Ofloxacin in lower respiratory tract infections--a comparison with amoxicillin.

This study aimed at determining the clinical efficacy and clinical and biological safety of ofloxacin compared to amoxicillin. 44 patients were included, and 41 were evaluable. 33 patients were treated according to the randomization list, whereas 11 patients were treated in an open study. All patients were suffering from acute, recurrent or chronic, lower respiratory tract infections. 29 patients started ofloxacin treatment with a dosage of 200 mg or 300 mg b.i.d., and 15 other patients received 1 g amoxicillin b.i.d. or t.i.d. Three patients of this last group were treated with ofloxacin after amoxicillin treatment failure. Bacteriological eradication was achieved in 95% of ofloxacin-treated and in 78% of amoxicillin-treated patients. Clinical cure occurred in 86% of ofloxacin- and in 55% of amoxicillin-treated patients. Successful treatment (bacteriologic eradication associated with clinical cure) was observed in 75% of patients from the ofloxacin-group and in 36% of the amoxicillin-group. No clinical adverse reactions were seen in amoxicillin-treated patients, whereas one patient in the ofloxacin-group was complaining of mild, definitely drug-related, hypochondrial pain. No major drug-related disturbances of biological parameters were observed neither in the ofloxacin- nor in the amoxicillin-group.

Clinical-benefit response in advanced non-small-cell lung cancer: A multicentre prospective randomised phase III study of single agent gemcitabine versus cisplatin-vindesine.

BACKGROUND: The modest improvement in median survival of advanced non-small-cell lung cancer (NSCLC) by cisplatin-based chemotherapy has led to the current opinion that clinical benefit for the patient is at least as important an end-point as objective response rate (ORR) or survival. Clinical benefit response was the primary end-point of this prospective randomised trial in symptomatic, advanced stage IIIB/IV NSCLC, comparing single agent gemcitabine (GEM) to cisplatin-based chemotherapy. PATIENTS AND METHODS: Patients received either GEM (1000 mg/m2, days 1, 8 and 15) or cisplatin (100 mg/M2, day 1) plus Vindesine (3 mg/m2, days 1 and 15) (PV), both every four weeks. Clinical benefit was measured by a simple metric based on changes in a visual analogue symptom score list, the Karnofsky performance status and the weight. RESULTS: One hundred sixty-nine patients were randomised (84 GEM, 85 PV). Prognostic factors and baseline symptoms were well balanced between the two arms. Most of the the objective responders and about half of the patients with disease stabilisation experienced clinical benefit. Compared to PV, a significantly larger number of GEM-treated patients experienced a clinical benefit (48.1 vs. 28.9%, P = 0.03) that lasted significantly longer (median duration 16 vs. 10 weeks, P = 0.01). No important differences in ORR, time-to-progression or median survival were observed. Grade 3 + 4 toxicity was significantly higher in the PV-group for leukopenia (P = 0.0003), neutropenia (P < 0.0001), nausea/vomiting (P = 0.0006), alopecia (P < 0.0001), and neurotoxicity (P = 0.04). Some severe pulmonary toxicity to GEM was noted. CONCLUSION: Comparison of GEM with cisplatin-based therapy in symptomatic, advanced NSCLC demonstrates that GEM produces significantly a stronger and longer-lasting clinical benefit, probably due to its equal effectiveness in terms of ORR, time-to-progression or survival, combined with significantly less severe therapy-related toxicity.