Cancer Research and Treatment

Original Articles

Gynecologic cancer

Safety and Tolerability of Weekly Genexol-PM, a Cremophor-Free Polymeric Micelle Formulation of Paclitaxel, with Carboplatin in Gynecologic Cancer: A Phase I Study: So Hyun Nam, Shin-Wha Lee, Young-Jae Lee, Yong Man Kim; Cancer Res Treat. 2023;55(4):1346-1354. Published online May 15, 2023; DOI: https://doi.org/10.4143/crt.2022.1436

Abstract PDF Supplementary Material PubReader ePub

Purpose
This phase I study was conducted to determine the maximum tolerated dose and the recommended phase II dose of weekly administered Genexol-PM combined with carboplatin in patients with gynecologic cancer.
Materials and Methods
This open-label, phase I, dose-escalation study of weekly Genexol-PM included 18 patients with gynecologic cancer, who were equally divided into three cohorts of dose levels. Cohort 1 received 100 mg/m² Genexol-PM and 5 area under the curve (AUC) carboplatin, cohort 2 received 120 mg/m² Genexol-PM and 5 AUC carboplatin, and cohort 3 received 120 mg/m² Genexol-PM and 6 AUC carboplatin. The safety and efficacy of each dose were analyzed for each cohort.
Results
Of the 18 patients, 11 patients were newly diagnosed and seven patients were recurrent cases. No dose-limiting toxicity was observed. The maximum tolerated dose was not defined, but a dose up to 120 mg/m² of Genexol-PM in combination with AUC 5-6 of carboplatin could be recommended for a phase II study. In this intention-to-treat population, five patients dropped out of the study (carboplatin-related hypersensitivity, n=1; refusal of consent, n=4). Most patients (88.9%) with adverse events recovered without sequelae, and no treatment-related death occurred. The overall response rate of weekly Genexol-PM in combination with carboplatin was 72.2%.
Conclusion
Weekly administered Genexol-PM with carboplatin demonstrated an acceptable safety profile in gynecologic cancer pati-ents. The recommended phase II dose of weekly Genexol-PM is up to 120 mg/m² when combined with carboplatin.

Citations

Citations to this article as recorded by

Multicore, SDS-Based Polyelectrolyte Nanocapsules as Novel Nanocarriers for Paclitaxel to Reduce Cardiotoxicity by Protecting the Mitochondria
Marzena Szwed, Anastazja Poczta-Krawczyk, Katarzyna D. Kania, Kacper Wiktorowski, Kamila Podsiadło, Agnieszka Marczak, Krzysztof Szczepanowicz
International Journal of Molecular Sciences.2025; 26(3): 901. CrossRef
Potent therapeutic efficacy of intranasally deliverable paclitaxel modified with pH-sensitive and PEGylated polymeric micelle against glioblastoma
Young-Beom Kim, Soo-Hwan Lee, Dayananda Kasala, Yuebin Zhao, Ao Jiao, JinWoo Hong, Jin Su Kim, A-Rum Yoon, Chae-Ok Yun
Journal of Controlled Release.2025; 382: 113711. CrossRef
Nanomaterials-driven in situ vaccination: a novel frontier in tumor immunotherapy
Naimeng Liu, Xiangyu Wang, Zhongzhao Wang, Yonemori Kan, Yi Fang, Jidong Gao, Xiangyi Kong, Jing Wang
Journal of Hematology & Oncology.2025;[Epub] CrossRef
Advances in the use of nanomicelles to enhance the efficacy of antitumour substances (review)
E. V. Sanarova, L. L. Nikolaeva, S. D. Shceglov, Zh. M. Kozlova, O. L. Orlova, N. A. Oborotova, A. V. Lantsova
Drug development & registration.2025;[Epub] CrossRef
Current insights into polymeric micelles for nasal drug delivery
Bence Sipos, Fatima Rajab, Gábor Katona, Ildikó Csóka
Expert Opinion on Drug Delivery.2025; : 1. CrossRef
Rational design of paclitaxel prodrugs for facile preparation of in-situ therapeutic system in antitumor applications
Lanqing Wang, Zhaofan Yang, Guanyu Jin, Bingzheng Yu, Wei Zhang, Xuesi Chen, Haochen Yao, Cuiping Yao, Shixian Lv
Chemical Engineering Journal.2025; : 164599. CrossRef
Redox-responsive polymer micelles co-encapsulating immune checkpoint inhibitors and chemotherapeutic agents for glioblastoma therapy
Zhiqi Zhang, Xiaoxuan Xu, Jiawei Du, Xin Chen, Yonger Xue, Jianqiong Zhang, Xue Yang, Xiaoyuan Chen, Jinbing Xie, Shenghong Ju
Nature Communications.2024;[Epub] CrossRef
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Songmu Pan, Zhuan Zou, Xiaofeng Zhou, Jiyong Wei, Huijiang Liu, Zhongyi Su, Gui Liao, Guangyu Huang, Zonggui Huang, Yi Xu, Minan Lu, Ronghe Gu
International Journal of Molecular Medicine.2024;[Epub] CrossRef
Functionalized Polymeric Micelles for Targeted Cancer Therapy: Steps from Conceptualization to Clinical Trials
Ana Serras, Célia Faustino, Lídia Pinheiro
Pharmaceutics.2024; 16(8): 1047. CrossRef
Simplified Gambogic Acid Prodrug Nanoparticles to Improve Efficiency and Reduce Toxicity for Clinical Translation Potential
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Advanced Healthcare Materials.2024;[Epub] CrossRef

