Neratinib 40mg tablets

ObjectiveThis study aimed to evaluate the efficacy and safety of small-molecule TKIs in neoadjuvant treatment of HER2-positive breast cancer using a network meta-analysis approach.MethodsA systematic literature search was conducted in the Medline, Embase, and Web of Science databases. Eligible studies that included HER2-positive breast cancer patients receiving neoadjuvant treatment with small-molecule TKIs before surgery were included. A Bayesian framework within a random-effects model was used for network meta-analysis to summarize direct and indirect evidence. Outcome measures included breast pathological complete response (breast pCR), total pathological complete response (total pCR) of the breast and lymph nodes, and selected safety endpoints.ResultsEight eligible studies involving a total of 1,841 participants were included. The most common treatment regimens were Trastuzumab (n = 8), Lapatinib (n = 6), and Lapatinib plus Trastuzumab (n = 6), while there were fewer studies on Pyrotinib plus Trastuzumab (n = 2). No studies about tucatinib and neratinib were enrolled. The rankings of efficacy for the breast pCR and total pCR endpoints were as follows: (i) Pyrotinib plus Trastuzumab, (ii) Lapatinib plus Trastuzumab, (iii) Trastuzumab, (iv) Lapatinib. Regarding safety endpoints of grade 3 or higher diarrhea, neutropenia, fatigue, and skin disorders, the rankings were as follows: (i) Trastuzumab, (ii) Lapatinib, (iii) Lapatinib plus Trastuzumab, (iv) Pyrotinib plus Trastuzumab for diarrhea; (i) Pyrotinib plus Trastuzumab, (ii) Trastuzumab, (iii) Lapatinib plus Trastuzumab, (iv) Lapatinib for neutropenia; (i) Lapatinib plus Trastuzumab, (ii) Trastuzumab, (iii) Lapatinib for fatigue; (i) Trastuzumab, (ii) Lapatinib plus Trastuzumab, (iii) Lapatinib for skin disorders.ConclusionFor HER2-positive breast cancer patients, the use of small-molecule TKIs in combination with trastuzumab as neoadjuvant treatment has certain advantages in improving the rate of pathological response. Dual-targeted therapy with pyrotinib shows objective efficacy and acceptable safety; however, further research is still needed to confirm these findings.

Abstract licence: CC BY-NC-ND

Abstract Background Neratinib plus capecitabine(N + C)has a good effect for HER2-positive metastatic breast cancer (MBC), but considering these tradeoffs in quality of life and cost, the optimal choice of treatment sequencing is unclear. Cost-effectiveness analysis can clearly quantify such tradeoffs to make more informed decisions. Our objective was to evaluate the social cost-effectiveness of the N + C regimen for HER2 positive MBC. METHODS Clinical data were extracted from a randomized controlled trial, NALA (NCT01808573). Patients were randomized into the N + C group or the lapatinib plus capecitabine (L + C) group. A Markov model was established with a 21-day cycle length. Costs were acquired from local hospitals, effect parameters included quality-adjusted life year (QALY) and incremental cost-effectiveness ratio (ICER). RESULTS In the main analysis, the QALY in N + C is 0.04492 higher than that in L + C (N + C, 0.62954 QALY; L + C, 0.58462 QALY). The ICER between N + C and L + C was − 1,796,801.93 CNY/QALY. In the subanalysis, the QALY in N + C is 0.05643 higher than that in L + C (N + C, 0.65047 QALY; L + C, 0.59404 QALY) in the Asian group. The ICER between N + C and L + C was − 1,584,528.96 CNY/QALY. Sensitivity analyses indicated the stability of the model and the impact of utility. CONCLUSION N + C was cost-effective compared with L + C for HER2 positive MBC.

Abstract licence: CC BY 4.0