Objective: To investigate the safety and efficacy of troxatabine in advanced or relapsed malignant tumors resistant to standard therapy in China. Methods: This is a phase Ⅰ prospective study. During dose escalation, patients in Cancer Hospital, Chinese Academy of Medical Sciences received a single-dose intravenous infusion of troxacitabine. The planned dosing groups were 1.8, 3.6, 4.8, 6.4 and 8.0 mg/m(2) on days 1 and 8 every 3 weeks. The data of all patients were collected for safety analyses. Safety and tolerability were evaluated by monitoring adverse events. Results: Nineteen patients were enrolled from April 2018 to May 2019. The major adverse events were fatigue (89.5%, 17/19), leukopenia (84.2%, 16/19) and neutropenia (78.9%, 15/19). The dose limiting toxicity was neutropenia. The maximum tolerated dose was 6.4 mg/m(2). The best effect was stable disease (43.8%). The half-life of elimination phase from 15.91 hours to 76.63 hours in each dose group. Conclusions: The toxicity of troxacitabine is well tolerant. We recommend that the dose for Phase Ⅱ clinical trial should be 6.4 mg/m(2).
Humans ; Antineoplastic Agents/adverse effects* ; Maximum Tolerated Dose ; Neoplasms/drug therapy* ; Neutropenia/chemically induced* ; Prospective Studies

OBJECTIVES: To investigate the incidence rate of adverse reactions of methimazole in children with hyperthyroidism. METHODS: A retrospective analysis was performed on the medical data of 304 children with hyperthyroidism who were hospitalized in Shengjing Hospital of China Medical University from January 2015 to May 2021. The incidence rate of methimazole-related adverse reactions was analyzed. The risk factors for common adverse reactions were evaluated. RESULTS: Among the 304 children, 87 (28.6%) experienced adverse reactions, among whom there were 20 boys (23%) and 67 girls (77%). Common adverse reactions included neutropenia (12.8%), rash (11.8%), elevated alanine aminotransferase (9.5%), and joint pain (3.0%), and some children experienced multiple adverse reactions simultaneously or intermittently. Neutropenia often occurred within 3 months after administration (25/39, 64%), elevated alanine aminotransferase often occurred within 1 month after administration (17/29, 59%), and rash often occurred within 3 months after administration (30/36, 83%). Most of the above adverse reactions returned to normal after symptomatic treatment. The multivariate logistic regression analysis showed that younger age and lower absolute neutrophil count before treatment were risk factors for neutropenia after methimazole treatment (P<0.05). CONCLUSIONS The adverse reactions of methimazole are common in children with hyperthyroidism, and most adverse reactions occur within 3 months after administration and can be relieved after symptomatic treatment. Children with a younger age or a lower baseline absolute neutrophil count may have a higher risk of neutropenia.
Male ; Child ; Female ; Humans ; Methimazole/adverse effects* ; Antithyroid Agents/adverse effects* ; Retrospective Studies ; Alanine Transaminase ; Hyperthyroidism/chemically induced* ; Neutropenia/chemically induced* ; Exanthema

OBJECTIVETo evaluate the efficacy, toxicity and safety of an new domestic docetaxel in the treatment of pretreated advanced breast cancer.

METHODSFourty-four breast cancer patients who had failed in first-line chemotherapy were included in this trial. They received docetaxel as the second-line chemotherapy. Docetaxel was administered alone at a dose of 70 mg/m2 every 3 weeks. The use of granulocyte colony-stimulating factor to prevent granulocytopenia was not permitted. The response rate and toxicity were evaluated by World Health Organization toxicity scale and performance status by Karnofsky scale.

RESULTSOf the 41 evaluable patients, 4 achieved complete response and 14 partial remission, with a response rate and clinical benefit rate of 43.9% and 85.4%, respectively. Grade 3 or grade 4 neutropenia developed in 42.9%, alopecia in 7.1% and vomiting in 4.8% of these patients. Fluid retention was not observed in this series.

CONCLUSIONThree-week administration of docetaxel alone at a dose of 70 mg/m2 is effective and tolerable. It provides an alternative for the pretreated advanced breast cancer patients.

