Dose-dense nab-paclitaxel (nanoparticle albumin-bound paclitaxel) in adjuvant chemotherapy for breast cancer: A feasibility study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 594-594 ◽  
Author(s):  
H. J. Burstein ◽  
E. L. Mayer ◽  
J. Peppercorn ◽  
L. M. Parker ◽  
K. Hannagan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Febrile Neutropenia ◽  
Patient Scheduling ◽  
Full Cohort ◽  
Treatment Delays ◽  
Grade 3 ◽  
Chemotherapy Patients ◽  
Dose Dense ◽  
Taxane Chemotherapy

594 Background: We sought to evaluate the feasibility of substituting nab-paclitaxel (ABI-007) for paclitaxel as part of “dose-dense” adjuvant sequential doxorubicin / cyclophosphamide (AC) followed by taxane chemotherapy. Patients and Methods: Eligible patients had stage I-III breast cancer receiving adjuvant/neoadjuvant chemotherapy, ANC > 1500, and LVEF > 50%. Patients received AC (60 mg/m2 and 600 mg/m2) every 2 weeks × 4 cycles with G-CSF support, followed by nab- paclitaxel 260 mg/m2 every 2 weeks × 4 cycles. The endpoint was incidence of treatment delay during nab-paclitaxel therapy. Results: 66 women (median age 48 years) were enrolled. Among the first 11 given nab-paclitaxel without G-CSF support, one developed febrile neutropenia, and 4 had nab-paclitaxel treatment delays related to neutropenia (ANC < 1,000). The protocol was amended to require G-CSF support (filgrastim or pegfilgrastim) during nab-paclitaxel. Among the next 55 patients, 3 had febrile neutropenia, none during nab- paclitaxel. In cycles 6–8, nab-paclitaxel was delayed only 6 times (1 neutropenia, 3 hepatic toxicity, 2 patient scheduling); 96% of these cycles were delivered on time. By comparison, 82% of such cycles were delivered on time in a prior institutional study using paclitaxel. In the full cohort, 8 patients had nab-paclitaxel dose reduction, 4 for neuropathy, while other neuropathy was moderate (grade 2, n = 6; grade 3, n=1; grade 4, n=0). Conclusions: Administration of nab-paclitaxel every 2 weeks is feasible but requires G-CSF support. Data comparing nab-paclitaxel dose-delivery, toxicities and quality of life to paclitaxel as seen in prior studies will be presented. No significant financial relationships to disclose.

Feasibility of pegfilgrastim as haematopoietic support for dose-dense every-2-week adjuvant chemotherapy in breast cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18606-18606 ◽  
Author(s):  
P. Gomez ◽  
E. Vilar ◽  
C. Saura ◽  
J. Cortes ◽  
A. Ocaña ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Febrile Neutropenia ◽  
Treatment Delays ◽  
Significant Difference ◽  
Grade 3 ◽  
Dose Dense ◽  
Number Of Treatment ◽  
Stimulating Factor ◽  
Indirect Comparisons

18606 Background: Dose-dense sequential chemotherapy has been safety supported with Filgrastim (F). Pegfilgrastim (PEGF) is a pegylated recombinant human granulocyte colony-stimulating factor (G-CSF) that has a long half-life, a fact that facilitates a less frequent dosing. Its safety and efficacy has been established in 21- and 28-days schedules. Methods: We have performed a retrospective analysis of medical records of 2 cohort of patients (n=38) treated at our institution between December 2003 and November 2005. All patients received Adriamicin 60 mg/m2 plus Ciclophosphamide 600 mg/m2 q2w for 4 cycles followed by Paclitaxel 175 mg/m2 q2w for 4 cycles. As G-CSF support, in Cohort A (n=29) PEGF was administered 6 mg on day 2 of each cycle and in Cohort B (n=9) F days 3 to 10 at 5 μg/kg. The primary end point was to explore the feasibility and safety in terms of febrile neutropenia (FN) events, number of treatment delays (TD), incidence of neutropenia grade 3 (NPG3) and 4 (NPG4) and mean absolute neutrophil count (ANC) on day 14 of cycle 1 to 7 for both groups. Indirect comparisons have been performed. Results: Patients characteristics in both cohorts were well balanced, except for age in cohort A compared with cohort B (44,89 versus 52,5, p = 0,02). FN events and TD were increased in cohort B compared with cohort A (22% versus 0%, p=0.051, both comparisons). No statistically significant difference in number of episodes of NPG3 and NPG4 was observed. Median ANC on day 14 for each treatment cycle was significantly greater for Cohort A than Cohort B, except for cycle 6. Conclusions: PEGF is very safe and efficacy in patients treated with dose-dense sequential adjuvant chemotherapy for breast cancer. It could be even more efficient than F in preventing febrile neutropenia events. [Table: see text]

