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

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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.

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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
Therapeutic impacts of GNE‑477‑loaded H2O2 stimulus‑responsive dodecanoic acid‑phenylborate ester‑dextran polymeric micelles on osteosarcoma
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
Ruyi Wang, Yuxiao Xiao, Zhongtao Zhang, Xiaoxian Huang, Wanfang Zhu, Xiao Ma, Feng Feng, Wenyuan Liu, Lingfei Han, Wei Qu
Advanced Healthcare Materials.2024;[Epub] CrossRef

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Genitourinary Cancer

Use of Gemcitabine plus Carboplatin is Associated with Poor Outcomes in Urothelial Carcinoma Patients with Chronic Kidney Disease Stage 4-5: Hyung-Don Kim, Hyeon-Su Im, Jwa Hoon Kim, Hyehyun Jeong, Shin Kyo Yoon, Inkeun Park, Jae Lyun Lee; Cancer Res Treat. 2021;53(4):1166-1173. Published online March 4, 2021; DOI: https://doi.org/10.4143/crt.2021.091

Abstract PDF Supplementary Material PubReader ePub

Purpose
This study aimed to investigate the clinical outcomes with gemcitabine-carboplatin (GCb), the standard treatment for patients with advanced urothelial carcinoma (UC) who are ineligible for cisplatin-based regimens, in advanced UC patients with a glomerular filtration rate (GFR) < 30 mL/min.
Materials and Methods
A retrospective cohort study involving GCb-treated advanced UC patients with GFR < 60 mL/min (n=89) was performed. Clinical outcomes were compared between subgroups with GFR < 30 mL/min and GFR ≥ 30 mL/min but < 60 mL/min.
Results
Most baseline characteristics were comparable between the two subgroups. Patients with GFR < 30 mL/min had a significantly lower objective response rate (12.5%) compared to those with higher GFR levels (56.7%) (p=0.004). The number of GCb cycles was significantly lower in patients with GFR < 30 mL/min (median 2 cycles) than in those with higher GFR levels (median 6 cycles) (p=0.002). Compared to those with GFR ≥ 30 mL/min but < 60 mL/min, patients with GFR < 30 mL/min showed significantly worse progression-free survival (PFS) and overall survival (OS) (p < 0.001 for both). Further stratification of patient subgroups according to their GFR (i.e., GFR ≥ 45 mL/min but < 60 mL/min vs. GFR ≥ 30 mL/min but < 45 mL/min vs. GFR < 30 mL/min) revealed significantly different PFS and OS (p < 0.001 for both).
Conclusion
The use of GCb is discouraged in advanced UC patients with GFR < 30 mL/min. Alternative therapeutic approaches with better efficacy are warranted for these patients.

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Onconephrology: mitigation of renal injury in chemotherapy administration
Umut Selamet, Rebecca S. Ahdoot, Reed Salasnek, Lama Abdelnour, Ramy M. Hanna
Current Opinion in Nephrology & Hypertension.2024; 33(2): 257. CrossRef
Management of bladder cancer in older patients
Shingo Hatakeyama, Shintaro Narita, Kazutaka Okita, Takuma Narita, Hiromichi Iwamura, Naoki Fujita, Junichi Inokuchi, Yoshiyuki Matsui, Hiroshi Kitamura, Chikara Ohyama
Japanese Journal of Clinical Oncology.2022; 52(3): 203. CrossRef

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Crizotinib versus Chemotherapy in Asian Patients with ALK-Positive Advanced Non-small Cell Lung Cancer: Makoto Nishio, Dong-Wan Kim, Yi-Long Wu, Kazuhiko Nakagawa, Benjamin J. Solomon, Alice T. Shaw, Satoshi Hashigaki, Emiko Ohki, Tiziana Usari, Jolanda Paolini, Anna Polli, Keith D. Wilner, Tony Mok; Cancer Res Treat. 2018;50(3):691-700. Published online July 6, 2017; DOI: https://doi.org/10.4143/crt.2017.280

Abstract PDF Supplementary Material PubReader ePub

Purpose
Crizotinib has demonstrated superior progression-free survival (PFS) and objective response rates (ORRs) versus chemotherapy in previously treated and untreated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). We report the safety and efficacy of crizotinib in Asian subpopulations of two global phase III trials.
Materials and Methods
This analysis evaluated previously treated and untreated patients in two randomized, openlabel phase III trials of crizotinib versus chemotherapy in ALK-positive advanced NSCLC in second-line (PROFILE 1007) and first-line settings (PROFILE 1014). Efficacy and safety were analyzed by race in the intention-to-treat and “as-treated” populations for efficacy and safety endpoints, respectively.
Results
In previously treated (n=157) and untreated (n=157) Asian patients, PFS was statistically significantly longer with crizotinib versus chemotherapy (hazard ratio for PFS, 0.526; 95% confidence interval, 0.363 to 0.762; p < 0.001 and hazard ratio, 0.442; 95% confidence interval, 0.302 to 0.648; p < 0.001, respectively). Similar antitumor activity was seen in the non-Asian and overall populations. ORRs were statistically significantly higher with crizotinib versus chemotherapy in both Asian and non-Asian previously treated and untreated patients (p < 0.05). The most common treatment-emergent adverse events (any grade)with crizotinib were vision disorder, diarrhea, and nausea, which were observed at a comparable incidence across Asian and non-Asian populations, irrespective of previous treatment status. Most adverse events were mild to moderate in severity.
Conclusion
These data, currently the only analysis showing Asian and non-Asian populations in the same study, support the efficacy and safety of crizotinib in Asian patients with previously treated or untreated ALK-positive advanced NSCLC.

