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.Treatment of Chronic Osteomyelitis on Medial Malleouls after Electrical Burn Injury by Propeller Flap: A Case Study.
Seung Bum PYO ; Seong Yoon LIM ; Jin Kyung SONG ; Hong Sil JOO
Journal of Korean Burn Society 2017;20(2):64-67
It is known that cases of osteomyelitis are less common than 5% in deep burn cases. This research presents a case of chronic osteomyelitis, presented 7 years after initial electrical burn injury. A 43-year-old male patient was admitted to the Department of Plastic Surgery, suffering from an 22900-voltage electrical burn on right medial malleolus in 2010. There was no postoperative complication for five years observation. In November 2016, he was admitted to the Plastic Surgery department, suffering from the skin and soft tissue defect on right medial malleolus without trauma history. The osteomyelitis on the right medial malleolus was found in bone scintigraphy. The medial malleolus was covered with a local flap two days after admission. Dehiscence was found after surgery and exudate was emerged continuously from the flap site. We decided to cover the raw surface with a perforator based propeller flap 22 days after admission considering reconstructive ladder. The flap survived successfully, and partial epidermal sloughing was healed completely by daily dressing at 51 days after the surgery. It is advisable to establish and access the prudent plan before surgery through many kinds of radiological tests and physical examinations considering vascular stability and delayed wound healing.
Adult
;
Bandages
;
Burns*
;
Exudates and Transudates
;
Humans
;
Male
;
Osteomyelitis*
;
Physical Examination
;
Postoperative Complications
;
Radionuclide Imaging
;
Skin
;
Surgery, Plastic
;
Wound Healing
5.Reconstruction of Large Orbital Floor Defect Caused by Maxillary Sinus Mucocele.
Seung Bum PYO ; Jin Kyung SONG ; Hong Sil JU ; Seong Yoon LIM
Archives of Craniofacial Surgery 2017;18(3):197-201
Maxillary sinus mucocele can occur due to many medical factors such as chronic infection, allergic sinonasal disease, trauma, and previous surgery. However, it occurs mainly after Caldwell-Luc operation, usually more than 10 years after surgery. There are a few cases of maxillary sinus mucocele with ocular symptoms. Also, a case causing ocular symptoms because of invasion to the orbital floor is rare. Therefore, we report a case of a 55-year-old male patient who underwent Caldwell-Luc operation about 30 years ago. Then, symptoms such as exophthalmos, diplopia, and visual disturbance developed suddenly 3 months prior to admission. Computed tomography showed a cyst invading the orbital floor which resulted in eyeball deviation. The orbital floor defect measured approximately 2.5×3.3 cm. Maxillary sinus mucocele was removed through an endoscopic approach. After this, we reconstructed the orbital floor through a subciliary incision. Observation was carried out after three years, and ocular symptoms such as diplopia and exophthalmos did not recur.
Diplopia
;
Exophthalmos
;
Humans
;
Male
;
Maxillary Sinus*
;
Middle Aged
;
Mucocele*
;
Orbit*
6.Periumbilical Dermal Graft as a Good Option for Volume Enhancement in Secondary Cleft Lip Deformity: A Case Report.
Seung Bum PYO ; Hong Sil JU ; Soo A LIM ; Jin Kyung SONG ; Seong Yoon LIM
Archives of Aesthetic Plastic Surgery 2017;23(1):53-56
Volume deficiency and poorly defined cupid's bow of the upper lip are frequently encountered problems in secondary cleft lip deformities. In this report, we present the method of a periumbilical dermal graft for correcting secondary cleft lip deformity. A 17-year-old male patient presented with a poorly defined notching cupid's bow and volume deficiency of the upper lip. He had undergone cleft lip surgery when he was 2 years old. We planned to perform a periumbilical dermal graft. There were sufficient amount of periumbilical subdermis and fat tissue thickness to obtain abundant volume. The periumbilical contour was similar to the natural contour of the lip. Less scarring was expected. There was no need to change the posture during operation, making it easy to harvest. Postoperative evaluations showed vermilion symmetry. Ideal cupid's bow shape and position were achieved without color mismatch. As a result, we obtained an ideal volume of the upper lip. Therefore a periumbilical dermal graft is a good option for correcting volume deficiency of the lip with good aesthetic outcomes.
