Estimating quality adjusted progression free survival of first-line treatments for EGFR mutation positive non small cell lung cancer patients in The Netherlands

Health and Quality of Life Outcomes

Anne-Marie C Dingemans⁴  Maria A de Peuter¹  Merel K Langenfeld²  Feike W van der Scheer²  Franz MNH Schramel⁵  Bonne Biesma³  S Cora Verduyn¹ 

[1] Mapi Consultancy, Houten, The Netherlands;AstraZeneca NL, Zoetermeer, The Netherlands;Department of Pulmonology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands;Department of Pulmonology, Maastricht University Medical Center, Maastricht, The Netherlands;Department of Pulmonology, Sint Antonius Hospital, Nieuwegein, The Netherlands

关键词: Progression free survival;    Quality of life;    Gefitinib;    EGFR mutation;    Tyrosine kinase inhibitors;    Advanced non-small cell lung cancer;   

Others  :  825162
DOI  :  10.1186/1477-7525-10-108

 received in 2012-03-02, accepted in 2012-08-31,  发布年份 2012

【 摘 要 】

Background

Gefitinib, a tyrosine kinase inhibitor, is an effective treatment in advanced non-small cell lung cancer (NSCLC) patients with an activating mutation in the epidermal growth factor receptor (EGFR). Randomised clinical trials showed a benefit in progression free survival for gefitinib versus doublet chemotherapy regimens in patients with an activated EGFR mutation (EGFR M+). From a patient perspective, progression free survival is important, but so is health-related quality of life. Therefore, this analysis evaluates the Quality Adjusted progression free survival of gefitinib versus three relevant doublet chemotherapies (gemcitabine/cisplatin (Gem/Cis); pemetrexed/cisplatin (Pem/Cis); paclitaxel/carboplatin (Pac/Carb)) in a Dutch health care setting in patients with EGFR M+ stage IIIB/IV NSCLC. This study uses progression free survival rather than overall survival for its time frame in order to better compare the treatments and to account for the influence that subsequent treatment lines would have on overall survival analysis.

Methods

Mean progression free survival for Pac/Carb was obtained by extrapolating the median progression free survival as reported in the Iressa-Pan-Asia Study (IPASS). Data from a network meta-analysis was used to estimate the mean progression free survival for therapies of interest relative to Pac/Carb. Adjustment for health-related quality of life was done by incorporating utilities for the Dutch population, obtained by converting FACT-L data (from IPASS) to utility values and multiplying these with the mean progression free survival for each treatment arm to determine the Quality Adjusted progression free survival. Probabilistic sensitivity analysis was carried out to determine 95% credibility intervals.

Results

The Quality Adjusted progression free survival (PFS) (mean, (95% credibility interval)) was 5.2 months (4.5; 5.8) for Gem/Cis, 5.3 months (4.6; 6.1) for Pem/Cis; 4.9 months (4.4; 5.5) for Pac/Carb and 8.3 (7.0; 9.9) for gefitinib.

Conclusions

In the Dutch health care setting, the previously established progression free survival benefit of first-line gefitinib in advanced NSCLC EGFR M+ patients in comparison to standard doublet chemotherapy is further supported by the Quality Adjusted PFS, which takes into account the additional health-related quality of life benefits of gefitinib over doublet chemotherapy.

