A Prospective Multicenter Feasibility Study With Short-Time Infusion of Panitumumab (Ship Trial)

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.