Songji Choi, Seyoung Seo, Ju Hyun Lee, Koung Jin Suh, Ji-Won Kim, Jin Won Kim, Se Hyun Kim, Yu Jung Kim, Keun-Wook Lee, Jwa Hoon Kim, Tae Won Kim, Yong Sang Hong, Sun Young Kim, Jeong Eun Kim, Sang-We Kim, Dae Ho Lee, Jae Cheol Lee, Chang-Min Choi, Shinkyo Yoon, Su-Jin Koh, Young Joo Min, Yongchel Ahn, Hwa Jung Kim, Jin Ho Baek, Sook Ryun Park, Jee Hyun Kim
Cancer Res Treat. 2024;56(2):404-413. Published online November 7, 2023
Purpose The female sex is reported to have a higher risk of adverse events (AEs) from cytotoxic chemotherapy. Few studies examined the sex differences in AEs and their impact on the use of medical services during adjuvant chemotherapy. This sub-study aimed to compare the incidence of any grade and grade ≥ 3 AEs, healthcare utilization, chemotherapy completion rate, and dose intensity according to sex.
Materials and Methods This is a sub-study of a multicenter cohort conducted in Korea that evaluated the impact of healthcare reimbursement on AE evaluation in patients who received adjuvant chemotherapy between September 2013 and December 2016 at four hospitals in Korea.
Results A total of 1,170 patients with colorectal, gastric, or non–small cell lung cancer were included in the study. Female patients were younger, had fewer comorbidities, and experienced less postoperative weight loss of > 10%. Females had significantly higher rates of any grade AEs including nausea, abdominal pain, stomatitis, vomiting, and neutropenia, and experienced more grade ≥ 3 neutropenia, nausea, and vomiting. The dose intensity of chemotherapy was significantly lower in females, and they also experienced more frequent dose reduction after the first cycle. Moreover, female patients receiving platinum-containing regimens had significantly higher rates of unscheduled outpatient visits.
Conclusion Our study found that females experienced a higher incidence of multiple any-grade AEs and severe neutropenia, nausea, and vomiting, across various cancer types, leading to more frequent dose reductions. Physicians should be aware of sex differences in AEs for chemotherapy decisions.
Citations
Citations to this article as recorded by
Cancer care for transgender and gender‐diverse people: Practical, literature‐driven recommendations from the Multinational Association of Supportive Care in Cancer Elizabeth J. Cathcart‐Rake, Alexandre Chan, Alvaro Menendez, Denise Markstrom, Carla Schnitzlein, Yee Won Chong, Don S. Dizon CA: A Cancer Journal for Clinicians.2025; 75(1): 68. CrossRef
Characterisation of the effects of the chemotherapeutic agent paclitaxel on neuropathic pain-related behaviour, anxiodepressive behaviour, cognition, and the endocannabinoid system in male and female rats Chiara Di Marino, Álvaro Llorente-Berzal, Alba M. Diego, Ariadni Bella, Laura Boullon, Esther Berrocoso, Michelle Roche, David P. Finn Frontiers in Pharmacology.2025;[Epub] CrossRef
Toxicidad del esquema FOLFOX-6, asociado o no a bolo de 5-fluorouracilo, en cáncer colorrectal metastásico María Teresa Garrido Martínez, María Rodríguez Jorge, Ignacio García Giménez, María Isabel Guzmán Ramos, Salvador Grutzmancher Sáiz, Victoria Aviñó Tarazona Farmacia Hospitalaria.2024;[Epub] CrossRef
Ki Hyeong Lee, Byoung Chul Cho, Myung-Ju Ahn, Yun-Gyoo Lee, Youngjoo Lee, Jong-Seok Lee, Joo-Hang Kim, Young Joo Min, Gyeong-Won Lee, Sung Sook Lee, Kyung-Hee Lee, Yoon Ho Ko, Byoung Yong Shim, Sang-We Kim, Sang Won Shin, Jin-Hyuk Choi, Dong-Wan Kim, Eun Kyung Cho, Keon Uk Park, Jin-Soo Kim, Sang Hoon Chun, Jangyoung Wang, SeokYoung Choi, Jin Hyoung Kang
Cancer Res Treat. 2024;56(1):48-60. Published online June 27, 2023
Purpose This subgroup analysis of the Korean subset of patients in the phase 3 LASER301 trial evaluated the efficacy and safety of lazertinib versus gefitinib as first-line therapy for epidermal growth factor receptor mutated (EGFRm) non–small cell lung cancer (NSCLC).
