There is a need and opportunity for China to develop education and practice innovations given that advance practice nurses (APNs) improve health care and outcomes.The China Medical Board (CMB)China Nursing Network (CC...There is a need and opportunity for China to develop education and practice innovations given that advance practice nurses (APNs) improve health care and outcomes.The China Medical Board (CMB)China Nursing Network (CCNN) began planning for an Advanced Nursing Practice Program for education and career development that will facilitate CCNN's contributions to meeting national nursing policy priorities.This paper presents the discussion,recommendations and action plans developed at the inaugural planning meeting on June 26,2015 at Fudan University in Shanghai.The recommendations are:Develop standards for advanced nursing practice;Develop Master's level curricula based on the standards;Commence pilot projects across a number of University affiliated hospitals;and Prepare clinical tutors and faculty.The strategic directions and actions are: Develop a clinical career ladder system;Expand the nursing role from hospital to community;and Build a specialty nurse accreditation system.展开更多
Objective:The extremely low incidence of male breast cancer (MBC) leads to lack of prospective randomized phase III studies worldwide. Especially in China,all studies on Chinese patients with MBC were based on small s...Objective:The extremely low incidence of male breast cancer (MBC) leads to lack of prospective randomized phase III studies worldwide. Especially in China,all studies on Chinese patients with MBC were based on small sample size and single institute experience. The aim of this study was to provide overall view of characteristics of Chinese patients with MBC by means of summarizing all related papers published in Chinese journals. Methods: An online search was made in CBM,VIP,CNKI,and CBA databases to find all published articles of interest on Chinese patients with MBC. And eight subjects including the proportion of MBC in all breast cancer,age,tumor location,clinical stages,pathological subtypes,treatment modalities,ER/PR expression,and 5-year survival rate were selected to calculate the proportion and their 95% interval confidence. Results: There were 122 papers with 2584 patients enrolled. The basic features of Chinese patients with MBC included:(1) MBC only with a proportion of 1.06% of all the breast cancer; (2) The mean age at diagnosis was 57.6 years old; (3) Tumor mainly located in the areolar region (74.83%) with obvious nipple and/or skin involvement; (4) Nearly 62.62% patients were in early stage before accepting treatment; (5) Infiltrating ductal carcinoma accounted for 79.05% of all pathological subtypes; (6) ER/PR expression rate was 65.86%; (7) Radical resection was up to 86.06% in all surgical modalities; (8) The 5-year survival rate was 57.33%. Conclusion: The results showed in this study were an overall view of Chinese patients with MBC whose characteristics were similar to that reported in the West. Though this study provided a little bit stronger confidence than a single study collected in this paper,studies with more powerful evidence are urgently demanding in China.展开更多
Objective:Gemcitabine,used as single agent for elderly patients with non-small cell lung cancer (NSCLC),was demonstrated effective in this population based on phase II studies.The aim of this study was to summarize al...Objective:Gemcitabine,used as single agent for elderly patients with non-small cell lung cancer (NSCLC),was demonstrated effective in this population based on phase II studies.The aim of this study was to summarize all those phase II studies with the hope to get a comprehensive understanding of gemcitabine efficacy.Methods:The PubMed database was used to search all the papers on NSCLC associated with gemcitabine used as single agent in the first line setting till to March 31st,2010.And the medians and their 95% CI of overall response rate (ORR),disease control rate (DCR),progression free survival (PFS),and overall survival (OS) were calculated.Results:1.There were 7 papers including 410 patients with performance status (PS) ≤ 2 and advanced stage collected.2.The dose-intensities of gemcitabine were 843.75 mg/m 2 /week-1125 mg/m 2 /week in the 4-week schedule,and 666.7 mg/m 2 /week in the 3-week schedule.3.The median age was 73.8 (95% CI was 72.44,75.16) years old;36.1% (95% CI:31.4%,40.7%) of patients with stage IIIB and 60.5% (95% CI:55.8%,65.2%) of patients with stage IV;35.9% (95% CI:31.2%,40.5%) patients were adenocarcinomas and 43.7% (95% CI:38.9%,48.5%) patients were squamous cell carcinomas (SCCs).4.The ORR,DCR,PFS/TTP,and OS were 22.3% (95% CI:18.2%,26.5%),58.4% (95% CI:53.5%,63.4%),3.6 (95% CI:2.9,5.15) months and 6.68 (95% CI:5.4,8.11) months,respectively.Conclusion:Gemcitabine as single agent applied in this special population was effective and can be well tolerated under different doses and usage.展开更多
