Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
Gemcitabine hydrochloride; gemcitabine (as hydrochloride)
Actavis Australia Pty Ltd
Medicine Registered
PRODUCT INFORMATION NAME OF THE MEDICINE GEMPLAN gemcitabine (as hydrochloride) 200mg powder for injection gemcitabine (as hydrochloride) 1000mg powder for injection NON-PROPRIETARY NAME: Gemcitabine Hydrochloride sustained worsening in any of the parameters. Sustained worsening was defined as four consecutive weeks with either an increase in pain intensity or analgesic consumption or a 20 point decrease in performance status occurring during the first 12 weeks of therapy. Or 2. The patient was stable on all aforementioned parameters and showed a marked sustained weight gain (greater than or equal to 7% increase maintained for greater than or equal to four weeks), not due to fluid accumulation. The first study was a multicentre, prospective, single blinded, two arm, randomised comparison of gemcitabine and FU in patients with locally advanced or metastatic pancreatic cancer who had received no prior treatment with chemotherapy. FU was administered intravenously at a weekly dose of 600 mg/m 2 for 30 minutes. The results for this randomised trial are shown in TABLE 1. Compared to FU, patients treated with gemcitabine had statistically significant increases in symptomatic improvement, survival and time to progressive disease (23.8% versus 4.8%). TABLE 1 Summary of Gemcitabine vs FU in pancreatic cancer Gemcitabine FU Number of patients 63 63 Total: 126 Stage IV disease 71.4% 76.2% Baseline KPS ≤ 70 69.8% 68.3% Clinical response 1 23.8% (N=15) 4.8% (N=3) p=0.0022 Survival p=0.0009 Median 5.7 months 4.2 months 6 month probability 46% (N=30) 29%(N=19) 9 month probability 24%(N=14) 5%(N=4) 1 year probability 18%(N=9) 2%(N=2) Range 0.2 to 18.6 months 0.4 to 15.1 + months Time to progressive disease p=0.0013 Median 2.1 months 0.9 months Range 0.1 + to 9.4 months 0.1 to 12.0 + months 1 As per pre Διαβάστε το πλήρες έγγραφο