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PharmacoEconomics Jan 2012In past decades, studies focusing on new chemotherapeutic agents for patients with inoperable non-small-cell lung cancer have reported only modest gains in survival.... (Review)
Review
In past decades, studies focusing on new chemotherapeutic agents for patients with inoperable non-small-cell lung cancer have reported only modest gains in survival. These health gains are achieved at considerable cost, but economic evidence is lacking on superiority of one agent in terms of cost effectiveness. The objective of this systematic review was to assess fully published cost-effectiveness studies comparing the new agents docetaxel, paclitaxel, vinorelbine, gemcitabine and pemetrexed, and the targeted therapies erlotinib and gefitinib with one another. We performed systematic searches in the bibliographic databases PubMed, EMBASE and Health Economic Evaluations (HEED) [via the Cochrane Library] for fully published studies from the past 10 years. Studies were screened by two independent reviewers according to a priori inclusion criteria. The methodological quality of the included studies was evaluated by two independent reviewers using standardized assessment tools. A total of 222 potential studies were identified; 11 studies and six reviews were included. The methodological quality of the full economic evaluations was fairly good. Transparency in costs and resource use, details on statistical tests and sensitivity analysis were points for improvement. In first-line treatment, gemcitabine+cisplatin was cost effective compared with other platinum-based regimens (paclitaxel, docetaxel and vinorelbine). In one study, pemetrexed+cisplatin was cost effective compared with gemcitabine+cisplatin in patients with non-squamous-cell carcinoma. In second-line treatment, docetaxel was cost effective compared with best supportive care; erlotinib was cost effective compared with placebo; and docetaxel and pemetrexed were dominated by erlotinib. We found indications of superiority in terms of cost effectiveness for gemcitabine+cisplatin in a first-line setting, and for erlotinib in a second-line setting.
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lung; Cost-Benefit Analysis; Health Care Costs; Humans; Lung Neoplasms
PubMed: 22201521
DOI: 10.2165/11595000-000000000-00000 -
Thoracic Cancer Nov 2011To evaluate the efficacy and safety of thymosin plus cisplatin with vinorelbine (NP)/gemcitabine with cisplatin (GP) program for patients with non-small cell lung...
OBJECTIVE
To evaluate the efficacy and safety of thymosin plus cisplatin with vinorelbine (NP)/gemcitabine with cisplatin (GP) program for patients with non-small cell lung cancer (NSCLC).
METHODS
We searched PubMed, EMBASE, Cochrane Library, ISI Web of Knowledge, Chinese Biomedical Database and other databases. Randomized controlled trials (RCT) comparing thymosin plus NP/GP with NP/GP alone for patients with NSCLC were eligible for our study. We evaluated the quality of included studies using Cochrane Handbook standards. Data analysis was conducted using Review Manager 5.0 software (The Nordic Cochrane Centre, Copenhagen, Denmark).
RESULTS
Ten RCT including 724 patients were eligible. The results of our study showed that: compared with an NP program alone, thymosin plus NP could increase overall response rate (odds ratio (OR) 1.86; 95% confidence interval (CI) 1.08-3.20), tumor control rate (OR 3.06; 95% CI: 1.36-6.88) and 1-year survival rate (OR 3.05; 95% CI: 1.34-6.96), improve the quality of life (OR 3.39; 95% CI: 1.54-7.47), CD4 (mean difference (MD) 6.7; 95% CI: 3.52-9.88) and NK cells (MD 6.53; 95% CI: 3.6-9.47). Compared with a GP program alone, thymosin plus GP could increase overall response rate (OR 1.67; 95% CI: 1.09-2.55), tumor control rate (OR 2.38; 95% CI: 1.01-5.62), improve quality of life (OR 3.84; 95% CI: 1.97-7.48), CD4 (MD 14.82; 95% CI: 8.05-21.59) and NK (MD 16.96; 95% CI: 4.90-29.03) Conclusion: Thymosin plus NP/GP is a better choice for patients with advanced NSCLC than NP/GP alone.
