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
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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)