Patients and treatment
toxicity, PD, NRAS
DISEASE PROGRESSION, RECURRENCE, METASTATIC DISEASE, ONCOLOGY, RECTAL CANCER
This is a prospective non-pharmacological trial aimed at validating This study involved 182 patients with mCRC treated with first-line chemotherapy plus Bev at the IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori” in Meldola. Patients ≥ 18 years of age, with histologically confirmed mCRC, one or more unidimensional measurable lesions according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (≤ 1 if age ≥ 70 years), and an estimated life expectancy of at least 12 weeks were included. Patients were required to have adequate hematological, hepatic and renal func-tion. Prior adjuvant chemotherapy for CRC or neoadjuvant/adjuvant chemo-radiotherapy for rectal cancer were permitted, if completed at least 6 months before recurrence; conversely, prior chemotherapy or immunotherapy for advanced or metastatic disease were not permitted. Patients received one of the following chemotherapy regimens in combina-tion with Bev: FOLFOX4, CAPOX, FOLFIRI, CAPIRI.Treatment was to continue until disease progression (PD), withdrawal of consent, or unacceptable toxicity, whichever came first. If a patient became eligible for curative resection of metastatic disease, Bev was discontinued at least 6–8 weeks prior to the scheduled surgery date. After surgery, the choice of treatment was at the physician's discretion, and patients could resume treatment at least 28 days after surgery or complete wound healing, until PD. We analyzed KRAS gene (codons 12, 13, 59, 61, 117, 146), BRAF gene (codons 594, 600, 601) and NRAS gene (codons 12, 13, 18, 59, 61, 117, 146) as for clinical practice.