Objective:Endocrine therapy with fulvestrant has shown synergistic antitumor effects with some chemotherapy drugs in vitro.This study evaluated the efficacy and safety of fulvestrant with vinorelbine in patients with ...Objective:Endocrine therapy with fulvestrant has shown synergistic antitumor effects with some chemotherapy drugs in vitro.This study evaluated the efficacy and safety of fulvestrant with vinorelbine in patients with hormone receptor positive(HR+)/human epidermal growth factor receptor-2-negative(HER2−)recurrent or metastatic breast cancer.Methods:Patients were intramuscularly administered fulvestrant 500 mg(day 1 per cycle for 28 days)and oral vinorelbine(60 mg/m2 on days 1,8,and 15 of each cycle).The primary endpoint was progression-free survival(PFS).Secondary endpoints included overall survival,objective response rate,disease control rate,duration of response,and safety.Results:A total of 38 patients with HR+/HER2−advanced breast cancer included in the study were followed up for a median time of 25.1 months.The overall median PFS was 9.86 months[95%confidence interval(CI)7.2-23.13],and the median PFS of the first-line and the second-line treatment population was 20.73 months(95%CI 9.82 to NR)and 4.27 months(95%CI 3.68 to NR),respectively.Most adverse events reported were of grade 1/2,and none were of grade 4/5.Conclusions:This is the first exploratory study of a fulvestrant and oral vinorelbine regimen in the treatment of HR+/HER2−recurrent and metastatic breast cancer.The combination chemo-endocrine therapy was efficacious,safe,and promising for patients with HR+/HER2−advanced breast cancer.展开更多
Purpose: To evaluate the feasibility of biweekly administration of cisplatin and vinorelbine as adjuvant chemotherapy for patients with completely resected non-small cell lung cancer (NSCLC). Patients and Methods: Thi...Purpose: To evaluate the feasibility of biweekly administration of cisplatin and vinorelbine as adjuvant chemotherapy for patients with completely resected non-small cell lung cancer (NSCLC). Patients and Methods: This was a single-arm, single-institutional study. Patients with completely resected NSCLC (p-Stage IB-IIIA) with no previous chemotherapy or radiotherapy were eligible. Simon’s optimal two-stage design was applied. Both cisplatin (50 mg/m2) and vinorelbine (25 mg/m2) were given on days 1 and 15, every 28 days. The primary endpoint of this study was the feasibility of this combination in the four cycles of treatment. Results: Twenty patients (19 lobectomies and 1 pneumonectomy) were enrolled in this study. 10 (50%) of patients had grade 3/4 neutropenia, and 3 (15%) had grade 3/4 anemia. Severe non-hematologic toxicities were uncommon in this series. No treatment-related death was encountered. 18 (90%) patients completed the planned 4 cycles of chemotherapy. The median intensity was 24.3 (range 18.1 to 25) mg/m2/week with an average of 23.6 (21 - 25) mg/m2/week cisplatin and 12.5 (range 10 to 12.5) mg/m2/week with an average of 12.3 (10 - 12.5) mg/m2/week vinorelbine. The median relative dose intensity of cisplatin was 97.5% (range 72.5% to 100%) with an average of 94.6% (72.5% - 100%) and that of vinorelbine was 100% (range 80% to 100%) with an average of 97.8% (80% - 100%). Conclusion: This regimen is feasible in the treatment of patients with completely resected NSCLC. A phase III trial is warranted to assess the efficacy of this regimen at promoting survival and preventing recurrence.展开更多
Objective:Apatinib is an oral TKI targeting VEGFR-2.Single-agent apatinib treatment has been shown to produce an objective response in patients with pretreated m BC.Oral vinorelbine also holds promise as a treatment o...Objective:Apatinib is an oral TKI targeting VEGFR-2.Single-agent apatinib treatment has been shown to produce an objective response in patients with pretreated m BC.Oral vinorelbine also holds promise as a treatment of choice in patients with m BC.This study aimed to investigate the efficacy and safety of the oral vinorelbine-apatinib combination in patients with pretreated m BC.In addition,we detected gene variants in ct DNA to explore the therapeutic implications.Methods:This study enrolled patients with HER2-negative m BC who were pretreated with anthracycline/taxanes.Patients were treated with apatinib at 500 mg/425 mg daily plus oral vinorelbine 60 mg/m2 on days 1,8,and 15 of every cycle(3 weeks).The primary endpoint was PFS.The secondary endpoints were ORR,CBR,OS,and safety.Patients eligible for ct DNA detection were evaluated before and during treatment.Results:Forty patients were enrolled.The median PFS was 5.2 months(95%CI,3.4–7.0 months),and the median OS was 17.4 months(95%CI,8.0–27.0 months).The ORR was 17.1%(6/35),and the CBR was 45.7%(16/35).The most common AEs included gastrointestinal reaction,myelosuppression,and hypertension.In 20 patients,ct DNA was detected at baseline and during treatment.A significant difference was found in PFS for undetected vs.detected baseline ct DNA(13.9 months vs.3.6 months,P=0.018).Conclusions:All-oral therapy with apatinib plus vinorelbine displayed objective efficacy in patients with heavily pretreated HER2-negative m BC,with acceptable and manageable toxicity profiles.Patients with no gene variant detected and lower variant allele frequencies in ct DNA at baseline showed longer PFS.展开更多
