A randomized phase II trial comparing two schedules of irinotecan (CPT11) in combination with capecitabine as first line chemotherapy in patients with metastatic colorectal cancer
Nel marzo 1999 é stato avviato uno studio sul tumore del colon-retto metastatico.
Lo studio (Protocollo 8/99) aveva l’obiettivo di valutare l’attività antitumorale e la tollerabilità dell’associazione capecitabina e CPT 11, quest’ultimo somministrato ad alta e bassa dose.
Sono stati arruolati 140 pazienti.
Lo studio ha dimostrato un’elevata attività antitumorale dell’associazione indipendente dalla dose di CPT 11. La tollerabilità è stata accettabile per il dosaggio più basso di Irinotecan.
Centri partecipanti : Istituto Nazionale Tumori, MILANO
Centro Riferimento Oncologico, AVIANO
Ospedale S. Orsola Malpighi, BOLOGNA
Spedali Civili, BRESCIA
Policlinico Universitario, CAGLIARI
Casa di Cura S. Maria, CASTELLANZA (VA)
Istituti Ospitalieri, CREMONA
Azienda ULSS 21, LEGNAGO (VR)
Ospedale L. Sacco, MILANO
Ospedale Niguarda, MILANO
Ospedale S. Giuseppe, MILANO
Policlinico P. Giaccone, PALERMO
Az. Osp. S. Maria degli Angeli, PORDENONE
Az. Ospedaliera di REGGIO CALABRIA
Istituto Regina Elena, ROMA
Presidio Ospedaliero di SIDERNO
Ospedale di Circolo Fondazione Macchi, VARESE
Ospedale S. Bortolo, VICENZA
Ospedale S. Raffaele, MILANO
Azienda Ospedaliera C. Poma, MANTOVA
- Randomized multicenter Phase II trial of two different schedules of irinotecan combined with capecitabine as first-line treatment in metastatic colorectal carcinoma.
(Bajetta E, Di Bartolomeo M, Mariani L, Cassata A, Artale S, Frustaci S, Pinotti G, Bonetti A, Carreca I, Biasco G, Bonaglia L, Marini G, Iannelli A, Cortinovis D, Ferrario E, Beretta E, Lambiase A, Buzzoni R; Italian Trials in Medical Oncology (I.T.M.O.) Group).
Cancer. 2004 Jan 15;100(2):279-87.
The aim of the current randomized Phase II study was to investigate the efficacy and safety of capecitabine combined with irinotecan as first-line treatment in metastatic colorectal carcinoma (CRC).
A total of 140 patients received capecitabine at a dose of 1250 mg/m(2) twice daily on Days 2-15 and irinotecan at a dose of either 300 mg/m(2) on Day 1 (Arm A) or 150 mg/m(2) on Days 1 and 8 (Arm B) every 3 weeks. During the course of the study, enrollment was continued using lower doses of capecitabine (1000 mg/m(2) twice daily) and irinotecan (Arm A: 240 mg/m(2); Arm B: 120 mg/m(2)) to improve the safety profile of the combinations.
Efficacy was evaluable in 134 patients (68 in Arm A, 66 in Arm B). Objective responses were observed in 46% of the patients (8% complete response [CR]), including 47% in Arm A (9% CR; 38% partial response [PR]) and 44% in Arm B (8% CR; 36% PR). The median progression-free survival was 8.3 months in Arm A and 7.6 months in Arm B. Among the first 52 patients treated with the higher doses, the most frequent Grade 3-4 adverse event was diarrhea (27%). The lower doses adopted in the subsequent 88 patients led to better diarrhea control, particularly in Arm A, and significant reductions in the incidence of all-grade hand-foot syndrome and abdominal pain.
The capecitabine and irinotecan combination was a highly active first-line therapy in metastatic CRC. An acceptable safety profile was observed after dose reduction, particularly when irinotecan was administered on 1 day.
PMID: 14716761 [PubMed – indexed for MEDLINE]
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