Paclitaxel is widely used in the treatment of patients with metastatic breast cancer (MBC). Formulations of paclitaxel contain surfactants and solvents or albumin derived from human blood. The use of co-solvents such as polyoxyethylated castor oil is thought to contribute to toxicity profile and hypersensitivity reactions as well as leaching of plasticizers from polyvinyl chloride bags and infusion sets. Currently, nab-paclitaxel, an albumin-bound paclitaxel in nanometer range continues to be the preferred taxane formulation used in clinic. This study (CTRI/2010/091/001116) investigated the efficacy and tolerability of a polyoxyethylated castor oil- and albumin-free formulation of paclitaxel [paclitaxel injection concentrate for nanodispersion (PICN)] compared with nab-paclitaxel in women with refractory MBC. The current study was a multicenter, open-label, parallel-group, randomized, comparative phase II/III trial evaluating the efficacy and safety of PICN (260 mg/m2 [n = 64] and 295 mg/m2 [n = 58] every 3 weeks) compared with nab-paclitaxel (260 mg/m2 every 3 weeks [n = 58]) in women 18 and 70 years old with confirmed MBC. Overall response rate (ORR) was assessed with imaging every 2 cycles. An independent analysis of radiologic data was performed for evaluable patients. Progression-free survival (PFS) was a secondary efficacy measure. Independent radiologist-assessed ORRs in the evaluable population of women aged ≥70 years were 35, 49, and 43 % in the PICN 260 mg/m2, PICN 295 mg/m2, and nab-paclitaxel 260 mg/m2 arms, respectively. Median PFS in the evaluable population was 23, 35, and 34 weeks in the PICN 260 mg/m2, PICN 295 mg/m2, and nab-paclitaxel 260 mg/m2 arms, respectively. Adverse events occurred in similar proportions of patients across treatment arms. Hypersensitivity reactions were not frequently observed with the clinical use of PICN across the treatment cohorts. In women with metastatic breast cancer, PICN at 260 and 295 mg/m2 every 3 weeks was effective and well tolerated and showed similar tolerability compared with nab-paclitaxel 260 mg/m2 every 3 weeks. Statistically, significant differences were not observed in the PICN and nab-paclitaxel treatment arms for radiologist-assessed ORR or median PFS. The novel paclitaxel formulation, PICN, offers apart from efficacy, potential safety advantage of decreased use of corticosteroid pretreatment and the absence of the risk of transmission of blood product-borne disease.
High resolution USG is not only an efficient modality in diagnosing and localizing the foreign body in soft tissue, but can also be utilized for guiding the foreign body removal.
An experimental study was conducted to evaluate the hepatotoxic effects in the progeny of dams treated with methimazole, monocrotophos (MCP) and lead acetate. Female pregnant albino rats of Wistar kyoto strain were divided into five groups and treated as follows, from day 3 of pregnancy till weaning of pups on postnatal day (PND) 21. Group 1 served as sham control, group 2 received methimazole 0.02% in drinking water, group 3 received MCP (0.3 mg/kg orally), group 4 received lead acetate at 0.2% in drinking water and group 5 received MCP + lead acetate. Thyroid hormone profile was recorded on 14
thday of gestation in dams. Eight pups from each group were euthanized on PND 21 and 90, and liver tissues were collected for analysis. Thiobarbituric acid reactive substances (TBARS), protein carbonyls and reduced glutathione (GSH) of liver were studied on PND 21 and 90, while the activities of Na +/K+ATPase and Mg 2+ATPase in the liver were studied on PND 90. T3, T4, GSH, Na+/K+ATPase and Mg2+ATPase were significantly (P<0.05) decreased, while TBARS and protein carbonyls were significantly (P < 0.05) increased in all the test groups as compared to group 1. From this study, it is concluded that both MCP and lead acetate have a possible influence on thyroid gland of dams as the thyroid profile was altered significantly and the hepatotoxic effects were comparable to those induced by methimazole.
A study was conducted to evaluate the protective effect of herbal Neonatal Chick care (NNCC) against iron-induced oxidative stress. A total of 130 day-old sexed male broiler chicks (Vencobb strain) were randomly divided into six groups consisting of 25 chicks each in groups 1-4 and 15 each in groups 5 and 6. Group 1 was maintained on basal diet, groups 2 and 3 on herbal NNCC at 6 and 8 g/chick/day, respectively, for 2 days immediately after hatching and later continued with basal diet up to 6 wk. Group 4 was given FeSO4 at 0.5% of feed for 6 wk, while groups 5 and 6 were given NNCC as in groups 2 and 3, and later continued with the FeSO4 as in group 4 for 6 wk. The concentration of thiobarbituric acid reactive substances (TBARS), protein carbonyls, glucose and calcium, and the activity of alanine transaminase (ALT) were significantly (P<0.05) increased in group 4 at the end of 6th week, while the concentration of reduced glutathione (GSH), and the activities of superoxide dismutase (SOD) and catalase, phytohemagglutinin (PHA) index and HI titer were significantly (P<0.05) decreased in group 4. The NNCC treated groups (2, 3, 5 and 6) showed marked improvement in all the above parameters. It can be concluded that herbal NNCC offered protection and proved beneficial in resisting the adverse effects of stressor.
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