scholarly journals Avoiding Peg-Filgrastim Prophylaxis During the Paclitaxel Portion of the Dose-Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen: A Prospective Study

2020 ◽  
Vol 38 (21) ◽  
pp. 2390-2397 ◽  
Author(s):  
Ines Vaz-Luis ◽  
Romualdo Barroso-Sousa ◽  
Antonio Di Meglio ◽  
Jiani Hu ◽  
Rebecca Rees ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Febrile Neutropenia ◽  
Standard Of Care ◽  
Current Standard ◽  
Treatment Delays ◽  
Breast Cancer Chemotherapy ◽  
Adjuvant Breast Cancer ◽  
Dose Dense ◽  
A Prospective Study ◽  
Dose Delay

PURPOSE The use of growth factors adds considerable expense and some toxicity to adjuvant breast cancer chemotherapy. We tested the feasibility and safety of omitting routine peg-filgrastim use during the paclitaxel portion of the dose-dense doxorubicin-cyclophosphamide–paclitaxel regimen. PATIENTS AND METHODS This was a prospective, single-arm study in which patients 18 to 65 years of age who completed 4 cycles of dose-dense doxorubicin-cyclophosphamide for stage I-III breast cancer received paclitaxel 175 mg/m2 every 2 weeks. Peg-filgrastim was administered after paclitaxel only if patients had had febrile neutropenia in a prior cycle or at investigator discretion if patients had infections or treatment delays of > 1 week. Once a patient received peg-filgrastim, it was administered in all future cycles. The primary end point was the rate of paclitaxel completion within 7 weeks from cycle 1 day 1 to cycle 4 day 1. If ≥ 100 out of 125 patients completed 4 cycles of paclitaxel without dose delay, the regimen would be considered feasible. RESULTS The enrollment goal of 125 patients was met. Median age was 46 years (range, 21-65 years), and 112 patients (90% [95% CI, 83% to 94%]) completed dose-dense paclitaxel within 7 weeks. Omission of peg-filgrastim was not causally related to noncompletion of paclitaxel in any patients. The most common reasons for dose reduction or delays were nonhematologic. One patient experienced febrile neutropenia but was able to complete paclitaxel on time. Eight patients (6.4%) received peg-filgrastim during the trial. Overall, peg-filgrastim was administered in only 4.3% of paclitaxel cycles. CONCLUSION Omission of routine peg-filgrastim during dose-dense paclitaxel according to a prespecified algorithm seems to be safe and feasible and was associated with a 95.7% reduction in the use of peg-filgrastim relative to the current standard of care.

scholarly journals Dose-Dense Epirubicin and Cyclophosphamide Followed by Docetaxel as Adjuvant Chemotherapy in Node-Positive Breast Cancer

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Hamid Reza Mirzaei ◽  
Parisa Sabet Rasekh ◽  
Fatemeh Nasrollahi ◽  
Parto Sabet Rasekh ◽  
Zahra Akbari Tirabad ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Febrile Neutropenia ◽  
Optimal Dose ◽  
Axillary Lymph ◽  
Node Positive ◽  
Hand Foot Syndrome ◽  
Grade 3 ◽  
Dose Dense ◽  
Positive Breast Cancer