Adolescent ; Adult ; Aged ; Alopecia ; chemically induced ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Breast Neoplasms ; drug therapy ; pathology ; Female ; Humans ; Middle Aged ; Neoplasm Staging ; Neutropenia ; chemically induced ; Remission Induction ; Taxoids ; adverse effects ; therapeutic use ; Treatment Outcome ; Vomiting ; chemically induced

OBJECTIVETo evaluate the efficacy and safety of combination chemotherapy of Docetaxel (Taxotere, TXT) combined with cisplatin (DDP) for anthracycline (ANT)-resistant advanced breast cancer (ABC).

METHODSFrom April 2000 to March 2005, 31 patients with ANT-resistant advanced breast cancer were treated with combination chemotherapy of TXT and DDP. TXT 75 mg/m2 and DDP 75 mg/m2 were used on day 1 every three weeks. The median number of cycles was 4 (range: 2 - 8 cycles).

RESULTSThe overall combination chemotherapy response rate was 54.9% with a median time to progression of 5 months. One-year survival rate was 66.7%. The main side effects were gastrointestinal and hematologic toxicities, including grade 3 to 4 nausea and vomiting in 3 patients (9.7%), leukopenia in 6 (19.3%), and neutropenia in 3 (9.7%).

CONCLUSIONTaxotere and displatin combination is active in the treatment for anthracycine-resistant advanced breast cancer patient with an acceptable toxicity, and may be a therapeutic alternative after anthracycline regimen has failed.

Adult ; Aged ; Anthracyclines ; pharmacology ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Breast Neoplasms ; drug therapy ; pathology ; Cisplatin ; administration & dosage ; adverse effects ; Drug Resistance, Neoplasm ; Female ; Humans ; Leukopenia ; chemically induced ; Liver Neoplasms ; drug therapy ; secondary ; Lung Neoplasms ; drug therapy ; secondary ; Middle Aged ; Nausea ; chemically induced ; Neutropenia ; chemically induced ; Remission Induction ; Survival Analysis ; Taxoids ; administration & dosage ; adverse effects ; Treatment Outcome ; Vomiting ; chemically induced

Antineoplastic Agents, Phytogenic ; adverse effects ; therapeutic use ; Camptothecin ; adverse effects ; analogs & derivatives ; therapeutic use ; Colorectal Neoplasms ; drug therapy ; genetics ; Diarrhea ; chemically induced ; Glucuronosyltransferase ; genetics ; Humans ; Neutropenia ; chemically induced ; Polymorphism, Single Nucleotide

OBJECTIVETo investigate the efficacy and safety of pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) in the salvage therapy for the grade IV neutropenia induced by concurrent chemoradiotherapy, and to provide evidence for its clinical rational application.

METHODS114 malignant tumor patients suffered with grade IV neutropenia induced by concurrent chemoradiotherapy were treated in the following groups. In the P-50 group, 42 patients received a single subcutaneous injection of 50 µg/kg PEG-rhG-CSF. In the P-100 group, 30 patients received a single subcutaneous injection of 100 µg/kg PEG-rhG-CSF. In the P+R group, 22 patients received a single subcutaneous injection of 50 µg/kg PEG-rhG-CSF and multiple subcutaneous injections of 5 µg×kg(-1)×d(-1) rhG-CSF, until the absolute neutrophil count (ANC) ≥ 2.0×10(9)/L. In the R group, 20 patients received multiple subcutaneous injections of 5 µg×kg(-1)×d(-1) rhG-CSF, until ANC ≥ 2.0×10(9)/L. The P-50, P-100 and P+R groups were experimental groups, and the R group was defined as control group. In each group, the neutrophil proliferation rate and the neutrophil counts at different time points, the period of neutropenia symptom relief, and the rate of adverse reactions induced by above drugs were analyzed.

RESULTSBoth neutrophil proliferation rates and neutrophil counts in the patients of experimental groups at different time points were significantly higher than those in the control group. In the experimental groups the period of the clinical effect began in 12-24 hours, and the conditions of neutropenia were improved in 36 hours. In the experimental groups, the period of the symptom relief such as fever and skeletal muscle pain was (30.00 ± 7.48) hours and (30.00 ± 5.10) hours, respectively, significantly shorter than (72.00 ± 17.89) hours and (59.00 ± 11.46) hours in the control group (P < 0.05). The adverse drug reaction rate was 26.1% in the experimental groups and 25.0% in the control group (P > 0.05).