Objective To examine the effects of pachyman in combination with vinorelbine and cisplatin on tumor growth and the expression of epidermal growth factor receptor(EGFR)and K-ras in a mouse model of lung cancer induced ...Objective To examine the effects of pachyman in combination with vinorelbine and cisplatin on tumor growth and the expression of epidermal growth factor receptor(EGFR)and K-ras in a mouse model of lung cancer induced using the human lung cancer cell line A549,and to investigate the molecular mechanisms underlying the antitumor effects of pachyman.Methods We recorded the size of the tumor xenografts in mice after treatment with pachyman monotherapy or pachymanin combination with vinorelbine and cisplatin.We performed immunohistochemical analysis to determine the levels of expression and distribution of EGFR and K-ras in lung cancer tissues.Real-time fluorescence quantitative PCR was used to determine the relative mRNA expression levels of EGFR and K-ras in lung cancer tissues.Results Vinorelbine and cisplatin significantly decreased the rate of growth of A549 xenografts,and pachyman increased the efficacy of vinorelbine and cisplatin.EGFR and K-ras were widely expressed in A549 xenografts.Vinorelbine and cisplatin could significantly decrease the expression,distribution and mRNA expression levels of EGFR and K-ras in tumor tissues.Pachyman monotherapy significantly decreased the distribution and the mRNA expression levels of EGFR in lung cancer tissues.In addition,pachyman in combination with vinorelbine and cisplatin markedly decreased the distribution and expression levels of EGFR in lung cancer tissues.However,pachyman monotherapy or combination therapy did not significantly decrease the mRNA expression levels of K-ras.Conclusion Thus,pachyman in combination with vinorelbine can significantly inhibit the growth of A549 xenografts,and pachyman can regulate the expression of the EGFR gene to increase the efficacy of vinorelbine and cisplatin in lung cancer and decrease the side effects associated with chemotherapy.展开更多
Objective: The aim of this study was to evaluate the anti-tumor activity and safety of Gemcitabine (GEM) combined with Vinorelbine (NVB) in patients with advanced TNABC after chemotherapy. Methods: Thirty-seven ...Objective: The aim of this study was to evaluate the anti-tumor activity and safety of Gemcitabine (GEM) combined with Vinorelbine (NVB) in patients with advanced TNABC after chemotherapy. Methods: Thirty-seven patients with immunohistochemical proved TNABC were enrolled. The patients received 21-day cycles of NVB 25mg/m^2 i.v. with GEM 1000 mg/m^2 i.v. on days 1 and 8. Results: A total of 136 cycles were given to 37 patients(median 4 cycles, ranged 2-6 cycles). The treatment response was evaluable in all patients. Of the 37 patients, 1 received complete remission (CR), 8 received partial remission (PR), 20 had stable disease (SD), 9 had progressive disease (PD). Overall objective response (CR+ PR) were 24.3 %. The median time to progress (TTP) was 6 months (95% CI, 4-6 months). The median overall survival was 24 months (95% CI, 11-37 months). The median 1-year survival rate was (66.24±8.43)%. The median 3-year survival rate was (28.77±11.96)%. The major adverse events were grade Ⅰ-Ⅱ myelosuppression, peripheral neurologic toxicities, nausea and vomiting. Some patients had rash and hepatic dysfunction. A total of 40% of patients experienced flu-like symptoms. Alopecia and diarrhea were rare. Conclusion: The combination of GEM and NVB is an effective and well tolerated regimen for the patients with TNABC.展开更多
Objective: The present study aimed to investigate the efficacy of Shenfu injection plus vinorelbine on the promotion of the quality of life (QOL) in elderly non-small cell lung cancer (NSCLC) patients. Methods: ...Objective: The present study aimed to investigate the efficacy of Shenfu injection plus vinorelbine on the promotion of the quality of life (QOL) in elderly non-small cell lung cancer (NSCLC) patients. Methods: A randomized single blind trial method was used. Forty-six patients with stage IIIB-IV of HSCLC were randomly divided into experimental group and control group. In the experimental group, the patients were treated with 50 mL Shenfu injection from day 1 to 14, plus vinorelbine (NVB) 25 mg/m^2 on day 1 and 8. In the control group, the patients were only treated with NVB 25 mg/m^2 on day 1 and 8. After two cycle's of treatment, QOL, efficacy and toxicity were observed. Results: The QOL was enhanced in both experimental group and control group. However, the difference of KPS after treatment in the experimental group was markedly higher than in the control group (14 ± 10 vs. 8 ± 10, t = 2.116, P = 0.04), improvement rate of QOL was better than in the control group (76.2% vs. 45.0%, χ^2 = 4.188, P = 0.041), treatment related toxicity in the experimental group was also markedly lower than in the control group (χ^2 = 3.866, P = 0.049), but the difference of efficacy between the two groups was not significant (14.3% vs. 15.0%, χ^2 = 0.161, P = 0.688). Conclusion: Shenfu injection plus vinorelbine can enhance QOL in elderly NSCLC patients.展开更多
A clinical study of the efficacy of vinorelbine plus cisplatin regimen in the management of advanced NSCLC was performed in 35 patients. Five of the 35 patients failed to finish one cycle of chemotherapy with this reg...A clinical study of the efficacy of vinorelbine plus cisplatin regimen in the management of advanced NSCLC was performed in 35 patients. Five of the 35 patients failed to finish one cycle of chemotherapy with this regimen because of severe and intractable leukopenia or rapid progress of the disease. Tumor response and toxicity were evaluated in the remaining 30 cases. Results showed that, with this regimen, the objective response rate (CR+PR) was 46.7%. The most common toxicity was leukopenia; other side effects included alopecia, gastrointestinal reactions, slight and transient renal and hepatic impairment and peripheral neuropathy. It suggested that vinorelbine plus cisplatin is a safe and effective regimen in the management of advanced NSCLC.展开更多
