The aim of the study was to compare efficacy and safety of first-line palliative chemotherapy with (EOX) epirubicin/oxaliplatin/capecitabine and (mDCF) docetaxel/cisplatin/5FU/leucovorin regimens for untreated advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma. Fifty-six patients were randomly assigned to mDCF (docetaxel 40 mg/m2 day 1, leucovorin 400 mg/m2 day 1, 5FU 400 mg/m2 bolus day 1, 5FU 1000 mg/m2/d days 1 and 2, cisplatin 40 mg/m2 day 3) or EOX (epirubicin 50 mg/m2 day 1, oxaliplatin 130 mg/m2 day 1, capecitabine 1250 mg/m2/d days 1–21). The primary endpoint was overall survival. The median overall survival was 9.5 months with EOX and 11.9 months with mDCF (p = 0.135), while median progression-free survival was 6.4 and 6.8 months, respectively (p = 0.440). Two-year survival rate was 22.2 % with mDCF compared to 5.2 % with EOX. Patients in the EOX arm had more frequent reductions in chemotherapy doses (34.5 vs. 3.7 %; p = 0.010) and delays in subsequent chemotherapy cycles (82.8 vs. 63.0 %; p = 0.171). There was no statistically significant difference in the rates of grade 3–4 adverse events (EOX 79.3 vs. mDCF 61.5 %; p = 0.234). As compared with the mDCF, the EOX regimen was associated with more frequent nausea (34.5 vs. 15.4 %), thromboembolic events (13.8 vs. 7.7 %), abdominal pain (13.8 vs. 7.7 %) and grades 3–4 neutropenia (72.4 vs. 50.0 %), but lower incidences of anemia (44.8 vs. 61.5 %), mucositis (6.9 vs. 15.4 %) and peripheral neuropathy (6.9 vs. 15.4 %). In conclusion, the mDCF regimen was associated with a statistically nonsignificant 2.4-month longer median overall survival without an increase in toxicity. This trial is registered at ClinicalTrials.gov, number NCT02445209.
and chronic forms of anthracycline-induced cardiotoxicity (AIC), which is classified into early-onset (first year) and late-onset cardiotoxicity. 6 Chronic AIC typically presents as irreversible myocardial dysfunction and heart failure (HF). The estimated incidence of HF ranges from 6.6% to 26%. 7,8 An asymptomatic INTRODUCTION Breast cancer (BC) is the most common malignancy in women worldwide. 1,2 The use of potentially cardiotoxic anthracyclines, cytostatic agents introduced many years ago, still remains the cornerstone of BC therapy. 3-5 Most sources distinguish between acute (throughout anthracycline treatment)
Combination treatment with BRAF (BRAFi) plus MEK inhibitors (MEKi) has demonstrated survival benefit in patients with advanced melanoma harboring activating BRAF mutations. Previous preclinical studies suggested that an intermittent dosing of these drugs could delay the emergence of resistance. Contrary to expectations, the first published phase 2 randomized study comparing continuous versus intermittent schedule of dabrafenib (BRAFi) plus trametinib (MEKi) demonstrated a detrimental effect of the “on−off” schedule. Here we report confirmatory data from the Phase II randomized open-label clinical trial comparing the antitumoral activity of the standard schedule versus an intermittent combination of vemurafenib (BRAFi) plus cobimetinib (MEKi) in advanced BRAF mutant melanoma patients (NCT02583516). The trial did not meet its primary endpoint of progression free survival (PFS) improvement. Our results show that the antitumor activity of the experimental intermittent schedule of vemurafenib plus cobimetinib is not superior to the standard continuous schedule. Detection of BRAF mutation in cell free tumor DNA has prognostic value for survival and its dynamics has an excellent correlation with clinical response, but not with progression. NGS analysis demonstrated de novo mutations in resistant cases.
