Data from Prognostic Value of Residual Disease after Neoadjuvant Therapy in HER2-Positive Breast Cancer Evaluated by Residual Cancer Burden, Neoadjuvant Response Index, and Neo-Bioscore
Tessa G. SteenbruggenMaartje van SeijenL. JanssenMette S. van RamshorstErik van WerkhovenMarie-Jeanne T.D.F. Vrancken PeetersJelle WesselingEsther H. LipsGabe S. Sonke
0
Citation
0
Reference
10
Related Paper
Abstract:
<div>AbstractPurpose:<p>In breast cancer, pathologic complete response (pCR) to neoadjuvant systemic therapy (NST) is associated with favorable long-term outcome. Trastuzumab emtansine as additional adjuvant therapy improves recurrence-free survival of patients with HER2-positive breast cancer without pCR, but it is uncertain whether all patients without pCR need additional therapy. We evaluated the prognostic value of residual disease after trastuzumab-based NST in patients with HER2-positive breast cancer using Residual Cancer Burden (RCB), Neoadjuvant Response Index (NRI), and Neo-Bioscore.</p>Experimental Design:<p>We included patients with stage II or III HER2-positive breast cancer treated with trastuzumab-based NST and surgery at The Netherlands Cancer Institute between 2004 and 2016. RCB, NRI, and Neo-Bioscore were determined. Primary endpoint was 5-year recurrence-free interval (RFI). A 3% difference compared with the pCR group was considered acceptable as noninferiority margin on the 5-year RFI estimate, based on a proportional hazards model, and its lower 95% confidence boundary.</p>Results:<p>A total of 283 women were included. Median follow-up was 67 months (interquartile range 44–100). A total of 157 patients (56%) with pCR (breast and axilla) had a 5-year RFI of 92% (95% CI, 88–97); patients without pCR had a 5-year RFI of 80% (95% CI, 72–88). Patients with an RCB = 1 (<i>N</i> = 40, 15%), an NRI score between 0.75 and 0.99 (<i>N</i> = 30, 11%), or a Neo-Bioscore of 0 to 1 (without pCR; <i>N</i> = 28, 11%) have a 5-year RFI that falls within a predefined noninferiority margin of 3% compared with patients with pCR.</p>Conclusions:<p>The RCB, NRI, and Neo-Bioscore can identify patients with HER2-positive breast cancer with minimal residual disease (i.e., RCB = 1, NRI ≥ 0.75, or Neo-Bioscore = 0–1) after NST who have similar 5-year RFI compared with patients with pCR.</p></div>Keywords:
Neoadjuvant Therapy
Interquartile range
Adjuvant Therapy
Trastuzumab emtansine
Lapatinib
Trastuzumab emtansine
Pertuzumab
Antibody-drug conjugate
Humanized antibody
Cite
Citations (484)
Objective: The aim of this study was to analyze esophageal cancer patients who previously underwent neoadjuvant therapy followed by a curative resection to determine whether additional adjuvant therapy is associated with improved survival outcomes. Summary Background Data: Neoadjuvant therapy followed by surgery is the standard of care for locally advanced esophageal cancer, whereas adjuvant therapy is typically employed for patients with residual disease. However, the role of adjuvant therapy after a curative resection is still uncertain. Methods: MEDLINE, EMBASE, and CENTRAL databases were searched for studies comparing patients with esophageal cancer who underwent neoadjuvant therapy and curative resection with and without adjuvant therapy. Primary outcome was overall survival (OS), and random effects meta-analysis was conducted where appropriate. Grading of recommendations, assessment, development, and evaluation was used to assess the certainty of evidence. Results: Ten studies involving 6462 patients were included. When compared to patients who received neoadjuvant therapy and esophagectomy alone, adjuvant therapy groups experienced a significant decrease in mortality by 48% at 1 year (Risk Ratio (RR) 0.52, 95% confidence interval [CI] 0.41–0.65, P < 0.001, moderate certainty ). This reduction in mortality was carried through to 5-year follow-up (RR 0.91, 95% CI 0.86–0.96, P < 0.001, moderate certainty ). The difference between the adjuvant therapy and the control group was uncertain regarding the secondary outcomes. Conclusion: Adjuvant therapy after neoadjuvant treatment and esophagectomy with negative resection margins provide an improved OS at 1 and 5 years with moderate to high certainty of evidence, but the benefit for disease-free survival and locoregional/distal recurrence remain uncertain due to limited reporting of these outcomes.