PubMed: 27755854
DOI: 10.1111/j.1759-7714.2011.00057.x -
The Lancet. Oncology Oct 2011No standard monotherapy or combination palliative chemotherapy currently exists for patients with advanced breast cancer pretreated with anthracyclines and taxanes. In... (Review)
Review
No standard monotherapy or combination palliative chemotherapy currently exists for patients with advanced breast cancer pretreated with anthracyclines and taxanes. In this systematic review we assess the current knowledge on the efficacy and safety of palliative single-agent chemotherapy drugs--capecitabine, vinorelbine, gemcitabine, and liposomal doxorubicin--commonly used in daily clinical practice. We identified 22 studies, of which ten investigated capecitabine, nine investigated vinorelbine, three investigated gemcitabine, and one investigated liposomal doxorubicin. The greatest amount of information was available for capecitabine and vinorelbine. These two drugs showed good efficacy. The disease control rate differed significantly between the four drugs, which is relevant in terms of how well tumour symptoms can be improved and whether quality of life can be maintained or even improved. To obtain more evidence of the efficacy and safety of chemotherapeutic agents used in this pretreated population of advanced breast cancer patients, randomised comparisons of the various drugs, as monotherapy and in combination with targeted agents, are needed.
Topics: Adult; Aged; Aged, 80 and over; Anthracyclines; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Capecitabine; Deoxycytidine; Disease-Free Survival; Doxorubicin; Drug Administration Schedule; Female; Fluorouracil; Humans; Middle Aged; Palliative Care; Quality of Life; Risk Assessment; Survival Rate; Taxoids; Treatment Outcome; Vinblastine; Vinorelbine; Gemcitabine
PubMed: 21621462
DOI: 10.1016/S1470-2045(11)70045-6 -
Zhongguo Fei Ai Za Zhi = Chinese... May 2011In recent years, there has been a large number of studies and reports about the efficacy and safety of recombinant human endostatin (rh-endostatin), an anti-angiogenic... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND OBJECTIVE
In recent years, there has been a large number of studies and reports about the efficacy and safety of recombinant human endostatin (rh-endostatin), an anti-angiogenic drug, in treatment of advanced lung cancer. Authentic assessment of rh-endostatin treatment in lung cancer is important. The aim of this study is to assess the clinical efficacy and safety of rh-endostatin combined with chemotherapy in the treatment of patients with non-small cell lung cancer (NSCLC).
METHODS
Cochrane systematic review methods were used in the data selection, and data were selected from the Cochrane Library, EMBASE, Medline, SCI, CBM, CNKI, and etc electronic database to get all clinical controlled trials. The retrieval time was March 2010. The objects of these randomized controlled trials were advanced NSCLC patients and in the experimental group was rh-endostatin combination chemotherapy, in the control group was chemotherapy alone to compare the efficacy of two groups. The quality of included trials were evaluated by two reviewers independently. The software RevMan 5.0 was used for meta-analyses.
RESULTS
Fifteen trials with 1,326 patients were included according to the including criterion. All trials were randomized controlled trials, and two trials were adequate in reporting randomization. Thirteen trials didn't mention the blinding methods. Meta analysis indicated that the NPE arm (Vinorelbine+cisplatin+rh-endostatin) had a different response rate compared with NP (Vinorelbine+cisplatin) arm (OR=2.16, 95%CI: 1.57-2.99). The incidences of severe leukopenia (OR=0.94, 95%CI: 0.66-1.32) and severe thrombocytopenia (OR=1.00, 95%CI: 0.64-1.57) and nausea and vomiting (OR=0.85, 95%CI: 0.61-1.20) were similar in the NPE arm compared with those in the NP arm. The NPE plus radiotherapy (RT) arm had a similar response rate compared with NP plus RT arm (OR=2.39, 95%CI: 0.99-5.79). The incidences of leukopenia (OR=0.83, 95%CI: 0.35-1.94) and thrombocytopenia (OR=0.78, 95%CI: 0.19-3.16) and radiation esophagitis (OR=1.00, 95%CI: 0.40-2.49) were similar in the NPE plus RT arm compared with those in the NP plus RT arm.
CONCLUSION
In the treatment of advanced NSCLC, rh-endostatin in combination with platinum-based chemotherapy improve the response rate without obviously raised side effects, however, when radiotherapy are added to NPE arm or NP arm, the response rates have a similar outcome. Owing to the small sample size and poor quality of included trials, more well-designed double-blinded randomized controlled trials should be performed.
Topics: Antineoplastic Agents; Carcinoma, Non-Small-Cell Lung; Drug-Related Side Effects and Adverse Reactions; Endostatins; Humans; Lung Neoplasms; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 21569645
DOI: 10.3779/j.issn.1009-3419.2011.05.05 -
Lung Cancer (Amsterdam, Netherlands) Aug 2011To assess the risk/benefit profiles of EGFR TKIs monotherapy using erlotinib or gefitinib in comparison with single-agent chemotherapy using third-generation cytotoxics... (Review)
Review
The safety and efficacy of EGFR TKIs monotherapy versus single-agent chemotherapy using third-generation cytotoxics as the first-line treatment for patients with advanced non-small cell lung cancer and poor performance status.