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Lung and Thoracic cancer

A Phase I/IIa Randomized Trial Evaluating the Safety and Efficacy of SNK01 Plus Pembrolizumab in Patients with Stage IV Non-Small Cell Lung Cancer: Eo Jin Kim, Yong-Hee Cho, Dong Ha Kim, Dae-Hyun Ko, Eun-Ju Do, Sang-Yeob Kim, Yong Man Kim, Jae Seob Jung, Yoonmi Kang, Wonjun Ji, Myeong Geun Choi, Jae Cheol Lee, Jin Kyung Rho, Chang-Min Choi; Cancer Res Treat. 2022;54(4):1005-1016. Published online December 3, 2021; DOI: https://doi.org/10.4143/crt.2021.986

Abstract PDF Supplementary Material PubReader ePub

Purpose
The aim of this study is to evaluate the safety and efficacy of ex vivo activated and expanded natural killer (NK) cell therapy (SNK01) plus pembrolizumab in a randomized phase I/IIa clinical trial.
Materials and Methods
Overall, 18 patients with advanced non–small cell lung cancer (NSCLC) and a programmed death ligand 1 tumor proportion score of 1% or greater who had a history of failed frontline platinum-based therapy were randomized (2:1) to receive pembrolizumab every 3 weeks +/– 6 weekly infusions of SNK01 at either 2×10⁹ or 4×10⁹ cells per infusion (pembrolizumab monotherapy vs. SNK01 combination). The primary endpoint was safety, whereas the secondary endpoints were the objective response rate (ORR), progression-free survival (PFS), overall survival, and quality of life.
Results
Since no dose-limiting toxicity was observed, the maximum tolerated dose was determined as SNK01 4×10⁹ cells/dose. The safety data did not show any new safety signals when SNK01 was combined with pembrolizumab. The ORR and the 1-year survival rate in the NK combination group were higher than those in patients who underwent pembrolizumab monotherapy (ORR, 41.7% vs. 0%; 1-year survival rate, 66.7% vs. 50.0%). Furthermore, the median PFS was higher in the SNK01 combination group (6.2 months vs. 1.6 months, p=0.001).
Conclusion
Based on the findings of this study, the NK cell combination therapy may consider as a safe treatment method for stage IV NSCLC patients who had a history of failed platinum-based therapy without an increase in adverse events.

Citations

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Clemente Humberto Zúñiga, Blanca Isaura Acosta, Rufino Menchaca, Cesar A. Amescua, Sean Hong, Lucia Hui, Minchan Gil, Yong-hee Rhee, Sangwook Yoon, Minji Kim, Paul Y. Chang, Yong Man Kim, Paul Y. Song, Katia Betito
Alzheimer's Research & Therapy.2025;[Epub] CrossRef
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Faith Abodunrin, Daniel J Olson, Oluwatosin Emehinola, Christine M Bestvina
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Jaya Lakshmi Thangaraj, Michael Coffey, Edith Lopez, Dan S. Kaufman
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Frontiers in Immunology.2022;[Epub] CrossRef

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Concurrent Chemoradiotherapy in Locally Advanced Carcinoma of the Uterine Cervix Preliminary Results of Phases III Prospective Randomized Trial: Young Seok Kim, Eun Kyung Choi, Jong Hoon Kim, Seung Do Ahn, Sang Wook Lee, Jong Hyeok Kim, Yong Man Kim, Young Tak Kim, Jung Eun Mok, Joo Hyun Nam; Cancer Res Treat. 2002;34(3):191-197. Published online June 30, 2002; DOI: https://doi.org/10.4143/crt.2002.34.3.191

