Cancer Research and Treatment

Review Article

Precision Oncology Clinical Trials: A Systematic Review of Phase II Clinical Trials with Biomarker-Driven, Adaptive Design: Hyerim Ha, Hee Yeon Lee, Jee Hyun Kim, Do Yeun Kim, Ho Jung An, SeungJin Bae, Hye-sung Park, Jin Hyoung Kang; Cancer Res Treat. 2024;56(4):991-1013. Published online May 7, 2024; DOI: https://doi.org/10.4143/crt.2024.128

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Novel clinical trial designs are conducted in the precision medicine era. This study aimed to evaluate biomarker-driven, adaptive phase II trials in precision oncology, focusing on infrastructure, efficacy, and safety. We systematically reviewed and analyzed the target studies. EMBASE and PubMed searches from 2015 to 2023 generated 29 eligible trials. Data extraction included infrastructure, biomarker screening methodologies, efficacy, and safety profiles. Government agencies, cancer hospitals, and academic societies with accumulated experiences led investigator-initiated precision oncology clinical trials (IIPOCTs), which later guided sponsor-initiated precision oncology clinical trials (SIPOCTs). Most SIPOCTs were international studies with basket design. IIPOCTs primarily used the central laboratory for biomarker screening, but SIPOCTs used both central and local laboratories. Most of the studies adapted next-generation sequencing and/or immunohistochemistry for biomarker screening. Fifteen studies included an independent central review committee for outcome investigation. Efficacy assessments predominantly featured objective response rate as the primary endpoint, with varying results. Nine eligible studies contributed to the United States Food and Drug Administration’s marketing authorization. Safety monitoring was rigorous, but reporting formats lacked uniformity. Health-related quality of life and patient-reported outcomes were described in some protocols but rarely reported. Our results reveal that precision oncology trials with adaptive design rapidly and efficiently evaluate anticancer drugs’ efficacy and safety, particularly in specified biomarker-driven cohorts. The evolution from IIPOCT to SIPOCT has facilitated fast regulatory approval, providing valuable insights into the precision oncology landscape.

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Original Articles

Breast cancer

Real-World Clinical Data of Palbociclib in Asian Metastatic Breast Cancer Patients: Experiences from Eight Institutions: Jieun Lee, Hyung Soon Park, Hye Sung Won, Ji Hyun Yang, Hee Yeon Lee, In Sook Woo, Kabsoo Shin, Ji Hyung Hong, Young Joon Yang, Sang Hoon Chun, Jae Ho Byun; Cancer Res Treat. 2021;53(2):409-423. Published online October 28, 2020; DOI: https://doi.org/10.4143/crt.2020.451

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Purpose
Use of cyclin-dependent kinase 4/6 inhibitors improved survival outcome of hormone receptor (HR) positive metastatic breast cancer (MBC) patients, including Asian population. However, Asian real-world data of palbociclib is limited. We analyzed the real-world clinical practice patterns and outcome in HR-positive, MBC Asian patients treated with palbociclib.
Materials and Methods
Between April 2017 to November 2019, 169 HR-positive, human epidermal growth factor-2–negative MBC patients treated with letrozole or fulvestrant plus palbocilib were enrolled from eight institutions. Survival outcome (progression-free survival [PFS]), treatment response and toxicity profiles were analyzed.
Results
Median age of letrozole plus palbociclib (145 patients, 85.8%) and fulvestrant plus palbociclib (24 patients, 14.2%) was 58 and 53.5 years, with median follow-up duration of 14.63 months (range 0.2 to 33.9 months). Median PFS (mPFS) of letrozole plus palbociclib and fulvestrant plus palbociclib was 25.6 (95% confidence interval [CI], 19.1 to not reached) and 6.37 months (95% CI, 5.33 to not reached), comparable to previous phase 3 trials. In letrozole plus palbociclib arm, luminal A (hazard ratio, 2.86; 95% CI, 1.20 to 6.80; p=0.017) and patients with good performance (Eastern Cooperative Oncology Group 0-1 [hazard ratio, 3.68; 95% CI, 1.70 to 7.96]) showed better mPFS. In fulvestrant plus palbociclib group, chemotherapy naïve patients showed better mPFS (hazard ratio, 12.51, 95% CI, 1.59 to 99.17; p=0.017). The most common grade 3 or 4 adverse event was neutropenia (letrozole 86.3%, fulvestrant 88.3%).
Conclusion
To our knowledge, this is the first real-world data of palbociclib reported in Asia. Palbociclib showed comparable benefit to previous phase 3 trials in Asian patients during daily clinical practice.

