Pegylated filgrastim is comparable with filgrastim as support for commonly used chemotherapy regimens: a multicenter, randomized, crossover phase 3 study.

The purpose of this study was to compare the efficacy and safety of a single subcutaneous injection of pegylated filgrastim with daily filgrastim as a prophylaxis for neutropenia induced by commonly used chemotherapy regimens. Fifteen centers enrolled 337 chemotherapy-naive cancer patients with normal bone marrow function. All patients randomized into AOB and BOA arms received two cycles of chemotherapy. Patients received a single dose of pegylated filgrastim 100 µg/kg in cycle 1 (AOB) or cycle 2 (BOA) and daily doses of filgrastim 5 µg/kg/day in cycle 1 (BOA) or cycle 2 (AOB). Efficacy and safety parameters were recorded. The primary end point was the rate of protection against grade 4 neutropenia after chemotherapy [defined as the rate at which the absolute neutrophil count (ANC) remained >0.5×10(9)/l throughout the entire cycle]. Ninety-four percent of patients receiving pegylated filgrastim or filgrastim did not develop grade 4 neutropenia. The incidence of ANC<1.0×10(9)/l was 16.0% (50/313) after support with either pegylated filgrastim or filgrastim. The incidences of febrile neutropenia and antibiotic administration were similar in both groups. Notably, faster ANC recovery was observed with pegylated filgrastim support. The ANC nadir was also earlier with pegylated filgrastim (day 7) support than with filgrastim support (day 9), although the depth of nadir was not significantly different. A single subcutaneous injection of pegylated filgrastim 100 µg/kg provided adequate and safe neutrophil support comparable with daily subcutaneous injections of unmodified filgrastim 5 µg/kg/day in patients receiving commonly used standard-dose mild-to-moderate myelosuppressive chemotherapy regimens.

The oral bioaccessibility and gingival cytotoxicity of metal(loid)s in wild vegetables from mining areas: Implication for human oral health.

Background: Heavy metal(loid)s are frequently detected in vegetables posing potential human health risks, especially for those grown around mining areas. However, the oral bioaccessibility and gingival cytotoxicity of heavy metals in wild vegetables remain unclear. Methods: In this study, we assessed the total and bioaccessible Cr, As, Cd, Pb, and Ni in four wild vegetables from mining areas in Southwest China. In addition, the cytotoxicity and underlying mechanisms of vegetable saliva extracts on human gingival epithelial cells (HGEC) were studied. Results: The Plantago asiatica L. (PAL) showed the highest bioaccessible Cr, As, Cd, and Pb, while the greatest bioaccessible Ni was in Taraxacum mongolicum (TMM). The Pteridium aquilinum (PAM), Chenopodium album L. (CAL), and TMM extracts decreased cell viability, induced apoptosis, caused DNA damage, and disrupted associated gene expressions. However, PAL extracts which have the highest bioaccessible heavy metals did not present adverse effects on HGEC, which may be due to its inhibition of apoptosis by upregulating p53 and Bcl-2. Conclusion: Our results indicated that polluted vegetable intake caused toxic effects on human gingiva. The heavy metals in vegetables were not positively related to human health risks. Collectively, both bioaccessibility and toxic data should be considered for accurate risk assessment.