Capecitabine and irinotecan with bevacizumab 2-weekly for metastatic colorectal cancer: the phase II AVAXIRI study.
BACKGROUND
The optimal sequence of chemotherapeutic agents is not firmly established for the treatment of metastatic colorectal cancer (mCRC). This phase II multi-centre study investigated the efficacy and tolerability of a standard capecitabine plus irinotecan (XELIRI) regimen with bevacizumab in previously untreated patients with mCRC.


METHODS
Patients received intravenous irinotecan 175 mg/m(2) on day 1 and oral capecitabine 1000 mg/m(2) (800 mg/m(2) for patients >65 years of age) twice daily on days 2-8, followed by a 1-week rest, and bevacizumab 5 mg/kg as an intravenous infusion on day 1 every 2 weeks.


RESULTS
Seventy-seven patients were included in the intention-to-treat and safety populations. Progression-free survival at 9 months was 61%. The overall response and disease control rates were 51% and 84%, respectively. Median progression-free and overall survival times were 11.9 and 24.8 months, respectively. 48 patients (62%) had at least one grade 3/4 adverse event, the most common being asthenia, diarrhoea and neutropenia. Quality of life varied little over the study period with mean visual analogue scale general health scores ranging from 71 to 76 over cycles 1-11.


CONCLUSIONS
Our study found irinotecan and capecitabine administered fortnightly with bevacizumab in patients with mCRC to be an effective and tolerable regimen.


BACKGROUND
clinicaltrials.gov identifier NCT00875771. Trial registration date: 04/02/2009.
Servicio de Oncología, Hospital Universitario Gregorio Marañón, C/Maiquez 7, 2nd floor, 28007, Madrid, Spain. pgarcaalfonso@gmail.com.
Pilar
P
Garcia-Alfonso
Servicio de Oncología, Hospital Virgen del Rocío, 41004, Sevilla, Spain. manuelchavesconde@gmail.com.
Manuel
M
Chaves
Servicio de Oncología, Hospital Universitario Gregorio Marañón, C/Maiquez 7, 2nd floor, 28007, Madrid, Spain. andresmunmar@hotmail.com.
Andrés
A
Muñoz
Servicio de Oncología, Hospital Lleida Arnau de Vilanova, 25198, Barcelona, Spain. asaluds@hotmail.com.
Antonieta
A
Salud
Servicio de Oncología, Hospital Universitario de Burgos, 09005, Burgos, Spain. meuris2903@gmail.com.
Maria
M
García-Gonzalez
Servicio de Oncología, Hospital 12 Octubre, 28041, Madrid, Spain. cgravalos@telefonica.net.
Cristina
C
Grávalos
Servicio de Oncología, Hospital General Universitario, 03011, Alicante, Spain. bmassutis@seom.org.
Bartomeu
B
Massuti
Servicio de Oncología, Hospital Virgen de las Nieves, 18014, Granada, Spain. encarna.gonzalez@hotmail.es.
Encarna
E
González-Flores
Servicio de Oncología, ICO. Hospital. Josep Trueta, 17007, Gerona, Spain. bqueralt@iconcologia.net.
Bernardo
B
Queralt
Servicio de Oncología, Hospital Nuestra Señora de Valme, 41014, Sevilla, Spain. alopezladron@yahoo.es.
Amelia
A
López-Ladrón
Servicio de Oncología, Hospital General de L'Hospitalet, 08906, Barcelona, Spain. ferran.losa@sanitatintegral.org.
Ferran
F
Losa
Servicio de Oncología, Hospital Puerta del Mar, 11009, Cádiz, Spain. mariajose.gomezreina@gmail.com.
Maria Jose
MJ
Gómez
Servicio de Oncología, Hospital Virgen de los Lirios, 03804, Alicante, Spain. oltra_amp@gva.es.
Amparo
A
Oltra
Reina Sofía Hospital, University of Córdoba, Maimonides Institute of Biomedical Research (IMIBIC). Spanish Cancer Network (RTICC), Instituto de Salud Carlos III, Córdoba, Spain. earandaa@seom.org.
Enrique
E
Aranda
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D000068258:Bevacizumab / Q000008:administration & dosage*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000069287:Capecitabine / Q000008:administration & dosage*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016896:Treatment Outcome
D000068258:Bevacizumab; D000069287:Capecitabine; D000077146:Irinotecan; D002166:Camptothecin