Background. Adding taxanes to anthracycline-based adjuvant chemotherapy has shown significant improvement particularly in node-positive patients, but optimal dose and schedule remain undetermined.Objectives. This study aimed to assess the feasibility of dose-dense epirubicin and cyclophosphamide followed by docetaxel in node-positive breast cancer.Methods. All Patients first received 4 cycles of epirubicin (100 mg/m2) and cyclophosphamide (600 mg/m2) at 2-week interval then followed by docetaxel (100 mg/m2) at 2-week interval for 4 cycles, with daily Pegfilgrastim (G-CSF) that was administered in all patients on days 3–10 after each cycle of epirubicin and cyclophosphamide infusion.Results. Fifty-eight patients with axillary lymph node-positive breast cancer were enrolled in the study, of whom 42 (72.4%) completed the regimen. There were two toxicity-related deaths, one patient due to grade 4 febrile neutropenia and the other due to congestive heart failure. Grade 3/4 neutropenia and febrile neutropenia were 13.8% and 5.1%. The most common grade 3/4 nonhematological complications were as follows: skin-nail disorders (48.3%), hand-foot syndrome (34.4%), paresthesia (38%), arthralgia (27.5%), and paresis (24.1%).Conclusions. Dose-dense epirubicin and cyclophosphamide followed by docetaxel with G-CSF support are not feasible, and it is not recommended for further investigation.

Incidence of peripheral neuropathy in high-risk early-stage breast cancer patients receiving dose-dense paclitaxel in central Pennsylvania

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11595-e11595
Author(s):  
A. C. Barochia ◽  
L. Cream ◽  
H. Harvey ◽  
J. Sivik
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Peripheral Neuropathy ◽  
High Risk ◽  
Cancer Patients ◽  
Breast Cancer Patients ◽  
Central Pennsylvania ◽  
Grade 3 ◽  
Dose Dense

e11595 Background: Paclitaxel (P) is an important part of chemotherapy regimens for early breast cancer. Breast cancer survivors may be left with iaotrogenic peripheral neuropathy which can affect their quality of life. Methods: We conducted a retrospective, IRB approved, medical chart review to determine the rate of peripheral neuropathy in a tertiary care practice in central Pennsylvania. Patients had biopsy proven, newly diagnosed, high risk breast cancer. Patients were treated with a standard dose dense (DD) regimen where 4 cycles of adriamycin (A) 60 mg/m2/cyclophosphamide (C) 600 mg/m2 were followed by four cycles of paclitaxel (P) 175 mg/m2 every 2 weeks (Citron et al) between 7/2006 to7/2008 at Penn State Cancer Institute. All patients who received dose dense chemotherapy by a single provider were included (n=23). No peripheral neuropathy (PN) was reported before initiating paclitaxel, but 3 of 23 patients had type II diabetes. Electronic medical charts were reviewed and data was abstracted to analyze incidence of peripheral neuropathy. These data were compared to reported published data. Results: 22 pts received dose dense AC followed by P chemotherapy. 100% completed 4 cycles of AC and 87% complete 4 cycles of P. Overall, 82% developed neuropathy (32% with grade 1, 41 % with grade 2, 9 % with grade 3). Almost 30% of patients required gabapentin for control of neuropathic pain. 35% of patients with PN had symptoms persisting >3 months after chemotherapy. Conclusions: A considerable percentage of high risk, early breast cancer patients treated with AC followed by DD paclitaxel developed at least mild neurotoxicity. Rates of Grade 3 neurotoxicity were much higher (9%) than the previous CALGB-9741 study (4%). This may be related to regional pharmacogenomic differences. Although dense dose paclitaxel has been shown to improve disease free survival, PN affects most patients treated with paclitaxel and for some patients can have a prolonged impact on their quality of life. Future studies should attempt identify which patients are at risk for severe peripheral neuropathy. No significant financial relationships to disclose.

scholarly journals Anemia Requiring Transfusion in Breast Cancer Patients on Dose-dense Chemotherapy: Prevalence, Risk Factors, Cost and Effect on Disease Outcome.

