Cancer Research and Treatment

Original Articles

Gastrointestinal cancer

A Phase 3 Randomized Clinical Trial to Compare Efficacy and Safety between Combination Therapy and Monotherapy in Elderly Patients with Advanced Gastric Cancer (KCSG ST13-10): Keun-Wook Lee, Dae Young Zang, Min-Hee Ryu, Hye Sook Han, Ki Hyang Kim, Mi-Jung Kim, Sung Ae Koh, Sung Sook Lee, Dong-Hoe Koo, Yoon Ho Ko, Byeong Seok Sohn, Jin Won Kim, Jin Hyun Park, Byung-Ho Nam, In Sil Choi; Cancer Res Treat. 2023;55(4):1250-1260. Published online May 25, 2023; DOI: https://doi.org/10.4143/crt.2023.333

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Purpose
This study evaluated whether combination therapy is more effective than monotherapy in elderly patients with metastatic or recurrent gastric cancer (MRGC) as first-line chemotherapy.
Materials and Methods
Elderly (≥ 70 years) chemo-naïve patients with MRGC were allocated to receive either combination therapy (group A: 5-fluorouracil [5-FU]/oxaliplatin, capecitabine/oxaliplatin, capecitabine/cisplatin, or S-1/cisplatin) or monotherapy (group B: 5-FU, capecitabine, or S-1). In group A, starting doses were 80% of standard doses, and they could be escalated to 100% at the discretion of the investigator. Primary endpoint was to confirm superior overall survival (OS) of combination therapy vs. monotherapy.
Results
After 111 of the planned 238 patients were randomized, enrollment was terminated due to poor accrual. In the full-analysis population (group A [n=53] and group B [n=51]), median OS of combination therapy vs. monotherapy was 11.5 vs. 7.5 months (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.56 to 1.30; p=0.231). Median progression-free survival (PFS) was 5.6 vs. 3.7 months (HR, 0.53; 95% CI, 0.34 to 0.83; p=0.005). In subgroup analyses, patients aged 70-74 years tended to have superior OS with combination therapy (15.9 vs. 7.2 months, p=0.056). Treatment-related adverse events (TRAEs) occurred more frequently in group A vs. group B. However, among severe TRAEs (≥ grade 3), there were no TRAEs with a frequency difference of > 5%.
Conclusion
Combination therapy was associated with numerically improved OS, although statistically insignificant, and a significant PFS benefit compared with monotherapy. Although combination therapy showed more frequent TRAEs, there was no difference in the frequency of severe TRAEs.

Citations

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Anlotinib plus toripalimab as a first-line treatment in patients with advanced gastric cancer and performance status 2: the phase II APICAL-GC trial
Ke Liu, Bao-Dong Qin, Shi-Qi Chen, Xue Zhong, Xiao-Peng Duan, Ying Wu, Zhan Wang, Yan Ling, Li Sun, Chen-Yang Ye, Dong-Min Shi, Ning Gao, Xiao-Dong Jiao, Yuan-Sheng Zang
Nature Communications.2025;[Epub] CrossRef
A prognostic nomogram to predict the cancer-specific survival of patients with initially diagnosed metastatic gastric cancer: a validation study in a Chinese cohort
Ziming Zhao, Erxun Dai, Bao Jin, Ping Deng, Zulihaer Salehebieke, Bin Han, Rongfan Wu, Zhaowu Yu, Jun Ren
Clinical and Translational Oncology.2024; 27(1): 135. CrossRef

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Multicenter Retrospective Analysis of Clinical Characteristics, Treatment Patterns, and Outcomes in Very Elderly Patients with Diffuse Large B-Cell Lymphoma: The Korean Cancer Study Group LY16-01: Jung Hye Choi, Tae Min Kim, Hyo Jung Kim, Sung Ae Koh, Yeung-Chul Mun, Hye Jin Kang, Yun Hwa Jung, Hyeok Shim, So Young Chong, Der-Sheng Sun, Soonil Lee, Byeong Bae Park, Jung Hye Kwon, Seung-Hyun Nam, Jun Ho Yi, Young Jin Yuh, Jong-Youl Jin, Jae Joon Han, Seok-Hyun Kim; Cancer Res Treat. 2018;50(2):590-598. Published online June 9, 2017; DOI: https://doi.org/10.4143/crt.2017.172

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Purpose
The treatment strategy for elderly patients older than 80 years with diffuse large B-cell lymphoma (DLBCL) has not been established because of poor treatment tolerability and lack of data.
Materials and Methods
This multicenter retrospective study was conducted to investigate clinical characteristics, treatment patterns and outcomes of patients older than 80 years who were diagnosed with DLBCL at 19 institutions in Korea between 2005 and 2016.
Results
A total of 194 patients were identified (median age, 83.3 years). Of these, 114 patients had an age-adjusted International Prognostic Index (aaIPI) score of 2-3 and 48 had a Charlson index score of 4 or more. R-CHOP was given in 124 cases, R-CVP in 13 cases, other chemotherapy in 17 cases, radiation alone in nine cases, and surgery alone in two cases. Twenty-nine patients did not undergo any treatment. The median number of chemotherapy cycles was three. Only 37 patients completed the planned treatment cycles. The overall response rate from 105 evaluable patientswas 90.5% (complete response, 41.9%). Twentynine patients died due to treatment-related toxicities (TRT). Thirteen patients died due to TRT after the first cycle. Median overall survival was 14.0 months. The main causes of death were disease progression (30.8%) and TRT (27.1%). In multivariate analysis, overall survival was affected by aaIPI, hypoalbuminemia, elevated creatinine, and treatment.
Conclusion
Age itself should not be a contraindication to treatment. However, since elderly patients show higher rates of TRT due to infection, careful monitoring and dose modification of chemotherapeutic agents is needed.

