Prospective Observational Cohort Study to Describe the Use of Panitumumab in Combination with Chemotherapy in Real-World Clinical Practice for Patients with Wild-Type RAS mCRC
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu časopisecké články, pozorovací studie, práce podpořená grantem
PubMed
30689133
PubMed Central
PMC6824336
DOI
10.1007/s12325-019-0874-6
PII: 10.1007/s12325-019-0874-6
Knihovny.cz E-zdroje
- Klíčová slova
- Metastatic colorectal cancer, Observational study, Panitumumab, RAS wild-type, Real-world data, Tumor location,
- MeSH
- dospělí MeSH
- fluoruracil aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- kamptothecin aplikace a dávkování škodlivé účinky analogy a deriváty terapeutické užití MeSH
- kohortové studie MeSH
- kolorektální nádory farmakoterapie patologie MeSH
- leukovorin aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- metastázy nádorů MeSH
- monoklonální protilátky terapeutické užití MeSH
- organoplatinové sloučeniny aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- panitumumab aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- prospektivní studie MeSH
- protokoly protinádorové kombinované chemoterapie aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- Ras proteiny biosyntéza MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- pozorovací studie MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Evropa MeSH
- Názvy látek
- fluoruracil MeSH
- kamptothecin MeSH
- leukovorin MeSH
- monoklonální protilátky MeSH
- organoplatinové sloučeniny MeSH
- panitumumab MeSH
- Ras proteiny MeSH
INTRODUCTION: This study aimed to better understand panitumumab use in real-life clinical practice in first- and second-line treatment of metastatic colorectal cancer in five European countries. METHODS: This is a combined analysis of two observational, non-interventional prospective cohort studies, one of which was conducted in Germany and France, the other in Bulgaria, Czech Republic, and Hungary. The studies observed patients with wild-type [Kirsten] rat sarcoma viral oncogene homolog ([K]RAS/RAS) metastatic colorectal cancer (mCRC), who had been treated with panitumumab in combination with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) in the first line or with panitumumab combined with fluorouracil, leucovorin, and irinotecan (FOLFIRI) in the second line following fluoropyrimidine-based chemotherapy. The planned duration of observation was 12 months from the first dose of panitumumab. RESULTS: A total of 332 patients treated with panitumumab + FOLFOX in the first line and 94 patients treated with panitumumab + FOLFIRI in the second line were analyzed. The median number of panitumumab infusions was 10.0 in first-line FOLFOX patients and 11.5 in second-line FOLFIRI patients; the median duration of panitumumab exposure was 5.7 and 6.9 months, respectively. The unadjusted overall response rate (complete or partial response) in patients with available post-baseline response assessment (n = 290) was 51.7% in first-line FOLFOX and 44.9% in second-line FOLFIRI patients. In the first-line setting, resectability was achieved in 9.3%. Reported hospitalizations were mostly cancer-related visits such as scheduled anticancer treatment administrations, tumor assessment visits, or interventions. The majority of adverse drug reactions were skin disorders, with 75.3% in first-line FOLFOX patients and 72.3% in second-line FOLFIRI patients. CONCLUSION: Overall, the study results show that treatment patterns, clinical efficacy, and the safety profile of panitumumab in routine clinical practice were comparable to those in randomized controlled trials. The relatively low skin toxicity rate could be attributed to increasing experience in managing panitumumab-associated rash and some degree of underreporting. FUNDING: Amgen.
Center for Observational Research Amgen Ltd Uxbridge UK
Department of Biostatistics Amgen Ltd Uxbridge UK
Department of Internal Medicine Stauferklinikum Schwäbisch Gmünd Mutlangen Germany
EU Medical Affairs Amgen GmbH Rotkreuz Switzerland
Medical Clinic 1 Klinikum Frankfurt Germany
Medical Development Amgen Brussels Belgium
Oncology Department Hetenyi G County Hospital Szolnok Hungary
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Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0, Cancer incidence and mortality worldwide: IARC CancerBase No. 11. 2013. http://globocan.iarc.fr. Accessed 15 Jan 2018.
Kindler HL, Shulman KL. Metastatic colorectal cancer. Curr Treat Options Oncol. 2001;2(6):459–471. doi: 10.1007/s11864-001-0068-7. PubMed DOI
Pazdur R, Coia L, Wagman LD, Ayoub JP. Colorectal and anal cancers. Cancer management: a multidisciplinary approach. Melville: PRR; 1999. pp. 149–175.
Van Cutsem E, Cervantes A, Adam R, et al. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol. 2016;27(8):1386–1422. doi: 10.1093/annonc/mdw235. PubMed DOI
Cohenuram M, Saif MW. Panitumumab the first fully human monoclonal antibody: from the bench to the clinic. Anticancer Drugs. 2007;18(1):7–15. doi: 10.1097/CAD.0b013e32800feecb. PubMed DOI
Argiles G, Dienstmann R, Elez E, Tabernero J. Panitumumab: a summary of clinical development in colorectal cancer and future directions. Future Oncol. 2012;8(4):373–389. doi: 10.2217/fon.12.20. PubMed DOI
European Medicines Agency. Vectibix® (panitumumab) summary of product characteristics. 2016. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000741/WC500047710.pdf. Accessed 15 Jan 2018.
European Medicines Agency. Vectibix: EPAR—scientific discussion. 2007. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000741/WC500047707.pdf. Accessed 6 Mar 2018.
