ABSTRACT
OBJECTIVES: The objective was to conduct a US multicenter, retrospective medical record study examining the effectiveness, safety, and patterns of use of valrubicin for treatment of nonmuscle-invasive bladder cancer (NMIBC) by clinicians since the 2009 reintroduction of valrubicin. METHODS: Patients ≥ 18 years with NMIBC who received had one or more instillations of valrubicin (October 2009- September 2011) were eligible. The primary endpoint was event-free survival (EFS). Safety and tolerability were also assessed. RESULTS: The medical records of 113 patients met the inclusion criteria; 100 patients (88.5%) completed valrubicin treatment. The median age was 75 years (range 42-95 years). The median NMIBC duration was 31 months since diagnosis: 51.3% (58/113) had carcinoma in situ (CIS) alone, and 31.9% (36/113) had unspecified NMIBC. Most patients, 94.7% (107/113), had more than three valrubicin instillations and 70.8% (80/113) completed a full course. The EFS rate (95% confidence interval) was 51.6% (40.9-61.3%), 30.4% (20.4-41.1%), and 16.4% (7.9-27.5%) at 3, 6, and 12 months, respectively. Median time to an event was 3.5 (2.5-4.0) months after the first valrubicin instillation. Local adverse reactions (LARs) were experienced by 49.6% (56/113) of patients; most LARs were mild (93.6%). The most frequent LARs were hematuria, pollakiuria, micturition urgency, bladder spasm, and dysuria. In total, 4.4% (5/113) of patients discontinued valrubicin because of adverse events or LARs. CONCLUSIONS: Data from the present retrospective study are consistent with previous prospective clinical trials that demonstrated valrubicin effectiveness and tolerability for select patients with CIS, before considering cystectomy. Additional prospective studies are warranted to evaluate valrubicin safety and efficacy in the broader patient population with NMIBC.
ABSTRACT
OBJECTIVES: Compare migraine duration with frovatriptan (versus baseline) in migraineurs reporting long- (24-72 h) or short-duration (<24 h) migraines at baseline. METHODS: Post hoc analysis of two postmarketing surveillance studies of migraineurs in German primary care clinics using frovatriptan (2.5 mg) to treat a single migraine attack. Using case-report forms, physicians recorded migraine characteristics at baseline (aura, duration, frequency, severity) and with frovatriptan (duration, severity, and recurrence). Patients and physicians rated frovatriptan effectiveness and tolerability versus previous therapy; physicians recorded adverse reactions. The primary analysis was change in migraine duration with frovatriptan versus baseline. RESULTS: At baseline, 44.2% (7178/16 253) and 55.8% (9075/16 253) of patients reported short- and long-duration migraines, respectively; long-duration migraines were more often frequent (> or =3/months; 55.5% [4893/8811] vs. 30.6% [2132/6973]; p < 0.001; 95% CI, 23.5-26.5%), severe (61.7% [5584/9047] vs. 33.9% [2427/7156]; p < 0.001; 95% CI, 26.3-29.3%), and accompanied by aura (46.8% [4199/8977] vs. 31.3% [2215/7088]; p < 0.001; 95% CI, 14.0-17.0%). Mean (SD) onset of frovatriptan effect was <1 h; 72.3% (11 592/16 040) of patients required only one frovatriptan tablet. With frovatriptan, patients were 26.8-fold more likely to experience decreased versus increased headache duration (p < 0.001; 95% CI, 23.5-30.2) and 76.5% of patients reporting long-duration migraines at baseline experienced short-duration migraines. Most patients (87-90%) and physicians (70-75%) rated frovatriptan more effective and tolerable than previous therapies. CONCLUSION: Patients with more severe migraine characteristics at baseline were more likely to have attacks lasting > or =24 h. When using frovatriptan, patients were 26.8-fold more likely to experience decreased versus increased headache duration. Frovatriptan might be a good option for patients with long-duration or recurrent migraine attacks. The post hoc design and analysis of a single migraine attack are possible study limitations.
