1.Second-Line Fluoropyrimidine-Based Chemotherapy in Advanced Biliary Tract Cancer: A Meta-analysis Based on Individual Patient-Level Data of Randomized Trials
Jaewon HYUNG ; Minsu KANG ; Ilhwan KIM ; Kyu-pyo KIM ; Baek-Yeol RYOO ; Jaekyung CHEON ; Hyewon RYU ; Ji Sung LEE ; Ji-Won KIM ; In Sil CHOI ; Jin Hyun PARK ; Ghassan K. ABOU-ALFA ; Jin Won KIM ; Changhoon YOO
Cancer Research and Treatment 2025;57(2):519-527
Purpose:
While fluoropyrimidine-based chemotherapy regimens are recommended second-line treatment for patients with advanced biliary tract cancer (BTC), there have been no studies comparing different regimens head-to-head.
Materials and Methods:
We performed individual patient-level meta-analysis based on data from the intention-to-treat population of the phase 2b NIFTY trial (liposomal irinotecan [nal-IRI] plus fluorouracil and leucovorin [5-FU/LV] vs. 5-FU/LV; NCT03542508) and the phase 2 FIReFOX trial (modified oxaliplatin plus 5-FU/LV [mFOLFOX] vs. modified irinotecan plus 5-FU/LV [mFOLFIRI]; NCT03464968). Pairwise log-rank tests and multivariable analysis using Cox proportional hazards modeling with shared frailty to account for the trial's effect were used to compare overall survival (OS) between regimens.
Results:
A total of 277 patients were included. The nal-IRI plus 5-FU/LV group (n=88) showed significantly better OS compared to the mFOLFOX group (n=49, pairwise log-rank, p=0.02), and mFOLFIRI group (n=50, p=0.03). Multivariable analysis showed consistent trends in OS with adjusted hazard ratios of 1.39 (mFOLFOX vs. nal-IRI plus 5-FU/LV: 95% confidence interval [CI], 0.93 to 2.07; p=0.11) and 1.36 (mFOLFIRI vs. nal-IRI plus 5-FU/LV: 95% CI, 0.92 to 2.03; p=0.13), respectively. Compared to the 5-FU/LV group, the mFOLFOX group and the mFOLFIRI group did not show differences in terms of OS (pairwise log-rank p=0.83 and p=0.58, respectively). The nal-IRI plus 5-FU/LV group experienced more frequent diarrhea, while the mFOLFOX group experienced peripheral neuropathy.
Conclusion
Nal-IRI plus 5-FU/LV showed favorable survival outcomes compared to mFOLFOX, mFOLFIRI, or 5-FU/LV. The safety profiles of these regimens should be considered along with efficacy.
2.Second-Line Fluoropyrimidine-Based Chemotherapy in Advanced Biliary Tract Cancer: A Meta-analysis Based on Individual Patient-Level Data of Randomized Trials
Jaewon HYUNG ; Minsu KANG ; Ilhwan KIM ; Kyu-pyo KIM ; Baek-Yeol RYOO ; Jaekyung CHEON ; Hyewon RYU ; Ji Sung LEE ; Ji-Won KIM ; In Sil CHOI ; Jin Hyun PARK ; Ghassan K. ABOU-ALFA ; Jin Won KIM ; Changhoon YOO
Cancer Research and Treatment 2025;57(2):519-527
Purpose:
While fluoropyrimidine-based chemotherapy regimens are recommended second-line treatment for patients with advanced biliary tract cancer (BTC), there have been no studies comparing different regimens head-to-head.
Materials and Methods:
We performed individual patient-level meta-analysis based on data from the intention-to-treat population of the phase 2b NIFTY trial (liposomal irinotecan [nal-IRI] plus fluorouracil and leucovorin [5-FU/LV] vs. 5-FU/LV; NCT03542508) and the phase 2 FIReFOX trial (modified oxaliplatin plus 5-FU/LV [mFOLFOX] vs. modified irinotecan plus 5-FU/LV [mFOLFIRI]; NCT03464968). Pairwise log-rank tests and multivariable analysis using Cox proportional hazards modeling with shared frailty to account for the trial's effect were used to compare overall survival (OS) between regimens.