Background: This study was performed to evaluate the efficacy and safety of switch maintenance therapy with oral vinorelbine in advanced non-small cell lung cancer (NSCLC) with adenocarcinoma limited to epidermal grow...Background: This study was performed to evaluate the efficacy and safety of switch maintenance therapy with oral vinorelbine in advanced non-small cell lung cancer (NSCLC) with adenocarcinoma limited to epidermal growth factor receptor (EGFR) wild type. Materials and Methods: In this single randomized trial, patients with advanced stage (IIIB and IV) NSCLC with adenocarcinoma EGFR wild-type status, treated with 6 cycles of platinum based chemotherapy. Patients did not show progression after first-line chemotherapy were randomly assigned to receive switch maintenance with vinorelbine (80 mg/m2, day 1, 8) (group I) or the best supportive care until disease progression (group II). Results: The median progression free survival (PFS) was 9.7 months for group I versus 5.7 months for group II with statistically significant difference between both groups [HR = 1.15;95% CI 1.19 to 1.49;P value = 0.002], while the median overall survival (OS) was 13.2 months for group I versus 11.9 months for group II with no statistically significant differences between both groups [HR = 1.24;95% CI 1.05 to 1.46;P value = 0. 3]. The patients who received oral vinorelbine had tolerable toxicity profile. Conclusion: Switch maintenance therapy with oral vinorelbine, though improve PFS, did not improve OS in patients with NSCLC with adenocarcinoma EGFR wild type.展开更多
Objective: The aim of our study was to compare the efficacy and toxicities of vinorelbine plus cisplatin(NP) regimen with that of vinorelbine plus capecitabine(NX) regimen in the treatment of anthracycline- and taxane...Objective: The aim of our study was to compare the efficacy and toxicities of vinorelbine plus cisplatin(NP) regimen with that of vinorelbine plus capecitabine(NX) regimen in the treatment of anthracycline- and taxane-refractory advanced breast cancer. Methods: Forty-six patients with anthracycline- and taxane-refractory advanced breast cancer were equally randomized into a NP group(n = 23) and a NX group(n = 23). Response rates and toxicities were evaluated after 2 cycles of chemotherapy. Results: The overall response rate were 48.0% in both groups. There were no significant differences in disease control rates(78.0% vs. 83%) or 1-year survival rates(54.6% vs. 55.9%). The main adverse events were bone marrow depression and gastrointestinal reaction, and no significant difference was found in toxicities between the groups. Conclusion: For anthracycline- and taxane-refractory advanced breast cancer, NP and NX regimens exerted similar curative effects with acceptable toxicity.展开更多
OBJECTIVE In China, vinorelbine plus an anthracycline is a common neoadjuvant regimen for locally-advanced breast cancer (LABC). Pegylated liposomal doxorubicin (PLD) is an alternate anthracycline formulation with...OBJECTIVE In China, vinorelbine plus an anthracycline is a common neoadjuvant regimen for locally-advanced breast cancer (LABC). Pegylated liposomal doxorubicin (PLD) is an alternate anthracycline formulation with a more favorable safety profile compared with conventional anthracyclines. METHODS In this open-label trial, 61 women with LABC received up to 6 cycles of PLD 30 mg/m2 on Day 1 and vinorelbine 25 mg/m2 on Days 1 and 8 every 21 days. Hormone receptor and/or HER2 status was not routinely available. RESULTS The overall clinical response rate (primary efficacy endpoint) was 80% (95% CI: 68%-89%). Two patients achieved a pathological complete response (3%), with 75% having their tumor down-staged, and 89% proceeding to tumor resection. The most frequent nonhematologic adverse events were stomatitis, fever, rash, and palmar-plantar erythrodysesthesia, with none considered serious. Grade 3 or 4 neutropenia and thrombocytopenia occurred in 10% and 2% of patients, respectively. CONCLUSION PLD plus vinorelbine demonstrated comparable efficacy to conventional anthracyclines plus vinorelbine in the neoadjuvant treatment of LABC, but may offer safety advantages.展开更多
Objective: To evaluate the efficacy and toxicity of docetaxel and vinorelbine as second-line chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC). Methods: 48 histologically or cytologicall...Objective: To evaluate the efficacy and toxicity of docetaxel and vinorelbine as second-line chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC). Methods: 48 histologically or cytologically confirmed NSCLC patients with progressive or recurrent disease after first-line treatment were treated with docetaxel and vinoretbine. The chemotherapy included vinorelbine (25 mg/m^2) on days 1,5 and docetaxel (60 mg/m^2) on day 1. The treatment was repeated every 3 weeks. Patients receiving at least two cycles were evaluated for efficacy and toxicity. Results: Of 48 patients, 1 patient achieved complete response and 16 achieved partial response. Overall response rate for all 48 patients was 35.4% (17/48). Main hematologic toxicities included neutropenia (60.4%) and febrile neutropenia (29.2%) and non-hematologic toxicities were mild. Conclusion: The combination of docetaxel-vinorelbine as second-line chemotherapy is an effective regimen with manageable toxicity for the treatment of advanced NSCLC. Further studies may confirm these results.展开更多
Objective: We aimed to investigate the safety and efficiency of vinorelbine/epirubidn/fluorouracil (NEF) regimen as adjuvant chemotherapy for breast cancer. Methods: From 2005 to 2008, 227 female breast cancer pat...Objective: We aimed to investigate the safety and efficiency of vinorelbine/epirubidn/fluorouracil (NEF) regimen as adjuvant chemotherapy for breast cancer. Methods: From 2005 to 2008, 227 female breast cancer patients were treated with the NEF regimen: vinorelbine 25 mg/m^2 iv on days 1 and 8; epirubicin 60 mg/m2 iv gtt on day 1; 5-Fu 500 mg/m2 iv gtt on day 1. Chemotherapy was repeated every 21-28 days for a total of 6 cycles. Results: The major side effects were neutrope- nia and gastrointestinal syndrome, with a 5-year survival rate of 85.4%, Conclusion: NEF regimen is safe and guarantees a high survival rate which could be recommended as a adjuvant chemotherapy regimen for breast cancer,展开更多
