ABSTRACT
OBJECTIVE: To explore the clinical application value of gonadotropin-releasing hormone antagonist (GnRH-A) combined with low-dose HCG regimen in patients with high ovarian response based on clinical characteristics and laboratory indicators. METHODS: The clinical data of 305 patients who received IVF/ICSI in the Hechi People's Hospital Reproductive Medicine Center from March 2018 to December 2021 were retrospectively included, and all patients were treated with GnRH-A combined with low-dose HCG regimen protocol. The patients were separated into an ovarian hyper-response group and a normal ovarian reaction group according to their ovarian reactivity. Risk factors for ovarian hyper-response in IVF/ICSI patients were screened by univariate and multivariate logistic analysis. The ROC curve area was used to evaluate the prediction effect. RESULTS: Of the 305 patients, 6 (1.97%) had poor ovarian reaction, 123 (40.33%) had ovarian hyper response, and 176 (57.70%) had normal ovarian reaction. The proportion of ovarian hyper response and normal ovarian reaction was 98.03% (299/305); the basic serum FSH level, AMH level, E2 on HCG level on HCG injection day and the incidence of moderate to severe OHSS in the Ovarian hyper-response group were compared with those in the normal ovarian reaction group (P < 0.05). Logistic reversion analysis showed that AMH (OR = 1.246, 95% CI = 1.107-1.402), E2 level on HCG injection day (OR = 1.050, 95% CI = 1.028-1.072) and P level on HCG injection day (OR = 5.831, 95% CI = 1.231-27.616) were factors for ovarian hyper response. Basal serum FSH (OR = 0.781, 95% CI = 0.647-0.94) and LH level on HCG injection day (OR = 0.594, 95% CI = 0.405-0.871) were negatively correlated with the occurrence of high response (P < 0.05). ROC curve analysis showed that AMH (AUC = 0.779), E2 level on HCG injection day (AUC = 0.802), P level on HCG injection day (AUC = 0.636), combined detection (AUC = 0.843), AUC > 0.5. Among them, the prediction effect of joint detection is better. CONCLUSION: GnRH-A combined with low-dose HCG regimen is feasible for patients with ovarian hyper-response during IVF-ET/ICSI, and does not affect the implantation rate, clinical pregnancy rate, live birth rate, and early abortion rate of such patients. Combined detection of basal serum FSH, AMH, LH, E2 and P levels on HCG injection day can effectively predict the occurrence of ovarian hyper-response.
ABSTRACT
OBJECTIVE: The clinical efficacy and safety profile of trastuzumab deruxtecan (T-DXd) have been demonstrated in previously treated patients with human epidermal growth factor receptor 2 (HER2)-low advanced breast cancer (BC). It is, however, necessary to evaluate the value of T-DXd considering both its clinical efficacy and its cost, given that it is high. This study aimed to evaluate the cost-effectiveness of T-DXd versus chemotherapy in patients with previously treated HER2-low advanced BC. METHODS: We used a partitioned survival model that included three mutually exclusive health states. The patients in the model were identified based on their clinical characteristics and outcomes from the DESTINY-Breast04. Probabilistic and one-way sensitivity analyses were performed to evaluate the model's robustness. Subgroup analyses were also conducted. The measures included costs, life years, quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), incremental net health benefits (INHBs), and incremental net monetary benefits (INMBs). RESULTS: The ICERs of T-DXd vs. chemotherapy were $83,892/QALY, $82,808/QALY, and $93,358/QALY in all HER2-low advanced BC patients, HER2-positive (HER2+) advanced BC patients and HER2-negative (HER2-) advanced BC patients, respectively. In one-way sensitivity analysis, the cost of T-DXd and hazard ratio (HR) for progression-free survival (PFS) and overall survival (OS) were also identified as key drivers. If the price of T-DXd decreased to $17.00/mg, $17.13/mg, and $14.07/mg, it would be cost-effective at a willingness to pay (WTP) threshold of $50,000/QALY in all HER2-low advanced BC patients, HER2+ advanced BC patients and HER2- advanced BC patients, respectively. At a WTP threshold of $100,000/QALY, the probability of T-DXd being cost-effective was 81.10%, 82.27%, and 73.78% compared to chemotherapy for all HER2-low advanced BC patients, HER2+ advanced BC patients and HER2- advanced BC patients, respectively. Most subgroups of patients with HER2+ disease had a cost-effectiveness probability of > 50%. CONCLUSION: From a third-party payer's perspective in the United States, the findings of the cost-effectiveness analysis revealed that, at the current price, T-DXd is a cost-effective alternative to chemotherapy for patients with prior HER2-low advanced BC, at WTP threshold of $100,000/QALY.
Subject(s)
Breast Neoplasms , Immunoconjugates , Humans , Female , Breast Neoplasms/drug therapy , Cost-Benefit Analysis , Trastuzumab/therapeutic useABSTRACT
Background: The efficiency and safety of sacituzumab govitecan (SG) for the therapy of hormone receptor-positive (HR+)/human epidermal receptor 2-negative (HER2-) metastatic breast cancer (BC) has been demonstrated. The aim of this study is to evaluate its cost-effectiveness on HR+/HER2- metastatic BC from the third-party payer perspective in the United States. Methods: We performed the cost-effectiveness of SG and chemotherapy using a partitioned survival model. TROPiCS-02 provided clinical patients for this study. We evaluated the robustness of this study by one-way and probabilistic sensitivity analyses. Subgroup analyses were also conducted. The outcomes were costs, life-years, quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICER), incremental net health benefit (INHB), and incremental net monetary benefit (INMB). Results: SG treatment was related to an increase of 0.284 life years and 0.217 QALYs over chemotherapy, as well as a cost increase of $132,689, reaching an ICER of $612,772/QALY. The INHB was -0.668 QALYs, and the INMB was -$100,208. SG was not cost-effective at the willingness to pay (WTP) threshold of $150,000/QALY. The outcomes were sensitive to patient body weight and cost of SG. SG may be cost-effective at the WTP threshold of $150,000/QALY if the price is less than $3.997/mg or the weight of patients is under 19.88 kg. Based on the subgroup analysis, SG did not prove cost-effective in all subgroups at the WTP threshold of $150,000/QALY. Conclusion: From a third-party payer standpoint in the United States, SG was not cost-effective, even though it had a clinically significant advantage over chemotherapy for the treatment of HR+/HER2- metastatic BC. The cost-effectiveness of SG can be improved if the price is substantially reduced.
