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Abstract S1-04: A phase II study of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC)

Publication ,  Conference
Tolaney, SM; Barry, WT; Dang, CT; Yardley, DA; Moy, B; Marcom, PK; Albain, KS; Rugo, HS; Ellis, M; Shapira, I; Wolff, AC; Carey, LA; Guo, H ...
Published in: Cancer Research
December 15, 2013

Background: Four large randomized phase III trials have reported significant improvements in disease-free (DFS) and overall survival for H administered with adjuvant polychemotherapy for HER2-positive high-risk BC. With the success of HER2-targeting, limiting chemotherapy is both reasonable and feasible, particularly for smaller, node-negative tumors. However data are limited.Methods: APT is a single arm three-stage, multicenter, phase II study of TH. Patients (pts) with HER2-positive BC (IHC 3 + and/or FISH amplified at > 2.0) with negative nodes (a single axillary lymph node micrometastasis was allowed) and tumor size < 3 cm were eligible. Pts received T (80 mg/m2) with H (4 mg/kg load ®2 mg/kg) x 12 weekly (w), followed by H x 39 w (2 mg/kg weekly or 6 mg/kg q 3 w). The primary endpoint was DFS. DFS events included invasive local, regional or distant recurrence, contralateral invasive breast cancer and death from any cause. The study had 95% power to distinguish between 3-year failure rates of 9.2% vs. 5% using a Poisson model based on the total patient-years of follow-up (PYFU). Planned interim analyses were designed to stop early for futility at 225 and 800 PYFU, and the regimen would be deemed worthy of further study with <40 failures after 1600 PYFU. All pts who began protocol therapy were included in the analyses.Results: 410 pts were enrolled from September 2007 to September 2010 and 406 began protocol therapy. The median age was 55 (range 24-85 years). Sixty-three percent had ER+ tumors. Three percent of tumors were T1mi; T1a; 20% T1b; 41% T1c, and 9% T2 ≤ 3cm. Six pts had a nodal micrometastasis. 356 pts (88%) completed all 52 wks of therapy, with 24 and 6 pts discontinuing due to protocol-specified or other toxicities, respectively. 358 (89%) completed all 12 weeks of combined TH therapy. The most common grade 3/4 toxicities included: neuropathy (4%), neutropenia (4%), transaminitis (3%), leukopenia (2%), fatigue (2%), and hypersensitivity reactions (2%). Reversible symptomatic CHF (grade 3 left ventricular systolic dysfunction) occurred in 2 patients (0.5%). Because of the limited number of events, the Data Safety Monitoring Board approved release of study results with 1316 PYFU and a median follow-up of 3.2 years. A total of 8 DFS events have been observed: 2 pts with metastatic disease, 2 with ipsilateral axillary recurrences, 3 with new contralateral BC (all HER2-), and 1 patient who died after diagnosis of primary ovarian cancer.Conclusion: This represents the first report of TH as adjuvant therapy for node-negative HER2-positive BC. The regimen appears well tolerated and few recurrences have been observed in the study population to date. An updated analysis of efficacy, including estimates of 3-year DFS, will be presented in December when a total of 1520 PYFU in this cohort is anticipated. Based on these early data, the TH regimen may be an acceptable treatment approach for low risk HER2-positive breast cancer.Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr S1-04.

Duke Scholars

Published In

Cancer Research

DOI

EISSN

1538-7445

ISSN

0008-5472

Publication Date

December 15, 2013

Volume

73

Issue

24_Supplement

Publisher

American Association for Cancer Research (AACR)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 3101 Biochemistry and cell biology
  • 1112 Oncology and Carcinogenesis
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Tolaney, S. M., Barry, W. T., Dang, C. T., Yardley, D. A., Moy, B., Marcom, P. K., … Winer, E. P. (2013). Abstract S1-04: A phase II study of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC). In Cancer Research (Vol. 73). American Association for Cancer Research (AACR). https://doi.org/10.1158/0008-5472.sabcs13-s1-04
Tolaney, S. M., W. T. Barry, C. T. Dang, D. A. Yardley, B. Moy, P. K. Marcom, K. S. Albain, et al. “Abstract S1-04: A phase II study of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC).” In Cancer Research, Vol. 73. American Association for Cancer Research (AACR), 2013. https://doi.org/10.1158/0008-5472.sabcs13-s1-04.
Tolaney SM, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, et al. Abstract S1-04: A phase II study of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC). In: Cancer Research. American Association for Cancer Research (AACR); 2013.
Tolaney, S. M., et al. “Abstract S1-04: A phase II study of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC).” Cancer Research, vol. 73, no. 24_Supplement, American Association for Cancer Research (AACR), 2013. Crossref, doi:10.1158/0008-5472.sabcs13-s1-04.
Tolaney SM, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Guo H, Hudis CA, Krop IE, Burstein HJ, Winer EP. Abstract S1-04: A phase II study of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC). Cancer Research. American Association for Cancer Research (AACR); 2013.

Published In

Cancer Research

DOI

EISSN

1538-7445

ISSN

0008-5472

Publication Date

December 15, 2013

Volume

73

Issue

24_Supplement

Publisher

American Association for Cancer Research (AACR)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 3101 Biochemistry and cell biology
  • 1112 Oncology and Carcinogenesis