Cancer Research and Treatment

Original Articles

Clinical Impact of TP53 Mutations in Patients with Head and Neck Cancer Who Were Treated with Targeted Therapies or Immunotherapy: Eun Joo Kang, Shinwon Hwang, Yun-Gyoo Lee, Jong-Kwon Choi, Seong Hoon Shin, Yoon Hee Choi, Keun-Wook Lee, Hyun Woo Lee, Min Kyoung Kim, Seung Taek Lim, Hwan Jung Yun, Sang-Gon Park, Sangwoo Kim, Sung-Bae Kim, Hye Ryun Kim; Received August 28, 2024 Accepted December 21, 2024 Published online December 23, 2024; DOI: https://doi.org/10.4143/crt.2024.836 [Accepted]

Abstract PDF: Purpose
TP53 mutations are common in head and neck squamous cell carcinoma (HNSCC). We evaluated their clinical impact in patients treated with targeted agents or immunotherapy in the KCSG HN15-16 TRIUMPH trial.
Materials and Methods
We analyzed clinical characteristics and outcomes of patients with TP53 mutations in the TRIUMPH trial, a multicenter, biomarker-driven umbrella trial in Korea. Patients were assigned to treatment groups based on genomic profiles: Group 1, alpelisib; Group 2, poziotinib; Group 3, nintedanib; and Group 4, abemaciclib. If there was no identifiable target, the patients were allocated to Group 5 (durvalumab ± tremelimumab).
Results
TP53 mutations were detected in 116/179 patients (64.8%), more frequently in HPV-negative and non-oropharyngeal cancers. Patients with TP53 mutations exhibited shorter progression-free survival (PFS) than TP53 wild-type in all the patients (1.7 vs. 3.8 months, p=0.002) and in those who received targeted treatments (2.5 vs. 7.3 months, p=0.009). Furthermore, TP53 mutations were strongly associated with poor overall survival than TP53 wild-type in all the patients (11.1 vs. 28.8 months, p=0.005) and in Group 5 (8.1 vs. 33.0 months, p=0.001).
Conclusion
TP53 mutations were associated with aggressive clinical characteristics and poor survival, particularly in HNSCC patients treated with immunotherapy.

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General

The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group: Bum Jun Kim, Chi Hoon Maeng, Bhumsuk Keam, Young-Hyuck Im, Jungsil Ro, Kyung Hae Jung, Seock-Ah Im, Tae Won Kim, Jae Lyun Lee, Dae Seog Heo, Sang-We Kim, Keunchil Park, Myung-Ju Ahn, Byoung Chul Cho, Hoon-Kyo Kim, Yoon-Koo Kang, Jae Yong Cho, Hwan Jung Yun, Byung-Ho Nam, Dae Young Zang; Cancer Res Treat. 2025;57(1):39-46. Published online July 10, 2024; DOI: https://doi.org/10.4143/crt.2024.421

Abstract PDF PubReader ePub: Purpose
The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients.
Materials and Methods
We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided.
Results
From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient.
Conclusion
Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.

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Hematologic malignancy

Pegfilgrastim Prophylaxis Is Effective in the Prevention of Febrile Neutropenia and Reduces Mortality in Patients Aged ≥ 75 Years with Diffuse Large B-Cell Lymphoma Treated with R-CHOP: A Prospective Cohort Study: Seong Hyun Jeong, Seok Jin Kim, Dok Hyun Yoon, Yong Park, Hye Jin Kang, Youngil Koh, Gyeong-Won Lee, Won-Sik Lee, Deok-Hwan Yang, Young Rok Do, Min Kyoung Kim, Kwai Han Yoo, Yoon Seok Choi, Hwan Jung Yun, Jun Ho Yi, Jae-Cheol Jo, Hyeon-Seok Eom, Jae-Yong Kwak, Ho-Jin Shin, Byeong Bae Park, Shin Young Hyun, Seong Yoon Yi, Ji-Hyun Kwon, Sung Yong Oh, Hyo Jung Kim, Byeong Seok Sohn, Jong Ho Won, Se-Hyung Kim, Ho-Sup Lee, Cheolwon Suh, Won Seog Kim; Cancer Res Treat. 2022;54(4):1268-1277. Published online December 30, 2021; DOI: https://doi.org/10.4143/crt.2021.1168

