Background: The possible impact of malnutrition on the efficacy and tolerability of modern chemotherapy for metastatic gastic adenocarcinoma (mGC) patients is unclear. With this study, we aimed to represent the possible impact of malnutrition on the efficacy and tolerability of chemotherapy, and also on the overall survival of mGC patients. Methods: In this prospective multicenter study, we collected demographic, oncological and nutritional data of our mGC patients. The nutritional status of patients were assessed with the Nutritional Risk Index (NRI), Body Mass Index (BMI) and weight loss percentage within 21-day period, between the chemotherapy cycles. All of these parameters along with toxicity assessment were evaluated after each courses of chemotherapy in order to determine inter-treatment weight loss. NRIs were calculated with a formula as follows; [1.519 × serum albumin level(g/L) + 41.7 × current weight/basic weight]. Patients were classified as having ‘no malnutrition’ (NRI > 97.5), ‘moderate malnutrition’ (97.5 ≥ NRI ≥ 83.5) or ‘severe malnutrition’ (NRI < 83.5). Drug-induced toxicities and treatment responses were evaluated via National Cancer Institute CTCAE version 4.0 and RECIST Criteria 1.1, respectively. Results: One hundred and sixteen mGC patients were enrolled into the study. Median age was 60 years with range 32–83. Primary location of the tumor was antrum in 40% of the patients and of which 24% had undergone primary tumor resection. Ninety-eight percent of the patients had WHO performance status 0 or 1. Malnutrition was diagnosed in 67% of the patients and was severe in 31% of them. All patients received chemotherapy as first-line setting. Severe malnutrition was not associated with chemotherapy responses (p = 0.57). Moderate/severe malnutrition was associated with more cytopenia, nausea/vomiting, diarrhea, neuropathy, (p < 0.05 for all parameters). Moderate/severe malnutrition is associated with worser non-hematological toxicities (p = 0.038). Forty-one percent of patients died during the follow up period (Median: 138 days, range: 21–378). Malnutritional level was associated with significantly reduced overall survival. Severe malnutrition was associated with shorter median overall survival (74 days (95% CI, 20.7–111.0) vs. 237 (95% CI, 148.4-325.6) in none/moderate groups, p = 0.007). Conclusions: In mGC patients, moderate/severe malnutrition is associated with worse non-hematological toxicities. Severe malnutrition is also associated with reduced overall survival.
25 October 2020 in Journal of Oncology Pharmacy Practice
Background: Metastatic and unresectable thymoma (T) or thymic carcinoma (TC) have limited treatment options, especially after first line. Methods: Patients with unresectable or recurrent thymic tumors who used minimum one dose of nivolumab at any line of treatment were evaluated retrospectively. Even though nivolumab was administered 3mg/kg dosage in PRIMER study, due to toxicity and financial concerns, we used low dose regimen mostly. Results: Among 46 unresectable and recurrent thymic epithelial tumors; 8 patients with TC (n = 3), T (n = 4) and mixt histology (n = 1) were reviewed. Three patients had myasthenia gravis history that had to be controlled before treatment. Four patients showed moderate (n = 2) or severe (n = 2) adverse events with nivolumab treatment. Interestingly, two severe adverse events were occurred at first dose even with 40 mg nivolumab and required cessation of treatment permanently. The median number of nivolumab received was four (range: 1–18). Best response was partial response. Two patients progressed at the 3rd and 5th month of treatment. Best duration of response for one patient with TC and one patient with T–B2 were 9 and 14 months, respectively. Median survival time after nivolumab was 7.4 months (range: 2–22.1). Conclusions: After the results of the previous study could be supported by randomized prospective studies with more number of patients, nivolumab may be considered as an option in patients with thymic epithelial tumors who have received multiple line treatments. However, given the high rate of severe toxicities, there is need to find out a reliable marker to prediction patients who will derive benefit or exhibit toxicity.
The aim of this study is to evaluate the efficacy and toxicity of trastuzumab emtansine (T-DM1) in cases with metastatic breast cancer (mBC) in different lines of treatment.Retrospective analysis o...
Introduction: Achieving a pCR serves as a biomarker indicating enhanced overall survival for breast cancer patients undergoing NST. Vitamin D enhances the antitumor effect of chemotherapeutics as demonstrated in cancer cells and animal models. In this prospective randomized clinical study, we aim to investigate the effect of oral vitamin D supplementation during neoadjuvant systemic therapy (NST) on pathologic complete response (pCR). Methods: Between June 2019 and June 2023, an oral form of 50,000 IU vitamin D3 (cholecalciferol) replacement was administered once a week during NST for the study group. Results: There were 114 (50.2%) cases in the study group and 113 (49.8%) in the control group (totally 227 cases). Factors that positively influenced pCR were higher clinical T stage, higher AJCC clinical stage, Estrogen receptor negativity, progesterone receptor negativity, human epidermal growth factor receptor 2 positivity, high Ki‐67 expression (≥ 20%), hormone negative molecular subtypes, and vitamin D intake in univariate analysis. In the multivariate analysis, factors significantly affecting pCR were vitamin D intake (OR: 2.33, 95% CI 1.20–4.53; p = 0.013), hormone receptor negativity (OR: 2.22, 95% CI 1.11–4.43; p = 0.024), and Ki‐67 ≥ 20% (OR: 3.27, 95% CI 1.03–10.34; p = 0.044). Conclusions: This is the first and only study to compare the effect of oral vitamin D supplementation on pCR during NST. Vitamin D supplementation during NST has a significant effect on pCR in breast cancer patients. Although this effect is not significant for axillary pCR, there is an almost significant correlation. Trial Registration: ClinicalTrials.gov (Identifier: NCT03986268)