Materials and Methods Patients with locally advanced or metastatic EGFRm NSCLC were randomized 1:1 to lazertinib (240 mg/day) or gefitinib (250 mg/day). The primary endpoint was investigator-assessed progression-free survival (PFS).
Results In total, 172 Korean patients were enrolled (lazertinib, n=87; gefitinib, n=85). Baseline characteristics were balanced between the treatment groups. One-third of patients had brain metastases (BM) at baseline. Median PFS was 20.8 months (95% confidence interval [CI], 16.7 to 26.1) for lazertinib and 9.6 months (95% CI, 8.2 to 12.3) for gefitinib (hazard ratio [HR], 0.41; 95% CI, 0.28 to 0.60). This was supported by PFS analysis based on blinded independent central review. Significant PFS benefit with lazertinib was consistently observed across predefined subgroups, including patients with BM (HR, 0.28; 95% CI, 0.15 to 0.53) and those with L858R mutations (HR, 0.36; 95% CI, 0.20 to 0.63). Lazertinib safety data were consistent with its previously reported safety profile. Common adverse events (AEs) in both groups included rash, pruritus, and diarrhoea. Numerically fewer severe AEs and severe treatment–related AEs occurred with lazertinib than gefitinib.
Conclusion Consistent with results for the overall LASER301 population, this analysis showed significant PFS benefit with lazertinib versus gefitinib with comparable safety in Korean patients with untreated EGFRm NSCLC, supporting lazertinib as a new potential treatment option for this patient population.
Citations
Citations to this article as recorded by
First-line treatment of EGFR-mutated non-small cell lung cancer with brain metastases: a systematic review and meta-analysis Jietao Ma, Xiaoxue Pang, Shuling Zhang, Letian Huang, Li Sun, Chengbo Han Scientific Reports.2024;[Epub] CrossRef
Ji-Youn Han, Ki Hyeong Lee, Sang-We Kim, Young Joo Min, Eunkyung Cho, Youngjoo Lee, Soo-Hyun Lee, Hyae Young Kim, Geon Kook Lee, Byung Ho Nam, Hyesun Han, Jina Jung, Jin Soo Lee
Cancer Res Treat. 2017;49(1):10-19. Published online May 3, 2016
Purpose We examined the efficacy of poziotinib, a second-generation epidermal growth factor receptor (EGFR)–tyrosine kinase inhibitor (TKI) in patients with lung adenocarcinoma with activating EGFR mutations, who developed acquired resistance (AR) to EGFR-TKIs.
Materials and Methods This single-arm phase II study included EGFR-mutant lung adenocarcinoma with AR to erlotinib or gefitinib based on the Jackman criteria. Patients received poziotinib 16 mg orally once daily in a 28-day cycle. The primary endpoint was progression-free survival (PFS). Prestudy tumor biopsies and blood samples were obtained to determine resistance mechanisms.
Results Thirty-nine patients were treated. Tumor genotyping was determined in 37 patients; 19 EGFR T790M mutations and two PIK3CAmutations were detected in the prestudy tumors, and seven T790M mutations were detected in the plasma assay. Three (8%; 95% confidence interval [CI], 2 to 21) and 17 (44%; 95% CI, 28 to 60) patients had partial response and stable disease, respectively. The median PFS and overall survival were 2.7 months (95% CI, 1.8 to 3.7) and 15.0 months (95% CI, 9.5 to not estimable), respectively. A longer PFS was observed for patients without T790M or PIK3CA mutations in tumor or plasma compared to those with these mutations (5.5 months vs. 1.8 months, p=0.003). The most frequent grade 3 adverse events were rash (59%), mucosal inflammation (26%), and stomatitis (18%). Most patients required one (n=15) or two (n=15) dose reductions.
Conclusion Low activity of poziotinib was detected in patients with EGFR-mutant non-small cell lung cancer who developed AR to gefitinib or erlotinib, potentially because of severe-toxicityimposed dose limitation.