Abstract PDF Supplementary Material PubReader ePub: Purpose
Febrile neutropenia (FN) can cause suboptimal treatment and treatment-related mortality (TRM) in diffuse large B-cell lymphoma (DLBCL) patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP).
Materials and methods
We conducted a prospective cohort study to evaluate the effectiveness of pegfilgrastim prophylaxis in DLBCL patients receiving R-CHOP, and we compared them with the PROCESS cohort (n=485).
Results
Since January 2015, 986 patients with DLBCL were enrolled. Pegfilgrastim was administered at least once in 930 patients (94.3%), covering 90.3% of all cycles. FN developed in 137 patients (13.9%) in this cohort (23.7% in the PROCESS cohort, p<0.001), and 4.2% of all cycles (10.2% in the PROCESS cohort, p<0.001). Dose delay was less common (≥3 days: 18.1% vs. 23.7%, p=0.015; ≥5 days: 12.0% vs. 18.3%, p=0.023) in this cohort than in the PROCESS cohort. The incidence of TRM (3.2% vs. 5.6%, p=0.047) and infection-related death (1.8% vs. 4.5%, p=0.004) was lower in this cohort than in the PROCESS cohort. The 4-year overall survival (OS) and progression-free survival (PFS) rates of the two cohorts were not different (OS: 73.0% vs. 71.9%, p=0.545; PFS: 69.5% vs. 68.8%, p=0.616). However, in patients aged ≥75 years, the 4-year OS and PFS rates were higher in this cohort than in the PROCESS cohort (OS: 49.6% vs. 33.7%, p=0.032; PFS: 44.2% vs. 30.3% p=0.047).
Conclusion
Pegfilgrastim prophylaxis is effective in the prevention of FN and infection-related death in DLBCL patients receiving R-CHOP, and it also improves OS in patients aged ≥75 years.

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Head and Neck cancer

Induction Chemotherapy as a Prognostication Index and Guidance for Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma: The Concept of Chemo-Selection (KCSG HN13-01): Yun-Gyoo Lee, Eun Joo Kang, Bhumsuk Keam, Jin-Hyuk Choi, Jin-Soo Kim, Keon Uk Park, Kyoung Eun Lee, Hyo Jung Kim, Keun-Wook Lee, Min Kyoung Kim, Hee Kyung Ahn, Seong Hoon Shin, Hye Ryun Kim, Sung-Bae Kim, Hwan Jung Yun; Cancer Res Treat. 2022;54(1):109-117. Published online April 27, 2021; DOI: https://doi.org/10.4143/crt.2020.1329

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Purpose
Certain patient subgroups who do not respond to induction chemotherapy (IC) show inherent chemoresistance in locally advanced head and neck squamous cell carcinoma (LA-HNSCC). This study aimed to assess the prognostic value of IC, and role of IC in guiding the selection of a definitive locoregional therapy.
Materials and Methods
Out of the 445 patients in multi-institutional LA-HNSCC cohort, 158 (36%) receiving IC were enrolled. The study outcome was to assess overall survival (OS) through IC responsiveness and its role to select subsequent treatments.
Results
Among 135 patients who completed subsequent treatment following IC, 74% responded to IC (complete response in 17% and partial response in 58%). IC-non-responders showed 4.5 times higher risk of mortality than IC-responders (hazard ratio, 4.52; 95% confidence interval, 2.32 to 8.81; p < 0.001). Among IC-responders, 84% subsequently received definitive concurrent chemoradiotherapy (CCRT) and OS was not differed by surgery or CCRT (p=0.960). Regarding IC-non-responders, 54% received CCRT and 46% underwent surgery, and OS was poor in CCRT (24-month survival rate of 38%) or surgery (24-month survival rate of 63%).
Conclusion
Response to IC is a favorable prognostic factor. For IC-responders, either surgery or CCRT achieved similar survival probabilities. For IC-non-responder, multidisciplinary approach was warranted reflecting patients’ preference, morbidity, and prognosis.

