Cancer Research and Treatment

Original Articles

General

Significant Dissatisfaction with an Outdated System: A Survey on the Experience of Application for Off-Label Use of Anti-cancer Drugs by the Korean Society of Medical Oncology: Jae Lyun Lee, Dong-Hoe Koo, Young-Woong Won, Young Saing Kim, Hee Kyung Ahn, Seungtaek Lim; Cancer Res Treat. 2025;57(4):942-950. Published online February 11, 2025; DOI: https://doi.org/10.4143/crt.2024.749

Abstract PDF Supplementary Material PubReader ePub: Purpose
This study evaluates the experiences and satisfaction levels of Korean medical oncologists with the prior authorization system for the off-label use of anti-cancer drugs. Conducted by the Korean Society of Medical Oncology (KSMO), the survey aimed to identify challenges and areas for improvement in the current regulatory framework.
Materials and Methods
A cross-sectional web-based survey was carried out between May 4 and May 14, 2023, targeting 261 active KSMO medical oncologists. Invitations were sent via email, and the survey, comprising 19 questions, was hosted on Microsoft Forms. The questions covered personal characteristics, work environment, experiences with the pre-application process, and post-approval experiences.
Results
For the 261 invitations sent, 110 responses (42.1%) were received. Most respondents had over 10 years of experience and worked in tertiary hospitals. Although 93.6% were familiar with the pre-application system, 67.3% expressed moderate to high dissatisfaction. The key issues included complex applications, long approval period, stringent criteria, and inconsistent reviews. Additionally, 74.4% of respondents spent over 3 hours on first-time applications, with 68.3% experiencing rejections. Emotional responses to rejections were largely negative, with many feeling disregarded. Post-approval, patients of 96.8% of respondents faced financial burdens leading to treatment discontinuation. Most oncologists (86.0%) supported selective reimbursement if the disease was controlled for a certain period.
Conclusion
The survey highlights significant dissatisfaction with the current system, suggesting the need for streamlining the application process, easing approval criteria, and reconsidering the financial aspects of post-approval treatments to support patient care and oncologists’ decision-making autonomy.

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Breast cancer

Eflapegrastim versus Pegfilgrastim for Chemotherapy-Induced Neutropenia in Korean and Asian Patients with Early Breast Cancer: Results from the Two Phase III ADVANCE and RECOVER Studies: Yong Wha Moon, Seung Ki Kim, Keun Seok Lee, Moon Hee Lee, Yeon Hee Park, Kyong Hwa Park, Gun Min Kim, Seungtaek Lim, Seung Ah Lee, Jae Duk Choi, Eunhye Baek, Hyesun Han, Seungjae Baek, Seock-Ah Im; Cancer Res Treat. 2023;55(3):766-777. Published online January 19, 2023; DOI: https://doi.org/10.4143/crt.2022.987

Abstract PDF Supplementary Material PubReader ePub

Purpose
We investigated the consistent efficacy and safety of eflapegrastim, a novel long-acting granulocyte-colony stimulating factor (G-CSF), in Koreans and Asians compared with the pooled population of two global phase 3 trials.
Materials and Methods
Two phase 3 trials (ADVANCE and RECOVER) evaluated the efficacy and safety of fixed-dose eflapegrastim (13.2 mg/0.6 mL [3.6 mg G-CSF equivalent]) compared to pegfilgrastim (6 mg based on G-CSF) in breast cancer patients who received neoadjuvant or adjuvant docetaxel/cyclophosphamide. The primary objective was to demonstrate non-inferiority of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN) in cycle 1, in Korean and Asian subpopulations.
Results
Among a total of 643 patients randomized to eflapegrastim (n=314) or pegfilgrastim (n=329), 54 Asians (29 to eflapegrastim and 25 to pegfilgrastim) including 28 Koreans (14 to both eflapegrastim and pegfilgrastim) were enrolled. The primary endpoint, DSN in cycle 1 in the eflapegrastim arm was non-inferior to the pegfilgrastim arm in Koreans and Asians. The DSN difference between the eflapegrastim and pegfilgrastim arms was consistent across populations: –0.120 days (95% confidence interval [CI], –0.227 to –0.016), –0.288 (95% CI, –0.714 to 0.143), and –0.267 (95% CI, –0.697 to 0.110) for pooled population, Koreans and Asians, respectively. There were few treatment-related adverse events that caused discontinuation of eflapegrastim (1.9%) or pegfilgrastim (1.5%) in total and no notable trends or differences across patient populations.
Conclusion
This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population.

