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000306677 1001_ $$0P:(DE-HGF)0$$aHeinrich, Kathrin$$b0
000306677 245__ $$aImpact of sex on efficacy and safety of 1st-line treatment with FOLFIRI plus cetuximab or bevacizumab in RAS/BRAF wildtype metastatic colorectal cancer - A subgroup analysis of the FIRE-3 (AIO KRK-0306) trial.
000306677 260__ $$aAmsterdam [u.a.]$$bElsevier$$c2026
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000306677 520__ $$aClinical trials in metastatic colorectal cancer (mCRC) are usually conducted irrespectively of sex. However, differences relating to safety and efficacy in the treatment of mCRC between male and female patients are of growing interest.The randomized FIRE-3 study compared first-line treatment with folinic acid, 5-fluorouracil and irinotecan (FOLFIRI) plus cetuximab to FOLFIRI plus bevacizumab in patients with RAS wildtype (RAS WT) mCRC. The present analysis focusses on the impact of sex and primary tumor (PT) sidedness on outcome parameters.Of 352 patients with RAS WT tumors, 249 (71 %) were male and 103 (29 %) female. In male patients with left-sided RAS/BRAF WT tumors, a significant benefit from cetuximab was noted with regard to ORR (OR 1.15; P = 0.035) and OS (0.66; P = 0.010), while in right-sided patients cetuximab improved ORR (OR 2.92) and had no significant effect on PFS or OS. In female patients with left-sided, RAS/BRAF WT PT, a comparable effect of cetuximab versus bevacizumab was observed with regard to ORR (OR 1.05; P > 0.999), while a numerical OS benefit was noted in the cetuximab-arm (HR 0.78; P = 0.385). By contrast, in female patients with right-sided PT, a clearly detrimental effect of cetuximab-based therapy was observed for ORR (OR 0.44; P = 0.617), PFS (HR 4.95; P = 0.005), and OS (HR 2.58; P = 0.080). In the bevacizumab arm, neutropenia grade ≥ 3 was more frequent in female versus male patients (30.6 % versus 18.3 %; P = 0.063). Otherwise, there was no significant difference of grade ≥ 3 adverse events between male and female patients.The exploratory analysis of FIRE-3 suggests that the efficacy of cetuximab combined with FOLFIRI in RAS wild-type mCRC is related to sex and primary tumor sidedness. The results support the inclusion of patient sex into the design of future trials.
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000306677 650_7 $$2Other$$aAnti-EGFR
000306677 650_7 $$2Other$$aCetuximab
000306677 650_7 $$2Other$$aColorectal cancer
000306677 650_7 $$2Other$$aGender
000306677 650_7 $$2Other$$aSex
000306677 7001_ $$0P:(DE-HGF)0$$aStintzing, Sebastian$$b1
000306677 7001_ $$aWeikersthal, Ludwig Fischer von$$b2
000306677 7001_ $$aDecker, Thomas$$b3
000306677 7001_ $$aKiani, Alexander$$b4
000306677 7001_ $$aKaiser, Florian$$b5
000306677 7001_ $$aAl-Batran, Salah-Eddin$$b6
000306677 7001_ $$aHeintges, Tobias$$b7
000306677 7001_ $$aLerchenmüller, Christoph$$b8
000306677 7001_ $$aKahl, Christoph$$b9
000306677 7001_ $$aSeipelt, Gernot$$b10
000306677 7001_ $$aKullmann, Frank$$b11
000306677 7001_ $$aMoehler, Markus$$b12
000306677 7001_ $$aScheithauer, Werner$$b13
000306677 7001_ $$aJung, Andreas$$b14
000306677 7001_ $$0P:(DE-HGF)0$$aHolch, Julian W$$b15
000306677 7001_ $$aHeld, Swantje$$b16
000306677 7001_ $$aModest, Dominik Paul$$b17
000306677 7001_ $$0P:(DE-HGF)0$$aHeinemann, Volker$$b18
000306677 773__ $$0PERI:(DE-600)1468190-0$$a10.1016/j.ejca.2025.116133$$gVol. 232, p. 116133 -$$p116133$$tEuropean journal of cancer$$v232$$x0959-8049$$y2026
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