Abstract
BackgroundIdentifying patients with metastatic colorectal cancer who will have an early disease progression during induction chemotherapy (IC) and identifying patients who may have a chemotherapy-free interval (CFI) after IC are two major challenges.MethodsA logistic model was used to identify factors associated with early progression during IC and with short duration of the first CFI in 488 patients enrolled in the PRODIGE 9 trial. Independent factors were defined with a threshold 0.10.ResultsIn multivariate analysis, baseline leukocytes >10 × 109/L (OR = 1.98 [1.02–3.8], p = 0.04), and stable or increasing CEA at 2 months (OR = 3.61 [1.68–7.75], p = 0.01) were independent factors associated with progression during IC. Male gender (OR = 1.725 [0.92–3.325], p = 0.09) and no tumour response at first evaluation (OR = 1.90 [0.96–3.76], p = 0.07) were significantly associated with a short CFI. The presence of BRAF V600E mutation was also associated with short CFI (OR = 4.59 [0.95; 22.3], p = 0.058).ConclusionHigh baseline leukocyte count and the lack of CEA decrease level at first evaluation were associated with early progression, and could be in favour of early chemotherapy intensification. Male gender, no tumour response at first evaluation and BRAF mutation are associated with a short CFI, and may be considered for maintenance chemotherapy after IC.Clinical trial numberNCT00952029.
Highlights
Identifying patients with metastatic colorectal cancer who will have an early disease progression during induction chemotherapy (IC) and identifying patients who may have a chemotherapy-free interval (CFI) after IC are two major challenges
Between March 2010 and July 2013, the PRODIGE 9 trial enrolled 494 patients. Six patients withdrew their consent (3) or were never treated (3); the modified intent-to-treat population was 488 patients randomly assigned to either FOLFIRI plus bevacizumab IC followed by bevacizumab maintenance (n = 245), or to the same IC followed by observation during CFI (n = 243)
Univariate analysis revealed that baseline WHO performance status of 2, baseline leukocytes >10 × 109/L, baseline carcinoembryonic antigen (CEA) upper limit of normal and stable or increasing CEA at 2 months after the beginning of IC were associated with a higher risk of progression during IC (Table 1)
Summary
Identifying patients with metastatic colorectal cancer who will have an early disease progression during induction chemotherapy (IC) and identifying patients who may have a chemotherapy-free interval (CFI) after IC are two major challenges. Previous recent large trials have reported prognostic factors for progression-free survival (PFS),[8,9,10] but not for early progression within the first 6 months of treatment. Two of these trials evaluated front-line treatment in the subgroup of patients with wild-type RAS mCRC.[8,9] The randomised phase 3, PRODIGE 9 study, aimed to assess the tumour control duration with bevacizumab maintenance or observation after irinotecan-based IC combined with bevacizumab.[11] Two other recent trials randomised
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