PURPOSE
To assess the risk/benefit profiles of EGFR TKIs monotherapy using erlotinib or gefitinib in comparison with single-agent chemotherapy using third-generation cytotoxics (gemcitabine, vinorelbine, taxanes) as the first-line treatment for chemonaÏve patients with advanced non-small cell lung cancer (ANSCLC) and poor performance status (PS).
METHODS
A pooled analysis and systematic review was performed using trials identified through MEDLINE, EMBASE, Cochrane Library, and the Clinical-Trials.gov. Data were collected from randomized and non-randomized phase II or III clinical trials of EGFR TKIs monotherapy or single-agent chemotherapy using third-generation cytotoxics published before 3/1/2010, and the pooled estimates for efficacy and safety outcomes of interest were calculated.
RESULTS
Fifteen eligible trials (1425 patients) were selected from 323 studies that initially were identified. In 5 of the selected single-agent chemotherapy studies, the elderly were included together with poor PS patients. Outcomes from these studies still were employed for a thorough analysis. Targeting poor PS patients, we found that the pooled response rate (95% confidence interval) to EGFR TKIs for unselected population was 6% (3-8%), not substantially different from 9% (6-13%) reported by single-agent chemotherapy trials using third-generation cytotoxics. However, EGFR TKIs had better disease control rates with a pooled estimate of 40% (33-47%), significantly higher than 30% (20-41%) of the cytotoxics. Single-agent chemotherapy trials enrolling both elderly and poor PS patients had better results with the pooled response rate and the pooled disease control rate was 13% (11-16%) and 41% (36-46%) respectively. For safety information, despite both treatments were well-tolerated, the toxicity profile of EGFR TKIs was clearly more favorable than that reported by chemotherapy. The severe hematological adverse events related to EGFR TKIs treatment were rare. EGFR TKIs also tended to be more effective in improvement of symptoms or quality-of-life (QOL).
CONCLUSION
Although, both of the treatments had low response rates, EGFR TKIs tended to be more effective in control of tumor progression, reduction of therapy-related toxicities, improvement of symptoms or quality-of-life in the first-line treatments of ANSCLC patients with poor PS. Moreover, our data also suggest that the elderly patients without selection carefully according their PS should be separated from this population. Further investigations with valid comparison groups are necessary.
Topics: Antineoplastic Agents; Carcinoma, Non-Small-Cell Lung; Clinical Trials as Topic; Deoxycytidine; ErbB Receptors; Erlotinib Hydrochloride; Gefitinib; Humans; Lung Neoplasms; Quinazolines; Taxoids; Vinblastine; Vinorelbine; Gemcitabine
PubMed: 21211862
DOI: 10.1016/j.lungcan.2010.12.006 -
Tumori 2010Trastuzumab, a humanized monoclonal antibody directed against the extracellular domain of ErbB, has determined clinical benefit for women affected by metastatic or early... (Meta-Analysis)
Meta-Analysis Review
AIMS AND BACKGROUND
Trastuzumab, a humanized monoclonal antibody directed against the extracellular domain of ErbB, has determined clinical benefit for women affected by metastatic or early stage HER2-positive breast cancer and never previously treated with trastuzumab. Trastuzumab is generally used as first-line treatment of HER2+ metastatic breast cancer and is currently administered beyond progression even without clear evidence supporting such clinical practice. In fact, HER2-positive metastatic breast cancer has a high risk of progressing after first-line therapy, and second-line treatments vary. The aim of the study was to investigate by a systematic review the efficacy of trastuzumab-based treatments beyond progression in HER2-positive metastatic breast cancer.
MATERIALS AND METHODS
We performed a systematic review using Medline, Embase and Cochrane Library data bases and publications in principal meetings or congresses of oncology in Europe and America until September 2008. The main selection criterium was the reporting of time to progression, calculated from the start of each trastuzumab-based therapy to the date of progressive disease or death.
RESULTS
Twelve studies were selected that included a total of 516 patients. The weighted mean time to progression was 23.66 weeks (standard deviation, 4.37) and the median was 26 weeks (range, 13-39). Interestingly, combined trastuzumab plus vinorelbine treatment showed a lower mean and median time to progression (20.59 and 19.57 weeks, respectively), whereas trastuzumab plus capecitabine yielded a mean time to progression of 30.33 weeks.
