Perioperative Bevacizumab-based Triplet Chemotherapy in Patients With Potentially Resectable Colorectal Cancer Liver Metastases |
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Authors: | Filippo Pietrantonio Christian Cotsoglou Giovanni Fucà Salvatore Lo Vullo Federico Nichetti Massimo Milione Jorgelina Coppa Marta Vaiani Alessandra Alessi Michele Prisciandaro Michele Droz-Dit Busset Federica Morano Salvatore Corallo Silvia Lazzati Maria Antista Alessia Mennitto Giovanni Randon Alessandra Raimondi Vincenzo Mazzaferro |
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Institution: | 1. Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy;2. Oncology and Hemato-Oncology Department, University of Milan, Milan, Italy;3. General Surgery and Liver Transplantation, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy;4. Clinical Epidemiology and Trial Organization, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy;5. Department of Pathology and Laboratory Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy;6. Radiology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy;7. Nuclear Medicine Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy |
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Abstract: | BackgroundIn colorectal cancer liver metastases (CRCLM), bevacizumab-based neoadjuvant strategies provide increased pathologic response. We aimed at assessing the activity of perioperative capecitabine, oxaliplatin, irinotecan, and bevacizumab (COI-B regimen) in patients with potentially resectable CRCLM, and investigating biomarkers for early prediction of pathologic response.Patients and MethodsThis was a single-center phase II study enrolling patients with liver-limited, borderline resectable disease and/or high-risk features. Patients received 5 preoperative and 4 postoperative cycles of biweekly COI-B (irinotecan 180 mg/m2 and bevacizumab 5 mg/Kg on day 1, oxaliplatin 85 mg/m2 on day 2, and capecitabine 1000 mg/m2 twice a day on days 2 to 6). The primary endpoint was pathologic response rate in the intention-to-treat population. A Simon 2-stage design was adopted to detect an increase from 30% to 50% with a power of 90%. Dynamic imaging biomarkers (early tumor shrinkage ETS], deepness of response, maximum standardized uptake volume SUVmax]/regression index) and next generation sequencing data were explored as surrogates.ResultsFrom June 2013 to March 2017, 46 patients were enrolled. Pathologic response was achieved in 63% patients (endpoint met), and responders achieved significantly better survival outcomes with respect to non-responders. The most frequent grade 3/4 adverse events were diarrhea and neutropenia (8.7%) in the preoperative phase and thromboembolic events (5.9%) in the postoperative phase. ETS and lower SUV-2 were significantly associated with pathologic response.ConclusionThe COI-B regimen is a feasible and highly active perioperative strategy in patients with molecularly unselected, potentially resectable CRCLM. ETS and SUV-2 have a promising role as imaging-based biomarkers for pathologic response. |
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Keywords: | Colorectal cancer liver metastases FGD-PET/CT Pathologic response Triplet chemotherapy Tumor regression grade |
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