Cancer Research and Treatment

Original Articles

Lung and Thoracic cancer

A Randomized Phase II Study of Irinotecan Plus Cisplatin with or without Simvastatin in Ever-Smokers with Extended Disease Small Cell Lung Cancer: Youngjoo Lee, Soo-Hyun Lee, Geon Kook Lee, Eun Jin Lim, Ji-Youn Han; Cancer Res Treat. 2023;55(3):885-893. Published online March 20, 2023; DOI: https://doi.org/10.4143/crt.2023.283

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Purpose
This study evaluated whether an addition of simvastatin to chemotherapy improves survival in ever-smokers with extensive disease (ED)–small cell lung cancer (SCLC).
Materials and Methods
This is an open-label randomized phase II study conducted in National Cancer Center (Goyang, Korea). Chemonaive patients with ED-SCLC, smoking history (≥ 100 cigarettes lifetime), and Eastern Cooperative Oncology Group performance status of ≤ 2 were eligible. Patients were randomized to receive irinotecan plus cisplatin alone or with simvastatin (40 mg once daily orally) for a maximum of six cycles. Primary endpoint was the the 1-year survival rate.
Results
Between September 16, 2011, and September 9, 2021, 125 patients were randomly assigned to the simvastatin (n=62) or control (n=63) groups. The median smoking pack year was 40 years. There was no significant difference in the 1-year survival rate between the simvastatin and control groups (53.2% vs. 58.7%, p=0.535). The median progression-free survival and overall survival between the simvastatin arm vs. the control groups were 6.3 months vs. 6.4 months (p=0.686), and 14.4 months vs. 15.2 months, respectively (p=0.749). The incidence of grade 3-4 adverse events was 62.9% in the simvastatin group and 61.9% in the control group. In the exploratory analysis of lipid profiles, patients with hypertriglyceridemia had significantly higher 1-year survival rates than those with normal triglyceride levels (80.0% vs. 52.7%, p=0.046).
Conclusion
Addition of simvastatin to chemotherapy provided no survival benefit in ever-smokers with ED-SCLC. Hypertriglyceridemia may be associated with better prognosis in these patient population.

Citations

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Cardiovascular/anti‐inflammatory drugs repurposed for treating or preventing cancer: A systematic review and meta‐analysis of randomized trials
David J. Benjamin, Alyson Haslam, Vinay Prasad
Cancer Medicine.2024;[Epub] CrossRef
Repurposing simvastatin in cancer treatment: an updated review on pharmacological and nanotechnological aspects
Nargis Ara, Abdul Hafeez, Shom Prakash Kushwaha
Naunyn-Schmiedeberg's Archives of Pharmacology.2024; 397(10): 7377. CrossRef
Strategies to Target Chemoradiotherapy Resistance in Small Cell Lung Cancer
Tony Yu, Benjamin H. Lok
Cancers.2024; 16(20): 3438. CrossRef
β-blockers and statins: exploring the potential off-label applications in breast, colorectal, prostate, and lung cancers
Pedro Gabriel Senger Braga, Janaína da Silva Vieira, Aline Rachel Bezerra Gurgel, Patricia Chakur Brum
Frontiers in Pharmacology.2024;[Epub] CrossRef
Statins—From Fungi to Pharmacy
Anna Sadowska, Patryk Osiński, Alicja Roztocka, Karolina Kaczmarz-Chojnacka, Ewa Zapora, Diana Sawicka, Halina Car
International Journal of Molecular Sciences.2023; 25(1): 466. CrossRef

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Lung cancer

Phase II Study of Pemetrexed as a Salvage Chemotherapy for Thymidylate Synthase–Low Squamous Cell Lung Cancer: Mihong Choi, Heung Tae Kim, Ji-Youn Han, Geon Kook Lee, Soo-Hyun Lee, Kun Young Lim, Jungnam Joo, Hye Jin Won, Jin Soo Lee, Youngjoo Lee; Cancer Res Treat. 2021;53(1):87-92. Published online August 13, 2020; DOI: https://doi.org/10.4143/crt.2020.741

