PURPOSE: We evaluated the tolerability and cardiac safety of docetaxel, cyclophosphamide, and trastuzumab (TCyH) for the treatment of early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer and compared to the standard trastuzumab-based chemotherapy regimens doxorubicin with cyclophosphamide followed by paclitaxel and trastuzumab (AC-TH) and docetaxel, carboplatin, and trastuzumab (TCaH). METHODS: We retrospectively reviewed early-stage, resectable, HER2-positive breast cancer patients treated with trastuzumab-based chemotherapy at a single comprehensive cancer center between 2004 and 2011. Patient characteristics, comorbidities, relative dose intensity (RDI) of each regimen, tolerability, and cardiac toxicity were evaluated. RESULTS: One hundred seventy-seven patients were included in the study (AC-TH, n=114; TCaH, n=39; TCyH, n=24). TCyH was solely administered in the adjuvant setting, whereas two-thirds of the AC-TH and TCaH groups were administered postoperatively. Patients treated with TCyH tended to have a more significant underlying cardiac history, higher Charlson comorbidity index, and were of an earlier stage. All patients treated with TCyH received granulocyte colony stimulating factor primary prophylaxis. No febrile neutropenia or grade > or =3 hematologic toxicity was observed in the TCyH group as compared to the AC-TH and TCaH groups. There were no significant differences in the rates of early termination, hospitalization, dose reduction, or RDI between the regimens. The symptomatic congestive heart failure rate between AC-TH, TCaH, and TCyH groups was not significantly different (4.4% vs. 2.6% vs. 8.3%, respectively, p=0.57). There was also no significant difference in the rate of early trastuzumab termination between patients treated with each regimen. CONCLUSION: TCyH is well tolerated and should be investigated as an alternative adjuvant chemotherapy option for patients who are not candidates for standard trastuzumab-containing regimens. Larger clinical trials are necessary to support the wider use of TCyH as an adjuvant regimen.
Breast Neoplasms* ; Carboplatin ; Chemotherapy, Adjuvant ; Colony-Stimulating Factors ; Comorbidity ; Cyclophosphamide* ; Doxorubicin ; Drug Therapy* ; Febrile Neutropenia ; Granulocytes ; Heart Failure ; Hospitalization ; Humans ; Paclitaxel ; Receptor, Epidermal Growth Factor* ; Retrospective Studies ; Trastuzumab

PURPOSE: After damage control surgery, trauma patients are transferred to intensive care units to restore the physiology. During this period, massive transfusion might be required for ongoing bleeding and coagulopathy. This research aimed to identify predictors of massive blood transfusion in the surgical intensive care units (SICUs). METHODS: This is an analysis of the THAI-SICU study which was a prospective cohort that was done in the 9-university-based SICUs in Thailand. The study included only patients admitted due to trauma mechanisms. Massive transfusion was defined as received ≥10 units of packed red blood cells on the first day of admission. Patient characteristics and physiologic data were analyzed to identify the potential factors. A multivariable regression was then performed to identify the significant model. RESULTS: Three hundred and seventy patients were enrolled. Sixteen patients (5%) received massive transfusion in the SICUs. The factors that significantly predicted massive transfusion were an initial sequential organ failure assessment (SOFA) ≥9 (risk difference (RD) 0.13, 95% confidence interval (CI): 0.03-0.22, p = 0.01); intra-operative blood loss ≥ 4900 mL (RD 0.33, 95% CI: 0.04-0.62, p = 0.02) and intra-operative blood transfusion ≥ 10 units (RD 0.45, 95% CI: 0.06 to 0.84, p = 0.02). The probability to have massive transfusion was 0.976 in patients who had these 3 factors. CONCLUSION Massive blood transfusion in the SICUs occurred in 5%. An initial SOFA ≥9, intra-operative blood loss ≥4900 mL, and intra-operative blood transfusion ≥10 units were the significant factors to predict massive transfusion in the SICUs.