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Hui-Chen Su, Ho-Wei Lin, Ka-Wai Tam
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Nationwide real-world practice pattern and clinical data of palbociclib in HR (+), HER2 (−) metastatic breast cancer patients in Korea (KCSG BR21-15)
Jieun Lee, Dae-Won Lee, Min Hwan Kim, Jee Hung Kim, Ju Won Kim, Jae-Ho Byun, Kyoung Eun Lee, Myoung Joo Kang, Su-Jin Koh, Soojung Hong, Hye Sung Won, Han Jo Kim, In Hae Park, Seong Hoon Shin, Sun Kyung Baek, Seul-Gi Kim, Sung Ae Koh, Joo Young Jung, Ji-Ye
The Breast.2025; 82: 104500. CrossRef
Clinical Prognosis and Nomograms for Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer Patients Treated with Palbociclib and Endocrine Therapy
Shubin Song, Luhao Sun, Xiaoyu Liu, Liang Zhang, Chao Li, Zhaoyun Liu, Fengzhen Liu, Zhiyong Yu
Breast Cancer: Targets and Therapy.2025; Volume 17: 669. CrossRef
Palbociclib treatment in patients with HR+/HER2− advanced or metastatic breast cancer and visceral metastasis: A systematic literature review
Julia C. Radosa, Sara López-Tarruella Cobo, Johanna Dzieran, Esther Glastetter, Connie Chen, Melissa Lingohr-Smith, Vinay Pasupuleti, Adam Brufsky
The Breast.2025; 84: 104569. CrossRef
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Francesco Schettini, Sabrina Nucera, Giuseppe Di Grazia, Fabiola Giudici, Carla Strina, Manuela Milani, Richard Tancredi, Benedetta Conte, Carmen Criscitiello, Mario Giuliano, Matteo Lambertini, Rodrigo Sánchez-Bayona, Tomás Pascual, Grazia Arpino, Lucia
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BMC Cancer.2025;[Epub] CrossRef
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F. Petrelli, A. Ghidini, L. Dottorini
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Etienne Brain, Connie Chen, Sofia Simon, Vinay Pasupuleti, Kathleen Vieira Pfitzer, Karen A. Gelmon
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Breast Cancer.2024; 31(4): 621. CrossRef
The Effect of C-Reactive Protein/Lymphocyte Ratio (CLR) on PFS in Metastatic Breast Cancer Patients Treated with CDK4/6 Inhibitors: A Novel Biomarker
Mehmet Buyukbayram, Zekeriya Hannarici, Yakup Duzkopru, Aykut Turhan, Alperen Caglar, Pınar Coban Esdur, Mehmet Bilici, Salim Tekin, Doğan Yazılıtaş
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The treatment pattern of advanced HR-positive and HER2-negative breast cancer in central southern China: a hospital-based cross-sectional study
Zhe-Yu Hu, Binliang Liu, Ning Xie, Xiaohong Yang, Liping Liu, Huawu Xiao, Jing Li, Hui Wu, Jianxiang Gao, Jun Lu, Xuming Hu, Min Cao, Zhengrong Shui, Can Tian, Quchang Ouyang
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Amit Rauthan, Ankita Jain, Manmohan Singh, Mehmet A. N. Sendur
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Real-world comparison of palbociclib, abemaciclib, and dalpiciclib as first-line treatments for Chinese HR+/HER2−metastatic breast cancer patients: a multicenter study (YOUNGBC-28)
Yifan Chen, Yizhao Xie, Die Sang, Ning Xie, Xinhua Han, Yanxia Zhao, Juanjuan Li, Jian Yue, Peng Yuan, Biyun Wang
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Carlo Palmieri, Alison Musson, Catherine Harper-Wynne, Duncan Wheatley, Gianfilippo Bertelli, Iain R. Macpherson, Mark Nathan, Ellie McDowall, Ajay Bhojwani, Mark Verrill, Joe Eva, Colm Doody, Ruhe Chowdhury
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Fábio Cardoso Borges, Filipa Alves da Costa, Adriana Ramos, Catarina Ramos, Catarina Bernardo, Cláudia Brito, Alexandra Mayer-da-Silva, Cláudia Furtado, Arlindo R. Ferreira, Diogo Martins-Branco, Ana Miranda, António Lourenço
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Lesang Shen, Jun Zhou, Yiding Chen, Jinhua Ding, Haiyan Wei, Jian Liu, Wenjie Xia, Bojian Xie, Xiaohong Xie, Xujun Li, Yuechu Dai, Guobing Zhang, Xia Qiu, Chao Li, Shanshan Sun, Wuzhen Chen, Dihe Gong, Hengyu Li, Jian Huang, Xia Jiang, Chao Ni
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Clinical Characteristics of Clear Cell Ovarian Cancer: A Retrospective Multicenter Experience of 308 Patients in South Korea: Hee Yeon Lee, Ji Hyung Hong, Jae Ho Byun, Hee-Jun Kim, Sun Kyung Baek, Jin Young Kim, Ki Hyang Kim, Jina Yun, Jung A Kim, Kwonoh Park, Hyo Jin Lee, Jung Lim Lee, Young-Woong Won, Il Hwan Kim, Woo Kyun Bae, Kyong Hwa Park, Der-Sheng Sun, Suee Lee, Min-Young Lee, Guk Jin Lee, Sook Hee Hong, Yun Hwa Jung, Ho Jung An; Cancer Res Treat. 2020;52(1):277-283. Published online July 12, 2019; DOI: https://doi.org/10.4143/crt.2019.292

