Patient-reported symptom burden as a prognostic factor in treatment with first-line cetuximab plus chemotherapy for unresectable metastatic colorectal cancer: Results of Phase II QUACK trial

Cancer Med. 2020 Mar;9(5):1779-1789. doi: 10.1002/cam4.2826. Epub 2020 Jan 21.

Abstract

Background: It remains unclear whether patients' self-perceptions of symptoms at baseline clinically impact the prognostic relevance, treatment efficacy, or toxicity profiles in metastatic colorectal cancer (mCRC) patients treated with the first-line cetuximab and standard chemotherapy.

Methods: The data were collected from a prospective trial that assessed the relationships between quality of life (QOL), treatment efficacy, and adverse events (AEs).

Results: The analysis of 137 mCRC patients revealed a significant association between the presence of baseline tumor-related symptoms and a lower overall survival (OS) compared to the absence of symptoms (HR, 2.49; 95% CI, 1.37-4.62; P = .003). The asymptomatic responders had favorable outcomes compared to the symptomatic nonresponders (2-year OS rates: 83.6% and 35.9%, respectively), while the symptomatic responders had similar outcomes to the asymptomatic nonresponders. The median postprogression survival differed significantly: 10.2 months for the symptomatic patients and 15.9 months for the asymptomatic patients (HR, 2.29; 95% CI, 1.25-4.29, P = .008). The objective response rates and patient toxicity profiles were similar irrespective of the severity of baseline symptoms.

Conclusion: Baseline symptoms were associated with worse OS but not with impaired treatment efficacy or more frequent AEs in mCRC patients treated with cetuximab in addition to chemotherapy.

Keywords: cetuximab; chemotherapy; colorectal cancer; quality of life; symptom.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Cetuximab / administration & dosage*
  • Cetuximab / adverse effects
  • Colorectal Neoplasms / complications
  • Colorectal Neoplasms / diagnosis
  • Colorectal Neoplasms / drug therapy*
  • Drug-Related Side Effects and Adverse Reactions / diagnosis*
  • Drug-Related Side Effects and Adverse Reactions / etiology
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Patient Reported Outcome Measures*
  • Prognosis
  • Progression-Free Survival
  • Prospective Studies
  • Quality of Life*
  • Response Evaluation Criteria in Solid Tumors
  • Self Report / statistics & numerical data
  • Severity of Illness Index

Substances

  • Cetuximab