WBI patients. This is quizzical since no diagnosis was given for hospitalization nor the time period over which they were hospitalized (was it APBI related[doubtful] or related to first chemotherapy cycle [perhaps] or other unrelated health issues [APBI often used in older, sicker patients who may not be candidates for 6-7 weeks of WBI]). In summary, this retrospective study of an inherently inacurate (no data on tumor characteristics and margin status - both known to be significant determiners of local recurrence) database with questionable outcomes (admission rate) and non-validated 'surrogate endpoints' (subsequent mastectomy=local recurrence) should be looked at with appropriate skepticism in the face of 20 years of retrospective studies and 2 prospective randomized trial to the contrary.
Thanks for the question! The San Antonio Breast Cancer Symposium is one of the largest and most prestigious breast cancer conferences, and often exciting and innovative research is presented. However at the recent meeting, a study was presented by a group from MD Anderson, questioning the safety and effectiveness of accelerated partial breast irradiation (APBI) for early-stage breast cancer - specifically they noted that patients undergoing this treatment have a higher rate of complications and eventual mastectomy. Unfortunately before the study was even presented, it received national media attention, leading to significant anxiety and confusion among women. This stresses the importance of reading the study, not just listening to the sound bite - here are some facts:
- The study used retrospective (after the fact) "claims data" to do their evaluation. That means they took Medicare billing information, not actual patient data, and drew some conclusions. It is NOT possible to accurately determine complication rates from claims data as they are not always reported. It is also not possible (and the authors admitted this) to determine why the women treated with APBI subsequently underwent mastectomy - it could have been for an entirely different cancer, even one in the other breast!
- The absolute increased risk of mastectomy was 1.8% which is quite low, and again we have no way to know why the women underwent mastectomy
- APBI has been the subject of multiple prospective (going-forward) and peer-reviewed studies, and has been shown to have an equivalent or in some cases better rate of breast cancer control compared to whole-breast irradiation; the complication rate is also equivalent.

3 respected professional medical societies published responses critical of the MD Anderson study, and I expect more criticism will come. The responses are from the American Society of Breast Surgeons: https://www.breastsurgeons.org/news/article.php?id=122, the American Brachytherapy Society: http://campaign.r20.constantcontact.com/render?llr=kdofiegab&v=001rj64Pj8NTf4ISgwN4cSdZYtZBR53GjAi73j4En_qeygPzWmSUe1qgGI7U-jt8HRV7NouL9sMViv1IOOeGT2QHMAaDWrfEuOApREAHj-8Z60%3D and the American Society for Radiation Oncology: https://astro.org/News-and-Media/News-Releases/2011/ASTRO--APBI-safe,-effective-for-some-breast-cancer-patients.aspx

It is again unfortunate that this poorly designed study with no real valid clinical data was allowed to be presented at such a prestigious meeting, and that it received immense national media attention before the scientific community was allowed to interpret the study and respond. I am hopeful that this will not happen in the future, as many women (and many physicians) were caused unnecessary anxiety regarding their breast cancer treatment options.