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Article ; Online: A phase III randomized controlled trial comparing local field with additional prophylactic irradiation in chemoradiotherapy for clinical-T1bN0M0 esophageal cancer: ARMADILLO trial (JCOG1904).

Sasaki, Keita / Nomura, Motoo / Kato, Ken / Sakanaka, Katsuyuki / Ito, Yoshinori / Kadota, Tomohiro / Machida, Ryunosuke / Kataoka, Tomoko / Minashi, Keiko / Tsubosa, Yasuhiro / Kajiwara, Takeshi / Fukuda, Haruhiko / Takeuchi, Hiroya / Mizowaki, Takashi / Nishimura, Yasumasa / Kitagawa, Yuko

Japanese journal of clinical oncology

2024 Volume 54, Issue 1, Page(s) 103–107

Abstract: Chemoradiotherapy has been considered as one of the standard treatment options for clinical T1bN0M0 esophageal squamous cell carcinoma with organ preservation. However, 20% of patients develop locoregional recurrence after chemoradiotherapy, which ... ...

Abstract	Chemoradiotherapy has been considered as one of the standard treatment options for clinical T1bN0M0 esophageal squamous cell carcinoma with organ preservation. However, 20% of patients develop locoregional recurrence after chemoradiotherapy, which requires salvage treatment including salvage surgery and endoscopic resection. Salvage surgery can cause complications and treatment-related death. Interestingly, chemoradiotherapy with elective nodal irradiation has been reported to reduce the locoregional recurrence of advanced esophageal squamous cell carcinoma. Hence, we are conducting a clinical trial to confirm whether modified chemoradiotherapy with elective nodal irradiation was superiority to that without elective nodal irradiation for the patients with cT1bN0M0 esophageal squamous cell carcinoma. The primary endpoint is major progression-free survival, defined as the time from randomization to the date of death or disease progression, excluding successful curative resection through salvage endoscopic resection. We plan to enroll 280 patients from 54 institutions over 4 years. This trial has been registered in the Japan Registry of Clinical Trials (jRCTs031200067).
MeSH term(s)	Humans ; Esophageal Neoplasms/pathology ; Esophageal Squamous Cell Carcinoma/therapy ; Esophageal Squamous Cell Carcinoma/pathology ; Neoplasm Recurrence, Local/pathology ; Chemoradiotherapy ; Japan ; Treatment Outcome ; Salvage Therapy ; Retrospective Studies
Language	English
Publishing date	2024-01-08
Publishing country	England
Document type	Randomized Controlled Trial ; Clinical Trial, Phase III ; Journal Article
ZDB-ID	190978-2
ISSN	1465-3621 ; 0368-2811
ISSN (online)	1465-3621
ISSN	0368-2811
DOI	10.1093/jjco/hyad137
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Article: Prospective observational study of zinc deficiency symptoms during first-line chemotherapy for gastric and colorectal cancer.

Sakaguchi, Chihiro / Nishina, Tomohiro / Kono, Yoshiyasu / Hino, Kaori / Asagi, Akinori / Ohno, Yoshinori / Kajiwara, Takeshi / Nadano, Seijin / Yamashita, Natsumi / Tohyama, Mikiko / Hyodo, Ichinosuke / Okada, Hiroyuki / Otsuka, Motoyuki

Journal of gastrointestinal oncology

2023 Volume 14, Issue 6, Page(s) 2384–2394

Abstract: Background: Zinc deficiency during long-term chemotherapy and its related symptoms, including skin rash, taste disorders, and oral mucositis, have not been sufficiently investigated.: Methods: This prospective observational study enrolled patients ... ...