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The hidden costs of PEG-rhG-CSF in autologous stem cell transplantation for newly diagnosed multiple myeloma
Ruiqi Wang, Hao Tian, Zhenxing Zhu, Dan Cong, Yuansong Bai, Wenlong Zhang
Scientific Reports.2025;[Epub] CrossRef
Efbemalenograstim Alfa, an Fc Fusion Protein, Long‑Acting Granulocyte Colony-Stimulating Factor for Reducing the Risk of Chemotherapy-Induced Neutropenia: Results of a Phase II Randomized, Multicenter, Open‑Label Trial
Dongmei Ji, Shufang Wang, Wei Yao, Denny Hou, Xiaoyan Wang, Changsheng Ye, Hongsheng Li, Hongjian Yang, Jilin Yi, Jinsong Lu, Haibo Wang, Xiaohong Xu, Dongyan Cai, Xiaoan Liu, Xi Yan, Jianyun Nie, Shude Cui, Hongchuan Jiang, Junning Cao
Clinical Drug Investigation.2025; 45(11): 889. CrossRef
Comparison of Prophylactic Efficacy of Eflapegrastim and Pegteograstim for Chemotherapy-induced Neutropenia in Pancreatic Cancer Patients Receiving FOLFIRINOX/mFOLFIRINOX
Eui Seon Lee, Min Jung Geum, Jong Hee Ko, Jae Song Kim, Eun Sun Son, Yun Mi Yu
Journal of Korean Society of Health-System Pharmacists.2024; 41(3): 253. CrossRef

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Impacts of Subtype on Clinical Feature and Outcome of Male Breast Cancer: Multicenter Study in Korea (KCSG BR16-09): Jieun Lee, Keun Seok Lee, Sung Hoon Sim, Heejung Chae, Joohyuk Sohn, Gun Min Kim, Kyung-Hee Lee, Su Hwan Kang, Kyung Hae Jung, Jae-ho Jeong, Jae Ho Byun, Su-Jin Koh, Kyoung Eun Lee, Seungtaek Lim, Hee Jun Kim, Hye Sung Won, Hyung Soon Park, Guk Jin Lee, Soojung Hong, Sun Kyung Baek, Soon Il Lee, Moon Young Choi, In Sook Woo; Cancer Res Treat. 2023;55(1):123-135. Published online March 24, 2022; DOI: https://doi.org/10.4143/crt.2021.1561

Abstract PDF Supplementary Material PubReader ePub

Purpose
The treatment of male breast cancer (MBC) has been extrapolated from female breast cancer (FBC) because of its rarity despite their different clinicopathologic characteristics. We aimed to investigate the distribution of intrinsic subtypes based on immunohistochemistry, their clinical impact, and treatment pattern in clinical practice through a multicenter study in Korea.
Materials and Methods
We retrospectively analyzed clinical data of 248 MBC patients from 18 institutions across the country from January 1995 to July 2016.
Results
The median age of MBC patients was 63 years (range, 25 to 102 years). Among 148 intrinsic subtype classified patients, 61 (41.2%), 44 (29.7%), 29 (19.5%), and 14 (9.5%) were luminal A, luminal B, human epidermal growth factor receptor 2, and triple-negative breast cancer, respectively. Luminal A subtype showed trends for superior survival compared to other subtypes. Most hormone receptor-positive patients (166 patients, 82.6%) received adjuvant endocrine treatment. Five-year completion of adjuvant endocrine treatment was associated with superior disease-free survival (DFS) in patients classified with an intrinsic subtype (hazard ratio [HR], 0.15; 95% confidence interval [CI], 0.04 to 0.49; p=0.002) and in all patients (HR, 0.16; 95% CI, 0.05 to 0.54; p=0.003).
Conclusion
Distribution of subtypes of MBC was similar to FBC and luminal type A was most common. Overall survival tended to be improved for luminal A subtype, although there was no statistical significance. Completion of adjuvant endocrine treatment was associated with prolonged DFS in intrinsic subtype classified patients. MBC patients tended to receive less treatment. MBC patients should receive standard treatment according to guidelines as FBC patients.

