Long term update of Trial ****: A Phase I/II Trial to Evaluate Three Dimensional Conformal Radiation Therapy (3D-CRT) Confined to the Region of the Lumpectomy Cavity for Stage I and II Breast Carcinoma

Publication date: Available online 3 September 2016
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Rachel Rabinovitch, Jennifer Moughan, Frank Vicini, Helen Pass, John Wong, Susan Chafe, Ivy Petersen, Douglas W. Arthur, Julia White
PurposeTrial **** was the first cooperative group trial in the US to evaluate 3-dimensional conformal radiation therapy (3D-CRT) accelerated partial breast irradiation (APBI). This report updates secondary endpoints of toxicity and efficacy.MethodsPatients (pts) with stage I/II invasive breast cancer (BrCa) (T≤3cm, N≤3 positive lymph nodes, negative margins) were eligible for 3D-CRT APBI - 38.5 Gy in 10 BID fractions. Pt characteristics and treatment details have previously been reported. Adverse Events (AEs) were graded with CTCAE v. 3.0. This analysis updates recurrences in the ipsilateral breast (IBR), contralateral breast (CBR), ipsilateral nodes (INR), and metastatic sites (DM), mastectomy rate (M), disease-free (DFS), mastectomy-free (MFS), and overall survival (OS).Results52 of 58 enrolled pts were eligible: median age 61 years (y), 94% stage I and 83% ER positive. Median follow up is 8y (min-max: 1.7 – 9.0). The 7y estimate of isolated IBR (no DM) is 5.9%. 7y estimates of all IBR, INR, M, and DM were 7.7%, 5.8%, 7.7%, and 7.7%, respectively. All 4 IBRs were invasive of which 3 had a component within the planning target volume. Patterns of failures were: 3 IBR, 1 INR, 2 DM, 1 INR+DM, and 1 IBR+INR+DM. 7y estimates of MFS, DFS, and OS are 71.2%, 71.2%, and 78.8%, respectively. 13 pts have died: 3 of BrCa, 10 of other causes. Four pts (7.7%) reported G3 treatment-related AE. No G3 pain, pulmonary, or cardiac toxicities were reported.ConclusionThis phase I/II trial of 3D-CRT APBI continues to demonstrate durable tumor control and minimal G3 toxicity, comparable to other APBI techniques. Mature phase III results will determine the appropriateness and limitations of this non-invasive APBI technique.

Teaser

Updated follow up of patients treated with 3D-conformal accelerated partial breast irradiation on Trial **** demonstrates durable ipsilateral breast tumor control and minimal grade 3 toxicity at 7 years, comparable to other published prospective APBI trials. No G3 pain, pulmonary, or cardiac toxicities were reported. Mature phase III results from pending randomized trials utilizing this non-invasive treatment technique are awaited to fully assess its role in early stage breast cancer management.


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