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Objective: To explore the application and efficacy of paclitaxel liposome in the treatment of advanced breast cancer among Chinese population in the real world. Methods: The clinical characteristics of patients with advanced breast cancer who received paclitaxel liposome as salvage treatment from January 1, 2016 to August 31, 2019 in 11 hospitals were collected and retrospectively analyzed. The primary outcome was progression free survival (PFS), and the secondary outcome included objective response rate (ORR) and safety. The survival curve was drawn by Kaplan-Meier analysis and the Cox regression model were used for the multivariate analysis. Results: Among 647 patients with advanced breast cancer who received paclitaxel liposome, the first-line treatment accounted for 43.3% (280/647), the second-line treatment accounted for 27.7% (179/647), and the third-line and above treatment accounted for 29.1% (188/647). The median dose of first-line and second-line treatment was 260 mg per cycle, and 240 mg in third line and above treatment. The median period of paclitaxel liposome alone and combined chemotherapy or targeted therapy is 4 cycles and 6 cycles, respectively. In the whole group, 167 patients (25.8%) were treated with paclitaxel liposome combined with capecitabine±trastuzumab (TX±H), 123 patients (19.0%) were treated with paclitaxel liposome alone (T), and 119 patients (18.4%) were treated with paclitaxel liposome combined with platinum ± trastuzumab (TP±H), 108 patients (16.7%) were treated with paclitaxel liposome combined with trastuzumab ± pertuzumab (TH±P). The median PFS of first-line and second-line patients (5.5 and 5.5 months, respectively) were longer than that of patients treated with third line and above (4.9 months, P<0.05); The ORR of the first line, second line, third line and above patients were 46.7%, 36.8% and 28.2%, respectively. Multivariate analysis showed that event-free survival (EFS) and the number of treatment lines were independent prognostic factors for PFS. The common adverse events were myelosuppression, gastrointestinal reactions, hand foot syndrome and abnormal liver function. Conclusion: Paclitaxel liposomes is widely used and has promising efficacy in multi-subtype advanced breast cancer.
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Humans , Female , Breast Neoplasms/chemically induced , Paclitaxel/adverse effects , Liposomes/therapeutic use , Retrospective Studies , Treatment Outcome , Trastuzumab/therapeutic use , Capecitabine/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/adverse effectsABSTRACT
OBJECTIVE：To investigate the role of clinical pharmacists in the diagnosis and treatment of liposome-induced hand-food syndrome （HFS），and to provide reference for rational use of liposome preparation in clinic. METHODS ：One case of elderly female patient with breast cancer ，admitted to our hospital suffered from HFS （grade 2）after treated with Doxorubicin hydrochloride liposome ；after successful therapy ，the patient had skin symptoms （grade 3）again due to Paclitaxel liposome ，and clinical pharmacist judged the recurrence of HFS. For symptomatic treatment ，stopping the treatment and external use of hormone was suggested ，and whole-process pharmaceutical care was provided. The pathogenesis ，differential diagnosis ，risk factors and therapeutic drugs of HFS were summarized based on literature review and 2 case reports in the database. RESULTS ：The physicians adopted the suggestion of clinical pharmacists ；the patient ’s symptoms improved significantly on the third day and disappeared after 1 week. Combined with literature analysis and 2 case reports ，doxorubicin liposome metabolized more slowly than non liposomes in palms and soles of feet ，resulting in accumulation of doxorubicin in sweat duct and stratum corneum ，aggravating skin damage and leading to HFS. Sequential paclitaxel in liposome form may also lead to the accumulation in eccrine duct ，further caused skin damage and induced HFS. CONCLUSIONS ：Clinical pharmacists actively participate in the diagnosis and treatment of ADR ， which is conducive to the rehabilitation of patients. At same time ，combination or sequential of Paclitaxel liposome with PLD should be avoided ，as it can lead to ADR as HFS.