Citations
Citations to this article as recorded by
Repeat biopsy versus initial biopsy in terms of complication risk factors and clinical outcomes for patients with non-small cell lung cancer: a comparative study of 113 CT-guided needle biopsy of lung lesions Yangyang Wang, Yongyuan Zhang, Nana Ren, Fangting Li, Lin Lu, Xin Zhao, Zhigang Zhou, Mengyu Gao, Meng Wang Frontiers in Oncology.2024;[Epub] CrossRef
EGFR-Tyrosine Kinase Inhibitor Retreatment in Non-Small-Cell Lung Cancer Patients Previously Exposed to EGFR-TKI: A Systematic Review and Meta-Analysis Isabella Michelon, Maysa Vilbert, Caio Ernesto do Rego Castro, Carlos Stecca, Maria Inez Dacoregio, Manglio Rizzo, Vladmir Cláudio Cordeiro de Lima, Ludimila Cavalcante Journal of Personalized Medicine.2024; 14(7): 752. CrossRef
3D bioprinted vascularized lung cancer organoid models with underlying disease capable of more precise drug evaluation Yoo-mi Choi, Haram Lee, Minjun Ann, Minyeong Song, Jinguen Rheey, Jinah Jang Biofabrication.2023; 15(3): 034104. CrossRef
Association of Hypokalemia Incidence and Better Treatment Response in NSCLC Patients: A Meta-Analysis and Systematic Review on Anti-EGFR Targeted Therapy Clinical Trials Jiawei Zhou, Jianling Bai, Yuanping Yue, Xin Chen, Theis Lange, Dongfang You, Yang Zhao Frontiers in Oncology.2022;[Epub] CrossRef
Anlotinib plus chemotherapy for T790M‐negative EGFR‐mutant non‐sqNSCLC resistant to TKIs: A multicenter phase 1b/2 trial Juan Li, Yuke Tian, Min Zheng, Jun Ge, Jiliang Zhang, Dejun Kong, Mei Chen, Ping Yu Thoracic Cancer.2022; 13(24): 3496. CrossRef
Computational Insights into the Potential of Withaferin-A, Withanone and Caffeic Acid Phenethyl Ester for Treatment of Aberrant-EGFR Driven Lung Cancers Vidhi Malik, Vipul Kumar, Sunil C. Kaul, Renu Wadhwa, Durai Sundar Biomolecules.2021; 11(2): 160. CrossRef
Validation of a multicellular tumor microenvironment system for modeling patient tumor biology and drug response Devin G. Roller, Stephen A. Hoang, Kristopher D. Rawls, Katherine A. Owen, Michael B. Simmers, Robert A. Figler, Julia D. Wulfkuhle, Emanuel F. Petricoin, Brian R. Wamhoff, Daniel Gioeli Scientific Reports.2021;[Epub] CrossRef
Geriatric Nutritional Risk Index as a Prognostic Factor for Mortality in Elderly Patients with Moderate to Severe Traumatic Brain Injuries Wei-Ti Su, Ching-Hua Tsai, Chun-Ying Huang, Sheng-En Chou, Chi Li, Shiun-Yuan Hsu, Ching-Hua Hsieh Risk Management and Healthcare Policy.2021; Volume 14: 2465. CrossRef
Geriatric nutritional risk index in screening malnutrition among young adult and elderly trauma patients Yueh-Wei Liu, Ching-Hua Tsai, Sheng-En Chou, Wei-Ti Su, Chi Li, Shiun-Yuan Hsu, Ching-Hua Hsieh Formosan Journal of Surgery.2021; 54(5): 183. CrossRef
In silico studies on p21-activated kinase 4 inhibitors: comprehensive application of 3D-QSAR analysis, molecular docking, molecular dynamics simulations, and MM-GBSA calculation Yinli Gao, Hanxun Wang, Jian Wang, Maosheng Cheng Journal of Biomolecular Structure and Dynamics.2020; 38(14): 4119. CrossRef
Novel drugs targeting EGFR and HER2 exon 20 mutations in metastatic NSCLC Iosune Baraibar, Laura Mezquita, Ignacio Gil-Bazo, David Planchard Critical Reviews in Oncology/Hematology.2020; 148: 102906. CrossRef
Overcoming trastuzumab resistance in HER2‐positive breast cancer using combination therapy Afshin Derakhshani, Zohreh Rezaei, Hossein Safarpour, Morteza Sabri, Atefeh Mir, Mohammad Amin Sanati, Fatemeh Vahidian, Ali Gholamiyan Moghadam, Ali Aghadoukht, Khalil Hajiasgharzadeh, Behzad Baradaran Journal of Cellular Physiology.2020; 235(4): 3142. CrossRef
