Cancer Research and Treatment

Original Articles

A Prospective, Single-Cohort, Open, Multi-Center, Observational Study of Sublingual Fentanyl for Breakthrough Cancer Pain: Effectiveness, Safety, and Tolerability in Korean Cancer Patients: Youn Seon Choi, Su-Jin Koh, Woo Kyun Bae, Se Hyung Kim, Seong Hoon Shin, So Yeon Oh, Sang Byung Bae, Yaewon Yang, Eun-Kee Song, Yoon Young Cho, Pyung Bok Lee, Ho-Suk Oh, MinYoung Lee, Jin Seok Ahn; Received June 13, 2024 Accepted December 24, 2024 Published online December 26, 2024; DOI: https://doi.org/10.4143/crt.2024.557 [Accepted]

Abstract PDF: Purpose
Fentanyl, a highly lipophilic opioid, was developed as a sublingual fentanyl tablet (SFT) for the management of breakthrough cancer pain (BTcP), and its efficacy and safety were confirmed in a randomized, controlled study. We investigated the effectiveness and safety of SFT administered to alleviate BTcP in a real-world setting.
Materials and Methods
In this prospective, open, single-cohort study, conducted in 13 referral hospitals in South Korea, opioid-tolerant cancer patients receiving around-the-clock opioids for persistent cancer pain were enrolled if the individual had BTcP ≥ 1 episode/day during the preceding week. The primary outcome was the SFT titration success rate.
Results
Among 113 patients evaluated for effectiveness, 103 patients (91.2%) had a successful titration of SFT, with an effective dose range between 100 µg and 400 µg. The most frequent dose was 100 µg, administered to 65.0%, 72.1%, and 81.8% of the patients at Week 1, 4, and 12, respectively. The proportion of patients achieving the personalized pain goal assessed in the first week was 75.2%. The mean change in pain intensity measured with a numeric rating scale at 30 and 60 minutes after taking SFT was -2.57 and -3.62, respectively (p<0.0001 for both). The incidence rate of adverse events related to SFT among 133 patients included for safety evaluation was 9.0% (12/133), which included vomiting (3.0%), nausea (2.3%), and headache (1.5%).
Conclusion
In a real-world setting, SFT provides rapid and effective analgesia in BTcP, even at the lowest dose (100 μg), and the safety profile was acceptable.

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Treatment Patterns and Changes in Quality of Life during First-Line Palliative Chemotherapy in Korean Patients with Advanced Gastric Cancer: Jin Won Kim, Jong Gwang Kim, Byung Woog Kang, Ik-Joo Chung, Young Seon Hong, Tae-You Kim, Hong Suk Song, Kyung Hee Lee, Dae Young Zang, Yoon Ho Ko, Eun-Kee Song, Jin Ho Baek, Dong‐Hoe Koo, So Yeon Oh, Hana Cho, Keun-Wook Lee; Cancer Res Treat. 2019;51(1):223-239. Published online October 19, 2018; DOI: https://doi.org/10.4143/crt.2018.073

Abstract PDF Supplementary Material PubReader ePub

Purpose
The purpose of this study was to evaluate chemotherapy patterns and changes in quality of life (QOL) during first-line palliative chemotherapy for Korean patients with unresectable or metastatic/recurrent gastric cancer (GC).
Materials and Methods
Thiswas a non-interventional, multi-center, prospective, observational study of 527 patients in Korea. QOL assessments were conducted using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)-C30 and QLQ-STO22 every 3 months over a 12-month period during first-line palliative chemotherapy. The specific chemotherapy regimens were selected by individual clinicians.
Results
Most patients (93.2%) received combination chemotherapy (mainly fluoropyrimidine plus platinum) as their first-line palliative chemotherapy. The median progression-free survival and overall survival were 8.2 and 14.8 months, respectively. Overall, “a little” changes (differences of 5-10 points from baseline)were observed in some of the functioning or symptom scales; none of the QOL scales showed either “moderate” or “very much” change (i.e., ≥ 11 point difference from baseline). When examining the best change in each QOL domain from baseline, scales related to some aspects of functioning, global health status/QOL, and most symptoms revealed significant improvements (p < 0.05). Throughout the course of first-line palliative chemotherapy, most patients’ QOL was maintained to a similar degree, regardless of their actual response to chemotherapy.
Conclusion
This observational study provides important information on the chemotherapy patterns and QOL changes in Korean patientswith advanced GC. Overall, first-line palliative chemotherapy was found to maintain QOL, and most parameters showed an improvement compared with the baseline at some point during the course.