CONCLUSIONS
The added value of the present study has been to provide a quantitative summary measure of time to progression which can be used for comparisons between current and future available regimens.
Topics: Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Capecitabine; Deoxycytidine; Disease Progression; Female; Fluorouracil; Humans; Linear Models; Multivariate Analysis; Receptor, ErbB-2; Trastuzumab; Vinblastine; Vinorelbine
PubMed: 20845797
DOI: 10.1177/030089161009600302 -
Zhongguo Fei Ai Za Zhi = Chinese... Feb 2010Cisplatin (DDP) plus vinorelbine (NVB) constitute the first-line regimen (NP regimen) for non-small cell lung cancer (NSCLC). Oxaliplatin (OXA) is another effective drug... (Review)
Review
BACKGROUND AND OBJECTIVE
Cisplatin (DDP) plus vinorelbine (NVB) constitute the first-line regimen (NP regimen) for non-small cell lung cancer (NSCLC). Oxaliplatin (OXA) is another effective drug in treatment of NSCLC with mild toxicities to gastrointestinal tract, kidney and bone marrow. The aim of this study is to evaluate the efficiency and safety between NVB plus OXA (NO) regimen and NP regimen for advanced NSCLC.
METHODS
We searched CBM CNKI, VIP, Cochrane Library, PubMed, EMBASE, ASCO etc. conference proceedings and internet information. Randomized controlled trials of NO versus NP for advanced NSCLC were included; we evaluated the quality of the included studies and analyzed data by Cochrane Collaboration's RevMan 5.0 software.
RESULTS
Fourteen randomized trials involving 1 270 patients were included. There were no statistical differences between NO and NP in overall response rate, disease control rate, 1-year survival rate, anemia and thrombocytopenia. Gastrointestinal toxicity, leucopenia, alopecia and kidney toxicity were more serious in NP (P < 0.05), but neuritis was more serious in NO, with significant difference (P < 0.05).
CONCLUSION
The clinical efficacy of NO and NP for advanced NSCLC was similar, but the side effects were different. The toxicity of NO has the tendency to be more tolerable.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lung; Cisplatin; Humans; Lung Neoplasms; Organoplatinum Compounds; Oxaliplatin; Randomized Controlled Trials as Topic; Treatment Outcome; Vinblastine; Vinorelbine
PubMed: 20673502
DOI: 10.3779/j.issn.1009-3419.2010.02.06 -
Journal of Thoracic Oncology : Official... Feb 2010Non-small cell lung cancer (NSCLC) frequently presents at an incurable stage, and a majority of patients will be considered for palliative chemotherapy at some point in... (Review)
Review
INTRODUCTION
Non-small cell lung cancer (NSCLC) frequently presents at an incurable stage, and a majority of patients will be considered for palliative chemotherapy at some point in their disease. This article reviews the growing evidence for first-line treatment in NSCLC.
METHODS
Studies of first-line chemotherapy regimens including new agents (docetaxel, gemcitabine, irinotecan, paclitaxel, pemetrexed, and vinorelbine) and targeted agents (bevacizumab, erlotinib, and gefitinib) were identified through Medline, Embase, the Cochrane databases, and web sites of guideline organizations.
RESULTS
Two evidence-based guidelines, 10 systematic reviews, and forty-six randomized trials were eligible for inclusion. Randomized studies suggest that platinum-based doublets (platinum plus new agent) are the standard of care for first-line systemic therapy. No one new agent is clearly superior for use in combination with a platinum agent. The survival advantage of platinum-based doublets over nonplatinum combinations or older combinations is modest. The addition of bevacizumab to carboplatin and paclitaxel has shown improved survival, although multiple exclusion criteria limit the applicability of these data to a subset of patients. In patients at least 70 years of age or with Eastern Collaborative Oncology Group performance status 2, a new single agent is an alternative. Treatment beyond four to six cycles impedes quality of life without prolonging life. Emerging data suggest that the choice of chemotherapy agent may be influenced by histologic subtype.
