Pathologic Complete Response With Six Compared With Three Cycles of Neoadjuvant Epirubicin Plus Docetaxel and Granulocyte Colony-Stimulating Factor in Operable Breast Cancer: Results of ABCSG-14

2007 ◽  
Vol 25 (15) ◽  
pp. 2012-2018 ◽  
Author(s):  
Günther G. Steger ◽  
Arik Galid ◽  
Michael Gnant ◽  
Brigitte Mlineritsch ◽  
Alois Lang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Complete Response ◽  
Breast Conserving Surgery ◽  
Operable Breast Cancer ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Stimulating Factor

Purpose Preoperative (neoadjuvant) chemotherapy for operable breast cancer downstages tumors initially not suitable for breast-conserving surgery. A pathologic complete response (pCR) to neoadjuvant chemotherapy may be a surrogate for longer overall survival, but this beneficial effect remains to be established. This phase III trial evaluated whether doubling the number of cycles of neoadjuvant treatment increased the pCR rate. Patients and Methods Patients with biopsy-proven breast cancer (T1-4a-c, N±, M0; stage I to III) were eligible and randomly assigned to either three or six cycles of epirubicin 75 mg/m2 and docetaxel 75 mg/m2 on day 1 and granulocyte colony-stimulating factor on days 3 through 10 (ED+G), every 21 days. The primary end point was the pCR rate of the breast tumor. Secondary end points were pathologic nodal status after surgery and the rate of breast-conserving surgery. Results A total of 292 patients were accrued, and 288 patients were assessable for efficacy and safety. Groups were well balanced for known prognostic factors. Six cycles of ED+G, compared with three cycles, resulted in a significantly higher pCR rate (18.6% v 7.7%, respectively; P = .0045), a higher percentage of patients with negative axillary status (56.6% v 42.8%, respectively; P = .02), and a trend towards more breast-conserving surgery (75.9% v 66.9%, respectively; P = .10). Rates of adverse events were similar, and no patients died on treatment. Conclusion Doubling the number of neoadjuvant ED+G cycles from three to six results in higher rates of pCR and negative axillary nodal status with no excess of adverse effects. Thus, six cycles of ED+G should be the standard neoadjuvant treatment for operable breast cancer if this combination is chosen.

Dose-Dense Doxorubicin, Docetaxel, and Granulocyte Colony-Stimulating Factor Support With or Without Tamoxifen as Preoperative Therapy in Patients With Operable Carcinoma of the Breast: A Randomized, Controlled, Open Phase IIb Study

2001 ◽  
Vol 19 (15) ◽  
pp. 3506-3515 ◽  
Author(s):  
Gunter von Minckwitz ◽  
Serban D. Costa ◽  
Günter Raab ◽  
Jens-Uwe Blohmer ◽  
Holger Eidtmann ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor Status ◽  
Breast Conservation ◽  
Operable Breast Cancer ◽  
Pathologic Response ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Nonsignificant Difference ◽  
Dose Dense ◽  
Stimulating Factor

PURPOSE: To investigate the effect of adding tamoxifen to a preoperative dose-dense doxorubicin and docetaxel regimen on the pathologic response of primary operable breast cancer. PATIENTS AND METHODS: Patients (tumor size ≥ 3 cm, N0 to 2, M0) were prospectively randomized to receive every 14 days a total of four cycles of doxorubicin 50 mg/m2 and docetaxel 75 mg/m2, either with (ADocT) or without (ADoc) simultaneous tamoxifen. Granulocyte colony-stimulating factor (G-CSF) was routinely given on days 5 to 10. Surgery followed 8 to 10 weeks after the start of treatment. RESULTS: Within 14 months, 250 patients were included in the study at 56 centers. Of 992 planned cycles, 97.9% were administered. Pathologically complete remission (pCR) with no detectable viable tumor cells was achieved in 9.7%. There was a nonsignificant difference of −1.2% in favor of ADoc, with a 95% confidence interval of −8.6% to 6.2%. A further 2.4% had only noninvasive tumor residues, and 13.8% had focal invasive residues. Complete and partial responses detected by palpation were observed in 28.9% and 52.4%, respectively. The response rates (complete and partial) by best appropriate imaging methods were 77.5% and 67.5% for ADocT and ADoc, respectively. Breast conservation was possible in 68.8% of the patients. A tendency toward more frequent toxic events was observed with ADocT treatment. Significant predictors of pCR to chemotherapy were negative lymph node and negative estrogen receptor status. CONCLUSION: A dose-dense regimen of ADoc with G-CSF offers high compliance, moderate toxicity, and rapid efficacy as a form of preoperative chemotherapy in operable breast cancer. Concurrent treatment with tamoxifen for 8 weeks could not improve the pathologic response rate.

