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Pritchard, Kathleen I.; Shepherd, Lois E.; Chapman, Judith-Anne W.; Norris, Brian D.; Cantin, Jacques; Goss, Paul E.; Dent, Susan F.; Walde, David; Vandenberg, Ted A.; Findlay, Brian; O'Reilly, Susan E.; Wilson, Carolyn F.; Han, Lei; Piura, Ettie; Whelan, Timothy J.; Pollak, Michael N.

Randomized Trial of Tamoxifen Versus Combined Tamoxifen and Octreotide LAR Therapy in the Adjuvant Treatment of Early-Stage Breast Cancer in Postmenopausal Women: NCIC CTG MA.14

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  • Media type: E-Article
  • Title: Randomized Trial of Tamoxifen Versus Combined Tamoxifen and Octreotide LAR Therapy in the Adjuvant Treatment of Early-Stage Breast Cancer in Postmenopausal Women: NCIC CTG MA.14
  • Contributor: Pritchard, Kathleen I.; Shepherd, Lois E.; Chapman, Judith-Anne W.; Norris, Brian D.; Cantin, Jacques; Goss, Paul E.; Dent, Susan F.; Walde, David; Vandenberg, Ted A.; Findlay, Brian; O'Reilly, Susan E.; Wilson, Carolyn F.; Han, Lei; Piura, Ettie; Whelan, Timothy J.; Pollak, Michael N.
  • Published: American Society of Clinical Oncology (ASCO), 2011
  • Published in: Journal of Clinical Oncology, 29 (2011) 29, Seite 3869-3876
  • Language: English
  • DOI: 10.1200/jco.2010.33.7006
  • ISSN: 0732-183X; 1527-7755
  • Origination:
  • Footnote:
  • Description: Purpose Somatostatin analogs act directly on breast cancer cells and indirectly on insulin and insulin-like growth factor 1 (IGF-1) levels. This trial was undertaken to assess whether octreotide would lower insulin and IGF-1 levels and reduce risk of breast cancer recurrence. Patients and Methods The NCIC CTG MA.14 (NCIC Clinical Trials Group MA.14) trial randomly assigned postmenopausal women to 5 years of tamoxifen 20 mg daily (TAM) or TAM plus 2 years of octreotide 90 mg depot intramuscular injections monthly (TAM-OCT) as adjuvant therapy. The primary end point was event-free survival (EFS). Secondary end points were relapse-free survival (RFS), overall survival (OS), toxicity, and effects of treatment on IGF physiology. Results Among 667 women with a median follow-up of 7.9 years, 220 events occurred—108 with TAM-OCT and 112 with TAM. Adjusted hazard ratios (HRs; TAM-OCT to TAM) were 0.93 for EFS (95% CI, 0.71 to 1.22; P = .62), 0.84 for RFS (95% CI, 0.59 to 1.18; P = .31), and 0.97 for OS (95% CI, 0.69 to 1.37; P = .86). Among patients with normal baseline gallbladder imaging, cholecystectomy was required in 23.0% of those receiving TAM-OCT but in only 1.4% of those receiving TAM (P < .001). At 4 months, TAM-OCT had significantly (P < .001) lowered IGF-1, IGF binding protein 3, and C-peptide levels. Older age (P = .02), tumor size (P = .001), nodal status (P = .01), high C-peptide levels (P < .001), and higher body mass index (BMI) in models excluding C-peptide (P < .001) were associated with poorer EFS in multivariate analysis. Conclusion Octreotide-related changes in circulating IGF-1 and C-peptide levels were statistically significant. Octreotide did not add significant clinical benefit. High C-peptide levels (surrogate for insulin secretion rate) and high BMI were associated with poor outcome.
  • Access State: Open Access