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Purpose
The purpose of this study was to evaluate clinical characteristics and treatment pattern of ovarian clear cell carcinoma (OCCC) in Korea and the role of adjuvant chemotherapy in early stage.
Materials and Methods
Medical records of 308 cases of from 21 institutions were reviewed and data including age, performance status, endometriosis, thromboembolism, stage, cancer antigen 125, treatment, recurrence, and death were collected.
Results
Regarding stage of OCCC, it was stage I in 194 (63.6%), stage II in 34 (11.1%), stage III in 66 (21.6%), and stage IV in 11 (3.6%) patients. All patients underwent surgery. Optimal surgery (residual disease ≤ 1 cm) was achieved in 89.3%. Majority of patients (80.5%) received postoperative chemotherapy. The most common regimen was taxane-platinum combination (96%). Median relapse-free survival (RFS) was 138.5 months for stage I, 33.4 for stage II, 19.3 for stage III, and 9.7 for stage IV. Median overall survival (OS) were not reached, 112.4, 48.7, and 18.3 months for stage I, II, III, and IV, respectively. Early-stage (stage I), endometriosis, and optimal debulking were identified as favorable prognostic factors for RFS. Early-stage and optimal debulking were also favorable prognostic factors for OS. Majority of patients with early-stage received adjuvant chemotherapy. However, additional survival benefit was not found in terms of recurrence.
Conclusion
Majority of patients had early-stage and received postoperative chemotherapy regardless of stage. Early-stage and optimal debulking were identified as favorable prognostic factors. In stage IA or IB, adding adjuvant chemotherapy did not show difference in survival. Further study focusing on OCCC is required.

