A comparison of the costs of paclitaxel and best supportive care in stage IV non-small-cell lung cancer. Cost-effectiveness of paclitaxel plus cisplatin in advanced non-small-cell lung cancer An estimate of the cost effectiveness of gemcitabine in stage IV non-small cell lung cancer. Cost-effectiveness of vinorelbine alone or vinorelbine plus cisplatin for stage IV NSCLC. Single-agent gemcitabine as second-line treatment in patients with advanced non small cell lung cancer (NSCLC): a phase II trial. Paclitaxel/ifosfamide or navelbine/ifosfamide chemotherapy for advanced non-small cell lung cancer: CALGB 9532. The cost-effectiveness of navelbine alone or in combination with cisplatin in comparison to other chemotherapy regimens and best supportive care in stage IV non-small cell lung cancer. Economic value of gemcitabine compared to cisplatin and etoposide in non-small cell lung cancer. Cost analysis of hospital treatment--two chemotherapic regimens for non-surgical non-small cell lung cancer. GFPC (Groupe Français Pneumo Cancérologie) The cost-effectiveness of paclitaxel (Taxol) + cisplatin is similar to that of teniposide + cisplatin in advanced non-small cell lung cancer: a multicountry analysis. Phase II study of taxol, merbarone, and piroxantrone in stage IV non-small-cell lung cancer: The Eastern Cooperative Oncology Group Results. Gemcitabine versus the combination of cisplatin and etoposide in patients with inoperable non-small-cell lung cancer in a phase II randomized study. Vinorelbine versus vinorelbine plus cisplatin in advanced non-small cell lung cancer: a randomized trial. Cost-effectiveness analysis of three regimens using vinorelbine (Navelbine) for non-small cell lung cancer. A randomized phase II trial of cisplatinum plus mitomycin-C plus vinorelbine and carboplatin plus vinorelbine in advanced non-small cell lung cancer. Gemcitabine plus vinorelbine versus vinorelbine alone in elderly patients with advanced non-small-cell lung cancer. Cost-effectiveness of gemcitabine in stage IV non-small cell lung cancer: an estimate using the Population Health Model lung cancer module. Attitudes to chemotherapy: comparing views of patients with cancer with those of doctors, nurses, and general public. Recruitment of patients with lung cancer into a randomised clinical trial: experience at two centres Randomized trial of paclitaxel plus supportive care versus supportive care for patients with advanced non-small-cell lung cancer.
PURPOSE To compare the expenditures associated with single-agent paclitaxel ( Taxol ) with those of best supportive care as treatment for stage IV non-small-cell lung cancer ( NSCLC ) . METHODS The primary data sets of 2 phase II trials of paclitaxel in advanced NSCLC were obtained . Paclitaxel delivery costs were estimated at the Ottawa Regional Cancer Centre using the mean paclitaxel dose from the 2 phase II trials , 214 mg/m2 , a 3-week schedule and a median of 3 treatment cycles . Data regarding dosage , costs and survival were incorporated into the Statistics Canada POpulation HEalth Model ( POHEM ) , which generated hypothetical cohorts of patients treated either with best supportive care or paclitaxel .  The POHEM model assigned diagnostic workup , treatment , disease progression and survival characteristics to each of these cohorts and tabulated the costs associated with each . RESULTS The total cost of administering 3 cycles of chemotherapy was Can$8143 per patient . The strategy of treating NSCLC patients with paclitaxel cost $ 3375 more per patient than best supportive care . On the basis of the difference in survival duration between stage IV patients treated in the best supportive care arm of a previous National Cancer Institute of Canada trial and those represented in the pooled phase II survival results , the cost per life-year saved was $ 4778 . For sensitivity analyses , the days of hospitalization for terminal care , number of cycles given and survival benefit produced were varied . The sensitivity analysis produced a cost per life-year saved of up to $ 21,377 under the least favourable assumptions . CONCLUSION If large phase III trials confirm the survival benefits observed in the phase II trials , paclitaxel can be considered to be a cost-effective agent in the management of advanced NSCLC Summary The aim of this study was to assess the cost-effectiveness of combination chemotherapy with paclitaxel/cisplatin , compared with st and ard etoposide/cisplatin in patients with advanced non-small cell lung cancer ( NSCLC ) . We obtained the primary survival and re source utilization data from a large three-arm r and omized trial comparing : paclitaxel 135 mg m–2 by 24-h intravenous ( i.v . ) infusion + cisplatin ; paclitaxel 250 mg m–2 by 24-h i.v . infusion + cisplatin + granulocyte colony-stimulating factor ( G-CSF ) ; and st and ard etoposide/cisplatin in patients with stage IIIb or IV NSCLC . We also modelled the regimens with paclitaxel 135 mg m–2 + cisplatin administered as an outpatient by 3-h infusion , as clinical data suggest that this is equivalent to 24-h infusion . We collected costing data from the Ottawa Regional Cancer Centre and applied it to the re sources consumed in