Citations

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A Randomized, Open-Label, Phase II Study Comparing Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed versus Pemetrexed Alone in Patients with Epidermal Growth Factor Receptor (EGFR)-Mutant Non-small Cell Lung Cancer after Failure of First-Line EGFR Tyrosine Kinase Inhibitor: KCSG-LU12-13: Kwai Han Yoo, Su Jin Lee, Jinhyun Cho, Ki Hyeong Lee, Keon Uk Park, Ki Hwan Kim, Eun Kyung Cho, Yoon Hee Choi, Hye Ryun Kim, Hoon-Gu Kim, Heui June Ahn, Ha Yeon Lee, Hwan Jung Yun, Jin-Hyoung Kang, Jaeheon Jeong, Moon Young Choi, Sin-Ho Jung, Jong-Mu Sun, Se-Hoon Lee, Jin Seok Ahn, Keunchil Park, Myung-Ju Ahn; Cancer Res Treat. 2019;51(2):718-726. Published online September 3, 2018; DOI: https://doi.org/10.4143/crt.2018.324

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Purpose
The optimal cytotoxic regimens have not been established for patients with non-small cell lung cancer (NSCLC) who develop disease progression on first-line epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI).
Materials and Methods
We conducted a multi-center randomized phase II trial to compare the clinical outcomes between pemetrexed plus cisplatin combination therapy followed by maintenance pemetrexed (PC) and pemetrexed monotherapy (P) after failure of first-line EGFR-TKI. The primary objective was progression-free survival (PFS), and secondary objectives included overall response rate (ORR), overall survival (OS), health-related quality of life (HRQOL), and safety and toxicity profiles.
Results
A total of 96 patientswere randomized, and 91 patientswere treated at 14 centers in Korea. The ORR was 34.8% (16/46) for the PC arm and 17.8% (8/45) for the P arm (p=0.066). With 23.4 months of follow-up, the median PFS was 5.4 months in the PC arm and 6.4 months in the P arm (p=0.114). The median OS was 17.9 months and 15.7 months in PC and P arms, respectively (p=0.787). Adverse events ≥ grade 3 were reported in 12 patients (26.1%) in the PC arm and nine patients (20.0%) in the P arm (p=0.491). The overall time trends of HRQOL were not significantly different between the two arms.
Conclusion
The outcomes of pemetrexed therapy in NSCLC patients with disease progression after firstline EGFR-TKI might not be improved by adding cisplatin.

Citations

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The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun Kim, Chi Hoon Maeng, Bhumsuk Keam, Young-Hyuck Im, Jungsil Ro, Kyung Hae Jung, Seock-Ah Im, Tae Won Kim, Jae Lyun Lee, Dae Seog Heo, Sang-We Kim, Keunchil Park, Myung-Ju Ahn, Byoung Chul Cho, Hoon-Kyo Kim, Yoon-Koo Kang, Jae Yong Cho, Hwan Jung Yu
Cancer Research and Treatment.2025; 57(1): 39. CrossRef
Osimertinib with Chemotherapy in EGFR -Mutated NSCLC

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Correspondence

TRIUMPH Trial: One Small Step Could Become One Giant Leap for Precision Oncology in Head and Neck Cancer: Bhumsuk Keam, Hye Ryun Kim, Hwan Jung Yun; Cancer Res Treat. 2019;51(1):413-414. Published online July 31, 2018; DOI: https://doi.org/10.4143/crt.2018.335

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Citations

Citations to this article as recorded by

Personalized Biomarker-Based Umbrella Trial for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: KCSG HN 15-16 TRIUMPH Trial
Bhumsuk Keam, Min Hee Hong, Seong Hoon Shin, Seong Gu Heo, Ji Eun Kim, Hee Kyung Ahn, Yun-Gyoo Lee, Keon-Uk Park, Tak Yun, Keun-Wook Lee, Sung-Bae Kim, Sang-Cheol Lee, Min Kyoung Kim, Sang Hee Cho, So Yeon Oh, Sang-Gon Park, Shinwon Hwang, Byung-Ho Nam, S
Journal of Clinical Oncology.2024; 42(5): 507. CrossRef
Comprehensive Analysis of Mutation-Based and Expressed Genes-Based Pathways in Head and Neck Squamous Cell Carcinoma
Bhumsuk Keam, Jin-Young Park, Jin-Pyo Kim, Gun-Do Kim, Yun-Suk Yu, Sang-Hee Cho, Sangwoo Kim, Hee-Kyung Ahn, Sang-Hoon Chun, Jung-Hye Kwon, Tak Yun, Ji-Won Kim, Ji-Eun Kim, Myung-Ju Ahn, Joo-Hang Kim, Hwan-Jung Yun
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Therapeutic implications of activating noncanonical PIK3CA mutations in head and neck squamous cell carcinoma
Nan Jin, Bhumsuk Keam, Janice Cho, Michelle J. Lee, Hye Ryun Kim, Hayarpi Torosyan, Natalia Jura, Patrick K.S. Ng, Gordon B. Mills, Hua Li, Yan Zeng, Zohar Barbash, Gabi Tarcic, Hyunseok Kang, Julie E. Bauman, Mi-Ok Kim, Nathan K. VanLandingham, Danielle
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What's New in Molecular Targeted Therapies for Head and Neck Cancer?
Seoyoung Lee, Hye Ryun Kim
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Original Articles

