598P - A prospective multicenter feasibility study with short-time infusion of panitumumab (SHIP trial)

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter Kohei Akiyoshi
Authors K. Akiyoshi1, T. Hamaguchi2, Y. Nagai3, H. Yasui4, G. Sakai5, S. Akatsuka6, A. Hosokawa7, S. Hirai8, K. Yoshimura9, Y. Shimada10
  • 1National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 2Gastrointestinal Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 3Clinical Trial Support Office, National Cancer Center Hospital, Tokyo/JP
  • 4Medical Oncology, Kyoto Medical Center, JP-612-0861 - Kyoto/JP
  • 5Division Of Gastrointestinal Medicine, Saiseikai Utsunomiya Hospital, Utsunomiya/JP
  • 6Division Of Medical Oncology, Yokohama Rosai Hospital, Yokohama/JP
  • 7Gastroenterology, Toyama University, Toyama/JP
  • 8Division Of Gastrointestinal Medicine, Toyama Prefectural Central Hospital, Toyama/JP
  • 9Dept. Clinical Trial Design & Management, Translational Research Center, Kyoto University Hospital, Kyoto/JP
  • 10Gastrointestinal Oncology Division, National Cancer Center Hospital, 104-0045 - Tokyo/JP

Abstract

Background

Panitumumab (Pmab) is now considered to be the standard treatment for metastatic colorectal cancer. Pmab infusions are normally administered over 60 minutes. In a previous study, 30-minute infusions of panitumumab showed similar safety, pharmacokinetics, and frequency of infusion reaction to 60-minute infusions. Because Pmab consists of fully human monoclonal antibodies, infusion reactions occur less frequently than with cetuximab, chimeric monoclonal antibodies. Short-time infusion of Pmab has the potential to improve patient convenience and reduce costs.

Purpose

We evaluated the safety of short-time infusion of panitumumab in a prospective multicenter study.

Methods

Between January 2011 and December 2011, from 14 centers in Japan, a phase II study of Pmab + irinotecan (CPT-11) or Pmab monotherapy in KRAS wild-type metastatic colorectal cancer refractory to CPT-11, oxaliplatin, and fluoropyrimidines was performed. As an additional study, the initial dose of Pmab was administered over 60 minutes, followed by 30-minute infusion; then, all subsequent doses were to be administered over 15 minutes.

Results

Forty-eight patients were enrolled. Their characteristics were median age of 62 (32-75); male/female, 27/21; Performance Status 0/1/2, 23/24/1; primary lesion in colon/rectum, 21/27; and treatment regimen of CPT-11 + Pmab/Pmab monotherapy, 43/5. The number of patients and doses with 60-/30-/15-minute administration were 48/45/38 cases and 67/56/206 doses, respectively. In all cases with 60-/30-/15-minute infusion, infusion reaction was not encountered. Grade 3/4 toxicities included anorexia 8%, stomatitis 4%, diarrhea 6%, fatigue 4%, rash acneiform 6%, perionychia 4%, leucopenia 8%, neutropenia 8%, anemia 15%, hyponatremia 4%, and hypomagnesemia 4%. This was similar to the results from previous clinical studies on panitumumab.

Conclusion

In this study, no infusion reactions with 60-/30-/15-minute administration of panitumumab and no increase of frequency of adverse events were observed. This is the first prospective study describing the feasibility of short-time infusion of panitumumab. This study suggests that 15-minute infusions of panitumumab are feasible in patients who tolerate a 60- and then 30-minute infusion sequence.

Disclosure

All authors have declared no conflicts of interest.