Results:
A total of 277 patients were included. The nal-IRI plus 5-FU/LV group (n=88) showed significantly better OS compared to the mFOLFOX group (n=49, pairwise log-rank, p=0.02), and mFOLFIRI group (n=50, p=0.03). Multivariable analysis showed consistent trends in OS with adjusted hazard ratios of 1.39 (mFOLFOX vs. nal-IRI plus 5-FU/LV: 95% confidence interval [CI], 0.93 to 2.07; p=0.11) and 1.36 (mFOLFIRI vs. nal-IRI plus 5-FU/LV: 95% CI, 0.92 to 2.03; p=0.13), respectively. Compared to the 5-FU/LV group, the mFOLFOX group and the mFOLFIRI group did not show differences in terms of OS (pairwise log-rank p=0.83 and p=0.58, respectively). The nal-IRI plus 5-FU/LV group experienced more frequent diarrhea, while the mFOLFOX group experienced peripheral neuropathy.
Conclusion
Nal-IRI plus 5-FU/LV showed favorable survival outcomes compared to mFOLFOX, mFOLFIRI, or 5-FU/LV. The safety profiles of these regimens should be considered along with efficacy.
3.Second-Line Fluoropyrimidine-Based Chemotherapy in Advanced Biliary Tract Cancer: A Meta-analysis Based on Individual Patient-Level Data of Randomized Trials
Jaewon HYUNG ; Minsu KANG ; Ilhwan KIM ; Kyu-pyo KIM ; Baek-Yeol RYOO ; Jaekyung CHEON ; Hyewon RYU ; Ji Sung LEE ; Ji-Won KIM ; In Sil CHOI ; Jin Hyun PARK ; Ghassan K. ABOU-ALFA ; Jin Won KIM ; Changhoon YOO
Cancer Research and Treatment 2025;57(2):519-527
Purpose:
While fluoropyrimidine-based chemotherapy regimens are recommended second-line treatment for patients with advanced biliary tract cancer (BTC), there have been no studies comparing different regimens head-to-head.
Materials and Methods:
We performed individual patient-level meta-analysis based on data from the intention-to-treat population of the phase 2b NIFTY trial (liposomal irinotecan [nal-IRI] plus fluorouracil and leucovorin [5-FU/LV] vs. 5-FU/LV; NCT03542508) and the phase 2 FIReFOX trial (modified oxaliplatin plus 5-FU/LV [mFOLFOX] vs. modified irinotecan plus 5-FU/LV [mFOLFIRI]; NCT03464968). Pairwise log-rank tests and multivariable analysis using Cox proportional hazards modeling with shared frailty to account for the trial's effect were used to compare overall survival (OS) between regimens.
Results:
A total of 277 patients were included. The nal-IRI plus 5-FU/LV group (n=88) showed significantly better OS compared to the mFOLFOX group (n=49, pairwise log-rank, p=0.02), and mFOLFIRI group (n=50, p=0.03). Multivariable analysis showed consistent trends in OS with adjusted hazard ratios of 1.39 (mFOLFOX vs. nal-IRI plus 5-FU/LV: 95% confidence interval [CI], 0.93 to 2.07; p=0.11) and 1.36 (mFOLFIRI vs. nal-IRI plus 5-FU/LV: 95% CI, 0.92 to 2.03; p=0.13), respectively. Compared to the 5-FU/LV group, the mFOLFOX group and the mFOLFIRI group did not show differences in terms of OS (pairwise log-rank p=0.83 and p=0.58, respectively). The nal-IRI plus 5-FU/LV group experienced more frequent diarrhea, while the mFOLFOX group experienced peripheral neuropathy.
Conclusion
Nal-IRI plus 5-FU/LV showed favorable survival outcomes compared to mFOLFOX, mFOLFIRI, or 5-FU/LV. The safety profiles of these regimens should be considered along with efficacy.
4.Effect of Cage Material and Size on Fusion Rate and Subsidence Following Biportal Endoscopic Transforaminal Lumbar Interbody Fusion
Ki-Han YOU ; Samuel K. CHO ; Jae-Yeun HWANG ; Sun-Ho CHA ; Min-Seok KANG ; Sang-Min PARK ; Hyun-Jin PARK
Neurospine 2024;21(3):973-983
Objective:
Biportal endoscopic transforaminal lumbar interbody fusion (BE-TLIF) is an emerging, minimally invasive technique performed under biportal endoscopic guidance. However, concerns regarding cage subsidence and sufficient fusion during BE-TLIF necessitate careful selection of an appropriate interbody cage to improve surgical outcomes. This study compared the fusion rate, subsidence, and other radiographic parameters according to the material and size of the cages used in BE-TLIF.
