Real-world evidence regarding the efficacy and toxicity of neoadjuvant trastuzumab and pertuzumab in the management of HER2-positive early-breast cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12108-e12108 ◽  
Author(s):  
Benjamin James Hall ◽  
Ajay Ashok Bhojwani ◽  
Helen Innes ◽  
Eliyaz Ahmed ◽  
Joanne Cliff ◽  
...  
Keyword(s):  
Real World ◽  
Tumour Size ◽  
Complete Response ◽  
Breast Tumour ◽  
Distant Recurrence ◽  
Axillary Node ◽  
Cancer Drug ◽  
Her2 Positive ◽  
Axillary Node Clearance ◽  
The Uk

e12108 Background: Neoadjuvant (NA) HER2 blockade with trastuzumab (T) and pertuzumab (P) results in pathological complete response (pCR) rates of 39% to 62%. Diarrhoea is reported in up to 73% of cases. No real-world studies have explored the efficacy and toxicity of this treatment. This study aimed to determine the efficacy and toxicity of NA T-P and CT within a routine NHS clinical practice in the UK. Methods: HER2+ BC patients given NA T-P (accessed via the Cancer Drug Fund) between Oct2016-Jan 2018 at Clatterbridge Cancer Centre NHS Foundation Trust were retrospectively identified. Clinico-pathological information, treatment data, nurse led toxicity and echocardiography were reviewed. Data lock: 30th January 2019. Final pathological response data is presented. Results: 78 female patients were identified with a median age of 50 years (IQR: 44.4-60.2). Diagnosis: median tumour size 30mm (IQR 23.0-47.5mm), 62% (48/78) LN+ & 71% ER+. CT regimens: 81% (63/78) given FEC-DHP; of these 19 (30%) switched to weekly paclitaxel (wP) or nab-paclitaxel; 5% (4/78) AC/EC-DHP; 9% (8/78) TCHP of which 1 (13%) switched to wP. All patients underwent definitive surgery: 50% (39/78) mastectomy & 50% (39/78) WLE. 44% (35/78) axillary node clearance (ANC) & 56% (43/78) sentinel node biopsy (4 prior to NA therapy). 91% (32/35) undergoing ANC were LN+ at diagnosis, of which 66% (21/32) were LN- at surgery. pCR rate (ypT0/is, N0) was 47% (37/78), pCR by HR: ER+ 42% (23/55) & ER- 61% (14/23). pCR for 20 cases switched to wP was 60% (12/20). 6% (5/78) achieved pCR in the breast alone (in these LN status ITCx1, micrometsx3 & macrometsx1). Median size of the 46% (36/78) with residual breast tumour was 14.5mm (1-65mm). Outcome: Median follow up 68 weeks with one local and one distant recurrence occurring but no deaths. Toxicity: Ejection fraction did not decline beyond 10% of baseline in any patients. Diarrhoea occurred in 74% of cases, and CTCAE grade 3-4 toxicity occurring in >2% of patients: diarrhoea, fatigue, and infection. Conclusions: This data confirms 1) the real world efficacy of NA T-P 2) a significant number of LN+ patients become LN- and measures to avoid ANC are needed 3) switching to NA wP is not uncommon and may be associated with a higher pCR 4) diarrhoea rates reflect the literature and measures to mitigate it are needed. Updated outcomes will be presented.

scholarly journals Breast MRI and tumour biology predict axillary lymph node response to neoadjuvant chemotherapy for breast cancer

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Samia Al-Hattali ◽  
Sarah J. Vinnicombe ◽  
Nazleen Muhammad Gowdh ◽  
Andrew Evans ◽  
Sharon Armstrong ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Core Biopsy ◽  
Breast Surgery ◽  
Complete Response ◽  
Breast Tumour ◽  
Nodal Metastasis ◽  
Axillary Node ◽  
Tumour Type ◽  
Axillary Node Clearance