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An Open-Label, Randomized, Parallel, Phase II Trial to Evaluate the Efficacy and Safety of a Cremophor-Free Polymeric Micelle Formulation of Paclitaxel as First-Line Treatment for Ovarian Cancer: A Korean Gynecologic Oncology Group Study (KGOG-3021): Shin-Wha Lee, Yong-Man Kim, Chi Heum Cho, Young Tae Kim, Seok Mo Kim, Soo Young Hur, Jae-Hoon Kim, Byoung-Gie Kim, Seung-Cheol Kim, Hee-Sug Ryu, Soon Beom Kang; Cancer Res Treat. 2018;50(1):195-203. Published online March 21, 2017; DOI: https://doi.org/10.4143/crt.2016.376

Abstract PDF PubReader ePub

Purpose
Genexol-PM is a biodegradable cremophor EL–free polymeric micelle formulation of paclitaxel. Here,we compared efficacy and safety of Genexol-PM plus carboplatin versus Genexol plus carboplatin for ovarian cancer treatment.
Materials and Methods
In this multicenter, randomized, phase II study, patients with International Federation of Gynecology and Obstetrics IC-IV epithelial ovarian cancer were randomly assigned (1:1) to receive Genexol-PM 260 mg/m² or Genexol 175 mg/m² with 5 area under the curve carboplatin every 3weeks (6 cycles). The primary endpointwas the carbohydrate antigen 125 and Response Evaluation Criteria In Solid Tumor composite overall response rate (ORR).
Results
Of 131 enrolled patients, 98 were included in intention-to-treat analysis. Mean dosages were 260.00±0.00 mg/m² Genexol-PM or 174.24±3.81 mg/m² Genexol. Median followup was 18.0 months (range, 6.1 to 33.8 months). ORR was 88.0% (95% confidence interval [CI], 80.4 to 95.6) with Genexol-PM, and 77.1% (95% CI, 67.1 to 87.1) with Genexol (noninferiority threshold, 16.3%). Median time to progression was 14.8 months (95% CI, 11.3 to 20.2) with Genexol-PM and 15.4 months (95% CI, 13.2 to 29.6) with Genexol (p=0.550). Overall, six patients died. Neutropenia was the most common toxicity (incidences of 86.0% vs. 77.1%, p=0.120). Peripheral neuropathy incidences were 84.0% versus 64.6% (p= 0.148). Peripheral neuropathy of ≥ grade 3 occurred in one patient receiving Genexol. All toxicities were manageable.
Conclusion
Genexol-PM plus carboplatin as first-line treatment in patients with epithelial ovarian cancer demonstrated non-inferior efficacy and well-tolerated toxicities compared with the standard paclitaxel regimen. Further studies are warranted to optimize the dose and schedule, and to investigate long-term outcomes.

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Results of a Phase II Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Patients Who Failed First-Line Therapy Containing Dacarbazine: Choong-kun Lee, Minkyu Jung, Hye Jin Choi, Hye Ryun Kim, Hyo Song Kim, Mi Ryung Roh, Joong Bae Ahn, Hyun Cheol Chung, Su Jin Heo, Sun Young Rha, Sang Joon Shin; Cancer Res Treat. 2015;47(4):781-789. Published online February 16, 2015; DOI: https://doi.org/10.4143/crt.2014.261

Abstract PDF PubReader ePub

Purpose
There is no standard second-line regimen for malignant melanoma patients with disease progression after first-line chemotherapy, and platinum-alkylating agents combined with paclitaxel have shown modest efficacy. Materials and Methods We conducted a phase II, open-label, single-arm study to test the efficacy of docetaxel combined with carboplatin for malignant melanoma patients who failed previous treatment with dacarbazine. Intravenous docetaxel (35 mg/m2 on days 1 and 8 of each cycle) and carboplatin (area under the curve 3 on days 1 and 8 of each cycle) was administered every 21 days. Primary end point was objective response rate (ORR).
Results
Thirty patients were enrolled in the study, and the median follow-up duration was 19.8 months. Among 25 per-protocol patients, there were three responders (1 with complete response and 2 with partial response) and 17 stable disease patients (ORR, 12.0%). Among the per-protocol population, the median progression-free survival (PFS) was 4.3 months and the median overall survival (OS) was 9.6 months. Uveal melanoma patients (n=9) showed the best prognosis compared to other subtypes (median PFS, 7.6 months; OS, 9.9 months). The most common grade 3 or 4 adverse event was neutropenia (n=15, 50.0%). Conclusion Docetaxel combined with carboplatin showed association with an acceptable safety profile and overall efficacy for patients with malignant melanoma who had progressed on chemotherapy containing dacarbazine.

