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Impact of adjuvant trastuzumab on locoregional failure rates in a randomized clinical trial: North Central Cancer Treatment Group N9831 (alliance) study.

Publication ,  Journal Article
Vargas, CE; Thorpe, CS; Dueck, AC; Tenner, KS; Davidson, NE; Martino, S; Pisansky, TM; Hwang, ES; Halyard, MY; Pockaj, BA; Perez, EA
Published in: Cancer
December 15, 2020

BACKGROUND: The goal of this study was to assess the impact of trastuzumab on locoregional failure. METHODS: The analysis included 2763 patients with HER2-positive (HER2+) breast cancer who were randomly assigned to adjuvant doxorubicin (A), cyclophosphamide (C), paclitaxel (T) and trastuzumab (H) (arm A, AC→T [n = 922]; arm B, AC→T→H [n = 988]; arm C, AC→T+H→H [n = 853]). Radiotherapy was given after AC→T concurrently with H. Radiotherapy was given after lumpectomy (L) or after mastectomy (M) with ≥4 positive lymph nodes but was optional for 1 to 3 positive lymph nodes. Locoregional failures at 10 years (LFR10) as first events were compared using competing risk analysis. RESULTS: The median follow-up was 13.0 years. The first site of failure was local-only in 96 cases, locoregional in 16 cases, regional in 32 cases, and not specified in 2 cases; LFR10 was 4.8% (95% CI 4.1%-5.7%). LFR10 was 5.5% (95% CI 4.3%-7.2%), 4.9% (95% CI 3.7%-6.4%), and 2.8% (95% CI 1.9%-4.1%) in arms A, B, and C (B vs A: hazard ratio [HR] 0.91, P = .62; C vs A: HR 0.72, P = .12). For estrogen receptor-positive patients, LFR10 was 3.7% (95% CI 2.8%-4.8%) and for estrogen receptor-negative patients, it was 6.1% (95% CI 5.0%-7.4%; HR 0.61, P = .004). Local treatment included L+RT (n = 1044 [38%]), M+RT (n = 1025 [37%]), and M (n = 694 [25%]). LFR10 was 6.% (95% CI 5.0%-7.8%), 3.0% (95% CI 2.1%-4.3%), and 5.5% (95% CI 4.0%-7.4%) for L+RT, M+RT, and M, respectively (M+RT vs L+RT: HR 0.43, P < .001; M vs L+RT: HR 0.88, P = .57). For 1 to 3 positive lymph nodes, LFR10 was 6.5% (95% CI 4.8%-8.9%), 4.1% (95% CI 2.4%-7.0%), and 4.3% (95% CI 2.9%-6.5%) in L+RT, M+RT, and M, respectively (M vs L+RT: HR 0.68, P = .14; M vs M+RT: HR 1.2, P = .6). CONCLUSION: Low 10-year LFRs were seen regardless of trastuzumab use. Differences in local therapy in patients with 1 to 3 positive lymph nodes did not appear to improve local control. Local therapy studies for HER2+ and other tumor characteristics are important as the role of local therapies continues to evolve.

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Published In

Cancer

DOI

EISSN

1097-0142

Publication Date

December 15, 2020

Volume

126

Issue

24

Start / End Page

5239 / 5246

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Trastuzumab
  • Survival Analysis
  • Paclitaxel
  • Oncology & Carcinogenesis
  • Middle Aged
  • Mastectomy, Segmental
  • Mastectomy
  • Humans
  • Female
 

Citation

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Vargas, C. E., Thorpe, C. S., Dueck, A. C., Tenner, K. S., Davidson, N. E., Martino, S., … Perez, E. A. (2020). Impact of adjuvant trastuzumab on locoregional failure rates in a randomized clinical trial: North Central Cancer Treatment Group N9831 (alliance) study. Cancer, 126(24), 5239–5246. https://doi.org/10.1002/cncr.33154
Vargas, Carlos E., Cameron S. Thorpe, Amylou C. Dueck, Kathleen S. Tenner, Nancy E. Davidson, Silvana Martino, Thomas M. Pisansky, et al. “Impact of adjuvant trastuzumab on locoregional failure rates in a randomized clinical trial: North Central Cancer Treatment Group N9831 (alliance) study.Cancer 126, no. 24 (December 15, 2020): 5239–46. https://doi.org/10.1002/cncr.33154.
Vargas CE, Thorpe CS, Dueck AC, Tenner KS, Davidson NE, Martino S, et al. Impact of adjuvant trastuzumab on locoregional failure rates in a randomized clinical trial: North Central Cancer Treatment Group N9831 (alliance) study. Cancer. 2020 Dec 15;126(24):5239–46.
Vargas, Carlos E., et al. “Impact of adjuvant trastuzumab on locoregional failure rates in a randomized clinical trial: North Central Cancer Treatment Group N9831 (alliance) study.Cancer, vol. 126, no. 24, Dec. 2020, pp. 5239–46. Pubmed, doi:10.1002/cncr.33154.
Vargas CE, Thorpe CS, Dueck AC, Tenner KS, Davidson NE, Martino S, Pisansky TM, Hwang ES, Halyard MY, Pockaj BA, Perez EA. Impact of adjuvant trastuzumab on locoregional failure rates in a randomized clinical trial: North Central Cancer Treatment Group N9831 (alliance) study. Cancer. 2020 Dec 15;126(24):5239–5246.
Journal cover image

Published In

Cancer

DOI

EISSN

1097-0142

Publication Date

December 15, 2020

Volume

126

Issue

24

Start / End Page

5239 / 5246

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Trastuzumab
  • Survival Analysis
  • Paclitaxel
  • Oncology & Carcinogenesis
  • Middle Aged
  • Mastectomy, Segmental
  • Mastectomy
  • Humans
  • Female