scholarly journals Adjuvant Trastuzumab with or without Chemotherapy in Stage 1 pT1N0 HER2+ Breast Cancer: A National Cancer Database Analysis

2021 ◽  
Author(s):  
Lifen Cao ◽  
Robert Shenk ◽  
Nickolas Stabellini ◽  
Megan E. Miller ◽  
Christopher W. Towe ◽  
...  
Keyword(s):  
Overall Survival ◽  
Disease Free Survival ◽  
Invasive Disease ◽  
Primary Diagnosis ◽  
National Cancer Database ◽  
Breast Cancers ◽  
Adjuvant Trastuzumab ◽  
Propensity Match ◽  
Her2 Breast Cancer ◽  
Stage 1

Abstract Purpose: Approximately 20% of all breast cancers (BC) are HER2 amplified. In the APT trial, weekly paclitaxel/ trastuzumab in node negative HER2+ BC with tumors <3 cm was associated with a 7-year invasive disease-free survival of 93%. However, this was in the context of a non-randomized trial, and for pT1N0 HER2+ BC it remains unclear whether HER2 monotherapy would provide similar clinical outcomes to chemo-HER2 therapy. We hypothesized that adjuvant chemo-HER2 therapy would be associated with a modestly improved overall survival compared to HER2 monotherapy in patients with tumors <2cm. Methods: In the National Cancer Database (2004-2017), patients with a primary diagnosis of pT1N0M0 HER2+ BC, were separated into two groups: (i) HER2 monotherapy, i.e. trastuzumab, and (ii) chemo-HER2 therapy. A 3:1 propensity match was performed to balance patient selection bias between the two different cohorts. Long-term overall survival (OS) was compared between both groups. Results: A total of 23, 281 patients met the criteria. 22,268 (96.7%) received chemo-HER2 therapy and 1,013 (4.4%) received HER2 monotherapy. Propensity match identified 1,995 patients who received chemo-HER2 therapy, and 666 who received HER2 monotherapy. After match, adjuvant chemo-HER2 therapy was associated with a modest survival advantage over HER2 monotherapy (5-year OS 94.1% vs. 90.6%, P=0.041). Conclusions: Even though there is a modest OS advantage favoring adjuvant chemo-HER2 therapy in pT1N0 HER2+ BC, HER2 monotherapy was associated with 5-year OS >90%. Therefore, in select patients who have contraindications for cytotoxic chemotherapy, or decline adjuvant chemotherapy, adjuvant trastuzumab monotherapy appears to be a reasonable alternative.

Adjuvant treatment with paclitaxel plus trastuzumab for node-negative breast cancer: real-life experience

2021 ◽  
Author(s):  
Omer Diker ◽  
Burak Yasin Aktas ◽  
Recep Ak ◽  
Bahadır Koylu ◽  
Onur Bas ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Life Experience ◽  
Real Life ◽  
Disease Free Survival ◽  
Invasive Disease ◽  
Breast Cancers ◽  
Node Negative ◽  
Her2 Breast Cancer ◽  
Node Negative Breast Cancer

Background: In node-negative HER2-overexpressed breast cancers, adjuvant paclitaxel plus trastuzumab treatment is a successful de-escalation approach with excellent survival outcomes. Methods: All patients with HER2+ breast cancer treated in our centers were retrospectively reviewed. Results: We analyzed 173 patients who were treated with adjuvant paclitaxel plus trastuzumab. The mean tumor size was 2.2 cm. There were eight invasive disease events or death: four distant recurrences (2.3%), three locoregional recurrences (1.7%) and one death without documented recurrence after a 52 month follow-up. The 3-year disease-free survival and recurrence-free interval rate was 96.6%. Conclusion: This real-life experience with adjuvant paclitaxel plus trastuzumab demonstrated few distant recurrences and is compatible with the APT trial findings.

Risk of recurrence in patients with HER2+ breast cancer who achieved a pathological complete response (pCR) after neoadjuvant pertuzumab and trastuzumab (nPT), and received adjuvant trastuzumab (aT): Real-world evidence.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12648-e12648
Author(s):  
Nicholas J. Robert ◽  
Joyce O'Shaughnessy ◽  
Srinivas Annavarapu ◽  
Jie Zhou ◽  
Jesse Sussell ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Real World ◽  
Disease Free Survival ◽  
Clinical Trial Data ◽  
Complete Response ◽  
Disease Recurrence ◽  
Invasive Disease ◽  
Receptor Expression ◽  
Adjuvant Trastuzumab ◽  
Her2 Breast Cancer

