P-0219 - Prospective multicenter phase II trial of 15-minute panitumumab infusion with irinotecan in patients with KRAS wild-type chemo-refractory metastatic...

Date 28 June 2014
Event World GI 2014
Session Poster Session
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter Tetsuya Hamaguchi
Citation Annals of Oncology (2014) 25 (suppl_2): ii14-ii104. 10.1093/annonc/mdu165
Authors H. Yasui1, G. Sakai2, S. Akatsuka3, K. Ogawa4, S. Hirai5, Y. Horita6, K. Akiyoshi7, K. Yoshimura8
  • 1Kyoto Medical Center, Kyoto/JP
  • 2Saiseikai Utsunomiya Hospital, Utsunomiya/JP
  • 3Yokohama Rosai Hospital, Yokohama/JP
  • 4Toyama University Hospital, Toyama/JP
  • 5Toyama Prefectural Central Hospital, Toyama/JP
  • 6Toyama Prefectual Central Hospital, Toyama/JP
  • 7National Cancer Center Hospital, Tsukiji/JP
  • 8Kobe University, Kobe/JP

Abstract

Introduction

Panitumumab is one of the standard targeted agents for metastatic colorectal cancer. The result of previous phase I trial suggest short infusion of panitumumab is tolerable without compromising activity, and a few studies demonstrate its efficacy and safety in combination with irinotecan as a third-line chemotherapy. This phase II study evaluated the efficacy and safety of short infusion of panitumumab with irinotecan in patients with chemotherapy-refractory metastatic colorectal cancer.

Methods

The inclusion criteria were as follows; Age ≥ 20 years; histologically proven colorectal cancer; resistant to or intolerant of irinotecan, fluoropyrimidine, or oxaliplatin; no previous anti-EGFR drug therapy; ECOG performance status of 0-2; adequate organ function; and written informed consent. The patients received panitumumab 6 mg/kg and irinotecan 150 mg/m2 biweekly until progressive disease or unacceptable toxicity. The initial dose of panitumumab was administered over 60 min., followed by a 30- and 15-min infusions thereafter. The primary endpoint was the response rate according to the RECIST version 1.0. Objective tumor response was evaluated by investigator every 4 cycles (ie. >8weeks) according to our current practice. All patients received prophylactic topical adapalene and oral minocycline for panitumumab-induced skin toxicity as reported previously (Yanai T et al., ESMO2012).

Results

Forty-three patients were enrolled between January and December 2011 in 14 centers in Japan. Median age: 62 years, male/female: 25/18, performance status 0/1: 23/20, colon/rectum: 20/23. 60-/30-/15-min. panitumumab infusion (dose): 62/55/187. The response rate was 18.6% (95% CI, 8.4-33.4%), and the disease control rate was 67.0% (95% CI: 53.4-81.5%). Median progression-free survival and overall survival were 5.8 months and 13.6 months, respectively. Grade 3/4 hematological toxicities included leucopenia (9%) and neutropenia (9%). Grade 3/4 nonhematological toxicities included anorexia (12%), fatigue (7%), diarrhea (7%), rash acneiform (7%), stomatitis (5%), perionychia (5%), hyponatremia (2%), and hypomagnesemia (2%). No infusion reactions were observed.

Conclusion

Disease control rate, progression free survival, overall survival and manageable toxicity were almost the same as those in the GERCOR study (Andre T et al., Ann Oncol. 2013), although short infusion of panitumumab with irinotecan resulted in lower response rate. Therefore short infusion of panitumumab with irinotecan might be a more convenient option for patients with chemo-refractory metastatic colorectal cancer.