the r and omized trial . We integrated these data into the Statistics Canada POpulation HEalth Model ( POHEM ) , which generated hypothetical cohorts of patients treated with each regimen . The POHEM model assigned diagnostic work-up , treatment , disease progression and survival characteristics to each individual in these cohorts and tabulated the costs associated with each . We did sensitivity analyses around the costs of chemotherapy and its administration , and the survival differences between the two regimens . All costs are in 1997 Canadian dollars ( $ 1.00 Canadian ~ £ 0.39 sterling ) . The perspective is that of the Canadian health care system . In the trial , the two paclitaxel-containing arms had almost identical survival curves with a median survival of 9.7 months compared with 7.4 months for etoposide/cisplatin . As administered in the trial , paclitaxel/cisplatin  cost $ 76 370 per life-year gained ( LYG ) and  paclitaxel/cisplatin/G-CSF  $ 138 578 per LYG relative to etoposide/cisplatin . However , when modelled as an outpatient 3-h infusion , paclitaxel/cisplatin was moderately cost-effective at $ 30 619 per LYG . When compared with historical controls treated with best supportive care , this regimen of paclitaxel/cisplatin cost $ 4539 per LYG . Assuming a 3-h paclitaxel infusion yields the same survival advantage as the 24-h infusion did in the r and omized trial , paclitaxel/cisplatin is a cost-effective improvement over st and ard etoposide/cisplatin for patients with advanced non-small cell lung cancer Statistics Canada ( Ottawa , Canada ) is developing a population health model ( POHEM ) that simulates the health and common illnesses of Canadians . The POHEM incorporates a model of lung cancer management based on Canadian practice , which has been used to estimate the total direct care costs of treating all lung cancer cases diagnosed in Canada in 1988 . One of the potential uses of the POHEM is to evaluate the cost and cost effectiveness of new therapeutic interventions as they are introduced into practice . Gemcitabine , a new nucleoside analog with a broad spectrum of antitumor activity , has been evaluated in the model and estimates have been made of its cost effectiveness in the management of lung cancer over a range of drug costs per treatment cycle ( $ Cdn 800 to $ Cdn 1,800 ) . The  survival of stage IV non-small cell lung cancer ( NSCLC ) patients treated on an international trial of gemcitabine ( E018 ) was used to estimate the potential survival gain relative to the survival of stage IV NSCLC patients managed with best supportive care on a r and omized trial conducted by the National Cancer Institute of Canada . Sensitivity analyses were performed assuming that the survival benefit was 25 % and 50 % less than that reported in the E018 trial . Based on the apparent survival advantage of the E018 trial , the cost per life-year gained ranged from $ Cdn 1,609 to $ Cdn 9,529 depending on the cost per treatment cycle . At the greatest cost per cycle ( $ Cdn 1,800 ) and with survival reduced by 50 % as compared with the E018 result , the cost per life-year gained was estimated to be $ Cdn 16,230 . From these estimates of direct care costs in the Canadian health care system , gemcitabine appears to be a cost-effective intervention for advanced NSCLC Le Chevalier and colleagues have reported results of a r and omized controlled clinical trial comparing vinorelbine alone , versus vinorelbine combined with cisplatin , versus st and ard treatment consisting of vindesine and cisplatin in the treatment of patients with advanced non-small-cell lung cancer ( NSCLC ) . Data on survival in the three study arms and estimates of the re sources used to treat these patients were extracted from the publication and inserted into Statistics Canada 's POpulation HEalth Model ( POHEM ) . This model includes data on diagnostic methods , treatment , and outcomes appropriate for stage at presentation , health care utilization , and direct care costs ( $ Canadian ) for best supportive care and for several " st and ard " chemotherapy regimens used to treat advanced NSCLC . POHEM was then used to model the cost of care per patient and the total burden of cost on the Canadian health care system for each of the chemotherapy treatment strategies and for best supportive care . Based on the published survival curves for each of the vinorelbine regimens , it was possible to estimate the survival gain relative to the st and ard chemotherapy regimens and to best supportive care , and to estimate their cost-effectiveness as cost per life year gained . Based on this analysis , the most cost-effective st and ard regimen relative to best supportive care was vinblastine/cisplatin , as it increased average survival while reducing costs by $ 2,846 per case . Vinorelbine/cisplatin increased survival to a greater degree , but inpatient administration costs associated with the delivery of cisplatin increased treatment costs by $ 2,983 per case and result ed in a cost-effectiveness ratio of $ 6,386 per life year gained . As high-dose cisplatin is not routinely administered in the inpatient setting in Canadian institutions , estimates were made of the