Tag Archives: Breast Neoplasms

The ACOSOG Z0011 Randomized Control Trial

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One discussion last week included the ACOSOG Z0011 RCT.

Reference: Giuliano AE, et al. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: the ACOSOG Z0011 (Alliance) randomized control trial. JAMA. 2017 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470.

Summary: The results of the American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial were first reported in 2005 with a median follow-up of 6.3 years. Longer follow-up was necessary because the majority of the patients had estrogen receptor-positive tumors that may recur later in the disease course. In this follow-up study, the authors sought to determine whether the 10-year overall survival of patients with 2 or fewer sentinel lymph node metastases treated with breast-conserving therapy and sentinel lymph node dissection (SLND) alone without axillary lymph node dissection (ALND) is noninferior to that of women treated with axillary dissection.

Compared with ALND, SLND alone was found to be noninferior for overall survival. The 10-year overall survival rate was 86.3% in the SLND alone group and 83.6% in the ALND group. The unadjusted HR comparing overall survival between the SLND alone group and the ALND group was 0.85 (1-sided 95% CI, 0–1.16), which did not cross the prespecified noninferiority HR margin of 1.3. The HR for overall survival adjusting for adjuvant therapy (chemotherapy, endocrine therapy, radiation, or a combination of these 3) and age for the SLND alone group compared with the ALND group was 0.93 (1-sided 95% CI, 0–1.28) (Table 2).

10yr survival

CONCLUSION: In this randomized clinical trial including 856 women, after median follow-up of 9.3 years, overall survival for patients treated with sentinel lymph node dissection alone was not inferior to those treated with completion axillary lymph node dissection (86.3% vs 83.6%, respectively; noninferiority hazard ratio margin of 1.3). These findings do not support the use of axillary lymph node dissection when 2 or fewer metastases are found with sentinel lymph node sampling in women with cT1-2M0 breast cancer.

What is the composition of seroma fluid?

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One discussion this week included the composition of post-surgical seroma fluid.

Reference: Valeta-Magara A, et al. Pro-oncogenic cytokines and growth factors are differently expressed in the post-surgical wound fluid from malignant compared to benign breast lesions. SpringerPlus. 2015 Sep 5;4:483. doi:10.1186/s40064-015-1260-8.

Summary: Post-operative accumulation of seroma in the surgical cavity following breast cancer surgery varies in incidence from 2.5 to 51 % of patients. Analysis of seroma has shown that it is an inflammatory exudate, classically seen in the first phase of wound repair. Given that seroma is derived from the wound-healing response of tumor-adjacent stroma, Valeta-Magara et al (2015) explored “whether seroma derived from the excision of benign tumors differs from that of malignant tumors, as malignant and benign tumors may activate or influence the adjacent stroma and infiltrating immune cells differently.”

Post-surgical seroma fluids from 59 patients who had undergone either lumpectomy or mastectomy breast surgery were collected at week 1 or 2 post-surgery by percutaneous aspiration.

It was found that surgical cavity seroma from breast cancer patients has ahigher expression of certain tumorpromoting cytokines, including GRO, ENA-78/CXCL5 and TIMP-2, and lower expression of tumor-inhibiting cytokines IGFBP-1, IL-16, IFN-γ, IL-3 and FGF-9, when compared to seroma from non-cancer patients (p.2). Patients with high body mass index also had higher levels of leptin regardless of malignancy.

In conclusion, breast post-surgical tumor cavity contains factors that are pro-inflammatory regardless of malignant or benign disease, but in malignant disease there is significant enrichment of additional pro-oncogenic chemokines, cytokines and growth factors, and reduction in tumor-inhibiting factors. These results are consistent with tumor conditioning of surrounding normal stromal tissue and creation of a pro-oncogenic environment that persists long after surgical removal of the tumor.

The authors also note that a differential expression of the eight factors between benign and malignant seroma fluid offers research hypotheses to be explored further to determine their role in breast tumor progression, local recurrence and metastasis.