Prognostic Value of Pathologic Complete Response After Primary Chemotherapy in Relation to Hormone Receptor Status and Other Factors

2006 ◽  
Vol 24 (7) ◽  
pp. 1037-1044 ◽  
Author(s):  
Valentina Guarneri ◽  
Kristine Broglio ◽  
Shu-Wan Kau ◽  
Massimo Cristofanilli ◽  
Aman U. Buzdar ◽  
...  

Purpose To evaluate whether hormonal receptor (HR) status can influence the prognostic significance of pathologic complete response (pCR). Patients and Methods This retrospective analysis included 1,731 patients with stage I to III noninflammatory breast cancer treated between 1988 and 2005 with primary chemotherapy (PC). Ninety-one percent of patients received anthracycline-based PC, and 66% received additional taxane therapy. pCR was defined as no evidence of invasive tumor in the breast and axillary lymph nodes. Results Median age was 49 years (range, 19 to 83 years). Sixty-seven percent of patients (n = 1,163) had HR-positive tumors. A pCR was observed in 225 (13%) of 1,731 patients; pCR rates were 24% in HR-negative tumors and 8% in HR-positive tumors (P < .001). A significant survival benefit for patients who achieved pCR compared with no pCR was observed regardless of HR status. In the HR-positive group, 5-year overall survival (OS) rates were 96.4% v 84.5% (P = .04) and 5-year progression-free survival (PFS) rates were 91.1% v 65.3% (P < .0001) for patients with and without pCR, respectively. For the HR-negative group, 5-year OS rates were 83.9% v 67.4% (P = .003) and 5-year PFS rates were 83.4% v 50.0% (P < .0001) for patients with and without pCR, respectively. After adjustment for adjuvant hormonal treatment, HR status, clinical stage, and nuclear grade, patients who achieved a pCR had 0.36 times the risk of death. Conclusion pCR is associated with better outcome regardless of HR status in breast cancer patients who receive PC.

2004 ◽  
Vol 22 (24) ◽  
pp. 4958-4965 ◽  
Author(s):  
Véronique Diéras ◽  
Pierre Fumoleau ◽  
Gilles Romieu ◽  
Michèle Tubiana-Hulin ◽  
Moïse Namer ◽  
...  

Purpose This randomized, noncomparative, parallel-group study was designed to evaluate the pathologic complete response (pCR) rate of combined doxorubicin plus paclitaxel (AP) and doxorubicin plus cyclophosphamide (AC) as neoadjuvant chemotherapy in patients with previously untreated breast cancer who were unsuitable for conservative surgery. Patients and Methods A total of 200 patients with T2-3, N0-1, M0 disease were randomly assigned in a 2:1 ratio to receive preoperative chemotherapy with either doxorubicin 60 mg/m2 plus paclitaxel 200 mg/m2 as a 3-hour infusion (AP) or doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (AC) every 3 weeks for 4 courses followed by surgery. Results A pCR (eradication of invasive carcinoma in tumor and in axillary lymph nodes) was found in 16% and 10% of patients in the AP and AC arms, respectively, by study center pathologists, and in 8% and 6% of patients, respectively, by independent pathologists. Patients with pCRs tended to have unifocal disease, tumors with negative hormonal receptor status, and less differentiation (Scarff, Bloom, and Richardson scale grade 3). Breast-conserving surgery was performed in 58% and 45% of patients in the AP and AC arms, respectively. An objective clinical response was achieved in 89% of patients in the AP arm and 70% in the AC arm. At a median follow-up of 31 months, disease-free survival (DFS) was higher in patients who reached pCR versus those without pCR (91% v 70%). Conclusion The encouraging pathologic and clinical responses of patients with breast cancer after neoadjuvant chemotherapy with doxorubicin plus paclitaxel warrant additional investigation of paclitaxel in the neoadjuvant setting of breast cancer management.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 1017-1017
Author(s):  
Sarah Schellhorn Mougalian ◽  
Xiudong Lei ◽  
Limin Hsu ◽  
Gabriel N. Hortobagyi ◽  
Henry Mark Kuerer ◽  
...  

