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CPT 19294 Intraoperative radiation therapy (IORT) concurrent with partial mastectomyLast reviewed at VbBS in November 2017. Minutes indicate that the staff recommendation was accepted without significant discussion. HERC approved the recommendations without change. Intraoperative radiation therapy for breast cancerCode: 19294 Preparation of tumor cavity, with placement of a radiation therapy applicator for intraoperative radiation therapy (IORT) concurrent with partial mastectomy (List separately in addition to code for primary procedure)Code placement: breast cancer and partial mastectomy CPT codes are on line 191 Cancer of breast; at high risk of breast cancerNCCN 2017: does not include IORT in their guidelines for treatment of breast cancerEvidence:Esposito 2015, review of TARGIT-A and ELIOT trialsTARGIT-A: 3451 patients, RCT of IORT vs post-operative whole breast irradiation (EBRT)ELIOT: 1305 patients, RCT of IORT vs EBRTResults: The TARGIT-A and ELIOT trials have demonstrated that IORT is associated with a low rate of local recurrence, although higher than that after EBRT (TARGIT-A: 3.3 versus 1.3 per cent respectively, P = 0.042; ELIOT: 4.4 versus 0.4 per cent, P < 0.001). However, the local recurrence rate for IORT fell within the predefined 2.5 per cent non-inferiority margin in TARGIT-A, and the 7.5 per cent equivalence margin in ELIOT. Conclusion: Longer follow-up data from existing trials, optimization of patient criteria and cost-effectiveness analyses are needed. Based on the current evidence, IORT can be offered as an alternative to EBRT to selected patients within agreed protocols, and outcomes should be monitored within national registries.Picot 2015, health technology assessment and economic review of IORT for breast cancerN=1 RCT (Targit-A trial)The review found that local recurrence was slightly higher following INTRABEAM IORT than whole-breast external beam radiotherapy (WB-EBRT), but the difference did not exceed the 2.5% non-inferiority margin providing INTRABEAM was given at the same time as breast conserving surgery (BCS). Overall survival was similar with both treatments.Statistically significant differences in complications were found for the occurrence of wound seroma requiring more than three aspirations (more frequent in the INTRABEAM group) and for a Radiation Therapy Oncology Group toxicity score of grade 3 or 4 (less frequent in the INTRABEAM group).Cost-effectiveness base-case analysis indicates that INTRABEAM is less expensive but also less effective than WB-EBRT because it is associated with lower total costs but fewer total quality-adjusted life-years gained. However, sensitivity analyses identified four model parameters that can cause a switch in the treatment option that is considered cost-effective.Conclusions and implications: A significant investment in INTRABEAM equipment and staff training (clinical and non-clinical) would be required to make this technology available across the NHS. Longer-term follow-up data from the TARGIT-A trial and analysis of registry data are required as results are currently based on a small number of events and economic modelling results are uncertainOther policies:Aetna: considers IORT for breast cancer experimentalCigna 2016: considers IORT for breast cancer experimentalAnthem 2017:External beam intraoperative partial breast irradiation (electron or low-energy x-ray radiotherapy) is considered medically necessary as an alternative to whole breast irradiation in the treatment of early stage breast cancer when all of the following criteria are met: Individual is 50 years of age or older; andClinically node negative on either preoperative physical examination (that is, non-palpable node[s]), or medical imaging if performed (for example, mammography, magnetic resonance imaging [MRI], or ultrasound); andTumor is either: Invasive ductal carcinoma measuring less than or equal to 2 centimeters (T1 disease) with negative margin widths of greater than or equal to 2 millimeters, no lymphovascular space invasion, estrogen-receptor positive (ER+), and BRCA negative; orLow or intermediate nuclear grade, screen-detected ductal carcinoma in situ measuring less than or equal to 2.5 centimeters with negative margin widths of greater than or equal to 3 millimeters.Expert input: Dr. Jeannie Louie, Providence oncologyI find the data for breast intra-operative radiation treatments (IORT) not very straightforward as some of the patients in the trials received external beam radiation treatments as well as IORT. The main data supporting IORT comes from the TARGIT-A randomized trial which was updated in a report in Lancet 2014. Although the title of the paper states that five year results are available, the median follow-up time is significantly less for most of the patients enrolled – 3,451 patients had a median follow-up of 29 months, 2,020 with a follow-up of 4 years and 1,222 with a follow-up of five years.? The total number of patients was 3,451.? Local recurrence was higher in the IORT group – 3.3% versus 1.3% which was significant.? Local recurrence rates were higher when IORT was delivered after lumpectomy (reopening the wound) as compared to IORT delivery at the time of lumpectomy.? About 15% of patients required external beam radiation when adverse pathologic factors were identified at the time of lumpectomy.? Surprisingly, the 5 year rate of ipsilateral breast recurrence in the post-pathology stratum (well-selected, favorable patients treated with IORT alone) was higher than in the pre-pathology stratum, in which about 15-20% of patients received whole breast radiation.? The absolute excess in local failure was 3.7% in the post-pathology stratum and 1% for patients in the pre-pathology stratum as compared to standard whole breast radiation therapy.? This suggests that the?TARGIT?dose (20Gy at the surface of the applicator – with 50 keV x-rays this is about 5Gy at 1cm from the surface of the applicator) is perhaps too low to be efficacious without whole breast radiation, even in low risk patients. I know OHSU has used this. But I would only use in a clinical trial setting.HERC staff summary: IORT for breast cancer has been studied in two trials to date, with follow up less than the usual time to recurrence for these types of cancers. This treatment appears promising, but still experimental. It is not included in the NCCN breast cancer therapy guidelines, nor covered by most major insurers, nor recommended by experts.HERC staff recommendation:Add 19294 Preparation of tumor cavity, with placement of a radiation therapy applicator for intraoperative radiation therapy (IORT) concurrent with partial mastectomy (List separately in addition to code for primary procedure) to line 660 CONDITIONS FOR WHICH CERTAIN TREATMENTS HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS; unproven treatments with an entry for GN173 as shown belowGUIDELINE NOTE 173, TREATMENTS THAT HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONS; unproven treatmentsThe following treatments are prioritized on Line 660, CONDITIONS FOR WHICH CERTAIN TREATMENTS HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS; unproven treatments for the conditions listed here:CPT/HCPCS codeINTERVENTIONRationaleDate of last Review19294Intraoperative radiation therapy (IORT) concurrent with partial mastectomy Unproven treatmentNovember, 2017 ................
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