Clinicopathologic Analysis of 722 Breast Cancer Patients Who Met the Inclusion Criteria of the TAILORx Trial
Breast cancer remains one of the most prevalent cancers among women worldwide, and the decision to administer adjuvant chemotherapy in early-stage cases is a critical yet often controversial topic. The TAILORx (Trial Assigning IndividuaLized Options for Treatment) trial has provided significant insights into this issue, suggesting that a substantial proportion of patients with early-stage, hormone receptor-positive, HER2-negative breast cancer can avoid chemotherapy and rely solely on adjuvant endocrine therapy. This retrospective study aimed to analyze the clinicopathologic features and prognostic factors of 722 breast cancer patients who met the inclusion criteria of the TAILORx trial, offering a real-world perspective on treatment decisions in the absence of multigene testing.
The study was conducted at Peking University First Hospital, where 2430 patients with early-stage breast cancer treated between January 2008 and December 2015 were reviewed. Among these, 722 patients (29.7%) met the TAILORx trial’s inclusion criteria, which included being aged 18 to 75 years, having a tumor diameter of 1.1 to 5.0 cm (or 0.6–1.0 cm with a histologic grade of 3), negative axillary lymph nodes, no distant metastasis, hormone receptor positivity, HER2 negativity, no preoperative treatment, surgical treatment, and standard adjuvant endocrine therapy. These patients were divided into two groups: 417 (57.8%) who received only adjuvant endocrine therapy (non-chemo group) and 305 (42.2%) who received adjuvant chemotherapy followed by endocrine therapy (chemo group).
The clinicopathologic characteristics of the patients were thoroughly analyzed. Significant differences were observed between the two groups in terms of age at diagnosis, menstrual status, T stage, pathologic type, histologic grade, Ki67 index, and the presence of vascular tumor thrombus. For instance, the mean age in the chemo group was 51.3 years, compared to 56.5 years in the non-chemo group. Additionally, 58% of the chemo group were postmenopausal, whereas 48.9% of the non-chemo group were postmenopausal. The T stage distribution also varied, with 78.4% of the chemo group having T1 tumors compared to 63% in the non-chemo group. Histologic grade and Ki67 index were other critical factors, with higher grades and indices more prevalent in the chemo group.
Prognostic analysis revealed that the 5-year overall survival (OS) rates were identical for both groups at 97.9%, indicating no significant difference in OS between the chemo and non-chemo groups. However, the 5-year disease-free survival (DFS) rate was higher in the non-chemo group (97.9%) compared to the chemo group (94.7%), with a statistically significant difference. This suggests that patients who received only endocrine therapy had a lower risk of recurrence or metastasis. The Cox regression analysis supported these findings, showing no significant difference in OS (HR = 1.00, 95% CI: 0.46–2.21) but a higher probability of recurrence and metastasis in the chemo group (HR = 3.05, 95% CI: 1.40–6.67).
The study also evaluated the clinical risk categories based on the 10th St. Gallen consensus, dividing patients into low-risk and intermediate-risk groups. Among the 722 patients, 223 (30.9%) were classified as low risk, and 499 (69.1%) as intermediate risk. No patients were categorized as high risk. In the low-risk group, 81.2% received only adjuvant endocrine therapy, while 18.8% received adjuvant chemotherapy. In the intermediate-risk group, 52.7% received adjuvant chemotherapy, and 47.3% received only endocrine therapy. The DFS in the non-chemo group was significantly higher than in the chemo group for intermediate-risk patients, further emphasizing the potential overuse of chemotherapy in this subgroup.
The findings of this study highlight the importance of clinicopathologic features in guiding treatment decisions for early-stage breast cancer patients, especially in settings where multigene testing is not available. The results suggest that clinicians can effectively identify a subset of patients who do not require adjuvant chemotherapy based on factors such as age, menstrual status, tumor size, histologic grade, Ki67 index, and the presence of vascular tumor thrombus. However, the study also underscores the need for more precise tools, such as multigene testing, to further refine treatment decisions and avoid unnecessary chemotherapy.
The study has several limitations, including its single-center design, which may introduce selection bias, and the lack of multigene testing data due to regulatory restrictions in China. Additionally, the follow-up period was relatively short, and the number of events was limited, which may affect the robustness of the survival analysis. Future multicenter studies with longer follow-up periods and the inclusion of multigene testing data are encouraged to provide more comprehensive insights.
In conclusion, this retrospective analysis of 722 breast cancer patients who met the TAILORx trial criteria demonstrates that clinicopathologic features can effectively guide treatment decisions in the absence of multigene testing. While a significant proportion of patients can avoid chemotherapy based on these features, the study also reveals that nearly half of the patients still receive adjuvant chemotherapy, raising questions about the necessity of such treatment. The integration of multigene testing into clinical practice could further optimize treatment strategies, particularly for intermediate-risk patients, ensuring that chemotherapy is reserved for those who truly benefit from it.
doi.org/10.1097/CM9.0000000000000548
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