1.Assessing taxane-associated adverse events using the FDA adverse event reporting system database.
Dong-Hui LAO ; Ye CHEN ; Jun FAN ; Jian-Zhong ZHANG
Chinese Medical Journal 2021;134(12):1471-1476
		                        		
		                        			BACKGROUND:
		                        			Taxanes are an essential class of antineoplastic agents used to treat various cancers and are a fundamental cause of hypersensitivity reactions. In addition, other adverse events, such as bone marrow toxicity and peripheral neuropathy, can lead to chemotherapy discontinuation. This study aimed to evaluate the safety of taxanes in the real world.
		                        		
		                        			METHODS:
		                        			Taxane-associated adverse events were identified by the Medical Dictionary for Regulatory Activities Preferred Terms and analyzed and compared by mining the US Food and Drug Administration Adverse Event Reporting System pharmacovigilance database from January 2004 to December 2019. Reported adverse events, such as hypersensitivity reaction, bone marrow toxicity, and peripheral neuropathy, were analyzed with the following signal detection algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), Bayesian confidence propagation neural network (BCPNN), and logistic regression methods. Adverse outcome events and death outcome rates were compared between different taxane groups using Pearson's χ2 test, whereas significance was determined at P < 0.05 with a 95% confidence interval (CI).
		                        		
		                        			RESULTS:
		                        			A total of 966 reports of hypersensitivity reactions, 1109 reports of bone marrow toxicity, and 1374 reports of peripheral neuropathy were analyzed. Compared with paclitaxel and docetaxel, bone marrow toxicity following the use of nab-paclitaxel had the highest ROR of 6.45 (95% two-sided CI, 6.05-6.88), PRR of 5.66, (χ2 = 4342.98), information component of 2.50 (95% one-sided CI = 2.34), and empirical Bayes geometric mean of 5.64 (95% one-sided CI = 5.34). Peripheral neuropathy following the use of nab-paclitaxel showed a higher ROR of 12.78 (95% two-sided CI, 11.55-14.14), PRR of 12.16 (χ2 = 4060.88), information component of 3.59 (95% one-sided CI = 3.25), and empirical Bayes geometric mean of 12.07 (95% one-sided CI = 11.09).
		                        		
		                        			CONCLUSIONS
		                        			The results showed that bone marrow toxicity and peripheral neuropathy were the major adverse events induced by taxanes. Nab-paclitaxel exhibited the highest potential for taxane-associated adverse events. Further research in the future is warranted to explain taxane-associated adverse effects in real-world circumstances.
		                        		
		                        		
		                        		
		                        			Adverse Drug Reaction Reporting Systems
		                        			;
		                        		
		                        			Bayes Theorem
		                        			;
		                        		
		                        			Bridged-Ring Compounds
		                        			;
		                        		
		                        			Taxoids/adverse effects*
		                        			;
		                        		
		                        			United States
		                        			;
		                        		
		                        			United States Food and Drug Administration
		                        			
		                        		
		                        	
2.Genetic polymorphisms of autophagy-related gene 5 (ATG5) rs473543 predict different disease-free survivals of triple-negative breast cancer patients receiving anthracycline- and/or taxane-based adjuvant chemotherapy.
Meiying LI ; Fei MA ; Jiayu WANG ; Qing LI ; Pin ZHANG ; Peng YUAN ; Yang LUO ; Ruigang CAI ; Ying FAN ; Shanshan CHEN ; Qiao LI ; Binghe XU
Chinese Journal of Cancer 2018;37(1):4-4
		                        		
		                        			BACKGROUND:
		                        			Autophagy plays a crucial role in chemotherapy resistance of triple-negative breast cancer (TNBC). Hence, autophagy-related gene 5 (ATG5), an essential molecule involved in autophagy regulation, is presumably associated with recurrence of TNBC. This study was aimed to investigate the potential influence of single-nucleotide polymorphisms in ATG5 on the disease-free survival (DFS) of early-stage TNBC patients treated with anthracycline- and/or taxane-based chemotherapy.
		                        		