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Purpose
Squamous cell carcinomas (SqCC) of the lung often express high levels of thymidylate synthase (TS), which is associated with primary resistance to pemetrexed. We explored the efficacy of pemetrexed in a selected population of patients with lung SqCC with low TS expression.
Materials and Methods
In this single-arm phase II trial, we enrolled 32 previously-treated patients with advanced lung SqCC exhibiting low immunohistochemical staining for TS (i.e., in 10% or less of tumor cells). The primary endpoint was 12-week progression-free survival (PFS) rate.
Results
Of 32 patients, eight patients (25%) had an Eastern Cooperative Oncology Group performance status of 2, and seven patients (22%) had previously received three or more lines of chemotherapy. The disease control rate from pemetrexed treatment was 30%, and no objective response was observed. The 12-week PFS rate was 24.5% (95% confidence interval [CI], 13.0 to 46.1). Median PFS was 1.3 months (95% CI, 1.3 to 2.7), and median overall survival was 11.8 months (95% CI, 8.1 to not applicable). Most of adverse events were grade 1 or 2.
Conclusion
Pemetrexed demonstrated modest activity as a salvage chemotherapy in patients with advanced lung SqCC with low TS expression, although its toxicity was generally manageable.

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Bioengineered miR-7-5p modulates non–small cell lung cancer cell metabolism to improve therapy
Gavin M. Traber, Mei-Juan Tu, Su Guan, Neelu Batra, Ai-Ming Yu
Molecular Pharmacology.2025; 107(1): 100006. CrossRef

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Lung Cancer Screening with Low-Dose CT in Female Never Smokers: Retrospective Cohort Study with Long-term National Data Follow-up: Hyae Young Kim, Kyu-Won Jung, Kun Young Lim, Soo-Hyun Lee, Jae Kwan Jun, Jeongseon Kim, Bin Hwangbo, Jin Soo Lee; Cancer Res Treat. 2018;50(3):748-756. Published online July 17, 2017; DOI: https://doi.org/10.4143/crt.2017.312

Abstract PDF Supplementary Material PubReader ePub

Purpose
Because of growing concerns about lung cancer in female never smokers, chest low-dose computed tomography (LDCT) screening is often performed although it has never shown clinical benefits. We examinewhether or not female never smokers really need annual LDCT screening when the initial LDCT showed negative findings.
Materials and Methods
This retrospective cohort study included 4,365 female never smokers aged 40 to 79 years who performed initial LDCT from Aug 2002 to Dec 2007. Lung cancer diagnosis was identified from the Korea Central Cancer Registry Database registered until December 31, 2013. We calculated the incidence, cumulative probability, and standardized incidence ratio (SIR) of lung cancer by Lung Imaging Reporting and Data System (Lung-RADS) categories showed on initial LDCT.
Results
After median follow-up of 9.69 years, 22 (0.5%) had lung cancer. Lung cancer incidence for Lung-RADS category 4 was 1,848.4 (95% confidence interval [CI], 1,132.4 to 3,017.2) per 100,000 person-years and 16.4 (95% CI, 7.4 to 36.4) for categories 1, 2, and 3 combined. The cumulative probability of lung cancer for category 4 was 10.6% at 5 years and 14.8% at 10 years while they were 0.07% and 0.17% when categories 1, 2, and 3 were combined. The SIR for subjects with category 4 was 43.80 (95% CI, 25.03 to 71.14), which was much higher than 0.47 (95% CI, 0.17 to 1.02) for categories 1, 2, and 3 combined.
Conclusion
Considering the low risk of lung cancer development in female never smokers, it seems unnecessary to repeat annual LDCT screening for at least 5 years or even longer unless the initial LDCT showed Lung-RADS category 4 findings.

