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

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.

[1]  Versione,et al.  Common Terminology Criteria for Adverse Events , 2020, Definitions.

[2]  M. Ando,et al.  A prospective Phase II study to examine the relationship between quality of life and adverse events of first‐line chemotherapy plus cetuximab in patients with KRAS wild‐type unresectable metastatic colorectal cancer: QUACK trial , 2018, Cancer medicine.

[3]  Jaap C. Reijneveld,et al.  Understanding the quality of life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire , 2018, Health and Quality of Life Outcomes.

[4]  C. Tournigand,et al.  How health-related quality of life assessment should be used in advanced colorectal cancer clinical trials , 2017, Annals of oncology : official journal of the European Society for Medical Oncology.

[5]  M. Socinski,et al.  Feasibility Assessment of Patient Reporting of Symptomatic Adverse Events in Multicenter Cancer Clinical Trials , 2017, JAMA oncology.

[6]  J. Pignon,et al.  Prognostic and predictive value of primary tumour side in patients with RAS wild-type metastatic colorectal cancer treated with chemotherapy and EGFR directed antibodies in six randomized trials † , 2017, Annals of oncology : official journal of the European Society for Medical Oncology.

[7]  M. Ando,et al.  Quality of Life Analysis in Patients With RAS Wild‐Type Metastatic Colorectal Cancer Treated With First‐Line Cetuximab Plus Chemotherapy , 2017, Clinical colorectal cancer.

[8]  A. Jemal,et al.  Colorectal cancer statistics, 2017 , 2017, CA: a cancer journal for clinicians.

[9]  E. Van Cutsem,et al.  Prognostic and Predictive Relevance of Primary Tumor Location in Patients With RAS Wild-Type Metastatic Colorectal Cancer: Retrospective Analyses of the CRYSTAL and FIRE-3 Trials , 2017, JAMA oncology.

[10]  J Ricke,et al.  ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. , 2016, Annals of oncology : official journal of the European Society for Medical Oncology.

[11]  F. Fiteni,et al.  Health-related quality-of-life as co-primary endpoint in randomized clinical trials in oncology , 2015, Expert review of anticancer therapy.

[12]  A. Gnanasakthy,et al.  Inclusion of patient-reported outcome measures in registered clinical trials: Evidence from ClinicalTrials.gov (2007-2013). , 2015, Contemporary clinical trials.

[13]  R. L. Coleman,et al.  Patient-reported outcomes as end points and outcome indicators in solid tumours , 2015, Nature Reviews Clinical Oncology.

[14]  Hartmut Link,et al.  FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. , 2014, The Lancet. Oncology.

[15]  E. Van Cutsem,et al.  Metastatic colorectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. , 2014, Annals of oncology : official journal of the European Society for Medical Oncology.

[16]  C. Tournigand,et al.  Could baseline health-related quality of life (QoL) predict overall survival in metastatic colorectal cancer? The results of the GERCOR OPTIMOX 1 study , 2014, Health and Quality of Life Outcomes.

[17]  M. Taphoorn,et al.  Does change in health-related quality of life score predict survival? Analysis of EORTC 08975 lung cancer trial , 2014, British Journal of Cancer.

[18]  M. Ando,et al.  A prospective observational study to examine the relationship between quality of life and adverse events of first-line chemotherapy plus cetuximab in patients with KRAS wild-type unresectable metastatic colorectal cancer: QUACK Trial. , 2014, Japanese journal of clinical oncology.

[19]  D. Osoba,et al.  A global analysis of multitrial data investigating quality of life and symptoms as prognostic factors for survival in different tumor sites , 2014, Cancer.

[20]  G. Grosso,et al.  Health related quality of life in colorectal cancer patients: state of the art , 2013, BMC Surgery.

[21]  Corneel Coens,et al.  Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. , 2011, Journal of the National Cancer Institute.

[22]  J. Grutsch,et al.  Can changes in health related quality of life scores predict survival in stages III and IV colorectal cancer? , 2011, Health and quality of life outcomes.

[23]  S. Wyke,et al.  Modifiable and fixed factors predicting quality of life in people with colorectal cancer , 2011, British Journal of Cancer.

[24]  A. Hauschild,et al.  Interdisciplinary management of EGFR-inhibitor-induced skin reactions: a German expert opinion. , 2011, Annals of oncology : official journal of the European Society for Medical Oncology.

[25]  M. Stockler,et al.  Self-reported health-related quality of life is an independent predictor of chemotherapy treatment benefit and toxicity in women with advanced breast cancer , 2010, British Journal of Cancer.

[26]  E. Van Cutsem,et al.  Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. , 2009, The New England journal of medicine.

[27]  Murielle Mauer,et al.  Baseline quality of life as a prognostic indicator of survival: a meta-analysis of individual patient data from EORTC clinical trials. , 2009, The Lancet. Oncology.

[28]  N. Pavlakis,et al.  Health-related quality of life in patients with advanced colorectal cancer treated with cetuximab: overall and KRAS-specific results of the NCIC CTG and AGITG CO.17 Trial. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[29]  A. Bottomley,et al.  Validation of patient's self-reported social functioning as an independent prognostic factor for survival in metastatic colorectal cancer patients: results of an international study by the Chronotherapy Group of the European Organisation for Research and Treatment of Cancer. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[30]  C. Gotay,et al.  The prognostic significance of patient-reported outcomes in cancer clinical trials. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[31]  T. Conroy,et al.  Health-related quality of life as a valid outcome in the treatment of advanced colorectal cancer. , 2007, European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology.

[32]  M. Kris,et al.  Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. , 2006, The Lancet. Oncology.

[33]  D. Sargent,et al.  Overall survival of patients with advanced colorectal cancer correlates with availability of fluorouracil, irinotecan, and oxaliplatin regardless of whether doublet or single-agent therapy is used first line. , 2005, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[34]  M. Piccart,et al.  Baseline health-related quality-of-life data as prognostic factors in a phase III multicentre study of women with metastatic breast cancer. , 2004, European journal of cancer.

[35]  W. Kuo,et al.  Quality of life as a survival predictor for esophageal squamous cell carcinoma treated with radiotherapy. , 2004, International journal of radiation oncology, biology, physics.

[36]  A. Norman,et al.  Baseline quality of life predicts survival in patients with advanced colorectal cancer. , 2002, European journal of cancer.

[37]  C. Moinpour,et al.  Quality of life in long term survivors of colorectal cancer , 2002, American Journal of Gastroenterology.

[38]  D. Osoba,et al.  The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. , 1993, Journal of the National Cancer Institute.

[39]  J. Tabernero,et al.  Pan-Asian adapted ESMO consensus guidelines for the management of patients with metastatic colorectal cancer: a JSMO–ESMO initiative endorsed by CSCO, KACO, MOS, SSO and TOS , 2018, Annals of oncology : official journal of the European Society for Medical Oncology.

[40]  S. Barni,et al.  Correlation of progression-free and post-progression survival with overall survival in advanced colorectal cancer. , 2013, Annals of oncology : official journal of the European Society for Medical Oncology.

[41]  E. Van Cutsem,et al.  Quality of life analysis in patients with KRAS wild-type metastatic colorectal cancer treated first-line with cetuximab plus irinotecan, fluorouracil and leucovorin. , 2013, European journal of cancer.

[42]  D. Osoba,et al.  Interpreting the significance of changes in health-related quality-of-life scores. , 1998, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.