Final results of the CAVE trial in RAS wild type metastatic colorectal cancer patients treated with cetuximab plus avelumab as rechallenge therapy: Neutrophil to lymphocyte ratio predicts survival |
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| Institution: | 1. Oncologia Medica, Dipartimento di Medicina di Precisione, Università degli Studi della Campania “L. Vanvitelli”, Naples, Italy;2. Oncologia Medica, Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy;3. Oncologia Medica, Istituto Nazionale dei Tumori di Milano, Milan, Italy;4. Oncologia Medica, Istituto Nazionale per lo Studio e la Cura dei Tumori “Fondazione Giovanni Pascale” – IRCCS, Naples, Italy;5. Oncologia Medica, Azienda Ospedaliera Universitaria, Università di Pisa, Pisa, Italy;1. School of Medicine, University of Texas Rio Grande Valley, Edinburg, TX;2. Department of Gastrointestinal Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX;3. Department of Health Services Research, University of Texas MD Anderson Cancer Center, Houston, TX;4. Department of Radiation Physics, University of Texas MD Anderson Cancer Center, Houston, TX;5. Department of Colon & Rectal Surgery, University of Texas MD Anderson Cancer Center, Houston, TX;1. Department of Medicine, Vanderbilt University Medical Center, Nashville, TN;2. Department of Pharmacy, Vanderbilt University Medical Center, Nashville, TN;3. Department of Medicine, Hematology/Oncology, Vanderbilt University Medical Center, Nashville, TN;1. Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;2. Department of Clinical Pathology, University of Melbourne, Melbourne, Victoria, Australia;3. Department of Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;4. The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia;1. Department of Oncology, Monash Health and School of Clinical Sciences, Monash University, Melbourne, Australia;2. Department of Oncology, Oslo University Hospital, and Institute of Clinical Medicine, University of Oslo, Oslo, Norway;3. Department of Radiotherapy, Leeds Cancer Centre, University of Leeds, Leeds, United Kingdom;4. Department of Gastrointestinal Oncology, Royal Marsden Hospital, London, United Kingdom;5. Department of Hematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden;6. Department of Translational Medicine, University of Eastern Piedmont and Department of Radiation Oncology, Maggiore della Carità’ University Hospital, Novara, Italy;7. Department of Radiation Oncology, Institute Gustave Roussy, Villejuif, France;8. Department of Medical Oncology, Asklepios Tumorzentrum Hamburg, AK Altona, Hamburg, Germany;9. Department of Oncology, Aarhus University Hospital, Aarhus, Denmark |
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| Abstract: | BackgroundHigh neutrophil-to-lymphocyte ratio (NLR) is a poor prognostic factor in metastatic colorectal cancer (mCRC). Here we provide final results of CAVE mCRC trial, of cetuximab plus avelumab rechallenge in chemo-refractory mCRC patients and investigated the predictive role of NLR.MethodsAll the 77 patients enrolled were included in the analysis. A cut-off of 3 was used to correlate baseline NLR with with overall survival (OS) and with progression free survival (PFS), in intention to treat (ITT) and in circulating tumor DNA (ctDNA) RAS/BRAF Wild Type (WT) patients.ResultsIn ITT population, NLR <3 (49%) group had median overall survival (mOS) of 17.8 months, vs. 8.9 months in NLR ≥ 3 group (51%) HR 0.50, (CI 95% 0.3-0.8), P = .006]. Median progression free survival (mPFS) was 3.9 months in NLR <3 group and 3.5 months in NLR≥3 HR 0.79, (CI 95% 0.5-1.24), P = .3]. In ctDNA RAS/BRAF WT population, mOS was 22 months in NLR <3 group (48%), vs. 8.9 months in NLR ≥3 group (52%), HR 0.38, (CI 95% 0.19-0.75), P = .005]. A trend towards increased mPFS was observed in patients with NLR <3 versus NLR ≥3: 5.3 vs. 3.6 months HR: 0.79, (CI 95% 0.44-1.4), P = .43]. In contrast, NLR did not correlate either with PFS or OS in ctDNA RAS/BRAF mutated patients.ConclusionIn the exploratory analysis of the CAVE mCRC trial, baseline NLR <3 significantly correlated with improved survival and may represent a potential predictive biomarker of cetuximab plus avelumab rechallenge activity in ctDNA RAS/BRAF WT patients, that must be confirmed in randomized studies. |
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| Keywords: | Colorectal cancer |
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