Citations

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Low Dose Computed Tomography for Lung Cancer Screening in Tuberculosis Endemic Countries: A Systematic Review and Meta-Analysis
Vikram Damaraju, Juhu Kiran Krushna Karri, Gayathri Gandrakota, Yamini Marimuthu, Adimulam Ganga Ravindra, Rajeev Aravindakshan, Navneet Singh
Journal of Thoracic Oncology.2025; 20(3): 296. CrossRef
Radiological Changes in Chest Computed Tomography Findings of School Cooks: A Comparative Study With Age-matched Controls
Jung Hee Hong, Jin Young Kim, Kiook Baek
Safety and Health at Work.2025;[Epub] CrossRef
Lung cancer screening for never smokers: current evidence and future directions
Kay Choong See
Singapore Medical Journal.2024;[Epub] CrossRef
Cooking oil fume exposure and Lung-RADS distribution among school cafeteria workers of South Korea
Minjun Kim, Yangho Kim, A Ram Kim, Woon Jung Kwon, Soyeoun Lim, Woojin Kim, Cheolin Yoo
Annals of Occupational and Environmental Medicine.2024;[Epub] CrossRef
Distribution of Solid Lung Nodules Presence and Size by Age and Sex in a Northern European Nonsmoking Population
Jiali Cai, Marleen Vonder, Gert Jan Pelgrim, Mieneke Rook, Gerdien Kramer, Harry J.M. Groen, Geertruida H. de Bock, Rozemarijn Vliegenthart
Radiology.2024;[Epub] CrossRef
Toward More Effective Lung Cancer Risk Stratification to Empower Screening Programs for the Asian Nonsmoking Population
Fu-Zong Wu, Yeun-Chung Chang
Journal of the American College of Radiology.2023; 20(2): 156. CrossRef
ACR Appropriateness Criteria® Lung Cancer Screening: 2022 Update
Kim L. Sandler, Travis S. Henry, Arya Amini, Saeed Elojeimy, Aine Marie Kelly, Christopher T. Kuzniewski, Elizabeth Lee, Maria D. Martin, Michael F. Morris, Neeraja B. Peterson, Constantine A. Raptis, Gerard A. Silvestri, Arlene Sirajuddin, Betty C. Tong,
Journal of the American College of Radiology.2023; 20(5): S94. CrossRef
Performance of Lung-RADS in different target populations: a systematic review and meta-analysis
Yifei Mao, Jiali Cai, Marjolein A. Heuvelmans, Rozemarijn Vliegenthart, Harry J. M. Groen, Matthijs Oudkerk, Marleen Vonder, Monique D. Dorrius, Geertruida H. de Bock
European Radiology.2023; 34(3): 1877. CrossRef
Preoperative computed tomography-guided patent blue localization for pulmonary nodules
Po-Chih Chang, Shah-Hwa Chou, Che-Yu Chuang, I-Hsiao Yang, Yu-Wei Liu, Ming-Cheng Shi, Reu-Sheng Sheu, Ting-Wei Chang
Formosan Journal of Surgery.2022; 55(3): 102. CrossRef
Lung cancer screening in never-smokers: facts and remaining issues
Maurizio V. Infante, Giuseppe Cardillo
European Respiratory Journal.2020; 56(5): 2002949. CrossRef
Low-dose chest computed tomographic screening and invasive diagnosis of pulmonary nodules for lung cancer in never-smokers
Yeon Wook Kim, Hye-Rin Kang, Byoung Soo Kwon, Sung Yoon Lim, Yeon Joo Lee, Jong Sun Park, Young-Jae Cho, Ho Il Yoon, Kyung Won Lee, Jae Ho Lee, Choon-Taek Lee
European Respiratory Journal.2020; 56(5): 2000177. CrossRef
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Li-Hsin Chien, Chung-Hsing Chen, Tzu-Yu Chen, Gee-Chen Chang, Ying-Huang Tsai, Chin-Fu Hsiao, Kuan-Yu Chen, Wu-Chou Su, Wen-Chang Wang, Ming-Shyan Huang, Yuh-Min Chen, Chih-Yi Chen, Sheng-Kai Liang, Chung-Yu Chen, Chih-Liang Wang, Mei-Hsuan Lee, Ren-Hua C
Cancer Epidemiology, Biomarkers & Prevention.2020; 29(2): 452. CrossRef
Role of Low-Dose Computerized Tomography in Lung Cancer Screening among Never-Smokers
Hye-Rin Kang, Jun Yeun Cho, Sang Hoon Lee, Yeon Joo Lee, Jong Sun Park, Young-Jae Cho, Ho Il Yoon, Kyung Won Lee, Jae Ho Lee, Choon-Taek Lee
Journal of Thoracic Oncology.2019; 14(3): 436. CrossRef
Prevention and Early Detection for NSCLC: Advances in Thoracic Oncology 2018
Haval Balata, Kwun M. Fong, Lizza E. Hendriks, Stephen Lam, Jamie S. Ostroff, Nir Peled, Ning Wu, Charu Aggarwal
Journal of Thoracic Oncology.2019; 14(9): 1513. CrossRef

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Randomized Phase II Study of Afatinib Plus Simvastatin Versus Afatinib Alone in Previously Treated Patients with Advanced Nonadenocarcinomatous Non-small Cell Lung Cancer: Youngjoo Lee, Ki Hyeong Lee, Geon Kook Lee, Soo-Hyun Lee, Kun Young Lim, Jungnam Joo, Yun Jung Go, Jin Soo Lee, Ji-Youn Han; Cancer Res Treat. 2017;49(4):1001-1011. Published online January 13, 2017; DOI: https://doi.org/10.4143/crt.2016.546