Citations

Citations to this article as recorded by

Health-related quality of life with bemarituzumab plus mFOLFOX6 in patients with FGFR2b-overexpressing, advanced gastric or gastroesophageal junction cancer
Z.A. Wainberg, P.C. Enzinger, S. Qin, K. Yamaguchi, J. Wang, X. Zhou, A. Gnanasakthy, K. Taylor, A. Yusuf, I. Majer, A. Jamotte, Y.-K. Kang
ESMO Gastrointestinal Oncology.2024; 6: 100095. CrossRef
Impact of systemic cancer treatment on quality of life and mental well-being: a comparative analysis of patients with localized and advanced cancer
Adán Rodríguez-Gonzalez, Alberto Carmona-Bayonas, Raquel Hernandez San Gil, Patricia Cruz-Castellanos, Mónica Antoñanzas-Basa, David Lorente-Estelles, María Jose Corral, Manuel González-Moya, Oscar Alfredo Castillo-Trujillo, Emilio Esteban, Paula Jiménez-
Clinical and Translational Oncology.2023; 25(12): 3492. CrossRef
Reminiscence therapy-based care program alleviates anxiety and depression, as well as improves the quality of life in recurrent gastric cancer patients
Xing Wu, Weiwei Zhang
Frontiers in Psychology.2023;[Epub] CrossRef
Toxicities and Quality of Life during Cancer Treatment in Advanced Solid Tumors
Eun Mi Lee, Paula Jiménez-Fonseca, Rocio Galán-Moral, Sara Coca-Membribes, Ana Fernández-Montes, Elena Sorribes, Esmeralda García-Torralba, Laura Puntí-Brun, Mireia Gil-Raga, Juana Cano-Cano, Caterina Calderon
Current Oncology.2023; 30(10): 9205. CrossRef
Psychosocial functioning in individuals with advanced oesophago-gastric cancer: a mixed methods systematic review
Cara Ghiglieri, Martin Dempster, Sam Wright, Lisa Graham-Wisener
BMC Palliative Care.2023;[Epub] CrossRef
Multicenter phase III trial of S-1 and cisplatin versus S-1 and oxaliplatin combination chemotherapy for first-line treatment of advanced gastric cancer (SOPP trial)
Keun-Wook Lee, Ik-Joo Chung, Min-Hee Ryu, Young Iee Park, Byung-Ho Nam, Ho-Suk Oh, Kyung Hee Lee, Hye Sook Han, Bong-Gun Seo, Jae-Cheol Jo, Hyo Rak Lee, Jin Won Kim, Sook Ryun Park, Sang Hee Cho, Yoon-Koo Kang
Gastric Cancer.2021; 24(1): 156. CrossRef
Effect of early tumor response on the health-related quality of life among patients on second-line chemotherapy for advanced gastric cancer in the ABSOLUTE trial
Kazumasa Fujitani, Kohei Shitara, Atsuo Takashima, Keisuke Koeda, Hiroki Hara, Norisuke Nakayama, Shuichi Hironaka, Kazuhiro Nishikawa, Yutaka Kimura, Kenji Amagai, Hisashi Hosaka, Yoshito Komatsu, Ken Shimada, Ryohei Kawabata, Hideki Ohdan, Yasuhiro Kode
Gastric Cancer.2021; 24(2): 467. CrossRef
Quality-of-Life Assessment in Patients Receiving Palliative Chemotherapy: Call for Action
Maheswari Senthil
Annals of Surgical Oncology.2021; 28(1): 7. CrossRef
Impact of gastric cancer treatment on quality of life of patients
Kerstin Schütte, Christian Schulz, Kristina Middelberg-Bisping
Best Practice & Research Clinical Gastroenterology.2021; 50-51: 101727. CrossRef
Influencing Factors and Effects of Treatment on Quality of Life in Patients With Gastric Cancer—A Systematic Review
Sophia Kristina Rupp, Andreas Stengel
Frontiers in Psychiatry.2021;[Epub] CrossRef
Chronological changes in quality of life and body composition after gastrectomy for locally advanced gastric cancer
Ki Bum Park, Ji Yeon Park, Seung Soo Lee, Ho Young Chung, Oh Kyoung Kwon
Annals of Surgical Treatment and Research.2020; 98(5): 262. CrossRef
Viennese risk prediction score for Advanced Gastroesophageal carcinoma based on Alarm Symptoms (VAGAS score): characterisation of alarm symptoms in advanced gastro-oesophageal cancer and its correlation with outcome
Hannah Christina Puhr, Eleonore Pablik, Anna Sophie Berghoff, Gerd Jomrich, Sebastian Friedrich Schoppmann, Matthias Preusser, Aysegül Ilhan-Mutlu
ESMO Open.2020; 5(2): e000623. CrossRef