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Pembrolizumab plus lenvatinib in recurrent gynaecological clear cell carcinoma (LARA): a multicentre, single-arm, phase 2 trial
Natalie Y L Ngoi, Jung-Yun Lee, Diana Lim, Yee Liang Thian, Yi Wan Lim, Jack J Chan, Wen Yee Chay, Zewen Zhang, Anil Gopinathan, Siew Eng Lim, Jeffrey Low, Joseph Ng, Pearl Tong, Yong-Jae Lee, Junsik Park, Jae-Weon Kim, Tuan Zea Tan, Junxian Zhu, Bee Choo
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The immunotherapy era in ovarian clear cell carcinoma: current evidence and future perspective
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Chengbin Lin, Zhiwei Wu, Yuanjun Cai
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From clinical management to personalized medicine: novel therapeutic approaches for ovarian clear cell cancer
Zesi Liu, Chunli Jing, Fandou Kong
Journal of Ovarian Research.2024;[Epub] CrossRef
SOX17 expression in ovarian clear cell carcinoma
Daichi Kodama, Motoki Takenaka, Chiemi Saigo, Masako Azuma, Yuki Hanamatsu, Masanori Isobe, Tamotsu Takeuchi
Journal of Ovarian Research.2024;[Epub] CrossRef
Construction of a Prediction Model of Cancer-Specific Survival after Ovarian Clear Cell Carcinoma Surgery
Mengqi Huang, Li Ling, Yanbo Liu, Yujuan Li
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Patients with stage IA ovarian clear cell carcinoma do not require chemotherapy following surgery
Li Shuqing, Zhu Zhiling
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Hamidreza Didar, Farah Farzaneh, Hanieh Najafiarab, Kosar Namakin, Kimiya Gohari, Ali Sheidaei, Sepehr Ramezani
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Cancer Control.2023;[Epub] CrossRef
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Satoe Fujiwara
Japanese Journal of Clinical Oncology.2023; 53(8): 664. CrossRef
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Journal of Gynecologic Oncology.2023;[Epub] CrossRef
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Yang Gao, Wei Ding, Pengpeng Qu
Clinical and Experimental Obstetrics & Gynecology.2023;[Epub] CrossRef
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Aglaja De Pauw, Eline Naert, Koen Van de Vijver, Tummers Philippe, Katrien Vandecasteele, Hannelore Denys
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Anastasios Tranoulis, Felicia Helena Buruiana, Bindiya Gupta, Audrey Kwong, Aarti Lakhiani, Jason Yap, Janos Balega, Kavita Singh
Archives of Gynecology and Obstetrics.2022; 305(5): 1279. CrossRef
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Peng Chen, Chi-Yuan Zhang
Frontiers in Oncology.2022;[Epub] CrossRef
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Abdulkarim Mohamed Farah, Shiyu Gu, Yan Jia
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Yasushi Iida, Aikou Okamoto, Robert L Hollis, Charlie Gourley, C Simon Herrington
International Journal of Gynecological Cancer.2021; 31(4): 605. CrossRef
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Chenchen Zhu, Jing Zhu, Lili Qian, Hanyuan Liu, Zhen Shen, Dabao Wu, Weidong Zhao, Weihua Xiao, Ying Zhou
BMC Cancer.2021;[Epub] CrossRef
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Caner ÇAKIR, Fatih KILIÇ, Çiğdem KILIÇ, Dilek YÜKSEL, Vakkas KORKMAZ, Günsu KİMYON CÖMERT, Osman TÜRKMEN, Taner TURAN
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Journal of Ovarian Research.2020;[Epub] CrossRef

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GRP78 Protein Expression as Prognostic Values in Neoadjuvant Chemoradiotherapy and Laparoscopic Surgery for Locally Advanced Rectal Cancer: Hee Yeon Lee, Ji-Han Jung, Hyun-Min Cho, Sung Hwan Kim, Kang-Moon Lee, Hyung-Jin Kim, Jong Hoon Lee, Byoung Yong Shim; Cancer Res Treat. 2015;47(4):804-812. Published online January 30, 2015; DOI: https://doi.org/10.4143/crt.2014.121