e12648 Background: The real-world risk of disease recurrence in patients with HER2+ early breast cancer who achieved pCR after receipt of nPT-based regimens and aT is unclear. Methods: Women with HER2+ breast cancer who achieved pCR after nPT-based regimens and received aT were identified in the US Oncology Network (USON). Patients initiated nPT between 2013 –2015 and were followed until recurrence of invasive disease or censoring. Data was sourced from structured fields and review of USON patient charts. Recurrence of invasive disease was defined as any of: recurrence of ipsilateral locoregional invasive breast cancer, contralateral breast cancer, distant disease recurrence, or death. Descriptive analyses were used to assess baseline demographic and clinical characteristics and the Kaplan-Meier method was used to assess invasive disease-free survival (iDFS), with stratification by nodal status. Results: A total of 238 pCR patients’ charts were reviewed. Median patient age was 52 (range: 23-88) years and a majority were White (77%). Most patients had stage IIA (39%) or IIB (24%) disease at diagnosis, ECOG score < 1 (85%), and tumor size > 2 cm (68%). At diagnosis, the majority of patients (57%) were node positive (N+) and negative for estrogen or progesterone receptor expression (51%). Median durations of therapy for nPT and aT were 4 (range: 1-8) and 7 (range: 0.03-53) months, respectively. The median duration of follow up was 47 (range: 1-70) months. Four-year iDFS probabilities are shown in the Table. Conclusions: Consistent with previously reported clinical trial data and several pooled analyses, results from this real-world study indicate that despite achieving pCR after nPT-based regimens, patients with HER2+ BC remain at risk for disease recurrence; in addition, node+ status appears to increase that risk. Therefore, patients should receive standard pertuzumab, trastuzumab adjuvant therapy to optimize treatment outcomes. [Table: see text]

Lobar versus Sublobar Resection in the Elderly for Early Lung Cancer: A Meta-Analysis

2021 ◽  
Author(s):  
Josiah Ng ◽  
Yoshio Masuda ◽  
Jun Jie Ng ◽  
Lowell Leow ◽  
Andrew M. T. L. Choong ◽  
...  
Keyword(s):  
Overall Survival ◽  
Elderly Patients ◽  
Meta Analysis ◽  
Cancer Recurrence ◽  
Disease Free Survival ◽  
The Elderly ◽  
Sublobar Resection ◽  
Cell Lung Carcinoma ◽  
Risk Of Death ◽  
Stage 1

Abstract Objectives We performed a systematic review and meta-analysis of outcomes of lobectomy versus sublobar resection in elderly patients (≥65) with stage 1 nonsmall cell lung carcinoma (NSCLC). Methods We searched for relevant articles using a set of inclusion and exclusion criteria. Meta-analytic techniques were applied. Results Twelve studies (n = 5834) were chosen. Our results indicate that in the elderly, lobectomy for stage 1 NSCLC confers a survival advantage over sublobar resection. Lobectomy patients had a lower risk of death within 5 years and lower odds of local cancer recurrence. Our results show that lobectomy had a better 5-year cancer-specific survival and 5-year disease-free survival that trended toward significance. The sublobar resection group showed better 30-day operative mortality that trended toward significance. Subgroup analysis of stage 1A cancer demonstrated no difference in 5-year overall survival rates. However, for stage 1B tumors 5-year overall survival favored lobectomy. Conclusion Lobectomy for stage 1 NSCLC in elderly patients is superior to sublobar resection in terms of survival and cancer recurrence and should be afforded where possible. For stage 1A tumors, sublobar resection is noninferior and may be considered. Further randomized controlled trials in this topic is required.

Commission on Cancer CP3R Compliance Rates for Treatment of Patients With Triple Negative and HER2+ Breast Cancer: A National Cancer Database Analysis

2021 ◽  
pp. 000313482110516
Author(s):  
Srivarshini C. Mohan ◽  
Joshua Tseng ◽  
Marissa Srour ◽  
Alice Chung ◽  
Ashley Marumoto ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Cox Regression ◽  
Quality Care ◽  
Private Insurance ◽  
National Cancer Database ◽  
Database Analysis ◽  
Her2 Breast Cancer ◽  
Academic Hospitals ◽  
Multi Agent