CONCLUSION
In NSCLC, a combination of a platinum agent plus a new agent continues to be the standard of care. As differences between regimens are small, toxicity and patient preference should help guide regimen choice.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma, Non-Small-Cell Lung; Cisplatin; Evidence-Based Medicine; Humans; Lung Neoplasms; Quality of Life; Randomized Controlled Trials as Topic; Survival Analysis
PubMed: 20101151
DOI: 10.1097/JTO.0b013e3181c6f035 -
European Journal of Cancer (Oxford,... Nov 2009Currently available evidence does not provide definitive guidance regarding the optimal chemotherapy agents and combinations in anthracycline- and taxane-pretreated... (Review)
Review
INTRODUCTION
Currently available evidence does not provide definitive guidance regarding the optimal chemotherapy agents and combinations in anthracycline- and taxane-pretreated advanced breast cancer. We performed a systematic review of controlled clinical trials of the cytotoxic agents currently used for this population in Europe: capecitabine, gemcitabine, vinorelbine, docetaxel, paclitaxel and paclitaxel protein-bound particles.
METHOD
A systematic review of randomised (RCT) and non-randomised controlled clinical trials (non-RCTs). The primary outcomes of interest were overall survival (OS) and progression-free survival (PFS); secondary outcomes were duration of response (DR), overall response rate (ORR), adverse events and quality of life (QoL). Six electronic databases and grey literature sources were searched; reference tracking was performed on included publications. A narrative synthesis was conducted: heterogeneity of study design and interventions prevented meta-analysis.
RESULTS
No randomised controlled trial (RCT) found any significant differences between any of the regimens in terms of OS. In terms of PFS, only gemcitabine plus vinorelbine performed significantly better than its comparator, vinorelbine alone. For secondary outcomes, only capecitabine plus bevacizumab had a significantly better outcome than its comparator, capecitabine alone, in terms of ORR. A low quality non-RCT found that both capecitabine monotherapy and a combination of capecitabine plus vinorelbine were significantly more effective than vinorelbine alone in terms of OS and ORR. Across all trials, median OS for these patients typically remained less than 16 months.
CONCLUSION
The quantity and quality of the available evidence regarding the efficacy of the particular chemotherapy regimens in patients with advanced breast cancer pretreated with an anthracycline and a taxane is extremely limited. New effective therapies are sorely needed in this population.
Topics: Anthracyclines; Antineoplastic Agents; Breast Neoplasms; Clinical Trials as Topic; Disease-Free Survival; Female; Humans; Multicenter Studies as Topic; Neoplasm Metastasis; Taxoids; Treatment Outcome
PubMed: 19615886
DOI: 10.1016/j.ejca.2009.05.035 -
Zhongguo Fei Ai Za Zhi = Chinese... Mar 2009In the past years, many reports on Kanglaite were publicated in China, researchers across the country. The aim of this study is to review the effectiveness and safety of...
BACKGROUND
In the past years, many reports on Kanglaite were publicated in China, researchers across the country. The aim of this study is to review the effectiveness and safety of Kanglaite for treating advanced non-small-cell lung cancer.
METHODS
Authors searched the Cochrane Library, Pubmed, Embase, Cancerlit, CBM, CNKI and VIP. Mannual and additional search were also conducted. All randomized controlled trials/quasi-RCT comparing Kanglaite with other lung cancer treatment were included. Two reviewers independently performed data extraction and appraised the publications using the Juni instrument, disagreements were resolved by consensus. Double data were entered and analyzed by RevMan 4.2 software are by Cochrane Collaboration.
RESULTS
Sixteen reports were included in the meta-analysis. The quality of 16 studies was low. Pooling data of 5 studies indicated that the effect of Kanglaite+NP (Vinorelbine+Cisplatin) was better than NP with RR 1.46, 95% Confidence Interval 1.13 to 1.91. Pooling data of 3 studies of MVP (Mitomycin+Vindsine+ Cisplatin) plus Kanglaite indicated that the effect was better with RR 1.84, 95%CI 1.22 to 2.76. Pooling data of 2 studies showed that the effect of GP (Gemcitabine+Cisplatin) plus Kanglaite was better than GP with RR 1.63, 95%CI 1.09 to 2.43. Fourteen studies revealed that Kanglaite may reduce the side-effect induced by regular treatment. Ten studies showed regular treatment plus Kanglaite can stabilite/improve quality of life.
CONCLUSIONS
Kanglaite can enhance clinical effect of regular treatment, reduce side-effect and stabilite/improve quality of life, but the effect of Kanglaite being used in clinical settings needs to be confirmed by further large and multicenter.
PubMed: 20716423
DOI: 10.3779/j.issn.1009-3419.2009.03.018