Abstract	Background: Zinc deficiency during long-term chemotherapy and its related symptoms, including skin rash, taste disorders, and oral mucositis, have not been sufficiently investigated. Methods: This prospective observational study enrolled patients with gastric and colorectal cancer who underwent standard first-line chemotherapy. According to the Practice Guidelines for Zinc Deficiency, zinc deficiency is defined as a serum level of <60 µg/dL. Serum zinc levels were measured before and after (1, 3, and 6 months) chemotherapy, and symptoms were assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events version 1.0. Repeated measures were analyzed using a generalized linear mixed model. Results: Of the 61 enrolled patients, 48 who underwent standard first-line chemotherapy with fluoropyrimidine plus oxaliplatin were analyzed. Zinc deficiency was observed in 18 patients (38%) before chemotherapy. The least-squares means of serum zinc levels significantly decreased at 3 and 6 months of chemotherapy in 30 patients without zinc deficiency at the start of chemotherapy (both P<0.01) but not in 18 with zinc deficiency at the beginning. Changes in serum zinc levels during chemotherapy negatively correlated with changes in taste, rash, and itching (all P<0.04) in patients without zinc deficiency before treatment initiation. Conclusions: Serum zinc levels decreased during chemotherapy in zinc-non-deficient patients at the beginning of chemotherapy and correlated with taste changes, skin rash, and itching. Therefore, investigating whether zinc supplementation ameliorates these symptoms is necessary.
Language	English
Publishing date	2023-11-23
Publishing country	China
Document type	Journal Article
ZDB-ID	2594644-4
ISSN	2219-679X ; 2078-6891
ISSN (online)	2219-679X
ISSN	2078-6891
DOI	10.21037/jgo-23-517
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Article: Sidedness-Dependent Prognostic Impact of Gene Alterations in Metastatic Colorectal Cancer in the Nationwide Cancer Genome Screening Project in Japan (SCRUM-Japan GI-SCREEN).

Kajiwara, Takeshi / Nishina, Tomohiro / Yamashita, Riu / Nakamura, Yoshiaki / Shiozawa, Manabu / Yuki, Satoshi / Taniguchi, Hiroya / Hara, Hiroki / Ohta, Takashi / Esaki, Taito / Shinozaki, Eiji / Takashima, Atsuo / Yamamoto, Yoshiyuki / Yamazaki, Kentaro / Yoshino, Takayuki / Hyodo, Ichinosuke

Cancers

2023 Volume 15, Issue 21

Abstract: The treatment strategies and prognoses of patients with metastatic colorectal cancer (CRC) differ according to the sidedness of the primary tumor. ...

Abstract	The treatment strategies and prognoses of patients with metastatic colorectal cancer (CRC) differ according to the sidedness of the primary tumor.
Language	English
Publishing date	2023-10-27
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers15215172
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Article ; Online: Renal impairment as a risk factor for trifluridine/tipiracil-induced adverse events in metastatic colorectal cancer patients from the REGOTAS study.

Shiroyama, Mamiko / Fukuoka, Shota / Masuishi, Toshiki / Takashima, Atsuo / Kumekawa, Yosuke / Kajiwara, Takeshi / Yamazaki, Kentaro / Shimada, Yasuhiro / Esaki, Taito / Makiyama, Akitaka / Moriwaki, Toshikazu

Scientific reports

2023 Volume 13, Issue 1, Page(s) 17931

Abstract: Renal impairment may be associated with an increased risk of hematologic events (AEs) in patients undergoing treatment with trifluridine/tipiracil (FTD/TPI). This study aimed to investigate the specific types of AEs linked to renal impairment in patients ...

Abstract	Renal impairment may be associated with an increased risk of hematologic events (AEs) in patients undergoing treatment with trifluridine/tipiracil (FTD/TPI). This study aimed to investigate the specific types of AEs linked to renal impairment in patients with metastatic colorectal cancer (mCRC) receiving FTD/TPI, using real-world data. Among the patients included in the REGOTAS study (a retrospective study of FTD/TPI versus regorafenib), those treated with FTD/TPI were evaluated. Creatinine clearance values of < 30, 30-60, 60-90, and > 90 mL/min were defined as severe, moderate, mild renal impairment, and normal renal function, respectively. Renal impairment was analyzed as a risk factor for grade 3 or higher AEs using a logistic regression model. Overall survival (OS) and progression-free survival (PFS) based on renal impairment were evaluated. A total of 309 patients were included in the analysis, with 124, 130, and 55 patients divided into the normal, mild, and moderate-to-severe groups, respectively. The risk of grade 3 or higher neutropenia was significantly higher in the moderate-to-severe group (odds ratio 3.47; 95% confidence interval 1.45-8.30; P = 0.005), but there was no significant increase in the risk of non-hematologic AEs in any of the groups. The OS and PFS of patients in the mild and moderate-to-severe groups were comparable to those in the normal group. Patients with mCRC and moderate/severe renal impairment receiving FTD/TPI therapy may develop severe neutropenia; however, FTD/TPI remains a viable treatment option due to its clinical benefit.
MeSH term(s)	Humans ; Uracil/therapeutic use ; Retrospective Studies ; Trifluridine/adverse effects ; Frontotemporal Dementia/drug therapy ; Colorectal Neoplasms/pathology ; Thymine/therapeutic use ; Pyrrolidines/adverse effects ; Colonic Neoplasms/drug therapy ; Rectal Neoplasms/drug therapy ; Drug Combinations ; Risk Factors ; Neutropenia/chemically induced ; Antineoplastic Combined Chemotherapy Protocols/adverse effects
Chemical Substances	tipiracil (NGO10K751P) ; Uracil (56HH86ZVCT) ; Trifluridine (RMW9V5RW38) ; Thymine (QR26YLT7LT) ; Pyrrolidines ; Drug Combinations
Language	English
Publishing date	2023-10-20
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-45244-7
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Article ; Online: Exploratory Biomarker Analysis Using Plasma Angiogenesis-Related Factors and Cell-Free DNA in the TRUSTY Study: A Randomized, Phase II/III Study of Trifluridine/Tipiracil Plus Bevacizumab as Second-Line Treatment for Metastatic Colorectal Cancer.