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Phase II Study of Consolidation Chemotherapy after Adjuvant or Primary Concurrent Chemoradiation Using Paclitaxel and Carboplatin to Treat High-Risk Early-Stage or Locally Advanced Cervical Cancer: Hee Seung Kim, Mi-Kyung Kim, Hak Jae Kim, Seung-Su Han, Jae Weon Kim; Cancer Res Treat. 2012;44(2):97-103. Published online June 30, 2012; DOI: https://doi.org/10.4143/crt.2012.44.2.97

Abstract PDF PubReader ePub

PURPOSE
This study investigated the efficacy and toxicity associated with consolidation chemotherapy using paclitaxel and carboplatin after concurrent chemoradiation (CCR) in cervical cancer patients.
MATERIALS AND METHODS
From a total of 37 patients, 19 with International Federation of Gynecology and Obstetrics (FIGO) stage IB1-IIA cervical cancer (group 1) underwent surgery followed by consolidation chemotherapy after CCR, and 18 with stage IIB-IVA disease (group 2) received consolidation chemotherapy after primary CCR. Three cycles of chemotherapy using paclitaxel (135 mg/m2) and carboplatin (AUC 5.0) were administered every 3 weeks for CCR therapy, and three cycles of consolidation chemotherapy using paclitaxel (175 mg/m2) and carboplatin (AUC 5.0) were used every 3 weeks after CCR.
RESULTS
The complete and partial response rates were 77.8% and 22.2% in group 2. Moreover, the 3-year progression-free and overall survival rates were 62.7% and 90.9% in group 1, and 51.9% and 60% in group 2, respectively. The most common grade 3 or 4 hematologic toxicities observed were leukopenia (group 1, 10.5%; group 2, 13.0%) and neutropenia (group 1, 7.0%; group 2, 14.8%), and grade 3 or 4 diarrhea (group 1, 1.8%) and febrile illness (group 2, 1.9%) were the most frequently observed non-hematologic toxicities. When we compared these results with previous reports, consolidation chemotherapy after CCR using paclitaxel and carboplatin revealed a relatively lower complete response rate (77.8% vs. 87-100%, respectively) and shorter progression-free survival (51.9-62.7% vs. 81-86%, respectively) and overall survival (60-90.9% vs. 81-95%, respectively) in spite of similar toxicity findings.
CONCLUSION
Due to low efficacy results, consolidation chemotherapy using paclitaxel and carboplatin after CCR is not a feasible treatment regimen for high-risk early-stage or locally advanced cervical cancer.

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Efficacy and safety of consolidation chemotherapy after adjuvant therapy in stage IB-IIA cervical cancer patients with risk factors: a retrospective single-center study
Jiaxin Wang, Huaijuan Guo, Jingjing Yang, Jingxian Mao, Ying Wang, Ruidong Gao, Xuebing Yan, Jie Wang
Frontiers in Oncology.2024;[Epub] CrossRef
The effectiveness of consolidation chemotherapy in high-risk early-stage cervical cancer patients following concurrent chemoradiation after radical surgery
Cong Wang, Chunli Fu, Changdong Ma, Qiuhong Qian, Fangfang He, Guangyu Zhang
Japanese Journal of Clinical Oncology.2023; 53(2): 122. CrossRef
Efficacy and safety of adjuvant chemotherapy for locally advanced cervical cancer: A systematic review and meta-analysis
Xiao Ma, Jin Fang, Lu Zhang, Yao Huang, Hui Shen, Xiaohua Ma, Shuixing Zhang, Bin Zhang
Critical Reviews in Oncology/Hematology.2023; 184: 103953. CrossRef
The effect of consolidation chemotherapy after concurrent chemoradiation on the prognosis of locally advanced cervical cancer: a systematic review and meta-analysis
Lan Zhong, Kemin Li, Liang Song, Rutie Yin
Journal of Obstetrics and Gynaecology.2022; 42(5): 830. CrossRef
Role of Adjuvant Chemotherapy After Concurrent Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer
Lingna Kou, Tao Zhang, Xiling Yang, Siyun Peng, Yifei Wang, Mingyang Yuan, Minmin Li
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Integration of Consolidation Chemotherapy After Concurrent Chemoradiation in the Treatment of Locally Advanced Uterine Cervical Cancer
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Seiji Mabuchi, Fumiaki Isohashi, Takeshi Yokoi, Masahiko Takemura, Kiyoshi Yoshino, Yasuhiko Shiki, Kimihiko Ito, Takayuki Enomoto, Kazuhiko Ogawa, Tadashi Kimura
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BMC Cancer.2015;[Epub] CrossRef
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Ying Liu, Haoran Sun, Renju Bai, Zhaoxiang Ye
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Siriwan Tangjitgamol, Kanyarat Katanyoo, Malinee Laopaiboon, Pisake Lumbiganon, Sumonmal Manusirivithaya, Busaba Supawattanabodee
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International Journal of Gynecological Cancer.2013; 23(7): 1279. CrossRef

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Phase II Clinical Trial of Genexol(R) (Paclitaxel) and Carboplatin for Patients with Advanced Non-small Cell Lung Cancer: Han Jo Kim, Kyoung Ha Kim, Jina Yun, Se Hyung Kim, Hyun Jung Kim, Sang-Cheol Lee, Sang Byung Bae, Chan Kyu Kim, Nam Su Lee, Kyu Taek Lee, Do-Jin Kim, Seong-Kyu Park, Jong-Ho Won, Dae Sik Hong, Hee Sook Park; Cancer Res Treat. 2011;43(1):19-23. Published online March 31, 2011; DOI: https://doi.org/10.4143/crt.2011.43.1.19