2021 ◽  
Author(s):  
Parth Sharma ◽  
Josh Thomas Georgy ◽  
Anand George Andrews ◽  
Ajoy Oommen John ◽  
Anjana Joel ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Cancer Patients ◽  
Transfusion Requirement ◽  
Low Grade ◽  
Breast Cancer Patients ◽  
Factors Associated ◽  
Grade 3 ◽  
Dose Dense ◽  
Delay In Treatment

Abstract Purpose: Dose dense chemotherapy improves survival but also increases toxicity and treatment related cost. Here we report the prevalence of anemia, understand the risk factors of chemotherapy related anemia and determine the cost and time-delay associated with transfusion requirement in Indian non-metastatic breast cancer patients on dose dense preoperative chemotherapy.Methods: In this study, 116 triple negative breast cancer (TNBC) patients were treated preoperatively with Docetaxel and Cyclophosphamide alternating with Epirubicin and Cisplatin every 2-weekly. Patients were evaluated for anemia pre- and post-chemotherapy. We examined trends in the cell counts, transfusion requirement, time to transfusion as well as risk factors associated with transfusion during treatment, along with delay in treatment due to anemia and the additional cost incurred.Results: One hundred and sixteen women with high-risk non-metastatic TNBC were treated. Median age was 44.5 years. 56.1% had stage III disease. Delivery of 6/8 planned doses was achieved in 98.3% of patients, and all 8 doses in 86% patients. Anemia was detected at baseline in 54(46.5%) patients with mild(10-12g/dl) anemia in 42(36.2%) patients and moderate(8-10g/dl) in 12(10.3%) patients. Forty-four patients (37.9%) required transfusion during chemotherapy with 55(47.4%) patients having grade 1-2 anemia and 40(34.5%) patients having grade 3 anemia. The factors associated with transfusion were low grade of tumor (OR 2.48 (95% CI 1.08 - 5.68), p = 0.025), hemoglobin post 2 cycles of chemotherapy (OR 1.74 (95% CI 1.21- 2.51), p = 0.003), thrombocytopenia grade 3 or 4 (OR 4.35 (95% CI 1.062-17.827), p = 0.034) and drop in hemoglobin after 2 cycles (OR 1.65 (95% CI 1.09-2.48), p = 0.017). Nearly one fourth of the study population had a delay between two cycles of chemotherapy due to anemia. A median additional cost of Rs 7000 (IQR-Rs 7000 – Rs 14000) was incurred on transfusion.Conclusion: Anemia is a common toxicity associated with dose dense chemotherapy during curative breast cancer treatment leading to delay in treatment and increased cost. Low grade tumor, grade 3 or 4 thrombocytopenia and Grade 2 or higher anemia after 2 cycles of chemotherapy are risk factors for blood transfusions during treatment.

scholarly journals Granulocyte Colony Stimulating Factor (G-CSF) Induced Splenic Infarction in Breast Cancer Patient Treated with Dose-Dense Chemotherapy Regimen

2019 ◽  
Vol 2019 ◽  
pp. 1-4 ◽  
Author(s):  
Majed A. Alshamrani ◽  
Meteb Al-Foheidi ◽  
Ahmed H. Abdulrahim
Keyword(s):  
Breast Cancer ◽  
Febrile Neutropenia ◽  
Splenic Infarction ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Rare Side Effect ◽  
Splenic Biopsy ◽  
Dose Dense ◽  
Stimulating Factor ◽  
Factor G

Introduction. Granulocyte colony-stimulating factor (G-CSF) is commonly used for prevention and treatment of febrile neutropenia among solid tumor patients. It is considered an effective and relatively safe supportive care medication; however, it can cause rare and serious side effects such as spleen rupture or infarction. Case Presentation. We are reporting a case of a 27-year-old female with breast cancer who has been treated with dose-dense chemotherapy and received colony-stimulating factor as primary prevention of febrile neutropenia that was complicated halfway through with splenic infarction. This finding was confirmed by computed tomography (CT) scan and splenic biopsy. Management was conservative without the need of surgical intervention. Conclusion. Although splenic infarction is an extremely rare side effect of G-CSF, it can be a serious complication that should be recognized, monitored, and managed carefully.