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Objective To evaluate the clinical effects and safety of paclitaxel liposome or gemcitabine combined with cisplatin in elderly patients with advanced lung squamous cell cancer. Methods A total of 52 elderly patients with advanced lung squamous cell cancer in Kunshan First People's Hospital from January 2012 to October 2016 who received paclitaxel liposome with cisplatin (n=24) or gemcitabine with cisplatin(n = 28) were analyzed retrospectively. The patients received at least 2 cycles of chemotherapy, 2-6 cycles in total. CT was rechecked every 2 cycles. The clinical effects and adverse reactions were evaluated by National Cancer Institute Response Evaluation Criteria in Solid Tumors (NCI RECIST) and NCI Common Terminology Criteria for Adverse Events (NCI CTCAE). Results The objective response rate (ORR) and the disease control rate(DCR)in paclitaxel liposome group and in gemcitabine group had a lot in common [ORR:29.2 %(7/24)vs.32.1 %(9/28),χ2=0.054,P =0.817;DCR:70.8 %(17/24)vs.71.4 %(20/28),χ2=0.002,P =0.962]. The median progression-free survival(PFS) time in gemcitabine group was longer than that in paclitaxel liposome group (5.7 months vs. 5.4 months, χ2= 0.466, P = 0.495). One-year survival rate in gemcitabine group (37.0 %) was higher than that in paclitaxel liposome group (34.8 %) and there was no statistically significant difference (χ 2= 0.027, P = 0.869). However, hematologic adverse reactions in paclitaxel liposome group were lower than those in gemcitabine group (P< 0.05). Conclusion The effect of paclitaxel liposomes combined with cisplatin for treatment of elderly patients with advanced lung squamous cell carcinoma is not inferior to gemcitabine combined with cisplatin, which has less adverse reactions and may be recommended as the first-line chemotherapy for the patients.
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Objective: To evaluate the clinical efficacy and safety of simultaneous modulated accelerated radiotherapy (SMART) in patients with locally metaphase or advanced cervical cancer. Methods: Total of 92 patients with locally metaphase or advanced cervical cancer treated in First Affiliated Hospital of Jinan University from January 2012 to January 2014 were collected and the clinical medical records were retrospectively analyzed. Of 92 patients, 68 patients who received SMART combined with weekly paclitaxel liposome and lobaplatin chemotherapy were designated into study group, and 24 patients who received threedimensional conformal radiotherapy combined with weekly paclitaxel liposome and lobaplatin chemotherapy were designated into control group. The clinical efficacy, survival and the safety were compared between the two groups. Results: The overall response rate of study group was 85.29%, which was significantly higher than that of the control group (58.33%, P = 0.022). The median survival time of the study group was 31 months, which was significantly longer than that of the control group (25 months). The incidence rate of marrow suppression in study group was lower than that in the control group (P = 0.041). The incidence rate of gastrointestinal reaction had no significant difference between the two groups (P = 0.704). The incidence rates of radiation-induced rectitis and cystitis were both lower than those in the control group (P = 0.001, P = 0.018). Conclusion: The efficacy of SMART combined with weekly paclitaxel liposome and lobaplatin chemotherapy is remarkable with tolerable adverse reactions. It is worth of further clinical application.
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Objective:To study the effects of the treatment for rabbit VX-2 tongue cancer with paclitaxel or paclitaxel liposome infusion through rabbit lingual artery or ear vein infusion.Methods:24 rabbits with VX-2 tongue cancer were divided into 6 groups(n =40) randomly.The rabits in 3 groups were respectively treated by intra-arterial infusion with paclitaxel,paclitaxel liposome and 5％ glucose,and those in other 3 groups by ear vein infusion with the same materials.After 7 days of treatment,the lesion volumes were measured for response evaluation,cells apotosis in the cancer tissure was detected by llowcytometry,P53 protein expression was examined by immunohistochemical staining,respectively.The data was analyzed by SPSS 20.0 software package.Results:The response rate and apotosis of the tumor cells in intra-arterial infusion with paclitaxel liposome group were higher than those in the other groups(P ＜ 0.05),P53 protein expression was lower than that of the other groups (P ＜ 0.05).Conclusion:Intra-arterial infusion through tongue artery with paclitaxel liposome is more effective than the other methods in the treatment of rabbit VX-2 tongue cancer.
