Phase II study of nimotuzumab, a humanized monoclonal anti-epidermal growth factor receptor (EGFR) antibody, in patients with locally advanced or metastatic pancreatic cancer
| Autor: | F. Bach, Norbert Marschner, Dirk Reuter, Dirk Strumberg, Ralf Axel Hilger, Max E. Scheulen, F. Lordick, Beate Schultheis, Jürgen Krauss, K. Mross, Lutz Edler |
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| Jazyk: | angličtina |
| Rok vydání: | 2012 |
| Předmět: |
Male
Oncology medicine.medical_specialty medicine.medical_treatment Medizin Phases of clinical research macromolecular substances Adenocarcinoma Antibodies Monoclonal Humanized EGFR Antibody Internal medicine Pancreatic cancer otorhinolaryngologic diseases medicine Humans Nimotuzumab Pharmacology (medical) Neoplasm Metastasis Aged Aged 80 and over Pharmacology Chemotherapy business.industry Middle Aged medicine.disease Rash Surgery ErbB Receptors Pancreatic Neoplasms Clinical trial Monoclonal Female medicine.symptom business medicine.drug |
| Popis: | Introduction Nimotuzumab is a humanized monoclonal antibody that binds to the EGFR. Based on phase I data, the recommended dose has been established at 200 mg weekly. This study was aimed at evaluating the safety and efficacy of nimotuzumab monotherapy in patients (pts) with locally advanced or metastatic pancreatic cancer. Methods Pts who failed first line standard chemotherapy for advanced disease and had at least one measurable lesion were eligible for the study. Nimotuzumab was given intravenously at 200 mg once weekly for 6 weeks (wks). Follow up by CT scan was performed after 8 weeks. Pts continued receiving treatment 3-weekly until disease progression or unacceptable toxicity occurred. Endpoints included tumor response (RECIST), progression-free survival (PFS), and safety. Results A total of 56 pts were enrolled for treatment (ECOG status of 1 [n = 41] or 0 [n = 15]), the majority (47 pts) had metastatic disease. Nearly half of the pts [n = 26] received ≥2 regimens. Pts evaluable for response: n = 36; CR: 0; PR: 0; SD: 6 pts. Median PFS for pts with SD was 19.2 weeks, for all pts 6.7 weeks (95% CI: 6.43–7.14 weeks). PFS after 1 year was 10.3% with a median overall survival of 18.1 weeks. Treatment-related adverse events were generally mild including rash grade 1 in 5 pts. After a single dose of 200 mg, the t1/2 was calculated to 45 h. Conclusion These data confirm that nimotuzumab is safe and very well tolerated. To improve efficacy, a randomized, placebo-controlled trial with Gem has been initiated. |
| Databáze: | OpenAIRE |
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