Biosimilar filgrastim vs filgrastim: a multicenter nationwide observational bioequivalence study in patients with chemotherapy-induced neutropenia

Background: We studied the comparative effectiveness of biosimilar filgrastim vs original filgrastim in patients with chemotherapy-induced neutropenia.Patients and methods: This multicenter, observational study was conducted at 14 centers. The study included 337 patients experiencing neutropenia under chemotherapy. Patients were given either filgrastim 30 MIU or 48 MIU (Neupogen (R)) or biosimilar filgrastim 30 MIU (Leucostim (R)). Data regarding age, chemotherapeutic agents used, number of chemotherapy courses, previous diagnosis of neutropenia, neutrophil count of patients after treatment, medications used for the treatment of neutropenia, and duration of neutropenia were collected. Time to absolute neutrophil count (ANC) recovery was the primary efficacy measure.Results: Ambulatory and hospitalized patients comprised 11.3% and 45.1% of the enrolled patients, respectively, and a previous diagnosis of neutropenia was reported in 49.3% of the patients, as well. Neutropenia occurred in 13.7% (n=41), 45.5% (n=136), 27.4% (n=82), 11.4% (n=34), and 2.0% (n=6) of the patients during the first, second, third, fourth, and fifth cycles of chemotherapy, respectively. While the mean neutrophil count was 0.53 +/- 0.48 before treatment, a significant increase to 2.44 +/- 0.66 was observed after treatment (p=0.0001). While 90.3% of patients had a neutrophil count,1.49 before treatment, all patients had a neutrophil count >= 1.50 after treatment. Neutropenia resolved within <= 4 days of filgrastim therapy in 60.1%, 56.7%, and 52.6% of the patients receiving biosimilar filgrastim 30 MIU, original filgrastim 30 MIU, and original filgrastim 48 MIU, respectively. However, there was no significant difference between the three arms (p=0.468). Similarly, time to ANC recovery was comparable between the treatment arms (p=0.332).Conclusion: The results indicate that original filgrastim and biosimilar filgrastim have comparable efficacy in treating neutropenia. Biosimilar filgrastim provides a valuable alternative; however, there is need for further studies comparing the two products in different patient subpopulations

Differentiation of Tuberculous Peritonitis from Peritonitis Carcinomatosa without Surgical Intervention

Background/Aim: Ascites of tuberculous peritonitis (TBP) is an exudative type and may well be misdiagnosed as carcinomatous peritonitis, especially in the elderly. The aim of this study was to identify independent predictors that can differentiate TBP from peritonitis carcinomatosa without surgical intervention. Patients and Methods: This prospective cohort study was performed on 75 subjects in the following groups: TBP (n=27) (TBP group), ovarian cancer complicated with ascites (n=24) (Ov Ca group), and gastric cancer complicated with ascites (n=24) (Ga Ca group). The frequency of clinical symptoms, laboratory parameters, and serum tumor markers levels were compared. Results: In univariate analysis; fever, night sweats, and abdominal pain were significantly more frequent in the TBP group compared to those in the Ov Ca group (P < 0.001, P < 0.001, and P = 0.035, respectively) and the Ga Ca group (P < 0.001, P < 0.001, and P = 0.015, respectively). Serum CA 19-9 and carcino embryonic antigen (CEA) levels were significantly lower in the TBP and Ov Ca group compared to the Ga Ca group (P < 0.001 and P < 0.001, respectively). Elevated serum CA 125 level was found in all patients with TBP and Ov Ca and in 86.6% of patients with Ga Ca. In the multivariate analysis, presence of fever (P < 0.001), night sweats (P < 0.001), age under 40 years (P = 0.008), and normal serum CA 19-9 level (P = 0.044) were independent predictor of diagnosis of TBP. Conclusion: The presence of fever, elevated serum CA 125 level, normal serum CA 19-9, and CEA associated with lymphocyte predominant benign ascites may establish the diagnosis of TBP

Association of age with breast cancer clinical and pathological factors: Analysis of Turkish National Breast Cancer Registry.

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