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Objective:To study the effect of paclitaxel liposome on the apoptosis of cancer cells in neck metastatic lymph node of rabbit tongue cancer.Methods:24 New Zealand rabbits with VX-2 tumor at tongue edge were divided into 6 groups randomly after neck lymph node metastasis.Paclitaxel liposome,free paclitaxel and 5％ glucose were injected into the lingual arterial and ear marginal vein,respectively.A week after chemotherapy metastasis lymph nodes were collected.The apoptosis of the cancer cells in the lymph nodes was examined by transmission electron microscope,flow cytometry,and SP immunohistochemical method for P53 protein expression of the cancer tissue.Results:The apoptosis rate of cancer cells in the intra-arterial chemotherapy group was higher than that in the intra-venous chemotherapy group,in the paclitaxel liposome injection group was higher than that in the free paclitaxel injection group(P ＜ 0.05).The positive rates of P53 protein expression in paclitaxel liposome group by intra-arterial injection was the lowest (P ＜ 0.05).Conclusion:Paclitaxel liposome is more effective than free paclitaxel,regional arterial infusion is more effective than intra-venous infusion in the apoptosis induction of lymph node metastasis cancer cells.
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Objective: To observe the clinical efficacy and adverse reactions of chemotherapy with oxaliplatin in combination with either S-1 or paclitaxel liposome as the first-line therapy for advanced gastric cancer. Methods: Ninety-two patients with advanced gastric carcinoma were divided into two groups. In group A (46 cases), oxaliplatin combined with S-1 were administered. In group B (46 cases), oxaliplatin combined with paclitaxel liposome were administered. The shortterm curative effect, progression-free survival (PFS), overall survival (OS) and adverse reactions were observed and compared between the two groups. Results: There were no significant differences in the objective response rate, disease control rate and median PFS between group A and group B (41.3% vs 45.7%, 73.9% vs 71.7%, 5.3 months vs 4.6 months; all P > 0.05). The median OS in group A and group B were 12.2 and 10.2 months, respectively, with a statistically significant difference (P < 0.05). The joint and muscle pain and neutropenia in group B were more severe than those in group A (P < 0.05). Conclusion: These two chemotherapy regimens have the similar clinical efficacy for advanced gastric cancer, but oxaliplatin combined with S-1 could be superior to oxaliplatin plus paclitaxel liposome in OS and tolerance of chemotherapeutic toxicities.
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Objective To evaluate the clinical efficacy and toxicity of paclitaxel liposome combined with cisplatin chemotherapy in NSCLC with brain metastasis. Methods Twenty-eight patients were newly diag-nosed NSCLC with brain metastasis(confirmed by pathology or cytology). The patients were treated with pacli-taxel liposome(135 mg/ m2 )on day 1 intravenous drip for 3 hours,cisplatin,25 mg/ m2 on day 1-3. The course of treatment was 21 days. The patients accepted the anti-allergy treatment before chemotherapy. Results Twenty-eight patients could be evaluated,and 101 treatment cycles were completed( 3. 6 cycles per patient). General lesion assessment presented that no patient got complete remission( CR),13 patients (46. 43% )got a partial response(PR),11(39. 28% )had a stable disease(SD)and 4(14. 29% )had a progressive disease( PD). The objective response rate( RR)was 46. 43% ,and the disease control rate (DCR) was 85. 71% . Local cerebral response assessment showed that no patient got CR,6 patients (21. 43% )got a PR,15(53. 58% )had a SD and 4(14. 29% )had a PD. The RR was 21. 43% ,and the DCR was 85. 71% . There was a significant difference in the RR(χ2 = 3. 90,P = 0. 03)but not in the DCR (χ2 = 0. 15,P = 0. 3)between the local cerebral disease and the general lesion. The median time to disease progression(TTP)for general lesion and local cerebral were 7. 2 months and 6. 2 months,respectively(χ2 =6. 43,P < 0. 05). The adverse reactions included bone marrow suppression,gastrointestinal reactions,elevated transaminases,alopecia,neurotoxicity,etc. All of these could be well controlled. Conclusion Paclitaxel liposome combined with cisplatin regimen demonstrates a higher efficacy and well tolerable against main metas-tasis of NSCLC,and the adverse effects are minor.