Investigating the Feasibility of Targeted Next-Generation Sequencing to Guide the Treatment of Head and Neck Squamous Cell Carcinoma: Sun Min Lim, Sang Hee Cho, In Gyu Hwang, Jae Woo Choi, Hyun Chang, Myung-Ju Ahn, Keon Uk Park, Ji-Won Kim, Yoon Ho Ko, Hee Kyung Ahn, Byoung Chul Cho, Byung-Ho Nam, Sang Hoon Chun, Ji Hyung Hong, Jung Hye Kwon, Jong Gwon Choi, Eun Joo Kang, Tak Yun, Keun-Wook Lee, Joo-Hang Kim, Jin Soo Kim, Hyun Woo Lee, Min Kyoung Kim, Dongmin Jung, Ji Eun Kim, Bhumsuk Keam, Hwan Jung Yun, Sangwoo Kim, Hye Ryun Kim; Cancer Res Treat. 2019;51(1):300-312. Published online May 9, 2018; DOI: https://doi.org/10.4143/crt.2018.012

Abstract PDF Supplementary Material PubReader ePub

Purpose
Head and neck squamous cell carcinoma (HNSCC) is a deadly disease in which precision medicine needs to be incorporated. We aimed to implement next-generation sequencing (NGS) in determining actionable targets to guide appropriate molecular targeted therapy in HNSCC patients.
Materials and Methods
Ninety-three tumors and matched blood samples underwent targeted sequencing of 244 genes using the Illumina HiSeq 2500 platform with an average depth of coverage of greater than 1,000×. Clinicopathological data from patients were obtained from 17 centers in Korea, and were analyzed in correlation with NGS data.
Results
Ninety-two of the 93 tumors were amenable to data analysis. TP53 was the most common mutation, occurring in 47 (51%) patients, followed by CDKN2A (n=23, 25%), CCND1 (n=22, 24%), and PIK3CA (n=19, 21%). The total mutational burden was similar between human papillomavirus (HPV)–negative vs. positive tumors, although TP53, CDKN2A and CCND1 gene alterations occurred more frequently in HPV-negative tumors. HPV-positive tumors were significantly associated with immune signature-related genes compared to HPV-negative tumors. Mutations of NOTCH1 (p=0.027), CDKN2A (p < 0.001), and TP53 (p=0.038) were significantly associated with poorer overall survival. FAT1 mutations were highly enriched in cisplatin responders, and potentially targetable alterations such as PIK3CA E545K and CDKN2A R58X were noted in 14 patients (15%).
Conclusion
We found several targetable genetic alterations, and our findings suggest that implementation of precision medicine in HNSCC is feasible. The predictive value of each targetable alteration should be assessed in a future umbrella trial using matched molecular targeted agents.