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HER2 expression and pathway status in male breast cancer patients: results of an integrated analysis among 6,150 patients
Boqiang Lyu, Shidi Zhao, Hui Wang, Shouping Gong, Biyuan Wang
Scientific Reports.2025;[Epub] CrossRef
Male breast cancer - a single center experience
Igor Djurisic, Milan Zegarac, Milan Kocic, Vladimir Jokic, Nikola Vucic, Ognjen Petrovic, Nada Santrac, Jovana Koncar, Andjela Ivezic, Srdjan Nikolic
Srpski arhiv za celokupno lekarstvo.2025; 153(1-2): 53. CrossRef
Clinicopathologic Features and Prognoses of Male Patients With Breast Cancer
Meiling Huang, Jingjing Xiao, Changjiao Yan, Rui Ling, Ting Wang
American Journal of Men's Health.2024;[Epub] CrossRef

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General

Comparison of the Data of a Next-Generation Sequencing Panel from K-MASTER Project with That of Orthogonal Methods for Detecting Targetable Genetic Alterations: Yoon Ji Choi, Jung Yoon Choi, Ju Won Kim, Ah Reum Lim, Youngwoo Lee, Won Jin Chang, Soohyeon Lee, Jae Sook Sung, Hee-Joon Chung, Jong Won Lee, Eun Joo Kang, Jung Sun Kim, Taekyu Lim, Hye Sook Kim, Yu Jung Kim, Mi Sun Ahn, Young Saing Kim, Ji Hyun Park, Seungtaek Lim, Sung Shim Cho, Jang Ho Cho, Sang Won Shin, Kyong Hwa Park, Yeul Hong Kim; Cancer Res Treat. 2022;54(1):30-39. Published online May 20, 2021; DOI: https://doi.org/10.4143/crt.2021.218

Abstract PDF PubReader ePub

Purpose
K-MASTER project is a Korean national precision medicine platform that screened actionable mutations by analyzing next-generation sequencing (NGS) of solid tumor patients. We compared gene analyses between NGS panel from the K-MASTER project and orthogonal methods.
Materials and Methods
Colorectal, breast, non–small cell lung, and gastric cancer patients were included. We compared NGS results from K-MASTER projects with those of non-NGS orthogonal methods (KRAS, NRAS, and BRAF mutations in colorectal cancer [CRC]; epidermal growth factor receptor [EGFR], anaplastic lymphoma kinase [ALK] fusion, and reactive oxygen species 1 [ROS1] fusion in non–small cell lung cancer [NSCLC], and Erb-B2 receptor tyrosine kinase 2 (ERBB2) positivity in breast and gastric cancers).
Results
In the CRC cohort (n=225), the sensitivity and specificity of NGS were 87.4% and 79.3% (KRAS); 88.9% and 98.9% (NRAS); and 77.8% and 100.0% (BRAF), respectively. In the NSCLC cohort (n=109), the sensitivity and specificity of NGS for EGFR were 86.2% and 97.5%, respectively. The concordance rate for ALK fusion was 100%, but ROS1 fusion was positive in only one of three cases that were positive in orthogonal tests. In the breast cancer cohort (n=260), ERBB2 amplification was detected in 45 by NGS. Compared with orthogonal methods that integrated immunohistochemistry and in situ hybridization, sensitivity and specificity were 53.7% and 99.4%, respectively. In the gastric cancer cohort (n=64), ERBB2 amplification was detected in six by NGS. Compared with orthogonal methods, sensitivity and specificity were 62.5% and 98.2%, respectively.
Conclusion
The results of the K-MASTER NGS panel and orthogonal methods showed a different degree of agreement for each genetic alteration, but generally showed a high agreement rate.