Peeters M, Siena S, Van Cutsem E, et al. Association of progression-free survival, overall survival, and patient-reported outcomes by skin toxicity and KRAS status in patients receiving panitumumab monotherapy. Cancer. 2009;115(7):1544–1554. doi: 10.1002/cncr.24088. PubMed DOI
Amado RG, Wolf M, Peeters M, et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol. 2008;26(10):1626–1634. doi: 10.1200/JCO.2007.14.7116. PubMed DOI
Douillard JY, Siena S, Cassidy J, et al. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. J Clin Oncol. 2010;28(31):4697–4705. doi: 10.1200/JCO.2009.27.4860. PubMed DOI
Peeters M, Price TJ, Cervantes A, et al. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol. 2010;28(31):4706–4713. doi: 10.1200/JCO.2009.27.6055. PubMed DOI
Cohn AL, Shumaker GC, Khandelwal P, et al. An open-label, single-arm, phase 2 trial of panitumumab plus FOLFIRI as second-line therapy in patients with metastatic colorectal cancer. Clin Colorectal Cancer. 2011;10(3):171–177. doi: 10.1016/j.clcc.2011.03.022. PubMed DOI
Mitchell EP, Piperdi B, Lacouture ME, et al. The efficacy and safety of panitumumab administered concomitantly with FOLFIRI or irinotecan in second-line therapy for metastatic colorectal cancer: the secondary analysis from STEPP (skin toxicity evaluation protocol with panitumumab) by KRAS status. Clin Colorectal Cancer. 2011;10(4):333–339. doi: 10.1016/j.clcc.2011.06.004. PubMed DOI
Kohne CH, Hofheinz R, Mineur L, et al. First-line panitumumab plus irinotecan/5-fluorouracil/leucovorin treatment in patients with metastatic colorectal cancer. J Cancer Res Clin Oncol. 2012;138(1):65–72. doi: 10.1007/s00432-011-1061-6. PubMed DOI PMC
Douillard JY, Oliner KS, Siena S, et al. Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer. N Engl J Med. 2013;369(11):1023–1034. doi: 10.1056/NEJMoa1305275. PubMed DOI
Hocking CM, Price TJ. Panitumumab in the management of patients with KRAS wild-type metastatic colorectal cancer. Ther Adv Gastroenterol. 2014;7(1):20–37. doi: 10.1177/1756283X13498660. PubMed DOI PMC
European Medicines Agency. Vectibix: Procedural steps taken and scientific information after the authorisation. 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Procedural_steps_taken_and_scientific_information_after_authorisation/human/000741/WC500047709.pdf. Accessed 3 July 2017.
Tejpar S, Stintzing S, Ciardiello F, et al. Prognostic and predictive relevance of primary tumor location in patients with RAS wild-type metastatic colorectal cancer: retrospective analyses of the CRYSTAL and FIRE-3 trials. JAMA Oncol. 2017;3(2):194–201. PubMed PMC
Schwartzberg LS, Rivera F, Karthaus M, et al. PEAK: a randomized, multicenter phase II study of panitumumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or bevacizumab plus mFOLFOX6 in patients with previously untreated, unresectable, wild-type KRAS exon 2 metastatic colorectal cancer. J Clin Oncol. 2014;32(21):2240–2247. doi: 10.1200/JCO.2013.53.2473. PubMed DOI
Rivera F, Karthaus M, Hecht JR, et al. Final analysis of the randomised PEAK trial: overall survival and tumour responses during first-line treatment with mFOLFOX6 plus either panitumumab or bevacizumab in patients with metastatic colorectal carcinoma. Int J Colorectal Dis. 2017;32(8):1179–1190. doi: 10.1007/s00384-017-2800-1. PubMed DOI PMC
Douillard JY, Siena S, Cassidy J, et al. Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer. Ann Oncol. 2014;25(7):1346–1355. doi: 10.1093/annonc/mdu141. PubMed DOI
Peeters M, Oliner KS, Price TJ, et al. Analysis of KRAS/NRAS mutations in a phase III study of panitumumab with FOLFIRI compared with FOLFIRI alone as second-line treatment for metastatic colorectal cancer. Clin Cancer Res. 2015;21(24):5469–5479. doi: 10.1158/1078-0432.CCR-15-0526. PubMed DOI
Lakomy R, Rogowski W, Piko B, Mihaylova Z, Pritzova E, Kvocekova L. Prospective noninterventional study on the use of panitumumab monotherapy in patients with recurrent or progressive colorectal cancer: the VECTIS study. Cancer Manage Res. 2015;7:311–318. doi: 10.2147/CMAR.S86796. PubMed DOI PMC
Lerchenmueller CA, Groschek M, Kroening H, et al. Panitumumab in patients with chemorefractory metastatic colorectal cancer: final analysis from a community-based, observational study (VECTOR) in Germany. J Clin Oncol. 2013;31(suppl 4):abstr 550. doi: 10.1200/jco.2013.31.4_suppl.550. DOI
Douillard JY, Siena S, Peeters M, Koukakis R, Terwey JH, Tabernero J. Impact of early tumour shrinkage and resection on outcomes in patients with wild-type RAS metastatic colorectal cancer. Eur J Cancer. 2015;51(10):1231–1242. doi: 10.1016/j.ejca.2015.03.026. PubMed DOI
Kripp M, Prasnikar N, Vehling-Kaiser U, et al. AIO LQ-0110: a randomized phase II trial comparing oral doxycycline versus local administration of erythromycin as preemptive treatment strategies of panitumumab-mediated skin toxicity in patients with metastatic colorectal cancer. Oncotarget. 2017;8(62):105061–105071. doi: 10.18632/oncotarget.21249. PubMed DOI PMC
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