【 授权许可】

   
2012 Verduyn et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]D'Addario G, Fruh M, Reck M, Baumann P, Klepetko W, Felip E: Metastatic non-small-cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow up. Ann Oncol 2010, 21(SUPPL 5):v116-v119. Date of Publication: May 2010 2010;v116-v119
• [2]Gupta A, Raina V: Geftinib. J Cancer Res Ther 2010, 6:249-254.
• [3]Maemondo M, Inoue A, Kobayashi K, Sugawara S, Oizumi S, Isobe H, Gemma A, Harada M, Yoshizawa H, Kinoshita I, Fujita Y, Okinaga S, Hirano H, Yoshimori K, Harada T, Ogura T, Ando M, Miyazawa H, Tanaka T, Saijo Y, Hagiwara K, Morita S, Nukiwa T: Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010, 362:2380-2388.
• [4]Mitsudomi T, Morita S, Yatabe Y, Negoro S, Okamoto I, Tsurutani J, Seto T, Satouchi M, Tada H, Hirashima T, Asami K, Katakami N, Takada M, Yoshioka H, Shibata K, Kudoh S, Shimizu E, Saito H, Toyooka S, Nakagawa K, Fukuoka M: Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol 2010, 11:121-128.
• [5]Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M: Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009, 361:947-957.
• [6]AstraZeneca: NICE, SINGLE TECHNOLOGY APPRAISAL (STA) for Gefitinib for the first line treatment of locally advanced or metastatic non-small lung cancer. 2010. http://www.nice.org.uk/nicemedia/live/12185/47251/47251.pdf webcite
• [7]Lee JS, Park K, Kim SW, Lee DH, Kim HT, Han YT, Yun T, Ahn JS, Suh C, Lee JS, Yu SY, Han JH, Lee JW, Sook JJ: A randomized Phase III study of gefitinib (IressaTM) versus standard chemotherapy (Gemcitabine and Cisplatin) as a first line treatment for never smokers with advanced or metastatic adenocarcinoma of the lung. San Francisco: 13th Biennial World Conference on Lung Cancer of the International Association for the Study of Lung Cancer (IASLC); 2009.
• [8]Yang C-H, Fukuoka M, Mok TS, Wu Y-L, Thongprasert S, Saijo N, Chu D-T, Jiang H, Duffield EL, Ichinose Y: Final overall survival (OS) results from a phase iii, randomised, open-label, first-line study of gefitinib (G) v carboplatin/paclitaxel (C/P) in clinically selected patients with advanced nonsmall cell lung cancer (NSCLC) in Asia (IPASS). Ann Oncol 2010, 21:viii1-viii2.
• [9]Thongprasert S, Duffield E, Wu Y, Yang C, Saijo N, Chu DT, Chan V, Mok T, Magill P, Fukuoka M: Quality Of Life (Qol) In A Randomized Phase III First-Line Study Of Gefitinib (G) Vs Carboplatin/Paclitaxel (CP) In Clinically Selected Asian Patients (Pts) With Advanced NSCLC (IPASS). J Thorac Oncol 2010, 5:S80-S81.
• [10]Praktijkonderzoek CDN: Customer information. Naarden, Netherlands: Cegedim; 2008. 2008
• [11]Lamers LM, Uyl-de Groot CA, Buijt I: The use of disease-specific outcome measures in cost-utility analysis: the development of Dutch societal preference weights for the FACT-L scale. Pharmacoeconomics 2007, 25:591-603.
• [12]Grutters JP, Joore MA, Wiegman EM, Langendijk JA, de Ruysscher D, Hochstenbag M, Botterweck A, Lambin P, Pijls-Johannesma M: Health-related quality of life in patients surviving non-small cell lung cancer. Thorax 2010, 65:903-907.
• [13]Latimer N: NICE DSU technical support document 14: survival analysis for economic evaluations alongside clinical trials - extrapolation with patient-level data. http://www.nicedsu.org.uk/NICE%20DSU%20TSD%20Survival%20analysis_finalv2.pdf webcite
• [14]Nafees B, Stafford M, Gavriel S, Bhalla S, Watkins J: Health state utilities for non small cell lung cancer. Health Qual Life Outcomes 2008, 6:84. BioMed Central Full Text
• [15]Doyle S, Lloyd A, Walker M: Health state utility scores in advanced non-small cell lung cancer. Lung Cancer 2008, 62:374-380.
• [16]Tabberer M, Stamuli E, Walker M, Summerhayes M, Lees M: Utilities associated with Non-Small Cell Lung Cancer (Nsclc): a community study. Value Health 2006, 9:A298.
• [17]Rosell R, Moran T, Queralt C, Porta R, Cardenal F, Camps C, Majem M, Lopez-Vivanco G, Isla D, Provencio M, Insa A, Massuti B, Gonzalez-Larriba JL, Paz-Ares L, Bover I, Garcia-Campelo R, Moreno MA, Catot S, Rolfo C, Reguart N, Palmero R, Sanchez JM, Bastus R, Mayo C, Bertran-Alamillo J, Molina MA, Sanchez JJ, Taron M: Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med 2009, 361:958-967.
• [18]de Lima LG Jr, Segel JE, Tan DS, Do YK, Mok T, Finkelstein EA: Cost-effectiveness of epidermal growth factor receptor mutation testing and first-line treatment with gefitinib for patients with advanced adenocarcinoma of the lung. Cancer 2012, 118:1032-1039.
• [19]Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C: Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. J clin oncol 2009, 27:1227-1234.
• [20]Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C: Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol 2010, 21:1804-1809.