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Objective:This study aimed to compare the efficacy and adverse reactions of two different chemotherapeutic regi-mens. In particular, chemotherapy with paclitaxel liposome was administered in combination with either S-1 or oxaliplatin as the first-line therapy of advanced gastric cancer. Methods:A total of 118 patients with advanced gastric cancer were randomly divided into groups A (61 cases) and B (57 cases). In group A, paclitaxel liposome combined with S-1 was administered;in group B, paclitaxel lipo-some combined with oxaliplatin was applied. The short-term efficacy, adverse reactions, Karnofsky performance status score, median time to progression (mTTP), and median overall survival (mOS) of the two groups were observed and compared. Results:No signifi-cant differences were observed in the objective response rate, disease control rate, and mTTP between groups A and B (31.1% vs. 29.8%, 75.4%vs. 71.9%, 4.2 months vs. 3.8 months;P>0.05). The mOS rates were 10.5 and 8.9 months in groups A and B, respectively, with statistically significant differences (P=0.006). The incidence of degreesⅢtoⅣdiarrhea and peripheral nerve toxicity was signifi-cantly higher in group B than in group A (P<0.05). No statistical differences were found between the two groups in terms of other side effects. Conclusion:The two paclitaxel liposome-based regimens showed similar therapeutic effect in patients with advanced gastric cancer. S-1/paclitaxel liposome treatment could be more effective in terms of mOS and had a tendency of lower toxicity.
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Objective To evaluate the difference of clinical short-term effect and adverse reaction between paclitaxel liposome and paclitaxel in non-small cell lung cancer patients with lymph node metastasis after pulmonary resection.Methods Sixty-eight patients after pulmonary resection were divided into two groups by random digits table method,37 patients in experimental group with paclitaxel liposome (135mg/m2) combined with carboplatin (CBP) at 300 mg/m2 in chemotherapy,and 31 patients in control group with paclitaxel (135 mg/m2) combined with CBP at 300 mg/m2 in chemotherapy.Results All patients were evaluable.In experimental group,5 patients had complete remission,10 patients had partial remission,17patients were stable,5 patients' condition aggravated,the total effective rate was 40.5％(15/37),clinical control rate was 86.5％ (32/37).In control group,2 patients had complete remission,8 patients had partial remission,15 patients were stable,6 patients' condition aggravated,the total effective rote was 32.3％(10/31),clinical control rate was 80.6％(25/31).The treatment effectiveness in experimental group was significantly higher than that in control group (P ＜ 0.05).The main adverse reaction included marrow suppression,hair loss,muscle and joint pain and gastrointestinal symptom,there was no serious hypersensitivity.The rate of hypotension,face flushing,paresthesia,muscle and joint pain,erythra in experimental group was lower than that in control group [0 vs.9.7％ (3/31),5.4％ (2/37) vs.19.4％ (6/31),10.8％ (4/37) vs.22.6％ (7/31),13.5％ (5/37) vs.38.7％ (12/31),5.4％ (2/37) vs.25.8％ (8/31)] (P ＜0.0 1 or ＜0.05).Conclusion The curative effect rate of paclitaxel liposome is better than paclitaxel in patients with lymph node metastasis after pulmonary resection and with lower incidence of side effects.
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Objective: To evaluate the efficacy and toxicity of paclitaxel liposome combined with nedaplatin as first-line chemotherapy for patients with advanced esophageal cancer. Methods: A total of 42 patients with pathologically confirmed advanced esophageal cancer were recruited into this study. On day 1, the patients were intravenously infused with 135 mg/m2 paclitaxel liposome followed by nedaplatin 80 mg/m2. This chemotherapy regimen was repeated every three weeks until the documented disease progression, unacceptable toxicity or patients' refusal. All patients received at least two cycles of chemotherapy, and the short-term response and toxicity were evaluated every two cycles. The patients were followed-up, and the survival was analyzed. The intention-to-treat analysis was applied. Results: Forty-one of the 42 patients were assessable for short-term response. The overall response rate was 40.5% (17/42) including complete response in one patient (2.4%) and partial response in 16 patients (38.1%). Fourteen patients (33.3%) received stable disease, and ten patients received progressive disease (23.8%). The overall response rates of chemotherapy in naive patients (n =18) and relapsed patients (n=24) were 55.6% and 29.2%, respectively. The estimate of overall one-year survival rate was 42.6%. The median time to progression and the median overall survival time were 6.3 months and 11.3 months, respectively. The common adverse reaction was hematologic toxicity including 7 patients with grade 3/4 neutropenia and 4 patients with grade 3 thrombocytopenia. The main non-hematologic toxicity was grade 3/4 vomiting in 3 patients(7.3%). No toxicity-related death occurred. Conclusion: The combined therapy of paclitaxel liposome and nedaplatin is effective and well tolerated in patients with advanced esophageal cancer. Copyright© 2011 by TUMOR.