cost of outpatient administration . The cost of outpatient care was $ 55 less per case demonstrating that this is the most cost-effective way to administer the regimen . Relative to etoposide/cisplatin and vinblastine/cisplatin , outpatient vinorelbine/cisplatin proved to be cost-effective . Various chemotherapy regimens used in the management of advanced NSCLC all fall within the boundaries of cost-effectiveness generally accepted for health care interventions in Canada . Therefore , cost and cost-effectiveness should not be barriers to the utilization of vinorelbine/cisplatin in Canada BACKGROUND Although the use of salvage chemotherapy in advanced non-small cell lung cancer ( NSCLC ) is controversial , pretreated symptomatic patients often need some kind of treatment to achieve symptoms relief .  Gemcitabine is one of the most active new drugs in advanced NSCLC and preliminary reports suggest that it is active also in patients previously treated with platinum compounds . AIM to evaluate activity and toxicity and the effect on quality of life of gemcitabine in platinum-pretreated patients with advanced NSCLC . METHODS single-stage phase 2 trial with p0 = 5 % , p1 = 20 % , alfa = 5 % , beta = 10 % ; 34 patients required and 4 objective responses expected to warrant further studies . Gemcitabine was administered at dose of 1000 mg/m2 , i.v . , d 18 - 15 , every 4 weeks , for a maximum of 6 cycles . Quality of life was measured by EORTC C-30 and LC-13 question naires . RESULTS from September 1996 to July 1998 , 30 patients have been enrolled . There were 6 ( 20 % exact 95 % CI 8 - 39 % ) partial responses ( 2 responses were in pts with brain metastases and 2 in patients progressed during first-line chemotherapy ) . All patients ( but one died because myocardial infa rct ion , progressed ; median time to progression was 10 weeks ( 95 % CI 7 - 12 ) ; 28 patients died ; median survival was 22 weeks ( 95 % CI 17 - 29 ) . Quality of life analysis showed no significant change but for the improvement of cough after 3 cycles of chemotherapy . There was no severe toxicity . CONCLUSION gemcitabine is active as second line for patients with advanced NSCLC who received platinum-based first line treatment . In view of such results r and omized trials comparing gemcitabine versus best supportive care are warranted In order to explore non-cisplatin containing regimens for advanced non-small cell lung cancer , Cancer and Leukemia Group B conducted a r and omized Phase-II study of two novel combinations , paclitaxel/ifosfamide and vinorelbine/ifosfamide . Both regimens were active with a 38 % response rate ( 95 % CI : 24 % , 53 % ) and 31 % ( 95 % CI : 18 % , 47 % ) , respectively . Median survivals were 8.5 and 7.4 months . Toxicity , mostly neutropenia , was acceptable . These two combinations establish a ' proof of principle ' that non-cisplatin containing regimens also have activity in this setting An economic evaluation was undertaken , using data from European and Canadian r and omised controlled trials of chemotherapy in advanced non-small cell lung cancer ( NSCLC ) , to determine the cost and cost-effectiveness of single-agent vinorelbine ( Navelbine , NVB ) therapy and NVB in combination with cisplatin ( NVB-P ) compared to vindesine in combination with cisplatin ( VDS-P ) , st and ard regimens including VP-16-cisplatin ( VP-16-P ) and vinblastine-cisplatin ( VLB-P ) and best supportive care ( BSC ) . The Population Health Model ( POHEM ) developed by Statistics Canada was used to model the cost of care per patient , the total burden of cost to the Canadian healthcare system and the cost-effectiveness of the therapeutic interventions relative to BSC and to st and ard chemotherapy regimens , expressed as the cost per life year gained ( LYG ) . Based on this analysis , VLB-P proved to be the most cost-effective chemotherapy regimen relative to BSC , as it increased average survival by 0.27 years while reducing costs by $ 3265 per case . NVB-P increased survival to a greater degree ( 0.44 years/patient ) while inpatient administration increased costs by $ 2451 per case , for a cost-effectiveness ratio of $ 5551 per LYG . Outpatient administration , which reduced the cost of care per case by $ 473 , was shown in the model to be the most cost-effective way to administer this regimen . Relative to VP-16-P and VLB-P , outpatient NVB-P regimen proved to be cost-effective at $ 7902 and $ 16404 per LYG , respectively . Based on our estimates , a variety of chemotherapy regimens , including outpatient NVB-P , are cost-effective in the management of advanced ( Stage IV ) NSCLC and competitive with some commonly used healthcare interventions . Therefore , cost and cost-effectiveness should not be barriers to the utilisation of NVB-P therapy in Canada Although chemotherapy costs have not been highlighted traditionally , there is increasing pressure to demonstrate the value of new treatments within the health care budget . Pharmaceutical companies are assessing the economic value of their products before launch . Gemcitabine is a nucleoside analogue developed for use in solid tumours . The purpose of this model was to investigate the clinical outcomes