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MP 8.01.13 Accelerated Breast Irradiation after Breast-Conserving Surgery for Early Stage Breast Cancer and Breast Brachytherapy as Boost with Whole-Breast Irradiation

Medical Policy    
Original Policy Date
Last Review Status/Date
Reviewed with literature search/12:2012
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Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Radiation therapy is the standard care for patients with breast cancer undergoing breast-conserving surgery (BCS), as it reduces recurrences and lengthens survival. The conventional radiation therapy regimen consists of approximately 25 treatments of 2 Gray (Gy; a measure of absorbed radiation dose) delivered over 5 to 6 weeks. Nonetheless, not all patients undergo radiation therapy following BCS; the duration and logistics of treatment may be barriers for some women. Accelerated radiotherapy approaches have been proposed to make the regimen less burdensome for patients with early-stage breast cancer at low risk of recurrence:

  • Accelerated (also called hypofractionated) whole-breast irradiation (AWBI) reduces the number of fractions and the duration of treatment to about 3 weeks. This approach has been commonly used in Canada and Europe.
  • Accelerated partial-breast irradiation (APBI) irradiates a limited part of the breast in and close to the tumor cavity. By reducing the area irradiated, fewer treatments are needed, and the total treatment takes about 1 week. Several approaches can be used to deliver APBI, including interstitial brachytherapy, balloon brachytherapy, external beam radiotherapy, or intraoperative radiotherapy (which occurs on only 1 day).

The critical question is whether these three approaches are equivalent in outcomes and adverse events to the conventional radiation therapy regimen.

Breast Conservation Therapy

Survival after breast-conservation therapy (BCT) is equivalent to survival after mastectomy for patients diagnosed with tumors categorized as stage I or II. BCT is a multimodality treatment that consists of BCS to excise the tumor with adequate margins, followed by whole-breast external-beam radiation therapy administered as 5 daily fractions per week over 5 to 6 weeks. Local boost irradiation to the tumor bed often is added to whole-breast irradiation to provide a higher dose of radiation at the site where recurrence most frequently occurs. For some patients, BCT also includes axillary lymph node dissection, sentinel lymph node biopsy, or irradiation of the axilla. A number of randomized, controlled trials (RCTs) have demonstrated that the addition of radiotherapy after BCS reduces recurrences and mortality. In an expanded update of an individual-level meta-analysis, the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) reported that radiotherapy halved the annual recurrence rate after 10 years for women with node-negative disease (n=7,287), from 31.0% for those not receiving radiotherapy to 15.6% for those receiving it. (1) It also reduced the 15-year risk of breast cancer death from 20.5% to 17.2% (p=0.005). For women with node-positive disease (n=1,050), radiotherapy reduced the 1-year recurrence risk from 26.0% to 5.1%. Radiotherapy also reduced the 15-year risk of breast cancer death from 42.8% to 51.3% (p=0.01).

Consequently, radiation therapy is generally recommended following BCS. A potential exception is for older women at low risk of recurrence. For example, the National Comprehensive Cancer Network (NCCN) guidelines state that women aged 70 or older may omit radiotherapy if they have estrogen-receptor positive, T1 tumors, clinically negative lymph nodes, and plans to take adjuvant endocrine therapy. (2) However, a recent study has raised questions about this recommendation.

Controversy continues on the length of follow-up needed to determine whether APBI is equivalent to whole-breast irradiation (for more information, see the recent update to the TEC Assessment on Accelerated Radiotherapy after Breast-Conserving Surgery for Early Stage Breast Cancer) (3); some 10-year data are already available on accelerated whole-breast irradiation. However, the issue may be resolved by statistical issues rather than biological ones. Because recurrences are relatively rare among low-risk early breast cancer patients, it may take considerable time for there to be enough recurrences to achieve sufficient power to compare rates for each radiotherapy approach. For example, in the large NSABP-39/RTOG 0413 trial comparing whole-breast irradiation versus APBI, the enrollment goal is 4,300, which may be achieved around the end of 2012. The length of the trial (presumably barring early termination) is determined by the occurrence of a prespecified number (175) of in-breast recurrences. The researchers expect that reaching that number of recurrences will take about 10 years.

Most patients diagnosed with stage I or II breast cancer now are offered a choice of BCT or modified radical mastectomy, but BCT is selected less often than expected. Studies have shown that those living furthest from treatment facilities are least likely to select BCT instead of mastectomy and most likely to forgo radiation therapy after BCS. (4-6) A study using data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) tumor registries from 1992 to 2002 examined how many women with early stage (I or II) breast cancer received radiotherapy within 4 months following BCS. (7) After adjusting for age, they found that in 2002, 30.8% of Caucasian women and 44.7% of African-American women had not received radiotherapy. Furthermore, these rates had increased from 24.7% for Caucasians and 34.0% for African Americans in 1992.

Given that duration and logistics appear to be barriers to completion of treatment, there has been interest in developing shorter radiotherapy regimens. Two approaches have been explored.

The first method is to provide the same dose to the whole breast in a shorter time by increasing the dose provided per treatment (hypofractionation). This approach was initially avoided out of concern that increasing doses to target the tumor more effectively might induce more severe adverse events from radiation exposure, thus tipping the balance between benefits and harms. More recent research, some of which is highlighted below, has allayed some of these concerns. Accelerated whole-breast irradiation (AWBI) has been used especially in Canada and Europe.

