7: Multicenter clinical trial for omission of breast surgery in invasive cancer following neoadjuvant systemic therapy: Longitudinal patient reported outcomes and decisional comfort planned analyses

Friday, March 24, 2023

5:01 PM – 5:11 PM

Location: Veterans Memorial Auditorium

Abstract Presenter(s)

Helen M. Johnson, MD (she/her/hers)

Breast Surgical Oncology Fellow
MD Anderson Cancer Center, United States

Disclosure(s): No financial relationships to disclose

Author(s)

Emilia Diego, MD

Chief, Section of Breast Surgery
University of Pittsburgh
Pittsburgh, PA, United States

Disclosure information not submitted.
SK

Savitri Krishnamurthy, MD

Department of Pathology
MD Anderson Cancer Center, United States

Disclosure information not submitted.
WY

Wei Yang, MBBS MHM

Department of Breast Imaging
MD Anderson Cancer Center, United States

Disclosure information not submitted.
Benjamin D. Smith, MD

Professor
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States

Disclosure information not submitted.
VV

Vincente Valero, MD

Department of Breast Medical Oncology
MD Anderson Cancer Center, United States

Disclosure information not submitted.
Anthony Lucci, Jr., MD

Professor
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States

Disclosure(s): No financial relationships to disclose
SS

Simona Shaitelman, MD EdM

Department of Radiation Oncology
MD Anderson Cancer Center, United States

Disclosure information not submitted.
MM

Melissa Mitchell, MD PhD

Department of Radiation Oncology
MD Anderson Cancer Center, United States

Disclosure information not submitted.
Judy C. Boughey, MD, FACS, FSSO (she/her/hers)

Professor of Surgery, W.H. Odell Professor in Individualized Medicine, Chair-Division of Breast and Melanoma Surgical Oncology, Department of Surgery
Mayo Clinic
Rochester, Minnesota, United States

Disclosure(s): Cairns Surgical: Other (Ongoing); Eli Lilly: Research Grant (Ongoing); OncLive: Speaker (Terminated); Peer View: Speaker (Terminated); PER: Speaker (Terminated); SymBioSis: Research Grant (Ongoing); UptoDate: Royalties (Ongoing)
Richard L. White, MD

Chief, Division of Surgical Oncology
Atrium Health-Levine Cancer Institute
Charlotte, NC, United States

Disclosure information not submitted.
GR

Gaiane Rauch, MD PhD

Department of Breast Imaging
MD Anderson Cancer Center, United States

Disclosure information not submitted.
Henry M. Kuerer, MD, PhD

Professor, Breast Surgical Oncology; Executive Director, Breast Programs MD Anderson Cancer Network
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States

Disclosure information not submitted.

Disclosure(s):

Helen M. Johnson, MD: No financial relationships to disclose

Anthony Lucci, MD, Jr.: No financial relationships to disclose

Judy C. Boughey, MD, FACS, FSSO: Cairns Surgical: Other (Ongoing); Eli Lilly: Research Grant (Ongoing); OncLive: Speaker (Terminated); Peer View: Speaker (Terminated); PER: Speaker (Terminated); SymBioSis: Research Grant (Ongoing); UptoDate: Royalties (Ongoing)

Introduction: In the current landscape of treatment de-escalation, it is imperative to ensure that patients have an active role in the decision to pursue or forgo specific therapies. We aimed to evaluate longitudinal patient reported outcomes (PROs) and decisional comfort among patients who elected to enroll in a clinical trial evaluating radiotherapy alone, without breast surgery, for cancers with an exceptional response to neoadjuvant systemic therapy (NST).

Methods: Validated PRO surveys prospectively administered on protocol included the Breast Cancer Treatment Outcomes Scale (BCTOS) and Decision Regret Scale (DRS) at baseline, 6 months and 12 months after completion of radiotherapy. Changes over time were evaluated with the student t-test.

Results: Between 2017 and 2021, 50 patients enrolled in this prospective, multicenter trial with T1-2 N0-1 triple-negative or Her2-positive invasive breast cancer resulting in 31 patients (62%) without residual disease on image guided biopsy following NST, with omission of breast surgery. At baseline, patients reported minimal difference between the treated and untreated breast with respect to function, cosmesis, breast pain, edema (Table) and expressed low levels of decision regret (DRS score mean 15.2, SD 15.9). From baseline to 6 months post-radiotherapy, there was a statistically significant increase in all BCTOS subscores (p < 0.05); however, the magnitude of the reported inter-breast difference remained low (overall BCTOS score mean 1.4, SD 0.3). There was a statistically significant decline in regret from baseline to 6 months after completion of radiotherapy (mean 4.8, SD 8.8; p=0.003). Results at 12 months post-radiotherapy were not significantly different than those at 6 months for all PROs (BCTOS p=0.604, DRS p=0.669).

Conclusions: Breast cancer clinical trial patients who elect to forgo breast surgery following exceptional tumor response to NST report minor differences between the treated and untreated breast with respect to function, cosmesis, pain, and edema following radiotherapy. Low baseline levels of decision regret further decline over time, suggesting high early satisfaction from shared decision-making and tailored oncologic care on this clinical trial.

Learning Objectives:

Upon completion, participants will be able to describe the participants in this clinical trial.
Upon completion, participants will be able to list two patient-reported outcome (PRO) survey instruments.
Upon completion, participants will be able to describe the patient reported outcomes (PROs) reported by clinical trial participants at baseline and over time.