		                        			METHODS:
		                        			We genotyped ATG5 SNP rs473543 in a cohort of 316 TNBC patients treated with anthracycline- and/or taxane-based chemotherapy using the sequenom's MassARRAY system. Kaplan-Meier survival analysis and Cox proportional hazard regression analysis were used to analyze the association between ATG5 rs473543 genotypes and the clinical outcome of TNBC patients.
		                        		
		                        			RESULTS:
		                        			Three genotypes, AA, GA, and GG, were detected in the rs473543 of ATG5 gene. The distribution of ATG5 rs473543 genotypes was significantly different between patients with and without recurrence (P = 0.024). Kaplan-Meier survival analysis showed that patients carrying A allele of ATG5 rs473543 had an increased risk of recurrence and shorter DFS compared with those carrying the variant genotype GG in rs473543 (P = 0.034). In addition, after adjusting for clinical factors, multivariate Cox regression analyses revealed that the AA/GA genotype of rs473543 was an independent predictor for DFS (hazard risk [HR], 1.73; 95% confidence interval [CI], 1.04-2.87; P = 0.034). In addition, DFS was shorter in node-negative patients with the presence of A allele (AA/GA) than in those with the absence of A allele (P = 0.027).
		                        		
		                        			CONCLUSION
		                        			ATG5 rs473543 genotypes may serve as a potential marker for predicting recurrence of early-stage TNBC patients who received anthracycline-and/or taxane-based regimens as adjuvant chemotherapy.
		                        		
		                        		
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Aged
		                        			;
		                        		
		                        			Anthracyclines
		                        			;
		                        		
		                        			administration & dosage
		                        			;
		                        		
		                        			adverse effects
		                        			;
		                        		
		                        			Autophagy-Related Protein 5
		                        			;
		                        		
		                        			genetics
		                        			;
		                        		
		                        			Bridged-Ring Compounds
		                        			;
		                        		
		                        			administration & dosage
		                        			;
		                        		
		                        			adverse effects
		                        			;
		                        		
		                        			Chemotherapy, Adjuvant
		                        			;
		                        		
		                        			Disease-Free Survival
		                        			;
		                        		
		                        			Female
		                        			;
		                        		
		                        			Genetic Association Studies
		                        			;
		                        		
		                        			Genetic Predisposition to Disease
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Kaplan-Meier Estimate
		                        			;
		                        		
		                        			Middle Aged
		                        			;
		                        		
		                        			Neoplasm Recurrence, Local
		                        			;
		                        		
		                        			drug therapy
		                        			;
		                        		
		                        			genetics
		                        			;
		                        		
		                        			pathology
		                        			;
		                        		
		                        			Polymorphism, Single Nucleotide
		                        			;
		                        		
		                        			genetics
		                        			;
		                        		
		                        			Taxoids
		                        			;
		                        		
		                        			administration & dosage
		                        			;
		                        		
		                        			adverse effects
		                        			;
		                        		
		                        			Triple Negative Breast Neoplasms
		                        			;
		                        		
		                        			drug therapy
		                        			;
		                        		
		                        			genetics
		                        			;
		                        		
		                        			pathology
		                        			
		                        		
		                        	
3.Clinical efficacy of integrated traditional Chinese and Western medicine for castration-resistant prostate cancer.
Yang ZHANG ; Bo-Han LEI ; Qing ZOU ; Qing-Yi ZHU ; Zi-Jie LU ; Yue WANG
National Journal of Andrology 2017;23(10):922-927
		                        		
		                        			Objective:
		                        			To investigate the clinical effects of integrated traditional Chinese and Western medicine in the treatment of castration-resistant prostate cancer (CRPC).
		                        		
		                        			METHODS:
		                        			A total of 54 CRPC patients were randomly divided into a control and a trial group, all treated by endocrine therapy (oral Bicalutamide at 50 mg per d plus subcutaneous injection of Goserelin at 3.6 mg once every 4 wk) and chemotherapy (intravenous injection of Docetaxel at 75 mg/m2 once every 3 wk plus oral Prednisone at 5 mg bid), while the latter group by Fuyang Huayu Prescription (a Traditional Chinese Medicine [TCM] prescription for tonifying yang and dispersing blood stasis) in addition, for a course of 24 weeks. Comparisons were made between the two groups of patients in the level of serum prostate-specific antigen (PSA), Karnofsky physical condition scores, function assessment of cancer therapy-prostate (FACT-P) scores, and TCM symptoms scores before and after 12 or 24 weeks of treatment.
		                        		