The second approach to reducing radiotherapy treatment time is accelerated partial-breast irradiation (APBI). It differs from conventional whole-breast irradiation in several ways. First, the radiation only targets the segment of the breast surrounding the area where the tumor was removed, rather than the entire breast. This approach was based in part on the finding that recurrences are more likely to occur close to the tumor site rather than elsewhere in the breast. Second, the duration of treatment is 4 to 5 days (or 1 day with intraoperative radiotherapy) rather than 5 to 6 weeks, because the radiation is delivered in fewer fractions at larger doses per fraction to the tumor bed. Third, the radiation dose is intrinsically less uniform within the target volume when APBI uses brachytherapy (i.e., the implantation of radioactive material directly in the breast tissue). The major types of radiotherapy used after BCS are outlined in Table 1. They differ in their techniques, instrumentation, dose delivery, and possibly in their outcomes.

Table 1. Major types of radiation therapy following breast-conserving surgery

RT Type




Whole (W) or partial (P) breast


External beam (E) or brachytherapy (B)


Approx duration of treatment


Published RCTs (length of follow-up in yrs)

Conventional whole-breast irradiation   N   W   E   5-6 wks   Multiple; >15 yrs2 
Accelerated whole-breast irradiation   Y   W   E   3 wks   4; 10 yrs  
Interstitial APBI*   Y   P   B   1 wk   2; 5.4yrs  
Balloon APBI§  Y   P   B   1 wk   0  
External beam APBI#  Y   P   E   1 wk   0  
Intraoperative APBI  Y   P   Not applicable   1 day   1; 4 yrs 

* Interstitial brachytherapy entails placement of multiple hollow needles and catheters to guide placement of the radioactive material by a remote afterloading device. It is more difficult to perform than other types of brachytherapy and has a steep learning curve.

§ Balloon brachytherapy, e.g., Mammosite, entails inserting a balloon into the tumor bed, inflating the balloon, confirming its position radiographically, and then using a remote afterloader to irradiate the targeted area. Some brachytherapy systems combine aspects of interstitial and balloon brachytherapy.

# External-beam APBI is delivered in the same way as conventional or accelerated whole-breast radiotherapy but to a smaller area. All 3 external-beam regimens can use 3-dimensional, conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT).

Intraoperative APBI is performed during breast-conserving surgery, when a single dose of radiation is delivered to the exposed tumor bed.

The authors reported 4-year outcomes, but fewer than 20% of participants had longer follow-up; other authors estimate that the median follow-up was about 2 years.

To appreciate the differences among radiotherapy techniques, it is useful to understand attributes of radiation delivery. The goals of cancer radiotherapy are usually to provide the tumor or tumor bed with a high dose of homogeneous radiation (e.g., all parts of the tumor cavity receive close to the targeted dose). Areas adjacent to the tumor may be treated with a lower dose of radiation (e.g., with whole-breast irradiation, to treat any unobserved cancerous lesions). Radiation outside the treatment area should be minimal or non-existent. The goal is to target the tumor or adjacent areas at risk of harboring unseen cancer with an optimum dose, while avoiding healthy tissues.

Brachytherapy Boost with Whole-Breast Irradiation

Brachytherapy can also be used as an alternative to external-beam radiation therapy to deliver boost radiation therapy combined with whole-breast external-beam radiation therapy. Most of the studies of local boost brachytherapy use temporarily implanted needles, wires, or seeds after patients recovered from surgery and completed whole-breast radiation therapy.

Regulatory Status

The various radiotherapy modalities presented in this report have been approved or cleared for marketing by the U.S. Food and Drug Administration (FDA) (for more details, see Appendix in TEC 2013 [3]). All brachytherapy devices have been approved through the 510(k) process and are either balloon brachytherapy or hybrid balloon-interstitial brachytherapy devices. One device can provide either intraoperative or intracavity treatments. The FDA has required a black box warning on each stating that “The safety and effectiveness of the … [device] as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.”


Following breast-conserving surgery for early stage breast cancer:

Accelerated whole breast irradiation may be considered medically necessary for patients who meet the following conditions:

  • invasive carcinoma of the breast. Exclude disease involving the margins of excision; tumors >5 cm in diameter; breast width >25 cm at posterior border of medial and lateral tangential beams.
  • negative lymph nodes
  • technically clear surgical margins

Accelerated whole-breast irradiation is considered investigational in all other situations.

Accelerated partial-breast irradiation (APBI), including interstitial APBI, balloon APBI, external beam APBI, and intra-operative APBI, is considered investigational.

Interstitial or balloon brachytherapy may be considered medically necessary for patients undergoing initial treatment for stage I or II breast cancer when used as local boost irradiation in patients who are also treated with breast-conserving surgery and whole-breast external-beam radiotherapy.

Policy Guidelines

There are CPT codes for placement of radiotherapy afterloading catheters:

19296: Placement of radiotherapy afterloading expandable catheter (single or multichannel) into the breast for interstitial radioelement application following partial mastectomy, includes imaging guidance; on date separate from partial mastectomy

19297: concurrent with partial mastectomy (List separately in addition to code for primary procedure)

19298: Placement of radiotherapy afterloading brachytherapy catheters (multiple tube and button type) into the breast for interstitial radioelement application following (at the time of or subsequent to) partial mastectomy, includes imaging guidance.

