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Palliative Medicine
Safety, Efficacy, and Patient Satisfaction with Initial Peripherally Inserted Central Catheters Compared with Usual Intravenous Access in Terminally Ill Cancer Patients: A Randomized Phase II Study
Eun Ju Park, Kwonoh Park, Jae-Joon Kim, Sang-Bo Oh, Ki Sun Jung, So Yeon Oh, Yun Jeong Hong, Jin Hyeok Kim, Joo Yeon Jang, Ung-Bae Jeon
Cancer Res Treat. 2021;53(3):881-888.   Published online December 22, 2020
DOI: https://doi.org/10.4143/crt.2020.1008
AbstractAbstract PDFPubReaderePub
Purpose
The purpose of this study was to investigate whether routine insertion of peripherally inserted central catheter (PICC) at admission to a hospice-palliative care (HPC) unit is acceptable in terms of safety and efficacy and whether it results in superior patient satisfaction compared to usual intravenous (IV) access.
Materials and Methods
Terminally ill cancer patients were randomly assigned to two arms: routine PICC access and usual IV access arm. The primary endpoint was IV maintenance success rate, defined as the rate of functional IV maintenance until the intended time (discharge, transfer, or death).
Results
A total of 66 terminally ill cancer patients were enrolled and randomized to study arms. Among them, 57 patients (routine PICC, 29; usual IV, 28) were analyzed. In the routine PICC arm, mean time to PICC was 0.84 days (range, 0 to 3 days), 27 patients maintained PICC with function until the intended time. In the usual IV arm, 11 patients maintained peripheral IV access until the intended time, and 15 patients underwent PICC insertion. The IV maintenance success rate in the routine PICC arm (27/29, 93.1%) was similar to that in the usual IV arm (26/28, 92.8%, p=0.958). Patient satisfaction at day 5 was better in the routine PICC arm (97%, ‘a little comfort’ or ‘much comfort’) compared with the usual IV arm (21%) (p <0.001).
Conclusion
Routine PICC insertion in terminally ill cancer patients was comparable in safety and efficacy and resulted in superior satisfaction compared with usual IV access. Thus, routine PICC insertion could be considered at admission to the HPC unit.