CONCLUSIONSFor the treatment of grade IV neutropenia induced by concurrent chemoradiotherapy, PEG-rhG-CSF is effective and safe. The recommend dose of this drug for the salvage therapy for those patients is a single hypodermal injection of 50 µg/kg. Usually it becomes effective in 12-24 hours.

Chemoradiotherapy ; Granulocyte Colony-Stimulating Factor ; genetics ; metabolism ; Humans ; Injections, Subcutaneous ; Leukocyte Count ; Neutropenia ; chemically induced ; Neutrophils ; Recombinant Proteins ; Salvage Therapy ; methods

OBJECTIVETo evaluate the efficacy and toxicity of oxaliplatin-based regimen in patients with advanced or metastatic gastric/esophagogastric junction cancer (AGC).

METHODSThe clinicopathological data of a total of 180 patients with AGC were retrospectively analyzed. Responses was evaluated by RECIST criteria, and toxicity were assessed according to the NCI-CTC AE version 3.0.

RESULTS155 patients received mFOLFOX regimen, and 25 patients received regimens of mEOF and CapOX, with a total chemotherapy of 717 cycles with a median of 3 cycles. The therapeutic response was evaluated in 150 patients, showing response rate (RR) of 30.0% and disease control rate (DCR) of 74.0%. The response was evaluated in 103 of 124 patients who received the therapy as 1st line, with RR of 34.0%, DCR of 74.8%, and overall survival of 11.3 months. The major grade III/IV adverse events were leucocytopenia (14.4%), neutropenia (17.8%), thrombocytopenia (3.8%), nausea/vomiting (8.9%), and peripheral neuropathy (2.2%), with no treatment related death.

CONCLUSIONOxaliplatin-based regimen is active and well tolerated in patients with advanced or metastatic gastric/esophagogastric junction cancer.

Adenocarcinoma ; drug therapy ; pathology ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Esophagogastric Junction ; Female ; Fluorouracil ; adverse effects ; therapeutic use ; Follow-Up Studies ; Humans ; Leucovorin ; adverse effects ; therapeutic use ; Leukopenia ; chemically induced ; Male ; Middle Aged ; Nausea ; chemically induced ; Neoplasm Staging ; Neutropenia ; chemically induced ; Organoplatinum Compounds ; administration & dosage ; adverse effects ; therapeutic use ; Remission Induction ; Retrospective Studies ; Stomach Neoplasms ; drug therapy ; pathology ; Survival Rate ; Thrombocytopenia ; chemically induced ; Vomiting ; chemically induced

OBJECTIVEThe aim of this study was to evaluate the efficacy, toxicity and safety of doxorubicin combined with domestically produced docetaxel versus with taxotere, and to investigate whether these two regimens result in similar outcomes in the treatment for non-small-cell lung cancer (NSCLC) patients who failed previous platinum-based chemotherapy.

METHODSEighty-eight NSCLC patients were enrolled into this clinical phase II trial. The patients randomly received either domestic docetaxel (study arm) or taxotere (control arm) at a dose of 70 mg/m2 on D2, while doxorubicin at a dose of 40 mg/m2 on D1 was administered in both groups. It was repeated every 3 weeks, totally for three cycles. No granulocyte colony-stimulating factor was used to prevent granulocytopenia. The response rate and toxicity were evaluated using World Health Organization toxicity scale and Karnofsky performance status scale.

RESULTSOf the 88 patients, 81 were evaluable in terms of efficacy. There was no complete responder in this series. The response rate (RR) was 17.1% in the study arm versus 7.5% in the control arm, and the clinical benefit rate (CBR) was 80.5% in the study group versus 72.5% in the control group. The most frequent grade 3 or 4 toxicities were neutropenia, leucopenia and gastrointestinal symptoms. Other toxicities such as alopecia and vomiting were mild and generally well tolerated. No fluid retention was noticed.

CONCLUSIONThe administration of doxorubicin 40 mg/m2 on D1 combined with domestic docetaxel 70 mg/m2 on D2 is proved to be as effective and tolerable as with taxotere. The domestic drug docetaxel may be considered as an alternative for patients with non-small-cell lung cancer who failed previous platinum-based chemotherapy.

Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; pathology ; Doxorubicin ; administration & dosage ; Female ; Humans ; Leukopenia ; chemically induced ; Lung Neoplasms ; drug therapy ; pathology ; Male ; Middle Aged ; Neoplasm Staging ; Neutropenia ; chemically induced ; Remission Induction ; Salvage Therapy ; Taxoids ; administration & dosage ; Treatment Failure ; Vomiting ; chemically induced

OBJECTIVETo investigate the efficacy of the combination of gemcitabine with capecitabine in the chemotherapy for patients with relapsed or metastatic biliary tract carcinoma.

METHODSForty-one patients with unresectable relapsed or metastatic carcinoma of the biliary tract were treated from March 2000 to December 2004. The regimen consisted of intravenous administration of gemcitabine plus oral intake of capecitabine every 3 weeks for more than 2 cycles. The parameters including tumor response, clinical benefit rate,survival and safety were observed.

RESULTSThirty-six patients were valuable and 5 patients were excluded from this series due to various reasons. Eleven patients (30.1%) had a partial response and another 11 patients (30.1%) experieced stable disease with a clinical benefit rates of 61.1%. The median overall survival time and time to progression were 10 months and 6 months, respectively. The one-year survival rate was 40.0%. The adverse events including nausea, diarrhea and hand-foot syndrome, fatigue, neutropenia, thrombocytopenia were frequently observed, which were usually in grade I or II, rarely in grade III and none in grade IV (NCI-CTC).

CONCLUSIONOur results show that the regimen of gemcitabine combined with capecitabine is effective and well tolerated in patients with unresectable relapsed or metastatic carcinoma of the biliary tract.

Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Bile Duct Neoplasms ; drug therapy ; pathology ; Bile Ducts, Intrahepatic ; Capecitabine ; Cholangiocarcinoma ; drug therapy ; pathology ; Deoxycytidine ; administration & dosage ; analogs & derivatives ; Diarrhea ; chemically induced ; Female ; Fluorouracil ; administration & dosage ; analogs & derivatives ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Nausea ; chemically induced ; Neoplasm Metastasis ; Neoplasm Recurrence, Local ; Neutropenia ; chemically induced ; Remission Induction ; Survival Rate

BACKGROUND AND OBJECTIVEThe platinum-based chemotherapy combined with 5-fluorouracil (5-FU) is most frequently used for nasopharyngeal carcinoma (NPC), but the efficacy has been maintained at 50%-60%. Docetaxel is an effective drug for head and neck tumors, its administration is simple, and the administration time is short. This study was to compare the short-term efficacy and toxicity between TC regimen (inductive chemotherapy with docetaxol plus carboplatin) and FC regimen (5-FU plus carboplatin) in local advanced NPC so as to provide a new chemotherapeutic regimen for NPC.

METHODSFifty-eight local advanced NPC patients without previous treatment in Sun Yat-sen University Cancer Center were randomly assigned to receive either TC or FC regimen inductive chemotherapy, followed by concurrent chemoradiotherapy with two cycles of carboplatin (AUC=6) plus radiotherapy of 60-78 Gy to the nasopharynx and 60-70 Gy to the neck. The short-term efficacy and adverse events were observed.

RESULTSMore chemotherapy cycles were finished in TC group than in FC group (3.31 vs. 2.83, P = 0.043). There was no significant difference in short-term efficacy and 1-year survival rate between the two groups (P > 0.05). More grades 3-4 neutropenia appeared in TC group than in FC group (72.4% vs. 37.9%, P < 0.05) , whereas less thrombocytopenia and emesis occurred in TC than in FC group (P = 0.013 and 0.018, respectively).

CONCLUSIONSThe short-term efficacy of TC regimen in local advanced NPC is similar to that of FC regimen with tolerable adverse events. But the long-term outcomes and toxicities need to be further investigated.

Adult ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Carboplatin ; administration & dosage ; adverse effects ; Female ; Fluorouracil ; administration & dosage ; adverse effects ; Humans ; Male ; Middle Aged ; Nasopharyngeal Neoplasms ; drug therapy ; pathology ; Neoplasm Staging ; Neutropenia ; chemically induced ; Survival Rate ; Taxoids ; administration & dosage ; adverse effects ; Thrombocytopenia ; chemically induced ; Vomiting ; chemically induced