IntroductionLaparoscopic technique combined with the ERAS (Enhanced Recovery after Surgery) protocol enables a shorter hospital stay and a lower complication rate. Although it has been widely used in many patients undergoing elective abdominal surgery, especially in patients with colorectal cancer, there are only a few papers describing laparoscopic total gastrectomy and the enhanced recovery protocol in patients with gastric cancer. Minimally invasive gastrectomy is still an uncommon procedure, mostly because of its difficulty.AimTo present the preliminary results of treatment of patients with gastric neoplasms who underwent laparoscopic gastrectomy D2 with perioperative care according to ERAS principles.Material and methodsEleven patients (5 male and 6 female, age 52–77 years) underwent laparoscopic D2 gastrectomy with intracorporeal esophagojejunal anastomosis. In all patients the ERAS protocol was implemented. We analyzed operation time, complications and hospital stay. Additionally we focused on operative technique as well as the perioperative care protocol.ResultsThe mean duration of the procedure was 245 min. There was 1 conversion due to unclear tumor infiltration. Mean hospital stay was 4.6 days. One postoperative complication (central venous catheter sepsis) was reported. Histological analysis confirmed the tentative diagnosis (R0 resection) in 10/11 patients. There were no readmissions.ConclusionsLaparoscopic gastrectomy is a valuable alternative to the classical approach and combined with the ERAS protocol can result in reduced hospital stay. However, due to the small group of patients it is difficult to adequately assess the incidence of early and late complications of the laparoscopic procedures; therefore further research is needed.
The quality of information that oncological patients receive from health care professionals is an underestimated issue in Poland and Eastern European countries. There is lack of sufficient data on this subject. The European Organization for Research and Treatment of Cancer (EORTC) supplies a new tool for measuring the quality of information provided to cancer patients. The purpose of the study is the translation into Polish, pilot testing and preliminary validation of the EORTC information module (INFO25). Following the EORTC translation procedures, forward and back translations of the questionnaire were performed (English → Polish, Polish → English). The intermediate version of the INFO25 was pilot-tested together with the general questionnaire of quality of life (EORTC QLQ-C30). Reliability, validity and known-group comparison tests were performed. A total of 21 patients with different cancer diagnoses were recruited into the study (7 women and 14 men; mean age of 60,2 years, age range 25–73 years). Apart from filling out the INFO25, patients were interviewed about the difficulties with answering every questionnaire item. Patients' comments were analyzed and minor language changes were made to the initial translation. The internal consistency of the INFO25 showed a reliability of 0,78. The final version of the Polish translation of the INFO25 module was obtained and approved by the EORTC Quality of Life Department. It can now be used in clinical setting and for scientific purposes.
Aim of the studyTo assess influencing factors and main health-related quality of life (HRQoL) issues in patients with cancers of the oesophago-gastric region using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire Core 30 (QLQ-C30) and its oesophago-gastric module (QLQ-OG25).Material and methodsPatients were qualified for this study based on the histological confirmation of oesophageal, oesophago-gastric or gastric cancers. Each patient filled out the Polish version of the EORTC QLQ-C30, the QLQ-OG25 module and a personal questionnaire. Patients were divided into groups based on gender, age, treatment intention, tumour localization, working status and level of education.ResultsOur study included 112 patients – 39 women (35%) and 73 men (mean age ± SD; 60.2 ±10.9). Thirty-five patients (31.3%) completed the questionnaires twice. Eighty-four (75%) patients had gastric cancer (GC), twenty-six (23.2%) oesophageal cancer (OC) and two (1.8%) cancer of the oesophago-gastric junction (OGJC). Eighty (71.4%) patients underwent surgical treatment prior to either chemo-, radio- or chemoradiotherapy. The Global Health Status scale of the QLQ-C30 inversely correlated with all the other QLQ-C30 and QLQ-OG25 symptom scales (r = –0.26 to –0.61; p < 0.05).ConclusionsThe main HRQoL problems of Polish OC, OGJC and GC patients are fatigue, insomnia, anxiety, and appetite and weight loss. Older age, receiving palliative treatment, having gastric cancer, being on retirement and having lower education are factors associated with higher symptom scores (worse symptoms) and thus poorer HRQoL.
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