Objective:To systematically evaluate the efficacy and safety of rh-endostain(YH-16,Endostar)combined with vinorelbine and cisplatin(NP regimen)in the treatment of non-small cell lung cancer(NSCLC),and to provide evide...Objective:To systematically evaluate the efficacy and safety of rh-endostain(YH-16,Endostar)combined with vinorelbine and cisplatin(NP regimen)in the treatment of non-small cell lung cancer(NSCLC),and to provide evidence-based reference for clinical drug use.Methods:Retrieved from PubMed,EMBASE,the Cochrane Library,Clinical Trials,CNKI,VIP and Wan Fang database,randomized controlled trials(RCT)about YH-16 combined with NP regimen(NPY regimen,trial group)vs.NP regimen(control group)for NSCLC were collected.After screening the literature and extracting the data,the two persons evaluated the quality of the included studies,and used Rev Man 5.3 software to merge effect size.Results:A total of 18 articles were included,with a total of 2051 patients.Results of Meta-analysis showed that response rate[RR=1.66,95%CI(1.44,1.91),P<0.00001]、clinical benefit rate[RR=1.21,95%CI(1.14,1.29),P<0.00001]and quality of life improvement rate[RR=3.42,95%CI(2.45,4.79),P<0.00001]of trial group were significantly higher than those of control group.Besides,the serum CEA level[MD=-4.78,95%CI(-7.11,-2.46),P<0.0001]and CA125 level[MD=-16.44,95%CI(-20.83,-12.05),P<0.00001]of trial group were significantly lower than that of control group.There was no statistical significance in the 1-year survival rate and the incidence of myelosuppression,cardiotoxicity,gastrointestinal reaction,damage to the kidneys and liver,and alopecia(P>0.05).Conclusion:Compared with NP regimen alone,NPY regimen can improve the efficacy and quality of life of NSCLC patients,reduce the level of tumor markers,and does not increase the occurrence of adverse reactions,and has good efficacy and safety.However,the existing evidence shows that NPY regimen has the same effect as NP regimen alone in improving the 1-year survival rate of patients.The above conclusions need to be confirmed by further studies.展开更多
Objective:It remains unclear whether simultaneous use of two chemotherapeutic drugs is better than sequential use.This trial was designed to explore efficacy and safety of sequential vs simultaneous use of vinorelbine...Objective:It remains unclear whether simultaneous use of two chemotherapeutic drugs is better than sequential use.This trial was designed to explore efficacy and safety of sequential vs simultaneous use of vinorelbine and capecitabine at the same dosage as first-line therapy in metastatic breast cancer (MBC).Methods:This was a un-icenter, randomized phase II trial.Patients randomized into the simultaneous group (group A) were simultaneously administered with vinorelbine and capecitabine while those in the sequential group (group B) received vinorelbine followed by capecitabine at the same dosage.Results:Sixty-six patients were screened and 30 patients were randomized into either group.There're significant differences in the clinical benefit rate (CBR) with 80.0% for group A vs 53.3% for group B (P=0.028).With a median follow up time of 13.5 months, there were no significant differences between the two groups in PFS (median PFS:7.70 months for group A vs 7.23 months for group B, P=0.436).Grade III or IV neutropenia (83.3% vs 50.0%, P=0.006), all grades of fatigue (56.7% vs 30.0%, P=0.037) and anorexia (53.3% vs 23.3%, P=0.017) were significantly more frequent in simultaneous group.Conclusion:Simultaneous administration of vinorelbine and capecitabine can bring about improvements in CBR, but cannot translate into long-term benefits, such as progression-free survival (PFS) or overall survival (OS).These findings, combined with a relatively better tolerability in sequential group, showed that both simultaneous and sequential administrations are reasonable options for MBC patients.展开更多
The purpose of this study was to investigate the efficacy and safety of oxaliplatin combined with tegafur,gimeracil and oteracil potassium(SOX regimen)and vinorelbine combined with Pt(NP regimen)in the treatment of ad...The purpose of this study was to investigate the efficacy and safety of oxaliplatin combined with tegafur,gimeracil and oteracil potassium(SOX regimen)and vinorelbine combined with Pt(NP regimen)in the treatment of advanced triple negative breast cancer(TNBC).First of all,88 patients with advanced breast cancer were selected and divided into observation group and control group with 44 cases each by random number method.Both groups received conventional supportive therapy.On this basis,SOX regimen was adopted in the observation group and NP regimen in the control group,and the efficacy,occurrence of toxic and side effects in the two groups were compared.The results showed that the objective effective rates and clinical benefit rates of the two groups were statistically significant(P<0.05).In addition,both groups had hand foot syndrome,diarrhea,liver function damage,decreased platelet(PLT)and other toxic side effects,but the incidence of rash,oral ulcer and pigmentation in the observation group was significantly lower than that in the control group(P<0.05).Therefore,both SOX regimen and NP regimen can effectively treat advanced TNBC adverse reactions,but SOX regimen was more effective.展开更多
基金supported by grants from the National Key R&D Program of China(Grant No.2018YFC0115204)the National Natural Science Foundation of China(Grant No.81672634)+3 种基金the Chinese Society of Clinical Oncology Foundation(Grant No.Y-2019AZMS-0377)the Beijing Medical Award Foundation(Grant No.YXJL-2020-0941-0763)Beijing Hope Run Special Fund of Cancer Foundation of China(Grant No.LC2019B16)Beijing Xisike Clinical Oncology Research Foundation(Grant No.Y-pirrefabre202101-0008).