Adolescent
;
Cicatrix
;
Cleft Lip*
;
Congenital Abnormalities*
;
Dermis
;
Humans
;
Lip
;
Male
;
Methods
;
Posture
;
Transplants*
;
Umbilicus
7.Pyogenic Liver Abscess: Changes in Clinical Features over the Last 10 Years.
Joo Ho PARK ; Tae Hee LEE ; Min Gyu KANG ; Mi Young LEE ; Myung Jun LEE ; Jin Sil PYO ; Jung Ho PARK ; Hoon Sup KOO ; Kyung Ho SONG ; Yong Seok KIM ; Sun Moon KIM ; Kyu Chan HUH ; Young Woo CHOI ; Young Woo KANG
Korean Journal of Medicine 2015;88(6):663-671
BACKGROUND/AIMS: A pyogenic liver abscess is an acute bacterial infection that can potentially lead to life-threatening sepsis. This study examined the clinical features and changing trends of pyogenic liver abscess over the last 10 years. METHODS: We investigated patient characteristics, laboratory findings, blood and abscess culture results, location and characteristics of the abscess, and treatment modality in the medical records of 146 patients. We divided them into three groups by period: period 1, 23 patients in 2002-2003; period 2, 46 patients in 2007-2008; and period 3, 77 patients in 2012-2013. RESULTS: The mean patient age was 64.3 +/- 15.1 years and 87 of the 146 patients were male (59.6%). Period 2 had a higher prevalence of chronic alcoholics (30.4% vs. 10.4%) and lower prevalence of fever and chills (73.9% vs. 92.2%) compared with period 3. Klebsiella pneumoniae was the most commonly cultured bacteria and the microbiological findings did not differ among the three periods. Pyogenic liver abscesses were more common in the right liver. The lengths of hospital stay and treatment modalities were similar in all three periods. CONCLUSIONS: Although there were slight differences in symptoms among the periods, there were no changes in the liver abscess characteristics, i.e., location, size, and culture results. As there were no changes, the treatment strategy also did not change. We should continue to investigate the clinical features of liver abscess.
Abscess
;
Alcoholics
;
Bacteria
;
Bacterial Infections
;
Chills
;
Drainage
;
Fever
;
Humans
;
Klebsiella pneumoniae
;
Length of Stay
;
Liver
;
Liver Abscess
;
Liver Abscess, Pyogenic*
;
Male
;
Medical Records
;
Prevalence
;
Sepsis
8.Necessity of Upper Gastrointestinal Endoscopy in Patients with Noncardiac Chest Pain.
Jin Sil PYO ; Sun Moon KIM ; Yoo Jin UM ; Joo Ah LEE ; Hoon Sup KOO ; Kyung Ho SONG ; Yong Seok KIM ; Tae Hee LEE ; Euyi Hyeog IM ; Kyu Chan HUH ; Yong Woo CHOI ; Young Woo KANG
Korean Journal of Medicine 2013;84(4):515-521
BACKGROUND/AIMS: Gastroesophageal reflux disease (GERD) is the most frequent cause of noncardiac chest pain (NCCP) in Western countries. Gastroduodenal disease has a high prevalence in Korea; thus, it is important to evaluate the stomach/duodenum. We retrospectively reviewed the findings in patients with chest pain who were diagnosed by coronary angiography (CAG) to be normal or who had minimal coronary lesions to evaluate the necessity of performing esophagogastroduodenoscopy (EGD) in patients with NCCP. METHODS: A total of 565 patients with chest pain underwent CAG followed by EGD from February 2000 to March 2011 at Konyang University Hospital. We excluded patients who underwent EGD more than 3 days after CAG or had significant coronary lesions. We retrospectively reviewed the EGD findings of the remaining 349 patients. RESULTS: Of the 349 patients, 151 were male, and the average age of the patients was 57.7+/-11.44 years. After performing EGD, GERD was diagnosed in 35 patients (10.0%; LA [Los Angeles classification]-A, 30; LA-B, three; LA-C, two) and peptic ulcer was diagnosed in 48 patients (13.8%; gastric ulcer, 34; duodenal ulcer, 10; gastric and duodenal ulcer, four). Gastritis was diagnosed in 253 patients (72.5%; erosive, 89; erythematous, 90; hemorrhagic, 10; mixed, 64). Duodenitis, esophagitis, Barrett's esophagus, hiatus hernia, and gastric cancer was diagnosed in 36 (10.3%), three (0.9%), two (0.6%), three (0.9%), and one patient, respectively. CONCLUSIONS: Unlike the situation in the west, stomach/duodenal lesions other than GERD are common causes of NCCP in Korea, Therefore, prior to proton pump inhibitor testing or empirical therapy, EGD is necessary to evaluate NCCP and to rule out gastroduodenal lesions.