Abstract PDF: PURPOSE
A prospective, randomized phase III, clinical trial was performed to assess treatment related acute toxicity, early response and survival difference, between a monthly 5-FU cisplatin, and a weekly cisplatin group alone, for concurrent chemoradiotherapy in the locally advanced uterine cervical carcinoma patients. MATERIALS AND METGODS: Between March 1998 and March 2000, 35 patients, with locally advanced (FIGO stage IIB to IVA) cervical carcinoma, were studied, but 5 patients were excluded inform the analysis due to their refusal of treatment. The patients were randomly assigned to 'monthly 5-FU cisplatin' (arm I), or 'weekly cisplatin' (arm II), groups. The patients of arm I received 5-FU cisplatin (5-FU 1,000 mg/m2/day cisplatin 20 mg/m2/day, IV continuous infusion, for 5 days, 3 cycles with 4-week intervals) with radiation therapy. Those of arm II received only cisplatin (cisplatin 30 mg/m2/day, IV bolus, 6 cycles with 1-week intervals) with radiation therapy. The radiation therapy consisted of external beam irradiation of 41.4~50.4 Gy/23~28 fractions, and high dose rate intracavitary treatments, delivering a dose of 30~35 Gy to point A in 6~7 fractions. During intracavitary radiation, a parametrial boost was delivered for a point B dose of 60 Gy in the non-thickened side, and 65 Gy in the thickened side. Treatment related acute toxicities were assessed using Radiation Therapy Oncology Group (RTOG) acute morbidity scoring criteria. The response to treatment, and survival, were analyzed. The median follow-up period was 19 months.
RESULTS
The FIGO stage distributions of arm I (n=16) and arm II (n=14) were as follows; IIB 10, IIIA 1, IIIB 4, IVA 1 in arm I, 12, 0, 1 and 1 in arm II respectively. The compliance of both arms were 80.0% and 93.3%, respectively (p=0.37). During radiation therapy, the incidences of leukopenia, greater than RTOG grade 2, were 25.0%, 14.3%, respectively. There were no patients with gastrointestinal or genitourinary toxicity greater than RTOG grade 2. The complete response rates at 3 months, following radiation therapy, were 87.5% and 92.9% respectively. Two-year disease free survival rates were 81.3%, 85.7%, respectively, for each arms.
CONCLUSION
There was no significant difference in response to treatment, or patterns of failure, between the monthly FP and weekly cisplatin arms. Although there were no statistically significant differences, the patients of the weekly cisplatin arm had better compliance. More patients, and a longer follow up, are needed for improved evaluation of the regimen.

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Everamplification of GER-2/neu Oncogene Detected by Differential PCR and its Prognostic Significance in Advanced Epithelial Ovarian Cancer: Sang Soo Lee, Jong Hyok Kim, Chang Won Ko, Joon Hee Na, Yong Man Kim, Young Tak Kim, Joo Hyun Nam, Jung Eun Mok; J Korean Cancer Assoc. 1998;30(4):752-761.

Abstract PDF: PURPOSE
S: The objectives of this study were to investigate the prevalence of HER-2/neu oncogene amplification by differential polymerase chain reaction and to examine whether HER-2/neu oncogene overamplification has any prognostic significance in advanced epithelial ovarial cancer patients.
MATERIALS AND METHODS
The study population comprised thirty patients with stage III or IV epithelial ovarian cancer who were managed at Asan Medical Center between January 1994 and December 1996. Fresh frozen tumor samples of primary lesion were analysed by differential polymerase chain reaction to assess amplification of HER-2/neu oncogene. The correlation between HER-2/neu oncogene overamplification and histologic subtype or tumor grade or serum CA 125 level after second chemotherapy were evaluated using chi-square test, and for survival analysis, Kaplan-Meier curves were plotted and the differences between the curves were tested for significance using Log-rank test.
RESULTS
HER-2/neu oncogene was amplified in all of the cases (100% 30/30), but significant overamplification [gene copy number > or =1.5 a.u.(arbitrary unit)] was observed in 46.7% (14/30). There was no significant correlation between HER-2/neu oncogene overamplification and histologic subtype or tumor grade or serum CA 125 level after second chemotherapy and there was no correlation between HER-2/neu oncogene overamplification and overall survival.
CONCLUSION
The prevalence of HER-2/neu oncogene overamplification is 46.7%, but it may not be a significant prognostic factor in advanced epithelial ovarian cancers.

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