Abstract 4659: Phase II study of a weekly liposomal paclitaxel formulation (Genexol®-PM) and gemcitabine® combination chemotherapy in patients with advanced biliary cancer
| Autor: | Jong Gwang Kim, Young Rok Do, Jin Ho Baek, Young June Jeon, Sung Hwa Bae, Kyung Hee Lee, Yoon Young Cho, Hun Mo Ryoo, Keon Uk Keon Uk, Yee Soo Chae, Jin Young Kim, Hong Suk Song, Min Kyoung Kim |
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| Rok vydání: | 2013 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty education.field_of_study business.industry Population Phases of clinical research Cancer Combination chemotherapy medicine.disease Gemcitabine Surgery Clinical trial Internal medicine Clinical endpoint Medicine Progression-free survival business education medicine.drug |
| Zdroj: | Cancer Research. 73:4659-4659 |
| ISSN: | 1538-7445 0008-5472 |
| DOI: | 10.1158/1538-7445.am2013-4659 |
| Popis: | OBJECTIVE: Advanced biliary cancer is associated with a poor prognosis due to wide resistance to chemotherapeutic agents. This phase II clinical trial was conducted to determine the efficacy and safety of weekly gemcitabine and liposomal paclitaxel in patients with unresectable of metastatic biliary cancer. METHODS: The eligibility criteria were patients 1) with pathologically proven biliary cancer, 2) with an ECOG performance status 0 to 2, 3) aged more than 18, 4) with measurable lesions, 5) with adequate hematologic, renal and liver functions, and 6) who provided written informed consent. Each treatment cycle was consisted of gemcitabine 1000 mg/m² and liposomal paclitaxel (Genexol-PM)100 mg/m² on days 1, 8 followed by rest perioid of 14 days. It was repeated until the appearance of disease progression or unacceptable toxicity up to maximal 10 cycles. The primary end point of this study was reponse rate, and secondary end points included toxicity, progression free survival and overall survival. RESULTS: Forty five patients were enrolled; median age was 63 years; male (n=33) and female (n=12). The median number of cycles administered was 4.0 (range,1-10). Thirty nine patients were assessable for efficacy. Ten partial responses and 18 stable diseases were confirmed. Giving an overall response rate was 25.6% and disease control rate was 71.8% in per-protocol population. The median time to progression and median overall survival was 4.0 (95% CI; 3.17∼4.83) months and 8.13 (95% CI; 4.76∼11.51) months, respectively. MUC4 expression was not significantly correlated with overall survival and progression free survival (p=0.391). CONCLUSION: Weekly gemcitabine combined with Genexol-PM® appears to be effective against advanced biliary cancers. Further randomized trials are needed to confirm this finding. Citation Format: Keon Uk Keon Uk, Jin Young Kim, Young Rok Do, Hong Suk Song, Young June Jeon, Hun Mo Ryoo, Sung Hwa Bae, Jong Gwang Kim, Jin Ho Baek, Yee Soo Chae, Min Kyoung Kim, Kyung Hee Lee, Yoon Young Cho. Phase II study of a weekly liposomal paclitaxel formulation (Genexol®-PM) and gemcitabine® combination chemotherapy in patients with advanced biliary cancer. [abstract]. In: Proceedings of the 104th Annual Meeting of the American Association for Cancer Research; 2013 Apr 6-10; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2013;73(8 Suppl):Abstract nr 4659. doi:10.1158/1538-7445.AM2013-4659 |
| Databáze: | OpenAIRE |
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