First-in-human phase II trial of the botanical formulation PHY906 with capecitabine as second-line therapy in patients with advanced pancreatic cancer
| العنوان: | First-in-human phase II trial of the botanical formulation PHY906 with capecitabine as second-line therapy in patients with advanced pancreatic cancer |
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| المؤلفون: | Shwu-Huey Liu, Lynne Lamb, Yung-Chi Cheng, Scott Bussom, Muhammad Wasif Saif, Kristin Kaley, K. Elligers, Jia Li, Zaoli Jiang |
| المصدر: | Cancer Chemotherapy and Pharmacology. 73:373-380 |
| بيانات النشر: | Springer Science and Business Media LLC, 2013. |
| سنة النشر: | 2013 |
| مصطلحات موضوعية: | Male, Oncology, Cancer Research, medicine.medical_specialty, Phases of clinical research, Pharmacology, Toxicology, Deoxycytidine, Article, Disease-Free Survival, Capecitabine, Pancreatic cancer, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Pharmacology (medical), In patient, Aged, Aged, 80 and over, Second-line therapy, business.industry, First in human, Middle Aged, medicine.disease, Gemcitabine, Phase i study, Pancreatic Neoplasms, Survival Rate, Treatment Outcome, Female, Fluorouracil, business, Drugs, Chinese Herbal, medicine.drug |
| الوصف: | Preclinical studies showed a Chinese botanical formula, PHY906, has synergistic anti-tumor activity with capecitabine. Our phase I study determined maximal tolerated dose of capecitabine 1,500 mg/m(2) BID day 1-7 and PHY906 800 mg BID day 1-4 every 2 weeks. We conducted this phase II study to explore the efficacy of capecitabine and PHY906 in patients with advanced pancreatic cancer who were previously treated with gemcitabine-based regimens.Patients with pancreatic cancer and an Eastern Cooperative Oncology Group performance status of 0-2 received PHY906 and capecitabine. Toxicity was assessed per NCI-CTCAE v3.0 and response per response evaluation criteria in solid tumors q 6 weeks. Correlative studies of cytokines, chemokines and growth factors were tested using a cytometric bead array. Quality of life was assessed by utilizing Edmonton symptom assessment system. The primary objective was overall survival.The study enrolled 25 patients. Median progression-free survival (mPFS) was 10.1 weeks (range 0.4-54.1) and median overall survival (mOS) was 21.6 weeks (range 0.4-84.1). Eighteen patients received at least 2 cycles, and achieved mPFS of 12.3 weeks and mOS of 28 weeks. Six-month survival rate was 44 % (11/25). Unsupervised clustering of patients grouped those with shortened survival together by their cytokine profile showed that only IL-6 had a significant difference (p .001) between short- and long-term survivors.Capecitabine plus PHY906 provides a safe and feasible salvage therapy after gemcitabine failure for APC. Role of IL-6 in tumor progression and tumor cachexia needs to be investigated with respect to its relation to pathophysiology of pancreatic cancer and development of anti-IL-6 therapeutics. |
| تدمد: | 1432-0843 0344-5704 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9e5ee51bad118cadc516d00296c2a5c2 https://doi.org/10.1007/s00280-013-2359-7 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....9e5ee51bad118cadc516d00296c2a5c2 |
| قاعدة البيانات: | OpenAIRE |
Find this article in full text from Springer Verlag. | تدمد: | 14320843 03445704 |
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