Locoregional recurrence following pathologic complete response in patients with T1-3 N0 breast cancer treated with neoadjuvant chemotherapy, breast conserving surgery and whole breast radiation: Is a trial of omission of radiation warranted?

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12625-e12625
Author(s):  
Elena Parvez ◽  
Thierry Muanza
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Endocrine Therapy ◽  
Locoregional Recurrence ◽  
Prospective Trial ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Breast Conserving Surgery ◽  
Study Objective

e12625 Background: Pathologic complete response(pCR) after neoadjuvant chemotherapy(NAC) in patients with breast cancer(BC) is associated with decreased recurrence and improved survival. In NSABP B18 and B27, 10-yr locoregional recurrence(LRR) after pCR in patients with Stage I-III BC undergoing breast conserving surgery(BCS) and whole breast RT(WBRT) was 5.2-6.9%. However, LRR may be overestimated as Her2 therapy was not used and only some eligible patients received endocrine therapy. A retrospective study using modern protocols found a 5-yr LRR of up to 2.6%. We hypothesize that LRR in N0 patients is even lower, and de-escalation of therapy should be examined. The study objective is to assess if a prospective trial of omission of WBRT after BCS in patients with N0 BC and pCR after NAC is warranted and to assess feasibility. Methods: Patients with T1-T3 N0 invasive BC diagnosed between Dec 2011-2017 treated with NAC and BCS were identified from a hospital BC registry. Health records were retrospectively reviewed to identify patients with pCR, defined as absence of residual invasive or in-situ disease(ypT0N0). Incidents of locoregional and distant recurrence were recorded. Results: Of 89 patients with T1-3 N0 invasive BC treated with NAC and BCS, 29(32.6%) had pCR. Median follow-up was 61.1 months. Median age was 55 yrs and median tumour size was 2.4cm. Receptor status was 16(55.2%) HR-Her2-, 4(13.8%) HR-Her2+, 7(24.1%) HR+Her2+ and 2(6.9%) HR+Her2-. NAC protocols consisted of an anthracycline and/or a taxane in 27(90%) patients, and 6 patients were treated on NAC trials. All patients with Her2+ disease received Her2 targeted therapy. Adjuvant endocrine therapy was taken by 8 of 9 patients with HR+ disease. All patients received WBRT without nodal RT. RT plan was available for 26(86.7%) patients. RT dose ranged from 40-50Gy, and all but 4 received tumour bed boost. There were no local or regional recurrence events at last follow-up. One patient developed brain metastases at 15.7 months. Conclusions: Over 6 years, 29 patients were identified that would be eligible for a prospective trial evaluating omission of WBRT after pCR in N0 patients treated with NAC and BCS. At median 5-yr follow-up, there were no locoregional recurrences in our cohort, demonstrating that the absolute benefit provided by WBRT is likely small. Our results indicate a prospective trial is warranted and will require multi-institution participation to accrue.

scholarly journals Tumor Biology Correlates With Rates of Breast-Conserving Surgery and Pathologic Complete Response After Neoadjuvant Chemotherapy for Breast Cancer

2014 ◽  
Vol 260 (4) ◽  
pp. 608-616 ◽  
Author(s):  
Judy C. Boughey ◽  
Linda M. McCall ◽  
Karla V. Ballman ◽  
Elizabeth A. Mittendorf ◽  
Gretchen M. Ahrendt ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Tumor Biology ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Breast Conserving Surgery

Impact of sequence order of anthracyclines and taxanes in neoadjuvant chemotherapy for breast cancer: Results from a prospective institutional database.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12619-e12619
Author(s):  
Megan Tesch ◽  
Nathalie LeVasseur ◽  
Christine E. Simmons ◽  
Stephen K. L. Chia
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Triple Negative ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Breast Conserving Surgery ◽  
Breast Cancer Patients ◽  
Duration Of Treatment ◽  
Eligibility Criteria ◽  
The Impact