		                        			RESULTS:
		                        			Compared with the baseline, the serum PSA level was significantly decreased after 12 weeks of treatment both in the control ([25.9 ± 39.3] vs [20.0 ± 21.1] μg/L, P <0.05) and in the trial group ([22.1 ± 33.9] vs [17.9 ± 19.1] μg/L, P <0.05), with no statistically significant differences between the two groups (P >0.05). At 24 weeks, however, the PSA levels in the control and trial groups were slightly increased to (23.1 ± 28.4) and (19.6 ± 23.5) μg/L, respectively, with no statistically significant differences in between (P >0.05). Karnofsky, FACT-P and TCM symptoms scores were all markedly improved in the trial group after 12 weeks of treatment (P <0.05) and remained stable at 24 weeks, but not in the control group either at 12 or at 24 weeks (P >0.05).
		                        		
		                        			CONCLUSIONS
		                        			TCM Fuyang Huayu Prescription combined with endocrine therapy and chemotherapy is effective for CRPC.
		                        		
		                        		
		                        		
		                        			Anilides
		                        			;
		                        		
		                        			administration & dosage
		                        			;
		                        		
		                        			Antineoplastic Agents, Hormonal
		                        			;
		                        		
		                        			therapeutic use
		                        			;
		                        		
		                        			Antineoplastic Combined Chemotherapy Protocols
		                        			;
		                        		
		                        			therapeutic use
		                        			;
		                        		
		                        			Docetaxel
		                        			;
		                        		
		                        			Drug Administration Schedule
		                        			;
		                        		
		                        			Goserelin
		                        			;
		                        		
		                        			administration & dosage
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Male
		                        			;
		                        		
		                        			Nitriles
		                        			;
		                        		
		                        			administration & dosage
		                        			;
		                        		
		                        			Prednisone
		                        			;
		                        		
		                        			administration & dosage
		                        			;
		                        		
		                        			Prostate-Specific Antigen
		                        			;
		                        		
		                        			blood
		                        			;
		                        		
		                        			Prostatic Neoplasms, Castration-Resistant
		                        			;
		                        		
		                        			blood
		                        			;
		                        		
		                        			drug therapy
		                        			;
		                        		
		                        			Taxoids
		                        			;
		                        		
		                        			administration & dosage
		                        			;
		                        		
		                        			Tosyl Compounds
		                        			;
		                        		
		                        			administration & dosage
		                        			;
		                        		
		                        			Treatment Outcome
		                        			
		                        		
		                        	
4.Survival Outcomes of Concurrent Treatment with Docetaxel and Androgen Deprivation Therapy in Metastatic Castration-Resistant Prostate Cancer.
Ho Seong JANG ; Kyo Chul KOO ; Kang Su CHO ; Byung Ha CHUNG
Yonsei Medical Journal 2016;57(5):1070-1078
		                        		
		                        			
		                        			PURPOSE: Docetaxel-based chemotherapy (DTX) improves overall survival (OS) of men with metastatic castration-resistant prostate cancer (mCRPC). Considering the potential existence of androgen receptors that remain active at this stage, we aimed to assess the impact of the combined use of androgen deprivation therapy (ADT) with DTX for mCRPC. MATERIALS AND METHODS: We performed a single-institutional retrospective analysis of patients with mCRPC who received either DTX alone (DTX group, n=21) or concurrent DTX and ADT (DTX+ADT group, n=26) between August 2006 and February 2014. All patients received DTX doses of 75 mg/m2 every three weeks for at least three cycles. In the DTX+ADT group, all patients used luteinizing hormone releasing hormone agonist continuously as a concurrent ADT. RESULTS: The median follow-up period was 24.0 months (interquartile range 12.0-37.0) for the entire cohort. The median radiographic progression-free survival (rPFS) was 9.0 months and 6.0 months in the DTX+ADT and DTX groups, respectively (log-rank p=0.036). On multivariable Cox regression analysis, concurrent administration of ADT was the only significant predictor of rPFS [hazard ratio (HR)=0.525, 95% confidence intervals (CI) 0.284-0.970, p=0.040]. The median OS was 42.0 and 38.0 months in the DTX+ADT and DTX groups, respectively (log-rank p=0.796). On multivariable analysis, hemoglobin level at the time of DTX initiation was associated with OS (HR=0.532, 95% CI 0.381-0.744, p<0.001). CONCLUSION: In chemotherapy-naive patients with mCRPC, the combined use of ADT with DTX improved rPFS. Our result suggests that the concurrent administration of ADT and DTX is superior to DTX alone.
		                        		