Toward a More Precise Future for Oncology Yonina R. Murciano-Goroff, Barry S. Taylor, David M. Hyman, Alison M. Schram Cancer Cell.2020; 37(4): 431. CrossRef
Nanocarrier centered therapeutic approaches: Recent developments with insight towards the future in the management of lung cancer Jigar D. Vanza, Rashmin B. Patel, Mrunali R. Patel Journal of Drug Delivery Science and Technology.2020; 60: 102070. CrossRef
Poziotinib Inhibits the Efflux Activity of the ABCB1 and ABCG2 Transporters and the Expression of the ABCG2 Transporter Protein in Multidrug Resistant Colon Cancer Cells Yongchao Zhang, Zhuo-Xun Wu, Yuqi Yang, Jing-Quan Wang, Jun Li, Zoey Sun, Qiu-Xu Teng, Charles R. Ashby, Dong-Hua Yang Cancers.2020; 12(11): 3249. CrossRef
Prolonged Central Nervous System Response in a Patient With HER2 Mutant NSCLC Treated With First-Line Poziotinib Nishan Tchekmedyian, Bill Paxton, Francois Lebel, Lena Keossayan, John V. Heymach JTO Clinical and Research Reports.2020; 1(4): 100081. CrossRef
Geriatric Nutritional Risk Index as a Screening Tool to Identify Patients with Malnutrition at a High Risk of In-Hospital Mortality among Elderly Patients with Femoral Fractures—A Retrospective Study in a Level I Trauma Center Wei-Ti Su, Shao-Chun Wu, Chun-Ying Huang, Sheng-En Chou, Ching-Hua Tsai, Chi Li, Shiun-Yuan Hsu, Ching-Hua Hsieh International Journal of Environmental Research and Public Health.2020; 17(23): 8920. CrossRef
Geriatric Nutritional Risk Index as a Tool to Evaluate Impact of Malnutrition Risk on Mortality in Adult Patients with Polytrauma Cheng-Hsi Yeh, Shao-Chun Wu, Sheng-En Chou, Wei-Ti Su, Ching-Hua Tsai, Chi Li, Shiun-Yuan Hsu, Ching-Hua Hsieh International Journal of Environmental Research and Public Health.2020; 17(24): 9233. CrossRef
Association between Geriatric Nutritional Risk Index and Mortality in Older Trauma Patients in the Intensive Care Unit Hang-Tsung Liu, Shao-Chun Wu, Ching-Hua Tsai, Chi Li, Sheng-En Chou, Wei-Ti Su, Shiun-Yuan Hsu, Ching-Hua Hsieh Nutrients.2020; 12(12): 3861. CrossRef
Safety and Tolerability of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitors in Oncology Rashmi R. Shah, Devron R. Shah Drug Safety.2019; 42(2): 181. CrossRef
Receptor tyrosine kinases in PI3K signaling: The therapeutic targets in cancer Wei Jiang, Meiju Ji Seminars in Cancer Biology.2019; 59: 3. CrossRef
Clinical Impact of Rare and Compound Mutations of Epidermal Growth Factor Receptor in Patients With Non–Small-Cell Lung Cancer Juliane Martin, Annika Lehmann, Frederick Klauschen, Michael Hummel, Dido Lenze, Christian Grohé, Antje Tessmer, Joachim Gottschalk, Berndt Schmidt, Hans-Wilhelm Pau, Christian Witt, Stefan Moegling, Robert Kromminga, Korinna Jöhrens Clinical Lung Cancer.2019; 20(5): 350. CrossRef
Metastasiertes Lungenkarzinom – therapierbare molekulare Alterationen W. M. Brückl, J. H. Ficker Der Pneumologe.2019; 16(6): 343. CrossRef
Successful Treatment of a Miliary Metastatic NSCLC Patient With Activating EGFR Exon 20 Insertion Mutation with Response to Poziotinib Juyin Yang, Jian Yang, Shao Ban, Xinmin Li, Xingde Chen, Jihua Yang, Jun Qian Journal of Thoracic Oncology.2019; 14(9): e198. CrossRef
Targeting Epidermal Growth Factor Receptor in Non-Small-Cell-Lung Cancer: Current State and Future Perspective Shui-Ming Bao, Qing-Hui Hu, Wen-Ting Yang, Yao Wang, Yin-Ping Tong, Wen-Dai Bao Anti-Cancer Agents in Medicinal Chemistry.2019; 19(8): 984. CrossRef