Abstract Background In patients who have had axillary nodal metastasis diagnosed prior to neoadjuvant chemotherapy for breast cancer, there is little consensus on how to manage the axilla subsequently. The aim of this study was to explore whether a combination of breast magnetic resonance imaging (MRI) assessed response and primary tumour pathology factors could identify a subset of patients that might be spared axillary node clearance. Methods A retrospective data analysis was performed of patients with core biopsy-proven axillary nodal metastasis prior to commencement of neoadjuvant chemotherapy (NAC) who had subsequent axillary node clearance (ANC) at definitive breast surgery. Breast tumour and axillary response at MRI before, during and on completion of NAC, core biopsy tumour grade, tumour type and immunophenotype were correlated with pathological response in the breast and the number of metastatic nodes in the ANC specimens. Results Of 87 consecutive patients with MRI at baseline, interim and after neoadjuvant chemotherapy who underwent ANC at time of breast surgery, 33 (38%) had no residual macrometastatic axillary disease, 28 (32%) had 1–2 metastatic nodes and 26 (30%) had more than 2 metastatic nodes. Factors that predicted axillary nodal complete response were MRI complete response in the breast (p < 0.0001), HER2 positivity (p = 0.02) and non-lobular tumour type (p = 0.015). Conclusion MRI assessment of breast tumour response to NAC and core biopsy factors are predictive of response in axillary nodes, and can be used to guide decision making regarding appropriate axillary surgery.

Discrepancy of pathologic complete response and outcome between breast tumor and axillary node in HER2 positive breast cancer after neoadjuvant chemotherapy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12503-e12503
Author(s):  
Shin-Cheh Chen ◽  
Hsien-Kun Chang ◽  
Yung-Chang Lin ◽  
Shih Che Shen ◽  
Wen-Lin Kuo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Targeted Therapy ◽  
Neoadjuvant Chemotherapy ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Axillary Node ◽  
Her2 Positive ◽  
The Impact ◽  
Better Than ◽  
Positive Breast Cancer

e12503 Background: The pathologic complete response (pCR) rate in primary tumor and axillary node after different chemotherapy regimens of neoadjuvant chemotherapy (NAC) in HER2 positive breast cancer (BC) is unknown, the impact of pCR on disease free survival (DFS) and overall survival (OS) is still controversial. Methods: A cohort of 350 HER2 positive BC (296 cytologically proved axillary node metastasis) received NAC with different regimens, antracyclin with taxotere (AT), docetaxel with transtuzumab (DT) and docetaxel with transtuzumab and pertuzumab( DTP) between 2005 and 2016 in a large medical center were analyzed retrospectively. The impact of pCR rates of breast and axillary node on DFS and OS were analyzed. Results: Of 350 women with HER2 positive BC received NAC, median age was 50 years(18~93), median tumor size was 4.3 cm, the pCR rates of breast and axillary node were 16.2% and 28.7% ( P= 0.018) in patients received AT( n= 130) , 47.6% and 66.9% ( P= 0.00028 ) in patients received DT( n= 191) ,65.5% and 77.8% ( P= 0.372 ) in patients received DTP( n= 29), respectively. The 5-year DFS were 79.3% and 66.0% ( p= 0.0023), 5-year OS were 89.5% and 76.6% ( P= 0.0201) in patients with breast pCR and non-pCR, respectively. The 5-year DFS were 75.7% and 58.4% ( P= 0.00037), 5-year OS were 85.7% and 72.6% ( P= 0.0024) in axillary pCR and non-pCR patients, respectively. The 5-year DFS were 79.3% and 75.7% ( P= 0.430), and 5-year OS were 89.5% and 85.7% ( P= 0.695) in breast and axillary pCR, respectively . The 5-year DFS in breast pCR whom received targeted therapy (DT and DTP groups) was significantly better than whom not received targeted therapy (AT groups), 85.3% and 65.0% ( P= 0.039), respectively Conclusions: Higher pCR rate in axillary node than breast was found in this cohort. Either pCR in axillary node or breast was associated with improved DFS and OS, but no difference of DFS and OS between breast and axillary pCR . The 5-year DFS in breast pCR received targeted therapy were significantly better than breast pCR patients received chemotherapy alone.

scholarly journals A further survey of surgical management of the axilla in UK breast cancer patients

2010 ◽  
Vol 92 (6) ◽  
pp. 506-511 ◽  
Author(s):  
Ronan W Glynn ◽  
Linda Williams ◽  
J Michael Dixon
Keyword(s):  
Breast Cancer ◽  
Surgical Oncology ◽  
Axillary Node ◽  
Axillary Lymph ◽  
Breast Cancer Patients ◽  
Internal Mammary Nodes ◽  
Axillary Node Clearance ◽  
Internal Mammary ◽  
Neo Adjuvant Chemotherapy ◽  
The Uk

