Intraoperative Radiation Therapy: A Critical Analysis of the ELIOT and TARGIT Trials. Part 2—TARGIT

Annals of Surgical Oncology, Aug 2014

Background Two randomized intraoperative radiation therapy trials for early-stage breast cancer were recently published. The ELIOT Trial used electrons (IOERT), and the TARGIT-A Trial Update used 50-kV X-rays (IORT). These studies were compared for similarities and differences. The results were analyzed and used to determine which patients might be suitable for single-dose treatment. Methods The primary sources of data were the ELIOT Trial and TARGIT-A Trial, as well as a comprehensive analysis of the peer-reviewed literature of accelerated partial breast irradiation (APBI) using 50-kV X-rays or electrons. Studies published or presented prior to March 2014 were analyzed for efficacy, patient restrictions, complications, and outcome. Results With a median follow-up of 5.8 years, the 5-year recurrence rates for ELIOT versus EBRT patients were 4.4 and 0.4 %, respectively, p = 0.0001. A low-risk ELIOT group was identified with a 5-year recurrence rate of 1.5 %. With a median follow-up of 29 months, the 5-year recurrence rates for the TARGIT-A versus EBRT patients were 3.3 and 1.3 %, respectively, p = 0.042. Conclusions With 5.8 years of median follow-up, IOERT appears to have a subset of low risk women for whom IOERT is acceptable. With 29 months of median follow-up the results of IORT with 50-kV devices are promising, but longer follow-up data are required. At the current time, single-fraction IOERT or IORT patients should be treated under strict institutional protocols.

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Intraoperative Radiation Therapy: A Critical Analysis of the ELIOT and TARGIT Trials. Part 2—TARGIT