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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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Efficacy and safety of multi-day antiemetic treatment for patients undergoing multi-day chemotherapy: a systematic review of Clinical Practice Guidelines for Antiemesis 2023 from Japan Society of Clinical Oncology
Kazuhisa Nakashima, Saki Harashima, Rena Kaneko, Ryuhei Tanaka, Masakazu Abe, Makoto Wada, Keiko Iino, Tatsuo Akechi, Hirotoshi Iihara, Chiyo K. Imamura, Ayako Okuyama, Keiko Ozawa, Yong-il Kim, Eriko Satomi, Masayuki Takeda, Takako Eguchi Nakajima, Naoki
International Journal of Clinical Oncology.2025; 30(1): 17. CrossRef
2020 ASCO, 2023 NCCN, 2023 MASCC/ESMO, and 2019 CCO: a comparison of antiemetic guidelines for the treatment of chemotherapy-induced nausea and vomiting in cancer patients
Samantha K. F. Kennedy, Shannon Goodall, Shing Fung Lee, Carlo DeAngelis, Allison Jocko, Flay Charbonneau, Katie Wang, Mark Pasetka, Yoo-Joung Ko, Henry C. Y. Wong, Adrian Wai Chan, Thenugaa Rajeswaran, Milena Gojsevic, Edward Chow, Richard J. Gralla, Ter
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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
Journal of Cancer Research and Clinical Oncology.2024;[Epub] CrossRef
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
Value in Health Regional Issues.2024; 44: 101028. CrossRef
Olanzapine as Antiemetic Prophylaxis in Moderately Emetogenic Chemotherapy
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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Efficacy and safety of dexamethasone sparing for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy: a systematic review and meta-analysis of Clinical Practice Guidelines for Antiemesis 2023 from Japan Society of Clin
Kazuhisa Nakashima, Ayako Yokomizo, Michiyasu Murakami, Kenji Okita, Makoto Wada, Keiko Iino, Tatsuo Akechi, Hirotoshi Iihara, Chiyo K. Imamura, Ayako Okuyama, Keiko Ozawa, Yong-il Kim, Hidenori Sasaki, Eriko Satomi, Masayuki Takeda, Ryuhei Tanaka, Takako
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Can olanzapine preserve life quality in cancer patients undergoing abdominal radiation therapy?
Meenu Vijayan, Sherin Joseph, Haridas M Nair, Debnarayan Dutta, M.P. Narmadha
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Chemotherapy: how to reduce its adverse effects while maintaining the potency?
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Aziz Eghbali, Tahereh Bagherloo, Ali Ghasemi, Roghayeh R. Afzal, Aygin Eghbali, Kazem Ghaffari
Advanced Biomedical Research.2023;[Epub] CrossRef
Olanzapine treatment effectively relieves breakthrough chemotherapy-induced nausea and vomiting: a real-world experience
Akihiro Uchiike, Haruka Kono, Katsuhiro Miura, Tatsuya Hayama, Daisuke Tsutsumi, Shinya Tsuboi, Susumu Ohtsuka, Shinji Hidaka
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Rony Dev, Linda L. Zhong, Abdulrazzak Zarifa, Aya A. Albittar, Laura Rubin, Suyu Liu, Timothy A. Yap, Shalini Dalal, David Hui, Daniel D. Karp, Apostolia M. Tsimberidou, Sarina A. Piha-Paul, Jordi Rodon Ahnert, Siqing Fu, Funda Meric-Bernstam, Aung Naing
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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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Efficacy and Safety of First-Line Necitumumab Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in East Asian Patients with Stage IV Squamous Non-small Cell Lung Cancer: A Subgroup Analysis of the Phase 3, Open-Label, Randomized SQUIRE Study: Keunchil Park, Eun Kyung Cho, Maximino Bello, Myung-Ju Ahn, Sumitra Thongprasert, Eun-Kee Song, Victoria Soldatenkova, Henrik Depenbrock, Tarun Puri, Mauro Orlando; Cancer Res Treat. 2017;49(4):937-946. Published online January 6, 2017; DOI: https://doi.org/10.4143/crt.2016.423