Citations

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Personalized Biomarker-Based Umbrella Trial for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: KCSG HN 15-16 TRIUMPH Trial
Bhumsuk Keam, Min Hee Hong, Seong Hoon Shin, Seong Gu Heo, Ji Eun Kim, Hee Kyung Ahn, Yun-Gyoo Lee, Keon-Uk Park, Tak Yun, Keun-Wook Lee, Sung-Bae Kim, Sang-Cheol Lee, Min Kyoung Kim, Sang Hee Cho, So Yeon Oh, Sang-Gon Park, Shinwon Hwang, Byung-Ho Nam, S
Journal of Clinical Oncology.2024; 42(5): 507. CrossRef
A Phase II Trial of Nintedanib in Patients with Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma: In-Depth Analysis of Nintedanib Arm from the KCSG HN 15-16 TRIUMPH Trial
Kyoo Hyun Kim, Sun Min Lim, Hee Kyung Ahn, Yun-Gyoo Lee, Keun-Wook Lee, Myung-Ju Ahn, Bhumsuk Keam, Hye Ryun Kim, Hyun Woo Lee, Ho Jung An, Jin-Soo Kim
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Impact of PIK3CA and cell cycle pathway genetic alterations on durvalumab efficacy in patients with head and neck squamous cell carcinoma: Post hoc analysis of TRIUMPH study
Dong Hyun Kim, Seung Taek Lim, Hye Ryun Kim, Eun Joo Kang, Hee Kyung Ahn, Yun-Gyoo Lee, Der Sheng Sun, Jung Hye Kwon, Sang-Cheol Lee, Hyun Woo Lee, Min Kyoung Kim, Bhumsuk Keam, Keon-Uk Park, Seong-Hoon Shin, Hwan Jung Yun
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Mai Atique, Isis Muniz, Fatemeh Farshadi, Michael Hier, Alex Mlynarek, Marco Macarella, Mariana Maschietto, Belinda Nicolau, Moulay A. Alaoui-Jamali, Sabrina Daniela da Silva
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A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy: Results of the Korean South West Oncology Group (KSWOG) Study: So-Yeon Jeon, Hye Sook Han, Woo Kyun Bae, Moo-Rim Park, Hyeok Shim, Sang-Cheol Lee, Se-Il Go, Hwan Jung Yun, Yong-Jin Im, Eun-Kee Song; Cancer Res Treat. 2019;51(1):90-97. Published online February 27, 2018; DOI: https://doi.org/10.4143/crt.2017.577

Abstract PDF PubReader ePub

Purpose
Data on the efficacy of olanzapine in patients receiving moderately emetogenic chemotherapy (MEC) are limited. This study aimed to evaluate and compare the efficacy of olanzapine versus placebo in controlling nausea and vomiting in patients receiving MEC.
Materials and Methods
We conducted a randomized, double-blind, placebo-controlled study to determine whether olanzapine can reduce the frequency of chemotherapy-induced nausea and vomiting (CINV) and improve the quality of life (QOL) in patients receiving palonosetron and dexamethasone as prophylaxis for MEC-induced nausea and vomiting. The primary end point was complete response for the acute phase (0-24 hours after chemotherapy). The secondary end points were complete response for the delayed (24-120 hours) and overall phase (0-120 hours), proportion of significant nausea (visual analogue scale ≥ 25 mm), use ofrescue medications, and effect on QOL.
Results
Fifty-six patients were randomized to the olanzapine (n=29) and placebo (n=27) groups. Complete response rates were not significantly different between the olanzapine and placebo groups in the acute (96.5% vs. 88.0%, p=0.326), delayed (69.0% vs. 48.0%, p=0.118), and overall phases (69.0% vs. 48.0%, p=0.118). However, the percentage of patients with significant nausea (17.2% vs. 44.0%, p=0.032) and the use of rescue medications (0.03±0.19 vs. 1.88±2.88, p=0.002) were lower in the olanzapine group than in the placebo. Furthermore, the olanzapine group demonstrated better QOL (p=0.015).
Conclusion
Olanzapine combined with palonosetron and dexamethasone significantly improved QOL and vomiting control among previously untreated patients receiving MEC, although the efficacy was limited to the reduction of the frequency of CINV.