Melvin J. Silverstein 1 2 Gerd Fastner 0 Sergio Maluta 6 Roland Reitsamer 5 Donald A. Goer 4 Frank Vicini 3 David Wazer 7 8 M. J. Silverstein e-mail: melsilver 7 @gmail.com 0 Radiotherapy and Radio-Oncology Landeskrankenhaus, Paracelsus Medical University , Salzburg, Austria 1 Department of Surgery, Keck School of Medicine, University of Southern California , Los Angeles, CA 2 Breast Center, Hoag Memorial Hospital Presbyterian , Newport Beach, CA 3 Radiation Oncology , St. Joseph Mercy Oakland, Pontiac, MI 4 Physics, IntraOp Medical , Sunnyvale, CA 5 Department of Senology, Paracelsus Medical University Salzburg , Salzburg, Austria 6 Radiation Oncology, Oncological Hyperthermia UnitMedical Center , Verona, Italy 7 Radiation Oncology, Albert Medical School of Brown University , Providence, RI 8 Radiation Oncology, Tufts University School of Medicine , Boston, MA Background. Two randomized intraoperative radiation therapy trials for early-stage breast cancer were recently published. The ELIOT Trial used electrons (IOERT), and the TARGIT-A Trial Update used 50-kV X-rays (IORT). These studies were compared for similarities and differences. The results were analyzed and used to determine which patients might be suitable for single-dose treatment. Methods. The primary sources of data were the ELIOT Trial and TARGIT-A Trial, as well as a comprehensive analysis of the peer-reviewed literature of accelerated partial breast irradiation (APBI) using 50-kV X-rays or electrons. Studies published or presented prior to March 2014 were analyzed for efficacy, patient restrictions, complications, and outcome. Results. With a median follow-up of 5.8 years, the 5-year recurrence rates for ELIOT versus EBRT patients were 4.4 and 0.4 %, respectively, p = 0.0001. A low-risk ELIOT group was identified with a 5-year recurrence rate of 1.5 %. With a median follow-up of 29 months, the 5-year recurrence rates for the TARGIT-A versus EBRT patients were 3.3 and 1.3 %, respectively, p = 0.042. Conclusions. With 5.8 years of median follow-up, IOERT appears to have a subset of low risk women for whom IOERT is acceptable. With 29 months of median follow-up the results of IORT with 50-kV devices are promising, but longer follow-up data are required. At the current time, single-fraction IOERT or IORT patients should be treated under strict institutional protocols. - TARGIT-A Trial Overview The TARGIT-A Trial randomized 3,451 patients either to standard EBRT treatment or to TARGIT-A. Eligibility criteria were age C 45 years, tumor size B 3.5 cm, N01, M0, and unifocal invasive ductal carcinoma. If the participating institution determined the patient was at high risk for recurrence, an additional 5 weeks of EBRT was given, calling this riskadapted IORT. The Trial began in March 2000. Beginning in 2004, approximately 30 % of the patients had TARGIT-A after final pathology in a second surgical y e e e g lu lu lu lo a a 2 a o v S v .7 v S th p N p 0 p N a e a a a y tev reb reb reb lgo s d r r r o raeb it ttaeS teho ti teho it teho it TR t-ahp % y rg t y rg y rg y rg B re .0 n a 0 o 9 n a 6 n a 9 n a 7 E p 2 A T 1 N 6 A T 4 A T 2 A T 1 l y T T taoT 11 23 34 tltrcaohoo EBR 11 lt-raeooghyp EBR 6 ltt-saoohgpo EBR 5 ltaoETBR .02% N17= .90% .23% .75% 84 littranyog T t p p e e e e e r r r r m r r r r tir ecu ecu ecu ecu te e r r r r g teovd lacoL itragT 6 SN 32 lacoL itragT 32 lacoL itragT 01 lacoL itragT 31 tltraa 2% 13= % % % r o . .1 .9 .2 9 o T 4 N 1 3 8 6 p e r E Y t S S t cu la L D e C C e e ap c c r B U n B B n ll K A T a A A a T S L S S L A f te 4 o r 2 n n o 1 6 e e 3 iirsseponm trseeenvp ..(05210 tsssaae= ,tibu31gv ,tibu31gv 01 ce ith itc =R tem 20 20 2 n a t t ilrrrseeceaecongun ttirrrsseceaecnnu bllrrrseceecun plitsaceaeuvnnSLN ti-ecean201p3pndxA jtr-rrrreceaeeceypodu titrreeaaepddndpndw Stttsaeond t:ttseaecan0120oNm .,rrseceecaun33wH% lttilrsaaogpuTETBR plisaceaevunnSLN plisaceaevunnSLN R D A ( L 5 A N L r T a b Ipsilateral Breast Recurrence Overall Breast Recurrence, All (a) IBTR, 3.3% Targit, 1.3% EBRT, p=0.042 (b) Overall breast cancer recurrence, p=0.053 (Iipsilateral, contralateral, axilla and distant) Presented at SABCS, but not in Lancet 2013 Prepathology, Local Recurrence Postpathology, Local Recurrence (c) IBTR, pre-pathology 2.1% Targit, 1.1% EBRT, p=0.31 (d) IBTR, post-pathology 5.4% Targit, 1.7% EBRT, p=0.069 FIG. 1 5-year KaplanMeier projections for recurrences from TARGIT-A treated patients vs EBRT treated patients. a Ipsilateral breast recurrence. b Overall breast recurrence. c Prepathology, local recurrence. d Postpathology, local recurrence. Adapted from Figs. 2 and 3 in Lancet7 procedure about 30 days after the original surgery. This group was designated the postpathology group as opposed to the prepathology group who received TARGIT-A during initial tumor surgery. The results for these different patient cohorts are shown in Table 1. Technique In the prepathology TARGIT-A patients, following tumor excision, an app (...truncated)


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Melvin J. Silverstein, Gerd Fastner, Sergio Maluta, Roland Reitsamer, Donald A. Goer, Frank Vicini, David Wazer. Intraoperative Radiation Therapy: A Critical Analysis of the ELIOT and TARGIT Trials. Part 2—TARGIT, Annals of Surgical Oncology, 2014, pp. 3793-3799, Volume 21, Issue 12, DOI: 10.1245/s10434-014-3999-5