Panitumumab and irinotecan every 3 weeks is an active and convenient regimen for second-line treatment of patients with wild-type K-RAS metastatic colorectal cancer

Clin Transl Oncol. 2013 Sep;15(9):705-11. doi: 10.1007/s12094-012-0993-x. Epub 2013 Jan 29.

Abstract

Purpose: To evaluate the efficacy and safety profile of the combination of panitumumab and irinotecan every 3 weeks in a phase II trial as second-line treatment in patients with advanced wild-type (WT) K-RAS colorectal cancer (CRC).

Methods: Fifty-three patients received 9 mg/kg of panitumumab followed by 350 mg/m(2) of irinotecan every 21 days until disease progression, unacceptable toxicity or consent withdrawal.

Results: Median age of patients included was 67 years. All patients had previously received 5-fluorouracil, 84 % oxaliplatin and 8 % irinotecan as first-line treatment. Patients received a median of five infusions of panitumumab and irinotecan. On an intention-to-treat analysis, 12 patients (23 %) achieved partial responses and 22 patients (41 %) achieved disease stabilization. Median progression-free survival and overall survival were 4.5 and 15.1 months, respectively. The most frequent treatment-related severe toxicities per patient were diarrhoea (35.8 %), followed by skin rash (32.1 %), asthenia (18.9 %) and neutropenia (13.2 %). A significant association between clinical response and incidence and grade of skin toxicity was observed (p = 0.0032).

Conclusion: This study shows that the administration of panitumumab plus irinotecan every 3 weeks is safe, active and feasible as second-line treatment in patients with advanced WT K-RAS CRC.

Trial registration: ClinicalTrials.gov NCT00475293.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal / administration & dosage*
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents, Phytogenic / administration & dosage
  • Camptothecin / administration & dosage
  • Camptothecin / analogs & derivatives*
  • Colorectal Neoplasms / drug therapy*
  • Colorectal Neoplasms / genetics*
  • Disease-Free Survival
  • Drug Administration Schedule
  • Female
  • Genes, ras
  • Humans
  • Irinotecan
  • Male
  • Middle Aged
  • Panitumumab
  • Prospective Studies
  • Time Factors
  • Treatment Outcome
  • ras Proteins / metabolism*

Substances

  • Antibodies, Monoclonal
  • Antineoplastic Agents
  • Antineoplastic Agents, Phytogenic
  • Panitumumab
  • Irinotecan
  • ras Proteins
  • Camptothecin

Associated data

  • ClinicalTrials.gov/NCT00475293