WELL this just SUCKS!!

Christine,

I'm putting it in a link that is easier to click on:

http://www.nytimes.com/2011/02/09/health/research/09breast.html?pagewanted=1&_r=2&hp

There had been reports of this from the San Antonio Breast Cancer Conference: I don't see link to the new study, but I'll look for it.

Yes, it is upsetting when it seems like you possibly underwent surgery that potentially did not benefit you.

Medicine evolves and it totally sucks when we later find out that what was the accepted best standard of care that we agreed to--using the best information available to us at the time--later turns out to be found not necessary.

This is still preliminary stuff, but more and more studies seem to be showing this, what everyone that they knew was necessary--to remove all the nodes for local control, may not be necessary.

We can only make the best decisions with the information available. I've read articles that lymph node sampling may become obsolete--they'll just do axillary ultrasounds and fine needle aspirates. Maybe that day will come.

You have every right to be upset. 

Many times I wish I knew at the time of diagnosis what I've learned since then. Hard lessons.

Kira

Here is the abstract from JAMA--the article comes out tomorrow:

JAMA. 2011;305(6):569-575. doi: 10.1001/jama.2011.90
Axillary Dissection vs No Axillary Dissection in Women With Invasive Breast Cancer and Sentinel Node Metastasis
A Randomized Clinical Trial

1. Armando E. Giuliano, MD;
2. Kelly K. Hunt, MD;
3. Karla V. Ballman, PhD;
4. Peter D. Beitsch, MD;
5. Pat W. Whitworth, MD;
6. Peter W. Blumencranz, MD;
7. A. Marilyn Leitch, MD;
8. Sukamal Saha, MD;
9. Linda M. McCall, MS;
10. Monica Morrow, MD

[+] Author Affiliations

1.
Author Affiliations: John Wayne Cancer Institute at Saint John's Health Center, Santa Monica, California (Dr Giuliano); M. D. Anderson Cancer Center, Houston, Texas (Dr Hunt); Mayo Clinic Rochester, Rochester, Minnesota (Dr Ballman); Dallas Surgical Group, Dallas, Texas (Dr Beitsch); Nashville Breast Center, Nashville, Tennessee (Dr Whitworth); Morton Plant Hospital, Clearwater, Florida (Dr Blumencranz); University of Texas Southwestern Medical Center, Dallas (Dr Leitch); McLaren Regional Medical Center, Michigan State University, Flint (Dr Saha); American College of Surgeons Oncology Group, Durham, North Carolina (Ms McCall); and Memorial Sloan-Kettering Cancer Center, New York, New York (Dr Morrow).

Abstract

Context Sentinel lymph node dissection (SLND) accurately identifies nodal metastasis of early breast cancer, but it is not clear whether further nodal dissection affects survival.

Objective To determine the effects of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer.

Design, Setting, and Patients The American College of Surgeons Oncology Group Z0011 trial, a phase 3 noninferiority trial conducted at 115 sites and enrolling patients from May 1999 to December 2004. Patients were women with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 to 2 SLNs containing metastases identified by frozen section, touch preparation, or hematoxylin-eosin staining on permanent section. Targeted enrollment was 1900 women with final analysis after 500 deaths, but the trial closed early because mortality rate was lower than expected.

Interventions All patients underwent lumpectomy and tangential whole-breast irradiation. Those with SLN metastases identified by SLND were randomized to undergo ALND or no further axillary treatment. Those randomized to ALND underwent dissection of 10 or more nodes. Systemic therapy was at the discretion of the treating physician.

Main Outcome Measures Overall survival was the primary end point, with a noninferiority margin of a 1-sided hazard ratio of less than 1.3 indicating that SLND alone is noninferior to ALND. Disease-free survival was a secondary end point.

