The National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31 and the North Central Cancer Treatment Group (NCCTG) N9831 trials

The National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31 and the North Central Cancer Treatment Group (NCCTG) N9831 trials

  • In 2000, two landmark trials combined results:
    • That compared adjuvant chemotherapy with or without concurrent trastuzumab therapy in women with surgically removed HER2-positive breast cancer
  • The NSABP B-31 trial compared:
    • Doxorubicin and cyclophosphamide followed by paclitaxel every 3 weeks (group 1) with the same regimen plus 52 weeks of trastuzumab given concurrently with paclitaxel (group 2). 
Trial Schema of NSABP B-31.
  • The North Central Cancer Treatment Group NCCTG N9831 trial conducted a similar study that compared three regimens: 
    • Group A:
      • Doxorubicin and cyclophosphamide followed by weekly paclitaxel
    • Group B:
      • Doxorubicin and cyclophosphamide followed by weekly paclitaxel, followed by 52 weeks of trastuzumab given after paclitaxel
    • Group C:
      • The same regimen in group A, followed by 52 weeks of trastuzumab initiated concurrentlywith paclitaxel
Trial Schema of NCCTG N9831.
  • The studies were combined to include a joint analysis:
    • Comparing groups 1 and group A (the control group) with groups 2 and group C (the trastuzumab group)
      • Group B was excluded
  • Results by 2005 reported 394 events (recurrence, second primary cancer, or death before recurrence):
    • Of these events, 133 were from the trastuzumab group and 261 were in the control group (hazard ratio, 0.48; P<0.0001)
  • At 3 years, the absolute difference in DFS between the trastuzumab group and the control group was:
    • 12% and trastuzumab therapy was associated with a 33% reduction in the risk of death(P=0.015)
  • The interim analyses of these trials favored trastuzumab so strongly:
    • That the trials were stopped early and patients in the other arms were offered trastuzumab
  • Long-term analysis of these studies was reported in 2014:
    • At a median follow-up time of 8.4 years:
      • The addition of trastuzumab to chemotherapy led to a 37% improvement in OS and an increase in 10-year survival rate from 75.2% to 84%
      • Outcomes in DFS showed an improvement of 40% and an increase in the 10-year DFS rate from 62.2% to 73.7%
  • This study showed that all subgroups of HER2-positive patients (small and large tumors, hormone receptor-positive and -negative, low and high number of positive nodes, young and old patients):
    • Benefited from the addition of the targeted anti-HER2 agent, making trastuzumab an integral drug in the treatment of HER2-positive breast cancer
  • References
    • Perez EA, Romond EH, Suman VJ, Jeong J-H, Sledge G, Geyer Jr GE, et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014;32(33):3744-3752.
    • Romond E, Perez E, Bryant J, Suman VJ, Geyer Jr GE, Davidson NE, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673-1684.

#Arrangoiz #BreastSurgeon #BreastCancer #CancerSurgeon #SurgicalOncologist #Miami #Mexico #NSABPB31 #NCCTGN9831

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s