Citations

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A prospective randomized controlled clinical trial investigating the efficacy of low-dose olanzapine in preventing nausea and vomiting associated with oxaliplatin-based and irinotecan-based chemotherapy
Jing Shen, Juan Zhao, Gaowa Jin, Hui Li, Ying Jiang, Yungaowa Wu, Jiali Gao, Feng Chen, Jiaxuan Li, Wenjuan Wang, Quanfu Li
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Health-Related Quality of Life and Economic Analysis of Olanzapine Versus Aprepitant in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy in Malaysia
Nurul Suhaida Badarudin, Noraida Mohamed Shah, Nurul Ain Mohd Tahir, Azmi Nor Mohd Farez Ahmat, Fuad Ismail, Farida Islahudin, Suhana Yusak, Syahir Muhammad, Kamarun Neasa Begam Mohd Kassim
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Vikas Ostwal, Anant Ramaswamy, Sarika Mandavkar, Prabhat Bhargava, Deepali Naughane, Sharon Flavia Sunn, Sujay Srinivas, Akhil Kapoor, Bal Krishna Mishra, Anuj Gupta, Bipinesh Sansar, Vikash Pal, Aparajita Pandey, Avinash Bonda, Indraja Siripurapu, Vamshi
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Akihiro Uchiike, Haruka Kono, Katsuhiro Miura, Tatsuya Hayama, Daisuke Tsutsumi, Shinya Tsuboi, Susumu Ohtsuka, Shinji Hidaka
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Priya Patel, Paula D. Robinson, Nora Wahib, Patrick Cheung, Thomas Wong, Sandra Cabral, Arden Parker, Marie Cohen, Katie Devine, Paul Gibson, Mark T. Holdsworth, Eloise Neumann, Andrea Orsey, Robert Phillips, Daniela Spinelli, Jennifer Thackray, Marianne
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Ջոակինո Ռոսինիի «Stabat Mater»-ը Հովհաննես Չեքիջյանի մեկնաբանությամբ (նվիրվում է Ռոսինիի «Stabat Mater»-ի ստեղծման 180-ամյակին և Հայաստանի ազգային ակադեմիական երգչախմբի հիմնադրման 85-ամյակին)
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Phase II Study of Irinotecan and Cisplatin Combination Chemotherapy in Metastatic, Unresectable Esophageal Cancer: Miso Kim, Bhumsuk Keam, Tae-Min Kim, Hoon-Gu Kim, Jin-Soo Kim, Sung Sook Lee, Seong Hoon Shin, Min Kyoung Kim, Keon Uk Park, Dong-Wan Kim, Hwan Jung Yun, Jong Seok Lee, Dae Seog Heo; Cancer Res Treat. 2017;49(2):416-422. Published online July 28, 2016; DOI: https://doi.org/10.4143/crt.2016.121

Abstract PDF PubReader ePub

Purpose
The objective of this multicenter phase II study was to evaluate the efficacy and safety of irinotecan and cisplatin combination chemotherapy in metastatic, unresectable esophageal cancer.
Materials and Methods
Patients were treated with irinotecan 65 mg/m² and cisplatin 30 mg/m² on days 1 and 8 of each 21-day treatment cycle. The primary endpoint was response rate, and secondary endpoints were survival, duration of response, initial metabolic response rate, and toxicity.
Results
A total of 27 patients with squamous cell histology were enrolled in the study. The median age of the patients was 61 years. The objective response rate of the 20 patients in the perprotocol group was 30.0% (90% confidence interval [CI], 13.2 to 46.9). The median follow-up duration was 10.0 months, and the median progression-free survival and overall survival were 4.5 months (95% CI, 1.6 to 6.2) and 8.8 months (95% CI, 4.7 to 10.5), respectively. Four of 13 patients (30.8%) evaluated showed initial metabolic response. The median duration of response for partial responders was 5.0 months (range, 3.4 to 8.0 months). The following grade 3/4 treatment-related hematologic toxicities were reported: neutropenia (40.7%), anaemia (22.2%), and thrombocytopenia (7.4%). Two patients experienced febrile neutropenia. The most common grade 3/4 non-hematologic toxicities were asthenia (14.8%) and diarrhoea (11.1%).
Conclusion
Irinotecan and cisplatin combination chemotherapy showed modest anti-tumour activity and manageable toxicity for patients with metastatic, unresectable esophageal cancer.

Citations

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Case Report

A Case of Recurrent Solid Pseudopapillary Tumor of the Pancreas with Involvement of the Spleen and Kidney: Sang Eun Park, Nam Sook Park, Jae Min Chun, Nam Whan Park, Young Joon Yang, Gak Won Yun, Hyo Jin Lee, Hwan Jung Yun, Deog Yeon Jo, Kyu Sang Song, Samyong Kim; Cancer Res Treat. 2006;38(2):118-120. Published online April 30, 2006; DOI: https://doi.org/10.4143/crt.2006.38.2.118

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Solid pseudopapillary tumor of the pancreas (SPTP) is a rare primary pancreatic tumor of an unknown etiology that is usually diagnosed in adolescent girls and young women. Most SPTPs are considered to be benign and only rarely metastasize. We report here on a 27-year old woman with recurrent SPTP with involvement of both the spleen and left kidney at the time of the initial diagnosis, and with aggressive behavior. In July 1995, she was admitted with abdominal discomfort and mass. She underwent exploratory laparotomy with distal pancrea tectomy, left nephrectomy and splenectomy, and was diagnosed with SPTP with invasion to both the spleen and left kidney. In June 2001, she again presented with abdominal pain and was diagnosed as having recurrence of the tumor. She underwent mass excision and omentectomy. Then she was lost to follow-up. In November 2005, she presented once again with an abdominal mass and was diagnosed with recurred SPTP, which formed a huge intraperitoneal mass with peritoneal seeding and the tumor showed multiple metastases in the liver. She is currently being treated conservatively.