Abstract PDF PubReader ePub

Purpose
The phase 3 randomized SQUIRE study revealed significantly longer overall survival (OS) and progression-free survival (PFS) for necitumumab plus gemcitabine and cisplatin (neci+GC) than for gemcitabine and cisplatin alone (GC) in 1,093 patients with previously untreated advanced squamous non-small cell lung cancer (NSCLC). This post hoc subgroup analysis assessed the efficacy and safety of neci+GC among East Asian (EA) patients enrolled in the study.
Materials and Methods
All patients received up to six 3-week cycles of gemcitabine (days 1 and 8, 1,250 mg/m²) and cisplatin (day 1, 75 mg/m²). Patients in the neci+GC arm also received necitumumab (days 1 and 8, 800 mg) until disease progression or unacceptable toxicity. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated from stratified Cox proportional hazards models.
Results
In EA patients, there were improvements for neci+GC (n=43) versus GC (n=41) in OS (HR, 0.805; 95% CI, 0.484 to 1.341) and PFS (HR, 0.720; 95% CI, 0.439 to 1.180), consistent with the results for non-EA patients observed in the present study. The overall safety data were consistent between EA and non-EA patients. A numerically higher proportion of patients experienced serious adverse events (AEs), grade ≥ 3 AEs, and AEs with an outcome of death for neci+GC versus GC in EA patients and EA patients versus non-EA patients for neci+GC.
Conclusion
Although limited by the small sample size and post hoc nature of the analysis, these findings are consistent with those of the overall study and suggest that neci+GC offers a survival advantage and favorable benefit/risk for EA patients with advanced squamous NSCLC.

Citations

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Phytochemicals intended for anticancer effects at preclinical levels to clinical practice: Assessment of formulations at nanoscale for non-small cell lung cancer (NSCLC) therapy
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Vincenzo di Noia, Ettore D’Argento, Sara Pilotto, Giulia Grizzi, Mario Caccese, Roberto Iacovelli, Giampaolo Tortora, Emilio Bria
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SELECT-3: a phase I study of selumetinib in combination with platinum-doublet chemotherapy for advanced NSCLC in the first-line setting
Alastair Greystoke, Nicola Steele, Hendrik-Tobias Arkenau, Fiona Blackhall, Noor Md Haris, Colin R Lindsay, Raffaele Califano, Mark Voskoboynik, Yvonne Summers, Karen So, Dana Ghiorghiu, Angela W Dymond, Stuart Hossack, Ruth Plummer, Emma Dean
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