DOI: https://doi.org/10.15587/2519-4852.2019.165681

Аналіз досліджень щодо переваг клінічної та економічної ефективності, безпеки інноваційного препарату цетуксимаб в лікуванні колоректального раку

Elena Litvinova

Анотація


Метою роботи є аналіз та систематизація даних літератури щодо переваг клінічної та економічної ефективності, безпеки цетуксимабу в лікуванні колоректального раку.

Матеріали та методи. Дослідження проводилися з використанням баз даних в мережі Інтернет: PubMed; Адміністрації з контролю за ліками та харчовими продуктами (Food and Drug Administration), Європейського агентства лікарських засобів (European Medicines Agency). Використано ретроспективний, логічний, статистичний та системно-аналітичний методи дослідження.

Результати. Проведений аналіз клінічних даних свідчить про додаткову корисність, високу ефективність цетуксимабу при лікуванні пацієнтів з метастатичним КРР RAS дикого типу та експресією рецепторів епідермального фактора росту EGFR в порівнянні з іншими препаратами. Цетуксимаб виявляє синергічну дію з рядом цитостатичних лікарських засобів (ЛЗ), а також підвищує ефект променевої терапії, при цьому посилення токсичних реакцій при спільному застосуванні не спостерігається. Включення цетуксимабу в схему лікування збільшує резектабельність первинно нерезектабельних метастазів в печінку, а також виживання без прогресування як у оперованих пацієнтів, так і в неоперабельних випадках. Препарат визнаний відносно безпечним. Шкірні висипи, викликані цетуксимабом, пов’язані зі значним поліпшенням показників загального виживання, виживання без прогресування і загальної частотою відповіді. Застосування цетуксимабу у пацієнтів КРР супроводжується меншим економічним навантаженням на бюджет лікарського забезпечення онкологічних хворих, ніж бевацизумаб. Слід зазначити, що створення біосимілярів цетуксимабу дозволить зменшити вартість лікування та підвищити доступ до терапії КРР.

Висновки. Таким чином, доведено, що цетуксимаб є не тільки клінічно ефективним та відносно безпечним ЛЗ для лікування КРР, але також показана його економічна ефективність та додаткові переваги в порівнянні з іншими препаратами, зокрема бевацизумабом


Ключові слова


цетуксимаб; колоректальний рак; клінічна та економічна ефективність; безпека; рецептор епідермального фактора росту

Повний текст:

PDF (English)

Посилання


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Пристатейна бібліографія ГОСТ


Cancer prevention and control through an integrated approach. Geneva: World Health Organization, 2017. URL: http://apps.who.int/gb/ebwha/pdf_files/WHA70-REC1/A70_2017_REC1-en.pdf

Celis J. E., Pavalkis D. A mission-oriented approach to cancer in Europe: a joint mission/vision 2030 // Molecular Oncology. 2017. Vol. 11, Issue 12. P. 1661–1672. doi: http://doi.org/10.1002/1878-0261.12143 

Mach J. P. Recombinant monoclonal antibodies, from tumor targetingto cancer immunotherapy, a critical overview // Molecular biology. 2017. Vol. 51, Issue 6. P. 1024–1038. doi: http://doi.org/10.7868/s0026898417060131 

Kelly R. J., Smith T. J. Delivering maximum clinical benefit at an affordable price: engaging stakeholders in cancer care // The Lancet Oncology. 2014. Vol. 15, Issue 3. P. e112–e118. doi: http://doi.org/10.1016/s1470-2045(13)70578-3 

New treatments for advanced cancer: an approach to prioritization / Ferguson J. S. J., Summerhayes M., Masters S., Schey S., Smith I. E. // British Journal of Cancer. 2000. Vol. 83, Issue 10. P. 1268–1273. doi: http://doi.org/10.1054/bjoc.2000.1406 

Collins M., Latimer N. NICE’s end of life decision making scheme: impact on population health // BMJ. 2013. Vol. 346, Issue 1. P. 1363–1363. doi: http://doi.org/10.1136/bmj.f1363 

Dilts D.M. Time Has Come to Raise the Bar in Oncology Clinical Trials // Journal of Clinical Oncology. 2014. Vol. 32, Issue 12. P. 1186–1187. doi: http://doi.org/10.1200/jco.2013.54.5277 