Objective： Male breast cancer （MBC） is a rare disease, and studies to compare the prognosis between the MBC and female breast cancer （FBC） available now were case-control studies and population-based studies, how...Objective： Male breast cancer （MBC） is a rare disease, and studies to compare the prognosis between the MBC and female breast cancer （FBC） available now were case-control studies and population-based studies, however, with controversial outcomes. To further investigate whether sex affects the prognosis of breast cancer, we performed a meta-analysis based on all the peered papers. Methods： The PubMed database was screened. Subsequently, the hazard ratios （HRs） for overall survival （OS） and disease special survival （DSS）, were pooled using the Review Manager 5.0 package. Results： This study comprised of 254 MBC and 733 FBC patients enrolled in six case-control studies. There was no statistically significant heterogeneity among the trials for either outcome variable. The pooled HR showed that there was no significant difference in 5-year or 10-year DSS （HR： 1.25, 95% CI： 0.76-2.08; HR： 1.04, 95% CI： 0.68-1.5g） and 5-year or 10-year OS （HR： 0.76, 95% CI： 0.51-1.14; HR： 0.74, 95% CI： 0.54-1.02） between MBCs and FBCs. Conclusion： MBC and FBC with similar prognosis are found in this meta-analysis based on only case-control studies which matched main potential prognostic factors such as age, clinical stage, and time at diagnosis.展开更多
Objective： The aim of the study was to compare the efficacies and toxicities of non-platinum doublets （doublets group） with a non-platinum single agent （single-agent group） in previously untreated advanced non-sm...Objective： The aim of the study was to compare the efficacies and toxicities of non-platinum doublets （doublets group） with a non-platinum single agent （single-agent group） in previously untreated advanced non-small cell lung cancer （NSCLC） patients with elderly age and/or poor performance status （PS）. Methods： The PubMed database was screened. Subsequently, the hazard ratios （HRs） for overall survival （OS） and progression-free survival （PFS）, relative risks （RRs） for overall response rate （ORR） and one-year survival, and odds ratios （ORs） for the different types of toxicities were pooled using the Review Manager 5.0 package. Results： This study comprised of 1427 patients enrolled in four randomized controlled trials. The pooled HR showed that the doublet group could increase ORR （P = 0.002） with no heterogeneity （P = 0.64）, and might improve OS （P = 0.01 / P = 0.06） with heterogeneity （P 0.001）. There was no significant difference in PFS （P = 0.16） and one-year survival （P = 0.25） between two treatment groups. The doublet group led to more grade 3/4 neutropenia and thrombocytopenia than the single-agent group （P = 0.02 and P = 0.000, respectively）. The incidences of grade 3/4 anemia, vomiting, mucositis, constipation, diarrhea, neurotoxicity, allergy, and fatigue between the two treatment groups were insignificant. Conclusion： Except for neutropenia and thrombocytopenia, the non-platinum doublets could increase ORR, and might improve OS for NSCLC patients with elderly age and/or poor PS without addition of more side effects; however, the doublets showed an increased rate of neutropenia and thrombocytopenia. The addition of doublets may not improve PFS and one-year survival.展开更多
Objective： The combination of cetuximab with standard chemotherapy was not widely studied though it was recommended by NCCN 2009 to apply in non-small cell lung cancer （NSCLC） first-line setting. The aim of this st...Objective： The combination of cetuximab with standard chemotherapy was not widely studied though it was recommended by NCCN 2009 to apply in non-small cell lung cancer （NSCLC） first-line setting. The aim of this study was to summary the efficacy and safety profiles of all the NSCLC patients available in openly published papers treated with above mentioned regimens. Methods： The PubMed database was used to search all the papers on NSCLC associated with cetuximab treatment, and only the clinical trails applied cetuximab combined with doublets cytotoxic chemotherapy in first-line setting till to 30 November 2009 were collected. And the medians and their 95% CI of objective response rate （ORR）, progression free survival （PFS）, overall survival （OS）, and the common adverse events were calculated. Results： （1） Eight papers including 1032 patients were collected, and all cases were at advanced stage. （2） The ratio of male and female patients was 1.6, 50.1% patients were adenocarcinoma and 28.2% patients were squamous cell carcinoma （SCC）, 90.0% patients were PS = 0-1, and 78.2% patients were white ethnic. （3） The disease control rate （DCR）, ORR, PFS, and OS were 65.2% （95% CI： 60.7%-69.7%）, 33.2% （95% CI： 30.3%-36.1%）, 5.0 months （95% CI： 4.7-5.3） and 10.9 months （95% Cl： 9.6-12.2）, respectively. Conclusion： This is the first study to summarize the efficacy and safety profiles of cetuximab combined with chemotherapy in NSCLC first-line setting based on all available patients. The addition of cetuximab caused promising prognosis and acceptable side effects excepting higher incidence of neutropenia, and febrile neutropenia.展开更多
Objective: The aim of this study was to investigate the efficacy and safety profiles of bevacizumab, the commonly used monoclonal antibody and its safety profiles were challenging, based on Chinese cancer patients. Me...Objective: The aim of this study was to investigate the efficacy and safety profiles of bevacizumab, the commonly used monoclonal antibody and its safety profiles were challenging, based on Chinese cancer patients. Methods: All the papers studied on Chinese cancer patients treated by bevacizumab were found in both databases of Chinese journal database for fulltext and PubMed were collected. The commonly used efficacy index such as disease control rate (CR + PR + SD) and response rate (CR + PR) were analyzed, and the bevacizumab related side effects were analyzed too. Results: (1) There were ten original papers contained total 199 patients who were the candidates to analyze the safety profiles, and 115 patients with colorectal cancer in five papers who were candidates to analyze the efficacy. (2) Nine in ten papers set the dose of bevacizumab in 2.5 mg/kg/week - 5 mg/kg/week, and the biweekly was the standard chemotherapy interval. (3) The disease control rate and response rate in Chinese colorectal cancer patients were 85% (95% CI: 79%-92%) and 61% (95% CI: 52%-70%), respectively. (4) The side effects related to bevacizumab were rare and most of them were grades 1-2, and only one case with grade 4 bleeding was recorded and only two cases with discontinuation of bevacizumab since hemoplysis. Also, the grades 3-4 side effects related cytotoxic agents were not common. Conclusion: This study summarized the data of Chinese cancer patients treated by bevacizumab-contained regimens, and it showed that the monoclonal antibody was effective and safe for Chinese patients as the West patients.展开更多
