Bevacizumab + capecitabine as maintenance therapy after initial bevacizumab + XELOX treatment in previously untreated patients with metastatic colorectal cancer: Phase iii stop and go study results - A turkish oncology group trial
Yalcin S.,Hacettepe University |
Uslu R.,Ege University |
Dane F.,Marmara University |
Yilmaz U.,Dokuz Eylül University |
And 8 more authors.
Oncology (Switzerland) | Year: 2013
Objective: It was the aim of this study to evaluate maintenance therapy with bevacizumab + capecitabine following induction with bevacizumab + capecitabine + oxaliplatin (XELOX) versus bevacizumab + XELOX until progression as first-line therapy in metastatic colorectal cancer (mCRC). Methods: Patients received either bevacizumab (7.5 mg/kg) + XELOX (capecitabine 1,000 mg/m 2 twice daily on days 1-14 + oxaliplatin 130 mg/m2 on day 1 every 3 weeks) until disease progression (arm A) or the same doses of bevacizumab + XELOX for 6 cycles followed by bevacizumab + capecitabine until disease progression (arm B). The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), objective response rate (ORR) and safety. Results: One hundred and twenty-three patients were randomized. Treatment compliance was similar in both groups. Median PFS was significantly longer for arm B than for arm A (11.0 vs. 8.3 months; p = 0.002). There was no significant difference between the two arms for ORR (66.7 vs. 59.0%; p = 0.861) or median OS (23.8 vs. 20.2 months; p = 0.100). Tolerability was acceptable in both treatment arms; the most frequent grade 3/4 treatment-related adverse events (arm B vs. arm A) were fatigue (6.6 vs. 16.1%), diarrhoea (3.3 vs. 11.3%), anorexia (3.3 vs. 11.3%), and neuropathy (1.6 vs. 8.1%). Conclusions: Maintenance therapy with bevacizumab + capecitabine can be considered an appropriate option following induction bevacizumab + XELOX in patients with mCRC instead of continuation of bevacizumab + XELOX. © 2013 S. Karger AG, Basel.
PubMed | Ankara Numune Research Hospital, Hitit University, Kocaeli Golcuk Necati Celik Hospital and Adiyaman University
Type: Comparative Study | Journal: Brazilian journal of anesthesiology (Elsevier) | Year: 2016
Tourniquet pain is one of the major obstacles for intravenous regional anesthesia. We aimed to compare tramadol and lornoxicam used in intravenous regional anesthesia as regards their effects on the quality of anesthesia, tourniquet pain and postoperative pain as well.After the ethics committee approval 51 patients of ASA physical status I-II aged 18-65 years were enrolled. The patients were divided into three groups. Group P (n = 17) received 3mg/kg 0.5% prilocaine; group PT (n = 17) 3mg/kg 0.5% prilocaine + 2 mL (100mg) tramadol and group PL (n = 17) 3mg/kg 0.5% prilocaine + 2 mL (8 mg) lornoxicam for intravenous regional anesthesia. Sensory and motor block onset and recovery times were noted, as well as tourniquet pains and postoperative analgesic consumptions.Sensory block onset times in the groups PT and PL were shorter, whereas the corresponding recovery times were longer than those in the group P. Motor block onset times in the groups PT and PL were shorter than that in the group P, whereas recovery time in the group PL was longer than those in the groups P and PT. Tourniquet pain onset time was shortest in the group P and longest in the group PL. There was no difference regarding tourniquet pain among the groups. Group PL displayed the lowest analgesic consumption postoperatively.Adding tramadol and lornoxicam to prilocaine for intravenous regional anesthesia produces favorable effects on sensory and motor blockade. Postoperative analgesic consumption can be decreased by adding tramadol and lornoxicam to prilocaine in intravenous regional anesthesia.