INTRODUCTION The aims of this study were to investigate the practice of axillary lymph node management within different units throughout the UK, and to assess changes in practice since our previous survey in 2004. SUBJECTS AND METHODS A structured questionnaire was sent to 350 members of the British Association of Surgical Oncology. RESULTS There were 177 replies from respondents who managed more than 100 patients a year with breast cancer. Of these: 12 did not perform axillary ultrasound at all in their centre; 17 (10%) employed axillary node clearance (ANC) on all patients; 122(69%) performed sentinel node biopsy (SNB) with dual localisation; and 111 respondents had attended the New Start Course. Radioisotope was most frequently injected 2 h or more before operation. Just 13 surgeons were convinced of the value of dissecting internal mammary nodes visualised on a scan. Reasons for not using dual localisation included lack of nuclear medicine facilities, no local ARSAC licence holder, no probe, and no funding. Sixty-six surgeons stated that, if they had an ARSAC licence and could inject the radioactivity in theatre, this would be a major improvement. In addition, 83 (47%) did not perform SLNB in patients receiving neo-adjuvant chemotherapy. CONCLUSIONS Despite significant changes since 2004, substantial variation remains in management of the axilla. A number of surgeons are practicing outwith current guidelines.

Real-world safety and efficacy data of patients with synchronous metastatic renal cell carcinoma (mRCC) treated with nivolumab and ipilimumab (N+I) and the primary tumour (PT) in place.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17083-e17083
Author(s):  
Aafke Meerveld-Eggink ◽  
Niels Graafland ◽  
Sofie Wilgenhof ◽  
Johannes V. Van Thienen ◽  
Michael Grant ◽  
...  
Keyword(s):  
Real World ◽  
Tumour Size ◽  
Primary Tumour ◽  
Standard Of Care ◽  
Complete Response ◽  
World Population ◽  
Safety And Efficacy ◽  
Poor Risk ◽  
Grade 3 ◽  
Metastatic Sites

e17083 Background: Following CARMENA and SURTIME, upfront cytoreductive nephrectomy (CN) is no longer standard of care. Intermediate and poor risk patients (pts) receive systemic therapy with the PT in place with the option to perform deferred CN in responding pts. This practice has been adopted after the recent shift to immune checkpoint inhibitor combination in frontline for mRCC. We assessed the safety and efficacy of this approach in a real-world population. Methods: A retrospective analysis of a clinical audit from 3 institutional datasets of pts treated with first-line N+I and the PT in place. Pts and tumour characteristics, International Metastatic RCC Database Consortium (IMDC) risk, overall response rate (ORR) in the PT and metastatic sites, time to response (TTR) of the PT, PT- and immune related- (ir) adverse events (AE), deferred CN rate, progression free- (PFS) and overall survival (OS) were assessed. Results: Of 41 pts treated with N+I and the PT in place, 46.3% were IMDC poor risk and 51.2% had > 3 metastatic sites. After a median follow-up of 5.9 (2-10.3) months, 29 had at least 1 CT scan from baseline. Of those, 7 (24.3% [95% confidence interval [CI] 0.10-0.43]) had a partial response (PR) of the PT with a median TTR of 5.3 (2.5-8.6) months. Mean and median PT reduction were 16.9% (+7.6 to -70.3%) and 10% from a baseline mean tumour size of 9.5 (3.8-16.1) cm. Pts with a PT reduction > median (n = 14) had a PR at metastatic sites in 86% (CI 0.57-0.98) and no progressive disease (PD). Pts with PT reduction < median (n = 14) had PR in only 21% and PD at metastatic sites in 57% (CI 0.28-0.82). None of the PT progressed. There was no complete response (CR) at metastatic sites . No CN was performed; 5 pts (12%) developed hematuria grade 1-3, requiring embolisation in 2 (4.9%). Grade 3-4 irAE were observed in 22% of pts. Median PFS and OS are 8.6 months and not reached. Conclusions: N+I with the PT in place is safe and PT reduction is associated with response at metastatic sites. Most PT responded by 6 months. No CR at metastatic sites were observed (compared to a 9% CR rate in the pivotal trial) in this real-world population with a relatively high percentage of poor-risk pts. Furthermore, no deferred CN has been performed, neither for near-CR at metastatic sites nor for PT symptoms.

