August, 2013 Journal Club
Moderator: Dr. Suzanne V. Klimberg
The aim of the study was to determine whether axillary surgery (Level I-III) could be omitted in clinically node negative older women (65-80 years) with cT1 breast cancer undergoing quadrantectomy and radiation. This underpowered randomized trial is small with only 219 women but has a median follow-up of 149 and 150 months in the ALND and no ALND groups demonstrating no difference in distant metastasis rate, overall survival and breast cancer mortality. Although 23% of the 109 patients who were treated with ALND had positive nodes there was only a 6% cumulative incidence at 15 years of clinically positive axillary disease in the no axillary dissection arm. There were 7 versus 4 local recurrences and 2 versus 8 contralateral breast cancers in the ALND and no ALND arms, respectively. The authors do not think that the similar outcomes of these two groups is secondary to irradiation of lymph nodes as they cite another study of 354 breast cancer quadrantectomy patients who did not receive ALND or irradiation who had a 15-year crude cumulative incidence of axillary relapse of 4.2%. No data is reported on the specifics of the patients who did have an axillary recurrence in terms of morbidity and mortality. This set of patients fared very poorly in the NSABP B04 trial. Overall the patients in this study were much more likely to die of something other than breast cancer.
Questions(answers appear below):
1. The removal of axillary nodes is:
c. enhances survival
d. prevents lymphedema
2. Based on this study ALND is:
a. no longer necessary
b. is statistically the same as ALND
c. is already supplanted by sentinel lymph node biopsy.
d. is not indicated for patients undergoing mastectomy.
3. Regional Recurrences were more common in:
a. the hormone receptor negative group
b. the Grade 3 cancers
c. the Grade 2 cancers
d. The molecular high risk patients.
Please feel free to comment on any or all of the questions above. We look forward to hearing from you, the Annals readers. This article can be accessed for free.
Answers to Questions:
1. B is the correct answer as ALND prognosticates survival even in the face of Oncotype DX. In other words it is additive to molecular testing. Predictive refers to whether the patient will respond to a given therapy. This study as well as the NSABP B04 trial and others do not show any survival advantage to removing clinically normal nodes. There is however an increased risk of lymphedema with ALND.
2. C is the correct answer. ALND still has a use for clinically positive nodes and for local regional recurrences. ALND for staging has been supplanted by SLNB according to the results of the NSABP B-32 trial. This study is underpowered to show a statistically significant difference but the long follow-up is clinically significant in terms of treating older patients. However, these results as well as those of the ACOSOG Z0011 trial cannot be extrapolated to patients undergoing mastectomy.
3. C is the correct answer meaning that in this study the characteristics of the primary tumor did not dictate regional recurrence. Although molecular testing was not done in this study, Oncotype scores do not predict lymph node positivity or recurrence.