Study objective:We hypothesized that oral administration of a single dose of pregabalin 2 hours before modified radical mastectomy (MRM) would produce dose-related reduction in postoperative opioid consumption. Design: Prospective randomized controlled clinical trial. Setting: Postanesthesia care unit. Patients: One hundred twenty adult women scheduled for unilateral (MRM) with axillary evacuation. Interventions: Patients were randomized to receive either, placebo capsule, pregabalin 75 mg, pregabalin 150 mg, or pregabalin 300 mg. Measurements: The assessment parameters were the postoperative analgesic effect using visual analog scale (VAS) pain scores, the subsequent 24-hour morphine consumption, and the systemic adverse effects of pregabalin doses. Main results: The VAS score at rest and movement was significantly decreased only in group P300 and group P150 in comparison to group P0 and group P75 at 0 hour (P b .01). The median (interquartile range) consumption of morphine in the first postoperative 24 hours was significantly decreased in group P300 in comparison to group P0 and group P75 (P300 vs P0: 6.5 [5-6.5] vs 20.5 [15.8-20.5] [P b .001]; P300 vs P75: 6.5 [5-6.5] vs 20 [14-20] [P b .001]), but there was no significant difference between group P300 and group P150. In addition, there was a significant decrease in consumption of morphine in group P150 in comparison to group P0 and group P75 (P150 vs P0: 7 [5-7] vs 20.5 [15.8-20.5] [P b .001]; P150 vs P75: 7 [5-7] vs 20 [14-20] [P b .001]). There were statistical significant increase in dizziness and blurred vision in group P300 in comparison to other groups (P b .05). Conclusions: A single preoperative oral dose of pregabalin 150 mg is an optimal dose for reducing postoperative pain and morphine consumption in patients undergoing MRM. © 2016 Elsevier Inc. All rights reserved.

Study objective:We hypothesized that oral administration of a single dose of pregabalin 2 hours before modified radical mastectomy (MRM) would produce dose-related reduction in postoperative opioid consumption. Design: Prospective randomized controlled clinical trial. Setting: Postanesthesia care unit. Patients: One hundred twenty adult women scheduled for unilateral (MRM) with axillary evacuation. Interventions: Patients were randomized to receive either, placebo capsule, pregabalin 75 mg, pregabalin 150 mg, or pregabalin 300 mg. Measurements: The assessment parameters were the postoperative analgesic effect using visual analog scale (VAS) pain scores, the subsequent 24-hour morphine consumption, and the systemic adverse effects of pregabalin doses. Main results: The VAS score at rest and movement was significantly decreased only in group P300 and group P150 in comparison to group P0 and group P75 at 0 hour (P b .01). The median (interquartile range) consumption of morphine in the first postoperative 24 hours was significantly decreased in group P300 in comparison to group P0 and group P75 (P300 vs P0: 6.5 [5-6.5] vs 20.5 [15.8-20.5] [P b .001]; P300 vs P75: 6.5 [5-6.5] vs 20 [14-20] [P b .001]), but there was no significant difference between group P300 and group P150. In addition, there was a significant decrease in consumption of morphine in group P150 in comparison to group P0 and group P75 (P150 vs P0: 7 [5-7] vs 20.5 [15.8-20.5] [P b .001]; P150 vs P75: 7 [5-7] vs 20 [14-20] [P b .001]). There were statistical significant increase in dizziness and blurred vision in group P300 in comparison to other groups (P b .05). Conclusions: A single preoperative oral dose of pregabalin 150 mg is an optimal dose for reducing postoperative pain and morphine consumption in patients undergoing MRM. © 2016 Elsevier Inc. All rights reserved.