Abstract PDF PubReader ePub

PURPOSE
This phase II clinical trial was conducted to evaluate the activity and safety of a combination treatment of paclitaxel (Genexol(R)) plus carboplatin in patients with advanced non-small cell lung cancer.
MATERIALS AND METHODS
Chemotherapy-naive patients having histologically confirmed advanced or metastatic non-small cell lung cancer were enrolled. Genexol(R) was administered at 225 mg/m2 intravenous (IV) infusion over 3 hours, followed by carboplatin (area under the concentration-time curve=6) IV on day 1 every 3 weeks.
RESULTS
Twenty-eight patients were enrolled between January 2003 and January 2005. A total of 110 cycles of chemotherapy were given. The median number of chemotherapy cycles was 4. A total of 25 study patients were evaluable. On an intent-to-treat basis, there were ten partial responses (response rate 35.7%). The median time-to-progression was 3.2 months (95% confidence interval [CI], 1.5 to 4.9) and the median overall survival was 8.2 months (95% CI, 4.1 to 12.3). The main hematologic grade 3/4 toxicity was neutropenia, which was observed in 14 (50.0%) patients. The main non-hematologic toxicity was peripheral neuropathy, which was observed in 12 patients (42.9%). Grade 3/4 neuropathy occurred in 8 patients (28.6%) and three patients discontinued treatment because of neuropathy.
CONCLUSION
In this trial, the combination of Genexol(R) and carboplatin showed significant activity as first line treatment for patients with advanced or metastatic non-small cell lung cancer. However, a modest dose reduction of Genexol(R) is needed due to sensory neuropathy.

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Therapeutic Nanoparticles: Advantages and Toxicity
Dr. Lata Ramrakhiani
Indian Journal of Environment Engineering.2022; 2(1): 19. CrossRef
Engineering Chimeric Receptors To Investigate the Size- and Rigidity-Dependent Interaction of PEGylated Nanoparticles with Cells
Wei-Chiao Huang, Pierre-Alain Burnouf, Yu-Cheng Su, Bing-Mae Chen, Kuo-Hsiang Chuang, Chia-Wei Lee, Pei-Kuen Wei, Tian-Lu Cheng, Steve R. Roffler
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Sophie C. Hofferberth, Mark W. Grinstaff, Yolonda L. Colson
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Nazila Kamaly, Basit Yameen, Jun Wu, Omid C. Farokhzad
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Ahmad Yari Khosroushahi, Hossein Naderi-Manesh, Hamid Yeganeh, Jaleh Barar, Yadollah Omidi
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Gemcitabine and Carboplatin Combination Chemotherapy for Elderly Patients with Advanced Non-small Cell Lung Cancer: A Feasibility Study: Young Jin Yuh, Hyo Rak Lee, Sung Rok Kim; Cancer Res Treat. 2008;40(3):116-120. Published online September 30, 2008; DOI: https://doi.org/10.4143/crt.2008.40.3.116

Abstract PDF PubReader ePub

Purpose

Although platinum based chemotherapy is known to improve the survival duration for the patients with non-small cell lung cancer, the role of platinum for elderly patient is not yet clear. We administered gemcitabine and carboplatin combination therapy to elderly patients with NSCLC. The aim of this study was to evaluate the efficacy and toxicities of this regimen for elderly patients.

Materials and Methods

The eligibility criteria were as follows: pathologically confirmed NSCLC, an age ≥65 years, advanced disease with stage IIIB or IV and the patients were chemotherapy-naive. The treatment regimen was as follows; gemcitabine 1,000 mg/m² was administered on days 1 and 8 and carboplatin AUC=5 was administered on day 1. This regimen was repeated every 3 weeks. The efficacy was evaluated in terms of the response rate, the time to progression and the overall survival duration.

Results

From Dec 2001 to Feb 2005, a total of 20 patients were entered into this study. The median patient age was 68 years (range: 65~75). 19 patients were evaluable for their treatment response. A partial response was obtained in 8 patients (response rate: 42.1%, 95% CI: 19.4~64.8%). The median time to progression and the survival duration were 136 days and 453 days, respectively. Among a total of 65 cycles of treatment, grade 3 or 4 leukopenia and thrombocytopenia were observed in 7.7% and 13.9% of the cycles, respectively. Grade 3 or 4 vomiting was observed in 7.7% of the cycles. Grade 3 skin rash developed in 1.5% of the cycles. 1 patient died of septic shock after chemotherapy.

Conclusions

Gemcitabine and carboplatin combination chemotherapy was relatively safe and effective for treating elderly patients with NSCLC.

