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Breast-cancer study questions lymph node removal

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4 Star

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Breast-cancer study questions lymph node removal

Our Review Summary

Room for improvement:

  • Readers would have benefited from early clarity that all participants in the study still had a sentinel lymph node biopsy and that the research focused on whether removal of all lymph nodes was necessary if the sentinel nodes were cancerous.
  • There was no discussion of cost impact of the findings, or about whether insurance might curtail coverage of lymph node dissection.
  • There was no discussion of the researchers’ admission of what could be potentially important limitations in the research.
  • The story didn’t explain how often complications of lymph node dissection occur.

 

Why This Matters

Women who have an axillary lymph node dissection (ALND) following a diagnosis of breast cancer, sometimes develop infections at the surgery site or lymphedema.  Depending on its severity, lymphedema can be painful, disfiguring, and expensive to treat.  While the symptoms of lymphedema can be treated, especially if caught early, once a person develops lymphedema, the person is always at risk for a recurrence of the lymphedema.

If ALND confers no mortality or disease-free survival benefit, it may no longer be recommended as standard treatment for women with T1 or T2 breast cancer with positive nodes as determined by sentinel lymph node dissection.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There was no discussion of costs.  The article does refer to an editorial that accompanied the paper.  The editorial observed that women would be spared “unnecessary surgery.”  Less surgery should result in lower costs for the patient.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The potential benefits were included in the article.  The “five-year ‘disease free’ survival rate was 83.9%…” for women who did not have the more aggressive surgery “…compared with 82.2% in those who did…”  Because full axillary lymph node dissection did not decrease mortality or decrease disease free survival, this may no longer be the standard recommendation.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The article accurately reported that the study found no benefit for the more aggressive full axillary lymph node dissection (ALND) among the 900 women studied with T1 or T2 breast cancer.  Because ALND poses risk of infection and lymphedema, more patients would be harmed by continuing the currently recommended treatment.  While the article mentions the potential complications of ALND, it does not quantify the incidence of infection or of lymphedema after ALND. Women should be told how often this occurs.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The article did not indicate that this study was a randomized trial.  The article should have noted that the trial was stopped early, after five years, at the recommendation of the data and safety monitoring committee because 20 years of follow-up would have been needed to observe 500 deaths as originally planned.  Because breast cancer is often diagnosed at an early stage, some doctors & patients prefer longer term follow-up than five years.

The article also did not include limitations of the study as reported by the researchers.  Possible limitations mentioned by the researchers were failure to achieve the originally planned accrual of 1900 patients and possible randomization imbalance favoring the group that had only the sentinel lymph node dissection. This is worth noting.

Does the story commit disease-mongering?

Satisfactory

There was no disease mongering.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The article included quotes from an editorial accompanying the study and from an independent source at the American Society of Clinical Oncology.  While the article did mention that the study was funded by the federal government, it would have been helpful for readers to know that it was funded by the National Cancer Institute.

Does the story compare the new approach with existing alternatives?

Satisfactory

The less extensive sentinel lymph node dissection surgery is clearly compared with the currently recommended axillary lymph node surgery.  The article points out that the more extensive surgery did not have a mortality or disease-free survival benefit.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

We’ll address the following concern under this criterion because we’re not sure where else to address it.  Readers would have benefited from early clarity that all participants in the study still had a sentinel lymph node biopsy and that the research focused on whether removal of all lymph nodes was necessary if the sentinel nodes were cancerous.

The article pointed out that if breast cancer has spread to any lymph nodes, doctors usually recommend removing all lymph nodes in the arm.

The article reported that in a phone interview, Gary Lyman of the American Society of Clinical Oncology said the group may revise its recommendations for full lymph node removal based on the results of this study.  Since many surgeons and oncologists base their advise to patients on these recommendations, patients may soon be offered this less extensive surgery option.
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Does the story establish the true novelty of the approach?

Satisfactory

The novelty of the study results were supported by quotes from an editorial that accompanied the study.  The editorial referred to the study as an “important contribution” and noted the study provided “strong evidence” that many women can safely forgo complete lymph node removal.
A representative of the American Society of Clinical Oncology characterized the study as “practice-changing” and thought the findings will probably prompt ASCO to revise its recommendations for breast cancer patients with T1 or T2 tumors who have positive sentinel lymph nodes.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The article includes information from a telephone interview with Gary Lyman of the American Society of Clinical Oncology which recommends surgery and treatment options for patients. And it includes comments from editorial authors.

Total Score: 7 of 10 Satisfactory

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