Maximum allele frequency observed in plasma: A potential indicator of liquid biopsy sensitivity Yong Tang, Xianling Liu, Zhu'an Ou, Zhe He, Qihang Zhu, Ye Wang, Mei Yang, Junyi Ye, Han Han‑Zhang, Guibin Qiao Oncology Letters.2019;[Epub] CrossRef
TAS6417/CLN-081 Is a Pan-Mutation–Selective EGFR Tyrosine Kinase Inhibitor with a Broad Spectrum of Preclinical Activity against Clinically Relevant EGFR Mutations Hibiki Udagawa, Shinichi Hasako, Akihiro Ohashi, Rumi Fujioka, Yumi Hakozaki, Mikiko Shibuya, Naomi Abe, Toshiharu Komori, Tomonori Haruma, Miki Terasaka, Ryoto Fujita, Akihiro Hashimoto, Kaoru Funabashi, Hiroyuki Yasuda, Kazutaka Miyadera, Koichi Goto, D Molecular Cancer Research.2019; 17(11): 2233. CrossRef
Preclinical characterization of anlotinib, a highly potent and selective vascular endothelial growth factor receptor‐2 inhibitor Chengying Xie, Xiaozhe Wan, Haitian Quan, Mingyue Zheng, Li Fu, Yun Li, Liguang Lou Cancer Science.2018; 109(4): 1207. CrossRef
Mechanisms and clinical activity of an EGFR and HER2 exon 20–selective kinase inhibitor in non–small cell lung cancer Jacqulyne P. Robichaux, Yasir Y. Elamin, Zhi Tan, Brett W. Carter, Shuxing Zhang, Shengwu Liu, Shuai Li, Ting Chen, Alissa Poteete, Adriana Estrada-Bernal, Anh T. Le, Anna Truini, Monique B. Nilsson, Huiying Sun, Emily Roarty, Sarah B. Goldberg, Julie R. Nature Medicine.2018; 24(5): 638. CrossRef
Clinical Activity of Pan-HER Inhibitors Against HER2-Mutant Lung Adenocarcinoma In-Jae Oh, Jae Young Hur, Cheol-Kyu Park, Young-Chul Kim, Seung Joon Kim, Min Ki Lee, Hee Joung Kim, Kye Young Lee, Jae Cheol Lee, Chang-Min Choi Clinical Lung Cancer.2018; 19(5): e775. CrossRef
Update review of skin adverse events during treatment of lung cancer and colorectal carcinoma with epidermal growth receptor factor inhibitors Yanmei Peng, Qiang Li, Jingyi Zhang, Wen Shen, Xu Zhang, Chenyao Sun, Huijuan Cui BioScience Trends.2018; 12(6): 537. CrossRef
EGFR Exon 20 Insertion Mutations Display Sensitivity to Hsp90 Inhibition in Preclinical Models and Lung Adenocarcinomas Susan E. Jorge, Antonio R. Lucena-Araujo, Hiroyuki Yasuda, Zofia Piotrowska, Geoffrey R. Oxnard, Deepa Rangachari, Mark S. Huberman, Lecia V. Sequist, Susumu S. Kobayashi, Daniel B. Costa Clinical Cancer Research.2018; 24(24): 6548. CrossRef
EGFR T790M ctDNA testing platforms and their role as companion diagnostics: Correlation with clinical outcomes to EGFR-TKIs Zhiyong Liang, Ying Cheng, Yuan Chen, Yanping Hu, Wei-Ping Liu, You Lu, Jie Wang, Ye Wang, Gang Wu, Jian-Ming Ying, He-Long Zhang, Xu-Chao Zhang, Yi-Long Wu Cancer Letters.2017; 403: 186. CrossRef
Comparison of cross-platform technologies for EGFR T790M testing in patients with non-small cell lung cancer Xuefei Li, Caicun Zhou Oncotarget.2017; 8(59): 100801. CrossRef
Seong Hoon Shin, Ho Sup Lee, Yang Soo Kim, Young Jin Choi, Sung Hyun Kim, Hyuk Chan Kwon, Sung Yong Oh, Jung Hun Kang, Chang Hak Sohn, Sang Min Lee, Jin Ho Baek, Young Joo Min, Choongrak Kim, Joo Seop Chung
Cancer Res Treat. 2014;46(4):331-338. Published online July 21, 2014
