Skin toxicity and quality of life in patients with metastatic colorectal cancer during first-line panitumumab plus FOLFIRI treatment in a single-arm phase II study
(2012) In BMC Cancer 12(438).- Abstract
- Background: Integument-related toxicities are common during epidermal growth factor receptor (EGFR)-targeted therapy. Panitumumab is a fully human monoclonal antibody targeting the EGFR that significantly improves progression-free survival when added to chemotherapy in patients with metastatic colorectal cancer who have wild-type (WT) KRAS tumours. Primary efficacy and tolerability results from a phase II single-arm study of first-line panitumumab plus FOLFIRI in patients with metastatic colorectal cancer have been reported. Here we report additional descriptive tolerability and quality of life data from this trial. Methods: Integument-related toxicities and quality of life were analysed; toxicities were graded using modified National... (More)
- Background: Integument-related toxicities are common during epidermal growth factor receptor (EGFR)-targeted therapy. Panitumumab is a fully human monoclonal antibody targeting the EGFR that significantly improves progression-free survival when added to chemotherapy in patients with metastatic colorectal cancer who have wild-type (WT) KRAS tumours. Primary efficacy and tolerability results from a phase II single-arm study of first-line panitumumab plus FOLFIRI in patients with metastatic colorectal cancer have been reported. Here we report additional descriptive tolerability and quality of life data from this trial. Methods: Integument-related toxicities and quality of life were analysed; toxicities were graded using modified National Cancer Institute Common Toxicity Criteria. Kaplan-Meier estimates of time to and duration of first integument-related toxicity were prepared. Quality of life was measured using EuroQoL EQ-5D and EORTC QLQ-C30. Best overall response was analysed by skin toxicity grade and baseline quality of life. Change in quality of life was analysed by skin toxicity severity. Results: 154 patients were enrolled (WT KRAS n = 86; mutant KRAS n = 59); most (98%) experienced integument-related toxicities (most commonly rash [42%], dry skin [40%] and acne [36%]). Median time to first integument-related toxicity was 8 days; median duration was 334 days. Overall, proportionally more patients with grade 2+ skin toxicity responded (56%) compared with those with grade 0/1 (29%). Mean overall EQ-5D health state index scores (0.81 vs. 0.78), health rating scores (72.5 vs. 71.0) and QLQ-C30 global health status scores (65.8 vs. 66.7) were comparable at baseline vs. safety follow-up (8 weeks after completion), respectively and appeared unaffected by skin toxicity severity. Conclusions: First-line panitumumab plus FOLFIRI has acceptable tolerability and appears to have little impact on quality of life, despite the high incidence of integument-related toxicity. (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/3371951
- author
- Thaler, Josef ; Karthaus, Meinolf ; Mineur, Laurent ; Greil, Richard ; Letocha, Henry ; Hofheinz, Ralf ; Fernebro, Eva LU ; Gamelin, Erick ; Banos, Ana and Koehne, Claus-Henning
- organization
- publishing date
- 2012
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Colorectal cancer, Panitumumab, Quality of life, Tolerability
- in
- BMC Cancer
- volume
- 12
- issue
- 438
- publisher
- BioMed Central (BMC)
- external identifiers
-
- wos:000312307900001
- scopus:84866646369
- pmid:23020584
- ISSN
- 1471-2407
- DOI
- 10.1186/1471-2407-12-438
- language
- English
- LU publication?
- yes
- id
- 6b472469-ad7a-4a83-a996-3edc16040bf2 (old id 3371951)
- date added to LUP
- 2016-04-01 14:22:33
- date last changed
- 2022-04-22 02:56:45
@article{6b472469-ad7a-4a83-a996-3edc16040bf2,
abstract = {{Background: Integument-related toxicities are common during epidermal growth factor receptor (EGFR)-targeted therapy. Panitumumab is a fully human monoclonal antibody targeting the EGFR that significantly improves progression-free survival when added to chemotherapy in patients with metastatic colorectal cancer who have wild-type (WT) KRAS tumours. Primary efficacy and tolerability results from a phase II single-arm study of first-line panitumumab plus FOLFIRI in patients with metastatic colorectal cancer have been reported. Here we report additional descriptive tolerability and quality of life data from this trial. Methods: Integument-related toxicities and quality of life were analysed; toxicities were graded using modified National Cancer Institute Common Toxicity Criteria. Kaplan-Meier estimates of time to and duration of first integument-related toxicity were prepared. Quality of life was measured using EuroQoL EQ-5D and EORTC QLQ-C30. Best overall response was analysed by skin toxicity grade and baseline quality of life. Change in quality of life was analysed by skin toxicity severity. Results: 154 patients were enrolled (WT KRAS n = 86; mutant KRAS n = 59); most (98%) experienced integument-related toxicities (most commonly rash [42%], dry skin [40%] and acne [36%]). Median time to first integument-related toxicity was 8 days; median duration was 334 days. Overall, proportionally more patients with grade 2+ skin toxicity responded (56%) compared with those with grade 0/1 (29%). Mean overall EQ-5D health state index scores (0.81 vs. 0.78), health rating scores (72.5 vs. 71.0) and QLQ-C30 global health status scores (65.8 vs. 66.7) were comparable at baseline vs. safety follow-up (8 weeks after completion), respectively and appeared unaffected by skin toxicity severity. Conclusions: First-line panitumumab plus FOLFIRI has acceptable tolerability and appears to have little impact on quality of life, despite the high incidence of integument-related toxicity.}},
author = {{Thaler, Josef and Karthaus, Meinolf and Mineur, Laurent and Greil, Richard and Letocha, Henry and Hofheinz, Ralf and Fernebro, Eva and Gamelin, Erick and Banos, Ana and Koehne, Claus-Henning}},
issn = {{1471-2407}},
keywords = {{Colorectal cancer; Panitumumab; Quality of life; Tolerability}},
language = {{eng}},
number = {{438}},
publisher = {{BioMed Central (BMC)}},
series = {{BMC Cancer}},
title = {{Skin toxicity and quality of life in patients with metastatic colorectal cancer during first-line panitumumab plus FOLFIRI treatment in a single-arm phase II study}},
url = {{https://lup.lub.lu.se/search/files/3938591/3910489.pdf}},
doi = {{10.1186/1471-2407-12-438}},
volume = {{12}},
year = {{2012}},
}