Polyakova D. Half of the new drugs does not carry additional benefits // Weekly Pharmacy. 2019. Vol. 1174, Issue 3. URL: https://www.apteka.ua/article/487540

EPIC: Phase III Trial of Cetuximab Plus Irinotecan After Fluoropyrimidine and Oxaliplatin Failure in Patients With Metastatic Colorectal Cancer / Sobrero A. F., Maurel J., Fehrenbacher L., Scheithauer W., Abubakr Y. A., Lutz M. P. et. al. // Journal of Clinical Oncology. 2008. Vol. 26, Issue 14. P. 2311–2319. doi: http://doi.org/10.1200/jco.2007.13.1193 

Randomized phase III study of irinotecan and 5FU/FA with or without cetuximab in the first-line treatment of patients with metastatic colorectal cancer. CRYSTAL trial / Cutsem E. Van, Nowacki M., Lang I., Cascinu S., Shchepotin I. et. al. // Journal of Clinical Oncology. 2007. Vol. 25, Issue 18. P. 164.

Cetuximab Plus Irinotecan, Fluorouracil, and Leucovorin As First-Line Treatment for Metastatic Colorectal Cancer: Updated Analysis of Overall Survival According to Tumor KRAS and BRAF Mutation Status / Van Cutsem E., Köhne C.-H., Láng I., Folprecht G., Nowacki M. P., Cascinu S. et. al. // Journal of Clinical Oncology. 2011. Vol. 29, Issue 15. P. 2011–2019. doi: http://doi.org/10.1200/jco.2010.33.5091 

Cetuximab Monotherapy and Cetuximab plus Irinotecan in Irinotecan-Refractory Metastatic Colorectal Cancer / Cunningham D., Humblet Y., Siena S., Khayat D., Bleiberg H., Santoro A. et. al. // New England Journal of Medicine. 2004. Vol. 351, Issue 4. P. 337–345. doi: http://doi.org/10.1056/nejmoa033025 

Randomized trial comparing cetuximab plus XELIRI versus cetuximab plus XELOX as first line treatment of patients with metastatic colorectal cancer (mCRC): A study of the german AIO CRC study group / Heinemann V., von Weikersthal L. F., Vehling-Kaiser U., Stauch M., Oruzio D., Schulze M. et. al. // Journal of Clinical Oncology. 2008. Vol. 26, Issue 15. P. 4033–4033. doi: http://doi.org/10.1200/jco.2008.26.15_suppl.4033 

Intermittent chemotherapy (CT) plus continuous or intermittent cetuximab (C) in the first-line treatment of advanced colorectal cancer (aCRC): Results of the two-arm phase II randomized MRC COIN-B trial. / Wasan H., Adams R. A., Wilson R. H., Pugh C., Fisher D., Madi A. et. al. // Journal of Clinical Oncology. 2012. Vol. 30, Issue 4. P. 536–536. doi: http://doi.org/10.1200/jco.2012.30.4_suppl.536 

Randomized Controlled Trial of Cetuximab Plus Chemotherapy for Patients WithKRASWild-Type Unresectable Colorectal Liver-Limited Metastases / Ye L.-C., Liu T.-S., Ren L., Wei Y., Zhu D.-X., Zai S.-Y. et. al. // Journal of Clinical Oncology. 2013. Vol. 31, Issue 16. P. 1931–1938. doi: http://doi.org/10.1200/jco.2012.44.8308 

Phase II trial of biweekly cetuximab and irinotecan as third-line therapy for pretreated KRAS exon 2 wild-type colorectal cancer / Osumi H., Shinozaki E., Mashima T., Wakatsuki T., Suenaga M., Ichimura T. et. al. // Cancer Science. 2018. Vol. 109, Issue 8. P. 2567–2575. doi: http://doi.org/10.1111/cas.13698 

Efficacy, Tolerability, and Biomarker Analyses of Once-Every-2-Weeks Cetuximab Plus First-Line FOLFOX or FOLFIRI in Patients With KRAS or All RAS Wild-Type Metastatic Colorectal Cancer: The Phase 2 APEC Study / Cheng A.-L., Cornelio G., Shen L., Price T., Yang T.-S., Chung I. J. et. al. // Clinical Colorectal Cancer. 2017. Vol. 16, Issue 2. P. 73–88. doi: http://doi.org/10.1016/j.clcc.2016.08.005 