Purpose To evaluate the efficacy of hydromorphone-OROS (HM-OROS) in reducing sleep disturbance and relieving cancer pain. Materials and Methods One hundred twenty cancer patients with pain (numeric rating scale [NRS] ≥ 4) and sleep disturbance (NRS ≥ 4) were evaluated. The initial HM-OROS dosing was based on previous opioid dose (HM-OROS:oral morphine=1:5). Dose adjustment of the study drug was permitted at the investigator’s discretion. Pain intensity, number of breakthrough pain episodes, and quality of sleep were evaluated. Results A total of 120 patients received at least one dose of HM-OROS; 74 of them completed the final assessment. Compared to the previous opioids, HM-OROS reduced the average pain NRS from 5.3 to 4.1 (p < 0.01), worst pain NRS from 6.7 to 5.4 (p < 0.01), sleep disturbance NRS from 5.9 to 4.1 (p < 0.01), incidence of breakthrough pain at night from 2.63 to 1.53 times (p < 0.001), and immediate-release opioids use for the management of breakthrough pain from 0.83 to 0.39 times per night (p = 0.001). Of the 74 patients who completed the treatment, 83.7% indicated that they preferred HM-OROS to the previous medication. The adverse events (AEs) were somnolence, asthenia, constipation, dizziness, and nausea. Conclusion HM-OROS was efficacious in reducing cancer pain and associated sleep disturbances. The AEs were manageable.
Citations
Citations to this article as recorded by
Pain and Analgesic Related Insomnia Jana Mlíchová, Zoltán Paluch, Ondřej Šimandl Pain Management Nursing.2023; 24(3): 254. CrossRef
Initial titration with 200 μg fentanyl buccal tablets: a retrospective safety analysis in Korean cancer patients Mi-Young Kwon, Ha-Na Cho, Dong-Hoe Koo, Yun-Gyoo Lee, Sukjoong Oh, Seung-Sei Lee The Korean Journal of Internal Medicine.2018; 33(3): 577. CrossRef
Endogenous Opiates and Behavior: 2015 Richard J. Bodnar Peptides.2017; 88: 126. CrossRef
Drug Formulation Advances in Extended-Release Medications for Pain Control Mark R. Jones, Martin J. Carney, Rachel J. Kaye, Amit Prabhakar, Alan D. Kaye Current Pain and Headache Reports.2016;[Epub] CrossRef
The Clinical Applications of Extended-Release Abuse-Deterrent Opioids Nalini Vadivelu, Erika Schermer, Gopal Kodumudi, Jack M. Berger CNS Drugs.2016; 30(7): 637. CrossRef
Once-Daily OROS Hydromorphone for Management of Cancer Pain: an Open-Label, Multi-Center, Non-Interventional Study Cheol Kyu Park, Hyun-Wook Kang, In-Jae Oh, Young-Chul Kim, Yeo-Kyeoung Kim, Kook-Joo Na, Sung-Ja Ahn, Tae Ok Kim, Young Jin Choi, Geun Am Song, Min Ki Lee Journal of Korean Medical Science.2016; 31(12): 1914. CrossRef
PURPOSE This study was conducted to determine the efficacy and safety of DA-3030 (a recombinant methionyl human granulocyte colony-stimulating factor, rhG-CSF), after remission induction chemotherapy, in patients with acute myelogenous leukemia (AML). MATERIALS AND METHODS: After the remission induction chemotherapy, with idarubicin (12 mg/m2/day for 3 days) and cytarabine (200 mg/m2/day for 7 days), 26 patients with newly diagnosed AML were assigned to receive DA-3030 (200mug/m2/day), starting 24 hours after the completion of the remission induction chemotherapy, until their neutrophil count recovered to greater than 1, 000/muL for 3 consecutive days. RESULTS: The median time from the initiation of the chemotherapy to the neutrophil recovery of 1, 000/muL was 21 days (range, 12~41). Treatment with DA-3030 was not associated with significant adverse side effects. The most frequently reported side effects were musculo-skeletal pain (13%) and headache (13%). CONCLUSION: The DA-3030 is a safe rhG-CSF for the treatment of neutropenia after remission induction chemotherapy in patients with AML.
