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Original Article
Psychometric Validation of Sheffield Profile for Assessment and Referral to Care (SPARC) in Korean Cancer Patients
Hong Jun Kim, Eun Hee Jung, Jung Hye Kwon, Yu Jung Kim, Su-Jin Koh, Myung Ah Lee, Jung Hun Kang, Sun Young Rha, Eun Mi Nam, Sun Kyung Baek, Ha Yeon Lee, Hun Ho Song, Young-Woong Won, Hanbyul Lee
Received July 26, 2024  Accepted December 4, 2024  Published online December 5, 2024  
DOI: https://doi.org/10.4143/crt.2024.706    [Accepted]
AbstractAbstract PDF
Purpose
Identifying the palliative care needs of patients with advanced cancer is important for maintaining quality of life and timely transition to palliative care. We aimed to validate the Korean Sheffield Profile for Assessment and Referral for Care (K-SPARC) in such patients and establish its psychometric properties, including reliability, validity, and responsiveness to change.
Materials and Methods
We used the forward-back translated version of SPARC, which was verified through a pilot study, to assess the palliative care needs of patients with advanced cancer. Reliability was evaluated by internal consistency using Cronbach's alpha coefficients and test-retest reliability. Criterion validity was analyzed against other questionnaires, including the Korean versions of the Functional Assessment of Cancer Therapy-General (FACT-G Korean) and Korean versions of the Edmonton Symptom Assessment System (K-ESAS). Factor analysis was used to assess construct validity.
Results
Two hundred fifty-nine patients were included from 2019 to 2022. Forty-nine percent of all patients were women, and the median age was 63 years. Cronbach’s alpha coefficient (range, 0.642–0.903) and test-retest reliability (range, 0.574–0.749) indicated acceptable reliability. The correlation coefficients between K-SPARC and FACT-G Korean suggested significant criterion validity. The correlation coefficients for the physical, social, emotional, and functional domains were 0.701, 0.249, 0.718, and 0.511, respectively (p-value <0.001, all). Factor analysis demonstrated satisfactory construct validity of the tool.
Conclusion
This study demonstrated the utility of K-SPARC as an evaluation tool for providing palliative care to patients with advanced cancer through psychometric validation; the tool had good internal consistency, reliability, and acceptable validity.
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Special Articles
The Situation of Life-Sustaining Treatment One Year after Enforcement of the Act on Decisions on Life-Sustaining Treatment for Patients at the End-of-Life in Korea: Data of National Agency for Management of Life-Sustaining Treatment
Ha Yeon Lee, Hwa Jung Kim, Jung Hye Kwon, Sun Kyung Baek, Young-Woong Won, Yu Jung Kim, Su Jin Baik, Hyewon Ryu
Cancer Res Treat. 2021;53(4):897-907.   Published online June 2, 2021
DOI: https://doi.org/10.4143/crt.2021.327
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
The “Act on Hospice and Palliative Care and Decisions on Life-Sustaining Treatment for Patients at the End-of-Life” was enacted on February 3, 2016 and went into effect on February 4, 2018 in Korea. This study reviewed the first year of determination to life-sustaining treatment (LST) through data analysis of the National Agency for Management of Life-Sustaining Treatment.
Materials and Methods
The National Agency for Management of LST provided data between February 4, 2018 and January 31, 2019 anonymously from 33,549 patients. According to the forms patients were defined as either elf-determinants or family-determinants.
Results
The median age of the patient was 73 and the majority was male (59.9%). Cancer patients were 59% and self-determinants were 32.1%. Cancer patients had a higher rate of self-determinants than non-cancer (47.3% vs. 10.1%). Plan for hospice service was high in cancer patients among self-determinants (81.0% vs. 37.5%, p < 0.001). In comparison to family-determinants, self-determinants were younger (median age, 67 years vs. 75 years; p < 0.001) and had more cancer diagnosis (87.1% vs. 45.9%, p < 0.001). Decision of withholding or withdrawing of LSTs in cancer patients was higher than non-cancer patients in four items.
Conclusion
Cancer patients had a higher rate in self-determination and withholding or withdrawing of LSTs than non-cancer patients. Continued revision of the law and education of the public will be able to promote withdrawing or withholding the futile LSTs in patients at end-of-life. Further study following the revision of the law should be evaluated to change of end-of-life care.