e12619 Background: There has been growing interest in the optimal sequencing of anthracyclines and taxanes in neoadjuvant chemotherapy (NACT) for breast cancer. However, data comparing efficacy of administering taxanes prior to anthracyclines as opposed to the opposite sequence remains limited and inconsistent. The objective of our study was to assess the impact of sequence order on pathologic and clinical outcomes in a real-world setting. Methods: A prospective institutional database was analyzed to identify all HER2-negative breast cancer patients treated with NACT from 2012 to 2019. Rates of pathologic complete response (pCR), down-staging, and breast-conserving surgery were compared between patients who received anthracyclines followed by taxanes (AC-T) to those who received taxanes followed by anthracyclines (T-AC). Chi-square and independent sample non-parametric tests were used to test for associations between variables and outcomes. Results: Of the 270 patients who met eligibility criteria, 175 (65%) received AC-T and 95 (35%) received T-AC. Median age was 55 (IQR 24-86). Overall, 83% of patients had stage IIB or greater tumors, 40% had grade 3 histology, and 36% had triple-negative disease. Characteristics were balanced between the AC-T and T-AC groups (all p < 0.05). Median duration of treatment with NACT was 102 days (IQR 29-203). Rates of pCR (19% vs 21%, p = 0.750), down-staging (68% vs 61%, p = 0.188), and conversion to breast-conserving surgery (26% vs 20%, p = 0.314) were similar for AC-T vs T-AC, respectively. pCR was higher in triple-negative compared to hormone-positive cases (33% vs 13%, p < 0.001). Conclusions: In this small population-based cohort, sequence order of anthracyclines and taxanes did not demonstrate statistically significant differences in evaluated outcomes from NACT for breast cancer. This supports the current variation in prescribing practice and highlights the need for further studies in this area.

Randomized Parallel Study of Doxorubicin Plus Paclitaxel and Doxorubicin Plus Cyclophosphamide As Neoadjuvant Treatment of Patients With Breast Cancer

2004 ◽  
Vol 22 (24) ◽  
pp. 4958-4965 ◽  
Author(s):  
Véronique Diéras ◽  
Pierre Fumoleau ◽  
Gilles Romieu ◽  
Michèle Tubiana-Hulin ◽  
Moïse Namer ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Disease Free Survival ◽  
Complete Response ◽  
Conservative Surgery ◽  
Axillary Lymph Nodes ◽  
Axillary Lymph ◽  
Cancer Management

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.

Response to neoadjuvant therapy and long-term survival in patients with triple-negative breast cancer (TNBC) in a Peruvian institute.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e12038-e12038
Author(s):  
Katerin Ingrid Rojas
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Complete Response ◽  
Age At Diagnosis ◽  
Term Survival ◽  
Response To Chemotherapy ◽  
Significant Difference ◽  
The Mean

e12038 Background: TNBC is defined by the lack of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 expressions (HER-2). This molecular classification is an excellent prognostic and predictive method in breast cancer (BC). This is an aggressive malignancy with a poor prognosis despite the high rates of response to chemotherapy. Methods: Observational descriptive. We included 165 patients with TNBC stage I-III who received neoadjuvant chemotherapy at National Cancer Institute of Peru from 2000 to 2010. Clinical and pathologic complete response rates, survival measurements, and organ-specific rates of relapse were evaluated. Overall survival (OS) and disease free survival (DFS). Results: The mean age at diagnosis was 48.6 years (range, 24-74 years). The mean size tumor before treatment was 7.7 cm (range, 1-25 cm). One hundred and fifty seven patients (95.2%) had ductal carcinoma. One hundred twenty nine cases (78.2%) were histological grade III. According to T stage, 65 (39.4%) T3 and 83 (50.3%) T4. Thirty four cases (20.6%) were N0. Seventy three patients (44.2%) received AC-Paclitaxel schedule. Thirty four patients (20.6%) had CR to neoadjuvant chemotherapy. There is a significant difference about tumor size before and after neoadjuvant treatment (7.7 vs. 3.6, p<0.05).OS at 5 years for patients with residual disease was 83.5%. In patients with complete response the DFS at 5 years was 55.1%. Locoregional and lung were the most frequent site of recurrence (15.8%) and (13.9%) respectively. According Miller and Paine to grade tumor response, 17 patients(10.3%) I ,33 (20.0%) II, 33 (20.0%) III, 20 (12.1%) IV and 27 (16.4%) V. Node response, 20 patients (12.1%) had type A, 51 (30.9%) type B, 23 (13.9%) type C and 34 (20.6%) type D. Conclusions:These results suggest that most TNBC are in accordance with literature data, especially concerning young age at diagnosis, high grade tumors, advances locally stage at diagnosis, and short time to relapse, high response rate to chemotherapy and excellent OS and DFS. We know it is a heterogeneous disease; however the clinical characteristics still play an important role to predict treatment response and survival.

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