HEBART, Holger, Michael KIEHL, Jiří TOMÁŠEK, Tibor CSOSZI, Reija KOUKAKIS, George KAFATOS, Anja KUHN, Katja BJORKLOF, Gaston DEMONTY and Tomáš BÜCHLER. 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. ADVANCES IN THERAPY. NEW YORK: SPRINGER, 2019, vol. 36, No 3, p. 670-683. ISSN 0741-238X. Available from: https://dx.doi.org/10.1007/s12325-019-0874-6.
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Basic information
Original name 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
Authors HEBART, Holger (276 Germany, guarantor), Michael KIEHL (276 Germany), Jiří TOMÁŠEK (203 Czech Republic, belonging to the institution), Tibor CSOSZI (348 Hungary), Reija KOUKAKIS (826 United Kingdom of Great Britain and Northern Ireland), George KAFATOS (826 United Kingdom of Great Britain and Northern Ireland), Anja KUHN (276 Germany), Katja BJORKLOF (756 Switzerland), Gaston DEMONTY (56 Belgium) and Tomáš BÜCHLER (203 Czech Republic).
Edition ADVANCES IN THERAPY, NEW YORK, SPRINGER, 2019, 0741-238X.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30104 Pharmacology and pharmacy
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 3.871
RIV identification code RIV/00216224:14110/19:00112792
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1007/s12325-019-0874-6
UT WoS 000462129500013
Keywords in English Metastatic colorectal cancer; Observational study; Panitumumab; RAS wild-type; Real-world data; Tumor location
Tags 14110811, rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 28/1/2020 11:17.
Abstract
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 12months 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 6.9months, 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.
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