Citations

Citations to this article as recorded by  
  • Factors Affecting Life-Sustaining Treatment Decisions and Changes in Clinical Practice after Enforcement of the Life-Sustaining Treatment (LST) Decision Act: A Tertiary Hospital Experience in Korea
    Yoon Jung Jang, Yun Jung Yang, Hoi Jung Koo, Hye Won Yoon, Seongbeom Uhm, Sun Young Kim, Jeong Eun Kim, Jin Won Huh, Tae Won Kim, Seyoung Seo
    Cancer Research and Treatment.2025; 57(1): 280.     CrossRef
  • Issues and implications of the life-sustaining treatment decision act: comparing the data from the survey and clinical data of inpatients at the end-of-life process
    Eunjeong Song, Dongsoon Shin, Jooseon Lee, Seonyoung Yun, Minjeong Eom, Suhee Oh, Heejung Lee, Jiwan Lee, Rhayun Song
    BMC Medical Ethics.2024;[Epub]     CrossRef
  • Recent Trends in the Withdrawal of Life-Sustaining Treatment in Patients with Acute Cerebrovascular Disease : 2017–2021
    Seung Hwan Kim, Ji Hwan Jang, Young Zoon Kim, Kyu Hong Kim, Taek Min Nam
    Journal of Korean Neurosurgical Society.2024; 67(1): 73.     CrossRef
  • Healthcare Utilization and Supportive Care Timing in South Korean People Living With Amyotrophic Lateral Sclerosis: A Single-Center Retrospective Study
    Min Seol Jang, Shin Hye Yoo, Min Sun Kim, Belong Cho, Kyae Hyung Kim, Jeongmi Shin, Inyoung Hwang, Seok-Jin Choi, Jung-Joon Sung, Sun Young Lee
    Journal of Clinical Neurology.2024; 20(2): 166.     CrossRef
  • Differences in end-of-life care patterns between types of hospice used for cancer patients: a retrospective cohort study
    Il Yun, Eun-Cheol Park, Chung Mo Nam, Jaeyong Shin, Suk-Yong Jang, Sung-In Jang
    BMC Palliative Care.2024;[Epub]     CrossRef
  • Validation of the Korean Version of the Clinical Frailty Scale-Adjusted Korean Triage and Acuity Scale for Older Patients in the Emergency Department
    Ho Sub Chung, Yunhyung Choi, Ji Yeon Lim, Keon Kim, Sung Jin Bae, Yoon Hee Choi, Dong Hoon Lee
    Medicina.2024; 60(6): 955.     CrossRef
  • Beyond Legal Boundaries: Public and Clinician Perspectives on Treatment Withdrawal in Infants With Poor Neurological Prognosis
    In Gyu Song, Jung Lee, Min Sun Kim, Ji Weon Lee, So Yeon Jeon, Shin Hye Yoo, Hye Yoon Park
    Journal of Korean Medical Science.2024;[Epub]     CrossRef
  • Preferred versus Actual Place of Care and Factors Associated with Home Discharge among Korean Patients with Advanced Cancer: A Retrospective Cohort Study
    In Young Hwang, Yohan Han, Min Sun Kim, Kyae Hyung Kim, Belong Cho, Wonho Choi, Yejin Kim, Shin Hye Yoo, Sun Young Lee
    Healthcare.2023; 11(13): 1939.     CrossRef
  • Comparison of the end-of-life decisions of patients with hospital-acquired pneumonia after the enforcement of the life-sustaining treatment decision act in Korea
    Ae-Rin Baek, Sang-Bum Hong, Soohyun Bae, Hye Kyeong Park, Changhwan Kim, Hyun-Kyung Lee, Woo Hyun Cho, Jin Hyoung Kim, Youjin Chang, Heung Bum Lee, Hyun-Il Gil, Beomsu Shin, Kwang Ha Yoo, Jae Young Moon, Jee Youn Oh, Kyung Hoon Min, Kyeongman Jeon, Moon S
    BMC Medical Ethics.2023;[Epub]     CrossRef
  • Problems Related to the Act on Decisions on Life-Sustaining Treatment and Directions for Improvement
    Dae Seog Heo, Shin Hye Yoo, Bhumsuk Keam, Sang Ho Yoo, Younsuck Koh
    The Korean Journal of Hospice and Palliative Care.2022; 25(1): 1.     CrossRef
  • Hospice-Palliative Medicine as a Model of Value-Based Healthcare
    Dae Seog Heo, Shin Hye Yoo, Bhumsuk Keam, Keunjoo Yoo, Insun Choi, Min-Jeong Kim
    Journal of Korean Medical Science.2022;[Epub]     CrossRef
  • Will implementation of the Life-sustaining Treatment Decisions Act reduce the incidence of cardiopulmonary resuscitation?