Se Haeng Cho, Sang Hee Kim, Young Joo Min, Sung Joon Choi, Jung Kyun Kim, Tae Won Kim, Jong Soo Choi, Dai Young Zang, Je Hwan Lee, Sung Bae Kim, Cheol Won Suh, Kyoo Hyung Lee, Jung Shin Lee, Woo Kun Kim, Se Hyun Ahn, Jung Mi Park, Sang We Kim
PURPOSE Positive correlation between dosage of antineoplastic agents and tumor response is well demonstrated in advanced breast cancer. But severe bone marrow depression limit the clinical application of high dose chemotherapy. Autologous peripheral blood stem cell transplantation(PBSCT) after high dose chemotherapy(HDC) was introduced to promote rapid bone marrow recovery. This study was designed to establish the feasibility of combining high dose cyclophosphamide, thiotepa, and carboplatin chemotherapy followed by stem cell rescue in patients with responsive metastatic or high risk primary breast cancer. MATERIALS AND METHOD Eligibility criteria included the presence of high risk primary breast cancer(10 or more involved axillary lymph node, n=4), recurrent disease after curative resection(n=6) or stage IV disease at the time of diagnosis(n=1). The responses of recurrent disease to initial chemotherapy were 4 complete responses and 1 partial responses. One recurrent case with solitary pulmonary metastasis underwent metastasectomy and got chemotherapy after operation. Colony stimulating factor was administered to mobilize stem cells from bone marrow to peripheral blood.
The stem cell collection was performed 4~10 times(median 4) and the number of collected stem cell was 1.95~7.34x10(8)kg(median 4.87x10(8)/kg). High dose chemotherapy with CTCb (cyclophosphamide 1,500 mg/m2/day, thiotepa 125 mg/m2/day, carboplatin 200 mg/m2/ day) was performed from day -7 to day -4 and peripheral stem cell infusion was performed on day 0 as planned. RESULT Eleven patients were enrolled in this study. Their median age was 39 years old. The median time for bone marrow recovery was 11 days for neutrophil(>500/mm2) and 28 days for platelet(>50,000/mm2). Packed red blood cell and platelet transfusion were performed in 11 patients. The group whose infused mononuclear cell count was less than 4.0 x 10(8)/kg(n=9) needed longer time for bone marrow recovery than those(n=2) who had more than 4.0 x 10(8)/kg( 20 vs 13 day, p < 0.05 ). For non-hematologic toxicity, none have experienced toxicity more than grade III. There were 2 recurrences of 4 cases with high risk breast cancer at the 22 th, and 25 th month but they are still alive at the 28 th, and 29 th month each. The other 2 cases are alive without recurrences at the 18 th, and 20 th months each. In the recurrent disease group, one case who showed partial response to initial chemotherapy recurred at the 4 th month and died at the 13 th month after PBSCT. The other 5 cases are alive without recurrence at the 1st, 3 rd, 3 rd, 5 th, and 31 th month each. One case with stage IV disease(bone metastasis) is alive without evidence of progression at the 3 rd month. CONCLUSION High dose chemotherapy with PBSCT can be performed safely. Long term survival of patients with advanced breast cancer would be possible by PBSCT after HDC.
Further clinical trials based on larger patient population is required to evaluate clinical efficacy of PBSCT after HDC in high risk and recurrent breast cancer.