Citations

Citations to this article as recorded by  
  • Implementation of Tunneled Peripherally Inserted Central Catheters Placement in Cancer Patients: A Randomized Multicenter Study
    Yuan Sheng, Li-Hong Yang, Yan Wu, Wei Gao, Sheng-Yi Dongye
    Clinical Nursing Research.2024; 33(1): 19.     CrossRef
  • The Use of a High Flow PICC Catheter for Stem Cell and Lymphocyte Apheresis: The Initial Experience of a Pediatric Oncology Center in Brazil
    Vilani Kremer, Andréia Rheinheimer, Ana Luiza Rodrigues, Andressa Taborda, Robson Coelho, Antonella Zanette
    Journal of Pediatric Surgery.2024; 59(8): 1600.     CrossRef
  • Analysis of Risk Factors for Peripherally Inserted Central Venous Catheter-Associated Bloodstream Infection
    Sungho Lee, Kwanhoon Park, Kang Yoon Lee, Dongbeen Choi, Ji Young Jang
    Journal of Acute Care Surgery.2024; 14(1): 9.     CrossRef
  • Central venous access device terminologies, complications, and reason for removal in oncology: a scoping review
    Kerrie Curtis, Karla Gough, Meinir Krishnasamy, Elena Tarasenko, Geoff Hill, Samantha Keogh
    BMC Cancer.2024;[Epub]     CrossRef
  • A Phase II Study About Efficacy and Safety of the Continuous IntraVenous Infusion of Ketamine as Adjuvant to Opioids in Terminally Ill Cancer Patients With Refractory Cancer Pain (CIVIK Trial)
    Kwonoh Park, Jae-Joon Kim, Sang-Bo Oh, So Yeon Oh, Yun Jeong Hong, Seo-jun Kim, Eun-Ju Park, Nayeon Choi, Seon-Hi Shin, Sungeun Kim, Heejung Ko
    American Journal of Hospice and Palliative Medicine®.2024;[Epub]     CrossRef
  • Use of peripherally inserted central venous catheters and midline catheters for palliative care in patients with cancer: a systematic review
    Eva Gravdahl, Dagny Faksvåg Haugen, Olav Magnus Fredheim
    Supportive Care in Cancer.2024;[Epub]     CrossRef
  • Machine Learning Predicts Peripherally Inserted Central Catheters-Related Deep Vein Thrombosis Using Patient Features and Catheterization Technology Features
    Yuan Sheng, Wei Gao
    Clinical Nursing Research.2024; 33(6): 460.     CrossRef
  • Safety of Cryopreserved Stem Cell Infusion through a Peripherally Inserted Central Venous Catheter
    Sławomir Milczarek, Piotr Kulig, Alina Zuchmańska, Bartłomiej Baumert, Bogumiła Osękowska, Anna Bielikowicz, Ewa Wilk-Milczarek, Bogusław Machaliński
    Cancers.2023; 15(4): 1338.     CrossRef
  • Use and safety of peripherally inserted central catheters and midline catheters in palliative care cancer patients: a retrospective review
    Eva Gravdahl, Siri Steine, Knut Magne Augestad, Olav Magnus Fredheim
    Supportive Care in Cancer.2023;[Epub]     CrossRef
  • Complications of Central Venous Access Devices Used in Palliative Care Settings for Terminally Ill Cancer Patients: A Systematic Review and Meta-Analysis
    Clement Chun-Him Wong, Horace Cheuk-Wai Choi, Victor Ho-Fun Lee
    Cancers.2023; 15(19): 4712.     CrossRef
  • Safety and Efficacy of Peripherally Inserted Central Catheter Placement by Surgical Intensivist–Led Vascular Access Team
    Byunghyuk Yu, Jihoon Hong
    Vascular Specialist International.2022;[Epub]     CrossRef
  • Effects of parenteral nutrition and hydration on survival in advanced cancer patients with malignant bowel obstruction: secondary analysis of a multicenter prospective cohort study
    Sayaka Arakawa, Koji Amano, Shunsuke Oyamada, Isseki Maeda, Hiroto Ishiki, Tomofumi Miura, Yutaka Hatano, Akemi Shirado Naito, Mamiko Sato, Tetsuya Ito, Kazuhiro Kosugi, Satoshi Miyake, Tatsuya Morita, Masanori Mori, Satoshi Inoue, Naosuke Yokomichi, Keng
    Supportive Care in Cancer.2021; 29(12): 7541.     CrossRef
  • Catheter-related bloodstream infection associated with multiple insertions of the peripherally inserted central catheter in patients with hematological disorders
    Yoshinori Hashimoto, Rina Hosoda, Hiromi Omura, Takayuki Tanaka
    Scientific Reports.2021;[Epub]     CrossRef
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Psychosocial Impact of Cancer Patients on Their Family Members
Sun Min Lim, Hyeon Chang Kim, Soohyeon Lee
Cancer Res Treat. 2013;45(3):226-233.   Published online September 30, 2013
DOI: https://doi.org/10.4143/crt.2013.45.3.226
AbstractAbstract PDFPubReaderePub
PURPOSE
A population-based study was conducted in order to examine the characteristics of family members of cancer patients in comparison with the general population and also to evaluate the psychosocial impact of cancer patients on their family members.
MATERIALS AND METHODS
From the Fourth Korea National Health and Nutrition Examination Surveys (KNHANES IV) (2007-2009) dataset, we identified 460 cancer patients and then selected family members of these patients who were aged 20 years or older (n=565). The control group was sampled from members of families without a cancer patient with matching for sex and age (n=2,260). Serial conditional logistic regression models were used for comparison of characteristics between family members of cancer patients and subjects in the control group.
RESULTS
Family members of cancer patients were less employed (57.9% vs. 63.0%, p<0.001), more functionally limited (20.2% vs. 16.5%, p=0.032), and had lower self-rated health (p=0.023) compared with sex and age-matched control subjects. They also had a significantly higher level of stress (79.7% vs. 76.1%, p=0.008), history of depression (12.9% vs. 10.2%, p=0.035), and current depressive symptoms (5.5% vs. 3.5%, p=0.038). However, higher physical activity was reported in family members of cancer patients (13.6% vs. 9.6%, p=0.003) than in control subjects. The presence of a cancer patient in the family showed an association with current depressive symptoms (odds ratio, 1.62; 95% confidence interval, 1.05 to 2.48; p=0.028), however, the association was no longer significant after adjustment for household income, education level, and employment status (p=0.304).
CONCLUSION
Family members of cancer patients are more susceptible to depression, probably due to adverse change in socioeconomic status. Use of multidisciplinary approaches for promotion of psychological health and well-being is essential.

