Abstract
BACKGROUND: A phase I/II study was performed to determine the safety and activity of a capecitabine plus oxaliplatin and irinotecan (COI) regimen using capecitabine concurrently with oxaliplatin and irinotecan in previously untreated patients with metastatic colorectal cancer. PATIENTS AND METHODS: Patients received irinotecan on day 1, oxaliplatin (85 mg/m(2)) on day 2 and capecitabine (1000 mg/m(2) orally twice daily) on days 2-6 of a biweekly schedule. Three dose levels ranging from 150 to 180 mg/m(2) were explored for irinotecan in sequential cohorts of three to six patients. Once the recommended dose was determined, a total of 28 eligible patients were planned at this dose level. RESULTS: Thirty-eight patients received a median of six cycles. The recommended phase II dose of irinotecan was 180 mg/m(2). Toxicity was manageable: the most common severe toxicities were diarrhoea (24%) and nausea (16%). Of 27 assessable patients treated at the recommended dose, 17 achieved a partial response (overall response rate (ORR) 63%; 95% confidece interval (CI), 44 to 78%), with eight patients undergoing liver metastasectomy. Estimated progression-free survival and overall median survival were 8.5 and 23.5 months, respectively. CONCLUSIONS: Biweekly COI is feasible and active. Tolerability and ease of administration make the regimen well suited for downsizing hepatic colorectal metastases before curative surgery.
| Original language | English |
|---|---|
| Pages (from-to) | 1810-1816 |
| Number of pages | 7 |
| Journal | Annals of Oncology |
| Volume | 18 |
| Issue number | 11 |
| DOIs | |
| Publication status | Published - Nov 2007 |
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Capecitabine plus oxaliplatin and irinotecan regimen every other week : a phase I/II study in first-line treatment of metastatic colorectal cancer. / Bajetta, E.; Celio, L.; Ferrario, E.; Di Bartolomeo, M.; Denaro, A.; Dotti, K.; Mancin, M.; Bajetta, R.; Colombo, A.; Pusceddu, S.
In: Annals of Oncology, Vol. 18, No. 11, 11.2007, p. 1810-1816.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Capecitabine plus oxaliplatin and irinotecan regimen every other week
T2 - a phase I/II study in first-line treatment of metastatic colorectal cancer.
AU - Bajetta, E.
AU - Celio, L.
AU - Ferrario, E.
AU - Di Bartolomeo, M.
AU - Denaro, A.
AU - Dotti, K.
AU - Mancin, M.
AU - Bajetta, R.
AU - Colombo, A.
AU - Pusceddu, S.
PY - 2007/11
Y1 - 2007/11
N2 - BACKGROUND: A phase I/II study was performed to determine the safety and activity of a capecitabine plus oxaliplatin and irinotecan (COI) regimen using capecitabine concurrently with oxaliplatin and irinotecan in previously untreated patients with metastatic colorectal cancer. PATIENTS AND METHODS: Patients received irinotecan on day 1, oxaliplatin (85 mg/m(2)) on day 2 and capecitabine (1000 mg/m(2) orally twice daily) on days 2-6 of a biweekly schedule. Three dose levels ranging from 150 to 180 mg/m(2) were explored for irinotecan in sequential cohorts of three to six patients. Once the recommended dose was determined, a total of 28 eligible patients were planned at this dose level. RESULTS: Thirty-eight patients received a median of six cycles. The recommended phase II dose of irinotecan was 180 mg/m(2). Toxicity was manageable: the most common severe toxicities were diarrhoea (24%) and nausea (16%). Of 27 assessable patients treated at the recommended dose, 17 achieved a partial response (overall response rate (ORR) 63%; 95% confidece interval (CI), 44 to 78%), with eight patients undergoing liver metastasectomy. Estimated progression-free survival and overall median survival were 8.5 and 23.5 months, respectively. CONCLUSIONS: Biweekly COI is feasible and active. Tolerability and ease of administration make the regimen well suited for downsizing hepatic colorectal metastases before curative surgery.
AB - BACKGROUND: A phase I/II study was performed to determine the safety and activity of a capecitabine plus oxaliplatin and irinotecan (COI) regimen using capecitabine concurrently with oxaliplatin and irinotecan in previously untreated patients with metastatic colorectal cancer. PATIENTS AND METHODS: Patients received irinotecan on day 1, oxaliplatin (85 mg/m(2)) on day 2 and capecitabine (1000 mg/m(2) orally twice daily) on days 2-6 of a biweekly schedule. Three dose levels ranging from 150 to 180 mg/m(2) were explored for irinotecan in sequential cohorts of three to six patients. Once the recommended dose was determined, a total of 28 eligible patients were planned at this dose level. RESULTS: Thirty-eight patients received a median of six cycles. The recommended phase II dose of irinotecan was 180 mg/m(2). Toxicity was manageable: the most common severe toxicities were diarrhoea (24%) and nausea (16%). Of 27 assessable patients treated at the recommended dose, 17 achieved a partial response (overall response rate (ORR) 63%; 95% confidece interval (CI), 44 to 78%), with eight patients undergoing liver metastasectomy. Estimated progression-free survival and overall median survival were 8.5 and 23.5 months, respectively. CONCLUSIONS: Biweekly COI is feasible and active. Tolerability and ease of administration make the regimen well suited for downsizing hepatic colorectal metastases before curative surgery.
UR - http://www.scopus.com/inward/record.url?scp=38449107093&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=38449107093&partnerID=8YFLogxK
U2 - 10.1093/annonc/mdm347
DO - 10.1093/annonc/mdm347
M3 - Article
C2 - 17823385
AN - SCOPUS:38449107093
VL - 18
SP - 1810
EP - 1816
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 11
ER -