		                        		
		                        		
		                        			Adenocarcinoma/blood/*drug therapy/secondary
		                        			;
		                        		
		                        			Aged
		                        			;
		                        		
		                        			Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
		                        			;
		                        		
		                        			Disease-Free Survival
		                        			;
		                        		
		                        			Gonadotropin-Releasing Hormone/administration & dosage/agonists
		                        			;
		                        		
		                        			Hemoglobins/metabolism
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Male
		                        			;
		                        		
		                        			Middle Aged
		                        			;
		                        		
		                        			Prostatic Neoplasms, Castration-Resistant/blood/*drug therapy/pathology
		                        			;
		                        		
		                        			Retrospective Studies
		                        			;
		                        		
		                        			Survival Rate
		                        			;
		                        		
		                        			Taxoids/administration & dosage
		                        			
		                        		
		                        	
5.A multicenter, randomized, controlled, phase Ⅲ clinical study of PEG-rhG-CSF for preventing chemotherapy-induced neutropenia in patients with breast cancer and non-small cell lung cancer.
Binghe XU ; Fuguo TIAN ; Jingrui YU ; Yanqiu SONG ; Jianhua SHI ; Baihong ZHANG ; Yanjun ZHANG ; Zhiping YUAN ; Qiong WU ; Qingyuan ZHANG ; Kejun NAN ; Qiang SUN ; Weilian LI ; Jianbing HU ; Jingwang BI ; Chun MENG ; Hong DAI ; Hongchuan JIANG ; Shun YUE ; Bangwei CAO ; Yuping SUN ; Shu WANG ; Zhongsheng TONG ; Peng SHEN ; Gang WU ; Lili TANG ; Yongchuan DENG ; Liqun JIA ; Kunwei SHEN ; Wu ZHUANG ; Xiaodong XIE ; Youhua WU ; Lin CHEN
Chinese Journal of Oncology 2016;38(1):23-27
OBJECTIVETo explore the safety and efficacy of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in preventing chemotherapy-induced neutropenia in patients with breast cancer and non-small cell lung cancer (NSCLC), and to provide the basis for clinical application.
METHODSAccording to the principle of open-label, randomized, parallel-group controlled clinical trial, all patients were randomized by 1∶1∶1 into three groups to receive PEG-rhG-CSF 100 μg/kg, PEG-rhG-CSF 6 mg, or rhG-CSF 5 μg/kg, respectively. The patients with breast cancer received two chemotherapy cycles, and the NSCLC patients received 1-2 cycles of chemotherapy according to their condition. All patients were treated with the combination chemotherapy of TAC (docetaxel+ epirubicin+ cyclophosphamide) or TA (docetaxel+ epirubicin), or the chemotherapy of docetaxel combined with carboplatin, with a 21 day cycle.
RESULTSThe duration of grade 3-4 neutropenia in the PEG-rhG-CSF 100 μg/kg and PEG-rhG-CSF 6 mg groups were similar with that in the rhG-CSF 5 μg/kg group (P>0.05 for all). The incidence rate of grade 3-4 neutropenia in the PEG-rhG-CSF 100 μg/kg group, PEG-rhG-CSF 6 mg group, and G-CSF 5 μg/kg group were 69.7%, 68.4%, and 69.5%, respectively, with a non-significant difference among the three groups (P=0.963). The incidence rate of febrile neutropenia in the PEG-rhG-CSF 100 μg/kg group, PEG-rhG-CSF 6 mg group and G-CSF 5 μg/kg group were 6.1%, 6.4%, and 5.5%, respectively, showing no significant difference among them (P=0.935). The incidence rate of adverse events in the PEG-rhG-CSF 100 μg/kg group, PEG-rhG-CSF 6 mg group and G-CSF 5 μg / kg group were 6.7%, 4.1%, and 5.5%, respectively, showing a non-significant difference among them (P=0.581).
