A phase II, randomized, multicenter study to assess the efficacy, safety, and tolerability of zibotentan (ZD4054) in combination with pemetrexed in patients with advanced non-small cell lung cancer
| العنوان: | A phase II, randomized, multicenter study to assess the efficacy, safety, and tolerability of zibotentan (ZD4054) in combination with pemetrexed in patients with advanced non-small cell lung cancer |
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| المؤلفون: | Christos Chouaid, Thomas Morris, Kristine Pemberton, F. E. Nathan |
| المساهمون: | Epidémiologie des maladies infectieuses et modélisation (ESIM), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), AstraZeneca |
| المصدر: | Cancer Chemotherapy and Pharmacology Cancer Chemotherapy and Pharmacology, Springer Verlag, 2011, 67 (5), pp.1203-8. ⟨10.1007/s00280-010-1538-z⟩ Cancer Chemotherapy and Pharmacology, Springer Verlag, 2010, 67 (5), pp.1203-1208. ⟨10.1007/s00280-010-1538-z⟩ Cancer Chemotherapy and Pharmacology, 2011, 67 (5), pp.1203-8. ⟨10.1007/s00280-010-1538-z⟩ |
| بيانات النشر: | HAL CCSD, 2011. |
| سنة النشر: | 2011 |
| مصطلحات موضوعية: | Oncology, Cancer Research, medicine.medical_specialty, Guanine, Lung Neoplasms, Pyrrolidines, Randomization, Pemetrexed, Toxicology, NSCLC, Endothelin, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Double-Blind Method, Glutamates, Zibotentan, Carcinoma, Non-Small-Cell Lung, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Neoplasm Metastasis, Lung cancer, Survival rate, ComputingMilieux_MISCELLANEOUS, Cancer, Pharmacology, business.industry, medicine.disease, 3. Good health, Surgery, Survival Rate, Clinical trial, Tolerability, chemistry, 030220 oncology & carcinogenesis, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, medicine.drug |
| الوصف: | International audience; PURPOSE: This study evaluated overall survival (OS) of patients with advanced non-squamous NSCLC following treatment with the specific endothelin A receptor antagonist, zibotentan in combination with pemetrexed compared with pemetrexed monotherapy. METHODS: In this double-blinded, placebo-controlled study, patients with advanced NSCLC with non-squamous histology who had failed first-line platinum-based chemotherapy were randomized to receive either once-daily zibotentan 10 mg in combination with 3-weekly pemetrexed 500 mg/m(2) or placebo plus 3-weekly pemetrexed 500 mg/m(2). OS was calculated as the interval from date of randomization to date of death from any cause. Safety and tolerability were evaluated by recording the incidence of adverse events (AE) according to Common Toxicity Criteria for AE (CTCAE). RESULTS: Sixty-six patients were randomized and completed the study (zibotentan plus pemetrexed, n = 30; placebo plus pemetrexed, n = 36). At the data cutoff, a total of 44 deaths had occurred, 20 and 24 in the zibotentan and placebo groups, respectively. No significant difference in OS was observed between the zibotentan and placebo treatment groups (HR, 1.13; 80% CI 0.77, 1.67; P = 0.69). The majority of AE were of CTCAE grade 1 or 2, and the most commonly reported AE in both treatment groups was anemia (23 and 25% of patients in the zibotentan and placebo groups, respectively). CONCLUSIONS: There was no survival signal in patients with NSCLC following treatment with zibotentan in combination with pemetrexed. No new issues related to safety for either zibotentan or pemetrexed were identified. |
| اللغة: | English |
| تدمد: | 0344-5704 1432-0843 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0c33d41804d7d57e2e805c34ff8a4419Test https://hal.sorbonne-universite.fr/hal-00596809Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....0c33d41804d7d57e2e805c34ff8a4419 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 03445704 14320843 |
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