Citations

Citations to this article as recorded by  
  • Pediatric cancers and family financial toxicity in the Philippines: insights for Southeast Asia and similarly resourced settings
    Rod Carlo Columbres, Erin Jay G. Feliciano, Kathleen Joy Taleon-Tampo, Katelyn Edelwina Y. Legaspi, Michelle Ann B. Eala, Kenrick Ng, Fumiko Chino, Frederic Ivan L. Ting, Edward Christopher Dee
    The Lancet Regional Health - Western Pacific.2024; 47: 101114.     CrossRef
  • Financial Sequelae of Cancer for Patients' Family Members and Caregivers: A Focus on the Philippines
    Rod Carlo Columbres, Erin Jay G. Feliciano, Lance Isidore Catedral, Jose Ma. H. Zaldarriaga, Michelle Ann B. Eala, Jerickson Abbie Flores, Enrico D. Tangco, Narjust Florez, Frederic Ivan L. Ting, Edward Christopher Dee
    JCO Global Oncology.2024;[Epub]     CrossRef
  • Psilocybin-Assisted Therapy for Brain Cancer Related Existential Distress: A Case-Report
    Jean-François Stephan, Sani Karam
    Journal of Palliative Medicine.2024;[Epub]     CrossRef
  • Benefits of Spiritual and Religious Support in the Pain Management of Cancer Patients: A Literature Scoping Review
    Iago Dillion Lima Cavalcanti, Diogo Timóteo Costa, José Cleberson Santos Soares, Mariane Cajubá de Britto Lira Nogueira
    Journal of Religion and Health.2023; 62(3): 1998.     CrossRef
  • Association between changes in having of cancer patients in the family and depression: A longitudinal panel study
    Yun Seo Jang, Na-Young Yoon, Kyungduk Hurh, Eun-Cheol Park, Min Jin Ha
    Journal of Affective Disorders.2023; 333: 482.     CrossRef
  • Cultural adaptation of meaning-centered psychotherapy for latino families: a protocol
    Normarie Torres Blasco, Rosario Costas Muñiz, Carolina Zamore, Laura Porter, Maria Claros, Guillermo Bernal, Megan Johnson Shen, William Breitbart, EM Castro
    BMJ Open.2022; 12(4): e045487.     CrossRef
  • Unmet supportive care needs of caregivers according to medical settings of cancer patients: a cross-sectional study
    Véronique Christophe, Amelie Anota, Laurence Vanlemmens, Alexis Cortot, Tatiana Ceban, Guillaume Piessen, Emilie Charton, Anne-Sophie Baudry
    Supportive Care in Cancer.2022; 30(11): 9411.     CrossRef
  • Information Received and Usefulness of the Sources of Information to Cancer Patients at a Tertiary Care Centre in Malaysia
    Yie Lin Lew, Fuad Ismail, Siti Azdiah Abdul Aziz, Noraida Mohamed Shah
    Journal of Cancer Education.2021; 36(2): 350.     CrossRef
  • Breaking News of Cancer Diagnosis: A Qualitative Study on the Experiences and Emotional Needs of Patients With Cancer in a Multiethnic Asian Setting
    Li-Ping Wong, Yek-Ching Kong, Nanthini Thevi Bhoo-Pathy, Shridevi Subramaniam, Ros Suzanna Bustamam, Nur Aishah Taib, Gwo-Fuang Ho, Hafizah Zaharah, Matin Mellor, Yin-Ling Woo, Cheng-Har Yip, Nirmala Bhoo-Pathy
    JCO Oncology Practice.2021; 17(4): e548.     CrossRef
  • Mood Disorder in Cancer Patients Undergoing Radiotherapy During the COVID-19 Outbreak
    Valerio Nardone, Alfonso Reginelli, Claudia Vinciguerra, Pierpaolo Correale, Maria Grazia Calvanese, Sara Falivene, Angelo Sangiovanni, Roberta Grassi, Angela Di Biase, Maria Angela Polifrone, Michele Caraglia, Salvatore Cappabianca, Cesare Guida