CONCLUSIONSIn patients with breast cancer and non-small cell lung cancer (NSCLC) undergoing TAC/TA chemotherapy, a single 100 μg/kg injection or a single fixed 6 mg dose of PEG-rhG-CSF at 48 hours after chemotherapy show definite therapeutic effect with a low incidence of adverse events and mild adverse reactions. Compared with the continuous daily injection of rhG-CSF 5 μg/kg/d, a single 100 μg/kg injection or a single fixed 6 mg dose of PEG-rhG-CSF has similar effect and is more advantageous in preventing chemotherapy-induced neutropenia.
Antineoplastic Agents ; adverse effects ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; Breast Neoplasms ; drug therapy ; Carboplatin ; administration & dosage ; adverse effects ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; Cyclophosphamide ; administration & dosage ; adverse effects ; Epirubicin ; administration & dosage ; adverse effects ; Female ; Granulocyte Colony-Stimulating Factor ; therapeutic use ; Humans ; Incidence ; Induction Chemotherapy ; Lung Neoplasms ; drug therapy ; Neutropenia ; chemically induced ; epidemiology ; prevention & control ; Polyethylene Glycols ; Recombinant Proteins ; administration & dosage ; Taxoids ; administration & dosage ; adverse effects
6.Efficacy and safety of cisplatin plus capecitabine for patients with metastatic triple negative breast cancer progressing after anthracycline and taxane treatment.
Qiao LI ; Binghe XU ; Email: XUBINGHE@MEDMAIL.COM.CN. ; Qing LI ; Pin ZHANG ; Peng YUAN ; Jiayu WANG ; Fei MA ; Yang LUO ; Ying FAN ; Ruigang CAI
Chinese Journal of Oncology 2015;37(12):938-941
OBJECTIVETo evaluate the efficacy and safety of cisplatin and capecitabine combination (XP) therapy for patients with metastatic triple negative breast cancer (TNBC) progressing after anthracycline and taxane treatment.
METHODSTwenty-nine metastatic TNBC patients were prospectively enrolled to receive capecitabine (1, 000 mg/m(2) twice daily on days 1-14) and cisplatin (75 mg/m(2) on day 1) , repeated every 3 weeks.
RESULTSWith a median of 6 cycles of XP, all 29 patients were evaluable for response, including 18 PR (62.1%), 6 SD (20.7%), 5 PD (17.2%) and no CR. The response rate was 62.1%. Patients with earlier stage at diagnosis (stage I to IIIA), longer post-operative disease free survival (>2 years) and less metastatic sites (≤ 3) obtained significantly higher response rate than patients with later stage at diagnosis (stage IIIB to IV), shorter post-operative disease free survival (≤ 2 years) and more metastatic sites (>3). The leading side effects were grade 1/2 gastrointestinal and hematological toxicities. Grade 3/4 toxicities included neutropenia (34.5%), leukocytopenia (31.0%), anemia (6.9%), thrombocytopenia (3.4%), nausea/vomiting (20.7%), stomatitis (3.4%), and hand-foot syndrome (3.4%).
CONCLUSIONCisplatin and capecitabine combination therapy is an active and well-tolerated doublet treatment in metastatic TNBC patients progressing after anthracycline and taxane treatments.
Anthracyclines ; administration & dosage ; Antibiotics, Antineoplastic ; administration & dosage ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Bridged-Ring Compounds ; administration & dosage ; Capecitabine ; administration & dosage ; adverse effects ; Cisplatin ; administration & dosage ; adverse effects ; Disease-Free Survival ; Female ; Hand-Foot Syndrome ; Humans ; Leukopenia ; chemically induced ; Neutropenia ; chemically induced ; Prospective Studies ; Taxoids ; administration & dosage ; Treatment Outcome ; Triple Negative Breast Neoplasms ; drug therapy ; pathology
7.Association between the expression of IGF1R and estrogen receptor and efficacy of neoadjuvant chemotherapy in beast cancer patients.
Chinese Journal of Oncology 2015;37(11):833-836