Objective:Cetuximab combined with chemotherapy has been used to treat non-small cell lung cancer (NSCLC) in recent years, most of them were first line setting.This study was to summarize our experiences in treating NS...Objective:Cetuximab combined with chemotherapy has been used to treat non-small cell lung cancer (NSCLC) in recent years, most of them were first line setting.This study was to summarize our experiences in treating NSCLC patients with cetuximab in the non-first line setting.Methods:From October 1st 2006 to December 31st 2009, six NSCLC patients were treated with cetuximab combined standard chemotherapy as non-first line setting in Sun Yat-sen University Cancer Center, China.The short-term efficacies and safeties were analyzed.Results:1.A total of 18 cycles of cetuximab treatment, with a median of two cycles in the whole group.2.There were 6 patients treated as non-first line setting, overall response rate (ORR) was 33.3% (2/6), disease control rate (DCR) was 33.3% (2/6), median time to progression (TTP) was 3.5 (3-4) months, and median OS was 18 (4-28) months.3.There were 50% (3/6) patients occurred acne-like rash within three weeks, their ORR was 66.7% (2/3), and DCR was 66.7% (2/3), however, both of ORR and DCR in patients who didn't occurred acne-like rash were 0% (0/3), the differences of ORR, DCR between two groups were in significant different (P=0.143).4.There was no treatment-associated death and no cetuximab-associated discontinuation.The incidence of acne-like rash was 50% occurred within three weeks, there were two patients suffered side effects associated with chemotherapy.Conclusion:The data of cetuximab application in non-first line setting for patients with NSCLC were rare, and the addition of cetuximab in those population was safe.展开更多
Objective: We aimed to evaluate the effect of bevacizumab in the palliative treatment of Chinese metastatic colorectal cancer(mCRC) and its efficacy in different lines. Methods: Patients of mCRC treated with bevacizum...Objective: We aimed to evaluate the effect of bevacizumab in the palliative treatment of Chinese metastatic colorectal cancer(mCRC) and its efficacy in different lines. Methods: Patients of mCRC treated with bevacizumab or not at Sun Yat-sen University Cancer Center from 2005 to 2013 were recruited as the study group and control group. The endpoints were objective response rate(ORR), disease control rate(DCR), overall survival(OS) and progression free survival(PFS). The OS and PFS of first-, second- and third-line treatment groups were compared between study group and control group. Results: The median PFS of the study and the control group were 8.2 months(7.0–9.4 months), 5.7 months(4.7–6.6 months), P = 0.001; OS were 26 months(5.4–130.5 months), 18 months(16.6–19.4 months), P < 0.001, respectively. The ORR and DCR of first-, second- and third-line were 30.3%(20/66), 20%(6/30), 17.6%(3/17) and 97%(64/66), 86.7%(26/30), 100%(17/17). In the first-line chemotherapy group, the OS of the study group and the control group were 22.9(5.4–96.7) months and 18(16.6–19.4) months(P < 0.001); PFS were 9.4(8.4–10.4) months and 5.7(4.7–6.6) months(P < 0.001), respectively. While in the second- and third-line setting, only OS were statistically different, PFS had no significant difference. Conclusion: The combination of bevacizumab and chemotherapy had a promising short-term and long-term efficacy in Chinese mCRC patients than those without bevacizumab regimens, and the effect could be better reflected in the first-line treatment.展开更多
Objective: The combination of hepatic arterial chemotherapy(HAIC) and systemic chemotherapy(SYC) has potential effect on colorectal cancer(CRC) patients with unresectable hepatic metastasis. The aim of this retrospect...Objective: The combination of hepatic arterial chemotherapy(HAIC) and systemic chemotherapy(SYC) has potential effect on colorectal cancer(CRC) patients with unresectable hepatic metastasis. The aim of this retrospective study was to investigate the efficacy and safety of this combined therapeutic regimen on Chinese patients based on single institute experiences. Methods: All 54 patients of this retrospective analysis were diagnosed with CRC with unresectable liver metastasis and received combined HAIC and SYC. Among the patients, 23 of them received HAIC plus SYC when they developed liver metastases as first-line treatment(Group 1), and 31 patients received HAIC plus SYC as non-first-line treatment(Group 2). The different efficacy in two groups was analyzed by SPSS 19.0. Results: The overall response rate(ORR) were 52.2% and 25.8% respectively in Groups 1 and 2(P = 0.047), and the disease control rate(DCR) were 65.2% and 35.5% respectively in Groups 1 and 2(P = 0.031). The median progression-free survival(PFS) were 6.8 and 3.3 months(P = 0.002), the median hepatic progression-free survival(H-PFS) were 8.8 and 3.7 months(P = 0.001), and the median overall survival(OS) were 18.8 and 13.7 months(P = 0.121) in Groups 1 and 2, respectively. No fatal reaction was observed and no significant difference of adverse reaction was found in two groups. Grade 3/4 toxic effects included neutropenia(9.7% in Group 2 only), gastrointestinal reaction(8.7% in Group 1 and 6.5% in Group 2), stomatitis(6.5% in Group 2 only) and hyperbilirubinemia(4.3% in Group 1 only). Conclusion: HAIC combined with SYC showed promising efficacy and safe profiles on CRC patients with unresectable liver metastases.展开更多