scholarly journals Impact of the Addition of Carboplatin and/or Bevacizumab to Neoadjuvant Once-per-Week Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide on Pathologic Complete Response Rates in Stage II to III Triple-Negative Breast Cancer: CALGB 40603 (Alliance)

2015 ◽  
Vol 33 (1) ◽  
pp. 13-21 ◽  
Author(s):  
William M. Sikov ◽  
Donald A. Berry ◽  
Charles M. Perou ◽  
Baljit Singh ◽  
Constance T. Cirrincione ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Stage Ii ◽  
Open Label ◽  
Grade 3 ◽  
Dose Dense ◽  
The Impact

Purpose One third of patients with triple-negative breast cancer (TNBC) achieve pathologic complete response (pCR) with standard neoadjuvant chemotherapy (NACT). CALGB 40603 (Alliance), a 2 × 2 factorial, open-label, randomized phase II trial, evaluated the impact of adding carboplatin and/or bevacizumab. Patients and Methods Patients (N = 443) with stage II to III TNBC received paclitaxel 80 mg/m2 once per week (wP) for 12 weeks, followed by doxorubicin plus cyclophosphamide once every 2 weeks (ddAC) for four cycles, and were randomly assigned to concurrent carboplatin (area under curve 6) once every 3 weeks for four cycles and/or bevacizumab 10 mg/kg once every 2 weeks for nine cycles. Effects of adding these agents on pCR breast (ypT0/is), pCR breast/axilla (ypT0/isN0), treatment delivery, and toxicities were analyzed. Results Patients assigned to either carboplatin or bevacizumab were less likely to complete wP and ddAC without skipped doses, dose modification, or early discontinuation resulting from toxicity. Grade ≥ 3 neutropenia and thrombocytopenia were more common with carboplatin, as were hypertension, infection, thromboembolic events, bleeding, and postoperative complications with bevacizumab. Employing one-sided P values, addition of either carboplatin (60% v 44%; P = .0018) or bevacizumab (59% v 48%; P = .0089) significantly increased pCR breast, whereas only carboplatin (54% v 41%; P = .0029) significantly raised pCR breast/axilla. More-than-additive interactions between the two agents could not be demonstrated. Conclusion In stage II to III TNBC, addition of either carboplatin or bevacizumab to NACT increased pCR rates, but whether this will improve relapse-free or overall survival is unknown. Given results from recently reported adjuvant trials, further investigation of bevacizumab in this setting is unlikely, but the role of carboplatin could be evaluated in definitive studies, ideally limited to biologically defined patient subsets most likely to benefit from this agent.

Safety and effectiveness of dose dense neoadjuvant chemotherapy in patients with stage II/III breast cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10622-10622
Author(s):  
S. A. McDaniel ◽  
H. Krontiras ◽  
J. T. Carpenter ◽  
L. M. Nabell ◽  
K. I. Bland ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Residual Disease ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Hematologic Toxicity ◽  
Newly Diagnosed ◽  
Grade 3 ◽  
Dose Dense ◽  
To Receive

