Post-marketing surveillance study of trifluridine/tipiracil in patients with metastatic colorectal cancer.

BACKGROUND: The novel oral nucleoside antineoplastic agent trifluridine/tipiracil was approved for metastatic colorectal cancer in Japan in March 2014. In this post-marketing surveillance study, we investigated the safety and efficacy of trifluridine/tipiracil in a real-world setting, particularly haematological drug reactions classified according to the baseline renal and hepatic functions. METHODS: We investigated patients with metastatic colorectal cancer who received trifluridine/tipiracil during the first four treatment cycles prospectively. The patients typically received 35 mg/m2 trifluridine/tipiracil twice daily on days 1-5 and 8-12 every 28 days. The primary objective was to assess the safety of trifluridine/tipiracil, but its efficacy was also evaluated. RESULTS: Between July 2014 and June 2016, 860 patients were enrolled in the study, and the safety and efficacy of trifluridine/tipiracil were evaluated in 823 patients. Adverse drug reactions occurred in 89.7% of the patients. The most common adverse drug reactions were decreased white blood cell count (67.0%) and neutrophil count (63.9%). Haematological drug reactions of grade ≥3 were observed in 41.7% of the patients with normal renal function; 50.3, 65.6 and 78.9% of the patients had mild, moderate and severe renal impairments, respectively. Hepatic impairment was not associated with a higher incidence of haematological drug reactions. The median overall survival was 8.4 months, with a 1-year survival rate of 33.7%. CONCLUSION: This post-marketing surveillance study further confirmed the safety and tolerability profile of trifluridine/tipiracil observed in a clinical study setting.

[Results of a Special Drug Use-Results Survey on Compliance to Tegafur/Uracil(UFT)Adjuvant Chemotherapy for Non-Small Cell Lung Cancer].

We report the results of a special drug use-results survey that used medication diaries about compliance to tegafur/uracil (UFT) adjuvant chemotherapy in patients who had undergone complete resection for non-small cell lung cancer. Between April1 , 2008, and March 31, 2010, 2,527 patients were enrolled. Of these patients, 2,411 and 1,811 were evaluated for treatment and compliance, respectively. The 2-year treatment completion rate was 59.1% in 2,093 of the 2,411 patients, excluding 318 patients with treatment failure owing to recurrence. The results were comparable with those from The Japan Lung Cancer Research Group on PostsurgicalAdjuvant Chemotherapy (JLCRG). The main reasons of the treatment failure were gastrointestinaland hepatic disorders. The proportion of patients with @75% compliance was 95.3% (1,726/1,811), and most of the patients who kept their medication diaries exhibited good compliance.

Evaluation of Usefulness of Propiverine Hydrochloride in Poor Responders to Previous Anticholinergics.

OBJECTIVES: In recent years, some patients have been unresponsive to anticholinergics used in the treatment of pollakisuria/urinary incontinence. It has been suggested that propiverine hydrochloride, which has not only anticholinergic activity, but also calcium antagonistic activity, may be useful in poor responders to other anticholinergics. In this study, a specific drug use-results survey was conducted in poor responders to other anticholinergics to evaluate the usefulness of propiverine hydrochloride. METHODS: In this survey, propiverine hydrochloride was administered for 12 weeks to poor responders to previous anticholinergics, and its usefulness was evaluated by the overactive bladder symptom score (OABSS). RESULTS: A total of 3851 subjects at 680 institutions were enrolled in the survey. Of the 3624 subjects included in the safety evaluation (male 1899, female 1725, mean age 73.4 years), 2932 were included in the efficacy evaluation (male 1610, female 1322, mean age 73.8 years). Propiverine hydrochloride significantly improved the OABSS without any safety concerns in poor responders to previous anticholinergics (OABSS, 8.22 at baseline, 6.50 at Week 4, 5.87 at Week 8, and 5.57 at Week 12, P < 0.001). CONCLUSIONS: The present findings indicate that propiverine hydrochloride may be a useful therapeutic option for poor responders to previous anticholinergics.