and potential cost savings for gemcitabine used as monotherapy compared to cisplatin and etoposide combination therapy in late stage non-small cell lung cancer ( NSCLC ) , in a palliative ( as opposed to aggressive ) chemotherapy setting . Gemcitabine treatment data were taken from a large NSCLC study and data from retrospective chart review s identified through the National Oncology Data Base . The model population and effectiveness of the two regimens were judged to be similar , except for baseline performance status . If drug costs were not included , the probability distribution result ing from the simulation showed median cost savings per cycle ranging from $ US 1504 to $ US 7425 , with a medium value of $ US 2154 . The model suggested that gemcitabine would result in cost savings per cycle more than 90 % of the time . Outpatient versus inpatient drug administrations accounted for the majority of potential cost savings . Most of the remaining cost savings were attributable to the difference in febrile neutropenia and antiemetic use . This economic model showed susbstantial savings if gemcitabine was used instead of cisplatin and etoposide combination therapy in the United States ' community care setting . Some savings would be realized even if the location of treatment for both regimens was mostly outpatient . Assessment of the product 's economic value before launch has assisted in our underst and ing of the potential areas of cost savings for gemcitabine and has guided us in the design of prospect i ve r and omized studies which included pharmacoeconomic endpoints STUDY OBJECTIVES compare the costs of two regimens of chemotherapy .  Apply weighted costs to an economic model in a hospital perspective . DESIGN prospect i ve r and omized study of two groups of patients receiving : branch B , mitomycin-navelbine-cisplatin ( MNP ) ; branch A , mitomycin-vindesine-cisplatin ( MVP ) .  SETTING pneumologic units of University and non-University hospitals . METHODS clinical evaluation during chemotherapy incorporated events enabling construction of an event tree . Direct hospital costs included those of :  cytostatic agents , material s used and nursing time ; costs of side-effects ( medical and paramedical time , diagnostic and therapeutic examinations ) . Effectiveness was measured in terms of response rates . PATIENTS 209 patients were included , 100 in arm B , 109 in arm A. RESULTS the response rates were 25 % in branch B , 17 % in branch A. In the hypothesis of equivalence of the two strategies , we compared only overall mean cost per patient . Despite the fact arm B needed more hospital injections , the difference was low ( + 4.6 % ) . For a difference in effectiveness , the opposite was observed for the average cost-effectiveness ratio : arm B was less costly ( -12 339.40 FF for a responder ) . CONCLUSION incorporation of economic parameters was found to have a bearing on the choice of chemotherapeutic regimen for the treatment of non-small cell lung cancer . Economic analyses of this kind can provide useful extra information for rational therapeutic decisions A large r and omized clinical trial in advanced , previously untreated , non-small cell lung cancer ( NSCLC ) patients revealed better response rates and better tolerance for paclitaxel+cisplatin ( TAXCIS ) compared to teniposide+cisplatin ( TENCIS ) . Since economic evidence is receiving increasing attention in health care , we conducted an economic evaluation based on the trial results in The Netherl and s , Belgium , France and Spain . The evaluation was based on ( i ) differences in drug costs , ( ii ) differences in chemotherapy administration and ( iii ) the economic consequences of significantly different clinical outcomes in the trial : anemia , thrombocytopenia , neutropenia , neuropathy and arthralgia/myalgia . Data regarding medical re source utilization were obtained from clinician interviews using a Delphi technique and vali date d by patient charts analysis . Differences in medical management occurred across countries , but TAXCIS was cost-additive in all countries , i.e. the extra cost of chemotherapy was only partially compensated by savings in medical re source use , result ing in a net cost per patient of US$ 2311 . In the trial , TAXCIS therapy produced a 37 % response rate compared to 26 % for TENCIS . The cost per extra responder for TAXCIS is on average US$ 21011 , which is comparable to the cost per responder obtained with TENCIS ( US$ 27266 ) . Thus , the cost-effectiveness of TAXCIS , expressed in cost per responder , is similar to the cost-effectiveness obtained with TENCIS BACKGROUND Patients with metastatic ( stage IV ) non-small-cell lung cancer usually have a poor prognosis and disease refractory to chemotherapy . Three new agents -- taxol , merbarone , and piroxantrone -- have shown promising antitumor treatment in vitro and in animals . Taxol is an antimicrotubular agent that interferes with mitosis during cell division . Merbarone , a conjugate of thiobarbituric acid and aniline , is a topoisomerase II inhibitor , which thus inhibits DNA synthesis and tumor growth . Piroxantrone , an anthracenedione derivative , is a DNA intercalating agent that has shown potent antitumor activity in animal studies . PURPOSE Our r and omized phase II study was design ed to evaluate the efficacy and toxicity of these agents in the treatment of stage IV metastatic non-small-cell lung cancer . METHODS Eligible patients ( 119 ) were r and omly assigned to receive one of the three treatments given every 3 weeks : 250 mg/m2 taxol by a 24-hour intravenous infusion , 1000 mg/m2 merbarone by continuous intravenous infusion through a central catheter daily for 5 days , or 150 mg/m2 piroxantrone by intravenous infusion over 1 hour . Patients had received no chemotherapy .  