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Seung Tae Kim, Jae Sook Sung, Uk Hyun Jo, Kyong Hwa Park, Sang Won Shin, Yeul Hong Kim
Medical Oncology.2013;[Epub] CrossRef
Efficacy and feasibility of gemcitabine and carboplatin as first-line chemotherapy in elderly patients with advanced non-small cell lung cancer
Kyu-Hyoung Lim, Hui-Young Lee, Seo-Young Song
Chinese Medical Journal.2013; 126(24): 4644. CrossRef
Randomized Phase II Study of Two Schedules of Carboplatin and Gemcitabine for Stage IIIB and IV Advanced Non-Small Cell Lung Cancer (JACCRO LC-01 Study)
Fumio Imamura, Makoto Nishio, Rintaro Noro, Masahiro Tsuboi, Norihiko Ikeda, Akira Inoue, Yoshinobu Ohsaki, Yukio Kimura, Kazumi Nishino, Junji Uchida, Takeshi Horai
Chemotherapy.2011; 57(4): 357. CrossRef
Carboplatin and Gemcitabine in First-Line Treatment of Elderly Patients with Advanced Non-Small Cell Lung Cancer: Data from a Retrospective Study
G. Genestreti, N. Giovannini, M. Frizziero, M. Maglie, S. Sanna, S. Cingarlini, A.M. Molino, S. Piciucchi, G.L. Cetto, A. Santo
Journal of Chemotherapy.2011; 23(4): 232. CrossRef
Comparison of gefitinib versus erlotinib in patients with nonsmall cell lung cancer who failed previous chemotherapy
Seung Tae Kim, Jeeyun Lee, Jeong‐hoon Kim, Young‐Woong Won, Jong‐Mu Sun, Jina Yun, Yeon Hee Park, Jin Seok Ahn, Keunchil Park, Myung‐Ju Ahn
Cancer.2010; 116(12): 3025. CrossRef
Treatment of Older Patients With Non–Small-Cell Lung Cancer: Walking the Therapeutic Tightrope
George R. Simon
Journal of Clinical Oncology.2010; 28(4): 523. CrossRef

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High-Dose Chemotherapy of Cyclophosphamide, Thiotepa and Carboplatin (CTCb) followed by Autologous Stem-Cell Transplantation as a Consolidation for Breast Cancer Patients with 10 or more Positive Lymph Nodes: a 5-Year follow-Up Results: Hee-Jung Sohn, Sang-Hee Kim, Gyeong-Won Lee, Shin Kim, Jin-Hee Ahn, Sung-Bae Kim, Sang-We Kim, Woo Kun Kim, Cheolwon Suh; Cancer Res Treat. 2005;37(3):137-142. Published online June 30, 2005; DOI: https://doi.org/10.4143/crt.2005.37.3.137

Abstract PDF PubReader ePub

Purpose

The benefit of consolidation high-dose chemotherapy (HDC) for high-risk primary breast cancer is controversial. We evaluated the efficacy and safety of consolidation HDC with cyclophosphamide, thiotepa and carboplatin (CTCb) followed by autologous stem-cell transplantation (ASCT) in resected breast cancer patients with 10 or more positive lymph nodes.

Materials and Methods

Between December 1994 and April 2000, 22 patients were enrolled. All patients received 2 to 6 cycles of adjuvant chemotherapy after surgery for breast cancer. The HDC regimen consisted of cyclophosphamide 1,500 mg/m²/day, thiotepa 125 mg/m²/day and carboplatin 200 mg/m²/day intravenous for 4 consecutive days.

Results

With a median follow-up of 58 months, 11 patients recurred and died. The median disease-free survival (DFS) and median overall survival (OS) were 49 and 69 months, respectively. The 5-year DFS and OS rates were 50% and 58%, respectively. The 12 patients with 10 to 18 involved nodes had better 5-year DFS (67%) and OS (75%) than 10 patients with more than 18 involved nodes (30% and 38%, respectively). The most common grade 3 or 4 nonhematologic toxicity was diarrhea, which occurred in 5 patients (23%). No treatment-related death was observed.

Conclusion

Consolidation HDC with CTCb followed by ASCT for resected breast cancer with more than 10 positive nodes had an acceptable toxicity but does not show promising survival.

Citations

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Real-world Experience of Improvement in the Survival of Lymphoma and Myeloma Patients with Autologous Stem Cell Transplantation over a 25-year Period
Hyungwoo Cho, Shin Kim, Kyoungmin Lee, Jung Sun Park, Cheolwon Suh
The Korean Journal of Medicine.2021; 96(6): 501. CrossRef
Prospective study of cyclophosphamide, thiotepa, carboplatin combined with adoptive DC-CIK followed by metronomic cyclophosphamide therapy as salvage treatment for triple negative metastatic breast cancers patients (aged <45)
X. Wang, J. Ren, J. Zhang, Y. Yan, N. Jiang, J. Yu, L. Di, G. Song, L. Che, J. Jia, X. Zhou, H. Yang, H. K. Lyerly
Clinical and Translational Oncology.2016; 18(1): 82. CrossRef

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High-Dose Chemotherapy of Cyclophosphamide, Thiotepa, and Carboplatin (CTCb) Followed by Autologous Stem-Cell Transplantation for Metastatic Breast Cancer Patients: A 6-Year Follow-Up Result: Hee-Jung Sohn, Sang-Hee Kim, Gyeong-Won Lee, Shin Kim, Hye Jin Kang, Jin-Hee Ahn, Sung-Bae Kim, Sang-We Kim, Woo Kun Kim, Cheolwon Suh; Cancer Res Treat. 2005;37(1):24-30. Published online February 28, 2005; DOI: https://doi.org/10.4143/crt.2005.37.1.24

Abstract PDF PubReader ePub

Purpose

The benefit of high-dose chemotherapy (HDC) for metastatic breast cancer (MBC) is controversial. We evaluated the efficacy and safety of HDC with cyclophosphamide, thiotepa, and carboplatin (CTCb) followed by autologous stem-cell transplantation (ASCT) for MBC patients.

