Disclosures: Eduardo Díaz-Rubio: Roche (C/A, RF); Auxiliadora Gómez-España: None; Bartomeu Massutí: Roche (C/A); Javier Sastre: None; Albert Abad: Roche (C/A); Manuel Valladares: Roche (C/A, RF, H); Fernando Rivera: Roche (C/A, RF); Maria J. Safont: None; Purificación Martínez de Prado: None; Manuel Gallén: None; Encarnación González: None; Eugenio Marcuello: None; Manuel Benavides: Roche (C/A); Carlos Fernández-Martos: None; Ferrán Losa: None; Pilar Escudero: None; Antonio Arrivi: None; Andrés Cervantes: Roche (H); Rosario Dueñas: None; Amelia López-Ladrón: None; Adelaida Lacasta: None; Marta Llanos: None; Jose M. Tabernero: Roche, Genentech, Sanofi- Aventis (C/A); Antonio Antón: None; Enrique Aranda: Roche, Merck Serono (C/A). (C/A) Consulting/advisory relationship; (RF) Research funding; (E) Employment; (H) Honoraria received; (OI) Ownership interests; (IP) Intellectual property rights/inventor/patent holder; (SAB) Scientific advisory board. Purpose: The aim of this phase III trial was to compare the efficacy and safety of bevacizumab alone with those of bevacizumab and capecitabine plus oxaliplatin (XELOX) as maintenance treatment following induction chemotherapy with XELOX plus bevacizumab in the first-line treatment of patients with metastatic colorectal cancer (mCRC). Patients and Methods: Patients were randomly assigned to receive six cycles of bevacizumab, capecitabine, and oxaliplatin every 3 weeks followed by XELOX plus bevacizumab or bevacizumab alone until progression. The primary endpoint was the progression-free survival (PFS) interval; secondary endpoints were the overall survival (OS) time, objective response rate (RR), time to response, duration of response, and safety. Results: The intent-to-treat population comprised 480 patients (XELOX plus bevacizumab, n = 239; bevacizumab, n = 241); there were no significant differences in baseline characteristics. The median follow-up was 29.0 months (range, 0–53.2 months). There were no statistically significant differences in the median PFS or OS times or in the RR between the two arms. The most common grade 3 or 4 toxicities in the XELOX plus bevacizumab versus bevacizumab arms were diarrhea, hand–foot syndrome, and neuropathy. Conclusion: Although the noninferiority of bevacizumab versus XELOX plus bevacizumab cannot be confirmed, we can reliably exclude a median PFS detriment >3 weeks. This study suggests that maintenance therapy with singleagent bevacizumab may be an appropriate option following induction XELOX plus bevacizumab in mCRC patients., Eduardo Díaz-Rubio, Auxiliadora Gómez-España, Bartomeu Massutí, Javier Sastre, Albert Abad, Manuel Valladares, Fernando Rivera, Maria J.Safont, Purificación Martínez De Prado, Manuel Gallén, Encarnación González, Eugenio Marcuello, Manuel Benavides, Carlos Fernández-Martos, Ferrán Losa, Pilar Escudero, Antonio Arrivi, Andrés Cervantes, Rosario Dueñas, Amelia López-Ladrón, Adelaida Lacasta, Marta Llanos, Jose M. Tabernero, Antonio Antón, Enrique Aranda, and Literatura 29
Aim: to improve treatment results of colorectal cancer, complicated carcinomatosis of abdominal cavity, by associated using of endolymphatic chemotherapy (ELCT) and local extremely high frequency (EHF) therapy. Igroup 21 people (33.3%) performed colostomy, then neoadjuvant systemic chemotherapy by the scheme FOLFOX4. It was held two cycles, after two cycles their were received cytoreductive surgery; II group 26 people (41,3%) received cytoreductive operations with early postoperative intraabdominal chemotherapy by oxaliplatin (200 mg/m(2) at day 1 and 5FU 650 mg/m(2) from days 1 to 4. III group 16 people (25,4%) also performed colostomy, then used 2 courses of ELCT with local EHF therapy and all patients were received cytoreductive operations. ELCT was carried out injecting oxaliplatin100 mg/m(2) a day during 12 hours and then 5 FU in doze of 600 mg/m2 a day during 72 hours by the instrumentality of the dozer and LV200 mg/m(2) (2h intravenous infusion). During ELCT patients received local EHF therapy in abdominal cavity for an hour. After chemotherapy the partial regress of tumor observed in 1st group in 4,8 % and in 3rd 37,5 %, stabilization of process noted in 28,6 and 50% cases, progressing 66,7 and 12,5% cases correspondingly to groups. Histomorphologic study of malignant foci after ELCT+EHF therapy showed reduction of specific area of parenchyma cancer cell from 57 till 39% simultaneous growth of stroma from 40 till 58% and in necrosis area from 1,8 till 2,5%. Mitotic activity of tumor cells in the 1st group decreased (average in 22 un.), but in 3rd group it decreased until 11 units. Analysis of life span showed that in 1st group of patients 2year survival rate was 66,7%. In 2nd group of patients 2year survival rate was 42,3%. ELCH+EHFtherapy has high clinic efficacy and promotes to decrease terms of progression of tumor process, increases life span from 0 till 24% and quality of life of the patients. ELCH+EHFtherapy brings to reduction of specific area of parenchyma in cancer cells from 57 till 39% with simultaneous growth of stroma area from 40 till 58% and necrosis area from 1,8 till 2,5%. ELCT+EHFtherapy lowers mitotic activity of tumor cells, activates apoptosis, hemodynamic and metabolic rates., Akbarov E.T., Navruzov S.N., Abdujapparov S.B., Islamov H.D., and Literatura