1017 Background: Pathologic complete response (pCR) of tumors in the breast and axillary lymph nodes (ALN) after primary systemic chemotherapy (PST) is associated with an excellent outcome. A previous analysis showed superior 5-year overall survival (OS) and relapse-free survival (RFS) for patients who achieved an ALN pCR after PST compared to those without a pCR in 5 prospective clinical trials. This study is an expanded analysis of all patients treated with PST at our institution examining the impact of ALN pCR on 10-year OS and RFS. Methods: Patients with clinical stage II/III and pathologically confirmed ALN metastases who underwent PST were categorized into 1 of 2 groups: ALN pCR and ALN residual disease. Additional data were collected, including breast cancer subtype, clinical tumor size, and lymph node staging, pathologic tumor (T) stage, and class of PST. RFS and OS were estimated by the Kaplan-Meier product limit method. Subset analyses were performed on patients with HER2-positive cancer. Results: 1,600 women diagnosed between 1989 and 2007 were identified. Median follow-up was 79 months (5-277); 454 (28.4%) achieved an ALN pCR. ALN pCR was associated with triple-negative and higher grade cancers, lower clinical stage, and lower pathologic breast T stage. 5-year OS and RFS estimates were similar to prior analysis. The 10-year OS was 85% and 58% and the 10-year RFS 83% and 55% (p < 0.001), for patients who achieved an ALN pCR and those with residual ALN disease. For HER2-positive breast cancers, 67.3% of patients who received HER2-targeted therapy achieved an ALN pCR vs. 32.3% without HER2-targeted therapy (p < 0.001). For patients receiving HER2-targeted therapy for HER2-positive breast cancer (n = 153), the 10-year OS was 92% and 52% (p = 0.006), and the 10-year RFS was 89% and 59% (p < 0.001) for those with and without an ALN pCR. Conclusions: ALN pCR is an excellent early surrogate marker for long-term outcome, 10-year RFS and OS. In HER2-positive breast cancers, HER2-targeted therapy is associated with high rates of pCR. Despite the aggressive nature of their disease, patients who achieve ALN pCR with PST have an excellent 10-year prognosis.


2021 ◽  
Author(s):  
Jue Wang ◽  
Yan Li ◽  
Shuo Li ◽  
Qiannan Zhu ◽  
Xiaoqing Shi ◽  
...  

Abstract BackgroundStudies show that axillary surgery can be potentially omitted in certain breast cancer patients who achieve breast pathologic complete response (pCR) after neoadjuvant systemic therapy (NST). However, potential differences between the ypT0 (no residual invasive or in situ carcinoma in the breast) and ypTis (in situ carcinoma in the breast) subgroups remain to be explored. Furthermore, whether axillary surgery can be omitted in patients with clinically assessed positive axillary lymph nodes (cN+) remains unknown.MethodsThis retrospective cohort study included 258 patients with early or locally advanced breast cancer who underwent breast and axillary surgery after NST. Clinical and pathologic data were compared between patients with breast pCR (ypT0/is) and those without breast pCR.ResultsAmong the patients with initial cN0, the rate of axillary pCR was similar between the breast pCR and breast non-pCR groups (P = 0.1543). Among those with breast pCR, the rate of axillary pCR was 100% in both the ypT0 and ypTis subgroups. Furthermore, among those with initial cN+, the rate of axillary pCR was higher in the breast pCR group than in the breast non-pCR group (P < 0.0001). Among the patients with breast pCR, the rate of axillary pCR was higher in the ypT0 subgroup than in the ypTis subgroup (P = 0.0034).ConclusionAxillary surgery may potentially be omitted in patients with initial cN0 who achieve breast pCR (ypT0/is), and may also be considered for omission in patients with initial cN+ who achieve ypT0 (not ypTis).


2021 ◽  
Author(s):  
Rui Chen ◽  
Shuo Li ◽  
Yan Li ◽  
Qiannan Zhu ◽  
Xiaoqing Shi ◽  
...  

Abstract Purpose Studies show that axillary surgery can be potentially omitted in certain breast cancer patients who achieve breast pathologic complete response (pCR) after neoadjuvant systemic therapy (NST). However, potential differences between the ypT0 and ypTis subgroups remain to be explored. Furthermore, whether axillary surgery can be omitted in patients with clinically assessed positive axillary lymph nodes (cN+) remains unknown. This study was to evaluate the status of axillary lymph nodes for patients who achieved breast pCR after NST in the real-world study. Methods This retrospective cohort study included 258 patients with early or locally advanced breast cancer who underwent breast and axillary surgery after NST. Clinical and pathologic data were compared between patients with breast pCR (ypT0/is) and those without breast pCR. Results The rate of breast pCR after NST was 27.1% (70/258). Among the patients with initial cN0, the rate of axillary pCR was similar between the breast pCR and breast non-pCR groups (100% vs. 85.7%, P = 0.1543). Among those with breast pCR, the rate of axillary pCR was 100% in both the ypT0 and ypTis subgroups. Furthermore, among those with initial cN+, the rate of axillary pCR was higher in the breast pCR group than in the breast non-pCR group (82.7% vs. 22.9%, P < 0.0001). Among the patients with breast pCR, the rate of axillary pCR was higher in the ypT0 subgroup than in the ypTis subgroup (94.3% vs. 58.8%, P = 0.0034). Conclusion Axillary surgery may potentially be omitted in patients with initial cN0 who achieve breast pCR (ypT0/is), and may also be considered for omission in patients with initial cN + who achieve ypT0 (not ypTis).


2005 ◽  
Vol 23 (28) ◽  
pp. 7098-7104 ◽  
Author(s):  
Ana M. Gonzalez-Angulo ◽  
Sean E. McGuire ◽  
Thomas A. Buchholz ◽  
Susan L. Tucker ◽  
Henry M. Kuerer ◽  
...  