OBJECTIVETo detect the expression of IGF1R and estrogen receptor, and to explore the relationship between their expression and the pathological complete response (pCR) rate of neoadjuvant chemotherapy (docetaxel plus epirubicin) in breast cancer patients.
METHODSWe selected 139 women with breast cancer who underwent neoadjuvant chemotherapy (docetaxel plus epirubicin), and detected the expression of IGF1R and estrogen receptor in the samples taken before chemotherapy by Immunohistochemistry. The association between their expression and pCR rate of neoadjuvant chemotherapy was analyzed.
RESULTSAmong the 139 cases, IGF1R was highly expressed in 45.3% (63/139) cases, and ER was positively expressed in 62.6% (87/139) cases. IGF1R was highly expressed in 54.0% (47/87) of the ER+ cases, significantly higher than that of ER- cases (30.8%, P<0.01). The overall pCR rate of all the 139 patients who received docetaxel plus epirubicin as neoadjuvant chemotherapy was 10.1% (14/139). The pCR rate was 19.2% (10/52) of the ER- patients and 4.6% (4/87) of the ER+ patients (P<0.05). The pCR rate was 10.5% (8/76) in the patients with low IGF1R expression and 9.5% (6/63) in the patients with high IGF1R expression (P>0.05). The patients with negative expression of ER and high expression of IGF1R showed the highest pCR rate (31.2%, P<0.01).
CONCLUSIONSBreast cancer patients with negative expression of ER and high expression of IGF1R are more sensitive to neoadjuvant chemotherapy of docetaxel plus epirubicin, and their pCR rate is significantly higher than that of other patients.
Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Biomarkers, Tumor ; Breast Neoplasms ; drug therapy ; metabolism ; Epirubicin ; administration & dosage ; Female ; Humans ; Immunohistochemistry ; Neoadjuvant Therapy ; Receptors, Estrogen ; metabolism ; Receptors, Somatomedin ; metabolism ; Taxoids ; administration & dosage
8.Efficacy and toxicity of vinorelbine (NVB)-based regimens in patients with metastatic triple negative breast cancer (mTNBC) pretreated with anthracyclines and taxanes.
Feng DU ; Peng YUAN ; Yang LUO ; Jiayu WANG ; Fei MA ; Ruigang CAI ; Ying FAN ; Qing LI ; Pin ZHANG ; Binghe XU ; Email: XUBINGHE@MEDMAIL.COM.CN.
Chinese Journal of Oncology 2015;37(10):788-792
OBJECTIVETo assess the efficacy of vinorelbine (NVB)-based regimens in patients with metastatic triple negative breast cancer (mTNBC) pretreated with anthracyclines and taxanes.
METHODSClinical data of 48 patients diagnosed and treated for mTNBC between 2004 and 2012 at the Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) were retrospectively analyzed. All patients were pretreated with anthracyclines and at least one taxane in neo-adjuvant, adjuvant or chemotherapy for mTNBC and patients should be having at least one measurable metastatic lesion. Totally, 48 patients were included in this study, of which 21 cases received first-line chemotherapy and 27 cases received second-line chemotherapy. Based on the regimen they received, 22 patients were treated with NVB plus platinum (NP), and 26 patients with NVB plus capecitabine (NX).
RESULTSAfter 70 months follow-up, in the total group of patients, the objective response rate was 20.8%, clinical benefit rate was 43.8%, median progression free survival (PFS) was 4.4 months and median overall survival (OS) was 15.5 months. In addition, the ORR was significantly better in the NP arm versus NX arm (33.8% vs.7.7%, P=0.029) as well as PFS was statistically improved in the NP arm than NX arm (5.3 m vs. 3.0 m, P=0.023). Similar trend was observed in the OS, although the difference was not statistically significant (27.7 m vs. 14.8 m, P=0.077). In all, the most frequently reported adverse events were G1/2 gastrointestinal toxicity (68.8%) and neutropenia (62.5%) . No significant difference was observed between the NP arm and NX arm (P>0.05). The percentage of patients who delayed chemotherapy administration in the NP arm and NX arm was 9.1% (n=2), and 3.8% (n=1), respectively.
