Use of early tumor shrinkage to predict long-term outcome in metastatic colorectal cancer treated with cetuximab
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Use of early tumor shrinkage to predict long-term outcome in metastatic colorectal cancer treated with cetuximab. / Piessevaux, Hubert; Buyse, Marc; Schlichting, Michael; Van Cutsem, Eric; Bokemeyer, Carsten; Heeger, Steffen; Tejpar, Sabine.
in: J CLIN ONCOL, Jahrgang 31, Nr. 30, 20.10.2013, S. 3764-75.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Use of early tumor shrinkage to predict long-term outcome in metastatic colorectal cancer treated with cetuximab
AU - Piessevaux, Hubert
AU - Buyse, Marc
AU - Schlichting, Michael
AU - Van Cutsem, Eric
AU - Bokemeyer, Carsten
AU - Heeger, Steffen
AU - Tejpar, Sabine
PY - 2013/10/20
Y1 - 2013/10/20
N2 - PURPOSE: Early tumor shrinkage (ETS) is associated with long-term outcome in patients with chemorefractory metastatic colorectal cancer (mCRC) receiving cetuximab. This association was investigated in the first-line setting in the randomized CRYSTAL and OPUS mCRC trials, after controlling for KRAS tumor mutation status.METHODS: Radiologic assessments at week 8 were used to calculate the relative change in the sum of the longest diameters of the target lesions. Time-dependent receiver operating characteristics provided Cτ-indices (time-dependent c-index). Cox regression models and subpopulation treatment effect pattern plot analysis investigated associations between ETS (radiologic tumor size decrease at week 8) and survival and progression-free survival (PFS).RESULTS: In both trials, in patients with KRAS wild-type mCRC, Cτ values for PFS and survival were higher (P < .001) in those receiving chemotherapy plus cetuximab versus chemotherapy alone, indicating a stronger predictive value of ETS for long-term outcome in these patients. In the CRYSTAL and OPUS trials, respectively, the cutoff value of ETS ≥ 20% (v < 20%) identified patients with KRAS wild-type mCRC receiving chemotherapy plus cetuximab with longer PFS (medians 14.1 v 7.3 months, hazard ratio [HR] = 0.32; P < .001, and medians 11.9 v 5.7 months, HR = 0.22; P < .001) and survival (medians 30.0 v 18.6 months, HR = 0.53; P < .001 and medians 26.0 v 15.7 months, HR = 0.43; P = .006).CONCLUSION: ETS was significantly associated with long-term outcome in patients with KRAS wild-type mCRC treated first-line with chemotherapy plus cetuximab. Validation in prospective trials is required to assess the value of this on-treatment marker in the clinical decision-making process.
AB - PURPOSE: Early tumor shrinkage (ETS) is associated with long-term outcome in patients with chemorefractory metastatic colorectal cancer (mCRC) receiving cetuximab. This association was investigated in the first-line setting in the randomized CRYSTAL and OPUS mCRC trials, after controlling for KRAS tumor mutation status.METHODS: Radiologic assessments at week 8 were used to calculate the relative change in the sum of the longest diameters of the target lesions. Time-dependent receiver operating characteristics provided Cτ-indices (time-dependent c-index). Cox regression models and subpopulation treatment effect pattern plot analysis investigated associations between ETS (radiologic tumor size decrease at week 8) and survival and progression-free survival (PFS).RESULTS: In both trials, in patients with KRAS wild-type mCRC, Cτ values for PFS and survival were higher (P < .001) in those receiving chemotherapy plus cetuximab versus chemotherapy alone, indicating a stronger predictive value of ETS for long-term outcome in these patients. In the CRYSTAL and OPUS trials, respectively, the cutoff value of ETS ≥ 20% (v < 20%) identified patients with KRAS wild-type mCRC receiving chemotherapy plus cetuximab with longer PFS (medians 14.1 v 7.3 months, hazard ratio [HR] = 0.32; P < .001, and medians 11.9 v 5.7 months, HR = 0.22; P < .001) and survival (medians 30.0 v 18.6 months, HR = 0.53; P < .001 and medians 26.0 v 15.7 months, HR = 0.43; P = .006).CONCLUSION: ETS was significantly associated with long-term outcome in patients with KRAS wild-type mCRC treated first-line with chemotherapy plus cetuximab. Validation in prospective trials is required to assess the value of this on-treatment marker in the clinical decision-making process.
KW - Adult
KW - Aged
KW - Antibodies, Monoclonal, Humanized
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Colorectal Neoplasms
KW - Disease-Free Survival
KW - Female
KW - Humans
KW - Kaplan-Meier Estimate
KW - Male
KW - Middle Aged
KW - Neoplasm Staging
KW - Predictive Value of Tests
KW - Proto-Oncogene Proteins
KW - ROC Curve
KW - Sensitivity and Specificity
KW - Time Factors
KW - Treatment Outcome
KW - ras Proteins
U2 - 10.1200/JCO.2012.42.8532
DO - 10.1200/JCO.2012.42.8532
M3 - SCORING: Journal article
C2 - 24043732
VL - 31
SP - 3764
EP - 3775
JO - J CLIN ONCOL
JF - J CLIN ONCOL
SN - 0732-183X
IS - 30
ER -