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Clinical Pattern of Preoperative Positron Emission Tomography/Computed Tomography (PET/CT) Can Predict the Aggressive Behavior of Resected Solid Pseudopapillary Neoplasm of the Pancreas
Ji-Su Kim, Emmanuel II-Uy Hao, Seoung-Yoon Rho, Ho-Kyoung Hwang, Woo-Jung Lee, Dong-Sub Yoon, Chang-Moo Kang
Cancers.2021; 13(9): 2119. CrossRef

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Original Articles

EAP - 2 ( etoposide , adriamycin , cisplatin ) Combination Chemotherapy for Metastatic Cancer of Unknown Origin: Eui Gun Chun, Jee Young Choi, Hwan Jung Yun, Jun Young Kil, Deog Yeon Jo, Sam Yong Kim; J Korean Cancer Assoc. 1994;26(1):119-127.

Abstract PDF: Background
Optimal management of patients with metastatic cancer of unknown origin (MUO) requires appropriate clinical and pathologic eveluation to identify treatable subgroups and administer specific therapy for each patients subgroup. But, the best treatment in a large population of patients with MUO still remain a problem. Cisplatin-based combination chemotherapy has not been completely studied in Korea. A total of 14 patients with metastatic cancer of unknown origin were studied to evaluate the effectiveness and toxicity of EAP-II combination chemotherapy. Methods: All patients were treated with etoposide 20 mg/m continous IV on Dayl-5, Adriamycin 10 mg/m bolus on Day 1, 5 and cisplatin 20 mg/m(2) continous IV on Day 1-5, every 4 weeks. Results: Of 12 patients evaluable for response, 1(8%) had complete response and 6(50%) showed partial response with a objective response rate of 58%. The median duration of response was 9.7(8-20hnonths and the median survival of all patients was 15.5(4-25hnonths, In the analysis of the response according to various characteristics of the patients, there was no significant difference according to various parameters(P>0.05). Toxicity was generally mild. Whereas nausea and vomiting were mild, neuropathy was the dose limiting toxicity. Conclusion: This study indicates that EAP-II regimen is an active therapy against metaatatic cancer of unknown origin but is associated with significent neurotoxicity. Less toxic and more effective treatment protocol is anticipated.

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Synergistic Antitumor Effects of 5-Fluorouracil ( 5-FU ) and Alpha-interferon 2a Gastric Cnancer Cells: Sam Yong Kim, Sang Jun Park, Jong Suk Kim, Jee Young Choi, Hwan Jung Yun, Eui Gun Chun, Deog Yeon Jo, Chin Sun Bae; J Korean Cancer Assoc. 1995;27(1):8-18.

Abstract PDF: Many in vitro studies or clinical trials reported synergistic effect of the combination of 5-FU and alpha-interferon 2a(IFNa-2a) in patients with colorectal cancer, urinary bladder cancer, and esophageal cancer. There have been few reports on the effects of the combination of 5-FU and IFN against gastric cancer ce11 lines. This study was conducted to investigate the com- bined cytotoxic effects of 5-FU or cisplatin with IFNa-2a against two gastric cancer cell lines. SNU-1 and SNU-l6 cell lines were treated with a serial concentrations of 5-FU plus IFNa-2a (5000: 1, molar ratio) and cisplatin plus IFNa-2a (400: 1, molar ratio). Cytotoxicity was determined using a tetrazolium-based colorimetric (MTT) assay. The combination effect of two drugs was evaluated by the median effect principle after Chou et aL Calculation of Assay-AUC was done after Park et aL In SNU-1 cell line, combination of 5-FU and IFNa-2a showed a synergistic effect (combination index, CI<1). Assay AUC of 5-FU was markedly reduced com- parable to clinically achievable-AUC in all combinations. In SNU-16 cell line, combination of 5- FU or cisplatin with IFNa-2a showed no synergism (CI> 1). But inhibitory concentration (IC ) value was markedly reduced. So 5-FU or cisplatin activity were markedly enhanced by IFNa- 2a, especially at low doses.