CONCLUSIONSNVB-based combination chemotherapy demonstrates moderate efficacy in mTNBC patients pretreated with anthracyclines and one taxane with manageable toxicity. NP regimen shows potential superiority over NX regimen, and should be further verified in randomized phase III clinical trial in larger cohort.
Anthracyclines ; therapeutic use ; Antibiotics, Antineoplastic ; adverse effects ; therapeutic use ; Antineoplastic Agents, Phytogenic ; adverse effects ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Bridged-Ring Compounds ; therapeutic use ; Capecitabine ; administration & dosage ; Cisplatin ; administration & dosage ; Disease-Free Survival ; Humans ; Neutropenia ; chemically induced ; Retrospective Studies ; Taxoids ; therapeutic use ; Triple Negative Breast Neoplasms ; drug therapy ; pathology ; Vinblastine ; adverse effects ; analogs & derivatives ; therapeutic use
9.Phase II clinical trial of two different modes of administration of the induction chemotherapy for locally advanced nasopharyngeal carcinoma.
Ting BI ; Feng JIN ; Weili WU ; Jinhua LONG ; Yuanyuan LI ; Xiuyun GONG ; Xiuling LUO ; Zhuoling LI ; Qianyong HE ; Bo QU
Chinese Journal of Oncology 2015;37(9):676-681
OBJECTIVETo compare the therapeutic effects, toxic side effects and influence on the immune function in patients treated with TPF [docetaxel (DOC) + cisplatin (DDP) + 5-fluorouracil (5-Fu)] induction chronochemotherapy and conventional chemotherapy for locally advanced nasopharyngeal (NPC).
METHODSSeventy patients with locally advanced nasopharyngeal carcinoma were treated in our department at their first visit from April 2013 to December 2013. They were divided randomly into two groups: the chronochemotherapy group (38 patients) and conventional chemotherapy group (32 patients). All of the patients were treated with TPF regimen with 2 cycles of induction chemotherapy in a 21-28-days/cycle. The chronochemotherapy group: DOC: 75 mg/m2, i. v. gtt, d1 (03: 30-04: 30); DDP: 75 mg/m2, 10 am-10 pm, c.i.v, d1-d5; 5-Fu: 750 mg·m(-2)·d(-1), 10 pm-10 am, c. i.v., d1-d5, both chemotherapies were administered by intravenous infusion using an automatic electric pump. The conventional chemotherapy group: Both DOC and DDP were administered intravenously at a dose of 75 mg/m2 on d1. 5-Fu was given at a dose of 750 mg/m2 for 24 hours from d1-d5 with continuous infusion in a total of 120 hours. In this procedure, prescribing the conventional intravenous infusion, intensity modulated radiation therapy was used after the induction chemotherapy. The prescribed nasopharyngeal lesion dose (GTVnx) was 69.96 Gy/33 fractions for the T1-T2 nasopharygeal cancer, while 73.92 Gy/33 fractions nasopharynx lesion dose (GTVnx) for the T3-T4 nasopharyngeal cancer. The planning target volume (PTV) of positive lymph node (PTVnd) dose was 69.96 Gy/33 fractions. Concurrent chemoradiotherapy: cisplatin 100 mg/m2, i. v. gtt. d1-d2, and there were two cycles in total and 21 days each cycle.
RESULTSSixty-six patients were evaluable for the response assessment. There were 36 patients in the chronochemotherapy group and 30 patients in the conventional chemotherapy group. After the induction chemotherapy, no CR case was found in both of the two groups. The PR was 80.6% in the chronochemotherapy group and 50.0% in the conventional chemotherapy group (P=0.009). After concurrent chemoradiotherapy, the CR rate in the chronocheotherapy group was 45.5%, significantly higher than 20.7% in the conventional chemotherapy group (P=0.040). Secondly, the incidence rates of adverse reactions including bone marrow suppression, nausea, vomiting, diarrhea, constipation, oral mucositis, fatigue, anorexia in the chrono-chemotherapy group were significantly lower than that in the conventional group (P<0.05 for all). Finally, compared the two groups, the CD4+ /CD8+ ratio was significantly lower in the chronochemotherapy group than that in the conventional chemotherapy group (P<0.05). The lymphocytes CD19+ and CD4+/CD8+ were decreased and CD3+, CD4+, CD8+, CD16++CD56+ were increased in the chronochemotherapy group, while only CD3+ and CD8+ were increased in the conventional chemotherapy group.