Results Clinical and tumor characteristics were similar between 445 patients randomized to ALND and 446 randomized to SLND alone. However, the median number of nodes removed was 17 with ALND and 2 with SLND alone. At a median follow-up of 6.3 years (last follow-up, March 4, 2010), 5-year overall survival was 91.8% (95% confidence interval [CI], 89.1%-94.5%) with ALND and 92.5% (95% CI, 90.0%-95.1%) with SLND alone; 5-year disease-free survival was 82.2% (95% CI, 78.3%-86.3%) with ALND and 83.9% (95% CI, 80.2%-87.9%) with SLND alone. The hazard ratio for treatment-related overall survival was 0.79 (90% CI, 0.56-1.11) without adjustment and 0.87 (90% CI, 0.62-1.23) after adjusting for age and adjuvant therapy.

Conclusion Among patients with limited SLN metastatic breast cancer treated with breast conservation and systemic therapy, the use of SLND alone compared with ALND did not result in inferior survival.

Yes, it's too late for us who has already had the surgery/removal of some of the lymph nodes, but it's not too late for women who is still in the beginning of this journey.

 In my case it wouldn't have made any change since I could feel the tumors in the armpit, the tumors in my breast was too small to feel or see during mammogram.

All I can say is that maybe this will make it easier to get LE appoinments?

Sigh.

It's so hard not to look back.

Okay, I'm reading the article (Otter where are you??)

And, this study was done 1999-2004, then results were analyzed.

Here is eligibility criteria:

Adult women with histologically confirmed invasive breast carcinoma clinically 5 cm or less, no palpable adenopathy, and an SLN containing metastatic breast cancer documented by frozen section, touch preparation, or hematoxylin-eosin staining on permanent section were eligible for participation. Patients with metastases identified initially or solely with immunohistochemical staining were ineligible. Treatment with lumpectomy to negative margins (no tumor at ink) was required. Women were ineligible if they had 3 or more positive SLNs, matted nodes, or gross extranodal disease, or if they had received neoadjuvant hormonal therapy or chemotherapy. 

Further comments in the article:

Surgical Morbidities

Paresthesias, shoulder pain, weakness, lymphedema, and axillary web syndrome are recognized morbidities of ALND.^7​,8,9​ As previously reported,¹⁰ the rate of wound infections, axillary seromas, and paresthesias among patients in the Z0011 trial was higher for the ALND group than for the SLND-alone group (70% vs 25%, P < .001). Lymphedema in the ALND group was significantly more common by subjective report (P < .001) and also tended to be higher by objective assessment of arm circumference. These findings are in accordance with other randomized comparisons of SLND with vs without ALND.

From the conclusion:

Despite limitations of the Z0011 trial, its findings could have important implications for clinical practice. Examination of the regional nodes with SLND can identify hematoxylin-eosin–detected metastases that would indicate a higher risk for systemic disease and the need for systemic therapy to reduce that risk. Results from Z0011 indicate that women with a positive SLN and clinical T1-T2 tumors undergoing lumpectomy with radiation therapy followed by systemic therapy do not benefit from the addition of ALND in terms of local control, disease-free survival, or overall survival. The only additional information gained from ALND is the number of nodes containing metastases. This prognostic information is unlikely to change systemic therapy decisions and is obtained at the cost of a significant increase in morbidity.¹⁰ The only rationale for ALND in these patients would be if the finding of additional nodal metastases would result in changes in systemic therapy. Because current guidelines do not support differences in adjuvant systemic therapy based on the number of positive lymph nodes, except in some uncommon select subgroups,^40​ ALND does not appear to be warranted in this patient population. 

Okay, I'm not Otter (a brillant analyst of medical literature), but what I see is:

1) Women had to have a limited number of positive nodes

2) Because IMRT wasn't in use during the time frame of the study, the radiation was tangential, which covers more of the axillary area

3) This sure does challenge some deeply entrenched assumptions.

As the onc I saw at Dana Farber told me, medical providers tend to be 1) early adopters--try something quickly, 2) medium adopters--wait until there is sufficient data to support a change in clinical practice and 3) late adopters--resistant to change (my boss STILL doesn't believe in the oncotype test....)

Remember that half the women were randomized to ALND in the trial, and we all made our decisions based on the best information we had, and there will still be physicians and centers who won't change their practice based on this information--but WE have the information and can use it.

We can have regrets, but we can't beat ourselves up, because we didn't have crystal balls, and if we weren't offered this study, we didn't know it was an option.

Kira