Specific CPT radiology codes exist for application of brachytherapy radiation sources (codes 77776-77787).

Effective July 1, 2007, there will be a CPT category III code specific to electronic brachytherapy:

0182T: High dose rate electronic brachytherapy, per fraction

Benefit Application

BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Therefore, FDA-approved devices may be assessed on the basis of their medical necessity.


This policy regarding accelerated breast irradiation following breast-conserving surgery (BCS) for early-stage breast cancer is based on a series of TEC Assessments, the latest of which was released in July 2010; an update will be released early in 2013. (3,8) This policy substantially revises and replaces MPRM Policy 08.01.13, Breast Brachytherapy after Breast-Conserving Surgery, as Boost with Whole-Breast Irradiation, or Alone as Accelerated Partial-Breast Irradiation. The use of brachytherapy as boost with whole-breast irradiation continues to be considered medically necessary and is not discussed further in this policy. A new radiotherapy regimen, accelerated whole-breast irradiation (AWBI) therapy, has been added to this policy. Intraoperative radiation therapy is also added to this policy.

Accelerated Whole-Breast Irradiation

Four randomized, controlled trials (RCTs) compared accelerated whole-breast radiotherapy to 5-week whole-breast radiotherapy, as well as a fifth, older, nonrandomized study. (9-14) Two of the studies are particularly useful, as they directly compare a 5-week to a 3-week regimen. They are both prospectively designed noninferiority trials. Both trials accepted a maximum loss of efficacy of 5 percentage points in local or local-regional recurrence in the accelerated group at 5 or 10 years (one-sided α=0.025 or 0.05). Although the studies differ in the specific fractionation schedules and patient characteristics, they report no difference in local recurrence rates (i.e., recurrence of the cancer in the same breast) across treatment arms.

One study from the United Kingdom includes women with grade 1–3 tumors. (10) Approximately 75% of the women have negative lymph nodes, and approximately 42% had a radiation boost to the tumor bed. Randomization was stratified for hospital, type of surgery (about 15% had a mastectomy), and plans for tumor bed boost. Systemic therapy, primarily tamoxifen, was used by some patients and appears to be fairly evenly distributed across treatment groups. The treatment arms compared a total dose of 40 Gy in 15 fractions over 3 weeks to 50 Gy in 25 fractions over 5 weeks. The hazard ratios for 40 Gy accelerated whole-breast radiotherapy versus conventional whole-breast radiotherapy were not statistically significant (using the log-rank test) for local or local-regional relapse. The absolute difference in local-regional relapse rates after 5 years was −0.7% (95% confidence interval [CI]: −1.7%, 0.9%). There were statistically significant differences in the two treatment regimens for distant relapse and overall survival (OS), with relapse more frequent and survival longer for the 40 Gy accelerated whole-breast irradiation (AWBI). This unexpected difference between treatment arms began to appear at about 1 year. The authors speculate that it could be due to chance and might change with longer follow-up. An article on patient-reported breast, arm, and shoulder symptoms, as well as body image, over 5 years of follow-up for both Standardisation of Breast Radiotherapy (START) trials was published in March 2010. (15) At 5 years’ follow-up, there is no evidence that providing radiotherapy in fewer, larger fractions increases these adverse events. The 6-year follow-up period on this trial is too short to reach firm conclusions; follow-up continues.

The second RCT from Canadian researchers compared AWBI versus whole-breast irradiation. (11,12) Of 2,429 eligible patients, 51% agreed to participate in the trial. Intention-to-treat (ITT) analysis was used. The 10-year local recurrence was 6.2% for the 42.5 Gy arm AWBI arm and 6.7% for the conventional 50 Gy whole-breast irradiation (absolute difference: −0.5%, 95% CI: −2.5%, 3.5%). Local recurrence rates with accelerated whole-breast radiotherapy were not worse than conventional whole-breast irradiation, when applying a noninferiority margin of 5%. In “exploratory” subgroup analyses, treatment effects were similar by age, tumor size, estrogen-receptor status, and chemotherapy use (48% had no systemic therapy). However, local recurrence at 10 years for patients with high-grade tumors was 4.7% for the conventional whole-breast irradiation arm and 15.6% for the 42.5 Gy AWBI arm. The absolute difference equals −10.9 percentage points (95% CI: −19.1, −2.8, test for interaction, p=0.01).

A Cochrane review on “Fraction Size in Radiation Treatment for Breast Conservation in Early Breast Cancer” (16) conducted a systematic review based on the 4 randomized, controlled trials described above. They concluded the following:

We have evidence from four low to medium quality randomised trials that using unconventional fractionation regimens (greater than 2 Gy per fraction) does not affect local recurrence, is associated with decreased acute toxicity and does not seem to affect breast appearance or late toxicity for selected women treated with breast conserving surgery.

The overall body of evidence on AWBI compared to conventional whole-breast irradiation suggests local recurrence rates with accelerated whole-breast radiotherapy were not worse than conventional whole-breast irradiation in patients meeting the criteria of the Canadian trial, when applying a noninferiority margin of 5%. Longer follow-up is needed for the United Kingdom trial.