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Purpose. The purpose of this prospective pilot study was to determine the efficacy of preoperative chemotherapy with six cycles of FOLFOX 6 (without radiation therapy) followed by radical surgery followed by six additional cycles ofFOLFOX6 for patients with stage II/III rectal cancer. Patients and Methods. From January 2010 to January 2014, patients with locally advanced rectal cancer who met the eligibility criteria were enrolled in this study. Patients received FOLFOX 6 chemotherapy comprising oxaliplatin and leucovorin calcium i.v. over 2 hours on day 1, then bolus, and then continuous fluorouracil i.v. over 46 hours on days 1 and 2. Treatment was repeated every 14 days for 6 courses followed by radical surgery followed by additional 6 cycles of FOLFOX 6. Results. In total, 45 patients were enrolled in this study. In the preoperative re-evaluation, the overall response rate was 68.8% (clinical complete response was 4.4%, and the partial response was 64.4%). There were 14 cases (31.2%) of stable disease. No patients had progressive disease. Postoperatively, the pathologic complete response ratewas8of45 (17.8%;95% confidence interval [CI]: 8.9%–28.9%). The median follow-up was 29 months (range 9–54 months). The actuarial 3-year overall survival and disease-free survival rates for all patients were 80.8% (standard error, 1.877; 95% CI: 69.3%–92.3%) and 67.9% (standard error, 2.319; 95% CI: 54.3%–81.5%), respectively. Conclusion. Neoadjuvant chemotherapy (FOLFOX) without radiotherapy is active and safe but cannot be considered a standard of care until the results of prospective randomized phase III trials are available.

Purpose. The purpose of this prospective pilot study was to determine the efficacy of preoperative chemotherapy with six cycles of FOLFOX 6 (without radiation therapy) followed by radical surgery followed by six additional cycles ofFOLFOX6 for patients with stage II/III rectal cancer. Patients and Methods. From January 2010 to January 2014, patients with locally advanced rectal cancer who met the eligibility criteria were enrolled in this study. Patients received FOLFOX 6 chemotherapy comprising oxaliplatin and leucovorin calcium i.v. over 2 hours on day 1, then bolus, and then continuous fluorouracil i.v. over 46 hours on days 1 and 2. Treatment was repeated every 14 days for 6 courses followed by radical surgery followed by additional 6 cycles of FOLFOX 6. Results. In total, 45 patients were enrolled in this study. In the preoperative re-evaluation, the overall response rate was 68.8% (clinical complete response was 4.4%, and the partial response was 64.4%). There were 14 cases (31.2%) of stable disease. No patients had progressive disease. Postoperatively, the pathologic complete response ratewas8of45 (17.8%;95% confidence interval [CI]: 8.9%–28.9%). The median follow-up was 29 months (range 9–54 months). The actuarial 3-year overall survival and disease-free survival rates for all patients were 80.8% (standard error, 1.877; 95% CI: 69.3%–92.3%) and 67.9% (standard error, 2.319; 95% CI: 54.3%–81.5%), respectively. Conclusion. Neoadjuvant chemotherapy (FOLFOX) without radiotherapy is active and safe but cannot be considered a standard of care until the results of prospective randomized phase III trials are available.

Purpose. The purpose of this prospective pilot study was to determine the efficacy of preoperative chemotherapy with six cycles of FOLFOX 6 (without radiation therapy) followed by radical surgery followed by six additional cycles ofFOLFOX6 for patients with stage II/III rectal cancer. Patients and Methods. From January 2010 to January 2014, patients with locally advanced rectal cancer who met the eligibility criteria were enrolled in this study. Patients received FOLFOX 6 chemotherapy comprising oxaliplatin and leucovorin calcium i.v. over 2 hours on day 1, then bolus, and then continuous fluorouracil i.v. over 46 hours on days 1 and 2. Treatment was repeated every 14 days for 6 courses followed by radical surgery followed by additional 6 cycles of FOLFOX 6. Results. In total, 45 patients were enrolled in this study. In the preoperative re-evaluation, the overall response rate was 68.8% (clinical complete response was 4.4%, and the partial response was 64.4%). There were 14 cases (31.2%) of stable disease. No patients had progressive disease. Postoperatively, the pathologic complete response ratewas8of45 (17.8%;95% confidence interval [CI]: 8.9%–28.9%). The median follow-up was 29 months (range 9–54 months). The actuarial 3-year overall survival and disease-free survival rates for all patients were 80.8% (standard error, 1.877; 95% CI: 69.3%–92.3%) and 67.9% (standard error, 2.319; 95% CI: 54.3%–81.5%), respectively. Conclusion. Neoadjuvant chemotherapy (FOLFOX) without radiotherapy is active and safe but cannot be considered a standard of care until the results of prospective randomized phase III trials are available.