    Frontiers in Psychology.2021;[Epub]     CrossRef
  • Therapeutic Advances in the Management of Smoldering Myeloma
    Rafiullah Khan, Umar Zahid, Vidya Kollu, Nusrat Jahan, McBride Ali, Guido Tricot, Faiz Anwer
    American Journal of Therapeutics.2020; 27(2): e194.     CrossRef
  • Music therapy and radiation oncology: State of art and future directions
    Valerio Nardone, Claudia Vinciguerra, Pierpaolo Correale, Cesare Guida, Paolo Tini, Alfonso Reginelli, Salvatore Cappabianca
    Complementary Therapies in Clinical Practice.2020; 39: 101124.     CrossRef
  • Supportive care needs: An aspect of Thai women with breast cancer undergoing chemotherapy
    Supanee Klungrit, Sureeporn Thanasilp, Chanokporn Jitpanya
    European Journal of Oncology Nursing.2019; 41: 82.     CrossRef
  • Profiles of caregivers most at risk of having unmet supportive care needs: Recommendations for healthcare professionals in oncology
    Anne-Sophie Baudry, Laurence Vanlemmens, Amelie Anota, Alexis Cortot, Guillaume Piessen, Veronique Christophe
    European Journal of Oncology Nursing.2019; 43: 101669.     CrossRef
  • Evidence-based feedback about emotional cancer challenges experienced in South Africa: A qualitative analysis of 316 photovoice interviews
    Lynn Barbara Edwards, Linda Estelle Greeff
    Global Public Health.2018; 13(10): 1409.     CrossRef
  • Family Members of Cancer Patients in Korea Are at an Increased Risk of Medically Diagnosed Depression
    Youngdae Cho, Yongwoo Jeon, Sung-In Jang, Eun-Cheol Park
    Journal of Preventive Medicine and Public Health.2018; 51(2): 100.     CrossRef
  • Stress and Depressive Symptoms in Cancer Survivors and Their Family Members: Korea Community Health Survey, 2012
    Mi Han
    International Journal of Environmental Research and Public Health.2017; 14(9): 999.     CrossRef
  • Psychological Status and Associated Factors among Korean Cancer Survivors: a Cross-Sectional Analysis of the Fourth & Fifth Korea National Health and Nutrition Examination Surveys
    Kyung-Hyun Choi, Sang Min Park
    Journal of Korean Medical Science.2016; 31(7): 1105.     CrossRef
  • Experiential Group Work for Cancer Patients Shaped by Experiences of Participants During Group Intervention
    Joan Nee Wey Khng, Ivan Mun Hong Woo, Gilbert Fan
    Future Oncology.2016; 12(24): 2817.     CrossRef
  • High-risk smoldering myeloma: Perspective on watchful monitoring
    Siyang Leng, Suzanne Lentzsch
    Seminars in Oncology.2016; 43(6): 697.     CrossRef
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  • 20 Crossref
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An Evaluation of Nutrition Support for Terminal Cancer Patients at Teaching Hospitals in Korea
Do Yeun Kim, Sang Min Lee, Kyoung Eun Lee, Hye Ran Lee, Jee Hyun Kim, Keun-Wook Lee, Jong Seok Lee, Soon Nam Lee
Cancer Res Treat. 2006;38(4):214-217.   Published online December 31, 2006
DOI: https://doi.org/10.4143/crt.2006.38.4.214
AbstractAbstract PDFPubReaderePub
Purpose

We wanted to analyze the use of nutrition support for terminal cancer patients, the effect of discussing withdrawal of nutrition support and do-not-resuscitate (DNR) consent on the use of intravenous nutrition during the patient's last week of life and at the time of death.

