FOLFOXIRI plus bevacizumab (BV) versus FOLFIRI plus BV as first-line treatment of metastatic colorectal cancer (MCRC): Preliminary safety results of the phase III randomized TRIBE study by the Gruppo Oncologico Nord-Ovest (GONO).
2010; Lippincott Williams & Wilkins; Volume: 28; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2010.28.15_suppl.3543
ISSN1527-7755
AutoresAlfredo Falcone, Fotios Loupakis, Samanta Cupini, Enrico Cortesi, Angela Buonadonna, Giovanni Tomasello, Maria Banzi, M. Ronzoni, Alberto Zaniboni, Gianluca Masi,
Tópico(s)Cancer Treatment and Pharmacology
Resumo3543 Background: The combination of BV with cytotoxic drugs is an efficacious strategy in the treatment of mCRC. The triple drug combination FOLFOXIRI demonstrated increased activity and efficacy over FOLFIRI in a randomized trial (Falcone, JCO 2007). The combination of FOLFOXIRI plus BV demonstrated promising results in phase II. Methods: TRIBE is a multicenter, randomized, Italian trial. CRC patients (pts) with metastatic disease deemed unresectable were randomized to receive in first-line BV in combination with FOLFIRI (arm A) or with FOLFOXIRI (arm B) for a maximum of 6 months (induction treatment). In both arms a maintenance treatment with BV and fluoropyrimidines until progression or unacceptable toxicity were scheduled. Primary endpoint is progression-free survival and the planned accrual is 450 pts. Results: The trial is still ongoing. We present the safety analysis of the first 100 randomized pts. Patients characteristics are (arm A/arm B): number 51/49, gender M45%-F55%/M61%-F39%, median age 60 (29-74) years/ 62 (29-74) years, ECOG PS=0 88%/84%, primary rectal 37%/33%, primary on site 24%/27%, multiple site of metastasis 73%/63%, prior adjuvant therapy 16%/10%. Administered cycles were: arm A 503 (median 12), arm B 485 (median 11). Main grade 3-4 observed toxicities are reported in the Table. For arm A and arm B respectively serious adverse events occurred in 18% and 20% of pts, probably treatment-related deaths in 3 pts (2 pulmonary embolism and 1 stroke) and 1 pt (GI bleeding). Conclusions: These preliminary results demonstrate that both treatment arms are safe and feasible, side effects occur with the expected incidence and there were not unexpected toxicities. NCI-CTC 3.0 grade 3-4 Arm A (FOLFIRI + BV) Arm B (FOLFOXIRI + BV) N % N % Vomiting 0 0% 2 4% Diarrhea 6 12% 9 18% Stomatitis 3 6% 4 8% Neutropenia 7 14% 26 53% Febrile neutropenia 3 6% 3 6% Thrombocytopenia 0 0% 1 2% Anemia 0 0% 0 0% Neurotoxicity (grade 2-3) NA NA 9 18% Asthenia 5 10% 2 4% Hypertension 1 2% 1 2% Bleeding 0 0% 1 2% Venous thrombosis 4 8% 3 6% Arterial thrombosis 1 2% 1 2% GI perforation 0 0% 1 2% Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen, Merck, Roche Amgen, Merck, Roche, sanofi-aventis Amgen, Merck, Roche
Referência(s)