Background Cancer Program Practice Profile Reports (CP3R) metrics were released by the Commission on Cancer to provide standards for high-quality care. One metric is the recommendation of combination chemotherapy or chemo-immunotherapy (CIT) within 120 days of diagnosis for women under 70 with AJCC T1cN0M0 or Stage IB-III HER2+ or hormone receptor negative breast cancer ([Multi-agent chemotherapy] MAC). Our study assesses national concordance rates for MAC and CIT. Methods The National Cancer Database was queried from 2004-2014. Results 122,045 patients met criteria, of whom treatment for 101,800 (83.4%) patients was concordant with MAC and CIT. Treatment concordance increased from 75.7% in 2004 to 89.5% in 2014. For HER2+ patients, use of CIT treatment downtrended with progression of pathological stage, from 70.1% (stage I) to 58.1% (stage III). Mean overall survival of patients whose treatment was concordant with MAC and CIT was longer than that of patients who were non-concordant (146.6 vs 143.8 months, P <.01). On Cox regression, there was a survival benefit for concordant patients who were treated at academic hospitals (HR .89, 95% CI 0.802-.976) and had private insurance (HR .76, 95% CI 0.65-.89). Conclusion Compliance with MAC and CIT has improved over the past decade and is associated with a significant improvement in overall survival.

Biological behavior of HER2+ breast cancer: Differences based in hormone receptor expression.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12120-e12120
Author(s):  
Maria Joao Ribeiro Da Silva ◽  
Miguel Henriques Abreu ◽  
Sergio Xavier Azevedo ◽  
Tiago Alpoim ◽  
Susana Sousa ◽  
...  
Keyword(s):  
Hormone Receptors ◽  
Disease Free Survival ◽  
Clinicopathological Characteristics ◽  
Receptor Expression ◽  
Biological Behavior ◽  
Her2 Receptor ◽  
Adjuvant Trastuzumab ◽  
Her2 Breast Cancer ◽  
The Impact

e12120 Background: Breast carcinoma is a heterogeneous disease whose therapeutic approach idepends on the classification into molecular subtypes. Despite the impact the expression of hormone receptors (HR) among patients with overexpression of HER2 is already the target of some studies, there is a lack of analysis in the era of treatment with adjuvant trastuzumab. Methods: This stydy consists in a retrospective analysis of cases of tumors with overexpression of the HER2 receptor (HER2 +), and HR- treated at an oncological center, comparing their biological behavior with cases of HR +/ HER2 + tumors, thus controlling for classic prognosis. Results: We analised a total of 420 patients, of whom 210 with HR+/HER2+ tumors and 210 HR- / HER2 +, with median ages of 52 years and 53 years, respectively. They accounted for 89.5% of cases of stage I to III disease. The groups were balanced in clinical characteristics. There was a higher proportion of undifferentiated and inflammatory tumors in the RH-/ HER2 + group, and in this group higher rates of complete pathological responses to treatment were observed (50.8% vs. 30.0%, p < 0.001). During the follow-up 30 recurrences occurred, 18 in the HR- / HER2 + group, and 12 in the HR + / HER2 +. There was lower disease-free survival in the HR-/HER2 +, on average 69.1 months, compared to 74.3 months in the group HR+/HER2 + (p = 0.001). The first metastatic site involved visceral location in 13 cases (72.2%) in HR- / HER2 + tumors (CNS involved in 8 cases), and in 8 cases (66.6%) in HR + / HER2 + tumors (CNS in 1 case). There was an association between relapse and response to primary systemic treatment (p = 0.003), with no relation demonstrated with other clinicopathological characteristics. In the global sample, there were 28 deaths, corresponding to 17 in the HR-/HER2 +, and 11 in the HR+/HER2 + group. There were significant diferences in OS, showing worse prognosis of HR- disease (mean of 70.7 months vs. 106.6 months, p = 0.001). There was an association of mortality with the presentation as an inflammatory tumor and involvement of the CNS. Conclusions: This study supports the concept of two distinct entities according to the expression in HER2 + disease, justifying therapeutic approaches and eventually different follow-up strategies.

