A Prospective Phase II Study of Cisplatin and Cremophor EL-Free Paclitaxel (Genexol-PM) in Patients with Unresectable Thymic Epithelial Tumors

Kim, Hae Su; Lee, Ji Yun; Lim, Sung Hee; Sun, Jong Mu; Lee, Se‐Hoon; Ahn, Jin Seok; Park, Keunchil; Moon, Seung Hwan; Ahn, Myung Ju

doi:10.1097/jto.0000000000000692

Cited by 34 publications

(19 citation statements)

References 34 publications

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“…Paclitaxel(PTX) has poor aqueous solubility and its intestinal uptake is severely hampered by the ATP-binding cassette (ABC) drug efflux transporter P-glycoprotein (P-gp) 1-6 , which severely limit its oral bioavailability 7,8 . Therefore, PTX requires to be co-injected with the detergent Cremophor EL, and this detergent frequently causes untoward hypersensitivity reactions, which has created significant problems in developing suitable pharmaceutical formulations suitable for chemotherapy [9][10][11] .…”

Section: T-13 and T-26 The Novel Taxanes With Improved Oral Bioavailmentioning

confidence: 99%

T-13 and T-26, the novel taxanes with improved oral bioavailability in rats

Yue

Zhou

Wang

2020

Sci Rep

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www.nature.com/scientificreports www.nature.com/scientificreports/ half-life of the terminal phase (t 1/2 ) and the mean residence time (MRT). Other parameters such as maximum plasma concentration (C max ) and the time to reach C max (T max ) were also analyzed after oral administration in rats. Statistical analysis.The data were presented as mean ± standard deviation of at least three experiments.The Mann-Whitney U-test was used to investigate statistical differences at a significance level of P < 0.05. All data processing was performed using the statistical package for social sciences (SPSS) software. ResultsThe mean plasma concentration-time profiles and the pharmacokinetic parameters of T-13 and T-26 after intravenous (5 mg/kg) and oral administration (60 mg/kg) in rats were presented in Fig. 2 and Table 1, respectively. As reflected in Table 1, T-13 and T-26 displayed similar values and demonstrated a higher capacity to promote the absorption in vivo. Finally, the oral bioavailability of T-13 and T-26 were calculated to be 10.71% and 65.79%, respectively, which were both higher than 5% for paclitaxel 15 . Scientific RepoRtS |(2020) 10:3211 | https://doi.

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Section: T-13 and T-26 The Novel Taxanes With Improved Oral Bioavailmentioning

confidence: 99%

T-13 and T-26, the novel taxanes with improved oral bioavailability in rats

Yue

Zhou

Wang

2020

Sci Rep

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“…Paclitaxel (PTX)‐loaded polymeric micelles formed from PEG‐ b ‐poly(D,L‐lactide) (Genexol‐PM) (Samyang Biopharm Co., Seoul, Korea) have been approved for the treatment of breast cancer, non‐small‐cell lung cancer, and ovarian cancer . Expansion of clinical applications of Genexol‐PM to other cancers is under clinical evaluation …”

Section: Polymeric Micelles Under Clinical Evaluationmentioning

confidence: 99%

“…(61,62) Expansion of clinical applications of Genexol-PM to other cancers is under clinical evaluation. (63,64) In our system, five micellar formulations incorporating PTX (NK105), cisplatin (NC-6004), SN-38 (NK102), dachplatin (active complex of oxaliplatin) (NC-4016), and epirubicin (NC-6300/K-912) are currently under clinical evaluation. (8,10) Among them, NC-6004 progressed to phase III study and approval application of NK105 will be undertaken in 2016.…”

Section: Polymeric Micelles Under Clinical Evaluationmentioning

confidence: 99%

Development of polymeric micelles for targeting intractable cancers

2016

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In relation to recent advances in nanobiotechnologies, cancer‐targeted therapy using nano‐scaled drug carriers (nanocarriers) has been attracting enormous attention with success in clinical studies. Polymeric micelles, core–shell‐type nanoparticles formed through the self‐assembly of block copolymers, are one of the most promising nanocarrier, because their critical features such as size, stability, and drug incorporation efficiency and release rate can be modulated by designing the constituent block copolymers. The utilities of polymeric micelles have been reported not only in experimental tumor models in mice but also in clinical studies. In this article, we aim to explain the rationale of designing polymeric micelles for targeting intractable cancers such as pancreatic cancer, glioblastoma, and metastases. Also, we review recent progress in clinical studies on polymeric micelles incorporating anticancer drugs. In addition, we introduce the next generation of polymeric micelles as the platform integrated with smart functionalities such as targetability, environmental sensitivity, and imaging properties. Thus, polymeric micelles can realize safe and effective cancer therapy, and offer tailor‐made medicines for individual patients.

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“…4,5 However, many TETs are detected in the advanced stage, owing to the lack of symptoms in the early stage. The standard treatment for unresectable TETs is controversial, including chemotherapy, [6][7][8][9][10][11][12][13][14][15][16][17][18] chemoradiation therapy, 19 and neoadjuvant chemotherapy 20,21 or chemoradiation therapy followed by surgery. 22 Despite the lack of high-level evidence, definitive chemoradiation therapy is generally performed for unresectable TETs.…”

Section: Introductionmentioning

confidence: 99%

Intensity Modulated Radiation Therapy Plus Etoposide/Cisplatin for Patients With Limited Advanced Unresectable Thymic Epithelial Tumors: A Prospective Phase 2 Study

Fan

Yang

Wang

et al. 2020

International Journal of Radiation Oncology*Biology*Physics

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We performed a phase 2 study to assess the safety and efficacy of intensity modulated radiation therapy plus etoposide/cisplatin for patients with limited advanced unresectable thymic epithelial tumors. The objective Purpose: This prospective phase 2 study evaluated the efficacy and safety of intensity modulated radiation therapy plus etoposide/cisplatin (EP) for patients with unresectable thymic epithelial tumors (TETs). Methods and Materials: Patients with limited advanced unresectable TETs whose lesions could be encompassed within radiation fields were enrolled in this study. Two cycles of EP (75 mg/m 2 etoposide and 25 mg/m 2 cisplatin on days 1-3 and days 29-31) were administered concurrently with radiation therapy, followed by 2 cycles after radiation therapy. The primary endpoint was the objective response rate. The secondary endpoints were the progression-free survival rate, overall survival rate, and incidence of adverse events.

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A Prospective Phase II Study of Cisplatin and Cremophor EL-Free Paclitaxel (Genexol-PM) in Patients with Unresectable Thymic Epithelial Tumors

Abstract: These data suggest that combination of cisplatin and Genexol-PM is highly effective and tolerable for the treatment of unresectable thymic epithelial tumors.

Cited by 34 publications

References 34 publications

T-13 and T-26, the novel taxanes with improved oral bioavailability in rats

T-13 and T-26, the novel taxanes with improved oral bioavailability in rats

Development of polymeric micelles for targeting intractable cancers

Intensity Modulated Radiation Therapy Plus Etoposide/Cisplatin for Patients With Limited Advanced Unresectable Thymic Epithelial Tumors: A Prospective Phase 2 Study

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