Original Title: Eficacia, efectividad y seguridad de la radioterapia intraoperatoria en carcinoma de mama

Authors' objectives: - To evaluate the effectiveness of the IOR in the treatment of breast cancer in terms of recurrence, survival, cosmetic results, patient satisfaction and impact on their quality of life. - To compare the safety of IOR versus standard radiotherapy treatment in terms of toxicity. - To define which subgroups of women with breast cancer may benefit more from treatment with IOR.

Authors' results and conclusions: In the conservative management of early breast cancer, if the adjuvant therapeutic option is radiotherapy, the standard option is the application of EBRT. The IOR is presented as an alternative to the substitution of EBRT in women with breast cancer in early stages and at low risk of recurrence (women with tumors of 2 cm or less, less than 4 positive lymph nodes, differentiated tumors, positive estrogen receptor and triple positive breast tumor). In women with breast cancer in the early stages, 5 years after the intervention, the rate of ipsilateral recurrence of the IOR is higher, being statistically significant from the analyzes of the individual studies, and not significant when meta-analyzing the data. From a non-inferiority perspective, the IOR is equivalent to the EBRT. In women with the same characteristics, when comparing IOR with EBRT, no statistically significant differences were observed in terms of mortality or appearance of metastasis. The occurrence of adverse events on the skin of the breast are more frequent with the use of EBRT, without differences being found in the appearance of fibrosis, breast retraction, pain or burning sensation. The appearance of fat necrosis and hematomas-seromas that require drainage is most frequently associated with the use of IOR. Both the women and the health professionals surveyed on their preference for the IOR versus the EBRT, assuming a risk of local recurrence somewhat greater with IOR and without seeing the overall survival modified, mostly opted for IOR. Between 8.6% of women and 3.3% of health professionals, they would never opt for IOR. The cosmetic results may be overestimated essentially because they are informed by the health professionals themselves. The quality of life is not affected after the application of one or another technique, except for the clinical differences in favor of the IOR during the first year, after which they are equal to the results obtained with EBRT. Both function and sexual satisfaction show better results after IOR during the first 4 to 5 years of follow-up. The centers that currently offer the RIO, must do it under institutional protocols, and ensure the active participation of women in decision making after being informed of the risk of recurrences, safety of the technique, advantages and limitations, cosmetic results and previous experiences of women on perceived quality of life. This information can be provided by relying on information resources that include graphic tools. Health professionals involved in the application of the technique should follow the radiological protection measures that include the use of leaded aprons in the operating room and maintain the maximum possible distance to the radiation source. Economic models should be developed that take into account the costs associated with the management of recurrences after the use of the IOR, the toxicity and the additional cost associated with previously undetected positive lymph nodes.

Authors' methods: Various databases specialized in systematic reviews, general databases, ongoing research projects and web pages of Health Technology Assessment Agencies and INAHTA were consulted. The studies by title and abstract were selected for reading in full text. After reading the full text, those that fulfilled the inclusion criteria were included, and those excluded and reasons that justified it were listed. Among the inclusion criteria, the design of the studies, sample size, characteristics of the patients, type of intervention, follow-up and measurement of results (ipsilateral recurrence of the disease, appearance of metastasis and mortality) were contemplated. The GRADE system was used to analyze the effectiveness of the IOR, taking into account the limitations in the design of the studies, inconsistency between the results, existence of direct or indirect evidence, imprecision of the estimators of effect and possible publication bias. The quality of the studies analyzed for the effectiveness of the IOR was evaluated through the critical reading tool developed by Osteba. For the remaining questions, given the low quality of the studies identified, their clinical and methodological heterogeneity, the GRADE system was not used.

Project Status: Completed

Year Published: 2019

URL for published report: http://www.iacs.es/wp-content/uploads/2019/10/06_IACS_2016_RIO_Cancer-de-mama_DEF_NIPO.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Health Sciences Institute in Aragon (IACS)

Contact Address: Avda, San Juan Bosco, 13, planta 2

Contact Name: María Pilar Calvo Pérez

Contact Email: direccion.iacs@aragon.es