Patient selection is key, and at this point, only patients similar to those in the Canadian trial should be considered for this therapy. Outcomes could vary in women with other disease characteristics. The patients in this trial all had invasive carcinoma of the breast with negative lymph nodes and surgical margins, and they did not have a radiotherapy boost to the tumor site. Exclusion criteria for the trial included “invasive disease or ductal carcinoma in situ involving the margins of excision, tumors that were larger than 5 cm in diameter, and a breast width of more than 25 cm at the posterior border of the medial and lateral tangential beams, which could increase the heterogeneity of the radiation dose to the breast.” In the trial, lymph node status was determined by axillary dissection, but recent reports suggest that sentinel lymph node biopsy is likely to be as effective. (e.g., see 17) Forty-one percent of the women took tamoxifen, despite the fact that 71% were estrogen-receptor positive.

Patients selecting this accelerated whole-breast radiotherapy should be told that while the current evidence on this radiotherapy regimen is strong, it is not as strong as that for conventional whole-breast irradiation. Additional RCTs or longer follow-up of the existing trials could uncover additional concerns. Some potential adverse events, such as cardiac ischemia, may take longer to become evident. This regimen has been widely used outside the U.S. without substantial reports of major adverse events. Potential patients should be carefully selected and given full information, while the results of longer follow-up for the START B trial are awaited.

Accelerated Partial-Breast Irradiation

There are 3 RCTs on interstitial, external-beam, or intraoperative accelerated partial-breast irradiation (APBI) compared to conventional whole-breast irradiation, as well as 7 nonrandomized comparative studies. (18-34) These studies evaluated interstitial, external, or intraoperative brachytherapy; no published comparative studies were found that assessed balloon brachytherapy. For the first, accrual was stopped before reaching the goal specified to evaluate differences in local recurrence, to allow patients to participate in another trial. (18-20) The randomization process was unclear, patients deemed “technically unsuitable” for interstitial brachytherapy were given external-beam APBI; and the patient characteristics and outcomes for each type of APBI were not reported separately. Finally, the sample size of 126 was relatively small, and longest follow-up reported was 66 months. Similar local and regional failure rates were found in the treatment arms.

The second RCT on APBI was reported in 1990 and 1993, and many changes in the care of breast cancer have occurred since. (21,22) The study was weakened by the fact that the initial groups were potentially unbalanced, and nodal status was based on clinical exam, among other factors. Recurrence was higher for the “limited field” treatment arm (analogous to partial-breast irradiation) than for the “wide field” arm (analogous to whole-breast irradiation), but some of the “excess” recurrences in the limited field arm were axillary. This may be accounted for by the fact that the axillary area was included in the wide field radiotherapy but not in the limited field; and the initial work-up for nodal involvement was limited. The follow-up was 65 months; and the sample size, 708.

The third randomized trial compared intraoperative to external-beam accelerated partial-breast irradiation. (23) It is a noninferiority trial with 28 centers in 9 countries and a sample size of 2,232. An ITT approach was used; 89% of the intraoperative group and 92% of the external radiotherapy group completed treatment. Patients were not blinded to treatment choice. As anticipated in advance, 14% of those in the intraoperative arm received external-beam radiotherapy as well, because of unfavorable pathologic features determined after surgery, e.g., lobular carcinoma. The pre-defined noninferiority margin was an absolute difference of 2.5% between groups for pathologically confirmed, ipsilateral local recurrence. After 4 years, wound seroma needing more than 3 aspirations was significantly more common in the intraoperative group than in the external radiotherapy group (2.1% vs. 0.8%,respectively; p=0.012). Conversely, Radiation Therapy Oncology Group (RTOG) toxicity grade of 3 or 4 was more common in the external radiotherapy group than in the intraoperative group (2.1% vs. 0.5%, respectively; p=0.002). The 4-year local recurrence rates in the ipsilateral breast were 1.20% (95% CI: 0.53%, 2.71%) in the intraoperative radiotherapy arm vs. 0.95% (95% CI: 0.39%, 2.31%) in the external radiotherapy arm (difference between groups=0.25%, 95% CI: -1.04%, 1.54%; log-rank test, p=0.41). Local recurrence rates after 4 years with intraoperative radiotherapy were not worse than with external irradiation, when applying a noninferiority margin of 2.5%. Fortunately for the patients, the recurrence rates are low: 6 in the intraoperative group versus 5 in the external radiotherapy group. But these small numbers make it more difficult to detect real differences between arms, if they exist. Also, while the results are interesting, the follow-up of 4 years is insufficient to reach a conclusion on the comparative benefits and adverse events of these 2 treatments.