Objective: Bevacizumab has been challenging in the treatment of metastatic breast cancer. To investigate its efficacy, optimal partner to combine with and maintenance therapy, we performed a retrospective study based ...Objective: Bevacizumab has been challenging in the treatment of metastatic breast cancer. To investigate its efficacy, optimal partner to combine with and maintenance therapy, we performed a retrospective study based on Chinese patients with metastatic breast cancer (MBC). Methods: Patients with MBC treated with bevacizumab-contained regimens at the Sun Yat-sen University Cancer Center from 2006 to 2010 were recruited to the study. The primary endpoints were overall survival (OS), time to progression (TTP), objective response rate (ORR), and disease control rate (DCR). These endpoints were analyzed using the Kaplan-Meier and Chi-squared tests, respectively. Results: (1) A total of 229 cycles of bevacizumab with a median cycle of 7 (1-34) were administered among 25 patients. (2) In the whole group, ORR and DCR were 60% (15/25) and 76% (19/25), respectively. The mTTP was 5 months (1-21), mOS from diagnosis was 48 months (13-172), mOS from bevacizumab administration was 24 months (1-45). (3) Both ORR (73.7% vs. 16.7%, P = 0.023) and DCR (94.7% vs. 33.3%, P = 0.005) were significant higher once patients treated with the combination of taxanes-based regimen and bevacizamab when compared with the combination with non-taxanes-based regimens. (4) In the taxanes-based group, no matter bevacizumab used in first line or non-first line, the differences of ORR (P = 0.637) and DCR (P = 0.316) were insignificant. However, the maintenance therapy with bevacizumab will bring more longer TTP (P < 0.001) than those without maintenance therapy. Conclusion: Taxanes-based regimens were the optimal candidate to combine with bevacizumab regardless the timing in palliative setting, however, the maintenance therapy with bevacizumab should be considered once indicated.展开更多
Objective： Cetuximab is an effective medicine for colorectal cancer bearing wild type Kras. However, few studies of cetuximab on patients with noncolorectal gastrointestinal cancer were available now. The aim of this...Objective： Cetuximab is an effective medicine for colorectal cancer bearing wild type Kras. However, few studies of cetuximab on patients with noncolorectal gastrointestinal cancer were available now. The aim of this study was to summarize the efficacy and safety profiles base-on the experiences of 16 patients with noncolorectal gastrointestinal cancer accepted cetuximab-contained regimens treatment. Methods： The clinical data of all patients with noncolorectal gastrointestinal cancer treated by cetuximab combined with chemotherapy and/or radiotherapy from October 1st 2006 to Jun 30th 2009 in Sun Yat-sen University Cancer Center were collected. Results： （1） A total of 16 patients enrolled, including gastric cancer, esophageal carcinoma, pancreatic cancer and cholangiocarcinoma （8, 6, 1 and 1, respectively）. The cetuximab was administered 92 cycles totally with median cycle of 4. （2） PR, SD and PD obtained in 4, 3 and 2 patients respectively in cetuximab ＋ chemotherapy group. The disease control rate, median l-rP and median OS were 77.8% （7/9）, 3.5 months and 3.5 months, respectively. （3） Both of patients in cetuximab ＋ radiotherapy group achieved PR with median TTP of 4 months and 7 months, with median OS of 14 and 28 months, respectively. （4） in evaluable patients, 3 PR obtained in first-line setting, 1 PD and 1 SD achieved in second-line setting, 2 SD and 1 PD appeared in third-line and more than third-line setting. （5） The commonly side effect was neutropenia, however, rash and hypomagnesemia were the common side effects related to cetuximab. Conclusion： Cetuximab-contained regimens show a promising disease control rate, especially in first-line setting, in patients with noncolorectal gastrointestinal cancer, and the side effects both related to cytotoxic agents and related to cetuximab itself is tolerable and manageable. Of course, more phase Ⅲ clinical trails are needed urgently.展开更多
文摘There is a need and opportunity for China to develop education and practice innovations given that advance practice nurses (APNs) improve health care and outcomes.The China Medical Board (CMB)China Nursing Network (CCNN) began planning for an Advanced Nursing Practice Program for education and career development that will facilitate CCNN's contributions to meeting national nursing policy priorities.This paper presents the discussion,recommendations and action plans developed at the inaugural planning meeting on June 26,2015 at Fudan University in Shanghai.The recommendations are:Develop standards for advanced nursing practice;Develop Master's level curricula based on the standards;Commence pilot projects across a number of University affiliated hospitals;and Prepare clinical tutors and faculty.The strategic directions and actions are: Develop a clinical career ladder system;Expand the nursing role from hospital to community;and Build a specialty nurse accreditation system.