10622 Background: NSABP B-18 randomized women with operable breast cancer to receive chemotherapy either pre- or postoperatively; OS and DSF rates at 9 years were identical. Importantly, pathologic complete response (pCR) was directly proportional to DFS and OS. Recently, dose dense adjuvant chemotherapy has shown a statistically significant improvement in DFS and OS. However, no data is available for the use of dose dense preoperative chemotherapy at this time. Methods: Women enrolled in the I-SPY correlative trial with newly diagnosed breast cancer, T ≥ 3cm, any N, M0 were evaluated to assess response rates and safety to dose dense neoadjuvant chemotherapy (doxorubicin 60 mg/m2 IV Q2 wks × 4, paclitaxel 175 mg/m2 IV Q2 wks × 4, and cyclophosphamide 600 mg/m2 IV Q2 wks × 4). Results: Since 02/2003, 43 pts have been treated with dose dense neoadjuvant chemotherapy on the I-SPY trial at UAB (mean age 47.9). 47% of the pts were ER+, 37% were PR+ and 5% were Her2+ by FISH. 2 pts dropped out for personal reasons and 9 pts are actively undergoing treatment. Overall, 32 pts received dose dense chemotherapy and proceeded to surgery. Of those, 31 received dose dense sequential ATC and 1 received dose dense concurrent AC followed by T. 34% had a pCR (breast & nodes) while an additional 10% had a pCR in the breast but residual disease in lymph nodes; 41% had a PR; 9% had SD; and 6% had PD. Hematologic toxicity consisted of grade 3 anemia in 2 pts, febrile neutropenia in 2 pts and no grade 4 thrombocytopenia. Non-hematologic grade 3–4 toxicity consisted of mediport-associated thrombosis in 2 pts, hyperglycemia in 2 pts, syncope in 1 pt, neuropathy in 1 pt, and disseminated varicella in 1 pt. Conclusion: Our results show that dose dense neoadjuvant chemotherapy achieves a pCR (breast & nodes) in about 1/3 of patients (34%) with tolerable toxicity. No significant financial relationships to disclose.

Neoadjuvant dose-dense docetaxel, carboplatinum, and trastuzumab (ddTCH) chemotherapy for HER2 overexpressing breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11557-e11557 ◽  
Author(s):  
S. Bayraktar ◽  
U. D. Bayraktar ◽  
I. M. Reis ◽  
M. Pegram ◽  
C. Welsh ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
High Risk Group ◽  
Her2 Positive ◽  
Her2 Positive Breast Cancer ◽  
Grade 3 ◽  
Dose Dense ◽  
Positive Breast Cancer

e11557 Background: Neoadjuvant chemotherapy for locally advanced breast cancer was shown to improve the complete pathologic (pCR) and clinical response (cCR) as well as the disease free survival (DFS). Docetaxel, cisplatin, and trastuzumab given every 21 days in her2-positive breast cancer demonstrated a pCR rate of 23%. The concept of dose dense chemotherapy regimens has attracted much attention and we hypothesized that dose-dense regimen would further improve pCR, cCR and would maintain the safety profile while being a suitable regimen for outpatient administration. Methods: 48 patients with stage II/III HER2-positive breast cancer were prospectively enrolled on a clinical trial of a neoadjuvant regimen consisting of docetaxel 70 mg/m2 on days 1, 15, 29, and 43; carboplatinum at an AUC of 6 on days 1, 15, 29, and 43; trastuzumab 4 mg/kg on day 1 and 2 mg/kg weekly x 10 starting on day 8; peg-filgastrim 6 mg on days 2, 16, 30, and 44. Results: The median age was 50 years (range 30–78). 52% of patients were premenopausal, 63% and 22% were of Hispanic and African descent, respectively. Estrogen receptor was positive in 52% patients and median tumor size was 5 cm at the time of diagnosis. TNM stage distribution at presentation: T1 2%, T2 25%, T3 57%, T4 16%; N0 29%, N1 46%, N2 16%, N3 7%; M0 100%. pCR in breast; axilla; and both breast and axilla was observed in 19 of 44 patients (43.2%; 95% CI 28.3% - 59.0%); in 29 of 44 patients (65.9%; 95% CI 50.1% - 79.5%); and in 16 of 44 patients (36.4%; 95% CI 22.4% - 52.2%), respectively. No grade 4 or 5 toxicity occurred. The most frequent grade 3 toxicities were hand-foot syndrome (7%), neutropenia (4%), nausea/vomiting (2%), and bone pain (2%). Grade 2 cardiotoxicity was seen in 8% of patients and no grade 3 cardiotoxicity was observed. Conclusions: This neoadjuvant regimen was well tolerated and yielded a good pCR rate for this high risk group of patients. No significant financial relationships to disclose.

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