CA19-9 capability as predictor of pancreatic cancer resectability in a Spanish cohort.

CA19-9 serum has been suggested as a marker of unresectability but different cut-off levels have been published. A cut-off of 500 U/ml is currently considered in an international consensus as biological criteria of borderline resectable pancreatic adenocarcinoma. To evaluate whether serum CA19-9 threshold of 500 U/ml could be adequate predictor of resectability in pancreatic adenocarcinoma. Multicenter, observational, prospective study performed in Spain including 203 patients diagnosed with pancreatic adenocarcinoma. 43 (21.2%) cases were resectable and 160 (78.8%) unresectable. Among the 176 preoperative CA19-9 available values, 98 (58.3%) were ≤ 500 U/ml and 73 (42.7%) > 500 U/ml. Resectability rate in those patients with CA19-9 ≤ 500 U/ml was 60% while it was found to be 18% when CA19-9 > 500 U/ml. Statistical model to predict resectability based on CA19-9 provide an AUC of 0.6618 (95% CI 0.53-0.83) when only CA19-9 values > 500 U/ml are studied. Serum levels of CA19-9 higher than 500 U/ml are indicative of unresectable disease, however reduced sensitivity and specificity lead to a limited clinical applicability for resectability.

Antimicrobial Susceptibility-Guided Therapy Versus Empirical Concomitant Therapy for Eradication of Helicobacter pylori in a Region with High Rate of Clarithromycin Resistance.

BACKGROUND: Nonbismuth quadruple (concomitant) regimen is recommended for first-line empirical Helicobacter pylori (HP) eradication treatment when clarithromycin resistance is more than 15-20%. Our objective was to evaluate the efficacy and tolerability of concomitant versus antimicrobial susceptibility-guided treatment in an area with high rates of clarithromycin resistance. METHODS: Three hundred consecutive HP-infected patients received antimicrobial susceptibility-guided therapy or empirical concomitant therapy for 10 days. The concomitant regimen was omeprazole (20 mg/12 hour), amoxicillin (1 g/12 hour), clarithromycin (500 mg/12 hour), and metronidazole (500 mg/12 hour) (OACM). Patients diagnosed by culture received one of three combinations of antibiotics based on susceptibility results: omeprazole, amoxicillin, and clarithromycin (OAC); omeprazole, amoxicillin, and levofloxacin (OAL); or omeprazole, amoxicillin, and metronidazole (OAM), at the aforementioned doses (and 500 mg/12 hour in the case of levofloxacin). Eradication was confirmed with a (13)C urea breath test, 6 weeks after treatment. Adverse events and adherence were assessed with questionnaires and reviewing medication sachets. RESULTS: The mean age was 50 years, 59% were women, and 14% had peptic ulcers. Concomitant and antimicrobial susceptibility-guided eradication rates were, respectively, 87% and 94% by intention-to-treat (p = .08) and 89% and 95% (p = .08) per protocol per-protocol analysis. Adverse effects were reported in 31% of patients on OACM and 15% of those on susceptibility-guided therapy (p < .05). CONCLUSIONS: For HP eradication in a region with high rates of multiple drug resistance, antimicrobial susceptibility-guided therapy is more effective than empirical concomitant therapy.

Clarithromycin for first-line treatment of Helicobacter pylori infection after culture in high-resistance regions.

OBJECTIVE: Resistance to antibiotics is the major cause of treatment failure of Helicobacter pylori (HP) infection. The culture-guided triple therapy (chosen on the basis of a preliminary in-vitro susceptibility test) might help to increase treatment success in high antibiotic resistance regions. The aim of this study was to evaluate the effectiveness of treatment with clarithromycin in patients with clarithromycin-sensitive culture compared with patients treated empirically. METHODS: In this prospective and controlled trial, 111 naive HP-positive patients were randomized to receive standard triple therapy omeprazole (20 mg twice daily), amoxicillin (1 g twice daily), and clarithromycin (500 mg twice daily) for 10 days (OAC) after antimicrobial susceptibility testing if there was no resistance to clarithromycin (ClariS) or empirical 10-day OAC for first-line therapy of HP (ClariNA). Eradication was confirmed using the C-labelled urea breath test 6 weeks after therapy. Our primary outcome was HP eradication. Treatment adherence and adverse effects were recorded. RESULTS: The effectiveness of eradication by protocol with 10-day OAC therapy in the ClariS was 94% [95% confidence interval (CI): 0.83-0.98], which was 22% higher than ClariNA 72% (95% CI: 0.58-0.85; P=0.006). The odds ratio of eradication in ClariS was 1.30 (95% CI: 1.10-1.60; P<0.05 by logistic regression) and the number needed to treat was 5 (95% CI: 3-13). We found no significant difference in the occurrence of adverse effects or in compliance between the two groups. CONCLUSION: The eradication rate was significantly higher with clarithromycin-based triple therapy for patients with clarithromycin-susceptible HP isolates compared with those for whom no information on the corresponding susceptibility was available (ClinicalTrials.gov number NCT01486082).