    In-Ae Song
    Acute and Critical Care.2022; 37(2): 256.     CrossRef
  • Aggressiveness of care in the last days of life in the emergency department of a tertiary hospital in Korea
    Jung Sun Kim, Sun Young Lee, Min Sung Lee, Shin Hye Yoo, Jeongmi Shin, Wonho Choi, Yejin Kim, Hyung Sook Han, Jinui Hong, Bhumsuk Keam, Dae Seog Heo
    BMC Palliative Care.2022;[Epub]     CrossRef
  • Hospice Care Preferences and Its Associated Factors among Community-Dwelling Residents in China
    Huijing Lin, Eunjeong Ko, Bei Wu, Ping Ni
    International Journal of Environmental Research and Public Health.2022; 19(15): 9197.     CrossRef
  • Impact of COVID-19 on the End-of-Life Care of Cancer Patients Who Died in a Korean Tertiary Hospital: A Retrospective Study
    Jeongmi Shin, Yejin Kim, Shin Hye Yoo, Jin-Ah Sim, Bhumsuk Keam
    The Korean Journal of Hospice and Palliative Care.2022; 25(4): 150.     CrossRef
  • The Law Changes Behaviors: Is It Just Enough?
    Dae Ho Lee
    Cancer Research and Treatment.2021; 53(4): 895.     CrossRef
  • 8,054 View
  • 211 Download
  • 15 Web of Science
  • 16 Crossref
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Preparation and Practice of the Necessary Documents in Hospital for the “Act on Decision of Life-Sustaining Treatment for Patients at the End-of-Life”
Sun Kyung Baek, Hwa Jung Kim, Jung Hye Kwon, Ha Yeon Lee, Young-Woong Won, Yu Jung Kim, Sujin Baik, Hyewon Ryu
Cancer Res Treat. 2021;53(4):926-934.   Published online June 2, 2021
DOI: https://doi.org/10.4143/crt.2021.326
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Six forms relating to decisions on life-sustaining treatment (LST) for patients at the end-of-life (EOL) in hospital are required by the “Act on Decision of LST for Patients at the EOL.” We investigated the preparation and creation status of these documents from the database of the National Agency for Management of LST.
Materials and Methods
We analyzed the contents and details of each document necessary for decisions on LST, and the creation status of forms. We defined patients completing form 1 as “self-determined” of LST, and those whose family members had completed form 11/12 as “family decision” of LST. According to the determination subject, we compared the four items of LST on form 13 (the paper of implementation of LST) and the documentation time interval between forms.
Results
The six forms require information about the patient, doctor, specialized doctor, family members, institution, decision for LST, and intention to use hospice services. Of 44,381 who had completed at least one document, 36,693 patients had form 13. Among them, 11,531, 10,976, and 12,551 people completed forms 1, 11, and 12, respectively. The documentation time interval from forms 1, 11, or 12 to form 13 was 8.6±13.6 days, 1.0±9.5 days, and 1.5±9.7 days, respectively.
Conclusion
The self-determination rate of LST was 31% and the mean time interval from self-determination to implementation of LST was 8.6 days. The creation of these forms still takes place when the patients are close to death.