Esophagectomy
Neoadjuvant Therapy
Adjuvant Therapy
Cite
Citations (26)
Neoadjuvant Therapy
Esophagectomy
Adjuvant Therapy
Esophageal adenocarcinoma
Esophagogastric junction
Barrett's esophagus
Cite
Citations (28)
Abstract Background The use of adjuvant therapy after neoadjuvant therapy followed by esophagectomy is controversial due to limited studies. The aim of this study was to investigate the role of adjuvant therapy for patients with esophageal adenocarcinoma (EAC) after neoadjuvant therapy and esophagectomy and to provide a basis for clinical decision-making. Methods Patients who were diagnosed as EAC and underwent neoadjuvant therapy followed by surgery were included in this study. The data of the patients in training group are derived from Surveillance, Epidemiology, and End Results (SEER) database. Patients from two institutions (West China Hospital and Nanjing Jinling Hospital) were used to validate the results. Results A total of 3445 EAC patients were identified from the SEER database according to the eligibility criteria. No significant difference was found between adjuvnat therapy and non-adjuvant therapy group (5-year overall survival (OS): 35.7 and 37.2%, p = 0.920; 5-year cancer-specific survival (CSS): 39.5 and 43.2%, p = 0.520). Meanwhile, 130 patients were identified from West China Hospital (n = 84) and Jinling Hospital (n = 46). The results showed that patients undergoing adjuvant therapy group had a better OS than non-adjuvant therapy group (p = 0.031). Conclusion On the basis of the SEER database, this study revealed no survival benefit of adjuvant therapy for patients with EAC after neoadjuvant therapy and surgery. However, the analysis results of patients from two institutions in China show that patients with EAC may benefit from adjuvant therapy after neoadjuvant therapy and esophagectomy.
Neoadjuvant Therapy
Esophagectomy
Adjuvant Therapy
Esophageal adenocarcinoma
Cite
Citations (0)
Breast cancer is one of the commonest causes of death from a cancer in women. Human epidermal growth factor receptor 2 overexpression, found in 20–30% of breast cancer patients is associated with aggressive tumour behavior, and poorer prognosis. Trastuzumab (Herceptin), a biologically engineered, humanized immunoglobulin-1, anti-HER2 monoclonal antibody (mAb) developed by Genentech/ Roche, directed against the extracellular domain of HER2. It is the first commercially available mAb-based therapy for the treatment of breast cancer. Trastuzumab has been extensively trialed and now is used in the early and metastatic settings. Ado-trastuzumab emastasine (T-DM1, Genentech Roche) is a novel antibody–drug conjugate, whereby trastuzumab (T) is linked to mertansine (DM1). It is currently undergoing multicentered phase 3 trials exploring its full role within the treatment of Her2 overexpression breast cancer, with promising early results.
Trastuzumab emtansine
Antibody-drug conjugate
Humanized antibody
Cite
Citations (3)
Pertuzumab
Lapatinib
Trastuzumab emtansine
Taxane
Cite
Citations (1)
Neoadjuvant therapy, an adjunctive therapy given before the main therapy, has become an integral part of modem multidisciplinary cancer management. Organized by the primary organ involved by cancer, this review summarizes the outcomes of neoadjuvant therapy for common malignant solid tumors, based on large, randomized, controlled trials. In locally advanced rectal, laryngeal, and breast cancer, neoadjuvant therapy enables organ preservation; however, it does not improve overall survival when compared with definitive treatment followed by adjuvant therapy. In locally advanced bladder and cervical cancer, patients who undergo neoadjuvant therapy before radical surgery appear to have better survival than those receiving definitive therapy alone; however, it is unclear if the neoadjuvant approach will be superior to definitive therapy followed by adjuvant therapy. To date, the survival benefits of neoadjuvant therapy for resectable non-small cell lung, esophageal, gastric, and prostate cancer remains under investigation.
Neoadjuvant Therapy
Adjuvant Therapy
Systemic therapy
Cite
Citations (13)
Antibody-drug conjugate
Linker
Trastuzumab emtansine
Conjugate
Cite
Citations (136)
Neoadjuvant Therapy
Adjuvant Therapy
Cite
Citations (0)