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: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
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: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.