Response and toxicity were evaluated every 3 weeks . RESULTS Twenty-five patients were r and omly assigned to receive taxol , 47 to receive merbarone , and 47 to receive piroxantrone . One of 44 assessable patients ( 2.3 % ) treated with piroxantrone had a complete response . Rates for partial response were 20.8 % ( five of 24 patients ) and 5.7 % ( two of 35 ) for assessable patients treated with taxol or merbarone , respectively . One-year survival rates were 41.7 % , 21.6 % , and 22.6 % , and median survival times were 24.1 , 19.9 , and 29.3 weeks for taxol , merbarone , and piroxantrone , respectively . These differences were not statistically significant , but this study was not design ed to compare survival . In general , toxicity was manageable . With premedication , no anaphylaxis was observed with taxol . The most common toxic effects were leukopenia with taxol or  piroxantrone  treatment and thromboembolic complications with merbarone .  Death directly related to treatment occurred in 4 % ( one patient ) , 11.4 % ( four ) , and 5 % ( two ) of the assessable patients receiving taxol , merbarone , and piroxantrone , respectively . Cardiotoxicity and neurotoxicity occurred only occasionally in all three arms . CONCLUSION On the basis of the response rate ( 20.8 % partial response ) and 1-year survival rate ( 41.7 % ) , taxol is an active agent for the treatment of metastatic non-small-cell lung cancer . Merbarone and piroxantrone are relatively inactive . IMPLICATION S Further study of taxol is warranted . In future studies , taxol should be combined with other agents , and granulocyte colony-stimulating factor should be used to ameliorate myelosuppression PURPOSE A phase II r and omized study was conducted to evaluate the efficacy and toxicity of gemcitabine ( GEM ) versus the combination of cisplatin and etoposide ( EP ) in Chinese patients with inoperable ( stage III or IV ) non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS From March 1995 to February 1996 , 53 patients were enrolled onto the study : 27 onto the GEM arm and 26 onto the EP arm . In the GEM arm , gemcitabine 1,250 mg/m2 was given as a 30-minute intravenous ( i.v . ) infusion on days 1 , 8 , and 15 of each 28-day cycle . In the EP arm , cisplatin 80 mg/m2 was given on day 1 and etoposide 80 mg/m2 was given on days 1 , 2 , and 3 of each 28-day cycle . RESULTS Twenty-six patients are assessable for treatment response on the GEM arm and 24 on the EP arm . Five patients ( 19.2 % ) on the GEM arm and five patients ( 20.8 % ) on the EP arm achieved a partial response ( PR ) . No complete responses were attained on either treatment arm . All patients enrolled onto the study were eligible for toxicity assessment . The main toxicities were myelosuppression and vomiting , which included World Health Organization ( WHO ) grade 3 or 4 leukopenia ( 3.7 % ) , thrombocytopenia ( 7.4 % ) , anemia ( 7.4 % ) , and nausea/vomiting ( 3.7 % ) on the GEM arm , and WHO grade 3 or 4 leukopenia ( 30.8 % ) , thrombocytopenia ( 7.7 % ) , anemia ( 15.4 % ) , and nausea/vomiting ( 34.6 % ) on the EP arm . The median survival time was 37 weeks on the GEM arm and 48 weeks on the EP arm . CONCLUSION Gemcitabine is a well-tolerated chemotherapeutic agent for NSCLC . The antitumor activity was promising , with a 19.2 % single-drug response rate , when compared with EP combination chemotherapy , which had a response rate of 20.8 % . The safety profile is better than that of EP treatment PURPOSE The purpose of the study was to assess the possible benefit of the combination vinorelbine (NVB)-cisplatin ( DDP ) in comparison with NVB alone in advanced non-small cell lung cancer ( NSCLC ) , not treated previously . It also involved confirmation of the efficacy of vinorelbine as monotherapy . PATIENTS AND METHODS In this phase III trial , 231 eligible patients were stratified by centre and r and omized to receive either NVB alone , 30 mg/m2/week or the combination of NVB 30 mg/m2/week and  DDP 80 mg/m2/3 weeks . Patients were to be treated for a minimum of 6 weeks , with the first response assessment performed 9 weeks after the beginning of treatment . RESULTS The two groups differed in terms of objective response rates ( 16 % and 43 % , respectively , p = 0.0001 ) and median time to progression ( 10 weeks and 20 weeks , p = 0.0001 ) . However , the difference was not significant for median survival time ( 32 weeks , 33 weeks , p = 0.48 ) . The addition of DDP result ed in an increase in toxicity , in particular renal , hematologic , neurologic and emetic . This toxicity led