文摘Objective:The extremely low incidence of male breast cancer (MBC) leads to lack of prospective randomized phase III studies worldwide. Especially in China,all studies on Chinese patients with MBC were based on small sample size and single institute experience. The aim of this study was to provide overall view of characteristics of Chinese patients with MBC by means of summarizing all related papers published in Chinese journals. Methods: An online search was made in CBM,VIP,CNKI,and CBA databases to find all published articles of interest on Chinese patients with MBC. And eight subjects including the proportion of MBC in all breast cancer,age,tumor location,clinical stages,pathological subtypes,treatment modalities,ER/PR expression,and 5-year survival rate were selected to calculate the proportion and their 95% interval confidence. Results: There were 122 papers with 2584 patients enrolled. The basic features of Chinese patients with MBC included:(1) MBC only with a proportion of 1.06% of all the breast cancer; (2) The mean age at diagnosis was 57.6 years old; (3) Tumor mainly located in the areolar region (74.83%) with obvious nipple and/or skin involvement; (4) Nearly 62.62% patients were in early stage before accepting treatment; (5) Infiltrating ductal carcinoma accounted for 79.05% of all pathological subtypes; (6) ER/PR expression rate was 65.86%; (7) Radical resection was up to 86.06% in all surgical modalities; (8) The 5-year survival rate was 57.33%. Conclusion: The results showed in this study were an overall view of Chinese patients with MBC whose characteristics were similar to that reported in the West. Though this study provided a little bit stronger confidence than a single study collected in this paper,studies with more powerful evidence are urgently demanding in China.
基金Support by a grant from Major Science and Technology Project of"National Significant New Drug Creation"(No. 2008ZX09312-002)
文摘Objective:Gemcitabine,used as single agent for elderly patients with non-small cell lung cancer (NSCLC),was demonstrated effective in this population based on phase II studies.The aim of this study was to summarize all those phase II studies with the hope to get a comprehensive understanding of gemcitabine efficacy.Methods:The PubMed database was used to search all the papers on NSCLC associated with gemcitabine used as single agent in the first line setting till to March 31st,2010.And the medians and their 95% CI of overall response rate (ORR),disease control rate (DCR),progression free survival (PFS),and overall survival (OS) were calculated.Results:1.There were 7 papers including 410 patients with performance status (PS) ≤ 2 and advanced stage collected.2.The dose-intensities of gemcitabine were 843.75 mg/m 2 /week-1125 mg/m 2 /week in the 4-week schedule,and 666.7 mg/m 2 /week in the 3-week schedule.3.The median age was 73.8 (95% CI was 72.44,75.16) years old;36.1% (95% CI:31.4%,40.7%) of patients with stage IIIB and 60.5% (95% CI:55.8%,65.2%) of patients with stage IV;35.9% (95% CI:31.2%,40.5%) patients were adenocarcinomas and 43.7% (95% CI:38.9%,48.5%) patients were squamous cell carcinomas (SCCs).4.The ORR,DCR,PFS/TTP,and OS were 22.3% (95% CI:18.2%,26.5%),58.4% (95% CI:53.5%,63.4%),3.6 (95% CI:2.9,5.15) months and 6.68 (95% CI:5.4,8.11) months,respectively.Conclusion:Gemcitabine as single agent applied in this special population was effective and can be well tolerated under different doses and usage.