Materials and Methods

From September 1994 to December 1999, 23 MBC patients were enrolled. All the patients received 2 to 10 cycles of induction chemotherapy. Before transplantation, 12 patients were in complete response (CR), nine were in partial response (PR), and two had progressive disease (PD). The HDC regimen consisted of cyclophosphamide 1,500 mg/m²/day, thiotepa 125 mg/m²/day and carboplatin 200 mg/m²/day intravenously for 4 consecutive days.

Results

After ASCT, 13 patients (56%) had a CR, five (22%) had a PR, three (13%) had no change, while two (9%) showed a PD. Seventeen patients relapsed or progressed during the median follow-up of 78 months. The median progression-free survival (PFS) time was 11 months and the median overall survival (OS) time was 23 months. The 5-year PFS and OS rates were 22% and 25%, respectively. On the multivariate analyses, less than 4 involved lymph nodes was predictive of a better PFS and OS.

Conclusion

HDC with CTCb for MBC has acceptable toxicity; however, this treatment does not show a survival benefit.

Citations

Citations to this article as recorded by

Real-world Experience of Improvement in the Survival of Lymphoma and Myeloma Patients with Autologous Stem Cell Transplantation over a 25-year Period
Hyungwoo Cho, Shin Kim, Kyoungmin Lee, Jung Sun Park, Cheolwon Suh
The Korean Journal of Medicine.2021; 96(6): 501. CrossRef

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A Phase II Study of Ifosfamide, Carboplatin, and Epirubicin (ICE) Combination Chemotherapy for Extensive Disease of Small Cell Lung Cancer: Jae Ho Byun, In Sook Woo, Hun Ho Song, Keun Seok Lee, Jin Seok Ahn, Dae Young Jang, Jung Ae Lee, Young Lee Park, Young Suk Park; Cancer Res Treat. 2002;34(6):416-420. Published online December 31, 2002; DOI: https://doi.org/10.4143/crt.2002.34.6.416

Abstract PDF: PURPOSE
To evaluate the efficacy and safety of ifosfamide, carboplatin and epirubicin (ICE) combination chemotherapy for extensive disease small cell lung cancer (SCLC) patients, who had received no previous chemotherapy, we performed phase II trial between August 1998 and January 2001.
MATERIALS AND METHODS
The study group comprised of 21 patients. Ifosfamide, 1,500 mg/m2, was given with mesna, 900 mg/m2, intravenously for 12 hours on days 1, 2 and 3, and carboplatin, 4.5 mg/ml/min, for target AUC, and epirubicin, 60 mg/m2, were given intravenously for 90 minutes on day 1. The cycle of treatment was repeated at 4 week intervals.
RESULTS
Twenty-one patients with extensive disease SCLC were treated at Hallym University between August 1998 and January 2001. One patient was unable to be evaluated because of lost to follow-up. Of the 20 patients able to be evaluated, an objective response was observed in 13 (65%). There were no complete responses. The median response duration, time to progression and median overall survival were 15.4, 18.3 and 34 weeks, respectively. Toxicities were acceptable, with dose reduction for myelosuppression necessary in only a minority of the patients. A total of 85 cycles of chemotherapy were given to the patients. The median number of cycles completed was 4. Grade III and IV hematological toxicities included anemia (4.7%), neutropenia (3.5%) and thrombocytopenia (3.5%). Most non-hematological toxicities were grade I or II.
CONCLUSION
These results suggested that ICE combination chemotherapy for extensive disease SCLC is effective, and can be safely administered with acceptable toxicities.

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A Phase II Study with Gemcitabine and Carboplatin in Patients with Advanced Non-small Cell Lung Cancer: Jae Wan Park, Hwan Yang Park, Yong Bae Park, Jung Won Kang, Sung Hung Kim, Gwi Lae Lee, Bong Seog Kim, Yong Ho Roh; Cancer Res Treat. 2002;34(1):23-27. Published online February 28, 2002; DOI: https://doi.org/10.4143/crt.2002.34.1.23

Abstract PDF

PURPOSE
To evaluate the efficacy and safety of gemcitabine and carboplatin (GC) in the treatment of advanced non-small-cell lung cancer (NSCLC).
MATERIALS AND METHODS
Between November 1999 and April 2001, 34 patients were enrolled in this study. The median age was 66 (range: 52-74) years old and all were male. Sixteen patients demonstrated stage IIIB, 15 stage IV, and 3 recurrence of disease after surgery. Twenty-two patients showed a ECOG performance status of 0 or 1 and 12 had 2. Twenty patients presented with squamous cell carcinoma, 11 adenocarcinoma and 3 unclassified NSCLC. The treatment regimen consisted of intravenous carboplatin AUC of 6 on day 1 and gemcitabine 1,250 mg/m2 on day 1 and 8. The treatment was repeated every 28 days. Toxicities were evaluated according to WHO toxicity criteria.
RESULTS
All thirty-four patients were evaluable. Partia responses were observed in 15 patients. The overall response rate was 44% (95% confidence interval: 27-61%) and the median response duration was 26 (range 8-60 ) weeks. The median survival of all patients was 50 (range 8-70 ) weeks. During a total of 144 cycles, granulocytopenia greater than WHO grade 2 occurred in 2%, thrombocytopenia in 2%, and anemia in 3%, respectively. Non- hematologic toxicities were minor and easily controlled.
CONCLUSION
A combination chemotherapy of intravenous gemcitabine and carboplatin has a relatively high activity with acceptable toxicities in patients with advanced NSCLC.

