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Objective: To evaluate the efficacy and safety of PEG-rhG-CSF therapy in the primary and secondary prevention of chemo-therapy-induced neutropenia . Methods: This single-center, one-arm, and open-label clinical study involved 217 patients with non-my-eloid malignant tumors. These patients included 18 gynecologic oncology (3 endometrial and 15 ovarian cancer), 50 breast cancer, 30 bone tumor, and 119 lymphoma patients who underwent a total of 774 cycles of chemotherapy, comprising 146 primary and 71 sec-ondary prevention patients. The patients ≥45 kg and those <45 kg received a single subcutaneous injection of 6 mg and 3 mg PEG-rhG-CSF, respectively, 24-48 h after the chemotherapy was completed. All patients received only one dose of PEG-rhG-CSF admin-istration per chemotherapy cycle. Results: The overall incidence of febrile neutropenia (FN) was found to be 5.7%, with rates of 4.9% and 7.2% in the primary and secondary prevention groups, respectively. Univariate and multivariate Logistic regression analyses re-vealed that the longer PEG-rhG-CSF was sustained in the treatment cycle, the lower the incidence of FN was. The incidence of FN was significantly lower in the second cycle of the treatment than in the first in both the primary and secondary prevention groups (cycle 1 vs. cycle 2: 11.6% vs. 4.4%, respectively, P=0.039, in the primary group; 16.9% vs. 5.6%, respectively, P=0.034, in the secondary group). The overall incidence of gradeⅣneutropenia was 10.3% (80/774), with rates of 6.7% (34/510) and 17.4% (46/264) in the primary and secondary prevention groups, respectively (P<0.001). The incidence of gradeⅣneutropenia was significantly lower in the second cy-cle of the treatment than in the first (cycle 1 vs. cycle 2: 17.1% vs. 5.3%, respectively, P=0.004, in the primary group; 46.5% vs. 11.3%, respectively, P<0.001, in the secondary group). The treatment-induced toxicity mainly involved bone pain, with 3.7% (8/217) and 1.8% (4/217) incidence rates for grade 1-2 and 3-4 bone pain, respectively. Conclusions: PEG-rhG-CSF administration can effectively reduce the incidence of FN (5.7%) when prophylactically applied to patients with non-myeloid malignant tumors. Primary prevention can sig- nificantly reduce the risk of grade IV neutropenia in all chemotherapy cycles relative to the secondary prevention.
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<p><b>OBJECTIVE</b>The aim of this study was to compare the efficacy of low molecular weight heparin (LMWH) combined with graduated compression stockings (GCS) with GCS alone as prophylactic measures for venous thromboembolism (VTE) in post-operative patients with gynecologic cancer.</p><p><b>METHODS</b>Patients diagnosed with gynecologic cancer undergoing primary major surgery between 2010 and 2011 in our institute were randomized to receive LMWH+GCS or GCS as VTE prophylaxis post-operatively.</p><p><b>RESULTS</b>Altogether 247 patients were enrolled. The incidence of VTE in patients treated with LMWH + GCS was significantly lower than that in patients using GCS alone (0.8% Vs. 8.1%, P = 0.01). There were no severe bleeding complications in the patients with prophylactic use of LMWH and the occurrence rate of wound dehiscence was comparable between the two groups (P > 0.05). Multivariable logistic regression analysis revealed that age over 60 years (P = 0.015) , duration of operation over 3 hours (P = 0.04) and without prophylactic use of LMWH (P = 0.02) were independent risk factors for VTE.</p><p><b>CONCLUSIONS</b>Dual prophylaxis with LMWH and GCS should be recommended for gynecologic cancer patients undergoing major surgery for its better efficacy than GCS. Prophylactic use of LMWH is safe and convenient. Patients with older age and prolonged operation time are at highest risk of developing VTE post-operatively.</p>
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Feminino , Humanos , Anticoagulantes , Usos Terapêuticos , Neoplasias dos Genitais Femininos , Cirurgia Geral , Heparina de Baixo Peso Molecular , Usos Terapêuticos , Complicações Pós-Operatórias , Período Pós-Operatório , Meias de Compressão , Tromboembolia VenosaRESUMO
