Abstract OT2-03-03: Delivery of a single fraction lumpectomy cavity boost using a novel immobilization device and treatment delivery system
Authors: Nichols EM , Becker S , Hong J , Cohen RJ , Mishra MV , Citron W , Cheston SB , Niu Y , Mutaf Y , Yu CX , Feigenberg SJ 
Published: February 2018

Background: The lumpectomy cavity (LPC) boost has been shown in 2 randomized studies to improve local control in breast cancer. Hypofraction is now being used for delivery of the LPC boost in some early-stage patients. This trial delivers the LPC boost in a single fraction using a novel breast immobilization device/treatment delivery system.

Trial design: Patients are enrolled in this trial after standard resection with lumpectomy/sentinel lymph node biopsy (as appropriate) and chemotherapy (as indicated per standard of care). At the time of CT simulation for whole-breast radiation therapy (RT), the radiation oncologist evaluates breast size and LPC position. If consented for treatment, the patient receives a single fraction “boost” treatment of 8 Gy in 1 fraction followed by standard whole-breast RT to start within 7 days of completion of the boost. Whole-breast radiation is delivered in the supine or prone position with the following fractionation schemes: 4005 cGy in 15 fractions or 5000 cGy in 25 fractions.

On the day of the boost treatment, the patient is fitted with the breast immobilization device, with a plastic inner cup that is fitted so that the breast fills all or most of the cup. A rigid outer cup with a built-in stereotactic fiducial system is attached. Moderate negative pressure is applied to immobilize the breast within the cup system. Patients then undergo CT simulation in the prone position. Clip placement and LPC cavity location must meet eligibility criteria before proceeding with treatment planning and delivery.

Eligibility criteria:

Eligibility criteria: age &gt;60 yo; female only; dx of invasive ductal or lobular carcinoma or ductal carcinoma in situ; estrogen receptor positive; successful completion of lumpectomy ± sentinel lymph node biopsy with negative margins for invasive or noninvasive cancer; greatest tumor dimension &lt;4 cm before surgery; weight &lt;330 lb; height &lt;76 inches; nonlactating and nonpregnant. Various additional dosimetric factors must be met prior to treatment. If these are unable to be met, the patient will become ineligible for treatment.

Specific aims: The aim of this study is to demonstrate the feasibility and safety of delivering the LPC boost RT using a single fraction with a novel immobilization device/treatment delivery system while ensuring coverage of the target volume with appropriate dose homogeneity and conformity. Secondary aims are evaluation of patient comfort, acute toxicity (1 month), and late toxicity (1 year).

Statistical methods: A Simon 2-stage design is utilized for this trial. After evaluating the device and treatment on 8 patients in the first stage, the trial was designed to be terminated and device rejected if the dose distribution was acceptable for ≤5 patients. The first stage was completed in spring 2017 and progressed to the second stage, designed to include a total of 17 patients.

Accrual and target accrual: Target accrual for this study is 14 patients successfully treated while meeting all protocol constraints. As of 6/2017, 16 patients have been enrolled, of whom 13 have been successfully treated while meeting all protocol constraints.

Citation Format: Nichols EM, Becker S, Hong J, Cohen RJ, Mishra MV, Citron W, Cheston SB, Niu Y, Mutaf Y, Yu CX, Feigenberg SJ. Delivery of a single fraction lumpectomy cavity boost using a novel immobilization device and treatment delivery system [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr OT2-03-03.