基金Supported by a grant from the Major Science and Technology Project of "National Significant New Drug Creation" (No. 2008ZX09312-002)
文摘Objective： Male breast cancer （MBC） is a rare disease, and studies to compare the prognosis between the MBC and female breast cancer （FBC） available now were case-control studies and population-based studies, however, with controversial outcomes. To further investigate whether sex affects the prognosis of breast cancer, we performed a meta-analysis based on all the peered papers. Methods： The PubMed database was screened. Subsequently, the hazard ratios （HRs） for overall survival （OS） and disease special survival （DSS）, were pooled using the Review Manager 5.0 package. Results： This study comprised of 254 MBC and 733 FBC patients enrolled in six case-control studies. There was no statistically significant heterogeneity among the trials for either outcome variable. The pooled HR showed that there was no significant difference in 5-year or 10-year DSS （HR： 1.25, 95% CI： 0.76-2.08; HR： 1.04, 95% CI： 0.68-1.5g） and 5-year or 10-year OS （HR： 0.76, 95% CI： 0.51-1.14; HR： 0.74, 95% CI： 0.54-1.02） between MBCs and FBCs. Conclusion： MBC and FBC with similar prognosis are found in this meta-analysis based on only case-control studies which matched main potential prognostic factors such as age, clinical stage, and time at diagnosis.
基金Supported by a grant of Major Science and Technology Project of "National Significant New Drug Creation" (No. 2008ZX09312-002)
文摘Objective： The aim of the study was to compare the efficacies and toxicities of non-platinum doublets （doublets group） with a non-platinum single agent （single-agent group） in previously untreated advanced non-small cell lung cancer （NSCLC） patients with elderly age and/or poor performance status （PS）. Methods： The PubMed database was screened. Subsequently, the hazard ratios （HRs） for overall survival （OS） and progression-free survival （PFS）, relative risks （RRs） for overall response rate （ORR） and one-year survival, and odds ratios （ORs） for the different types of toxicities were pooled using the Review Manager 5.0 package. Results： This study comprised of 1427 patients enrolled in four randomized controlled trials. The pooled HR showed that the doublet group could increase ORR （P = 0.002） with no heterogeneity （P = 0.64）, and might improve OS （P = 0.01 / P = 0.06） with heterogeneity （P 0.001）. There was no significant difference in PFS （P = 0.16） and one-year survival （P = 0.25） between two treatment groups. The doublet group led to more grade 3/4 neutropenia and thrombocytopenia than the single-agent group （P = 0.02 and P = 0.000, respectively）. The incidences of grade 3/4 anemia, vomiting, mucositis, constipation, diarrhea, neurotoxicity, allergy, and fatigue between the two treatment groups were insignificant. Conclusion： Except for neutropenia and thrombocytopenia, the non-platinum doublets could increase ORR, and might improve OS for NSCLC patients with elderly age and/or poor PS without addition of more side effects; however, the doublets showed an increased rate of neutropenia and thrombocytopenia. The addition of doublets may not improve PFS and one-year survival.
基金Supported by the grant of Major Science and Technology Project of "National Significant New drug Creation" (No. 2008ZX09312-002)
文摘Objective： The combination of cetuximab with standard chemotherapy was not widely studied though it was recommended by NCCN 2009 to apply in non-small cell lung cancer （NSCLC） first-line setting. The aim of this study was to summary the efficacy and safety profiles of all the NSCLC patients available in openly published papers treated with above mentioned regimens. Methods： The PubMed database was used to search all the papers on NSCLC associated with cetuximab treatment, and only the clinical trails applied cetuximab combined with doublets cytotoxic chemotherapy in first-line setting till to 30 November 2009 were collected. And the medians and their 95% CI of objective response rate （ORR）, progression free survival （PFS）, overall survival （OS）, and the common adverse events were calculated. Results： （1） Eight papers including 1032 patients were collected, and all cases were at advanced stage. （2） The ratio of male and female patients was 1.6, 50.1% patients were adenocarcinoma and 28.2% patients were squamous cell carcinoma （SCC）, 90.0% patients were PS = 0-1, and 78.2% patients were white ethnic. （3） The disease control rate （DCR）, ORR, PFS, and OS were 65.2% （95% CI： 60.7%-69.7%）, 33.2% （95% CI： 30.3%-36.1%）, 5.0 months （95% CI： 4.7-5.3） and 10.9 months （95% Cl： 9.6-12.2）, respectively. Conclusion： This is the first study to summarize the efficacy and safety profiles of cetuximab combined with chemotherapy in NSCLC first-line setting based on all available patients. The addition of cetuximab caused promising prognosis and acceptable side effects excepting higher incidence of neutropenia, and febrile neutropenia.
