We studied the comparative effectiveness of biosimilar filgrastim vs original filgrastim in patients with chemotherapy-induced neutropenia.
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
) or biosimilar filgrastim 30 MIU (Leucostim
). 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.
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 (
=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 (
=0.468). Similarly, time to ANC recovery was comparable between the treatment arms (
=0.332).
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.
Objective
The aim of this study was to assess whether trastuzumab usage is a risk factor for the development of brain metastasis (BM) in human epidermal growth factor receptor 2 (HER2)-positive ...metastatic breast cancer (MBC) and factors affecting survival after development of BM.
Materials and methods
One hundred thirty-two patients treated with (treatment group) or without trastuzumab (control group) with brain metastasis were retrospectively analyzed.
Results
Ninety of the 132 HER2-positive MBC patients were in the treatment group and 42 were in the control group. BM was significantly increased in patients who were treated with trastuzumab in two or more lines (58.5 vs 24.1 %,
p
< 0.001). Trastuzumab and lapatinib usage after BM and age were independent prognostic factors for overall survival in univariate and multivariate analysis.
Conclusion
The risk for BM was increased in patients who were treated with trastuzumab in two or more lines. Using trastuzumab and lapatinib after BM and age were independent prognostic factors for time to death from BM.
The present study aimed to establish the epidemiological and clinical characteristics of patients who were histopathologically diagnosed with malignant melanoma (MM).
The present study ...retrospectively analyzed the data of 78 patients who were histopathologically diagnosed with MM in Dicle University Medical Faculty, Dermatology and Medical Oncology departments between 2005 and 2014.
The study included 78 patients in total with 44 (56.4%) male and 34 (43.6%) female. Median age of the patients was 62.50 years (range: 27 - 84 years). Of the patients, 78.2% (n = 61) had cutaneous melanoma, 8.9% had solid organ melanoma, and 2.5% had ocular and mucosal melanoma. The most common tumor localization among the patients was the lower extremities with 29.4% (n = 23). The most common histopathological type was nodular malignant melanoma with 35.8% (n = 28). Based on TNM, Clark and Breslow classifications, 26.9% (n = 21) of the patients were stage 4, 26.9% (n = 21) were Clark stage 4, and 37.1% (n = 29) were Breslow stage 4. Median overall survival in all patients was 14.9 months (95% CI 10.9 - 18.8 months). In the multivariate Cox analysis, only stage statistically significantly affecting survival odds ratio (OR): 0.54; (95% CI 0.16-1.82, p = 0.02).
Malignant melanoma data are also important for the optimal utilization of effective methods and healthcare resources to prevent the disease. In order to minimize MM mortality and morbidity, not only the society but also physicians from primary and secondary care hospitals should become familiar with melanoma.
Background
Optimal duration of adjuvant trastuzumab in early breast cancer is an unresolved issue. In this observational study, we compared the outcome of 9 weeks and 1 year adjuvant trastuzumab in ...early breast cancer patients in Turkey.
Methods
Records of 680 patients with HER2-positive early breast cancer who received adjuvant trastuzumab plus chemotherapy were obtained and patients were followed up to compare the disease-free survival (DFS) outcome of 9 weeks versus 1 year trastuzumab.
Results
Nine weeks and 1 year trastuzumab was given to 202 (29.7 %) and 478 (70.3 %) patients, respectively. There was a significantly lower rate of patients with negative lymph nodes in the 9-week trastuzumab group. At median 3 years of follow-up from the date of starting trastuzumab, the DFS rates were 88.6 and 85.6 %, respectively (
p
= 0.670). When adjusted for all the prognostic factors that were significant on univariate analysis, again there was no significant difference in DFS between the groups (HR 0.675; 95 % CI 0.370–1.231;
p
= 0.200). Cardiac toxicity defined as a ≥15 % decrease in LVEF was significantly higher in the 1-year trastuzumab group (1.88 % versus none for 1-year and 9-week trastuzumab groups, respectively;
p
= 0.050).
Conclusion
The results of this observational study suggest that DFS outcome of 9 weeks of adjuvant trastuzumab may be comparable to 1 year adjuvant trastuzumab: this needs confirmation by randomized trials.
Objective: 18-Fluorodeoxyglucose positron emission tomography-computed tomography (18F-FDG PET-CT) is one of the most valuable imaging types and tumor metabolic volume is another parameter that can ...be obtained from PET-CT. Our primary objective is to evaluate the effect of PET-CT metabolic parameters on survival in patients with malignant pleural mesothelioma (MPM).Methods: A total of 29 patients with MPM had been evaluated with 18F-FDG PET-CT between January 2016 and December 2017. Metabolic tumor volume (MTV), total lesion glycolysis (TLG), standardized uptake values (SUVmax) and TLG/liver SUVmean values were calculated. Also, effects of these parameters on survival rates were evaluated.Results: Histological subtypes of the disease were determined as epithelioid (n=24), biphasic (n=3), sarcomatoid (n=2). Median overall survival was 255 days (21-903). Median MTV was 225 cm3 (10-1879), median TLG was 1056 g/ml·cm3 (36-18927), median SUVmax was 7.7 (1.5-20) and TLG/liver SUVmean ratio was 561.2 (14.9-8113.7). Sensitivity and specificity for MTV 113 cut-off value were 86.4% and 85.7%, respectively. Determined cut-off value for TLG was 419.5, sensitivity and specificity of the value were 81.8% and 85.7%, respectively. Additionally, determined cut-off value for TLG/liver SUVmean ratio was 107.4, the rate of sensitivity and specificity for this value were 95.5% and 71.4%, respectively. The patients with higher MTV, TLG and TLG/liver SUVmean had worse survival rate.Conclusion: We confirmed significant association between MTV, TLG and TLG/liver SUVmean values and patients survival. These promising PET derived parameters can be used for evaluating treatment response and prognosis in MPM.