Perioperative Triplet Chemotherapy and Cetuximab in Patients With RAS Wild Type High Recurrence Risk or Borderline Resectable Colorectal Cancer Liver Metastases / Pietrantonio F., Di Bartolomeo M., Cotsoglou C., Mennitto A., Berenato R., Morano F. et. al. // Clinical Colorectal Cancer. 2017. Vol. 16, Issue 3. P. 191–198. doi: http://doi.org/10.1016/j.clcc.2016.09.007 

Impact of BRAF and RAS mutations on first-line efficacy of FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab: analysis of the FIRE-3 (AIO KRK-0306) study / Stintzing S., Miller-Phillips L., Modest D. P., Fischer von Weikersthal L., Decker T., Kiani A. et. al. // European Journal of Cancer. 2017. Vol. 79. P. 50–60. doi: http://doi.org/10.1016/j.ejca.2017.03.023 

Pharmacogenetic determinants of outcomes on triplet hepatic artery infusion and intravenous cetuximab for liver metastases from colorectal cancer (European trial OPTILIV, NCT00852228) / Lévi F., Karaboué A., Saffroy R., Desterke C., Boige V., Smith D. et. al. // British Journal of Cancer. 2017. Vol. 117, Issue 7. P. 965–973. doi: http://doi.org/10.1038/bjc.2017.278 

A Phase Ib Dose-Escalation Study of Encorafenib and Cetuximab with or without Alpelisib in Metastatic BRAF-Mutant Colorectal Cancer / Van Geel R. M. J. M., Tabernero J., Elez E., Bendell J. C., Spreafico A., Schuler M. et. al. // Cancer Discovery. 2017. Vol. 7, Issue 6. P. 610–619. doi: http://doi.org/10.1158/2159-8290.cd-16-0795 

Prognostic Impact of Primary Tumor Location on Clinical Outcomes of Metastatic Colorectal Cancer Treated With Cetuximab Plus Oxaliplatin-Based Chemotherapy: A Subgroup Analysis of the JACCRO CC-05/06 Trials / Sunakawa Y., Ichikawa W., Tsuji A., Denda T., Segawa Y., Negoro Y. et. al. // Clinical Colorectal Cancer. 2017. Vol. 16, Issue 3. P. e171–e180. doi: http://doi.org/10.1016/j.clcc.2016.09.010 

Cetuximab continuation after first progression in metastatic colorectal cancer (CAPRI-GOIM): a randomized phase II trial of FOLFOX plus cetuximab versus FOLFOX / Ciardiello F., Normanno N., Martinelli E., Troiani T., Pisconti S., Cardone C. et. al. // Annals of Oncology. 2016. Vol. 27, Issue 6. P. 1055–1061. doi: http://doi.org/10.1093/annonc/mdw136 

Randomized phase II study of cetuximab versus irinotecan and cetuximab in patients with chemo-refractory KRAS codon G13D metastatic colorectal cancer (G13D-study) / Nakamura M., Aoyama T., Ishibashi K., Tsuji A., Takinishi Y., Shindo Y. // Cancer Chemotherapy and Pharmacology. 2016. Vol. 79, Issue 1. P. 29–36. doi: http://doi.org/10.1007/s00280-016-3203-7 

FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab for metastatic colorectal cancer (FIRE-3): a post-hoc analysis of tumour dynamics in the final RAS wild-type subgroup of this randomised open-label phase 3 trial / Stintzing S., Modest D. P., Rossius L., Lerch M. M., von Weikersthal L. F., Decker T. et. al. // The Lancet Oncology. 2016. Vol. 17, Issue 10. P. 1426–1434. doi: http://doi.org/10.1016/s1470-2045(16)30269-8 

Fc- Receptor Polymorphisms, Cetuximab Therapy, and Survival in the NCIC CTG CO.17 Trial of Colorectal Cancer / Liu G., Tu D., Lewis M., Cheng D., Sullivan L. A., Chen Z. et. al. // Clinical Cancer Research. 2016. Vol. 22, Issue 10. P. 2435–2444. doi: http://doi.org/10.1158/1078-0432.ccr-15-0414 

