In previous studies, the relaxant, anticholinergic (functional antagonism) antihistaminic, effects of Nigella sativa have been demonstrated on guinea-pig tracheal chains. In the present study, the prophylactic effect of boiled extract of N. sativa on asthmatic disease was examined. Twenty-nine asthmatic adults were randomly divided into control group (14 patients) and study group (15 patients), and they were studied for 3 months. In the study group 15 mL/kg of 0.1 g% boiled extract and in the control group a placebo solution was administrated daily throughout the study. Asthma symptom score, asthma severity, frequency of symptoms/week and wheezing were recorded in the beginning (first visit), 45 days after treatment (second visit), and at the end of the study (third visit). Pulmonary function tests (PFTs) were also measured, and the drug regimen of the patients was evaluated at three different visits. All asthma symptoms, frequency of asthma symptoms/week, chest wheezing, and PFT values in the study group significantly improved in the second and third visits compared with the first visit (P < 0.05 to P < 0.001). In addition, further improvement of chest wheezing and severity of disease on the third visit were observed compared with the second visit in this group (P < 0.05 for both cases). In the third visit all symptoms in the study group were significantly different from those of the control group (P < 0.01 to P < 0.001). However, in the control group, there were only small improvements in some parameters in just the second visit. The usage of inhaler and oral beta-agonists, oral corticosteroid, oral theophylline and even inhaler corticosteroid in the study group decreased at the end of the study while there were no obvious changes in usage of the drugs in control subjects. The results of phase I study generally suggest a prophylactic effect of N. sativa on asthma disease and warrant further research regarding this effect.

719 Background: Although Folfirinox (FFX) prolonged survival in metastatic and adjuvant setting, the role of preoperative FFX is still controversial. Our aim is to evaluate how surgery after neoadjuvant FFX with or without radiotherapy (RT) affects the clinical outcome in these patients. Methods: This is a single arm, open-label, phase 2 prospective study. Based on resectability criteria (NCCN-V.1.2017), patients prospectively were divided into 3 groups of resectable, borderline resectable (BR), locally advanced (LA). Patients received 6 cycles of preoperative FFX. Patients with adequate response, underwent resection. Continuation of chemotherapy or radiation was given to the patients who were deemed unresectable after 6 cycles. Primary objective is time to progression (TTP), and secondary objectives are safety, R0/R1 resection rate, response rate (RR) and overall survival (OS). Results: 20 consecutive patients with pancreatic adenocarcinoma enrolled. The frequency of each group was 4, 8, 8 patients, respectively. Median age was 64 years old (range, 49-78). 45% of patients had primary tumor in head or uncinate process. 25% of cases presented with normal CA 19-9 value. 85% (17/20) of patients completed the preoperative treatment. Folfirinox was given within median of 11.5 weeks (range, 8-17) and median of 6 cycles (range, 1-7). Median relative dose intensity (RDI) was 85.89%. Grade III-IV (G3+4) adverse event (CTCAE-4.03) observed in 47.4% (9/19). RR (RECIST) was 89% (16/18). Best response was partial response (PR) and stable disease (SD) with 22.2% (4/18) and 66.7% (12/18). Resection rate was 64.3% (9/14, 1 case scheduled for resection). R0 and negative lymph node (LN) achieved in 87.50% (7/8) and 62.50% (5/8) of patients. Complete pathological response (cPR) was seen in one patient 12.5% (1/8) who preoperatively reported as SD. Patients TTP and OS will be reported during the meeting. Conclusions: Preoperative FFX was associated with high clinical and pathological response rate translating in high resection rate in majority of BRPC and LAPC, and appears to be a safe treatment strategy. Patients received higher FFX dose intensity than it was reported in adjuvant setting. However, these results need to be assessed in a randomized trial. Clinical trial information: NCT03167112.

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