ABSTRACT
BACKGROUND: The HER2DX genomic test predicts pathological complete response (pCR) and survival outcome in early-stage HER2-positive (HER2+) breast cancer. Here, we evaluated the association of HER2DX scores with (i) pCR according to hormone receptor status and various treatment regimens, and (ii) survival outcome according to pCR status. MATERIALS AND METHODS: Seven neoadjuvant cohorts with HER2DX and clinical individual patient data were evaluated (DAPHNe, GOM-HGUGM-2018-05, CALGB-40601, ISPY-2, BiOnHER, NEOHER and PAMELA). All patients were treated with neoadjuvant trastuzumab (n = 765) in combination with pertuzumab (n = 328), lapatinib (n = 187) or without a second anti-HER2 drug (n = 250). Event-free survival (EFS) and overall survival (OS) outcomes were available in a combined series of 268 patients (i.e. NEOHER and PAMELA) with a pCR (n = 118) and without a pCR (n = 150). Cox models were adjusted to evaluate whether HER2DX can identify patients with low or high risk beyond pCR status. RESULTS: HER2DX pCR score was significantly associated with pCR in all patients [odds ratio (OR) per 10-unit increase = 1.59, 95% confidence interval 1.43-1.77; area under the ROC curve = 0.75], with or without dual HER2 blockade. A statistically significant increase in pCR rate due to dual HER2 blockade over trastuzumab-only was observed in HER2DX pCR-high tumors treated with chemotherapy (OR = 2.36 (1.09-5.42). A statistically significant increase in pCR rate due to multi-agent chemotherapy over a single taxane was observed in HER2DX pCR-medium tumors treated with dual HER2 blockade (OR = 3.11, 1.54-6.49). The pCR rates in HER2DX pCR-low tumors were ≤30.0% regardless of treatment administered. After adjusting by pCR status, patients identified as HER2DX low-risk had better EFS (P < 0.001) and OS (P = 0.006) compared with patients with HER2DX high-risk. CONCLUSIONS: HER2DX pCR score and risk score might help identify ideal candidates to receive neoadjuvant dual HER2 blockade in combination with a single taxane in early-stage HER2+ breast cancer.
Subject(s)
Breast Neoplasms , Humans , Female , Breast Neoplasms/drug therapy , Breast Neoplasms/genetics , Breast Neoplasms/pathology , Receptor, ErbB-2/genetics , Treatment Outcome , Trastuzumab , Taxoids , Neoadjuvant Therapy/adverse effects , Antineoplastic Combined Chemotherapy Protocols/adverse effectsABSTRACT
INTRODUCTION: The aim of this study is to evaluate the cost-effectiveness and impact of gene-expression assays (GEAs) on treatment decisions in a real-world setting of early-stage breast cancer (ESBC) patients. METHODS: This is a regional, prospective study promoted by the Council Health Authorities in Madrid. Enrolment was offered to women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, node-negative or micrometastatic, stage I or II breast cancer from 21 hospitals in Madrid. Treatment recommendations were recorded before and after knowledge of tests results. An economic model compared the cost-effectiveness of treatment, guided by GEAs or by common prognostic factors. RESULTS: 907 tests (440 Oncotype DX® and 467 MammaPrint®) were performed between February 2012 and November 2014. Treatment recommendation changed in 42.6% of patients. The shift was predominantly from chemohormonal (CHT) to hormonal therapy (HT) alone, in 30.5% of patients. GEAs increased patients' confidence in treatment decision making. Tumor grade, progesterone receptor positivity and Ki67 expression were associated with the likelihood of change from CHT to HT (P < 0.001) and from HT to CHT (P < 0.001). Compared with current clinical practice genomic testing increased quality-adjusted life years by 0.00787 per patient and was cost-saving from a national health care system (by 13.867 per patient) and from a societal perspective (by 32.678 per patient). CONCLUSION: Using GEAs to guide adjuvant therapy in ESBC is cost-effective in Spain and has a significant impact on treatment decisions.