文摘Objective:Endocrine therapy with fulvestrant has shown synergistic antitumor effects with some chemotherapy drugs in vitro.This study evaluated the efficacy and safety of fulvestrant with vinorelbine in patients with hormone receptor positive(HR+)/human epidermal growth factor receptor-2-negative(HER2−)recurrent or metastatic breast cancer.Methods:Patients were intramuscularly administered fulvestrant 500 mg(day 1 per cycle for 28 days)and oral vinorelbine(60 mg/m2 on days 1,8,and 15 of each cycle).The primary endpoint was progression-free survival(PFS).Secondary endpoints included overall survival,objective response rate,disease control rate,duration of response,and safety.Results:A total of 38 patients with HR+/HER2−advanced breast cancer included in the study were followed up for a median time of 25.1 months.The overall median PFS was 9.86 months[95%confidence interval(CI)7.2-23.13],and the median PFS of the first-line and the second-line treatment population was 20.73 months(95%CI 9.82 to NR)and 4.27 months(95%CI 3.68 to NR),respectively.Most adverse events reported were of grade 1/2,and none were of grade 4/5.Conclusions:This is the first exploratory study of a fulvestrant and oral vinorelbine regimen in the treatment of HR+/HER2−recurrent and metastatic breast cancer.The combination chemo-endocrine therapy was efficacious,safe,and promising for patients with HR+/HER2−advanced breast cancer.
文摘Purpose: To evaluate the feasibility of biweekly administration of cisplatin and vinorelbine as adjuvant chemotherapy for patients with completely resected non-small cell lung cancer (NSCLC). Patients and Methods: This was a single-arm, single-institutional study. Patients with completely resected NSCLC (p-Stage IB-IIIA) with no previous chemotherapy or radiotherapy were eligible. Simon’s optimal two-stage design was applied. Both cisplatin (50 mg/m2) and vinorelbine (25 mg/m2) were given on days 1 and 15, every 28 days. The primary endpoint of this study was the feasibility of this combination in the four cycles of treatment. Results: Twenty patients (19 lobectomies and 1 pneumonectomy) were enrolled in this study. 10 (50%) of patients had grade 3/4 neutropenia, and 3 (15%) had grade 3/4 anemia. Severe non-hematologic toxicities were uncommon in this series. No treatment-related death was encountered. 18 (90%) patients completed the planned 4 cycles of chemotherapy. The median intensity was 24.3 (range 18.1 to 25) mg/m2/week with an average of 23.6 (21 - 25) mg/m2/week cisplatin and 12.5 (range 10 to 12.5) mg/m2/week with an average of 12.3 (10 - 12.5) mg/m2/week vinorelbine. The median relative dose intensity of cisplatin was 97.5% (range 72.5% to 100%) with an average of 94.6% (72.5% - 100%) and that of vinorelbine was 100% (range 80% to 100%) with an average of 97.8% (80% - 100%). Conclusion: This regimen is feasible in the treatment of patients with completely resected NSCLC. A phase III trial is warranted to assess the efficacy of this regimen at promoting survival and preventing recurrence.
基金funded by the National Natural Science Foundation of China(Grant No.81472753 and 81672634)。
文摘Objective:Apatinib is an oral TKI targeting VEGFR-2.Single-agent apatinib treatment has been shown to produce an objective response in patients with pretreated m BC.Oral vinorelbine also holds promise as a treatment of choice in patients with m BC.This study aimed to investigate the efficacy and safety of the oral vinorelbine-apatinib combination in patients with pretreated m BC.In addition,we detected gene variants in ct DNA to explore the therapeutic implications.Methods:This study enrolled patients with HER2-negative m BC who were pretreated with anthracycline/taxanes.Patients were treated with apatinib at 500 mg/425 mg daily plus oral vinorelbine 60 mg/m2 on days 1,8,and 15 of every cycle(3 weeks).The primary endpoint was PFS.The secondary endpoints were ORR,CBR,OS,and safety.Patients eligible for ct DNA detection were evaluated before and during treatment.Results:Forty patients were enrolled.The median PFS was 5.2 months(95%CI,3.4–7.0 months),and the median OS was 17.4 months(95%CI,8.0–27.0 months).The ORR was 17.1%(6/35),and the CBR was 45.7%(16/35).The most common AEs included gastrointestinal reaction,myelosuppression,and hypertension.In 20 patients,ct DNA was detected at baseline and during treatment.A significant difference was found in PFS for undetected vs.detected baseline ct DNA(13.9 months vs.3.6 months,P=0.018).Conclusions:All-oral therapy with apatinib plus vinorelbine displayed objective efficacy in patients with heavily pretreated HER2-negative m BC,with acceptable and manageable toxicity profiles.Patients with no gene variant detected and lower variant allele frequencies in ct DNA at baseline showed longer PFS.