A number of reviews and editorials discussed the preliminary results of the TARGIT-A trial. (35-38) While recognizing the potential benefits of intraoperative radiotherapy, including convenience, “excellent delineation of the tumour bed under visual control, very good dose homogeneity, and high sparing of normal tissue”, (35) a number of concerns have been expressed. They include the following:

  • If intraoperative radiation therapy (IORT) is performed during the surgery to excise the tumor, the definitive pathology is not available when the radiotherapy is performed. Therefore, a subset of patients must also undergo whole-breast external-beam radiotherapy following surgery. The article reports that 14% of patients in the IORT arm also received whole-breast external-beam radiotherapy. When only those who received IORT during initial surgery are considered, 21% received whole-breast external-beam radiotherapy. There are limited data suggesting that breast symptoms and pain following treatment may be greater for patients receiving both IORT and whole-breast external radiotherapy compared with IORT alone and that patients’ satisfaction is greater for whole-breast external radiotherapy or IORT alone compared to the combined treatment. (39) Therefore, IORT may result in harm for a subset of patients who receive both IORT and whole-breast external radiotherapy.
  • Whether the radiation dose and type is actually equivalent to the standard radiation therapy regimen. Of particular concern is the rapid drop in dose with distance from the applicator and whether any residual disease will eradiated. Some argue that the TARGIT-A trial alleviates this concern, while others do not.
  • The length of follow-up is insufficient to determine long-term toxicity and efficacy, particularly since only 19% of the participants in the TARGIT-A trial completed 4 years of follow-up. The median follow-up is not reported but appears to be around 2 years.

While the Intrabeam device is subject to U.S. Food and Drug Administration (FDA) regulation, it does not fall under the regulatory purview of the U.S. Nuclear Regulatory Commission. In some states, the participation of radiation oncologists in delivering radiation is not required. There is another form of intraoperative radiotherapy using electrons, called ELIOT. (40) An RCT has completed accrual, and initial results are awaited. Other IORT modalities are also being researched, e.g., using the Xoft® Axxent® eBx™ system (NCT01644669; see online site

The other 8 nonrandomized, comparative studies were all flawed, due to potential baseline differences in treatment groups, lack of multivariable analyses to account for them, inclusion of patients who did not meet eligibility criteria, variations in treatment within arms, and generally small sample sizes and insufficient follow-up. (24-34)

Smith et al. (2012) analyzed Medicare data on 92,735 women, 67 years or older diagnosed with breast cancer between 2003 and 2007 who underwent lumpectomy followed by radiation therapy. (41) The mean age was 74.8 years (standard deviation [SD]=5.5). They found that the use of brachytherapy rose from 3.5% in 2003-2004 to 12.5% in 2007 (p<0.001 for trend). Brachytherapy patients were more likely to undergo a subsequent mastectomy than matched whole-breast irradiation (WBI) patients, even after adjusting for imbalanced covariates (hazard ratio [HR]: 1.87; 95% CI: 1.36, 2.58; p<0.001). This finding held true when all WBI patients were compared to all brachytherapy patients using multivariable analysis (HR: 2.19; 95% CI: 1.84, 2.61; p<0.001). Variables in the multivariable analysis significantly associated with subsequent mastectomy besides brachytherapy included age 75-79 (p=0.01), axillary lymph node involvement (p=0.004), and living in the South (p=0.005). The cause of the mastectomies, e.g., recurrence or treatment complications, could not be determined from the claims data. Breast brachytherapy was also associated with a higher risk of postoperative complications, both infectious and noninfectious (27.56% [95% CI: 26.51%, 28.63%] vs. 16.92% for WBI patients [95% CI: 16.67%, 17.18%]; p<0.001).

Overall, the body of evidence on interstitial APBI compared to conventional whole-breast irradiation is weak; and it is extremely weak (i.e., no comparative studies) for balloon brachytherapy and external-beam APBI. The strongest published evidence is on intraoperative radiotherapy, but the follow-up is insufficient at this time. Furthermore, it is becoming increasingly clear that each type of APBI should be judged on its own merits, and studies comparing different APBI techniques to each other, as well as to whole-breast irradiation, are needed. Fortunately, a number of large RCTs are underway.

Given the current level of evidence, it is important for patients to be aware of the uncertainty regarding the outcomes of this approach. This information should include failure rates for the specific devices (e.g., explantation for Mammosite, incomplete expansion of the catheters for some of the hybrid devices), as well as the uncertainty regarding their comparative effectiveness. The intermediate alternative provided by AWBI should also be presented to women who meet the criteria for the Canadian trial, as well as the critical importance of completing radiotherapy for the majority of patients undergoing BCS.

A large, multicenter RCT of APBI versus whole-breast irradiation was initiated in 2005 to compare APBI to whole-breast irradiation. It is led by the National Surgical Adjuvant Breast and Bowel Project and the Radiation Therapy Oncology Group and referred to as NSABP B-39/RTOG 0413 (available online at: Patients are randomized to whole-breast irradiation (total dose: 60-66.6 Gy) or APBI (total dose: 34-38.5 Gy). Within the APBI group, the participant’s physician may choose whether to use interstitial brachytherapy, Mammosite balloon brachytherapy, or external-beam radiotherapy using 3-dimensional, conformal radiation therapy (3D-CRT). The initial target sample size of 3,000 was increased to 4,300 in 2007. The accrual targets for the women with a lower risk of recurrence were met by the end of 2006; only women in the higher risk groups are still being recruited. As of May 16, 2012, 4,217 patients had been accrued. The estimated completion date is June 1, 2015.There are another 6 RCTs on the use of APBI versus whole-breast irradiation underway, as well as 2 trials comparing 2 forms of APBI (available online at:; see Appendix I). There is also a study on using ABI as a boost with whole-breast irradiation and 3 randomized trials comparing standard whole-breast irradiation and AWBI. It appears that the first randomized trial that compares recurrence for APBI and whole-breast irradiation will be completed in November 2014. The study is being conducted by the University of Erlangen-Nurnberg Medical School and has 1,300 participants.