to treatment discontinuation in 8 % and 21 % of patients , respectively . Respectively 3 % and 13 % of patients stopped treatment early during objective response ( toxicity or refusal ) . CONCLUSIONS The NVB-DDP combination increased objective response rates and time to progression in comparison with NVB alone , but did not influence the survival of patients . The activity of NVB in the treatment of advanced NSCLC was confirmed The costs and cost-effectiveness of different treatments are increasing concerns in healthcare . Vinorelbine ( Navelbine ; Burroughs Wellcome Co , Research Triangle Park , NC ; Pierre Fabre Medicament , Paris , France ) , the first new agent approved for the treatment of metastatic non-small cell lung cancer ( NSCLC ) in more than a decade , was recently approved in the United States . In this report the terminology of cost-effectiveness analysis is review ed and the findings from a comparative cost-effectiveness analysis of three regimens for NSCLC are discussed . The findings are from a r and omized clinical trial of vinorelbine alone versus vinorelbine plus cisplatin versus vindesine plus cisplatin in 612 European patients with NSCLC ( J Clin Oncol 12:360 - 367 , 1994 ) and from cost data from the Medical College of Virginia . In this study the vinorelbine plus cisplatin regimen was the most effective , with a mean survival of 49.6 weeks . Using vinorelbine alone as the baseline , vinorelbine plus cisplatin added 56 days of life at an additional cost of $ 2,700 , result ing in an incremental cost-effectiveness ratio of $ 17,700 per year of life gained . Similarly , vindesine plus cisplatin added 19 days of life at a cost of $ 1,150 , or $ 22,100 per year of life gained . Compared with vindesine plus cisplatin , vinorelbine plus cisplatin added 37 days of life at a cost of $ 1,570 , or $ 15,500 per year of life gained . The cost-effectiveness of the vinorelbine plus cisplatin regimen was within the accepted limits for medical interventions . If vinorelbine is preferred because of its more favorable toxicity profile , adding cisplatin to the treatment regimen substantially increases efficacy at an acceptable cost . The study demonstrated that , compared with other available medical interventions , chemotherapy for NSCLC has acceptable efficacy and cost effectiveness . Access to treatment should not be denied on the basis of clinical or economic grounds Vinorelbine represents one of the most active agents in advanced non-small cell lung cancer ( NSCLC ) , with response rates of 14 - 33 % . We therefore evaluated the activity and tolerability of two novel vinorelbine-containing regimens in stage IIIB-IV NSCLC . Fifty-two patients were enrolled in a r and omized phase II study of cisplatinum ( 100 mg/m(2 ) ) day 1 , mitomycin-C ( 8 mg/m(2 ) ) day 1 , and vinorelbine ( 25 mg/m(2 ) ) days 1 and 8 ( Arm A ) ; and carboplatin ( 400 mg/m(2 ) ) day 1 , in combination with vinorelbine ( 25 mg/m(2 ) ) days 1 and 8 ( Arm B ) . Cycles were repeated every 3 weeks . All patients were assessable for reponse and side effects . Patients were well balanced between the two Arms in terms of major characteristics . A total of 98 and 91 cycles were delivered respectively in Arm A and Arm B. Eleven objective responses ( 42 % ; 95 % confidence interval 26 - 63 % ) were observed in Arm A and 7 responses ( 27 % ; 95 % confidence interval 12 - 48 % ) in Arm B. Main toxicity was mild or moderate , nausea and vomiting for Arm A and hematological for Arm B. Other side effects included infections and phlebitis and were similar for the two Arms . In conclusion , both schedules demonstrated activity in advanced NSCLC . The three-drug regimen appeared very promising in terms of activity and manageable toxicity PURPOSE To evaluate whether the addition of gemcitabine ( G ) to vinorelbine ( V ) improves survival and quality of life ( QoL ) among elderly patients with advanced non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS Patients with NSCLC aged > /= 70 years with advanced disease were r and omly allocated to receive V 30 mg/m(2 ) on days 1 and 8 every 3 weeks or G 1,200 mg/m(2 ) + V 30 mg/m(2 ) on days 1 and 8 every 3 weeks . The estimated sample size was 120 patients per arm , but an interim analysis of survival was planned based on the first 60 patients per arm . RESULTS In May 1999 , the survival data were analyzed of 120 eligible patients ( V group = 60 ; G + V group = 60 ) who had been r and omized from June 1997 to February 1999 . Forty-nine patients had stage IIIB disease , and 71 had stage IV . At a median potential follow-up of 14 months ( range , 3 to 22 months ) , 93 patients had died ( G + V group = 41 ; V group = 52 ) . In the G + V group , median survival time was 29 weeks and projected 1-year survival was 30 % ; these values were 18 weeks and 13 % in the V group . According to multivariate Cox analysis , the risk of death in the G + V arm compared with the V arm was 0.48 ( 95 % confidence interval , 0 . 