Citations

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Genomic Profiling of Driver Gene Alterations in Patients With Non–Small Cell Lung Cancer, Patterns of Treatment and Impact on Survival Outcomes: A Single Center Experience of More Than 1200 Patients
Minit Shah, Vanita Noronha, Vijay Patil, Ajay Kumar Singh, Nandini Menon, Supriya Goud, Srushti Shah, Sucheta More, Akhil Kapoor, Bal Krishna Mishra, Pratik Chandrani, Anuradha Chougule, Vinod Gupta, Priyanka Pange, Omshree Shetty, Trupti Pai, Rajiv Kaush
Clinical Lung Cancer.2025; 26(4): e270. CrossRef
Integrated clinical and genomic models using machine-learning methods to predict the efficacy of paclitaxel-based chemotherapy in patients with advanced gastric cancer
Yonghwa Choi, Jangwoo Lee, Keewon Shin, Ji Won Lee, Ju Won Kim, Soohyeon Lee, Yoon Ji Choi, Kyong Hwa Park, Jwa Hoon Kim
BMC Cancer.2024;[Epub] CrossRef
Supporting Biomarker-Driven Therapies in Oncology: A Genomic Testing Cost Calculator
Albrecht Stenzinger, Brian Cuffel, Noman Paracha, Eric Vail, Jesus Garcia-Foncillas, Clifford Goodman, Ulrik Lassen, Gilles Vassal, Sean D Sullivan
The Oncologist.2023; 28(5): e242. CrossRef
Genomic analysis of plasma circulating tumor DNA in patients with heavily pretreated HER2 + metastatic breast cancer
Kyoungmin Lee, Jongwon Lee, Jungmin Choi, Sung Hoon Sim, Jeong Eun Kim, Min Hwan Kim, Yeon Hee Park, Jee Hyun Kim, Su-Jin Koh, Kyong Hwa Park, Myoung Joo Kang, Mi Sun Ahn, Kyoung Eun Lee, Hee-Jun Kim, Hee Kyung Ahn, Han Jo Kim, Keon Uk Park, In Hae Park
Scientific Reports.2023;[Epub] CrossRef
Recommendations for the Use of Next-Generation Sequencing and the Molecular Tumor Board for Patients with Advanced Cancer: A Report from KSMO and KCSG Precision Medicine Networking Group
Shinkyo Yoon, Miso Kim, Yong Sang Hong, Han Sang Kim, Seung Tae Kim, Jihun Kim, Hongseok Yun, Changhoon Yoo, Hee Kyung Ahn, Hyo Song Kim, In Hee Lee, In-Ho Kim, Inkeun Park, Jae Ho Jeong, Jaekyung Cheon, Jin Won Kim, Jina Yun, Sun Min Lim, Yongjun Cha, Se
Cancer Research and Treatment.2022; 54(1): 1. CrossRef

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Case Report

Two Cases of Humoral Hypercalcemia of Malignancy in Metastatic Cholangiocarcinoma: Seungtaek Lim, Jungwoo Han, Kyeong Hye Park, Won Jai Jung, Yong Kang Lee, Ara Choi, Young Jae Kim, Jong-Chan Lee, Hye Jin Choi; Cancer Res Treat. 2013;45(2):145-149. Published online June 30, 2013; DOI: https://doi.org/10.4143/crt.2013.45.2.145

Abstract PDF PubReader ePub

Humoral hypercalcemia of malignancy (HHM) is rarely associated with cholangiocarcinoma (CC), and represents dismal prognosis. A 63-year-old male was admitted for evaluation of an intrahepatic mass. He was diagnosed with HHM associated with locally advanced CC. As the tumor responded to the concurrent chemoradiotherapy with capecitabine and cisplatin, serum calcium level was normalized. However, according to the disease progression, he suffered recurrence of HHM and he expired approximately one year after initial diagnosis. A 68-year-old male who presented with abdominal pain was diagnosed with metastatic CC. After the eighth cycle of gemcitabine and cisplatin, progression of the disease was found with HHM. He was treated with the best supportive care, until his demise approximately one month after the diagnosis of HHM. We report on two cases of HHM associated with CC that demonstrate strong correlation between hypercalcemia and disease burden.