In a review of the APBI trials currently underway, Mannino and Yarnold (note Yarnold is a lead author on the START A and B trials) raise several concerns regarding variations across the trials. (42) The extent of the initial BCS can vary substantially across studies, as well as the definition of the targeted tumor cavity. A larger margin is usually drawn around the tumor cavity for 3D-CRT, for example, because of the need to allow for variations in set-up and respiration motion. Studies of APBI usually distinguish between “same site relapse,” i.e., close to the irradiated area and “elsewhere relapse,” yet it is unclear whether what constitutes the same site varies across studies. The percentage of relapses occurring “elsewhere” in the ipsilateral breast in studies of whole-breast radiotherapy following BCS range from 18% to 42% (these studies may include some patients at higher risk of recurrence). Proponents of APBI have sometimes asserted that “elsewhere” tumors are rare, that they are mostly new primary tumors (rather than a recurrence), or that earlier studies have shown that radiotherapy is not effective on these tumors in any case. Mannino and Yarnold challenge each of these points in turn, although they also conclude that the results of the trials currently underway will provide level-1 evidence for or against APBI.

Use as Local Boost Radiotherapy

This section is based on a 1996 TEC Assessment that concluded net health outcomes after brachytherapy for local boost were equivalent to outcomes after external-beam radiation therapy for local boost in women given BCS plus whole-breast radiation therapy as initial treatment for stage I or stage II breast cancer. In 7 nonrandomized comparisons (total N=2,022), the rate of local control at 5 years after treatment was 88–98% for those given brachytherapy for local boost, compared to 91–99% for those given external-beam radiation therapy.

Clinical Input Received through Physician Specialty Societies and Academic Medical Centers

In response to requests, input was received from 1 physician specialty society and 4 academic medical centers while this policy was under review in 2011. While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. There was near-unanimous support for the policy statement regarding accelerated whole-breast irradiation (AWBI). The input was mixed regarding accelerated partial-breast irradiation (APBI); those agreeing with the conclusion noted the need to define the risks and benefits of this approach in patient subgroups and noted that current data are inconclusive concerning the effectiveness of APBI compared to whole-breast irradiation.


The overall body of evidence on accelerated whole-breast irradiation (AWBI) compared to conventional whole-breast irradiation suggests local recurrence rates with accelerated whole-breast radiotherapy were not worse than conventional whole-breast irradiation in patients meeting the criteria of the Canadian trial, when applying a noninferiority margin of 5%. Patient selection is important, and at this point, only patients similar to those in the Canadian trial should be considered for this therapy. Thus, accelerated whole-breast irradiation may be considered medically necessary for these patients with clinical characteristics noted in the medically necessary policy statement. Outcomes could vary in women with other disease characteristics.

For patients treated with whole-breast external-beam radiation and breast-conserving surgery, local boost irradiation via interstitial or balloon brachytherapy is likely to result in equivalent outcomes compared to local boost given by external beam. This is based on results on nonrandomized, comparative studies, a TEC Assessment, and specialty society guidelines. As a result, interstitial or balloon brachytherapy may be considered medically necessary for these patients when used as local boost irradiation.

Overall, the body of evidence on interstitial APBI compared to conventional whole-breast irradiation is weak; and it is extremely weak (i.e., no comparative studies) for balloon brachytherapy and external-beam APBI. The strongest published evidence is on intraoperative radiotherapy, but the follow-up is insufficient at this time. Furthermore, it is becoming increasingly clear that each type of APBI should be judged on its own merits, and studies comparing different APBI techniques to each other, as well as to whole-breast irradiation are needed. Thus, these techniques are considered investigational. Fortunately, a number of large randomized, controlled trials are underway to provide additional data.

Practice Guidelines and Position Statements

According to the National Comprehensive Cancer Network (NCCN) guidelines, (2) “Preliminary studies of APBI suggest rates of local control in selected patients with early stage breast cancer may be comparable to those treated with standard whole breast RT [radiotherapy]. Follow-up, however, is limited and studies are on-going. Patients are encouraged to participate in clinical trials. If not trial eligible, per the consensus statement from the American Society for Radiation Oncology (ASTRO), patients who may be suitable are….” (see below). For whole-breast radiotherapy, NCCN recommends either a conventional whole-breast irradiation regimen or a total dose of 42.5 Gy with 2.66 Gy per fraction, which equals 16 fractions. Although the NCCN guidelines do not specify the duration of treatment, the latter is presumably an accelerated whole-breast irradiation regimen. A boost to the tumor bed is recommended for higher risk whole-breast radiotherapy patients, i.e., those who are younger than 50-years-old and have positive axillary nodes, lymphovascular invasion, or close margins.

The American Society of Breast Surgeons and the American Society for Radiation Oncology (ASTRO) have issued guidelines for the selection of patients for APBI, which are summarized in Table 2. (43) According to the authors, the impetus for this guideline was the increased use of APBI outside of clinical trials, even as the results of those trials are awaited. The authors cite estimates that more than 32,000 women have already been treated with the MammoSite,® a mechanism for delivering APBI. The statement says that the guidelines are based on the results of a systematic review, which is not described in much detail, and expert opinion.