文摘Objective: The aim of this study was to investigate the efficacy and safety profiles of bevacizumab, the commonly used monoclonal antibody and its safety profiles were challenging, based on Chinese cancer patients. Methods: All the papers studied on Chinese cancer patients treated by bevacizumab were found in both databases of Chinese journal database for fulltext and PubMed were collected. The commonly used efficacy index such as disease control rate (CR + PR + SD) and response rate (CR + PR) were analyzed, and the bevacizumab related side effects were analyzed too. Results: (1) There were ten original papers contained total 199 patients who were the candidates to analyze the safety profiles, and 115 patients with colorectal cancer in five papers who were candidates to analyze the efficacy. (2) Nine in ten papers set the dose of bevacizumab in 2.5 mg/kg/week - 5 mg/kg/week, and the biweekly was the standard chemotherapy interval. (3) The disease control rate and response rate in Chinese colorectal cancer patients were 85% (95% CI: 79%-92%) and 61% (95% CI: 52%-70%), respectively. (4) The side effects related to bevacizumab were rare and most of them were grades 1-2, and only one case with grade 4 bleeding was recorded and only two cases with discontinuation of bevacizumab since hemoplysis. Also, the grades 3-4 side effects related cytotoxic agents were not common. Conclusion: This study summarized the data of Chinese cancer patients treated by bevacizumab-contained regimens, and it showed that the monoclonal antibody was effective and safe for Chinese patients as the West patients.
基金Supported by a grant of Major Science and Technology Project of "National Significant New Drug Creation" (No.2008ZX09312-002)
文摘Objective:Cetuximab combined with chemotherapy has been used to treat non-small cell lung cancer (NSCLC) in recent years, most of them were first line setting.This study was to summarize our experiences in treating NSCLC patients with cetuximab in the non-first line setting.Methods:From October 1st 2006 to December 31st 2009, six NSCLC patients were treated with cetuximab combined standard chemotherapy as non-first line setting in Sun Yat-sen University Cancer Center, China.The short-term efficacies and safeties were analyzed.Results:1.A total of 18 cycles of cetuximab treatment, with a median of two cycles in the whole group.2.There were 6 patients treated as non-first line setting, overall response rate (ORR) was 33.3% (2/6), disease control rate (DCR) was 33.3% (2/6), median time to progression (TTP) was 3.5 (3-4) months, and median OS was 18 (4-28) months.3.There were 50% (3/6) patients occurred acne-like rash within three weeks, their ORR was 66.7% (2/3), and DCR was 66.7% (2/3), however, both of ORR and DCR in patients who didn't occurred acne-like rash were 0% (0/3), the differences of ORR, DCR between two groups were in significant different (P=0.143).4.There was no treatment-associated death and no cetuximab-associated discontinuation.The incidence of acne-like rash was 50% occurred within three weeks, there were two patients suffered side effects associated with chemotherapy.Conclusion:The data of cetuximab application in non-first line setting for patients with NSCLC were rare, and the addition of cetuximab in those population was safe.
基金Supported by grants from the National Natural Science Foundation of China(No.81272641,81071872)
文摘Objective: We aimed to evaluate the effect of bevacizumab in the palliative treatment of Chinese metastatic colorectal cancer(mCRC) and its efficacy in different lines. Methods: Patients of mCRC treated with bevacizumab or not at Sun Yat-sen University Cancer Center from 2005 to 2013 were recruited as the study group and control group. The endpoints were objective response rate(ORR), disease control rate(DCR), overall survival(OS) and progression free survival(PFS). The OS and PFS of first-, second- and third-line treatment groups were compared between study group and control group. Results: The median PFS of the study and the control group were 8.2 months(7.0–9.4 months), 5.7 months(4.7–6.6 months), P = 0.001; OS were 26 months(5.4–130.5 months), 18 months(16.6–19.4 months), P < 0.001, respectively. The ORR and DCR of first-, second- and third-line were 30.3%(20/66), 20%(6/30), 17.6%(3/17) and 97%(64/66), 86.7%(26/30), 100%(17/17). In the first-line chemotherapy group, the OS of the study group and the control group were 22.9(5.4–96.7) months and 18(16.6–19.4) months(P < 0.001); PFS were 9.4(8.4–10.4) months and 5.7(4.7–6.6) months(P < 0.001), respectively. While in the second- and third-line setting, only OS were statistically different, PFS had no significant difference. Conclusion: The combination of bevacizumab and chemotherapy had a promising short-term and long-term efficacy in Chinese mCRC patients than those without bevacizumab regimens, and the effect could be better reflected in the first-line treatment.
