Randomized Phase II Trial of a Toll-Like Receptor 9 Agonist Oligodeoxynucleotide, PF-3512676, in Combination With First-Line Taxane Plus Platinum Chemotherapy for Advanced-Stage Non–Small-Cell Lung Cancer
| العنوان: | Randomized Phase II Trial of a Toll-Like Receptor 9 Agonist Oligodeoxynucleotide, PF-3512676, in Combination With First-Line Taxane Plus Platinum Chemotherapy for Advanced-Stage Non–Small-Cell Lung Cancer |
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| المؤلفون: | Donald Woytowitz, Arthur M. Krieg, J. Mezger, Vera Hirsh, Donald Gravenor, Christian Manegold, Mohammed J Al-Adhami, David Robert John Readett, Gary Albert, Cynthia G. Leichman |
| المصدر: | Journal of Clinical Oncology. 26:3979-3986 |
| بيانات النشر: | American Society of Clinical Oncology (ASCO), 2008. |
| سنة النشر: | 2008 |
| مصطلحات موضوعية: | Male, Oncology, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Randomization, Paclitaxel, Docetaxel, Carboplatin, law.invention, Randomized controlled trial, law, Carcinoma, Non-Small-Cell Lung, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Carcinoma, Humans, Lung cancer, Aged, Neoplasm Staging, Taxane, business.industry, Cancer, Middle Aged, medicine.disease, Surgery, Clinical trial, Oligodeoxyribonucleotides, Toll-Like Receptor 9, Female, Taxoids, Cisplatin, business, medicine.drug |
| الوصف: | Purpose This study assessed the efficacy of the combination of standard taxane plus platinum chemotherapy with the synthetic Toll-like receptor 9–activating oligodeoxynucleotide PF-3512676 in patients with non–small-cell lung cancer (NSCLC). Patients and Methods Chemotherapy-naive patients with stage IIIB to IV NSCLC were randomly assigned (one to two ratio) to receive four to six cycles of taxane/platinum chemotherapy alone or with 0.2 mg/kg of subcutaneous PF-3512676 on days 8 and 15 of each 3-week cycle. The primary end point was objective response rate (ORR). Results Baseline demographics were similar between treatment arms, although significantly more patients in the PF-3512676 arm had stage IV disease (85% compared with 62% in the chemotherapy-alone arm). The modified intent-to-treat analysis (n = 111) demonstrated a 38% ORR (confirmed and unconfirmed) in the PF-3512676 arm (n = 74) and 19% in the chemotherapy-alone arm (n = 37) by investigator evaluation. Blinded, independent radiologic review for 90 patients showed a similar trend in confirmed response rate (19% and 11%, respectively). Median survival was 12.3 months in the PF-3512676 arm and 6.8 months in the chemotherapy-alone arm, and 1-year survival was 50% and 33%, respectively. Mild to moderate local injection site reactions and flu-like symptoms were the most common PF-3512676–related adverse events, but grade 3/4 neutropenia, thrombocytopenia, and anemia were all reported more commonly for patients in the PF-3512676 arm. Conclusion The addition of PF-3512676 to taxane plus platinum chemotherapy for first-line treatment of NSCLC improves objective response and may improve survival. Confirmatory phase III trials are ongoing. |
| تدمد: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2007.12.5807 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a72d135e2c3192cf0e332e99c54abaf4 https://doi.org/10.1200/jco.2007.12.5807 |
| رقم الانضمام: | edsair.doi.dedup.....a72d135e2c3192cf0e332e99c54abaf4 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15277755 0732183X |
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| DOI: | 10.1200/jco.2007.12.5807 |