The relationship between quality of life (QoL) and tumor response in patients (pts) with metastatic colorectal cancer (mCRC) receiving panitumumab (pmab) plus FOLFIRI as first-line therapy: An analysis of study 314.

Abstract

3634 Background: Study 314 was a phase II, single-arm, multicenter study designed to assess the efficacy/safety by KRAS tumor status of first-line pmab plus FOLFIRI in pts with mCRC. Here, we investigate the relationship between QoL and tumor response. Methods: Pmab (6mg/kg) and FOLFIRI were administered every 14 days until disease progression, consent withdrawal, or unacceptable toxicity. EUROQOL EQ-5D Index scores were recorded at screening, every 8 wks until wk 32, every 3 months thereafter until disease progression, and 56 days after stopping study treatment (safety follow up visit). EQ-5D scores range from –0.594 to 1 (1=perfect health). A change of ≥0.08 may be considered clinically meaningful. Data were analyzed descriptively by tumor KRAS status (wild type [WT] or mutant [MT]) and by best overall response. Results: A trend for better tumor response in pts with higher baseline EQ-5D scores was observed. In pts who achieved CR/PR, the difference in EQ-5D score between the WT group and the MT group exceeded the clinically meaningful threshold at wks 8 and 24. Conclusions: Patients with WT KRAS mCRC who respond to panitumumab appear to maintain their EQ-5D score over time. The relationship between QoL and tumor response in this treatment setting should be evaluated in a larger patient population. Change in EQ-5D score from baseline. CR or PR SD PD WT MT WT MT WT MT Mean (SE) baseline score n 45 22 25 26 4 3 0.812 (0.034) 0.817 (0.052) 0.833 (0.039) 0.790 (0.034) 0.720 (0.178) 0.588 (0.205) Mean (SE) change from baseline Wk 8 n 43 21 23 23 3 2 +0.049 (0.032) –0.036 (0.052) –0.023 (0.044) +0.015 (0.030) +0.047 (0.047) –0.087 (0.122) Wk 16 n 39 22 20 19 1 1 +0.067 (0.031) +0.018 (0.045) +0.024 (0.039) –0.007 (0.073) –0.240 (–) –0.327 (–) Wk 24 n 33 19 10 9 1 0 +0.053 (0.028) –0.027 (0.033) +0.014 (0.073) +0.111 (0.046) 0.000 – Wk 32 n 15 8 3 5 1 0 +0.019 (0.037) –0.015 (0.080) +0.195 (0.195) +0.172 (0.081) –0.311 (–) – Safety follow-up visit n 19 14 13 15 2 1 +0.048 (0.042) –0.019 (0.038) –0.040 (0.060) –0.034 (0.085) –0.087 (0.343) +0.000 (–) Abbreviations: CR, complete response; PD, disease progression; PR, partial response; SD, stable disease; SE, standard error.