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Title: | The prognostic role of inflammatory markers in patients with metastatic colorectal cancer treated with bevacizumab: A translational study [ASCENT]. | Authors: | Burge M.;Segelov E. ;Tebbutt N.C.;Reece W.H.H.;Price T.;Molloy M.P.;Marx G.;Jones K.;Gibbs P.;Feeney K.;Clarke S.J. | Monash Health Department(s): | Oncology | Institution: | (Clarke) Cancer Services, Royal North Shore Hospital, St Leonards, Australia (Burge) Cancer Care Services, Royal Brisbane and Women Hospital, University of Queensland, Herston, Australia (Feeney) Department of Oncology, Haematology and Palliative Care, St John of God Murdoch Hospital, Murdoch, Australia (Gibbs) Medical Oncology, Western Hospital, Footscray, Australia (Jones) Medical Affairs, Roche Products, Pty, Limited, Sydney, Australia (Marx) Integrated Cancer Centre, Sydney Adventist Hospital, University of Sydney, Wahroonga, Australia (Molloy) Australian, Proteome Analysis Facility, Macquarie University, Sydney, Australia (Price) Haematology and Medical Oncology, Queen Elizabeth Hospital, University of Adelaide, Adelaide, Australia (Reece) Biostatistics, Covance Pty Ltd, Sydney, Australia (Segelov) Medical Oncology, St Vincent's Hospital, Darlinghurst, Australia (Tebbutt) Medical Oncology, Austin Health, Heidelberg, Australia (Segelov) Monash University and Monash Health, Clayton, Australia | Issue Date: | 19-Mar-2020 | Copyright year: | 2020 | Publisher: | Public Library of Science (E-mail: plos@plos.org) | Place of publication: | United States | Publication information: | PLoS ONE. 15 (3) (no pagination), 2020. Article Number: e0229900. Date of Publication: 2020. | Journal: | PLoS ONE | Abstract: | Background In spite of demonstrating prognostic and possibly predictive benefit in retrospective cohorts and meta-analyses of cancer populations, including colorectal cancer (CRC), prospective evaluation of the relationship between neutrophil to lymphocyte ratio (NLR) and treatment outcomes in previously untreated mCRC patients receiving bevacizumab-based therapy has not yet been performed. Methods An open-label, single arm, multi-centre study. Patients received first-line bevacizumab plus XELOX or mFOLFOX6 (Phase-A) and continued bevacizumab plus FOLFIRI beyond first progression (Phase-B). Analyses included the association of NLR with phase A progression free survival (PFS) and overall survival (OS). A sub-study investigated the safety in patients with the primary in situ tumor. An exploratory sub-study examined relationships of circulating proteomic markers with PFS. Results Phase-A enrolled 128 patients; median age was 64 years (range: 26-84), 70 (55%) were female, 71 (56%) were PS-0 and 51 (40%) had primary in situ tumor. Fifty-three (41%) patients entered Phase-B. The median baseline (b) NLR was 3.2 (range: 1.5-20.4) with 32 (25%) patients having bNLR > 5. The PFS hazard ratio (HR) by bNLR > 5 versus <= 5 was 1.4 (95% CI: 0.9-2.2; p = 0.101). The median PFS was 9.2 months (95% CI: 7.9-10.8) for Phase-A and 6.7 months (95% CI: 3.0-8.2) for Phase-B. The HR for OS based on bNLR > 5 versus <= 5 was 1.6 (95% CI: 1.0-2.7; p = 0.052). The median OS was 25 months (95% CI: 19.2-29.7) for the full analysis set and 14.9 months for Phase-B. Baseline levels of nine proteomic markers showed a relationship with PFS. Treatment related toxicities were consistent with what has previously been published. There were 4 (3%) instances of GI perforation, of which, 3 (6%) occurred in the primary in situ tumor group. Conclusions Results from this study are aligned with the previously reported trend towards worse PFS and OS in patients with higher bNLR.Copyright © 2020 Clarke et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1371/journal.pone.0229900 | PubMed URL: | 32142532 [http://www.ncbi.nlm.nih.gov/pubmed/?term=32142532] | ISSN: | 1932-6203 (electronic) | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/29334 | Type: | Article | Subjects: | intestine fistula intestine perforation large intestine perforation lung embolism metastatic colorectal cancer mucosa inflammation multiple cycle treatment nausea neutropenia neutrophil lymphocyte ratio paresthesia perianal abscess peripheral neuropathy phase 4 progression free survival proteinuria proteomics rectum perforation survival rate vomiting bevacizumab bevacizumab/ct capecitabine plus oxaliplatin/ct capecitabine plus oxaliplatin proteome abdominal pain aged alopecia anus fistula cancer combination chemotherapy cancer carcinoma in situ constipation decreased appetite diarrhea digestive system perforation drug safety epistaxis exploratory research fatigue gastroesophageal reflux hand foot syndrome hypertension |
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