Citations

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The peculiar clinical presentation and diagnostic results of a case of widely metastatic cholangiocellular carcinoma in a Siberian Husky dog
Hannah Reichert, Alexandra Macleod, Leslie Sharkey, Cornelia Peterson
Topics in Companion Animal Medicine.2024; 63: 100923. CrossRef
Prevalence and Clinicopathologic Characteristics of Hypercalcemia in Patients With Cholangiocarcinoma
Eirini Konstantinidou, Jordan R. Maurer, Stephanie L. Reyes, Islam Baiev, Jennifer R. Stanton, Ryan D. Nipp, Lipika Goyal
JAMA Oncology.2023; 9(5): 714. CrossRef
Recurrent distal cholangiocarcinoma and humoral hypercalcemia of malignancy: report of a rare case and literature review
Jun Ito, Kiten Sakai, Yuki Yamamoto, Rikako Nakajima, Kei Ito, Masanao Fujii, Hideki Matsumura, Norio Takayashiki, Masanao Kurata, Satoshi Inagawa, Hiroaki Yagyu
Endocrine Journal.2023; 70(4): 375. CrossRef
Hypercalcemia of Malignancy in a Dog Diagnosed With Cholangiocellular Carcinoma
Laura Martínez-Sogues, Anna Vila, Xavier Roura, Josep Pastor, Rosa Novellas, Alberto Marco, Maria Cuvertoret-Sanz, Jorge Martínez, Laia Solano-Gallego
Topics in Companion Animal Medicine.2019; 35: 1. CrossRef
Combined Hepatocholangiocarcinoma Associated with Humoral Hypercalcemia of Malignancy and Chronic Inflammatory Demyelinating Polyneuropathy
Ruben Manuel Luciano Colunga Biancatelli, Marco Ciacciarelli, Alessandro Polidoro, Piera Clemenzi, Viviana Congedo, Leonardo Calvosa, Eleonora D’Armiento, Carmen Misurale, Davide Bellini, Stefano Badia, Massimiliano Mancini, Vincenzo Petrozza, Luigi Iulia
Case Reports in Oncological Medicine.2019; 2019: 1. CrossRef
Humoral Hypercalcemia of Malignancy with a Parathyroid Hormone-Related Peptide-Secreting Intrahepatic Cholangiocarcinoma Accompanied by a Gastric Cancer
Katsushi Takeda, Ryosuke Kimura, Nobuhiro Nishigaki, Shinya Sato, Asami Okamoto, Kumiko Watanabe, Sachie Yasui
Case Reports in Endocrinology.2017; 2017: 1. CrossRef
Denosumab is Effective for Controlling Serum Calcium Levels in Patients with Humoral Hypercalcemia of Malignancy Syndrome: A Case Report on Parathyroid Hormone-related Protein-producing Cholangiocarcinoma
Norihiro Ashihara, Koji Nakajima, Yoshiyuki Nakamura, Mutsuhiro Kobayashi, Kumiko Shirahata, Chika Maeda, Takeshi Uehara, Daisuke Gomi, Nobuo Ito
Internal Medicine.2016; 55(23): 3453. CrossRef
Esophageal Cancer Initially Presenting as Severe Paraneoplastic Hypercalcemia Requiring Hemodialysis
Hye Shin Ahn, Jong Min Yun, Yeong Bok Lee, Yu Mi Ko, Jung Eun Lee, Hye Sung Won, Sung Soo Kim, Young Ok Kim
The Korean Journal of Gastroenterology.2015; 65(6): 361. CrossRef

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