Materials and Methods

The study involved 362 patients with terminal cancer from four teaching hospitals, and they all died between January 1 2003 and December 31 2005. The basic demographic data, the use of intravenous nutrition during the patient's last week of life and at death, discussion of terminal nutrition withdrawal and DNR consent were evaluated.

Results

In the week before death, the patients received artificial nutrition such as total parenteral nutrition (31%), intravenous albumin infusion (25%), and feeding tube placements (9%). A discussion concerning withdrawal of nutrition support was limited to 25 (7%) patients. DNR consent was obtained from 294 (81%) patients. None of the patients were directly involved in any of these decisions. The discussion about withdrawal of terminal nutrition and DNR consent with the patient's surrogates did not have any effect on reducing the use of parenteral nutrition.

Conclusion

The majority of patients dying of terminal cancer were still given potentially futile nutritional support. Modern clinical guidelines and ethical education about nutritional support at the end of life care is urgently needed in Korean medical practice to provide proper administration of terminal nutrition for end of life care.

Citations

Citations to this article as recorded by  
  • Report of the Lancet Commission on the Value of Death: bringing death back into life
    Libby Sallnow, Richard Smith, Sam H Ahmedzai, Afsan Bhadelia, Charlotte Chamberlain, Yali Cong, Brett Doble, Luckson Dullie, Robin Durie, Eric A Finkelstein, Sam Guglani, Melanie Hodson, Bettina S Husebø, Allan Kellehear, Celia Kitzinger, Felicia Marie Kn
    The Lancet.2022; 399(10327): 837.     CrossRef
  • A National Study of Life-Sustaining Treatments in South Korea: What Factors Affect Decision-Making?
    So-Youn Park, Bomyee Lee, Jeong Yeon Seon, In-Hwan Oh
    Cancer Research and Treatment.2021; 53(2): 593.     CrossRef
  • The Trend of Aggressive Treatments in End-of-Life Care for Older People With Dementia After a Policy Change in Taiwan
    Ying Hsin Hsu, Ming Yueh Chou, Hsiu-Min Chen, Wei-Cheng Chang, Che Sheng Chu, Yu-Chun Wang, Chiao-Lin Hsu, Chih-Kuang Liang, Ching-Chih Lee, Yu Te Lin
    Journal of the American Medical Directors Association.2020; 21(6): 858.     CrossRef
  • Implication of the Life-Sustaining Treatment Decisions Act on End-of-Life Care for Korean Terminal Patients
    Jung Sun Kim, Shin Hye Yoo, Wonho Choi, Yejin Kim, Jinui Hong, Min Sun Kim, Hye Yoon Park, Bhumsuk Keam, Dae Seog Heo
    Cancer Research and Treatment.2020; 52(3): 917.     CrossRef
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  • A Randomized Phase II Study To Assess the Effectiveness of Fluid Therapy or Intensive Nutritional Support on Survival in Patients with Advanced Cancer Who Cannot be Nourished via Enteral Route
    So Yeon Oh, Hyun Jung Jun, Sung Jae Park, In Ki Park, Ga Jin Lim, Yeonsil Yu, Sung-Ja Cho, Aeran Song
    Journal of Palliative Medicine.2014; 17(11): 1266.     CrossRef
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    Younsuck Koh, Dae-Seog Heo, Young Ho Yun, Jeong-Lim Moon, Hyoung Wook Park, Ji Tae Choung, Hyo Sung Jung, Bark Jang Byun, Yoon-Seong Lee
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    Lalit Krishna
    Nursing Ethics.2011; 18(4): 485.     CrossRef
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  • 12 Crossref
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Phase 1b Clinical Trial and Pharmacokinetic Evaluation of Recombinant Human Granulocyte - Macrophage Colony
Jae Kyung Roh, Jin Hyuk Choi, Hyung Keun Roh, Sun Young Rha, Kyung Hee Lee, Hye Ran Lee, Jee Sook Hahn, Pum Soo Kim, Byung Soo Kim
J Korean Cancer Assoc. 1994;26(3):495-510.
AbstractAbstract PDF