Table 2. Professional medical society criteria for performing APBI





ASTRO Criteria: “Suitable”


ASTRO Criteria: “Cautionary”


ASTRO Criteria: “Unsuitable”


Criteria for APBI from American Society of Breast Surgeons


Patient factors

Age   >60 y   50-59 y   <50 y   >45 y  
BRCA1/2 mutation   Not present     Present    

Pathologic factors

Tumor size   <2 cm   2.1-3.0 cm   >3 cm   <3 cm  
T stage   T1   T0 or T2   T3-4    
Margins   Negative >2 mm   Close (<2 mm)   Positive   Microscopically negative  
Grade   Any        
LVSI   No   Limited/focal   Extensive    
ER status   Positive   Negative*      
Multicentricity   Unicentric     Present    
Multifocality   Clinically unifocal, total size <2.0 cm   Clinically unifocal, total size: 2.1-3.0 cm   Clinically multifocal or microscopically multifocal, total size >3 cm    
Histology   Invasive ductal or other favorable subtypes   Invasive lobular     Invasive ductal carcinoma or DCIS  
Pure DCIS   Not allowed   <3 cm   >3 cm   <3 cm  
EIC   Not allowed   <3 cm   >3 cm    
Associated LCIS   Allowed        

Nodal factors

N stage   pN0 (i, i+)     pN1, pN2, pN3  

SN pN0

Nodal surgery   SN Bx, ALND     None performed  
Treatment factors  Neoadjuvant therapy   Not allowed     If used    

Gray shading=not reported

*Strongly encouraged to enroll in NSABP B-39/RTOG 04-13 trial.

Key: DCIS, ductal carcinoma in situ; EIC, extensive intraductal component; ER status, estrogen receptor status; LCIS, lobular carcinoma in situ; LVSI, lymphovascular space invasion; N stage, nodal stage; T stage, tumor stage.

Sources: 43-45

Several studies have tried to assess the validity of these recommendations by comparing recurrence rates retrospectively for patients that meet the criteria for one or more of these categories. Beitsch et al. used data from the American Society of Breast Surgeons MammoSite® Registry. (46) The database does not contain data on all of the elements in the recommendations (multifocality, multicentrality, presence of lymph-vascular space invasion, histology of invasive cancer, BRCA 1 or 2 mutation, and type of nodal surgery performed). Of the total of 1,449 patients in the Registry study, 1,025 (70.7%) could be grouped into the Consensus Statement categories. Of these, 176 fell in the unsuitable category (73.9% were younger than 50-years-old; 21.6% had positive nodes; 10.2% had more than 2 characteristics that put them in this category; 7.4% had positive margins; 5.1% had extensive intraductal component greater than 3 cm; and 3.4% had tumors greater than 3 cm). The 5-year actuarial rate of ipsilateral breast tumor recurrence was 5.25% in this group (7 patients; 2 at lumpectomy site and 5 elsewhere); 4.04% in the suitable or cautionary categories (24 of 849 patients; 8 recurrences at the lumpectomy site and 16 elsewhere). This difference was not statistically significant (p=0.3223). There were no other statistically significant differences between these 2 groups for any of the other outcomes reported either: regional nodal failure, distant metastases, disease-free survival, cause-specific survival, and overall survival. Another study that appears to be using the data on the same patients but was able to assign them to all 3 consensus statement categories (suitable, cautionary, and unsuitable) reached similar conclusions. (47) A third study compared 199 patients at a single institution who underwent APBI with 199 matched controls who received whole-breast irradiation. (48) When each group was stratified into the 3 categories in the ASTRO consensus statement, there was no statistically significant difference in the 10-year, ipsilateral breast recurrence rates across categories. There did appear to be a statistically significant difference across the categories for the patients treated with APBI, with no patients in the suitable group having distant metastases at 10 years versus 7.1% of the cautionary group and 11.2% of the unsuitable group (p=0.018); this statistically significant trend was not repeated in the patients receiving whole-breast irradiation. Similarly, a statistically significant difference in regional nodal failure at 10 years was evident among all patients (0% for the suitable group; 0.7% for the cautionary group; and 4.0% for the unsuitable group); but not for either the APBI or whole-breast irradiation group. The authors state that little evidence was available for the consensus panel in deciding which patients were not suitable and called for further research. The generalizability of the findings is open to question, however, because of the small number of events upon which these calculations are based, as well as missing data elements in the MammoSite® registry that are included in the consensus statement categorization. One researcher was an author on all three articles.

ASTRO released guidelines on fractionation for whole-breast irradiation in 2010. (49) They rely on the Canadian trial (11,12), START A (14) and START B, (10) and the Owen/Yarnold trial (9,13). They conclude that “Data are sufficient to support the use of HF-WBI [hypofractionated or accelerated, whole breast irradiation] for patients with early breast cancer who meet all of the aforementioned criteria,” including aged 50 years or older, disease Stage pT1-2 pN0, no chemotherapy, and treatment with radiation dose homogeneity within + 7% in the central axis plane. The task force did not agree on whether it is recommended to use HF-WBI when receiving a tumor boost.

Medicare National Coverage

There is no national coverage determination.



