The total number of dissected lymph nodes for primary lung cancer surgery by single-port video-assisted thoracoscopic surgery (VATS) was higher than by multiport VATS in univariable, multivariable linear regression and Box-Cox transformed multivariable analyses. This study confirmed that highly effective lymph node dissection could be achieved through single-port VATS in our setting.
There had been several studies using gene-expression profiling in predicting distant recurrence in breast cancer. In this study, we developed an 18-gene classifier (18-GC) to predict distant recurrence of breast cancer and compared it with the 21-gene panel (Oncotype DX®, ODx) in performance. Included were 224 breast cancer patients with positive hormonal receptor (HR+) and negative human epidermal growth factor receptor 2 (HER2-). We compared the demographic, clinical, and survival information of the patients, and further compared the prediction of recurrence risk obtained by using the 18-GC with that by ODx. To have the best combined sensitivity and specificity, receiver operating characteristics (ROC) curve analysis was performed to determine the cutoff values for several breakpoint scores. For the new 18-GC, a breakpoint score of 21 was adopted to produce a combined highest sensitivity (95%) and specificity (39%) in detecting distant recurrence. At this breakpoint score, 164 of the 224 patients were classified by the 18-GC in the same risk level as by ODx, giving a concordance rate of 73%. Along with patient age and tumor stage, this 18-GC was found to be an independent significant prognostic factor of distant metastasis of breast cancer. We have thus created a new gene panel assay for prediction of distant recurrence in HR+ and HER2- breast cancer patients. With a high concordance rate with ODx, this new assay may serve as a good tool for individual breast cancer patients to make an informed decision on whether adjuvant chemotherapy should be performed post-surgery.
Purpose
A clinical-genomic prognostic multigene panel (RI-DR assay, RecurIndex
®
), predicting the risk level of distant recurrence (DR) in early-stage breast cancer (EBC) patients with an Asian background, has been validated as a valuable tool for identifying high-risk patients to develop distant recurrence (metastasis). Although the clinical benefit of adjuvant chemotherapy from the assay’s prediction is already proved, its affordability remains uncertain. This study is the first time in which the long-term cost-effectiveness of the RI-DR assay is evaluated.
Patients and Methods
A lifetime Markov decision-analytic model was developed from a societal perspective to estimate the life-years gained (LYGs), quality-adjusted life-years (QALYs), medical costs, and incremental cost-effectiveness ratios (ICERs), comparing EBC women with and without RI-DR genomic testing. A decision tree was used to classify patients in one of the fifteen end nodes (by order, each arm was stratified by a patient being tested or not with the RI-DR assay, being treated or not with adjuvant chemotherapy and had no, minor, major, or fatal toxicity after adjuvant chemotherapy). Health utilities, costs, transition probabilities, and survival data were extracted from the scientific literature. Deterministic sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) were performed on variables to assess the robustness of the model. A willingness-to-pay (WTP) threshold of 790,000 NT$ per QALY gained was considered as a cost-effectiveness criterion.
Results
The incremental cost per QALY gained under base-case assumptions of the model was 173,842 NT$. Findings on the variation in model input parameters were robust and confirmed that every key variable was cost-effective for the benefit of RI-DR testing.
Conclusion
The clinical-genomic RI-DR assay is cost-effective in guiding adjuvant chemotherapy decisions compared to current clinical practice guidelines.
BackgroundNumerous prospective studies, predominantly in the Caucasian population, have proven the clinical utility of using multigene expression tests to prevent overtreatment in early-stage breast cancer patients with early-stage disease. In this study, we used an Asian population to validate a clinical-genomic assay (RecurIndex®) for estimating the risk of distant recurrence and relapse in early-stage breast cancer patients. MethodsA total of 298 patients with early-stage breast cancer, luminal-like subtype (85.6%) and HER2-enriched/ triple-negative subtype (14.4%), was enrolled in a retrospective study across five participating medical centers in Taiwan. The inclusion criteria were as follows: women (1) who underwent primary surgery without prior induction treatments, (2) with an early pathologic N stage and (3) who received either mastectomy or breast-conserving surgery. Kaplan Meier method and Cox proportional hazards model were used to, respectively, identify independent prognostic factors and calculate the 5- and 10-year survival rates of patients in the low- and high-risk groups assigned by the diagnostic test. A forest plot was produced to assess hazard ratios and 95% confidence intervals. The primary endpoint was distant recurrence-free survival (DRFS) and the secondary endpoint was relapse-free survival (RFS).ResultsThe 10-year DRFS rate was significantly higher in the good prognosis group than in the poor prognosis group (91.9% [95% CI, 86.1-98.1%] versus 62.9% [95% CI, 49.8-79.4%]). The overall hazard ratio for distant recurrence was 1.031 [95% CI, 1.017 - 1.046] per unit Recurrence index-distant recurrence (RI-DR) score increment. ConclusionsThe present study provides robust evidence of the clinical utility of using the RI-DR score to accurately predict clinical outcomes. RecurIndex® could be used to determine the utility of adjuvant chemotherapy in Asian patients, especially those having hormone-receptor positive tumors, leading to a meaningful reduction in adjuvant chemotherapy recommendations.
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