基金support from the National Natural Science Foundation of China(No.81774126,No.81503445 and No.81703919)China Postdoctoral Science Foundation(No.2017M622587)+5 种基金Hunan Provincial Natural Science Foundation(No.2016JJ2095 and No.2017JJ3232)Hunan Provincial Traditional Chinese Medicine Key Research Project(No.201701)Hunan Education Department Scientific Research Project(16C1203 and 16C1216)Hunan Health Department Scientific Research Project(C2015-16,C2016049 and B2016093)Busky Pharmaceutical Collaborative Research Fund,Hunan Provincial Higher Educational Institutions Research Team "Traditional Chinese Medicine prevention and treatment research on infectious diseases" Funding program(No.15)Hunan Province Teaching and Science "Thirteenth Five-Year Plan" Project(No.XJK17BGD057)
文摘Objective To examine the effects of pachyman in combination with vinorelbine and cisplatin on tumor growth and the expression of epidermal growth factor receptor(EGFR)and K-ras in a mouse model of lung cancer induced using the human lung cancer cell line A549,and to investigate the molecular mechanisms underlying the antitumor effects of pachyman.Methods We recorded the size of the tumor xenografts in mice after treatment with pachyman monotherapy or pachymanin combination with vinorelbine and cisplatin.We performed immunohistochemical analysis to determine the levels of expression and distribution of EGFR and K-ras in lung cancer tissues.Real-time fluorescence quantitative PCR was used to determine the relative mRNA expression levels of EGFR and K-ras in lung cancer tissues.Results Vinorelbine and cisplatin significantly decreased the rate of growth of A549 xenografts,and pachyman increased the efficacy of vinorelbine and cisplatin.EGFR and K-ras were widely expressed in A549 xenografts.Vinorelbine and cisplatin could significantly decrease the expression,distribution and mRNA expression levels of EGFR and K-ras in tumor tissues.Pachyman monotherapy significantly decreased the distribution and the mRNA expression levels of EGFR in lung cancer tissues.In addition,pachyman in combination with vinorelbine and cisplatin markedly decreased the distribution and expression levels of EGFR in lung cancer tissues.However,pachyman monotherapy or combination therapy did not significantly decrease the mRNA expression levels of K-ras.Conclusion Thus,pachyman in combination with vinorelbine can significantly inhibit the growth of A549 xenografts,and pachyman can regulate the expression of the EGFR gene to increase the efficacy of vinorelbine and cisplatin in lung cancer and decrease the side effects associated with chemotherapy.
基金Supported by a grant from the Comprehensive Prevention and Treat-ment Project for Chronic Diseases of Shanghai Municipal Hospitals (No. SHDC12007304)
文摘Objective: The aim of this study was to evaluate the anti-tumor activity and safety of Gemcitabine (GEM) combined with Vinorelbine (NVB) in patients with advanced TNABC after chemotherapy. Methods: Thirty-seven patients with immunohistochemical proved TNABC were enrolled. The patients received 21-day cycles of NVB 25mg/m^2 i.v. with GEM 1000 mg/m^2 i.v. on days 1 and 8. Results: A total of 136 cycles were given to 37 patients(median 4 cycles, ranged 2-6 cycles). The treatment response was evaluable in all patients. Of the 37 patients, 1 received complete remission (CR), 8 received partial remission (PR), 20 had stable disease (SD), 9 had progressive disease (PD). Overall objective response (CR+ PR) were 24.3 %. The median time to progress (TTP) was 6 months (95% CI, 4-6 months). The median overall survival was 24 months (95% CI, 11-37 months). The median 1-year survival rate was (66.24±8.43)%. The median 3-year survival rate was (28.77±11.96)%. The major adverse events were grade Ⅰ-Ⅱ myelosuppression, peripheral neurologic toxicities, nausea and vomiting. Some patients had rash and hepatic dysfunction. A total of 40% of patients experienced flu-like symptoms. Alopecia and diarrhea were rare. Conclusion: The combination of GEM and NVB is an effective and well tolerated regimen for the patients with TNABC.
文摘Objective: The present study aimed to investigate the efficacy of Shenfu injection plus vinorelbine on the promotion of the quality of life (QOL) in elderly non-small cell lung cancer (NSCLC) patients. Methods: A randomized single blind trial method was used. Forty-six patients with stage IIIB-IV of HSCLC were randomly divided into experimental group and control group. In the experimental group, the patients were treated with 50 mL Shenfu injection from day 1 to 14, plus vinorelbine (NVB) 25 mg/m^2 on day 1 and 8. In the control group, the patients were only treated with NVB 25 mg/m^2 on day 1 and 8. After two cycle's of treatment, QOL, efficacy and toxicity were observed. Results: The QOL was enhanced in both experimental group and control group. However, the difference of KPS after treatment in the experimental group was markedly higher than in the control group (14 ± 10 vs. 8 ± 10, t = 2.116, P = 0.04), improvement rate of QOL was better than in the control group (76.2% vs. 45.0%, χ^2 = 4.188, P = 0.041), treatment related toxicity in the experimental group was also markedly lower than in the control group (χ^2 = 3.866, P = 0.049), but the difference of efficacy between the two groups was not significant (14.3% vs. 15.0%, χ^2 = 0.161, P = 0.688). Conclusion: Shenfu injection plus vinorelbine can enhance QOL in elderly NSCLC patients.