Subject(s)
Breast Neoplasms/drug therapy , Gene Expression Profiling/economics , Registries , Adolescent , Adult , Aged , Biomarkers, Tumor/genetics , Breast Neoplasms/economics , Breast Neoplasms/genetics , Breast Neoplasms/pathology , Chemotherapy, Adjuvant , Clinical Decision-Making , Cost-Benefit Analysis , Female , Gene Expression Profiling/methods , Humans , Middle Aged , Prospective Studies , Quality-Adjusted Life Years , Spain/epidemiology , Young AdultABSTRACT
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Subject(s)
Humans , Male , Aged , Erythema/chemically induced , Erythema/complications , Erythema/therapy , Drug-Related Side Effects and Adverse Reactions/complications , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/therapy , Antineoplastic Agents/adverse effects , Emollients/metabolism , Emollients/therapeutic use , Keratosis/therapy , Keratoderma, Palmoplantar/complications , Keratoderma, Palmoplantar/therapyABSTRACT
Local rectal cancer recurrences represent a great challenge, as surgical re-excisions or re-irradiation procedures are not always feasible. Moreover, scar or local recurrence is hard to elucidate with conventional diagnosis techniques. Emerging diagnostic and therapeutic procedures may be useful in this setting. A local rectal cancer recurrence radiofrequency ablation is reported. PET scan confirmed the recurrence, defined the target volume and assessed the success of the local therapy.
Subject(s)
Adenocarcinoma/surgery , Catheter Ablation , Neoplasm Recurrence, Local/surgery , Rectal Neoplasms/surgery , Adenocarcinoma/diagnostic imaging , Adenocarcinoma/pathology , Adult , Catheter Ablation/adverse effects , Humans , Male , Neoplasm Recurrence, Local/diagnostic imaging , Neoplasm Recurrence, Local/pathology , Positron-Emission Tomography , Rectal Neoplasms/diagnostic imaging , Rectal Neoplasms/pathology , Tomography, X-Ray Computed , Urinary Retention/etiologyABSTRACT
Local rectal cancer recurrences represent a great challenge, as surgical re-excisions or re-irradiation procedures are not always feasible. Moreover, scar or local recurrence is hard to elucidate with conventional diagnosis techniques. Emerging diagnostic and therapeutic procedures may be useful in this setting. A local rectal cancer recurrence radiofrequency ablation is reported. PET scan confirmed the recurrence, defined the target volume and assessed the success of the local therapy (AU)
No disponible
Subject(s)
Humans , Male , Adult , Catheter Ablation/adverse effects , Adenocarcinoma/surgery , Rectal Neoplasms/surgery , Adenocarcinoma/pathology , Adenocarcinoma , Neoplasm Recurrence, Local/pathology , Neoplasm Recurrence, Local , Positron-Emission Tomography/methods , Tomography, X-Ray Computed/methods , Tomography, X-Ray Computed , Rectal Neoplasms/pathology , Rectal Neoplasms , Urinary Retention/etiologyABSTRACT
No disponible
Subject(s)
Humans , Male , Female , Head and Neck Neoplasms/therapy , Head and Neck Neoplasms/complications , Head and Neck Neoplasms/epidemiology , Head and Neck Neoplasms/mortalityABSTRACT
Locally advanced gastric adenocarcinoma has a poor outcome. Neoadjuvant treatment is being tested in locally advanced non-resectable tumours and in those resectable tumours with a high risk of recurrence. Efforts to identify prognostic factors and more active and less toxic preoperative regimens are being searched for. We report the case of a patient achieving a complete histopathological complete response following docetaxel- based neoadjuvant chemotherapy.
Subject(s)
Adenocarcinoma/drug therapy , Antineoplastic Agents/therapeutic use , Stomach Neoplasms/drug therapy , Taxoids/therapeutic use , Adult , Chemotherapy, Adjuvant , Disease Progression , Docetaxel , Humans , Male , Neoadjuvant TherapyABSTRACT
Locally advanced gastric adenocarcinoma has a poor outcome. Neoadjuvant treatment is being tested in locally advanced non-resectable tumours and in those resectable tumours with a high risk of recurrence. Efforts to identify prognostic factors and more active and less toxic preoperative regimens are being searched for. We report the case of a patient achieving a complete histopathological complete response following docetaxel- based neoadjuvant chemotherapy (AU)
No disponible