29 to 0.79 ; P < .01 ) . Combination therapy was also associated with a clear delay in symptom and QoL deterioration . The overall response rates were 22 % and 15 % in the G + V and V groups , respectively . CONCLUSION In elderly patients with NSCLC , G + V treatment is associated with significantly better survival than is V alone Statistics Canada ( Ottawa , Ontario , Canada ) is in the process of developing the Population Health Model to simulate the health and common illnesses of Canadians . The Population Health Model incorporates a lung cancer module that is based on contemporary Canadian practice . This microsimulation model can be used to estimate the total direct care costs of treating all lung cancer cases diagnosed in Canada and to evaluate the cost and cost-effectiveness of new therapeutic interventions as they are introduced into practice . Gemcitabine , a new nucleoside analogue with a broad spectrum of antitumor activity , is about to be introduced on the Canadian market . The Population Health Model has been used to estimate the cost-effectiveness of gemcitabine in the management of lung cancer over a range of drug doses per treatment cycle starting at 1,000 mg/m2 weekly x 3 , as well as potential survival benefits . The  survival of stage IV non-small cell lung cancer ( NSCLC ) patients treated on an international trial of gemcitabine ( EO-18 ) was used to estimate the potential survival gain relative to the survival of stage IV NSCLC patients managed with best supportive care on a r and omized trial conducted by the National Cancer Institute of Canada ( BR 5 ) . Sensitivity analyses were performed assuming that the survival gain was 25 % or 50 % less than that reported in the EO-18 trial . The perspective of the economic analysis is that of the government as payer in a universal health care system , and all costs are expressed in 1993 Canadian dollars . Based on the apparent survival advantage of the EO-18 trial in comparison to best supportive care , the cost per life-year gained ranged from $ 632 to $ 9,285 , depending on the dose per treatment cycle . At the highest dose per cycle ( 2,000 mg/m2 ) and with survival reduced by 50 % as compared with the EO-18 result , the cost per life-year gained was estimated to be $ 17,390 . From these estimates of direct care costs in the Canadian health care system , gemcitabine appears to be a cost-effective intervention for advanced NSCLC OBJECTIVE --To compare responses of patients with cancer with those of a matched control group , cancer specialists , general practitioners , and cancer nurses in assessing personal cost-benefit of chemotherapy . DESIGN -- Prospect i ve study of consecutively recruited patients with cancer and other groups by question naire ; half of the patients received the question naire again three months after starting treatment . SETTING --A medical oncology ward of a London teaching hospital . SUBJECTS--106 Patients with newly diagnosed solid tumours referred to the unit for consideration of treatment with cytotoxic chemotherapy , 100 of whom were able to complete the question naire . 100 Matched controls , 315 cancer doctors ( 238 radiotherapists and 77 medical oncologists ) , 1500 r and omly chosen general practitioners , and 1000 r and omly chosen cancer nurses . MAIN OUTCOME MEASURES --Percentage chance of cure , prolonging life , or palliation of symptoms required to make treatment worth while with two hypothetical chemotherapy treatments , with severe and mild side effects respectively . RESULTS --Respondents to the question naire comprised 100 patients , 100 controls , 60 ( 78 % ) medical oncologists , 88 ( 37 % ) radiotherapists , 790 ( 53 % ) general practitioners , and 303 ( 30 % ) cancer nurses . Most patients were willing to accept intensive chemotherapy for a very small chance of benefit . The median benefit required to make the hypothetical intensive treatments worth while for patients compared with controls were : for chance of a cure ( range 1 to 100 % ) 1 % v 50 % , for prolonging life ( range three months to five years ) 12 months v 24 - 60 months , and for relief of symptoms ( range 1 to 100 % ) 10 % v 75 % respectively . There were no significant differences in the responses of the 50 patients completing the question naire on a second occasion . Doctors and nurses were less likely to accept radical treatment for minimal benefit compared with the patients ( median scores 10 - 50 % , 12 - 24 months , and 50 - 75 % , for chance of cure , prolonging life , and relief of symptoms respectively ) . Significantly more patients than controls accepted treatments giving the minimal benefit for each category ( cure 53.1 v 19.0 % , 67.0 v 35.0 % ; prolonging life 42.1 v 10.0 % , 53.0 v 25.0 % ; relief of symptoms 42.6 v 10.0 % , 58.7 v 19.0 % for intensive and mild treatments respectively , p less than 0.001 ) as was the case for comparison of patients with other groups . CONCLUSION -- Patients with cancer are much more likely to opt for radical treatment with minimal chance of benefit than people who do not have cancer , including medical and nursing professionals . This could be taken into account when discussing treatment options with patients and their relatives BACKGROUND The entry of patients into r and omised clinical trials ( RCTs ) in lung cancer is low . A study was undertaken to assess the reasons why patients with non-small cell lung cancer