To define the clinical safeties and hematologic effects of subcutaneously administered yeast- derived recombinant human granulocyte-macrophage colony stimulatina factor(rh GM-CSF, LBD-005h and to determine the maximally tolerated dose(MTD) and the pharmacokinetics. Sngle arm open non-randomized phase Ib study was carried in 15 cancer patients#(14 patients evaluable) with chemotherapy induced bone marrow depression. Rh GM-CSF by once-daily subcutaneous administration to groups of 3-6 patients at doses of 50, 100, 150, 250, 350, 500, 700 ug/m/d for 10 consecutive days was escalated unless greater than WHO grade III toxicites were observed. Intrapatient dose escalation was permitted. Clinical safeties and toxicities were observed with frequent hematologic monitering. Blood and urine were collected on day 1, and 8 of rh GM-CSF administration to evaluate the parmacokinetic parameters. Of the 15 enrolled patients, 14 patients were evaluable. Male to female ratio was 8: 6 with median age 32 y-o(10~70 y-o). Seven patients had osteosarcoma, 2 malignant lymphoma, 2 gastric carcinoma, 2 lung cancer and 1 had uterine leiomyosarcoma. The total administered cycles of rh GM-CSF were 24. At each dose step, 3 patients were treated with exception of 6 patients at 500 ug/m/d dose. At all the doses administered, fever and flue-like syndrome were common side effects. Grade I fever and flue-like syndrome 50~150 pg/m dose, and grade II fever flue- like syndrome were observed at the dose of grater than 250 u/m(2)/d dose. Even at the 700 ug/m(2)/ d dose, no greater than grade III toxicities were observed. Leucocytosis were dose dependent with 120-480% increment of baseline. Pharmacokinetic parameters are as follows; Cmax were dose dependent(0.42-11.7 ng/ml) with 2-4 hours of Tmax. AUC were also dose dependent(3.93~87.9ng.hr/ml) with sustained serum levels(0.2-2ng/ml) up to 12 hours after rh GM-CSF administration. Urinary excretion(0-24 hours) after GM-CSF was less than 1% of administered dose. Yeast-derived rh GM-CSF induces leucocytosis in the dose range of 150~500ug/m(2)/d with tolerable side effects. Subcutaneously administered rh GM-CSF has sustained serum levels up to 12 hours after administration. The doses of 150-500 ug/m/d would be appropriated for the further trials.
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A Phase 2 Clinical Trial of Recombinant Human Granulocyte Macrophage Colony Stimulatin
Sun Young Rha, Jae Kyung Roh, Kyung Hee Lee, Hyun Cheol Chung, Jong Inn Lee, Jin Hyuk Choi, Hye Ran Lee, Nae Chun Yoo, Joo Hang Kim, Dae Seog Heo, Jin Hyuk Choi, Ho Yeong Lim, Jee Sook Hahn, Byung So
J Korean Cancer Assoc. 1995;27(3):490-504.
AbstractAbstract PDF
Background
; Rh GM-CSF is known to stimulate the growth of granulocyte-macrophage pre- cursors and can prevent the neutropenia and infection after high dose chemotherapy. We planned to evaluate the efficacy and toxicities of rh GM-CSF and to determine the clinically recommended dose of yeast-derived rh GM-CSF(LBD-005), based on the biologicaily active doses from phase I clinical triaL Methods; Open non-randomized phase II study was carried out in 40 cancer patients with chemotherapy induced myelosuppression. After the control period(chemotherapy without rh GM-CSF), rh GM-CSF was started 24 hours after the second chemotherapy to 3 groups of patients with the doses of 150, 250, 350 ug/m(2)/d by once-daily subcutaneous admlnistration for 10 days. Resnlts; Of the 40 enrolled patients, two patients refused to be followed and. one patient couldn't finish the study due to the disease progression. So 37 patients were evaluable and the number of patients at the dose of 150, 250, 350 pg/m/d were 12, 12 and 13 petients, respectively. They were consisted of 12 with stomach cancers, 10 with breast cancers, 5 with osteosarcoma and 10 patients with other malignancies, and received