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Objective To elucidates the effects of HPV18 E6 siRNA targeting at human papillomavirus(HPV)18 E6 gene on the proliferative activity of HeLa cells and chemotherapy sensitivity.Methods HPV18 E6 expression of HeLa cells was inhibited by siRNA interference,the change of P53 and P21 proteins expression level was measured by Western blot.MTT assay was used to detected proliferative activity and sensitivity to paclitaxel liposome of HeLa cells.Results After inhibition of E6 expression,P53 and P21 proteins increased and the growth of HeLa cells was decreased(P ＜0.01).The inhibition rate of HeLa was markedly increased after transfection of HPV18 E6 siRNA and paclitaxel liposome.Conclusion HPV18 E6 siRNA can effectively silence gene expression of E6 and inhibit proliferation of HeLa cells.HeLa cells are more sensitive to combine HPV18 E6 siRNA with paclitaxel liposome than that of control groups.
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Objective To observe the effect on body distribution tendency of paclitaxel liposome in the lung cancer rats after acupuncture of Feishu,Taiyuan acupoints in order to develop the new path for the target study of anticancer drugs.Method The paclitaxel liposome was labeled by technetium(Tc).Four methods including tail intravenous injection of paclitaxel liposome merely and the combination of tail intravenous injection of paclitaxel liposome with acupuncture of Feishu,Taiyuan(concerned acupoint) and Shenmen(unconcerned acupoint) acupoints respectively were carried on the intervention to the lung cancer rat models(18 in each group).The rats were sentenced to death at 60,90,120 minutes(6 at each time point) respectively after drug injection,and the drug content of paclitaxel liposome in the lung,liver,kidney organs were measureed by the ?-radiate immunity counting implement respectively.Result Acupuncturing at Feishu and Taiyuan can lead to the drug content increment of paclitaxel liposome in the lung organization of the lung cancer rats in all or parts of time points.On the contrary,acupuncturing at Shenmen can not.Conclusion Acupuncturing Feishu and Taiyuan can make tropism effect on the disposition of paclitaxel liposome in vivo in lung cancer rats.Feishu is stronger than Taiyuan on the drug tropism of the lung.
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OBJECTIVE:To evaluate the safety of several pretreatment protocols of paclitaxel liposome as a chemotherapy for upper gastrointestinal tumor.METHODS:26 patients with upper gastrointestinal tumors receiving paclitaxel liposome in combination with other chemotherapeutics were enrolled.The patients were injected intravenously with dexamethasone 10 mg (i ) or dexamethasone 5 mg(ii ) or prednisolone 40 mg(iii ) 30 minutes prior administration of paclitaxel liposome,or treated with oral dexamethasone at a dose of 6 mg(i ),4.5 mg(ii ) or 2.25 mg(iii ) 12 hours or 2 hours prior administration of paclitaxel liposome.RESULTS:Chemotherapy- induced toxic adverse reactions manifested as gradeⅠ～Ⅱleucopenia,anemia, nausea and vomiting,but recovered after symptomatic treatment.Pretreatment- related adverse reactions manifested as insomnia, hyperglycemia,fatigue and vertigo,but no allergic shock or treatment- related death occurred.CONCLUSION:Intravenous injection of prednisolone 40 mg 30 minutes prior administration of paclitaxel liposome or oral administration of dexamethasone 2.25 mg 12 hours and 2 hours prior administration of paclitaxel liposome are preferable pretreatment methods of paclitaxel liposome.