Gemcitabine Combined With The Monoclonal Antibody Nimotuzumab Is An Active First-Line Regimen In Kras Wildtype Patients With Locally Advanced Or Metastatic Pancreatic Cancer: A Multicenter, Randomized Phase Iib Study
| Autor: | Matthias P.A. Ebert, Friedrich Overkamp, Erdem Göker, Dirk Reuter, Dirk Strumberg, Jens T. Siveke, Suayip Yalcin, Wolfgang E. Berdel, Markus Dommach, M. Bulitta, R.D. Hofheinz, Michael Kneba, Andrea Kerkhoff, Tilman Steinmetz, Frank Schlegel, Beate Schultheis, S De Dosso, Wolfgang E. Schmidt, Dirk Behringer, Robert Rohrberg |
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| Přispěvatelé: | İç Hastalıkları, Ege Üniversitesi |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Male
0301 basic medicine Oncology medicine.medical_specialty endocrine system diseases pancreatic cancer Antibodies Monoclonal Humanized Placebo medicine.disease_cause Deoxycytidine Disease-Free Survival Placebos Proto-Oncogene Proteins p21(ras) 03 medical and health sciences 0302 clinical medicine Double-Blind Method Internal medicine Pancreatic cancer Antineoplastic Combined Chemotherapy Protocols KRAS wildtype Humans Medicine Nimotuzumab Progression-free survival Cetuximab nimotuzumab business.industry gemcitabine Hematology Middle Aged medicine.disease Gemcitabine Pancreatic Neoplasms Survival Rate EGFR inhibitor Regimen 030104 developmental biology 030220 oncology & carcinogenesis Female KRAS business medicine.drug |
| Popis: | WOS: 000411827200016 PubMed ID: 28961832 Background: This randomized study was designed to investigate the superiority of gemcitabine (gem) plus nimotuzumab (nimo), an anti-epidermal growth factor receptor monoclonal antibody, compared with gem plus placebo as first-line therapy in patients with advanced pancreatic cancer. Patients and methods: Patients with previously untreated, unresectable, locally advanced or metastatic pancreatic cancer were randomly assigned to receive gem: 1000 mg/m(2), 30-min i.v. once weekly (d1, 8, 15; q29) and nimo: fixed dose of 400 mg once weekly as a 30-min infusion, or gem plus placebo, until progression or unacceptable toxicity. The primary end point was overall survival (OS), secondary end points included time to progression, overall response rate, safety and quality of life. Results: A total of 192 patients were randomized, with 186 of them being assessable for efficacy and safety (average age 63.6 years). One-year OS/progression-free survival (PFS) was 34%/22% for gem plus nimo compared with 19%/10% for gem plus placebo (HR = 0.69; P = 0.03/HR = 0.68; P = 0.02). Median OS/PFS was 8.6/5.1 months for gem plus nimo versus 6.0/3.4 mo in the gem plus placebo group (HR = 0.69; P = 0.0341/HR = 0.68; P = 0.0163), with very few grade 3/4 toxicities. KRAS wildtype patients experienced a significantly better OS than those with KRAS mutations (11.6 versus 5.6 months, P = 0.03). Conclusion: This randomized study showed that nimo in combination with gem is safe and well tolerated. The 1-year OS and PFS rates for the entire population were significantly improved. Especially, those patients with KRAS wildtype seem to benefit. The study was registered as protocol ID OSAG101-PCS07, NCT00561990 and EudraCT 2007-000338-38. Oncoscience AG, Schenefeld, Germany This multi-institutional, randomized phase IIb trial was sponsored by Oncoscience AG, Wedel (recently Schenefeld), Germany. There is no grant number applicable. |
| Databáze: | OpenAIRE |
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