chemotherapeutic agents like VP-16, cisplatinum, adriamycin. When we compared the hematologic parameters between the control and treatment periods, the mean nadir of WBC counts(/mm(3)) at the dose of 150ug/m(2)/d were 1480, 2085, each, l280, l997 at the dose of 250 ug/m/d, and 1091, 1788 at the dose of 350 ug/m(2)/d respectively. Also the recovery days of WBC counts from nadir to 4000/m(3) were improved from 8 days in control period to 4.7 days in treatment period at the dose of 150 ug/m(2)/d. There were the same results at the dose of 250 and 350 ug/m(2)/d, such as from 7.4 days to 4.4 days and from 8.5 days to 5.2 days, respectively. In view of neutrophils, we could find the same results(p<0.05). There are trends that the recovery from nadir at the dose of 250 ug/m(2)/d or more is rapid, rather than l50ug/m(2)/d. Two patients with 350ug/m(2)/d complained of severe (WHO toxicity grade III) skin reaction and chest tightness, but they tolerated well after reduction to 250 ug/m(2) /d dose. Conclasion; This study suggested the effects of yeast-derived rh GM-CSF with the dose of 1SO, 250, 350ug/m(2)/d, S.Q. for 10 days to prvent the chemotherapy induced neutropenia. And when we considered the efficacy and tolerability, 250 ug/m(2)/d is appropriate for phase III clinical triaL
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A Phase 3 Clinical Trial of Recombinant Human Granulocyte - Macrophage Colony Stimulating
Kyung Hee Lee, Sun Young Rha, Jae Kyung Roh, Jong In Lee, Hae Ran Lee, Jun Oh Park, Jae Woong Cho, Hyun Cheol Chung, Joo Hang Kim, Jee Sook Hahn, Yun Woong Ko, Byung Soo Kim, Ho Young Lim, Jin Hyuk Choi
J Korean Cancer Assoc. 1995;27(5):804-816.
AbstractAbstract PDF
Background
Recombinant human granulocyte-macrophage colony stimulating factor(rhGM- CSF, LBD-005) may reduce chemotherapy induced myelosuppression, and thus reduce the incidence of neutropenic fever and infection after the dose intensive chemotherapy. In previous phase I and II studies, clinical efficacies and side effects of rhGM-CSF were evaluated, and the dose of 250ug/m(2)/day for 10 consecutive days subcutaneous administration was recommended for the further clinical triaL Methods: In this phase III trial, we evaluated the efficacy and safety of rhGM-CSF in 35 advanced cancer pstients after combination chemotherapy. Every eligible patients received at least 2 cycles of chemotherapy with the same dose and schedule. At the first cycle, control period, scheduled chemotherapy was given without rhGM-CSF, and at the second cycle, treatment period, rhGM-CSF was administered for 10 consecutive days subcutaneously with the dose of 250u/m(2)/day after the same chemotherapy given previously. During observation and treatment period, clinical and pathoiogical effects were monitered. Resnlta: All enrolled 35 patients were evaluable, and 14 patients(40%) had stomach cancer. The hematologic parameters were compared between two periods; mean nadir of WBC(neutrophil) counts during the control period and treatment period were 1,154+-485/mm(3)(241/mm(3)+ 242) and 2,486+1,554/mm(3)(912+-1,186/mm(3)) respectively(P<0.0001). Also the recovery time of neutropenia was shortened(P<0.0001). Incidence of infection and the necessities of antibiotics administration were decreased(days of antibiotics adminiatration: 7 days during control period and 10 days during treatment period). Most petients showed mild, talerable toxicities like chest tightness and general malaise, except 2 patients with the reduced dose of 150 ug/m(2)/day due to grade II toxicities of chest tightness and abdominal pain. Conclnsion: Above results suggested that the administration of rhGM-CSF after chemotherapy can reduce the degree of neutropenia and the side effects of rhGM-CSF were acceptable.
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