Survival outcomes between surgery with adjuvant therapy compared to neoadjuvant therapy with surgery in stage I pancreatic adenocarcinoma: Results from a large national cancer database.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 335-335 ◽  
Author(s):  
Samit Kumar Datta ◽  
Geoffrey Belini ◽  
Maharaj Singh ◽  
Wesley Allan Papenfuss ◽  
Federico Augusto Sanchez ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adjuvant Therapy ◽  
Neoadjuvant Therapy ◽  
Pancreatic Adenocarcinoma ◽  
Reference Group ◽  
Clinical Stage ◽  
National Cancer Database ◽  
Nccn Guidelines ◽  
Significant Difference ◽  
Stage 1

335 Background: There has been a paradigm shift in the treatment of stage 1 pancreatic adenocarcinoma (PAC) from surgery first followed by adjuvant therapy (AT) to Neoadjuvant therapy (NAT) first followed by surgery and this is reflected in the current NCCN guidelines as well. Data comparing these two modalities are limited. AIM: To compare long time survival between surgery vs Surgery + AT and NAT + Surgery in a large National Cancer Database. Methods: We identified patients with surgically resected AJCC clinical stage 1, 1A, and 1B PAC between 2004-2014. Patients were stratified into 3 groups to assess outcomes. Exclusion criteria: those with incomplete survival and sequence of therapy data. Hazard ratios (HR) were calculated for evaluation of survival, as well as for 30-Day and 90-Day Mortality between the 3 groups. Results were adjusted for age and Deyo-Charlson comorbidity index. Results: A total of 9684 pts with Clincal stage 1, 1A, 1B PAC between 2004-2014 were identified. Of these 2266 pts underwent surgery alone; 6222 had surgery followed by AT; and 1196 pts had neoadjuvant therapy followed by surgery. There was a HR of 0.995 (95% CI 0.935-1.058 p = 0.864) and 0.984 (95% CI 0.924-1.048, p = 0.617) for 30- and 90-Day mortality comparing upfront surgery to NAT, respectively. With AT as the reference group for survival, there was a HR of 1.362 (95% CI 1.286-1.443, p < 0.001) for surgery only and HR of 0.929 (95% CI 0.859-1.004, p = 0.064) for NAT. Conclusions: 1. Surgery alone had worse overall survival. 2. There was no significant difference in overall survival when comparing AT and NAT 3. A prospective randomized trial evaluating the differences in survival is needed.

Does increasing time to surgery affect survival in stage I renal cell carcinoma? Analysis of the national cancer database.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 635-635
Author(s):  
Brittney Cotta ◽  
Stephen Ryan ◽  
Ahmed Eldefrawy ◽  
Reith Sarkar ◽  
Aaron Bradshaw ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Surgical Treatment ◽  
Multivariable Analysis ◽  
Surgical Care ◽  
National Cancer Database ◽  
Factors Associated ◽  
Time To Surgery ◽  
Kaplan Meier ◽  
Stage 1

635 Background: Optimal timing for surgical treatment of localized renal cell carcinoma (RCC) remains undefined. We sought to determine the survival impact of time to definitive surgical treatment for Stage 1 RCC and elucidate factors associated with a delay in surgical care utilizing the National Cancer Database (NCDB). Methods: The NCDB was queried for Stage 1 RCC cases (cT1N0M0) from 2004-2013 treated with partial or radical nephrectomy. Quartiles were formed from the range of time to surgery of the entire cohort in days: early defined as the first two quartiles and delayed as the fourth. Descriptive analyses were conducted between early and delayed groups. Overall survival (OS) between early and delayed groups was calculated with Kaplan-Meier analysis. Multivariable analysis was performed to determine factors associated with delay in surgical care. Results: 38,859 patients were analyzed. Median time to treatment was 40 days (IQR 22-68). Early (≤40 days, n = 23,712) and delayed ( > 68 days, n = 15,147) groups had a median follow-up of 44.8 and 41 months, respectively (p < 0.001). Delayed surgery was more frequent with African-Americans (14.8% vs. 9.1%, p < 0.001), patients with government or no insurance (53.7% vs. 45.1%, p < 0.001), males (60.7% vs. 58.3%, p = 0.001), and Charlson Comorbidity Index (CCI) ≥2 (9.7% vs. 6.7%, p < 0.001). Kaplan-Meier analysis demonstrated survival benefit to the earlier treatment group, with 5 year OS of 85.5% and 80.9% (p < 0.001; Figure). On multivariable analysis, increasing age (OR = 1.001, p = 0.015), African-American race (OR = 1.5, p < 0.001), increasing distance from treatment center (OR = 1.005, p = 0.001), residence in areas with low high school graduation rates (OR = 1.42, p < 0.001), residence in an area of > 1 million population (OR = 1.6, p < 0.001), and CCI ≥2 (OR = 1.4, p < 0.001) were independently associated with increasing time to surgery. Conclusions: Surgery of T1 RCC carried out beyond 9 weeks after diagnosis is associated with reduced overall survival compared to patients treated within 6 weeks. Time to definitive surgical treatment should be a quality of care metric, with special attention given to populations most at risk for delays in care.

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