Methods:
In this retrospective cohort study, patients who underwent single-segment BE-TLIF between April 2019 and February 2023 were divided into 3 groups: group A, regular-sized three-dimensionally (3D)-printed titanium cages; group B, regular-sized polyetheretherketone cages; and group C, large-sized 3D-printed titanium cages. Radiographic parameters, including lumbar lordosis, segmental lordosis, anterior and posterior disc heights, disc angle, and foraminal height, were measured before and after surgery. The fusion rate and severity of cage subsidence were compared between the groups.
Results:
No significant differences were noted in the demographic data or radiographic parameters between the groups. The fusion rate on 1-year postoperative computed tomography was comparable between the groups. The cage subsidence rate was significantly lower in group C than in group A (41.9% vs. 16.7%, p=0.044). The severity of cage subsidence was significantly lower in group C (0.93±0.83) than in groups A (2.20±1.84, p=0.004) and B (1.79±1.47, p=0.048).
Conclusion
Cage materials did not affect the 1-year postoperative outcomes of BE-TLIF; however, subsidence was markedly reduced in large cages. Larger cages may provide more stable postoperative segments.
5.Effect of Cage Material and Size on Fusion Rate and Subsidence Following Biportal Endoscopic Transforaminal Lumbar Interbody Fusion
Ki-Han YOU ; Samuel K. CHO ; Jae-Yeun HWANG ; Sun-Ho CHA ; Min-Seok KANG ; Sang-Min PARK ; Hyun-Jin PARK
Neurospine 2024;21(3):973-983
Objective:
Biportal endoscopic transforaminal lumbar interbody fusion (BE-TLIF) is an emerging, minimally invasive technique performed under biportal endoscopic guidance. However, concerns regarding cage subsidence and sufficient fusion during BE-TLIF necessitate careful selection of an appropriate interbody cage to improve surgical outcomes. This study compared the fusion rate, subsidence, and other radiographic parameters according to the material and size of the cages used in BE-TLIF.
Methods:
In this retrospective cohort study, patients who underwent single-segment BE-TLIF between April 2019 and February 2023 were divided into 3 groups: group A, regular-sized three-dimensionally (3D)-printed titanium cages; group B, regular-sized polyetheretherketone cages; and group C, large-sized 3D-printed titanium cages. Radiographic parameters, including lumbar lordosis, segmental lordosis, anterior and posterior disc heights, disc angle, and foraminal height, were measured before and after surgery. The fusion rate and severity of cage subsidence were compared between the groups.
Results:
No significant differences were noted in the demographic data or radiographic parameters between the groups. The fusion rate on 1-year postoperative computed tomography was comparable between the groups. The cage subsidence rate was significantly lower in group C than in group A (41.9% vs. 16.7%, p=0.044). The severity of cage subsidence was significantly lower in group C (0.93±0.83) than in groups A (2.20±1.84, p=0.004) and B (1.79±1.47, p=0.048).
Conclusion
Cage materials did not affect the 1-year postoperative outcomes of BE-TLIF; however, subsidence was markedly reduced in large cages. Larger cages may provide more stable postoperative segments.
6.Effect of Cage Material and Size on Fusion Rate and Subsidence Following Biportal Endoscopic Transforaminal Lumbar Interbody Fusion
Ki-Han YOU ; Samuel K. CHO ; Jae-Yeun HWANG ; Sun-Ho CHA ; Min-Seok KANG ; Sang-Min PARK ; Hyun-Jin PARK
Neurospine 2024;21(3):973-983
Objective:
Biportal endoscopic transforaminal lumbar interbody fusion (BE-TLIF) is an emerging, minimally invasive technique performed under biportal endoscopic guidance. However, concerns regarding cage subsidence and sufficient fusion during BE-TLIF necessitate careful selection of an appropriate interbody cage to improve surgical outcomes. This study compared the fusion rate, subsidence, and other radiographic parameters according to the material and size of the cages used in BE-TLIF.
Methods:
In this retrospective cohort study, patients who underwent single-segment BE-TLIF between April 2019 and February 2023 were divided into 3 groups: group A, regular-sized three-dimensionally (3D)-printed titanium cages; group B, regular-sized polyetheretherketone cages; and group C, large-sized 3D-printed titanium cages. Radiographic parameters, including lumbar lordosis, segmental lordosis, anterior and posterior disc heights, disc angle, and foraminal height, were measured before and after surgery. The fusion rate and severity of cage subsidence were compared between the groups.