Citations

Citations to this article as recorded by

Treatment Patterns and Costs Among US Patients With Diffuse Large B-Cell Lymphoma not Treated With 2L Stem Cell Transplantation
Teofilia Acheampong, Tao Gu, Trong Kim Le, Scott J Keating
Future Oncology.2024; 20(10): 623. CrossRef
Identification of independent risk factors for hypoalbuminemia in patients with CKD stages 3 and 4: the construction of a nomogram
Chong-Hui Wang, Meng-Han Jiang, Ji-Min Ma, Ming-Cong Yuan, Lei Liao, Hao-Zhang Duan, Dan Wang, Lian Duan
Frontiers in Nutrition.2024;[Epub] CrossRef
TRAIL Score: A Simple Model to Predict Immunochemotherapy Tolerability in Patients With Diffuse Large B-Cell Lymphoma
Will Harris, Edward J. Bataillard, Yoonha Choi, Tarec C. El-Galaly, Vaikunth Cuchelkar, Carsten Henneges, Antonia Kwan, Daniel J. Schneider, Joseph N. Paulson, Tina G. Nielsen
JCO Clinical Cancer Informatics.2022;[Epub] CrossRef
A Multicenter Study of 239 Patients Aged Over 70 Years With Diffuse Large B-Cell Lymphoma in China
Chunli Yang, Qiaoer Li, Ke Xie, Yakun Zhang, Dania Xiang, Yunwei Han, Liqun Zou
Frontiers in Pharmacology.2022;[Epub] CrossRef
Cachexia index as a potential biomarker for cancer cachexia and a prognostic indicator in diffuse large B‐cell lymphoma
Se‐Il Go, Mi Jung Park, Sungwoo Park, Myoung Hee Kang, Hoon‐Gu Kim, Jung Hun Kang, Jung Hoon Kim, Gyeong‐Won Lee
Journal of Cachexia, Sarcopenia and Muscle.2021; 12(6): 2211. CrossRef
Treatment approaches for older and oldest patients with diffuse large B-cell lymphoma – Use of non-R-CHOP alternative therapies and impact of comorbidities on treatment choices and outcome: A Humedica database retrospective cohort analysis, 2007–2015
Vicki A. Morrison, Laurie Hamilton, Augustina Ogbonnaya, Aditya Raju, Kristin Hennenfent, Aaron Galaznik
Journal of Geriatric Oncology.2020; 11(1): 41. CrossRef
Clinical characteristics, treatment patterns and outcomes of patients older than 80 years diagnosed with DLBCL in China over a 10-year period
Zhan Shi, Xi Tang, Qianwen Shen, Jiayan Chen, Fei Liu, Xi Chen, Jingwen Wang, Jie Zhuang
Cancer Chemotherapy and Pharmacology.2019; 84(1): 127. CrossRef
Antineoplastics

Reactions Weekly.2018; 1701(1): 32. CrossRef

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Effect of Dose Escalation with Single Opioid, Fentanyl Matrix in Patients Not Controlling Cancer Pain: A Multicenter, Prospective, Observational Study in Korea: Sung Ae Koh, Kyung Hee Lee, Mi Jung Kim, Kyu Taek Lee, Seung Woo Park, Seung Hyun Nam, Hun Mo Ryoo; Cancer Res Treat. 2013;45(4):263-269. Published online December 31, 2013; DOI: https://doi.org/10.4143/crt.2013.45.4.263

Abstract PDF PubReader ePub: PURPOSE
End-of-dose failure (EOD) is a clinically common observation and many cancer patients increase the frequency of opioid administration. Fentanyl matrix use is known to be effective in patients with chronic cancer pain. To measure the effectiveness of increase in a single dose of fentanyl matrix in patients whose pain was not controlled sufficiently, we perform this study.
MATERIALS AND METHODS
A multi-center, open-label, prospective, observational study was conducted in 30 hospitals in Korea, between August and December 2008.
RESULTS
A total of 452 patients were enrolled; 404 patients completed the study. The mean pain intensity decreased from 5.27 at the first visit to 3.37 at the end of the trial. There was a significant difference in pain intensity (p < 0.001) between the first and last visits. The percentage of pain intensity difference was 30.1%. The prevalence of EOD at the first visit was 73% from the 452 enrolled patients. After the use of fentanyl patch, EOD decreased from 73% to 56%. Pain intensity of patients experiencing EOD was 5.64 at the baseline compared to 4.27 in patients without EOD. On final visit, pain intensity in patients with and without EOD was 4.02 and 2.54, respectively. The observed adverse events were mainly nausea, asthenia, constipation and diarrhea.
CONCLUSION
This study demonstrated that increasing dose of fentanyl patch decreased pain intensity and decreased the rate of patients experiencing EOD. Thus, fentanyl patch may be an effective modality in cancer patients whose pain was previously not controlled sufficiently; the side effects were as could be expected with an opioid.

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