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Objective. Gastro-oesophageal reflux disease (GORD) symptoms have a significant impact on patients' well-being. Onset of symptom relief is therefore an important consideration in GORD treatment. The primary objective was to compare the efficacy of rabeprazole (20 mg) and omeprazole (20 mg) regarding onset of heartburn control during the first 7 days of treatment in patients with erosive oesophagitis. Secondary objectives included maintenance of sustained heartburn control, control of other GORD symptoms (e.g. acid regurgitation, epigastric pain, dysphagia), effect on quality of life, patient satisfaction with treatment, and adverse events. Material and methods. In this multicentre, randomized, parallel-group, double-blind, comparative study, performed in Europe and Iceland, patients with endoscopically confirmed erosive oesophagitis were randomized to receive once-daily treatment with rabeprazole 20 mg (n=358) or omeprazole 20 mg (n=359) for 7 days. Symptoms were recorded (scored on a 5-point Likert scale) twice daily by the patients on their diary cards. Results. Median time to reach heartburn control was 1.5 days for both the rabeprazole and omeprazole groups (p<0.43). The results were similar between treatments for other study parameters. Both treatments were well tolerated. Conclusions. Unlike previous studies, no significant differences were found between treatments with rabeprazole (20 mg) and omeprazole (20 mg) in this study. Further studies are needed to evaluate the potential benefit of fast-acting proton-pump inhibitors, such as rabeprazole, with respect to onset of symptom control in erosive GORD. [ABSTRACT FROM AUTHOR]

AFM13 is a bispecific, tetravalent chimeric antibody construct (TandAb) designed for the treatment of CD30-expressing malignancies. AFM13 recruits natural killer (NK) cells via binding to CD16A as immune effector cells. In this phase 1 dose-escalation study, 28 patients with heavily pretreated relapsed or refractory Hodgkin lymphoma received AFM13 at doses of 0.01 to 7 mg/kg body weight. Primary objectives were safety and tolerability. Secondary objectives included pharmacokinetics, antitumor activity, and pharmacodynamics. Adverse events were generally mild to moderate. The maximum tolerated dose was not reached. Pharmacokinetics assessment revealed a half-life of up to 19 hours. Three of 26 evaluable patients achieved partial remission (11.5%) and 13 patients achieved stable disease (50%), with an overall disease control rate of 61.5%. AFM13 was also active in brentuximab vedotin-refractory patients. In 13 patients who received doses of ≥1.5 mg/kg AFM13, the overall response rate was 23% and the disease control rate was 77%. AFM13 treatment resulted in a significant NK-cell activation and a decrease of soluble CD30 in peripheral blood. In conclusion, AFM13 represents a welltolerated, safe, and active targeted immunotherapy of Hodgkin lymphoma. A phase 2 study is currently planned to optimize the dosing schedule in order to further improve the therapeutic efficacy. [ABSTRACT FROM AUTHOR]

Purpose: E7070 is a sulfonamide that induces arrest at the G(1)-S boundary with subsequent dose and exposure-dependent apoptosis. The objectives of this study were (a) to determine the maximum-tolerated dose (MTD) and recommended safe dose (RD) of E7070 for additional evaluation, (b) to define the dose limiting toxicity(ies) [DLT(s)], (c) to study the pharmacokinetics of E7070, and (d) to seek preliminary evidence of antitumor activity., Experimental Design: Patients with solid tumors who had either failed or were not amenable to established forms of treatment were eligible for the study. E7070 was administered i.v. at weekly intervals for 4 consecutive weeks to cohorts of 3-6 patients at each dose level. Treatment was repeated six weekly in the absence of tumor progression. A Fibonacci-like scheme was used for dose escalation. The MTD was determined in a stepwise procedure for two cohorts of patients; the "initial patient cohort" who met the original inclusion criteria (group A) and the "better prognosis cohort" (group B) who had adequate hepatic function, less extensive tumor involvement of the liver, and no more than three previous lines of chemotherapy. The RD was defined as the highest dose at which the incidence of definitely drug-related DLTs was <33%. The pharmacokinetic profile of E7070 was determined., Results: Overall, 46 patients entered the study; information from 36 of the 37 patients forming group A was used to determine the overall MTD. An additional 9 patients plus 9 patients from group A who met the more restrictive inclusion criteria made up group B. The MTD was 500 mg/m(2)/week for both groups. Reversible neutropenia and thrombocytopenia were the most common DLTs. Other DLTs included stomatitis, hyperglycemia, sepsis, fever, hemorrhage, diarrhea, nausea, and fatigue. The pharmacokinetics of E7070 were nonlinear over the dose range 160-500 mg/m(2). One partial response was observed in a patient with an endometrial adenocarcinoma who had previously been treated with radiotherapy. Twelve other patients had stable disease as their best response (27%); among them. 1 patient with metastatic melanoma who received 21 cycles of therapy., Conclusions: The RD for further study of E7070 using this administration schedule is 400 mg/m(2)/week. Using this schedule, the predominant toxicity of E7070 is myelosuppression. E7070 has anticancer activity in pretreated patients.