Long-term results from the Contura multilumen balloon breast brachytherapy catheter phase 4 registry trial

Laurie W Cuttino; Douglas W Arthur; Frank Vicini; Dorin Todor; Thomas Julian; Nitai Mukhopadhyay

doi:10.1016/j.ijrobp.2014.08.341

Long-term results from the Contura multilumen balloon breast brachytherapy catheter phase 4 registry trial

Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1025-9. doi: 10.1016/j.ijrobp.2014.08.341. Epub 2014 Oct 13.

Authors

Laurie W Cuttino¹, Douglas W Arthur², Frank Vicini³, Dorin Todor², Thomas Julian⁴, Nitai Mukhopadhyay²

Affiliations

¹ Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia. Electronic address: lcuttino@mcvh-vcu.edu.
² Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia.
³ Michigan Healthcare Professionals/21st Century Onoclogy, Farmington Hills, Michigan.
⁴ Allegheny Hospital, Temple School of Medicine, Pittsburgh, Pennsylvania.

PMID: 25442036
DOI: 10.1016/j.ijrobp.2014.08.341

Abstract

Purpose: To describe the long-term outcomes from a completed, multi-institutional phase 4 registry trial using the Contura multilumen balloon (CMLB) breast brachytherapy catheter to deliver accelerated partial breast irradiation (APBI) in patients with early-stage breast cancer.

Methods and materials: Three hundred forty-two evaluable patients were enrolled by 23 institutions between January 2008 and February 2011. All patients received 34 Gy in 10 fractions, delivered twice daily. Rigorous target coverage and normal tissue dose constraints were observed.

Results: The median follow-up time was 36 months (range, 1-54 months). For the entire patient cohort of 342 patients, 10 patients experienced an ipsilateral breast tumor recurrence (IBTR). Eight of these IBTR were classified as true recurrences/marginal miss (TRMM), and 2 were elsewhere failures (EF). Local recurrence-free survival was 97.8% at 3 years. For the entire cohort, 88% of patients had good to excellent overall cosmesis. The overall incidence of infection was 8.5%. Symptomatic seroma was reported in only 4.4% of patients. A separate analysis was performed to determine whether improved outcomes would be observed for patients treated at high-volume centers with extensive brachytherapy experience. Three IBTR were observed in this cohort, only 1 of which was classified as a TRMM. Local recurrence-free survival at high-volume centers was 98.1% at 3 years. Overall cosmetic outcome and toxicity were superior in patients treated at high-volume centers. In these patients, 95% had good to excellent overall cosmesis. Infection was observed in only 2.9% of patients, and symptomatic seroma was reported in only 1.9%.

Conclusion: Use of the CMLB for APBI delivery is associated with acceptable long-term local control and toxicity. Local recurrence-free survival was 97.8% at 3 years. Significant (grade 3) toxicity was uncommon, and no grade 4 toxicity was observed. Treatment at high-volume centers was associated with decreased late toxicity.

Trial registration: ClinicalTrials.gov NCT00699101.

Publication types

Clinical Trial, Phase IV
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Brachytherapy / instrumentation
Brachytherapy / methods*
Breast Neoplasms / epidemiology
Breast Neoplasms / radiotherapy*
Cancer Care Facilities
Carcinoma, Ductal, Breast / epidemiology
Carcinoma, Ductal, Breast / radiotherapy*
Carcinoma, Lobular / epidemiology
Carcinoma, Lobular / radiotherapy*
Catheters
Disease-Free Survival
Dose Fractionation, Radiation
Female
Follow-Up Studies
Hospitals, High-Volume
Humans
Incidence
Neoplasm Recurrence, Local* / epidemiology
Neoplasms, Second Primary / epidemiology
Seroma / epidemiology
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT00699101