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- W1820332011 abstract "3611 Background: CALGB 80405, a phase III trial, was originally designed to compare toxicity and overall survival of metastatic colorectal patients treated with standard chemotherapy (choice of FOLFOX or FOLFIRI) and either: 1) Bevacizumab; 2) Cetuximab; or 3) both Bevacizumab and Cetuximab. Because Cetuximab causes a prominent acneiform skin rash, adverse effects on QOL were anticipated and assessed in a QOL companion. Methods: The QOL companion enrolled the first 518 consenting patients randomized to CALGB 80405 between 10/2005-9/2007, the majority prior to amendments that eliminated the dual biologic arm and restricted participation to patients with KRAS wttumors. QOL was assessed at baseline, 6 weeks, and 3, 6 and 9 months post-randomization, using the EORTC QLQ-30 and the Dermatology-Specific Quality of Life (DSQL) Scale. We hypothesized that patients receiving Cetuximab would have lower satisfaction with appearance, reduced social functioning and lower overall QOL at 3 months, (a primary assessment point). Results: Patients had a mean age of 59, were predominantly male (58%), performance status 0 (62%), and non-Hispanic White (85%). 83% completed a 3 month assessment. There were no differences in global health functioning (p=0.164) or other items/subscales of the EORTC at 3 months by treatment arm. However, significant differences were found across arms in skin symptoms (p<.0001), limitations in social activities due to skin condition (p=0.008), and concerns about appearance (p<.0001), as measured by the DSQL. Patients randomized to Bevacizumab reported fewer skin symptoms, fewer social limitations and appearance concerns than patients receiving Cetuximab alone or Cetuximab + Bevacizumab. The choice of chemotherapy (FOLFOX or FOLFIRI) had no bearing on these results. Conclusions: Global QOL, as well as physical, role, social and emotional functioning, were not significantly different across treatment arms. However, Cetuximab recipients reported greater symptoms and QOL concerns relating to their skin than those receiving Bevacizumab alone. Interventions to more adequately address skin problems from Cetuximab treatment are warranted. Participants are still being followed to determine survival differences between the biologics. Clinical trial information: NCT00265850." @default.
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- W1820332011 date "2013-05-20" @default.
- W1820332011 modified "2023-10-17" @default.
- W1820332011 title "Quality of life (QOL) and toxicity among patients in CALGB 80405." @default.
- W1820332011 doi "https://doi.org/10.1200/jco.2013.31.15_suppl.3611" @default.
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