CHAMP: A Phase II Study of Panitumumab With Pemetrexed and Cisplatin Versus Pemetrexed and Cisplatin in the Treatment of Patients With Advanced-Stage Primary Nonsquamous Non-Small-Cell Lung Cancer With Particular Regard to the KRAS Status.

Abstract

INTRODUCTION:

The aim of the study was to investigate the efficacy and tolerability of panitumumab, a fully human antiepidermal growth factor receptor monoclonal antibody, in combination with pemetrexed/cisplatin in patients with stage IIIB to IV primary nonsquamous non-small-cell lung cancer and wild type V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS). Results were compared with those obtained in a control group of patients who received a pemetrexed/cisplatin regimen only.

PATIENTS AND METHODS:

This was a phase II, randomized, open-label study with 2 treatment arms. In total, 96 patients received panitumumab at a dose of 9 mg/kg in combination with pemetrexed 500 mg/m(2) and cisplatin 75 mg/m(2) (n = 49) or pemetrexed/cisplatin alone (n = 47). The primary outcome measure was progression-free survival at 6 months. Secondary end points of the study included overall survival, tumor response, quality of life, and safety outcomes. The CHAMP study is registered with ClinicalTrials.gov, number NCT01088620.

RESULTS:

Progression-free survival at 6 months did not indicate a benefit of panitumumab as a supplement to the standard therapy of pemetrexed/cisplatin whereas the overall survival showed a clear difference between the treatment groups in favor of the standard therapy. Results might be affected by the higher rates of serious adverse events and higher death rates within the panitumumab arm.

CONCLUSIONS:

Results from the present study indicate that combination of cisplatin/pemetrexed with panitumumab should not be recommended for patients with adenocarcinoma and KRAS wild type because of lack of efficacy, lack of improvement of quality of life, and because of the increase in toxicity rates compared with patients in the control arm, who received standard chemotherapy of pemetrexed/cisplatin.

• Authors: Wolfgang Schuette, Dirk Behringer, Jan Stoehlmacher, Jens Kollmeier, Sibylle Schmager, Ludwig Fischer von Weikersthal, Christian Schumann, Joerg Buchmann
• Journal: Clinical lung cancer (Clin Lung Cancer) Vol. 16 Issue 6 Pg. 447-56 (Nov 2015) ISSN: 1938-0690 [Electronic] United States
• PMID: 26094080 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 Elsevier Inc. All rights reserved.

Chemical References

• Antibodies, Monoclonal
• KRAS protein, human
• Pemetrexed
• Panitumumab
• Proto-Oncogene Proteins p21(ras)
• Cisplatin

Topics

• Adult
• Aged
• Antibodies, Monoclonal (administration & dosage, adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy, genetics, mortality)
• Cisplatin (administration & dosage, adverse effects)
• Female
• Follow-Up Studies
• Humans
• Lung Neoplasms (drug therapy, genetics, mortality)
• Male
• Middle Aged
• Panitumumab
• Pemetrexed (administration & dosage, adverse effects)
• Proto-Oncogene Proteins p21(ras) (genetics)
• Survival Analysis
• Treatment Outcome
• Tumor Burden (drug effects)