基金Supported by grants of National Natural Science Foundation of China(No.81302141)Administration of Traditional Chinese Medicine of Guangdong Province,China(No.20111169)+1 种基金Science and Technology Planning Project of Guangdong Province,China(No.2010B031600317)the Sun Yat-sen University Young Teacher Training Project(No.12ykpy56)
文摘Objective: The combination of hepatic arterial chemotherapy(HAIC) and systemic chemotherapy(SYC) has potential effect on colorectal cancer(CRC) patients with unresectable hepatic metastasis. The aim of this retrospective study was to investigate the efficacy and safety of this combined therapeutic regimen on Chinese patients based on single institute experiences. Methods: All 54 patients of this retrospective analysis were diagnosed with CRC with unresectable liver metastasis and received combined HAIC and SYC. Among the patients, 23 of them received HAIC plus SYC when they developed liver metastases as first-line treatment(Group 1), and 31 patients received HAIC plus SYC as non-first-line treatment(Group 2). The different efficacy in two groups was analyzed by SPSS 19.0. Results: The overall response rate(ORR) were 52.2% and 25.8% respectively in Groups 1 and 2(P = 0.047), and the disease control rate(DCR) were 65.2% and 35.5% respectively in Groups 1 and 2(P = 0.031). The median progression-free survival(PFS) were 6.8 and 3.3 months(P = 0.002), the median hepatic progression-free survival(H-PFS) were 8.8 and 3.7 months(P = 0.001), and the median overall survival(OS) were 18.8 and 13.7 months(P = 0.121) in Groups 1 and 2, respectively. No fatal reaction was observed and no significant difference of adverse reaction was found in two groups. Grade 3/4 toxic effects included neutropenia(9.7% in Group 2 only), gastrointestinal reaction(8.7% in Group 1 and 6.5% in Group 2), stomatitis(6.5% in Group 2 only) and hyperbilirubinemia(4.3% in Group 1 only). Conclusion: HAIC combined with SYC showed promising efficacy and safe profiles on CRC patients with unresectable liver metastases.
文摘Objective: Bevacizumab has been challenging in the treatment of metastatic breast cancer. To investigate its efficacy, optimal partner to combine with and maintenance therapy, we performed a retrospective study based on Chinese patients with metastatic breast cancer (MBC). Methods: Patients with MBC treated with bevacizumab-contained regimens at the Sun Yat-sen University Cancer Center from 2006 to 2010 were recruited to the study. The primary endpoints were overall survival (OS), time to progression (TTP), objective response rate (ORR), and disease control rate (DCR). These endpoints were analyzed using the Kaplan-Meier and Chi-squared tests, respectively. Results: (1) A total of 229 cycles of bevacizumab with a median cycle of 7 (1-34) were administered among 25 patients. (2) In the whole group, ORR and DCR were 60% (15/25) and 76% (19/25), respectively. The mTTP was 5 months (1-21), mOS from diagnosis was 48 months (13-172), mOS from bevacizumab administration was 24 months (1-45). (3) Both ORR (73.7% vs. 16.7%, P = 0.023) and DCR (94.7% vs. 33.3%, P = 0.005) were significant higher once patients treated with the combination of taxanes-based regimen and bevacizamab when compared with the combination with non-taxanes-based regimens. (4) In the taxanes-based group, no matter bevacizumab used in first line or non-first line, the differences of ORR (P = 0.637) and DCR (P = 0.316) were insignificant. However, the maintenance therapy with bevacizumab will bring more longer TTP (P < 0.001) than those without maintenance therapy. Conclusion: Taxanes-based regimens were the optimal candidate to combine with bevacizumab regardless the timing in palliative setting, however, the maintenance therapy with bevacizumab should be considered once indicated.
基金Supported by a grant from the Major Science and Technology Project of "National Significant New Drug Creation" (No. 2008ZX09312-002)
文摘Objective： Cetuximab is an effective medicine for colorectal cancer bearing wild type Kras. However, few studies of cetuximab on patients with noncolorectal gastrointestinal cancer were available now. The aim of this study was to summarize the efficacy and safety profiles base-on the experiences of 16 patients with noncolorectal gastrointestinal cancer accepted cetuximab-contained regimens treatment. Methods： The clinical data of all patients with noncolorectal gastrointestinal cancer treated by cetuximab combined with chemotherapy and/or radiotherapy from October 1st 2006 to Jun 30th 2009 in Sun Yat-sen University Cancer Center were collected. Results： （1） A total of 16 patients enrolled, including gastric cancer, esophageal carcinoma, pancreatic cancer and cholangiocarcinoma （8, 6, 1 and 1, respectively）. The cetuximab was administered 92 cycles totally with median cycle of 4. （2） PR, SD and PD obtained in 4, 3 and 2 patients respectively in cetuximab ＋ chemotherapy group. The disease control rate, median l-rP and median OS were 77.8% （7/9）, 3.5 months and 3.5 months, respectively. （3） Both of patients in cetuximab ＋ radiotherapy group achieved PR with median TTP of 4 months and 7 months, with median OS of 14 and 28 months, respectively. （4） in evaluable patients, 3 PR obtained in first-line setting, 1 PD and 1 SD achieved in second-line setting, 2 SD and 1 PD appeared in third-line and more than third-line setting. （5） The commonly side effect was neutropenia, however, rash and hypomagnesemia were the common side effects related to cetuximab. Conclusion： Cetuximab-contained regimens show a promising disease control rate, especially in first-line setting, in patients with noncolorectal gastrointestinal cancer, and the side effects both related to cytotoxic agents and related to cetuximab itself is tolerable and manageable. Of course, more phase Ⅲ clinical trails are needed urgently.
