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Original Investigation
November 21, 2019

Effectiveness of Breast-Conserving Surgery and 3-Dimensional Conformal Partial Breast Reirradiation for Recurrence of Breast Cancer in the Ipsilateral Breast: The NRG Oncology/RTOG 1014 Phase 2 Clinical Trial

Author Affiliations
  • 1Massey Cancer Center, Virginia Commonwealth University, Richmond
  • 2NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania
  • 3University of Texas MD Anderson Cancer Center, Houston
  • 4Rutgers Cancer Institute of New Jersey, New Brunswick
  • 5Thomas Jefferson University Hospital, Philadelphia, Pennsylvania
  • 6Fox Chase Cancer Center, Philadelphia, Pennsylvania
  • 7Memorial Sloan Kettering Cancer Center, New York, New York
  • 8University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland
  • 9Michigan Cancer Research Consortium, Ypsilanti
  • 10Cape Cod Hospital, Hyannis, Massachusetts
  • 11Wake Forest University Health Sciences, Winston-Salem, North Carolina
  • 12Froedtert and the Medical College of Wisconsin, Milwaukee
  • 13University of Colorado Hospital, Aurora
  • 14University of Michigan Comprehensive Cancer Center, Ann Arbor
  • 15Ohio State University Comprehensive Cancer Center, Columbus
JAMA Oncol. Published online November 21, 2019. doi:https://doi.org/10.1001/jamaoncol.2019.4320
Key Points

Question  Is partial breast reirradiation after a second lumpectomy for recurrence of breast cancer in the ipsilateral breast after previous whole breast irradiation associated with long-term local control?

Findings  In this phase 2 clinical trial of 58 patients with recurrence of breast cancer, the 5-year estimate of re-recurrence of breast cancer in the ipsilateral breast was 5%. Late grade 3 treatment-related adverse events were reported in 7% of patients, with no grade 4 or higher adverse events reported, and the 5-year cumulative incidence of ipsilateral mastectomy was 10%.

Meaning  The findings suggest that a second lumpectomy followed by partial breast reirradiation is an effective alternative to mastectomy in those experiencing recurrence of breast cancer in the ipsilateral breast after an initial lumpectomy and whole breast irradiation.

Abstract

Importance  Mastectomy is standard for recurrence of breast cancer after breast conservation therapy with whole breast irradiation. The emergence of partial breast irradiation led to consideration of its application for reirradiation after a second lumpectomy for treatment of recurrence of breast cancer in the ipsilateral breast.

Objectives  To assess the effectiveness and adverse effects of partial breast reirradiation after a second lumpectomy and whether the treatment is an acceptable alternative to mastectomy.

Design, Setting, and Participants  The NRG Oncology/Radiation Therapy Oncology Group 1014 trial is a phase 2, single-arm, prospective clinical trial of 3-dimensional, conformal, external beam partial breast reirradiation after a second lumpectomy for recurrence of breast cancer in the ipsilateral breast after previous whole breast irradiation. The study opened on June 4, 2010, and closed June 18, 2013. Median follow-up was 5.5 years. This analysis used all data received at NRG Oncology through November 18, 2018. Eligible patients experienced a recurrence of breast tumor that was less than 3 cm and unifocal in the ipsilateral breast more than 1 year after breast-conserving therapy with whole breast irradiation and who had undergone excision with negative margins.

Interventions  Adjuvant partial breast reirradiation, 1.5 Gy twice daily for 30 treatments during 15 days (45 Gy), using a 3-dimensional conformal technique.

Main Outcomes and Measures  The main outcomes of the present study were the predefined secondary study objectives of recurrence of breast cancer in the ipsilateral breast, late adverse events (>1 year after treatment), mastectomy incidence, distant metastasis–free survival, overall survival, and circulating tumor cell incidence.

Results  A total of 65 women were enrolled, with 58 evaluable for analysis (mean [SD] age, 65.12 [9.95] years; 48 [83%] white). Of the recurrences of breast cancer in the ipsilateral breast, 23 (40%) were noninvasive and 35 (60%) were invasive. In all 58 patients, 53 (91%) had tumors 2 cm or smaller. All tumors were clinically node negative. A total of 44 patients (76%) tested positive for estrogen receptor, 33 (57%) for progesterone receptor, and 10 (17%) for ERBB2 (formerly HER2 or HER2/neu) overexpression. Four patients had breast cancer recurrence, with a 5-year cumulative incidence of 5% (95% CI, 1%-13%). Seven patients underwent ipsilateral mastectomies for a 5-year cumulative incidence of 10% (95% CI, 4%-20%). Both distant metastasis–free survival and overall survival rates were 95% (95% CI, 85%-98%). Four patients (7%) had grade 3 and none had grade 4 or higher late treatment adverse events.

Conclusions and Relevance  For patients experiencing recurrence of breast cancer in the ipsilateral breast after lumpectomy and whole breast irradiation, a second breast conservation was achievable in 90%, with a low risk of re-recurrence of cancer in the ipsilateral breast using adjuvant partial breast reirradiation. This finding suggests that this treatment approach is an effective alternative to mastectomy.

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