Abstract PDF PubReader ePub

Purpose
We investigated the relationships between biomarkers related to endoplasmic reticulum stress proteins (glucose-regulated protein of molecular mass 78 [GRP78] and Cripto-1 [teratocarcinoma-derived growth factor 1 protein]), pathologic response, and prognosis in locally advanced rectal cancer. Materials and Methods All clinical stage II and III rectal cancer patients received 50.4 Gy over 5.5 weeks, plus 5- fluorouracil (400 mg/m2/day) and leucovorin (20 mg/m2/day) bolus on days 1 to 5 and 29 to 33, and surgery was performed at 7 to 10 weeks after completion of all therapies. Expression of GRP78 and Cripto-1 proteins was determined by immunohistochemistry and was assessed in 101 patients with rectal cancer treated with neoadjuvant chemoradiotherapy (CRT).
Results
High expression of GRP78 and Cripto-1 proteins was observed in 86 patients (85.1%) and 49 patients (48.5%), respectively. Low expression of GRP78 protein was associated with a significantly high rate of down staging (80.0% vs. 52.3%, respectively; p=0.046) and a significantly low rate of recurrence (0% vs. 33.7%, respectively; p=0.008) compared with high expression of GRP78 protein. Mean recurrence-free survival according to GRP78 expression could not be estimated because the low expression group did not develop recurrence events but showed a significant correlation with time to recurrence, based on the log rank method (p=0.007). GRP78 also showed correlation with overall survival, based on the log rank method (p=0.045). Conclusion GRP78 expression is a predictive and prognostic factor for down staging, recurrence, and survival in rectal cancer patients treated with 5-fluorouracil and leucovorin neoadjuvant CRT.

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A Randomized Double-Blind, Double-Dummy, Multicenter Trial of Azasetron versus Ondansetron to Evaluate Efficacy and Safety in the Prevention of Delayed Nausea and Vomiting Induced by Chemotherapy: Hee Yeon Lee, Hoon-Kyo Kim, Kyung Hee Lee, Bong-Seog Kim, Hong Suk Song, Sung Hyun Yang, Joon Hee Kim, Yeul Hong Kim, Jong Gwang Kim, Sang-We Kim, Dong-Wan Kim, Si-Young Kim, Hee Sook Park; Cancer Res Treat. 2014;46(1):19-26. Published online January 15, 2014; DOI: https://doi.org/10.4143/crt.2014.46.1.19

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PURPOSE
This study was conducted to evaluate the efficacy and safety of azasetron compared to ondansetron in the prevention of delayed chemotherapy-induced nausea and vomiting.
MATERIALS AND METHODS
This study was a multi-center, prospective, randomized, double-dummy, double-blind and parallel-group trial involving 12 institutions in Korea between May 2005 and December 2005. A total of 265 patients with moderately and highly emetogenic chemotherapy were included and randomly assigned to either the azasetron or ondansetron group. All patients received azasetron (10 mg intravenously) and dexamethasone (20 mg intravenously) on day 1 and dexamethasone (4 mg orally every 12 hours) on days 2-4. The azasetron group received azasetron (10 mg orally) with placebo of ondansetron (orally every 12 hours), and the ondansetron group received ondansetron (8 mg orally every 12 hours) with placebo of azasetron (orally) on days 2-6.
RESULTS
Over days 2-6, the effective ratio of complete response in the azasetron and ondansetron groups was 45% and 54.5%, respectively (95% confidence interval, -21.4 to 2.5%). Thus, the non-inferiority of azasetron compared with ondansetron in delayed chemotherapy-induced nausea and vomiting was not proven in the present study. All treatments were well tolerated and no unexpected drug-related adverse events were reported. The most common adverse events related to the treatment were constipation and hiccups, and there were no differences in the overall incidence of adverse events.
CONCLUSION
In the present study, azasetron showed inferiority in the control of delayed chemotherapy-induced nausea and vomiting compared with ondansetron whereas safety profiles were similar between the two groups.

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