文摘A clinical study of the efficacy of vinorelbine plus cisplatin regimen in the management of advanced NSCLC was performed in 35 patients. Five of the 35 patients failed to finish one cycle of chemotherapy with this regimen because of severe and intractable leukopenia or rapid progress of the disease. Tumor response and toxicity were evaluated in the remaining 30 cases. Results showed that, with this regimen, the objective response rate (CR+PR) was 46.7%. The most common toxicity was leukopenia; other side effects included alopecia, gastrointestinal reactions, slight and transient renal and hepatic impairment and peripheral neuropathy. It suggested that vinorelbine plus cisplatin is a safe and effective regimen in the management of advanced NSCLC.
文摘Background: This study was performed to evaluate the efficacy and safety of switch maintenance therapy with oral vinorelbine in advanced non-small cell lung cancer (NSCLC) with adenocarcinoma limited to epidermal growth factor receptor (EGFR) wild type. Materials and Methods: In this single randomized trial, patients with advanced stage (IIIB and IV) NSCLC with adenocarcinoma EGFR wild-type status, treated with 6 cycles of platinum based chemotherapy. Patients did not show progression after first-line chemotherapy were randomly assigned to receive switch maintenance with vinorelbine (80 mg/m2, day 1, 8) (group I) or the best supportive care until disease progression (group II). Results: The median progression free survival (PFS) was 9.7 months for group I versus 5.7 months for group II with statistically significant difference between both groups [HR = 1.15;95% CI 1.19 to 1.49;P value = 0.002], while the median overall survival (OS) was 13.2 months for group I versus 11.9 months for group II with no statistically significant differences between both groups [HR = 1.24;95% CI 1.05 to 1.46;P value = 0. 3]. The patients who received oral vinorelbine had tolerable toxicity profile. Conclusion: Switch maintenance therapy with oral vinorelbine, though improve PFS, did not improve OS in patients with NSCLC with adenocarcinoma EGFR wild type.
基金Supported by a grant from the Key Project of National 12th Five-year Research Program of China(No.2012ZX0903016-002)
文摘Objective: The aim of our study was to compare the efficacy and toxicities of vinorelbine plus cisplatin(NP) regimen with that of vinorelbine plus capecitabine(NX) regimen in the treatment of anthracycline- and taxane-refractory advanced breast cancer. Methods: Forty-six patients with anthracycline- and taxane-refractory advanced breast cancer were equally randomized into a NP group(n = 23) and a NX group(n = 23). Response rates and toxicities were evaluated after 2 cycles of chemotherapy. Results: The overall response rate were 48.0% in both groups. There were no significant differences in disease control rates(78.0% vs. 83%) or 1-year survival rates(54.6% vs. 55.9%). The main adverse events were bone marrow depression and gastrointestinal reaction, and no significant difference was found in toxicities between the groups. Conclusion: For anthracycline- and taxane-refractory advanced breast cancer, NP and NX regimens exerted similar curative effects with acceptable toxicity.
文摘OBJECTIVE In China, vinorelbine plus an anthracycline is a common neoadjuvant regimen for locally-advanced breast cancer (LABC). Pegylated liposomal doxorubicin (PLD) is an alternate anthracycline formulation with a more favorable safety profile compared with conventional anthracyclines. METHODS In this open-label trial, 61 women with LABC received up to 6 cycles of PLD 30 mg/m2 on Day 1 and vinorelbine 25 mg/m2 on Days 1 and 8 every 21 days. Hormone receptor and/or HER2 status was not routinely available. RESULTS The overall clinical response rate (primary efficacy endpoint) was 80% (95% CI: 68%-89%). Two patients achieved a pathological complete response (3%), with 75% having their tumor down-staged, and 89% proceeding to tumor resection. The most frequent nonhematologic adverse events were stomatitis, fever, rash, and palmar-plantar erythrodysesthesia, with none considered serious. Grade 3 or 4 neutropenia and thrombocytopenia occurred in 10% and 2% of patients, respectively. CONCLUSION PLD plus vinorelbine demonstrated comparable efficacy to conventional anthracyclines plus vinorelbine in the neoadjuvant treatment of LABC, but may offer safety advantages.
文摘Objective: To evaluate the efficacy and toxicity of docetaxel and vinorelbine as second-line chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC). Methods: 48 histologically or cytologically confirmed NSCLC patients with progressive or recurrent disease after first-line treatment were treated with docetaxel and vinoretbine. The chemotherapy included vinorelbine (25 mg/m^2) on days 1,5 and docetaxel (60 mg/m^2) on day 1. The treatment was repeated every 3 weeks. Patients receiving at least two cycles were evaluated for efficacy and toxicity. Results: Of 48 patients, 1 patient achieved complete response and 16 achieved partial response. Overall response rate for all 48 patients was 35.4% (17/48). Main hematologic toxicities included neutropenia (60.4%) and febrile neutropenia (29.2%) and non-hematologic toxicities were mild. Conclusion: The combination of docetaxel-vinorelbine as second-line chemotherapy is an effective regimen with manageable toxicity for the treatment of advanced NSCLC. Further studies may confirm these results.