Citations

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A Phase II Study of Single-Agent Gemcitabine as a Second-Line Treatment in Advanced Non-Small Cell Lung Cancer
Keun-Hyok Cho, Young-Bong Song, Ik-Sung Choi, Eun-Hee Cho, Jae-Won Choi, Young Mi Ahn, Yong Ho Roh, Seung-Hyun Nam, Bong-Seog Kim
Japanese Journal of Clinical Oncology.2006; 36(1): 50. CrossRef
A 21-day Schedule of Gemcitabine and Cisplatin Administration in the Treatment of Advanced Non-Small Cell Lung Carcinoma: a Phase II Study
Jong-Sung Park, Chang-Min Lee, Shin-Ae Lee, Chang-kil Jung, Sung-Hyun Kim, Hyuk-Chan Kwon, Jae-Seok Kim, Hyo-Jin Kim
Cancer Research and Treatment.2004; 36(1): 62. CrossRef

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A Phase II Study with Vinorelbine and Carboplatin in Patients with Advanced Non-small Cell Lung Cancer: Jong Lyul Kim, Bong Seog Kim, Byoung Ju Na, Mi Jin So, Jin Han Lee, Oh Young Chung, Gwi Lae Lee, Yong Ho Roh; J Korean Cancer Assoc. 2000;32(4):690-698.

Abstract PDF: PURPOSE
To evaluate the efficacy and safety of vinorelbine and carboplatin in advanced non- small-cell lung cancer (NSCLC).
MATERIALS AND METHODS
Between August 1998 and July 1999, 25 patients were enrolled. The median age was 68 (range, 46~77) years and male:female ratio was 23:2. Two patients had stage IIIa, 15 had stage IIIb and 8 had stage IV. Sixteen patients had ECOG performance status of 0 or 1 and 9 had 2 or 3. Sixteen patients had squamous cell carcinoma, 8 had adenocarcinoma and 1 had undifferentiated NSCLC. Treatment consists of intravenous carboplatin 400 mg/m2 on day 1 and vinorelbine 25 mg/m2 on days 1 and 8. The treatment was repeated every 28 days.
RESULTS
Twenty-three of 25 patients were evaluable. Partial response were observed in 11 patients. The overall response rate was 48% (95% confidence interval: 27~69%) and the median response duration was 19 (range 7 ~44 ) weeks. The median survival of 25 patients was 52 (range 3~53 ) weeks. Toxicities were evaluated by WHO criteria. During a total of 108 cycles, granulocytopenia worse than WHO grade 3 occurred in 2%, thrombocytopenia in 4% and anemia in 10%, respectively. Treatment-related death occurred in 1 patient due to sepsis during cytopenic period. Non-hematologic toxicity was minor and easily controlled.
CONCLUSION
A combination chemotherapy of intravenous vinorelbine and carboplatin has relatively high activity with acceptable toxicities in patients with advanced NSCLC.

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The Effect of Combination Chemotherapy with Vinorelbine, Carboplatin, and Ifosfamide in Patients with Advanced Non-Small Cell Lung Cancer: Young Woo Lee, Baek Yeol Ryoo, Tae You Kim, Bong Seog Kim, Yeon Hee Park, Hyun Ju Hong, Jin Young Kwag, Sang Won Lee, Yoon Koo Kang; J Korean Cancer Assoc. 1999;31(6):1227-1235.

Abstract PDF: PURPOSE
Despite recent advances in chemotherapy, the treatment outcome of advanced non-small cell lung cancer (NSCLC) remains poor and NSCLC is still the predominant source of cancer-related mortality in worldwide. Thus, we evaluated the efficacy and safety of a combination chemotherapy with vinorelbine, carboplatin, and ifosfamide (NCI) in advanced NSCLC patients.
MATERIALS AND METHODS
A total of 26 patients was enrolled in this study between December 1997 and June 1998. All entered patients were treated with NCI combination chemotherapy (vinorelbine 25 mg/m2/day i.v. days 1 and 8; carboplatin 300 mg/m2/day i.v. day 1; ifosfamide 3 g/m2/day i.v. day I; and mesna 2.4 g/m2/day i.v. day 1 after completion of ifosfamide infusion, treatment repeated every 4 weeks).
RESULTS
Among 26 patients, 23 patients were evaluable. Nine out of 23 evaluable patients had a partial response (response rate 39%; 95% confidence interval 19~59%). The median survival of the total 23 evaluable patients was 7.4 (range; 3~9.3+) months. The median progression-free survival was 2.8 (range; 0~7.7+) months. Among total 70 cycles of chemotherapy, leukopenia of grade II or more was observed in 6%, and tbrombo- cytopenia of grade II or more in 1%. There was no treatment-related death. Main non-hematologic toxicities were nausea/vomiting, stomatitis and peripheral phlebitis, almost of which were tolerable.
CONCLUSION
NCI chemotherapy seemed to be moderately active and well tolerated in patients with advanced NSCLC.

