E Dell'Aquila1, C Cremolini2, T Zeppola1, S Lonardi3, F Bergamo3, G Masi4, M Stellato1, F Marmorino4, M Schirripa3, F Urbano5, M Ronzoni6, G Tomasello7, A Zaniboni8, P Racca9, A Buonadonna10, G Allegrini11, E Fea12, S Di Donato13, S Chiara14, G Tonini1, D Tomcikova15, L Boni15, A Falcone4, D Santini1. 1. Department of Medical Oncology, Università Campus Bio-Medico di Roma, Rome, Italy. 2. Department of Translational Research and New Technologies in Medicine and Surge, Unit of Medical Oncology 2, Azienda Ospedaliera Universitaria Pisana, Istituto Toscano Tumori, Pisa, Italy. Electronic address: chiaracremolini@gmail.com. 3. Department of Clinical and Experimental Oncolog, Medical Oncology Unit 1, Istituto Oncologico Veneto Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy. 4. Department of Translational Research and New Technologies in Medicine and Surge, Unit of Medical Oncology 2, Azienda Ospedaliera Universitaria Pisana, Istituto Toscano Tumori, Pisa, Italy. 5. Department of Radiologica, Oncological and Pathological Sciences, Umberto I Policlinico di Roma, Rome, Italy. 6. Medical Oncology, IRCCS San Raffaele, Milan, Italy. 7. S. C. Oncologia, ASST Ospedale di Cremona, Cremona, Italy. 8. Department of Medical Oncology, Fondazione Poliambulanza, Brescia, Italy. 9. SSD ColoRectal Cancer Unit-A.O.U. Department of Oncology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Turin, Italy. 10. Division of Medical Oncology B, Centro di Riferimento Oncologico, Aviano, Italy. 11. Department of Oncology, Ospedale F. Lotti, Pontedera, Italy. 12. Department of Medical Oncology, Azienda Ospedaliera S Croce e Carle, Cuneo, Italy. 13. Department of Oncology, AUSL 4 Prato, Prato, Italy. 14. Medical Oncology 2, Policlinico San Martino Hospital IRCCS per l'Oncologia, Genoa, Italy. 15. Clinical Trials Coordinating Cente, Istituto Toscano Tumori, University Hospital Careggi, Florence, Italy.
Abstract
Background: Neutrophil/lymphocyte ratio (NLR), defined as absolute neutrophils count divided by absolute lymphocytes count, has been reported as poor prognostic factor in several neoplastic diseases but only a few data are available about unresectable metastatic colorectal cancer (mCRC) patients (pts). The aim of our study was to evaluate the prognostic and predictive role of NLR in the TRIBE trial. Patients and methods: Pts enrolled in TRIBE trial were included. TRIBE is a multicentre phase III trial randomizing unresectable and previously untreated mCRC pts to receive FOLFOXIRI or FOLFIRI plus bevacizumab. A cut-off value of 3 was adopted to discriminate pts with low (NLR < 3) versus high (NLR ≥ 3) NLR, as primary analysis. As secondary analysis, NLR was treated as an ordinal variable with three levels based on terciles distribution. Results: NLR at baseline was available for 413 patients. After multiple imputation at univariate analysis, patients with high NLR had significantly shorter progression-free survival (PFS) [hazard ratio (HR) 1.27 (95% CI 1.05-1.55), P = 0.017] and overall survival (OS) [HR 1.56 (95% CI 1.25-1.95), P < 0.001] than patients with low NLR. In the multivariable model, NLR retained a significant association with OS [HR 1.44 (95% CI 1.14-1.82), P = 0.014] but not with PFS [HR 1.18 (95% CI 0.95-1.46), P = 0.375]. No interaction effect between treatment arm and NLR was evident in terms of PFS (P for interaction = 0.536) or OS (P for interaction = 0.831). Patients with low [HR 0.84 (95% CI 0.64-1.08)] and high [HR 0.73 (95% CI 0.54-0.97)] NLR achieved similar PFS benefit from the triplet and consistent results were obtained in terms of OS [HR 0.83 (95% CI 0.62-1.12) for low NLR; HR 0.82 (95% CI 0.59-1.12) for high NLR]. Conclusion: This study confirmed the prognostic role of NLR in mCRC pts treated with bevacizumab plus chemotherapy in the first line, showing the worse prognosis of pts with high NLR. The advantage of the triplet is independent of NLR at baseline.
RCT Entities:
Background: Neutrophil/lymphocyte ratio (NLR), defined as absolute neutrophils count divided by absolute lymphocytes count, has been reported as poor prognostic factor in several neoplastic diseases but only a few data are available about unresectable metastatic colorectal cancer (mCRC) patients (pts). The aim of our study was to evaluate the prognostic and predictive role of NLR in the TRIBE trial. Patients and methods: Pts enrolled in TRIBE trial were included. TRIBE is a multicentre phase III trial randomizing unresectable and previously untreated mCRC pts to receive FOLFOXIRI or FOLFIRI plus bevacizumab. A cut-off value of 3 was adopted to discriminate pts with low (NLR < 3) versus high (NLR ≥ 3) NLR, as primary analysis. As secondary analysis, NLR was treated as an ordinal variable with three levels based on terciles distribution. Results: NLR at baseline was available for 413 patients. After multiple imputation at univariate analysis, patients with high NLR had significantly shorter progression-free survival (PFS) [hazard ratio (HR) 1.27 (95% CI 1.05-1.55), P = 0.017] and overall survival (OS) [HR 1.56 (95% CI 1.25-1.95), P < 0.001] than patients with low NLR. In the multivariable model, NLR retained a significant association with OS [HR 1.44 (95% CI 1.14-1.82), P = 0.014] but not with PFS [HR 1.18 (95% CI 0.95-1.46), P = 0.375]. No interaction effect between treatment arm and NLR was evident in terms of PFS (P for interaction = 0.536) or OS (P for interaction = 0.831). Patients with low [HR 0.84 (95% CI 0.64-1.08)] and high [HR 0.73 (95% CI 0.54-0.97)] NLR achieved similar PFS benefit from the triplet and consistent results were obtained in terms of OS [HR 0.83 (95% CI 0.62-1.12) for low NLR; HR 0.82 (95% CI 0.59-1.12) for high NLR]. Conclusion: This study confirmed the prognostic role of NLR in mCRC pts treated with bevacizumab plus chemotherapy in the first line, showing the worse prognosis of pts with high NLR. The advantage of the triplet is independent of NLR at baseline.
Authors: C Pedrazzani; G Turri; G Mantovani; C Conti; R Ziello; S Conci; T Campagnaro; A Ruzzenente; A Guglielmi Journal: Clin Transl Oncol Date: 2019-04-02 Impact factor: 3.405
Authors: Claudia Marchetti; Marco D'Indinosante; Carolina Bottoni; Chiara Di Ilio; Stefano Di Berardino; Barbara Costantini; Angelo Minucci; Laura Vertechy; Giovanni Scambia; Anna Fagotti Journal: Sci Rep Date: 2021-05-27 Impact factor: 4.379