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VACOP-B ( VP-16 , doxorubicin , cyclophosphamide , vincristine , prednisone , and bleomycin ) Chemotherapy for Non - Hodgkin's Lymphoma: Jun Young Kil, Jee Young Choi, Hwan Jung Yun, Eui Gun Chun, Deog Yeon Jo, Sam Yong Kim; J Korean Cancer Assoc. 1995;27(1):92-101.

Abstract PDF: Background
VACOP-B(VP-16, doxorubicin, vincristine, prednisone, and bleomycin), a regi- men emphasizing weekly treatment and brief duration (12weeks), has been reported to be ef- fective for the treatment of aggressive non-Hodgkin's lymphoma. We assessed the efficacy and the toxicity of VACOP-B treatment on an outpatient basis in patients with non-Hodgkin's lym- phoma. Patients and Methods: Between August 1990 and August 1994, 25 patients with non-Hodgkin's lymphoma were treated with VACOP-B regimen on an outpatient basis. 23 of the 25 patients (92%)had intermediate-or high-grade lymphomas. Of the 23 evaluable patients, six received prior chemotherapy or radiation therapy. Results: Among the 23 evaluable patients, 19(76%) achieved a complete response and three (12%) achieved partial respones. With a medinan follow-up of 24 months, survival ranged 2~44 + months. The acturial 3 year survival was 54%. Out of the 25 patients, eight (32%) experienced a marked leukopenia (<1,000/mm(3)), of whom seven rmuired hospitalization due to infection. Non-hematologic toxicities were mild; grade I or II toxicities were noticed (mucositis 36%: peripheral neuropathy 68%). Two died of the toxicity related to the chemotherapy(infection1 Lower stage, complete response rather than partial response were associated with a longer survivaL Conclusion: These results indicate that VACOP-B is effective, well tolerated, and feasible on an outpatient basis in the treatment of non-HodRkin's lymphoma. The use of hemopoietic growth factors such as granulocyte-colony stimulating factor or granulocyte-macrophage-colo- ny stimulating factor might circumvent the leukopenia and facilitate delivery of chemotherapy at full doses.

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Effect of Granulocyte-macrophage Colony-stimulating Factor during FCL ( 5-FU , Carboplatin , Leucovorin ) Chemotherapy: Jee Young Choi, Heon Soo Kim, Jong Suk Kim, Sang Jun Park, Hwan Jung Yun, Deog Yeon Jo, Sam Yong Kim; J Korean Cancer Assoc. 1996;28(4):761-768.

Abstract PDF: Background
One of the major side effects of cancer chemotherapy is myelosuppression. Neutropenia and/or thrombocytopenia are dose-limiting factors in chemotherapy. Colony stimulating factor induces proliferation and functional maturation of hematopoietic progenitor cells. GM-CSF is primarily active on progenitor cells of granulocytic and monocytic lineage. Methods: Fifteen patients with histologically proven malignancy diagnosed at Chungnam National University Hospital from January 1993 to August 1995 were included in this study. We could evaluate the clinical efficacy of GM-CSF in l3 patients undergoing FCL(5- FU, Carboplatin and Leucovorin) chemotherapy; the first cycles involved no GM-CSF while the second cycles involved GM-CSF on day 6 through 15 of chemotherapy. Resulte: 1) The subjects were fifteen patients in all, there were five patients with head and neck cancer, which was the most common types of maligancy. There were four patients with colon cancer, two patients with stomach cancer, and one patient with breast cancer, gallbladder cancer, cervix cancer and cholangiocarcinoma respectively. two patients, who did not complete two cycles of chemotherapy were excluded. 2) Age distribution was from 38 years to 78 years with a median age of 57. 3) In FCL chemotherapy cycles with GM-CSF, the duration of neutropenia(<500/￥iL) was 0.5¡¾0.3 day, while FCL chemotherapy cycles without GM-CSF, it was 2.9¡¾0.7 day(P=0.008). 3) There was no significant difference in platelet count between the two chemotherapy cycles(P= 0.133). 4) Febrile duration without GM-CSF was 4.9¡¾2.l day, but with GM-CSF the duration was 1.3¡¾0.7 day, which was significantly different(P=0.003). The duration of antibiotics use with GM-CSF was 1.7¡¾1.2 day and without GM-CSF was 6.8¡¾3.2 day, also significantly different(P= 0.002). But hospital stay between the two cycles were not significantly different(P=0.064). Conclusion: GM-CSF was effective in preventing or restorig bone marrow depression after FCL chemotherapy.

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