J 2019

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

HEBART, Holger, Michael KIEHL, Jiří TOMÁŠEK, Tibor CSOSZI, Reija KOUKAKIS et. al.

Základní údaje

Originální název

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

Autoři

HEBART, Holger (276 Německo, garant), Michael KIEHL (276 Německo), Jiří TOMÁŠEK (203 Česká republika, domácí), Tibor CSOSZI (348 Maďarsko), Reija KOUKAKIS (826 Velká Británie a Severní Irsko), George KAFATOS (826 Velká Británie a Severní Irsko), Anja KUHN (276 Německo), Katja BJORKLOF (756 Švýcarsko), Gaston DEMONTY (56 Belgie) a Tomáš BÜCHLER (203 Česká republika)

Vydání

ADVANCES IN THERAPY, NEW YORK, SPRINGER, 2019, 0741-238X

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30104 Pharmacology and pharmacy

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

Impakt faktor

Impact factor: 3.871

Kód RIV

RIV/00216224:14110/19:00112792

Organizační jednotka

Lékařská fakulta

DOI

UT WoS

000462129500013

Klíčová slova anglicky

Metastatic colorectal cancer; Observational study; Panitumumab; RAS wild-type; Real-world data; Tumor location

Štítky

Příznaky

Mezinárodní význam, Recenzováno
Změněno: 28. 1. 2020 11:17, Mgr. Tereza Miškechová

Anotace

V originále

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.