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CPT  19296  Placement of radiotherapy afterloading catheter (single or multichannel)  into the breast for interstitial radioelement application following partial mastectomy, includes imaging guidance; on date separate from partial mastectomy
  19297  Concurrent with partial mastectomy (List separately in addition to code for primary procedure) (new 1/1/05) 
  19298  Placement of radiotherapy afterloading brachytherapy catheters (multiple tube and butt on type) into the breast for interstitial radioelement application following (at the time or subsequent to) partial mastectomy, includes imaging guidance (new 1/1/05) 
  77261, 77262, 77263  Therapeutic radiology treatment planning code range 
  77280, 77285, 77290, 77295  Therapeutic radiology simulation-aided field-setting code range 
  77326  Brachytherapy isodose calculation; simple (calculation made from single plane, 1 to 4 sources/ribbon application, remote afterloading brachytherapy, 1 to 8 sources) 
  77327  Intermediate (multiplane dosage calculations, application involving 5 to 10 sources/ribbons, remote afterloading brachytherapy, 9 to 12 sources) 
  77328  Complex (multiplane isodose plan, volume implant calculations, over 10 sources/ribbons used, special spatial reconstruction, remote afterloading brachytherapy, over 12 sources) 
  77776, 77777, 77778  Interstitial radioelement application code range 
  0182T High dose rate electronic brachytherapy, per fraction (effective July 1, 2007)
ICD-9 Procedure  85.0  Mastotomy 
  92.27  Implantation/insertion of radioactive elements 
ICD-9 Diagnosis  174.0–174.9  Primary malignant neoplasm of breast, female 
  175.0–175.9  Primary malignant neoplasm of breast, male 
  198.81  Secondary malignant neoplasm of breast (male/female) 
HCPCS C1717 Brachytherapy source, high dose rate iridium 192, per source
  C9726 Placement and removal (if performed) or applicator into breast for radiation therapy
  Q3001  Radioelements for brachytherapy, any type, each
ICD-10-CM (effective 10/1/14) C50.011-C50.929 Malignant neoplasm male and female breast code range
   C79.81 Secondary malignant neoplasm of breast
ICD-10-PCS (effective 10/1/14)   ICD-10-PCS codes are only used for inpatient services.There is no specific ICD-10-PCS code for this procedure.
    DM1097Z, DM1098Z, DM1099Z, DM109BZ, DM109CZ, DM109YZ, DM10B7Z, DM10B8Z, DM10B9Z, DM10BBZ, DM10BCZ, DM10BYZ, DM1197Z, DM1198Z, DM1199Z, DM119BZ, DM119CZ, DM119YZ,
Radiation oncology, breast, brachytherapy, code by body part (right or left), modality qualifier (high dose rate or low dose rate), and isotope (Cesium 137, Iridium 192, Iodine 125, Palladium 103, Californium 252, or other isotope)
    0HHT01Z, 0HHT31Z, 0HHT71Z, 0HHT81Z, 0HHTX1Z, 0HHU01Z, 0HHU31Z, 0HHU71Z, 0HHU81Z, 0HHUX1Z, 0HHV01Z, 0HHV31Z, 0HHV71Z, 0HHV81Z, 0HHVX1Z Surgical, skin & breast, insertion, radioactive element, code by body part (right, left or bilateral), and approach (open, percutaneous, via natural or artificial opening, via natural or artificial opening endoscopic, or external)
   0HCT0ZZ, 0HCT3ZZ, 0HCU0ZZ, 0HCU3ZZ, 0HCV0ZZ, 0HCV3ZZ Surgical, skin & breast, extirpation, breast, code by body part (right, left or bilateral) and approach (open or percutaneous)
Type of Service  Radiotherapy 
Place of Service  Inpatient 



Breast Brachytherapy
Brachytherapy, Breast

Partial Breast Brachytherapy
Intraoperative Radiotherapy

Policy History
Date Action Reason
7/31/96 Add to Therapy section New policy
5/15/02 Replace policy Policy updated but unchanged; rationale added to source section
12/18/02 Replace policy Policy updated to include conclusions of 2002 TEC Assessment; policy statement unchanged
11/9/04 Replace policy Policy updated; new references added; no change to policy statement
12/14/05 Replace policy Policy updated; new references added; no change to policy statement. Reference numbers 10–21 added
04/25/06 Replace policy Added updated NCCN statement and one reference. No change to policy statement
10/10/06 Replace policy Policy updated with literature search; new references added (new 13-24). No change to policy statement.
05/08/08 Replace policy Policy updated with literature search; reference citations from the 2007 update corrected and references 30, 35, and 40-48 added. No change to policy statement
4/14/11 Replace policy Policy updated with literature review and TEC Assessment; clinical input reviewed; policy extensively edited; new references added. Title changed to “Accelerated Breast Irradiation after Breast-Conserving Surgery for Early Stage Breast Cancer and Breast Brachytherapy as Boost with Whole-Breast Irradiation” (from Brachytherapy-Accelerated Partial Breast Irradiation); accelerated whole breast irradiation may be considered medically necessary in specific situations; accelerated partial breast irradiation (APBI), including intraoperative APBI, remains investigational.
12/13/12 Replace Policy Policy updated with literature review. References 1, 16, 28-30, 35-41 added. Policy statement on criteria for accelerated whole breast radiation changed from “negative surgical margins” to “technically clear surgical margins”; no change to intent of policy statement.