Results:
No significant differences were noted in the demographic data or radiographic parameters between the groups. The fusion rate on 1-year postoperative computed tomography was comparable between the groups. The cage subsidence rate was significantly lower in group C than in group A (41.9% vs. 16.7%, p=0.044). The severity of cage subsidence was significantly lower in group C (0.93±0.83) than in groups A (2.20±1.84, p=0.004) and B (1.79±1.47, p=0.048).
Conclusion
Cage materials did not affect the 1-year postoperative outcomes of BE-TLIF; however, subsidence was markedly reduced in large cages. Larger cages may provide more stable postoperative segments.
7.Effect of Cage Material and Size on Fusion Rate and Subsidence Following Biportal Endoscopic Transforaminal Lumbar Interbody Fusion
Ki-Han YOU ; Samuel K. CHO ; Jae-Yeun HWANG ; Sun-Ho CHA ; Min-Seok KANG ; Sang-Min PARK ; Hyun-Jin PARK
Neurospine 2024;21(3):973-983
Objective:
Biportal endoscopic transforaminal lumbar interbody fusion (BE-TLIF) is an emerging, minimally invasive technique performed under biportal endoscopic guidance. However, concerns regarding cage subsidence and sufficient fusion during BE-TLIF necessitate careful selection of an appropriate interbody cage to improve surgical outcomes. This study compared the fusion rate, subsidence, and other radiographic parameters according to the material and size of the cages used in BE-TLIF.
Methods:
In this retrospective cohort study, patients who underwent single-segment BE-TLIF between April 2019 and February 2023 were divided into 3 groups: group A, regular-sized three-dimensionally (3D)-printed titanium cages; group B, regular-sized polyetheretherketone cages; and group C, large-sized 3D-printed titanium cages. Radiographic parameters, including lumbar lordosis, segmental lordosis, anterior and posterior disc heights, disc angle, and foraminal height, were measured before and after surgery. The fusion rate and severity of cage subsidence were compared between the groups.
Results:
No significant differences were noted in the demographic data or radiographic parameters between the groups. The fusion rate on 1-year postoperative computed tomography was comparable between the groups. The cage subsidence rate was significantly lower in group C than in group A (41.9% vs. 16.7%, p=0.044). The severity of cage subsidence was significantly lower in group C (0.93±0.83) than in groups A (2.20±1.84, p=0.004) and B (1.79±1.47, p=0.048).
Conclusion
Cage materials did not affect the 1-year postoperative outcomes of BE-TLIF; however, subsidence was markedly reduced in large cages. Larger cages may provide more stable postoperative segments.
8.Effect of Cage Material and Size on Fusion Rate and Subsidence Following Biportal Endoscopic Transforaminal Lumbar Interbody Fusion
Ki-Han YOU ; Samuel K. CHO ; Jae-Yeun HWANG ; Sun-Ho CHA ; Min-Seok KANG ; Sang-Min PARK ; Hyun-Jin PARK
Neurospine 2024;21(3):973-983
Objective:
Biportal endoscopic transforaminal lumbar interbody fusion (BE-TLIF) is an emerging, minimally invasive technique performed under biportal endoscopic guidance. However, concerns regarding cage subsidence and sufficient fusion during BE-TLIF necessitate careful selection of an appropriate interbody cage to improve surgical outcomes. This study compared the fusion rate, subsidence, and other radiographic parameters according to the material and size of the cages used in BE-TLIF.
Methods:
In this retrospective cohort study, patients who underwent single-segment BE-TLIF between April 2019 and February 2023 were divided into 3 groups: group A, regular-sized three-dimensionally (3D)-printed titanium cages; group B, regular-sized polyetheretherketone cages; and group C, large-sized 3D-printed titanium cages. Radiographic parameters, including lumbar lordosis, segmental lordosis, anterior and posterior disc heights, disc angle, and foraminal height, were measured before and after surgery. The fusion rate and severity of cage subsidence were compared between the groups.
Results:
No significant differences were noted in the demographic data or radiographic parameters between the groups. The fusion rate on 1-year postoperative computed tomography was comparable between the groups. The cage subsidence rate was significantly lower in group C than in group A (41.9% vs. 16.7%, p=0.044). The severity of cage subsidence was significantly lower in group C (0.93±0.83) than in groups A (2.20±1.84, p=0.004) and B (1.79±1.47, p=0.048).
