Advantages with prophylactic PEG-rhG-CSF versus rhG-CSF in breast cancer patients receiving multiple cycles of myelosuppressive chemotherapy: an open-label, randomized, multicenter phase III study.

BACKGROUND: PEG-rhG-CSF reduces neutropenia and improves chemotherapy safety. In China's registration trial (CFDA: 2006L01305), we assessed its efficacy and safety against rhG-CSF, and prospectively explored its value over multiple cycles of chemotherapy. METHODS: In this open-label, randomized, multicenter phase 3 study, breast cancer patients (n = 569) were randomized to receive PEG-rhG-CSF 100 µg/kg, PEG-rhG-CSF 6 mg, or rhG-CSF 5 µg/kg/d after chemotherapy. The primary endpoints were the incidence and duration of grade 3/4 neutropenia during cycle 1. Secondary endpoints included the incidence and duration of grade 3/4 neutropenia during cycles 2-4, the incidence of febrile neutropenia, and the safety. RESULTS: A once-per-cycle PEG-rhG-CSF at either 100 µg/kg or 6 mg was not different from daily injections of rhG-CSF for either incidence or duration of grade 3/4 neutropenia. Interestingly, a substantial difference was noted during cycle 2, and the difference became bigger over cycles 3-4, reaching a statistical significance at cycle 4 in either incidence (P = 0.0309) or duration (P = 0.0289) favoring PEG-rhG-CSF. A significant trend toward a lower incidence of all-grade adverse events was noted at 129 (68.98%), 142 (75.53%), and 160 (82.47%) in the PEG-rhG-CSF 100 µg/kg and 6 mg and rhG-CSF groups, respectively (P = 0.0085). The corresponding incidence of grade 3/4 drug-related adverse events was 2/187 (1.07%), 1/188 (0.53%), and 8/194 (4.12%), respectively (P = 0.0477). Additionally, PFS in metastatic patients preferred PEG-rhG-CSF to rhG-CSF despite no significance observed by Kaplan-Meier analysis (n = 49, P = 0.153). CONCLUSIONS: PEG-rhG-CSF is a more convenient and safe formulation and a more effective prophylactic measure in breast cancer patients receiving multiple cycles of chemotherapy.

[The retractive effects of different gingival retraction agents].

OBJECTIVE: To evaluate the retractive effects of different gingival retraction agents. METHODS: Thirty subjects with healthy gingival conditions were recruited to the trial, and the buccal gingival sulcus of the hibateral first max-illary premolars of each subject (n=60) were treated randomly with one of the six agents--Group A was tetrahydrozoline hydrochloride, Group B was oxymetazoline hydrochloride, Group C was epinephrine hydrochlorid, Group D was AlCl3, Group E was Fe2 (SO4)3, and Group F was normal saline as control. Both pre-treated and post-treated accurate impressions of buccal gingival sulcus of the experimental teeth were made, so were the anhydrite casts. The casts of experimental teeth were sectioned into 2 mm slices bucco-lingually at the buccal eminence. Then the width of the sulcus was measured as the distance from the tooth to the crest of the gingival under a low-power microscope to compare the effect of these gingival retraction agents. RESULTS: The width of gingival sulcus became larger after the treatment in all groups (P < 0.05). Either Group A or Group B had greater gingival retraction effects than Group C and Group F (P < 0.05). Except Group F, both Group D and Group E had no significant differences from the other groups (P > 0.05). There was no statistically signification between Group D and Group E (P > 0.05), neither was there any statistically significance between Group A and Group B (P > 0.05). CONCLUSION: Tetrahydrozoline manifested excellent effect of gingival retraction.