Barrett Esophagus
;
Chest Pain
;
Coronary Angiography
;
Duodenal Ulcer
;
Duodenitis
;
Endoscopy
;
Endoscopy, Digestive System
;
Endoscopy, Gastrointestinal
;
Esophagitis
;
Gastritis
;
Gastroesophageal Reflux
;
Hernia, Hiatal
;
Humans
;
Korea
;
Male
;
Peptic Ulcer
;
Prevalence
;
Proton Pumps
;
Retrospective Studies
;
Stomach Neoplasms
;
Stomach Ulcer
;
Thorax
9.A Case of Crohn's Disease Accompanied by Peutz-Jeghers Syndrome.
Yoo Jin UM ; Sun Moon KIM ; Jin Sil PYO ; Joo Ah LEE ; Hoon Sup KOO ; Kyu Chan HUH
The Korean Journal of Gastroenterology 2013;62(4):243-247
Peutz-Jeghers syndrome is an autosomal dominant inherited disorder characterized by multiple gastrointestinal hamartomatous polyps and mucocutaneous pigmentation. Peutz-Jeghers syndrome has an incidence of approximately 1 in 25,000 to 300,000 births. Crohn's disease is a chronic inflammatory bowel disease that typically manifests as regional enteritis with its incidence ranging from 3.1 to 14.6 cases per 100,000 person-years in North America. Herein, we report a case of a 30-year-old male patient who had both Peutz-Jeghers syndrome and Crohn's disease. We believe that this is the first case in Korea and the second report in the English literatures on Peutz-Jeghers syndrome coincidentally accompanied by Crohn's disease.
Adult
;
Crohn Disease/complications/*diagnosis/pathology
;
Endoscopy, Gastrointestinal
;
Humans
;
Intestinal Obstruction/etiology
;
Intestinal Perforation/etiology
;
Intestinal Polyps/pathology/surgery
;
Male
;
Peutz-Jeghers Syndrome/complications/*diagnosis/genetics
;
Protein-Serine-Threonine Kinases/genetics
10.A Case of Rectal Ulcer Bleeding Caused by Garlic Inserted into the Rectum.
Mahn LEE ; Han Na LEE ; Ji Hye KIM ; Hyun Jung SONG ; Dong Ju YANG ; Jin Sil PYO ; Yoo Jin UM ; Kyu Chan HUH
Intestinal Research 2012;10(2):206-209
Lower gastrointestinal bleeding can be caused by various etiologies including hemorrhoids, diverticulitis, neoplasms, and ulcerative colitis. However, a rectal ulcer is rarely caused by lower gastrointestinal bleeding, and an anorectal foreign body is a very rare cause of a rectal ulcer. We report the case of a 48-year-old male patient who presented to the emergency department with massive hematochezia and hypovolemic shock that occurred 5 days after inserting garlic into the rectum for treatment of benign prostate hyperplasia.
Colitis, Ulcerative
;
Diverticulitis
;
Emergencies
;
Foreign Bodies
;
Garlic
;
Gastrointestinal Hemorrhage
;
Hemorrhage
;
Hemorrhoids
;
Humans
;
Hyperplasia
;
Male
;
Middle Aged
;
Prostate
;
Rectum
;
Shock
;
Ulcer

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