A Phase II Study of XELOX and Cetuximab as First-Line Therapy in Patients With KRAS Wild Type Metastatic Colorectal Cancer (FLEET2 Study) / Hazama S., Maeda H., Iwamoto S., Kim H. M., Takemoto H., Kobayashi K. et. al. // Clinical Colorectal Cancer. 2016. Vol. 15, Issue 4. P. 329–336. doi: http://doi.org/10.1016/j.clcc.2016.07.003 

Multicenter phase II study of combination therapy with cetuximab and S-1 in patients with KRAS exon 2 wild-type unresectable colorectal cancer previously treated with irinotecan, oxaliplatin, and fluoropyrimidines (KSCC 0901 study) / Takahashi T., Emi Y., Oki E., Kobayashi K., Tsuji A. et. al. // Cancer Chemotherapy and Pharmacology. 2016. Vol. 78, Issue 3. P. 585–593. doi: http://doi.org/10.1007/s00280-016-3109-4 

Phase II study of cetuximab with irinotecan for KRAS wild-type colorectal cancer in Japanese patients / Terazawa T., Nishitani H., Kato K., Hashimoto H., Akiyoshi, K., Ito Y. // Asia-Pacific Journal of Clinical Oncology. 2015. Vol. 13, Issue 2. P. e132–e137. doi: http://doi.org/10.1111/ajco.12405 

Survival of patients with initially unresectable colorectal liver metastases treated with FOLFOX/cetuximab or FOLFIRI/cetuximab in a multidisciplinary concept (CELIM study)† / Folprecht G., Gruenberger T., Bechstein W., Raab H.-R., Weitz J., Lordick F. et. al. // Annals of Oncology. 2014. Vol. 25, Issue 5. P. 1018–1025. doi: http://doi.org/10.1093/annonc/mdu088 

Abdel-Rahman O., Fouad M. Correlation of cetuximab-induced skin rash and outcomes of solid tumor patients treated with cetuximab: A systematic review and meta-analysis // Critical Reviews in Oncology/Hematology. 2015. Vol. 93, Issue 2. P. 127–135. doi: http://doi.org/10.1016/j.critrevonc.2014.07.005 

Different Toxicity of Cetuximab and Panitumumab in Metastatic Colorectal Cancer Treatment: A Systematic Review and Meta-Analysis / Petrelli F., Ardito R., Ghidini A., Zaniboni A., Ghidini M., Barni S., Tomasello G. // Oncology. 2018. Vol. 94, Issue 4. P. 191–199. doi: http://doi.org/10.1159/000486338 

Efficacy of bevacizumab versus epidermal growth factor receptor inhibitors for wild-type RAS metastatic colorectal cancer: a meta-analysis / Jiang W., Yu Q., Ning R., Zhao W., Wei C. // OncoTargets and Therapy. 2018. Vol. 11. P. 4271–4281. doi: http://doi.org/10.2147/ott.s168695 

The impact of primary tumor location on efficacy of cetuximab in metastatic colorectal cancer patients with different Kras status: a systematic review and meta-analysis / Cao D.-D., Xu H.-L., Xu X.-M., Ge W. // Oncotarget. 2017. Vol. 8, Issue 32. P. 53631–53641. doi: http://doi.org/10.18632/oncotarget.19022 

Overall survival of patients with KRAS wild-type tumor treated with FOLFOX/FORFIRI±cetuximab as the first-line treatment for metastatic colorectal cancer / Yang Y.-F., Wang G.-Y., He J.-L., Wu F.-P., Zhang Y.-N. // Medicine. 2017. Vol. 96, Issue 12. P. e6335. doi: http://doi.org/10.1097/md.0000000000006335 

Cost-Effectiveness of Cetuximab as First-line Treatment for Metastatic Colorectal Cancer in the United States / Shankaran V., Ortendahl J. D., Purdum A. G., Bolinder B., Anene A. M., Sun G. H., Bentley T. G. K. // American Journal of Clinical Oncology. 2015. Vol. 41, Issue 1. P. 65–72. doi: http://doi.org/10.1097/coc.0000000000000231 







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