Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Сравнительный анализ эффективности, безопасности и стоимости применения режимов пеметрексед/цисплатин, бевацизумаб/гемцитабин/цисплатин и гемцитабин/цисплатин в терапии неплоскоклеточного немелкоклеточного рака легкого поздних стадий
Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Ключевые слова: бевацизумаб, цисплатин, затраты, гемцитабин, непрямое сравнение, неплоскоклеточный рак, немелкоклеточный рак легкого, пеметрексед.
________________________________________________
This study evaluated the compared the efficiency, safety, cost-effectiveness of pemetrexed/cisplatin (PemC) and bevacizumab/gemcitabine/cisplatin (BevGC) as treatment for nonsquamous non-small cell lung cancer (NSCLC). An indirect comparative analysis of the JMDB and AVAiL studies provided data on the efficiency and safety of these chemotherapy regimens. Estimation of overall survival (OS) rates indicated a statistically significant increase in this indicator with PemC versus BevGC in a dose of 15 mg/kg (p=0,042). The indirect comparison of OS for PemC and BevGC in a dose of 7,5 mg/kg and a comparative analysis of progression-free survival revealed no statistically significant differences between the groups (p>0,05 for all cases). The relative incidence (odds ratio) of treatment-emergent grade 3–4 toxicity was statistically significantly less in the PemC group than in the BevGC group in doses of 7,5 mg/kg (p=0,013) and 15 mg/kg (p<0,001). Calculation of cost-effectiveness for the Russian health care system, which has been made from the data on the average cost, duration, and safety of the above regimens, has shown that the average cost of saving with PemC versus BevGC in 7,5 mg/kg will be 339,392 rubles. These data suggest that it is expedient to use PemC as firtst-line chemotherapy for nonsquamous NSCLC.
Key words: bevacizumab, cisplatin, expenditures, gemcitabine, indirect comparison, nonsquamous cancer, non-small cell lung cancer, pemetrexed.
2. Sandler A, Gray R, Perry MC et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006; 355 (24): 2542–50.
3. Reck M, von Pawel J, Zatloukal P et al. Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results fr om a randomised phase III trial (AVAiL). Ann Oncol 2010; 21 (9): 1804–9.
4. Scagliotti GV, Parikh P, von PJ et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 2008; 26 (21): 3543–51.
5. Nuijten M, Heigener DF, Bischoff HG et al. Effectiveness of bevacizumab- and pemetrexed-cisplatin treatment for patients with advanced non-squamous non-small cell lung cancer. Lung Cancer 2010; 69 (Suppl. 1): s4–10.
6. Reck M, von Pawel J, Zatloukal P et al. 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 (8): 1227–34.
7. Scagliotti G, Hanna N, Fossella F et al. The differential efficacy of pemetrexed according to NSCLC histology: a review of two Phase III studies. Oncologist 2009; 14 (3): 253–63.
8. Bucher HC, Guyatt GH, Griffith LE et al. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol 1997; 50 (6): 683–91.
9. Register of Lim it Selling prices on the SLDL. http://grls.rosminzdrav.ru/pricelims.aspx
10. Price lists of local distributors. http://www.pharmindex.ru
11. In-patient bed-day costs, 2010 State Guarantees Program. http://www.minzdravsoc.ru/docs/government/postan/250
12. Pazdur R. Memorandum to the file BLA 125 085 Avastin (bevacizumab). FDA Center for Drug Evaluation and Research 2010. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders...
13. Ranpura V, Hapani S, Wu S. Treatment-related mortality with bevacizumab in cancer patients: a meta-analysis. JAMA 2011; 305 (5): 487–94.
14. Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (Vers. 4.3). Australian Pharmaceutical Benefits Advisory Committee 2008. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbacguidelines-index
1 Азиатско-Тихоокеанское отделение статистических наук, Эли Лилли Австралия Лтд., Сидней, Австралия
2 Эли Лилли Интерамерика Инк., Буэнос-Айрес, Аргентина
3 Институт пульмонологии, Санкт-Петербург, Россия
4 Отдел оценки медицинских технологий, Эли Лилли Австралия Лтд., Сидней, Австралия
5 Иллюминейт хелс консалтинг, Сидней, Австралия
6 Эли Лилли Восток С.А., Москва, Россия
7 Эли Лилли энд Компани, Индианаполис, США
________________________________________________
Helen Barraclough, Mauro Orlando, Sergei Orlov, Narayan Rajan, Peter Davey, Yana Canivets, Baoguang Han, Alan Brnabic