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

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.

Associations of baseline patient‐reported outcomes with treatment outcomes in advanced gastrointestinal cancer

“…38,39 In keeping with prior work, the results of the current study have demonstrated an association between a greater number of sites of metastasis, increased physical symptom burden, and worse QOL. 40 We also found a novel relationship between PROs and patient baseline CEA levels. These relationships suggest a potential underlying link between patients' tumor burden and their physical symptoms.…”

Disagreement between patient‐ and physician‐reported outcomes on symptomatic adverse events as poor prognosis in patients treated with first‐line cetuximab plus chemotherapy for unresectable metastatic colorectal cancer: Results of Phase II QUACK trial

“…Moreover, 55 patients (40%) reported "very much" or "quite a bit" on at least one of the corresponding symptom items of the EORTC QLQ-C30. 13 High compliance rates for the EORTC QLQ-C30 questionnaire were maintained throughout the study period (i.e., 97.9% at baseline, 97.0% at 4 weeks, and 81.1% at 24 weeks).…”

“…Although the substantial variability between physician and patient assessments of symptomatic AEs may depend on specific cancer types and treatment, no prior studies have directly compared patients’ and physicians’ reports of symptomatic AEs in mCRC patients treated with first‐line cetuximab plus chemotherapy. In addition, we and others have previously shown that baseline patient‐reported symptoms are predictors of survival in CRC, 13–16 but the prognostic value of the disagreement between patient‐ and physician‐reported outcomes for symptomatic AEs during chemotherapy has not yet been determined.…”

“…The QUACK study was prospectively performed to assess the quality of life (QOL) of mCRC patients treated with cetuximab plus chemotherapy in a routine care setting. 13,17 This study provides the valuable opportunity to assess…”

“…The QUACK study was prospectively performed to assess the quality of life (QOL) of mCRC patients treated with cetuximab plus chemotherapy in a routine care setting 13,17 . This study provides the valuable opportunity to assess clinical questions as follows; the aims of this study were (a) to assess the agreement status of symptomatic AEs reported by patients and physicians, (b) to characterize the nature of such disagreements, and (c) to determine whether their disagreement could contribute to poor treatment efficacy and prognostic outcomes.…”