A Prospective Phase II Study of Cisplatin and Cremophor EL-Free Paclitaxel (Genexol-PM) in Patients with Unresectable Thymic Epithelial Tumors
- Authors
- Kim, H.S.[Kim, H.S.]; Lee, J.Y.[Lee, J.Y.]; Lim, S.H.[Lim, S.H.]; Sun, J.-M.[Sun, J.-M.]; Lee, S.H.[Lee, S.H.]; Ahn, J.S.[Ahn, J.S.]; Park, K.[Park, K.]; Moon, S.H.[Moon, S.H.]; Ahn, M.-J.[Ahn, M.-J.]
- Issue Date
- 2015
- Keywords
- Thymic epithelial tumor; Cisplatin; Paclitaxel; Prospective study
- Citation
- Journal of Thoracic Oncology, v.10, no.12, pp.1800 - 1806
- Journal Title
- Journal of Thoracic Oncology
- Volume
- 10
- Number
- 12
- Start Page
- 1800
- End Page
- 1806
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/48847
- DOI
- 10.1097/JTO.0000000000000692
- Abstract
- Background: We conducted a prospective phase II study of cisplatin plus cremophor EL-free paclitaxel (Genexol-PM) in patients with unresectable thymic epithelial tumors to determine the efficacy and tolerability of the combination therapy. Methods: Patients were treated with cisplatin (70 mg/m2) and Genexol-PM (230 mg/m2) on day 1 of a 3-week cycle as first-line palliative chemotherapy. The primary end point of this study was objective response rate, and the secondary end points included toxicity, progression-free survival (PFS), overall survival, correlation between early 18F-fluorodeoxyglucose positron emission tomography/computed tomography response and PFS, and correlation between baseline flurododeoxyglucose uptake and histology. Results: Forty-two patients with unresectable thymoma (n = 14) or thymic carcinoma (n = 28) were enrolled between May 2012 and October 2014. The median age was 59 years (range: 25-77) and 30 patients (71%) were male, and 39 patients (93%) had an ECOG PS of 1. The median number of treatment cycles was six (range: 1-6). For 40 assessable patients, the objective response rate was 62.5% (95% confidence interval [CI]: 47.6-77.4) with rates of 46% (95% CI: 23.3-76.9) for advanced thymoma (n = 13) and 70% (95% CI: 52.0-82.1) for thymic carcinoma (n = 27). With a median follow-up of 15.5 months, the median PFS for all 42 patients was 9.8 months (11.4 months for thymoma versus 8.1 months for thymic carcinoma). The 2-year overall survival was 77.9% for thymoma and 65.9% for thymic carcinoma. There were no treatment-related deaths. The most common grade 3 and 4 treatment-related adverse event was neutropenia in 11 patients (26%). Eight patients (19%) experienced grade 2 hypersensitivity reactions. There was no correlation between early positron emission tomography response and PFS, but tumor histology (thymoma versus thymic carcinoma) was correlated with SUVmax before chemotherapy. Conclusions: These data suggest that combination of cisplatin and Genexol-PM is highly effective and tolerable for the treatment of unresectable thymic epithelial tumors. © 2015 by the International Association for the Study of Lung Cancer.
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Collections - Medicine > Department of Medicine > 1. Journal Articles
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