Citations

Citations to this article as recorded by  
  • Advance Care Planning in South Korea
    Yu Jung Kim, Sun-Hyun Kim
    Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen.2023; 180: 68.     CrossRef
  • Use of antimicrobial agents in actively dying inpatients after suspension of life-sustaining treatments: Suggestion for antimicrobial stewardship
    Dayeong Kim, Subin Kim, Kyoung Hwa Lee, Sang Hoon Han
    Journal of Microbiology, Immunology and Infection.2022; 55(4): 651.     CrossRef
  • The Law Changes Behaviors: Is It Just Enough?
    Dae Ho Lee
    Cancer Research and Treatment.2021; 53(4): 895.     CrossRef
  • 5,786 View
  • 133 Download
  • 3 Web of Science
  • 3 Crossref
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Life-Sustaining Treatment States in Korean Cancer Patients after Enforcement of Act on Decisions on Life-Sustaining Treatment for Patients at the End of Life
Young-Woong Won, Hwa Jung Kim, Jung Hye Kwon, Ha Yeon Lee, Sun Kyung Baek, Yu Jung Kim, Do Yeun Kim, Hyewon Ryu
Cancer Res Treat. 2021;53(4):908-916.   Published online June 2, 2021
DOI: https://doi.org/10.4143/crt.2021.325
AbstractAbstract PDFPubReaderePub
Purpose
In Korea, the “Act on Hospice and Palliative Care and Decisions on Life-sustaining Treatment for Patients at the End of Life” was enacted on February 4, 2018. This study was conducted to analyze the current state of life-sustaining treatment decisions based on National Health Insurance Service (NHIS) data after the law came into force.
Materials and Methods
The data of 173,028 cancer deaths were extracted from NHIS qualification data between November 2015 and January 2019.
Results
The number of cancer deaths complied with the law process was 14,438 of 54,635 cases (26.4%). The rate of patient self-determination was 49.0%. The patients complying with the law process have used a hospice center more frequently (28% vs. 14%). However, the rate of intensive care unit (ICU) admission was similar between the patients who complied with and without the law process (ICU admission, 23% vs. 21%). There was no difference in the proportion of patients who had undergone mechanical ventilation and hemodialysis in the comparative analysis before and after the enforcement of the law and the analysis according to the compliance with the law. The patients who complied with the law process received cardiopulmonary resuscitation at a lower rate.
Conclusion
The law has positive effects on the rate of life-sustaining treatment decision by patient’s determination. However, there was no sufficient effect on the withholding or withdrawing of life-sustaining treatment, which could protect the patient from unnecessary or harmful interventions.

Citations

Citations to this article as recorded by  
  • Factors Affecting Life-Sustaining Treatment Decisions and Changes in Clinical Practice after Enforcement of the Life-Sustaining Treatment (LST) Decision Act: A Tertiary Hospital Experience in Korea
    Yoon Jung Jang, Yun Jung Yang, Hoi Jung Koo, Hye Won Yoon, Seongbeom Uhm, Sun Young Kim, Jeong Eun Kim, Jin Won Huh, Tae Won Kim, Seyoung Seo
    Cancer Research and Treatment.2025; 57(1): 280.     CrossRef
  • Characteristics and outcomes of patients with do-not-resuscitate and physician orders for life-sustaining treatment in a medical intensive care unit: a retrospective cohort study
    Song-I Lee, Ye-Rin Ju, Da Hyun Kang, Jeong Eun Lee
    BMC Palliative Care.2024;[Epub]     CrossRef
  • Characteristics of Life-Sustaining Treatment Decisions: National Data Analysis in South Korea
    Jiyeon Choi, Heejung Jeon, Ilhak Lee
    Asian Bioethics Review.2024; 16(1): 33.     CrossRef
  • Recent Trends in the Withdrawal of Life-Sustaining Treatment in Patients with Acute Cerebrovascular Disease : 2017–2021
    Seung Hwan Kim, Ji Hwan Jang, Young Zoon Kim, Kyu Hong Kim, Taek Min Nam
    Journal of Korean Neurosurgical Society.2024; 67(1): 73.     CrossRef