Objective:To analyze the prognosis-related factors of ovarian serous adenocarcinoma in order to set up a prognostic model of serous adenocarcinoma and verify the effectiveness of the model as prognostic clinical criteria.Methods:The clinical, patholo-gical and follow-up data from 181 training samples with ovarian serous adenocarcinoma in Peking University First Hospital during January 1995 to December 2003 and another 42 detection samples with ovarian serous adenocarcinoma in Beijing Cancer Hospital during January 1999 to December 2005 were analyzed retrospectively. Kaplan-Meier univariate analysis was used to screen out prognostic factors; COX univariate and multivariate analyses were used to determine the risk coefficient of each factor and different layers in each factor; Pearson rank correlation analysis was used to identify the correlation of each factor. The prognostic model of ovarian serous adenocarcinoma was established on the conversion of risk coefficient to prognostic score and receiver operating characteristic (ROC) analysis was used to determine the cut-off value. The clinical data were collected to verify the sensitivity and specificity of the prognostic model based on the 3-year survival rate and Ki67 value.Results:The survival rate of patients with ovarian serous adenocarcinoma correlated with 6 factors including FIGO stage, histological grade, residual size, metastasis of lymph nodes, general condition after chemotherapy, and serum CA125 levels. The postoperative chemotherapy was an independent factor for prognosis. The prognostic model directly reflected the survival probability of classical COX risk ratio model, with higher score indicating lower survival probability and poorer prognosis. If combining prognostic score with Ki67 the sensitivity and specificity reached 64.7% and 96.0%, respectively.Conclusion:FIGO stage, histological grade, residual size, metastasis of lymph nodes, postoperative chemotherapy and serum CA125 were the prognostic factors of patients with ovarian serous adenocarcinoma. The prognostic model of ovarian serous adenocarcinoma can moderately reflect the actual survival status, and combination with Ki67 will increase the sensitivity and specificity.
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Objective To evaluate the efficacy and toxicity of combined pegylated liposomaldoxorubicin (PLD) and carboplatin in the treatment of patients with recurrent epithelial ovarian cancer.Methods We retrospectively reviewed 67 patients with recurrent epithelial ovarian cancer or primaryperitoneal adenocarcinoma (8 eases) who were treated with combined PLD and earboplatin. The responserate, survival and toxicity were evaluated. The mean age for 67 patients was 52.1 (39-76) years. All ofthem received eytoreductive surgery followed by platinum-based chemotherapy either with paclitaxel orcyclophosphamide and doxorubicin after diagnosis. Combined PLD and carboplatin was used as first orsecond-line treatment or even after multiple lines of treatment after disease recurred. Patients were treatedwith PLD at 35-40 mg/m2combined with carboplatin at an area under curve ( AUC ) of 5 once every 4weeks. Results Forty-nine. Patients were evaluable for response. Twenty-three (47%) patients had acomplete response, 13 (27%) had a partial response, 3 (6%) had stable disease and 10 (20%) hadprogressive disease. The estimated median progression-free survival (PFS) was 8 months. The 1-year and 2-year survival rates were 73% and 55%, respectively. All of the 67 patients were evaluated for toxicity. Thetreatment was terminated in 2 patients due to allergic-like infusion reaction. Four patients who had acuteinfusion reaction with shortness of breath and tightness of chest did not terminate the treatment because nosuch reaction occurred when restarted the infusion. There were 2 patients with G2and 3 patients with G3hand-foot syndrome, 2 patients had G4stomatitis, and 8 patients had G3leukopeni,, No G4leukopenia orcardiotoxicity eceurred. Conclusion The combination of PLD and carboplatin is an active and wellotolerated regimen in the treatment of patients with recurrent epithelial ovarian cancer.