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Effect of FCL (5-FU, carboplatin, leucovorin) Chemotherapy in Advanced Head and Neck Cancer: Samyong Kim, Jee Young Choi, Hyeon Su Kim, Sang Jun Park, Jong Suk Kim, Byung Kook Kim, Deog Yeon Jo; J Korean Cancer Assoc. 1997;29(1):38-45.

Abstract PDF: PURPOSE
The purpose of this study was to evaluate the efficacy and the toxicities of recently developed second generation platinum, carboplatin in combination with 5-fluorouracil and leucovorin in head and neck cancer patients. PATIENTS AND METHODS: Between March 1993 and Apirl 1996, 22 patients with locally advanced/metastatic head and neck cancer were treated with FCL combination chemotherapy. Of these 20 patients were evaluable.
RESULTS
Median age was 58 years. The number of patients with stage III and IV patients was 4 and 18 respectively. Among the 20 evaluable patients, 1 (7.2%) achieved a complete response and 8 (40%) achieved partial responses. The median duration of the response was 24 weeks and the median survival duration was 12 months. Out of 77 chemotherapy cycles, 1 patient (1.3%) had anemia of WHO grade 2, 7 patients (9.1%) experienced leukopenia (WHO grade > or =2) and 7 (9.1%) experienced thrombocytopenia (WHO grade > or =2). Non-hematologic toxicities were mild; nausea and voming of WHO grade > or =2 was 12 (15.6%), stomatitis (WHO grade > or =2) was 6 (7.8%).
CONCLUSION
FCL chemotherapy was effective in locally advanced head and neck cancer. Toxocities were minimal compaired to cisplatin based combination chemotherapy.Further studies on increased dose of FCL chemotherapy in head and neck cancer patients is warranted.

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Neoadjuvant Chemotherapy Combined Carboplatin in High Risk Carvial Cancer: Ho Sun Choi, Ji Soo Byun, Woong Ki Chung; J Korean Cancer Assoc. 1994;26(3):438-445.

Abstract PDF: Objective: Survival of patients with bulky cervical cancer treated with surgery or radiotherapy has been poor. This has led to the another therapeutic modality. Neoadjuvant chemotherapy with cisylatin combination has been employed extensively. Carboplatin is an an- alog of cisplatin with minimal nephrotoxicity and neurotoxicity at conventional dosage. The purpose of this study was to assess the local response and toxicity of carboplatin combination therapy for high risk cervical cancer. Methads: Neoadjuvant chemotherapy with carboplatin, vinblastin, bleomycin combination(20 patients) or cisplatin, vinblastin, bleomycin combination (20 patients)were tried to high risk squamous cell cancer of the uterine cervix. Randomization was well balanced for age, clinical stage and histologic type. Both drugs were given every 21 days with carboplatin 300 mg/m, vinblastin 4 mg/m(2), bleomycin 20 mg and cisplatin 75 mg/m, vinblastin 4 mg/m(2), bleomycin 20 mg. Results: The response rate of carboplatin combination and cisplatin combination were 25% and 30% of patients. The major toxic effects for carboplatin combination and cisplatin combination included nause and vomiting in 70% and 80% of patients, leukopenia in 40% and 60%, thrombocytopenia in 25% and l0%, and anemia in 35% and 40%, respectively. Conclusion: The activity of carboplatin combination for high risk cervical cancer is similar to the activity of cisplatin combination. However, the toxicity of the former is substantially better than that of the latter.

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Combination Chemotherapy with 5-Fluorouracil and Carboplatin for Advanced Head and Neck Cancer: Eun Kyung Cho, Won Sup Lee, Chul Won Jung, Keun Seok Lee, Won Seog Kim, Ki Hyeong Lee, Dae Seog Heo, Yung Jue Bang, Kwang Hyun Kim, Charn II Park, Noe Kyeong Kim; J Korean Cancer Assoc. 1996;28(1):94-104.

Abstract PDF: Twenty-nine patients with previously untreated, locally advanced head and neck cancer were treated with two or three cycles of combination chemotherapy consisting of 5- fluorouracil infusion and carboplatin, followed by surgery and/or curative radiotherapy. Nine patients with recurrent head and neck cancer were treated with the same combination chemotherapy. The results were as follows; 1) Among 28 evaluable patients, response rate was 71.4%(partial response) after neoadjuvant chemotherapy. Following local modality(surgery and/or radiotherapy), response rate was 79%(complete response 51.4%, and partial response 25%). 2) One year survival rate in neoadjuvant group was 83% and one year progression-free survival rate, 68.8%. The progression-free survival of responders was significantly prolonged in comparison with that of non-responders(p<0.05). 3) In palliative treatment group, one partial response(11%) was observed among nine patients. Median time to progression was 6.8 weeks and median survival was 17.7 weeks; there was no significant difference between responders and non-responders. 4) Nausea and vomiting were frequently observed but easily controlled. Hematologic toxicities-leukopenia and thrombocytopenia were observed but were reversible. In conclusion, combination chemotherapy with carboplatin and 5-FU was effective for locally advanced head and neck cancer in neoadjuvant setting, but it had limited benefits for recurrent diseases. Toxicities were tolerable and neurotoxicity, ototoxicity, and nephrotoxicity were not observed.

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