  • The Impact of Withdrawing or Withholding of Life-Sustaining Treatment: A Nationwide Case-Control Study Based on Medical Cost Analysis
    Claire Junga Kim, Do-Kyong Kim, Sookyeong Mun, Minkook Son
    Journal of Korean Medical Science.2024;[Epub]     CrossRef
  • For the Universal Right to Access Quality End-of-Life Care in Korea: Broadening Our Perspective After the 2018 Life-Sustaining Treatment Decisions Act
    Hye Yoon Park, Min Sun Kim, Shin Hye Yoo, Jung Lee, In Gyu Song, So Yeon Jeon, Eun Kyung Choi
    Journal of Korean Medical Science.2024;[Epub]     CrossRef
  • Differences in end-of-life care patterns between types of hospice used for cancer patients: a retrospective cohort study
    Il Yun, Eun-Cheol Park, Chung Mo Nam, Jaeyong Shin, Suk-Yong Jang, Sung-In Jang
    BMC Palliative Care.2024;[Epub]     CrossRef
  • Epidemiology of patients who died in the emergency departments and need of end-of-life care in Korea from 2016 to 2019
    Sun Young Lee, Young Sun Ro, Sang Do Shin, Eunsil Ko, Seong Jung Kim
    Scientific Reports.2023;[Epub]     CrossRef
  • Use of high‐flow nasal cannula oxygen therapy for patients with terminal cancer at the end of life
    Jung Sun Kim, Jeongmi Shin, Nam Hee Kim, Sun Young Lee, Shin Hye Yoo, Bhumsuk Keam, Dae Seog Heo
    Cancer Medicine.2023; 12(13): 14612.     CrossRef
  • Preferred versus Actual Place of Care and Factors Associated with Home Discharge among Korean Patients with Advanced Cancer: A Retrospective Cohort Study
    In Young Hwang, Yohan Han, Min Sun Kim, Kyae Hyung Kim, Belong Cho, Wonho Choi, Yejin Kim, Shin Hye Yoo, Sun Young Lee
    Healthcare.2023; 11(13): 1939.     CrossRef
  • Healthcare resource utilization and medical costs in patients with terminal cancer during best supportive care
    Dong-Won Kang, Yoon-Bo Shim, Eui-Kyung Lee, Mi-Hai Park, Wen-Chi Chou
    PLOS ONE.2022; 17(6): e0269565.     CrossRef
  • Aggressiveness of care in the last days of life in the emergency department of a tertiary hospital in Korea
    Jung Sun Kim, Sun Young Lee, Min Sung Lee, Shin Hye Yoo, Jeongmi Shin, Wonho Choi, Yejin Kim, Hyung Sook Han, Jinui Hong, Bhumsuk Keam, Dae Seog Heo
    BMC Palliative Care.2022;[Epub]     CrossRef
  • Effect of life-sustaining treatment decision law on pediatric in-hospital cardiopulmonary resuscitation rate: A Korean population-based study
    Jaeyoung Choi, Ah Young Choi, Esther Park, Meong Hi Son, Joongbum Cho
    Resuscitation.2022; 180: 38.     CrossRef
  • Association of perceived life satisfaction with attitudes toward life-sustaining treatment among the elderly in South Korea: a cross-sectional study
    Il Yun, Hyunkyu Kim, Eun-Cheol Park, Suk-Yong Jang
    BMC Palliative Care.2022;[Epub]     CrossRef
  • Willingness of patients with cancer pain to participate in end-of-life decisions: a multi-center cross-sectional study from three coastal provinces in southern China
    Xi Ke, Hongyu Zhu, Yu Zhang, Ling Yang, Simei Shi, Fang Zhu, Huiyu Luo
    BMC Palliative Care.2022;[Epub]     CrossRef
  • The Law Changes Behaviors: Is It Just Enough?
    Dae Ho Lee
    Cancer Research and Treatment.2021; 53(4): 895.     CrossRef
  • 6,119 View
  • 155 Download
  • 16 Web of Science
  • 16 Crossref
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Current Status and Cardinal Features of Patient Autonomy after Enactment of the Life-Sustaining Treatment Decisions Act in Korea
Hwa Jung Kim, Yu Jung Kim, Jung Hye Kwon, Young-Woong Won, Ha Yeon Lee, Sun Kyung Baek, Hyewon Ryu, Do Yeun Kim
Cancer Res Treat. 2021;53(4):917-925.   Published online June 2, 2021
DOI: https://doi.org/10.4143/crt.2021.324
AbstractAbstract PDFPubReaderePub
Purpose
The main purpose of the Life-Sustaining Treatment Decisions Act recently enacted in Korea is to respect the patient’s self-determination. We aimed to investigate the current status and features of patient self-determination after implementation of the law.