Abstract PDF PubReader ePub

Purpose
This phase II study examined whether the addition of simvastatin to afatinib provides a clinical benefit compared with afatinib monotherapy in previously treated patients with nonadenocarcinomatous non-small cell lung cancer (NA-NSCLC).
Materials and Methods
Patientswith advancedNA-NSCLCwho progressed after one ortwo chemotherapy regimens were randomly assigned to a simvastatin (40 mg/day) plus afatinib (40 mg/day) (AS) arm or to an afatinib (A) arm. The primary endpoint was response rate (RR).
Results
Sixty-eight patients were enrolled (36 in the AS arm and 32 in the A arm). The RR was 5.7% (95% confidence interval [CI], 0.7 to 19.2) for AS and 9.4% (95% CI, 2.0 to 25.0) for A (p=0.440). In arms AS and A, the median progression-free survival (PFS) was 1.0 versus 3.6 months (p=0.240) and the overall survival was 10.0 months versus 7.0 months (p=0.930), respectively. Skin rash, stomatitis, and diarrhea were the most common adverse events in both arms. More grade 3 or 4 diarrhea was observed in arm A (18.8% vs. 5.6% in arm AS). In all patients, the median PFS for treatment including afatinib was not correlated with the status of epidermal growth factor receptor (EGFR) mutation (p=0.122), EGFR fluorescence in situ hybridization (p=0.944), or EGFR immunohistochemistry (p=0.976). However, skin rash severity was significantly related to the risk of progression for afatinib (hazard ratio for skin rash grade ≥ 2 vs. grade < 2, 0.44; 95% CI, 0.25 to 0.78; p=0.005).
Conclusion
There were no significant differences in the efficacy between AS and A arms in patients with NA-NSCLC.

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A Phase II Study of Poziotinib in Patients with Epidermal Growth Factor Receptor (EGFR)-Mutant Lung Adenocarcinoma Who Have Acquired Resistance to EGFR–Tyrosine Kinase Inhibitors: Ji-Youn Han, Ki Hyeong Lee, Sang-We Kim, Young Joo Min, Eunkyung Cho, Youngjoo Lee, Soo-Hyun Lee, Hyae Young Kim, Geon Kook Lee, Byung Ho Nam, Hyesun Han, Jina Jung, Jin Soo Lee; Cancer Res Treat. 2017;49(1):10-19. Published online May 3, 2016; DOI: https://doi.org/10.4143/crt.2016.058

Abstract PDF Supplementary Material PubReader ePub

Purpose
We examined the efficacy of poziotinib, a second-generation epidermal growth factor receptor (EGFR)–tyrosine kinase inhibitor (TKI) in patients with lung adenocarcinoma with activating EGFR mutations, who developed acquired resistance (AR) to EGFR-TKIs.
Materials and Methods
This single-arm phase II study included EGFR-mutant lung adenocarcinoma with AR to erlotinib or gefitinib based on the Jackman criteria. Patients received poziotinib 16 mg orally once daily in a 28-day cycle. The primary endpoint was progression-free survival (PFS). Prestudy tumor biopsies and blood samples were obtained to determine resistance mechanisms.
Results
Thirty-nine patients were treated. Tumor genotyping was determined in 37 patients; 19 EGFR T790M mutations and two PIK3CAmutations were detected in the prestudy tumors, and seven T790M mutations were detected in the plasma assay. Three (8%; 95% confidence interval [CI], 2 to 21) and 17 (44%; 95% CI, 28 to 60) patients had partial response and stable disease, respectively. The median PFS and overall survival were 2.7 months (95% CI, 1.8 to 3.7) and 15.0 months (95% CI, 9.5 to not estimable), respectively. A longer PFS was observed for patients without T790M or PIK3CA mutations in tumor or plasma compared to those with these mutations (5.5 months vs. 1.8 months, p=0.003). The most frequent grade 3 adverse events were rash (59%), mucosal inflammation (26%), and stomatitis (18%). Most patients required one (n=15) or two (n=15) dose reductions.
Conclusion
Low activity of poziotinib was detected in patients with EGFR-mutant non-small cell lung cancer who developed AR to gefitinib or erlotinib, potentially because of severe-toxicityimposed dose limitation.

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