RESUMO
Background: The risk factors for breast implant reconstruction complications and prosthetic reconstruction failure are currently inconclusive. Besides, there is a lack of studies regarding the relationship between radiation dose distribution and complications. This study explored the risk factors for breast implant reconstruction complications and analyzed the influence of radiation dose distribution on complications. Methods: Patients undergoing breast prosthesis reconstruction between January 2012 and June 2020 were retrospectively reviewed. Patient demographics, treatments, and perioperative factors were recorded, as well as complications and prosthetic reconstruction failures. Multivariable logistic regression models were used to explore the risk factors of reconstruction complications and prosthesis reconstruction failure. The radiation dose distribution was obtained by examining the dose-volume histogram and compared among patients with and without complications. Results: Two hundred and sixteen patients (221 reconstructions) were not irradiated, whereas 59 (59 reconstructions) received radiotherapy (RT). The median follow-up period was 47.7 months. Multivariate regression analysis showed that RT [odds ratio (OR) =2.000; 95% confidence interval (CI): 1.065-3.754; P=0.031] and chemotherapy (OR =2.226; 95% CI: 1.032-4.799; P=0.041) were independent risk factors for overall reconstruction complications; and hypertension (HT) (OR =8.222; 95% CI: 1.056-64.034; P=0.044) or RT (OR =2.442; 95% CI: 1.009-5.908; P=0.048) were risk factors for prosthetic reconstruction failure. There was a statistically significant difference in the radiation dose distribution between patients with and those without complications. Patients with complications had a significantly higher mean dose of 5 or 10 cc around the maximum radiation dose in the planning target volume (PTV) (P=0.045 and P=0.034, respectively), irradiation volume with a dose of 107% of prescription dose (P=0.027), and proportion of irradiation volume with doses of 105% and 107% of prescription dose to the total PTV (P=0.019 and P=0.042, respectively). Conclusions: RT can increase implant reconstruction complications and prosthetic reconstruction failure, but remains an acceptable option in a multidisciplinary setting. In addition to RT, chemotherapy is a risk factor for overall complications of breast implant reconstruction. HT is a risk factor for prosthetic reconstruction failure, so the patient's blood pressure should be actively monitored and controlled during the perioperative period. The radiation dose level and the volume with high-dose radiation should be limited to reduce complications.
RESUMO
Background: Palbociclib is the first cyclin dependent kinase 4/6 (CDK4/6) inhibitor approved in China to be combined with endocrine therapy (ET) for patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. However, palbociclib has only been used in China for a short amount of time, and there is limited data on its real-world applications. This study observed the efficacy and safety of palbociclib plus ET in a real-world setting in southwest China and we hope to provide some references for the treatment of patients with breast cancer in China. Methods: This was an observational study of patients with HR+/HER2- advanced breast cancer (ABC) who received palbociclib plus ET. The primary endpoint of the study was progression-free survival (PFS) and the 6- and 12-month progression-free rates. The secondary endpoint included the objective response rate (ORR) and the clinical benefit rate (CBR). Results: A total of 64 patients were enrolled in this study, and 54.7% of them received palbociclib plus ET as the first-line treatment for ABC. The median PFS was 21.6 months (95% CI: 11.2-32.0 months) after a median follow-up period of 13.8 months (95% CI: 11.9-15.7 months). The 6-month progression-free rate was 75.4%, and 48.9% of patients remained progression-free at 12 months. Overall, the ORR was 21.6% and the CBR was 76.5%. Patients with the molecular typing of Luminal A (P=0.035), a lower Ki67 level (P<0.001), sensitivity or acquired resistance to ET (P=0.003), less than 3 visceral metastases lesions (P=0.001), and those who received palbociclib plus ET as first-line or second-line of treatment for ABC (P=0.001) showed longer PFS. A total of 53.1% of patients had grade 3-4 adverse events (AEs), but only 4.7% of patients experienced permanent discontinuation of treatment due to intolerable AEs. Conclusions: The efficacy of palbociclib plus ET is worthy of recognition and the toxicity was acceptable in this study, which is similar to previously reported data from randomized clinical trials and other real-world evidence. Treatment for ABC using palbociclib plus ET should be recommended more widely in China due to the efficacy and safety.