Materials and Methods
Between February 2018 and January 2019, 54,635 cancer deaths were identified from the National Health Insurance Service (NHIS) database. We analyzed the characteristics of decedents who complied with the law process by self-determination compared with decedents with family determination and with decedents who did not comply with the law process.
Results
In multivariable analysis, patients with self-determination were younger, were less likely to live in rural areas, were less likely to belong to the highest income quintile, were less likely to be treated in general hospitals, and were more likely to show a longer time from cancer diagnosis compared with patients with family determination. Compared with patients who did not comply with the law process, patients with self-determination were younger, lived in Seoul or capital area, were less likely to belong to the highest income quintile, were treated in general hospitals, were less likely to have genitourinary or hematologic malignancies, scored higher on the Charlson comorbidity index, and showed a longer time from cancer diagnosis. Patients with self-determination were more likely to use hospice and less likely to use intensive care units (ICUs) at the end-of-life (EOL).
Conclusion
Decedents with self-determination were more likely to be younger, reside in the Seoul or capital area, show a longer time from cancer diagnosis, and were less likely to belong to the highest income quintile. They utilized hospice more frequently, and received less ICU care at the EOL.

Citations

Citations to this article as recorded by  
  • The effects of hospice care on healthcare expenditure among cancer patients
    Hoyol Jhang, Wonjeong Jeong, Hyun-Soo Zhang, Dong-Woo Choi, Hyejung Kang, Sohee Park
    BMC Health Services Research.2023;[Epub]     CrossRef
  • Problems Related to the Act on Decisions on Life-Sustaining Treatment and Directions for Improvement
    Dae Seog Heo, Shin Hye Yoo, Bhumsuk Keam, Sang Ho Yoo, Younsuck Koh
    The Korean Journal of Hospice and Palliative Care.2022; 25(1): 1.     CrossRef
  • Aggressiveness of care in the last days of life in the emergency department of a tertiary hospital in Korea
    Jung Sun Kim, Sun Young Lee, Min Sung Lee, Shin Hye Yoo, Jeongmi Shin, Wonho Choi, Yejin Kim, Hyung Sook Han, Jinui Hong, Bhumsuk Keam, Dae Seog Heo
    BMC Palliative Care.2022;[Epub]     CrossRef
  • Use of antimicrobial agents in actively dying inpatients after suspension of life-sustaining treatments: Suggestion for antimicrobial stewardship
    Dayeong Kim, Subin Kim, Kyoung Hwa Lee, Sang Hoon Han
    Journal of Microbiology, Immunology and Infection.2022; 55(4): 651.     CrossRef
  • Association of perceived life satisfaction with attitudes toward life-sustaining treatment among the elderly in South Korea: a cross-sectional study
    Il Yun, Hyunkyu Kim, Eun-Cheol Park, Suk-Yong Jang
    BMC Palliative Care.2022;[Epub]     CrossRef
  • The Law Changes Behaviors: Is It Just Enough?
    Dae Ho Lee
    Cancer Research and Treatment.2021; 53(4): 895.     CrossRef
  • 6,258 View
  • 134 Download
  • 4 Web of Science
  • 6 Crossref
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Original Article
A Randomized, Open-Label, Phase II Study Comparing Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed versus Pemetrexed Alone in Patients with Epidermal Growth Factor Receptor (EGFR)-Mutant Non-small Cell Lung Cancer after Failure of First-Line EGFR Tyrosine Kinase Inhibitor: KCSG-LU12-13
Kwai Han Yoo, Su Jin Lee, Jinhyun Cho, Ki Hyeong Lee, Keon Uk Park, Ki Hwan Kim, Eun Kyung Cho, Yoon Hee Choi, Hye Ryun Kim, Hoon-Gu Kim, Heui June Ahn, Ha Yeon Lee, Hwan Jung Yun, Jin-Hyoung Kang, Jaeheon Jeong, Moon Young Choi, Sin-Ho Jung, Jong-Mu Sun, Se-Hoon Lee, Jin Seok Ahn, Keunchil Park, Myung-Ju Ahn
Cancer Res Treat. 2019;51(2):718-726.   Published online September 3, 2018
DOI: https://doi.org/10.4143/crt.2018.324
AbstractAbstract PDFPubReaderePub
Purpose
The optimal cytotoxic regimens have not been established for patients with non-small cell lung cancer (NSCLC) who develop disease progression on first-line epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI).