Incidence of brain metastases in patients receiving neoadjuvant chemotherapy (NAC) with trastuzumab and pertuzumab (HP) in HER2-positive early breast cancer (BC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12653-e12653
Author(s):  
Emanuela Ferraro ◽  
Andrea Veronica Barrio ◽  
Sujata Patil ◽  
Mark E. Robson ◽  
Chau T. Dang
Keyword(s):  
Brain Metastases ◽  
Residual Disease ◽  
Standard Of Care ◽  
Complete Response ◽  
Analysis Data ◽  
Distant Recurrence ◽  
Invasive Disease ◽  
Her2 Status ◽  
Her2 Positive

e12653 Background: The addition of pertuzumab in the neoadjuvant setting has become a standard of care in stage II-III HER2-positive BC. In the Katherine study the incidence of brain metastases (BM) at the follow-up of 3-years was 5.9 % in patients (pts) with residual disease who received TDM1. The aim of this study was to assess the incidence of BM in pts who received NAC with HP at a single center who were found to have pathological complete response (pCR) (ypT0/is ypN0) versus non-pCR at the time of surgery. Methods: Chart review on HER2-positive pts treated with NAC and HP between September 1, 2013 to May 1, 2018 was conducted. Only surgical specimens of pts whose pre-NAC specimens were internally reviewed for HER2 status by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) were included in this analysis. Data on BM as component of distant recurrence along with invasive disease-free (IDFS) and overall survival (OS) were collected. Results: 540 pts were identified. Cases with no internally verified-HER2 status (387), equivocal status (10) and discordant internal assessment (13) were excluded. 130 pts with preoperative HER2 status confirmed by dedicated breast pathologists were included. Clinicopathological features are described in Table. pCR was achieved in 77/130 (60%) of cases, residual disease in 53/130 (40%). The median follow-up was 2.83 (0.35-5.3) years. The rate of BM as first presentation of distant disease was 3.8 % (3/77) and 3.7 % (2/53) in pts with pCR and non-pCR, respectively. Median time to development BM was 35 (13-58) months and 11.7 (9-14) months in the pCR group and non-pCR, respectively. Conclusions: In our cohort, the combination of HP was associated with a high pCR rate. At a median follow-up of 2.8 years, the incidence of BM appeared to be similar in pts who achieved pCR versus non-pCR. The data of IDFS and OS will be reported. Further data are needed to validate our findings before designing clinical trials to test prophylactic strategies to prevent BM. [Table: see text]

scholarly journals Residual lymph node tumour burden following removal of a single axillary sentinel lymph with macrometastatic disease in women with screen-detected invasive breast cancer

BJS Open ◽  
2020 ◽  
Vol 5 (2) ◽  
Author(s):  
R V Dave ◽  
S Cheung ◽  
M Sibbering ◽  
O Kearins ◽  
J Jenkins ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Invasive Breast Cancer ◽  
Tumour Size ◽  
Growth Factor Receptor ◽  
Breast Conserving Surgery ◽  
Lymph Node Biopsy ◽  
Axillary Node ◽  
Axillary Node Clearance

Abstract Background Women with screen-detected invasive breast cancer who have macrometastatic disease on axillary sentinel lymph node biopsy (SLNB) are usually offered either surgical axillary node clearance (ANC) or axillary radiotherapy. These treatments can lead to significant complications for patients. The aim of this study was to identify a group of patients who may not require completion ANC. Methods Data from the NHS Breast Screening Programme between 1 April 2012 and 31 March 2017 were interrogated to identify women with invasive breast carcinoma and a single sentinel lymph node (SLN) with macrometastatic disease who subsequently proceeded to completion ANC. Univariable and multivariable analyses were performed to identify patients with a single positive SLN who had no further lymph node metastasis on ANC. Results Of the 2401 women included in the cohort, the presence of non-sentinel node disease was significantly affected by: the number of nodes obtained at SLNB (odds ratio (OR) 0.49 for retrieval of more than 1 node), invasive size of tumour (OR 1.63 for size greater than 20 mm), surgical treatment (OR 1.34 for mastectomy), human epidermal growth factor receptor (HER) 2 status (OR 0.71 for HER2 positivity), and patient age (OR 1.10 for age less than 50 years; OR 1.46 for age greater than 70 years). Patients aged less than 70 years, with tumour size smaller than 2 cm, more than one node retrieved on SLNB, and who had breast-conserving surgery had a lower chance of positive non-sentinel nodes on completion ANC compared with other patients. Conclusion This study, of a purely screen-detected breast cancer cohort, identified a subset of patients who may be spared completion ANC in the event of a single axillary SLN with macrometastasis.

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