文摘Objective: We aimed to investigate the safety and efficiency of vinorelbine/epirubidn/fluorouracil (NEF) regimen as adjuvant chemotherapy for breast cancer. Methods: From 2005 to 2008, 227 female breast cancer patients were treated with the NEF regimen: vinorelbine 25 mg/m^2 iv on days 1 and 8; epirubicin 60 mg/m2 iv gtt on day 1; 5-Fu 500 mg/m2 iv gtt on day 1. Chemotherapy was repeated every 21-28 days for a total of 6 cycles. Results: The major side effects were neutrope- nia and gastrointestinal syndrome, with a 5-year survival rate of 85.4%, Conclusion: NEF regimen is safe and guarantees a high survival rate which could be recommended as a adjuvant chemotherapy regimen for breast cancer,
基金General Program of the National Natural Science Foundation of China(No.81973815)General Program of Fund of the Traditional Chinese Medicine Bureau of Guangdong Province(No.20201107)。
文摘Objective:To systematically evaluate the efficacy and safety of rh-endostain(YH-16,Endostar)combined with vinorelbine and cisplatin(NP regimen)in the treatment of non-small cell lung cancer(NSCLC),and to provide evidence-based reference for clinical drug use.Methods:Retrieved from PubMed,EMBASE,the Cochrane Library,Clinical Trials,CNKI,VIP and Wan Fang database,randomized controlled trials(RCT)about YH-16 combined with NP regimen(NPY regimen,trial group)vs.NP regimen(control group)for NSCLC were collected.After screening the literature and extracting the data,the two persons evaluated the quality of the included studies,and used Rev Man 5.3 software to merge effect size.Results:A total of 18 articles were included,with a total of 2051 patients.Results of Meta-analysis showed that response rate[RR=1.66,95%CI(1.44,1.91),P<0.00001]、clinical benefit rate[RR=1.21,95%CI(1.14,1.29),P<0.00001]and quality of life improvement rate[RR=3.42,95%CI(2.45,4.79),P<0.00001]of trial group were significantly higher than those of control group.Besides,the serum CEA level[MD=-4.78,95%CI(-7.11,-2.46),P<0.0001]and CA125 level[MD=-16.44,95%CI(-20.83,-12.05),P<0.00001]of trial group were significantly lower than that of control group.There was no statistical significance in the 1-year survival rate and the incidence of myelosuppression,cardiotoxicity,gastrointestinal reaction,damage to the kidneys and liver,and alopecia(P>0.05).Conclusion:Compared with NP regimen alone,NPY regimen can improve the efficacy and quality of life of NSCLC patients,reduce the level of tumor markers,and does not increase the occurrence of adverse reactions,and has good efficacy and safety.However,the existing evidence shows that NPY regimen has the same effect as NP regimen alone in improving the 1-year survival rate of patients.The above conclusions need to be confirmed by further studies.
文摘Objective:It remains unclear whether simultaneous use of two chemotherapeutic drugs is better than sequential use.This trial was designed to explore efficacy and safety of sequential vs simultaneous use of vinorelbine and capecitabine at the same dosage as first-line therapy in metastatic breast cancer (MBC).Methods:This was a un-icenter, randomized phase II trial.Patients randomized into the simultaneous group (group A) were simultaneously administered with vinorelbine and capecitabine while those in the sequential group (group B) received vinorelbine followed by capecitabine at the same dosage.Results:Sixty-six patients were screened and 30 patients were randomized into either group.There're significant differences in the clinical benefit rate (CBR) with 80.0% for group A vs 53.3% for group B (P=0.028).With a median follow up time of 13.5 months, there were no significant differences between the two groups in PFS (median PFS:7.70 months for group A vs 7.23 months for group B, P=0.436).Grade III or IV neutropenia (83.3% vs 50.0%, P=0.006), all grades of fatigue (56.7% vs 30.0%, P=0.037) and anorexia (53.3% vs 23.3%, P=0.017) were significantly more frequent in simultaneous group.Conclusion:Simultaneous administration of vinorelbine and capecitabine can bring about improvements in CBR, but cannot translate into long-term benefits, such as progression-free survival (PFS) or overall survival (OS).These findings, combined with a relatively better tolerability in sequential group, showed that both simultaneous and sequential administrations are reasonable options for MBC patients.
文摘The purpose of this study was to investigate the efficacy and safety of oxaliplatin combined with tegafur,gimeracil and oteracil potassium(SOX regimen)and vinorelbine combined with Pt(NP regimen)in the treatment of advanced triple negative breast cancer(TNBC).First of all,88 patients with advanced breast cancer were selected and divided into observation group and control group with 44 cases each by random number method.Both groups received conventional supportive therapy.On this basis,SOX regimen was adopted in the observation group and NP regimen in the control group,and the efficacy,occurrence of toxic and side effects in the two groups were compared.The results showed that the objective effective rates and clinical benefit rates of the two groups were statistically significant(P<0.05).In addition,both groups had hand foot syndrome,diarrhea,liver function damage,decreased platelet(PLT)and other toxic side effects,but the incidence of rash,oral ulcer and pigmentation in the observation group was significantly lower than that in the control group(P<0.05).Therefore,both SOX regimen and NP regimen can effectively treat advanced TNBC adverse reactions,but SOX regimen was more effective.