Materials and Methods
We conducted a multi-center randomized phase II trial to compare the clinical outcomes between pemetrexed plus cisplatin combination therapy followed by maintenance pemetrexed (PC) and pemetrexed monotherapy (P) after failure of first-line EGFR-TKI. The primary objective was progression-free survival (PFS), and secondary objectives included overall response rate (ORR), overall survival (OS), health-related quality of life (HRQOL), and safety and toxicity profiles.
Results
A total of 96 patientswere randomized, and 91 patientswere treated at 14 centers in Korea. The ORR was 34.8% (16/46) for the PC arm and 17.8% (8/45) for the P arm (p=0.066). With 23.4 months of follow-up, the median PFS was 5.4 months in the PC arm and 6.4 months in the P arm (p=0.114). The median OS was 17.9 months and 15.7 months in PC and P arms, respectively (p=0.787). Adverse events ≥ grade 3 were reported in 12 patients (26.1%) in the PC arm and nine patients (20.0%) in the P arm (p=0.491). The overall time trends of HRQOL were not significantly different between the two arms.
Conclusion
The outcomes of pemetrexed therapy in NSCLC patients with disease progression after firstline EGFR-TKI might not be improved by adding cisplatin.

Citations

Citations to this article as recorded by  
  • The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
    Bum Jun Kim, Chi Hoon Maeng, Bhumsuk Keam, Young-Hyuck Im, Jungsil Ro, Kyung Hae Jung, Seock-Ah Im, Tae Won Kim, Jae Lyun Lee, Dae Seog Heo, Sang-We Kim, Keunchil Park, Myung-Ju Ahn, Byoung Chul Cho, Hoon-Kyo Kim, Yoon-Koo Kang, Jae Yong Cho, Hwan Jung Yu
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    Frontiers in Oncology.2023;[Epub]     CrossRef
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    Oncology Letters.2022;[Epub]     CrossRef
  • Haematological toxicity of pemetrexed in patients with metastatic non-squamous non-small cell carcinoma of lung with third-space fluid
    Wang Chun Kwok, Tan Fong Cheong, Ka Yan Chiang, James Chung Man Ho, David Chi Leung Lam, Mary Sau Man Ip, Terence Chi Chun Tam
    Lung Cancer.2021; 152: 15.     CrossRef
  • Exploring the role of epidermal growth factor receptor variant III in meningeal tumors
    Rashmi Rana, Vaishnavi Rathi, Kirti Chauhan, Kriti Jain, Satnam Singh Chhabra, Rajesh Acharya, Samir Kumar Kalra, Anshul Gupta, Sunila Jain, Nirmal Kumar Ganguly, Dharmendra Kumar Yadav, Timir Tripathi
    PLOS ONE.2021; 16(9): e0255133.     CrossRef
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    Wang Chun Kwok, Ka Yan Chiang, James Chung Man Ho, David Chi Leung Lam, Mary Sau Man Ip, Terence Chi Chun Tam
    Lung Cancer.2021; 162: 169.     CrossRef
  • Impact of Value Frameworks on the Magnitude of Clinical Benefit: Evaluating a Decade of Randomized Trials for Systemic Therapy in Solid Malignancies
    Ellen Cusano, Chelsea Wong, Eddy Taguedong, Marcus Vaska, Tasnima Abedin, Nancy Nixon, Safiya Karim, Patricia Tang, Daniel Y. C. Heng, Doreen Ezeife
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    Wang Chun Kwok, David Chi Leung Lam, Ka Yan Chiang, James Chung Man Ho, Mary Sau Man Ip, Terence Chi Chun Tam
    Journal of Chemotherapy.2020; 32(8): 429.     CrossRef
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