Breast cancer is the most common malignancy among Turkish women and the rate of early stage disease is increasing. The Oncotype DX(®) 21-gene assay is predictive of distant recurrence in ER-positive, ...HER2-negative early breast cancer. We aimed to evaluate the impact of the Recurrence Score(®) (RS) on treatment decisions and physician perceptions in Turkey. We also studied correlations between RS and routine risk factors.
Ten academic centers across Turkey participated in this prospective trial. Consecutive breast cancer patients with pT1-3, pN0-N1mic, ER-positive, and HER2-negative tumors were identified at multidisciplinary tumor conferences. The initial treatment decision was recorded before tumor blocks were sent to the central laboratory. Each case was brought back to tumor conference after receiving the RS result. Both pre- and post-RS treatment decisions and physician perceptions were recorded on questionnaire forms. Correlations between RS and classical risk factors were evaluated using univariate and multivariate analyses.
Ten centers enrolled a total of 165 patients. The median tumor size was 2 cm. Of 165 patients, 57% had low RS, 35% had intermediate RS, and 8% had high RS, respectively. The overall rate of change in treatment decision was 33%. Initially, chemotherapy followed by hormonal therapy (CT+HT) was recommended to 92 (56%) of all patients, which decreased to 61 (37%) patients post-RS assay (p<0.001). Multivariate analysis indicated that progesterone receptor (PR) and Ki-67 scores were significantly related to RS.
Oncotype DX testing may provide meaningful additional information in carefully selected patients.
The aim of this study was to assess the use of 5-fluorouracil (5-FU), leucovorin and oxaliplatin (FOLFOX) regimens in clinical practice according to their efficacy and toxicity.
Patients who received ...oxaliplatin-containing regimens after curative resection for colorectal carcinoma from 10 different oncology centers between May 2004 and December 2009 were included in the study. All patients were treated with FOLFOX regimens. Patients with rectal carcinoma were also treated with chemoradiotherapy with 5-FU after 2 cycles of a FOLFOX regimen.
The median age of the patients was 56 years (range 17-78). Of the total 667 patients, 326 were given FOLFOX-4, 232 were given modified FOLFOX-4 and 109 were given FOLFOX-6. The distribution according to disease stage was 33 patients with stage IIIA colorectal cancer, 382 patients with stage IIIB and 252 patients with stage IIIC. The most common adverse events were neutropenia (54%), nausea (36.9%), neuropathy (38.2%) and anemia (33.1%) for all grades. The median follow-up time was 23 months (range 1-79). Three-year disease-free survival and overall survival were 65 and 85.7%, respectively.
The different oxaliplatin-containing 5-FU-based adjuvant chemotherapy regimens in patients with stage III colorectal cancer seemed to be at least equal in terms of efficacy regardless of the method of 5-FU administration or oxaliplatin dose.
Primary or metastatic dura mater sarcomas are rarely seen, and dural synovial sarcomas are quite rare. Here we report the case of a 60-year-old man who presented with headache, nausea, and vomiting ...and was found to have a 63×33×40-mm mass with solid and cystic components in parieto-occipital lobe. The mass was resected completely, with no residue detected on postoperative magnetic resonance imagining. On pathological evaluation, a vimentin-, S100-, transducer-like enhancer of split 1-, BCL-2-, and EMApositive and desmin-, PR-, CD99-, PANCK-, and GFAP-negative synovial sarcoma with Ki-67 proliferation index of 12% was detected. Postoperatively, chemotherapy has been started, and it will be followed by radiotherapy. Primary meningeal-derived sarcomas are rare, and differential diagnosis with other meningeal mesenchymal tumors is based on the findings of morphological and immunohistochemical analyses.
Hematological malignancies are associated with the release of different autoantibodies and rheumatological manifestations. Systemic vasculitides are rare in hematological malignancies, and ...antineutrophil cytoplasmic antibodies (ANCA) have not been described sufficiently in hematological malignancies. In this present prospective study, we examined the prevalence of ANCA and related disease in Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL) patients in the southeast region of Turkey. We examined 119 patients with previously or newly diagnosed NHL and 60 patients with HL for the presence of ANCA and related autoimmune diseases between December 2002 and February 2007. ANCA positivity was detected in only 8 patients (4.4%); and all of these ANCA positivities were detected in patients in the HL group (13.3%); p-ANCA positivity was detected in 6 patients (3.3%); and c-ANCA positivity was detected in 2 patients (1.1%). There was statistically significant difference between patients with HL and NHL in terms of p-ANCA (
p
= 0.001) but none in c-ANCA (
p
= 0.111) positivity. None of the ANCA positive patients had vasculitides or rheumatic manifestations. In addition, we did not detect any ANCA positivity in the NHL group. In conclusion, ANCA positivities were detected only in HL patients; but we did not detect the association between ANCA positivities and rheumatic manifestations or vasculitis and also the different treatment responses in HL patients.
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