Purpose To identify clinicopathological factors predictive of distant metastasis in patients who had a pathologic complete response (pCR) after neoadjuvant chemotherapy (NC). Methods Retrospective review of 226 patients at our institution identified as having a pCR was performed. Clinical stage at diagnosis was I (2%), II (36%), IIIA (27%), IIIB (23%), and IIIC (12%). Eleven percent of all patients were inflammatory breast cancers (IBC). Ninety-five percent received anthracycline-based chemotherapy; 42% also received taxane-based therapy. The relationship of distant metastasis with clinicopathologic factors was evaluated, and Cox regression analysis was performed to identify independent predictors of development of distant metastasis. Results Median follow-up was 63 months. There were 31 distant metastases. Ten-year distant metastasis-free rate was 82%. Multivariate Cox regression analysis using combined stage revealed that clinical stages IIIB, IIIC, and IBC (hazard ratio [HR], 4.24; 95% CI, 1.96 to 9.18; P < .0001), identification of ≤ 10 lymph nodes (HR, 2.94; 95% CI, 1.40 to 6.15; P = .004), and premenopausal status (HR, 3.08; 95% CI, 1.25 to 7.59; P = .015) predicted for distant metastasis. Freedom from distant metastasis at 10 years was 97% for no factors, 88% for one factor, 77% for two factors, and 31% for three factors (P < .0001). Conclusion A small percentage of breast cancer patients with pCR experience recurrence. We identified factors that independently predicted for distant metastasis development. Our data suggest that premenopausal patients with advanced local disease and suboptimal axillary node evaluation may be candidates for clinical trials to determine whether more aggressive or investigational adjuvant therapy will be of benefit.


2021 ◽  
Author(s):  
Guixin Wang ◽  
Shuhao Zhang ◽  
Meiling Wang ◽  
Lin Liu ◽  
Yaqian Liu ◽  
...  

Abstract Background: Occult metastases in axillary lymph nodes have been reported to be associated with poor prognosis in patients with breast cancer. However, studies on the prognostic value of occult metastases remain controversial. This meta-analysis aimed to evaluate the prognostic significance of occult lymph node metastases in breast cancer.Methods: Studies published published until May, 2020, which retrospectively examined negative lymph nodes by step sectioning and/or immunohistochemistry, were retrieved from MEDLINE, EMBASE, CNKI, and Cochrane Library. The pooled Relative risk (RR) with 95% confidence interval (95% CI) for overall survival (OS) and disease-free survival (DFS) were calculated to appraise the associations between occult metastases and prognosis.Results: The results showed patients with occult metastases in axillary lymph nodes had poorer five-year DFS (RR = 0.930; 95% CI = 0.907–0.954) and OS (RR = 0.972; 95% CI = 0.954–0.990). Furthermore, the DFS (RR = 0.887; 95% CI = 0.810–0.972) and OS (RR = 0.896; 95% CI = 0.856–0.939) of patients with occult metastases were much lower after a ten-year follow-up.Conclusions: Occult metastases in the axillary lymph nodes of patients with breast cancer are associated with poorer disease-free and overall survival. Occult metastases might serve as a predictive factor of survival outcomes in patients with breast cancer.


1997 ◽  
Vol 15 (4) ◽  
pp. 1401-1408 ◽  
Author(s):  
B E Hillner ◽  
M K McDonald ◽  
L Penberthy ◽  
C E Desch ◽  
T J Smith ◽  
...  

PURPOSE To demonstrate the use of a combined data base to evaluate the care for local/regional invasive breast cancer in a large insured population of women aged less than 64 years. PATIENTS AND METHODS We linked the procedural and hospital claims from Blue Cross Blue Shield (BCBS) of Virginia with clinical stage data from the Virginia Cancer Registry (VCR) from 1989 to 1991. A total of 918 women were assessed with a median age of 50 years; 68% had tumors less than 2 cm, 30% had positive axillary nodes, and 68% were assessed as having local summary stage. A quality-of-care "report card" was used based on standards of care from international Consensus Conferences. RESULTS Eight percent had a mastectomy as the initial biopsy procedure. Sixty-nine percent of women ultimately underwent mastectomy. Of those women who underwent lumpectomy, 86% had subsequent radiation. Within 3 months of diagnosis, 43% had a bone scan and 20% a computed tomography (CT) scan. Of women with positive axillary lymph nodes, 83% aged less than 51 years and 52% aged 51 to 64 years received chemotherapy. Fifty-six percent of all women had claims from a medical oncologist. Of women having a total mastectomy, 27% had claims from a plastic surgeon. Sixty-six percent to 76% of women had a mammogram, 24% a bone scan, and 14% a CT scan in the 0-18 and 18-36 month intervals following primary treatment. CONCLUSION This study confirms the feasibility of linking sources of data that provide complementary information needed to develop measurements regarding standards of quality and efficiency of oncologic care. This report should serve as an initial benchmark while we await reports from other populations to define the best practice.


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