527P - A Phase I/II study of bi-weekly XELIRI with capecitabine 1,000 mg/m2 twice daily and irinotecan 180 mg/m2 plus bevacizumab(BV) for patient with met...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Colon and Rectal Cancer
Biological Therapy
Presenter Mitsukuni Suenaga
Citation Annals of Oncology (2014) 25 (suppl_4): iv167-iv209. 10.1093/annonc/mdu333
Authors N. Mizunuma1, M. Suenaga1, S. Matsusaka1, E. Shinozaki1, M. Ozaka1, M. Ogura1, K. Chin1, T. Yamaguchi2
  • 1Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 135-8550 - Tokyo/JP
  • 2Gastroenterology Center, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 135-8550 - Tokyo/JP



Tri-weekly XELIRI is not completely regarded as a valid substitute for FOLFIRI in mCRC because of the potential for greater toxicity. Reduced dose tri-weekly XELIRI is officially recommended recently. This time, we conducted a PI/II study to assess bi-weekly XELIRI plus BV in efficacy and safety as second-line chemotherapy in mCRC.


Patients with prior chemotherapy including oxaliplatin and BV for mCRC, wild or hetero type of UGT1A1 *6*28 were eligible for this study. Treatment comprised capecitabine 1,000 mg/m2 twice daily from the evening of day 1 to the morning of day 8, intravenous irinotecan on day 1, and BV 5mg/kg on day 1 every two weeks. PI study was composed of two steps (irinotecan 150 and 180 mg/m2), and dose limiting toxicity was assessed during the first treatment cycle. The primary endpoint of PII study was progression-free survival (PFS).


Recommended dose of irinotecan was determined as 180mg/m2 in PI study. Between Nov 2010 and Aug 2013, 44 patients were enrolled in PII study. Characteristics of patients were as follows (N = 44): median age, 60 yrs (range 32-80 yrs); male/female, 21/23; ECOG PS0, 86.4%; colon/rectum, 23/21; UGT1A1 wild/hetero type, 29/15; and 1st chemo regimen FOLFOX/XELOX, 18/26. The median number of treatment cycles was 10.5. Median PFS was 6.8 months (95%CI, 5.3-8.2 months), and the primary endpoint was met. Median overall survival (OS) was 18.3 months (95%CI, 13.4 - 23.1 months). Response rate was 22.7% (95%CI, 9.8-35.6%). No significant differences in PFS or OS occurred in UGT1A1 status and 1st chemo regimen. Grade 3 or greater adverse events observed were: neutropenia in six, diarrhea in five, nausea in four, anorexia in one, vomiting in one, stomatitis in one, fatigue in one, hand-foot skin reaction in one, hypertension in one, and interstitial pneumonia in one. There were no other severe adverse events and treatment related deaths.


In mCRC patients with wild or hetero of UGT1A1*6*28 genotype, biweekly XELIRI + BV is effective and feasible as 2nd line chemotherapy. Bi-weekly XELIRI + BV could be a valid substitute for FOLFIRI + BV in mCRC.


All authors have declared no conflicts of interest.