CONCLUSIONSCompared with the conventional chemotherapy, the chronochemotherapy may be more favorable in the treatment of NPC, with a better therapeutic effects and effectiveness than that of conventional chemotherapy after induction chemotherapy, with less side effects, and can improve the immune function in the patients.
Antineoplastic Combined Chemotherapy Protocols ; administration & dosage ; Carcinoma ; Chemoradiotherapy ; Cisplatin ; administration & dosage ; Drug Chronotherapy ; Fluorouracil ; administration & dosage ; Humans ; Induction Chemotherapy ; methods ; Nasopharyngeal Neoplasms ; drug therapy ; pathology ; radiotherapy ; Nausea ; Neoplasm Staging ; Radiotherapy, Intensity-Modulated ; Taxoids ; administration & dosage ; Treatment Outcome
10.Characteristics of recurrence in patients with gastric cancer after radical gastrectomy and adjuvant chemotherapy.
Chunxia DU ; Chunguang GUO ; Quan XU ; Jinwan WANG ; Aiping ZHOU
Chinese Journal of Oncology 2015;37(8):622-627
OBJECTIVETo analyze the characteristics of recurrence in gastric cancer patients after radical gastrectomy and adjuvant chemotherapy.
METHODSThe clinicopathological data of 110 gastric cancer patients who developed recurrence or second primary malignancies after radical gastrectomy and adjuvant chemotherapy with FOLFOX4 regimen or docetaxel plus FOLFOX4 regimen were analyzed retrospectively.
RESULTSThe median time to recurrence was 13.9 months (range, 1.7 to 63.1 months), and the median overall survival was 27.4 months (range, 6.9 to 90.7 months) in the whole group. The median survival time after recurrence was 10.1 months (range, 0.3 to 73.9 months). 82 (74.5%) patients had recurrence within 2 years after gastrectomy. The modes of surgical procedure and lymph node dissection influenced significantly on the time to recurrence (P<0.05 for both). Among the 110 patients with recurrence, 46 (41.8%) patients had peritoneal metastases, 33 (30.0%) had hematogenous metastases and 32 (29.1%) had locoregional lymph node metastases. Single, double, triple and quatro recurrences were observed at the first time of relapse in 78 (70.9%), 21(19.1%), 9(8.2%) and 2 cases (1.8%), respectively. Patients who developed simultaneous quatro recurrence had the poorest prognosis with a median overall survival of 15.2 months, significantly shorter than that of patients with single recurrence (31.8 months, P=0.003). Patients with peritoneal recurrence died most quickly ( mean 5.6 months), and patients with surgical field recurrence alone survived longest (mean 17.1 months).
CONCLUSIONSPeritoneal, hematogenous and locoregional lymph node metastases are the most frequent recurrences after radical gastrectomy and adjuvant chemotherapy in patients with gastric cancer. Single recurrence occurred in most patients at the first relapse. Combination with other adjuvant treatments should be considered besides adjuvant chemotherapy in gastric cancer patients after radical gastrectomy.
Antineoplastic Combined Chemotherapy Protocols ; administration & dosage ; therapeutic use ; Chemotherapy, Adjuvant ; Fluorouracil ; administration & dosage ; Gastrectomy ; methods ; Humans ; Leucovorin ; administration & dosage ; Lymph Node Excision ; Lymphatic Metastasis ; Neoplasm Recurrence, Local ; mortality ; Neoplasms, Second Primary ; Organoplatinum Compounds ; administration & dosage ; Prognosis ; Retrospective Studies ; Stomach Neoplasms ; mortality ; therapy ; Taxoids ; administration & dosage ; Time Factors
            
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