did not enter a trial involving r and omisation to receive or not receive three courses of cisplatin based chemotherapy in addition to primary treatment by surgery , radiotherapy , or best supportive care . METHODS The study was carried out in two large London institutions with a special interest in recruiting patients to lung cancer trials . Patients recently diagnosed as having non-small cell lung cancer were prospect ively identified and followed to see whether they entered the RCT and , if not , to identify the main reasons why . RESULTS Six hundred and eighty eight patients newly diagnosed with non-small cell lung cancer were identified between November 1995 and July 1998 ; 274 ( 39.8 % ) were deemed ineligible for the RCT for clinical reasons , most frequently their general condition rendering them unfit for chemotherapy . Another 161 ( 23.4 % ) were ineligible for logistical reasons —for example , they were discharged to centres not participating in the RCT or they were not considered for the trial at an appropriate time in their management . Of 253 potentially eligible patients , only 63 ( 24.9 % of those eligible ) agreed to enter the RCT and four entered another study . Of those who did not enter , 77 ( 41.4 % ) declined without stating a reason , 61 ( 32.8 % ) did not want  chemotherapy  , and only eight ( 4.3 % ) expressed a wish to have chemotherapy .  CONCLUSIONS Despite considerable time and effort , the proportion of patients recruited was small ( 9.2 % ) . Many seen were ineligible but , of 253 potentially eligible patients , 186 ( 73.5 % ) refused to enter the RCT BACKGROUND In phase II trials , paclitaxel has been shown to have antitumor activity in patients with advanced non-small-cell lung cancer ( NSCLC ) . However , the survival and quality -of-life ( QOL ) benefits of paclitaxel used as a single agent compared with supportive care alone have not been assessed in a r and omized clinical trial . METHODS A total of 157 patients with stage IIIB or IV NSCLC who had received no prior chemotherapy were r and omly assigned to receive either best supportive care alone ( 78 patients ) or paclitaxel plus supportive care ( 79 patients ) . Paclitaxel was administered as a 3-hour intravenous infusion every 3 weeks . Supportive care included palliative radiotherapy and supportive therapy with corticosteroids , antibiotics , analgesics , antiemetics , transfusions , and other symptomatic therapy as required . The primary end point of the study was survival . Time to disease progression , response rate , adverse events , and QOL were secondary end points . RESULTS Pretreatment characteristics were evenly distributed between the two arms . Survival was statistically significantly better in the paclitaxel plus supportive care arm than in the supportive care alone arm ( two-sided P = .037 ) ( median survival = 6.8 months versus 4.8 months ) . Cox multivariate analysis showed paclitaxel plus supportive care to be statistically significantly associated with improved survival ( two-sided P = .048 ) . QOL was similar for both treatment arms , except for the functional activity score of the Rotterdam Symptom Checklist , where QOL data statistically significantly favored the paclitaxel plus supportive care arm ( two-sided P = .043 ) . CONCLUSION The addition of paclitaxel to best supportive care significantly improved survival and time to disease progression compared with best supportive care in patients with advanced NSCLC and may improve some aspects of QOL
BACKGROUND The incidence of lung cancer is declining following a drop in smoking rates , but it is still the leading cause of death from cancer in Engl and and Wales , with about 30,000 deaths a year .
Survival rates for lung cancer are poor everywhere , but they appear to be better in the rest of the European Community and the USA than in the UK .
Only about 5 per cent of people with lung cancer survive for 5 years , and nearly all of these are cured by surgery after fortuitously early diagnosis .
At present , only a small proportion of patients ( probably about 5 per cent ) with non-small-cell lung cancer are being given chemotherapy .
Some centres treat a greater proportion .
OBJECTIVES This review examines the clinical effectiveness and cost-effectiveness of four of the newer drugs - vinorelbine , gemcitabine , paclitaxel and docetaxel - used for treating the most common type of lung cancer ( non-small-cell lung cancer ) .
The first three drugs are used for first-line treatment , but at present docetaxel is used only after first-line chemotherapy has failed .
RESULTS - COSTS : The total cost to the NHS of using these new drugs in Engl and and Wales might be about GBP 10 million per annum , but is subject to a number of factors .
CONCLUSIONS - IMPLICATION S OF THE NEWER DRUGS : One of the present constraints on chemotherapy is availability of inpatient beds .
The advent of newer and gentler forms of chemotherapy given on an outpatient basis would not only overcome this , but it would allow more patients to be treated .
This might apply particularly to older patients .
The treatment of more patients would increase workload for oncologists , cancer nurses and pharmacists .