Conclusion
Cage materials did not affect the 1-year postoperative outcomes of BE-TLIF; however, subsidence was markedly reduced in large cages. Larger cages may provide more stable postoperative segments.
9.Innovative Developments in Lumbar Interbody Cage Materials and Design: A Comprehensive Narrative Review
Sam Yeol CHANG ; Dong-Ho KANG ; Samuel K. CHO
Asian Spine Journal 2024;18(3):444-457
This review comprehensively examines the evolution and current state of interbody cage technology for lumbar interbody fusion (LIF). This review highlights the biomechanical and clinical implications of the transition from traditional static cage designs to advanced expandable variants for spinal surgery. The review begins by exploring the early developments in cage materials, highlighting the roles of titanium and polyetheretherketone in the advancement of LIF techniques. This review also discusses the strengths and limitations of these materials, leading to innovations in surface modifications and the introduction of novel materials, such as tantalum, as alternative materials. Advancements in three-dimensional printing and surface modification technologies form a significant part of this review, emphasizing the role of these technologies in enhancing the biomechanical compatibility and osseointegration of interbody cages. In addition, this review explores the increase in biodegradable and composite materials such as polylactic acid and polycaprolactone, addressing their potential to mitigate long-term implant-related complications. A critical evaluation of static and expandable cages is presented, including their respective clinical and radiological outcomes. While static cages have been a mainstay of LIF, expandable cages are noted for their adaptability to the patient’s anatomy, reducing complications such as cage subsidence. However, this review highlights the ongoing debate and the lack of conclusive evidence regarding the superiority of either cage type in terms of clinical outcomes. Finally, this review proposes future directions for cage technology, focusing on the integration of bioactive substances and multifunctional coatings and the development of patient-specific implants. These advancements aim to further enhance the efficacy, safety, and personalized approach of spinal fusion surgeries. Moreover, this review offers a nuanced understanding of the evolving landscape of cage technology in LIF and provides insights into current practices and future possibilities in spinal surgery.
10.Comparison of cardiovascular event predictability between the 2009 and 2021 Chronic Kidney Disease Epidemiology Collaboration equations in a Korean chronic kidney disease cohort: the KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease
Ji Hye KIM ; Minjung KANG ; Eunjeong KANG ; Hyunjin RYU ; Yujin JEONG ; Jayoun KIM ; Sue K. PARK ; Jong Cheol JEONG ; Tae-Hyun YOO ; Yaeni KIM ; Yong Chul KIM ; Seung Seok HAN ; Hajeong LEE ; Kook-Hwan OH
Kidney Research and Clinical Practice 2023;42(6):700-711
The 2009 Chronic Kidney Disease Epidemiology Collaboration creatinine-based estimated glomerular filtration rate (eGFRcr) equation contains a race component that is not based on biology and may cause a bias in results. Therefore, the 2021 eGFRcr and creatinine-cystatin C–based eGFR (eGFRcr-cysC) equations were developed with no consideration of race. This study compared the cardiovascular event (CVE) and all-cause mortality and CVE combined predictability among the three eGFR equations in Korean chronic kidney disease (CKD) patients. Methods: This study included 2,207 patients from the KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease. Receiver operating characteristic (ROC) and net reclassification improvement (NRI) index were used to compare the predictability of the study outcomes according to the 2009 eGFRcr, 2021 eGFRcr, and 2021 eGFRcr-cysC equations. Results: The overall prevalence of CVE and all-cause mortality were 9% and 7%, respectively. There was no difference in area under the curve of ROC for CVE and mortality and CVE combined among all three equations. Compared to the 2009 eGFRcr, both the 2021 eGFRcr (NRI, 0.013; 95% confidence interval [CI], – 0.002 to 0.028) and the eGFRcr-cysC (NRI, –0.001; 95% CI, –0.031 to 0.029) equations did not show improved CVE predictability. Similar findings were observed for mortality and CVE combined predictability with both the 2021 eGFRcr (NRI, –0.019; 95% CI, –0.039–0.000) and the eGFRcr-cysC (NRI, –0.002; 95% CI, –0.023 to 0.018). Conclusion: The 2009 eGFRcr equation was not inferior to either the 2021 eGFRcr or eGFRcr-cysC equation in predicting CVE and the composite of mortality and CVE in Korean CKD patients.

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