Sunakawa, Yu / Kuboki, Yasutoshi / Watanabe, Jun / Terazawa, Tetsuji / Kawakami, Hisato / Yokota, Mitsuru / Nakamura, Masato / Kotaka, Masahito / Sugimoto, Naotoshi / Ojima, Hitoshi / Oki, Eiji / Kajiwara, Takeshi / Yamamoto, Yoshiyuki / Tsuji, Yasushi / Denda, Tadamichi / Tamura, Takao / Ishihara, Soichiro / Taniguchi, Hiroya / Nakajima, Takako Eguchi /

Morita, Satoshi / Shirao, Kuniaki / Takenaka, Naruhito / Ozawa, Daisuke / Yoshino, Takayuki

Targeted oncology

2024 Volume 19, Issue 1, Page(s) 59–69

Abstract: Background: The TRUSTY study evaluated the efficacy of second-line trifluridine/tipiracil (FTD/TPI) plus bevacizumab in metastatic colorectal cancer (mCRC).: Objective: This exploratory biomarker analysis of TRUSTY investigated the relationship ... ...

Abstract	Background: The TRUSTY study evaluated the efficacy of second-line trifluridine/tipiracil (FTD/TPI) plus bevacizumab in metastatic colorectal cancer (mCRC). Objective: This exploratory biomarker analysis of TRUSTY investigated the relationship between baseline plasma concentrations of angiogenesis-related factors and cell-free DNA (cfDNA), and the efficacy of FTD/TPI plus bevacizumab in patients with mCRC. Patients and methods: The disease control rate (DCR) and progression-free survival (PFS) were compared between baseline plasma samples of patients with high and low plasma concentrations (based on the median value) of angiogenesis-related factors. Correlations between cfDNA concentrations and PFS were assessed. Results: Baseline characteristics (n = 65) were as follows: male/female, 35/30; median age, 64 (range 25-84) years; and RAS status wild-type/mutant, 29/36. Patients in the hepatocyte growth factor (HGF)-low and interleukin (IL)-8-low groups had a significantly higher DCR (risk ratio [95% confidence intervals {CIs}]) than patients in the HGF-high (1.83 [1.12-2.98]) and IL-8-high (1.70 [1.02-2.82]) groups. PFS (hazard ratio {HR} [95% CI]) was significantly longer in patients in the HGF-low (0.33 [0.14-0.79]), IL-8-low (0.31 [0.14-0.70]), IL-6-low (0.19 [0.07-0.50]), osteopontin-low (0.39 [0.17-0.88]), thrombospondin-2-low (0.42 [0.18-0.98]), and tissue inhibitor of metalloproteinase-1-low (0.26 [0.10-0.67]) groups versus those having corresponding high plasma concentrations of these angiogenesis-related factors. No correlation was observed between cfDNA concentration and PFS. Conclusion: Low baseline plasma concentrations of HGF and IL-8 may predict better DCR and PFS in patients with mCRC receiving FTD/TPI plus bevacizumab, however further studies are warranted. Clinical trial registration number: jRCTs031180122.
MeSH term(s)	Humans ; Male ; Female ; Adult ; Middle Aged ; Aged ; Aged, 80 and over ; Bevacizumab/pharmacology ; Bevacizumab/therapeutic use ; Colorectal Neoplasms/pathology ; Interleukin-8/therapeutic use ; Uracil/therapeutic use ; Trifluridine/pharmacology ; Trifluridine/therapeutic use ; Angiogenesis ; Frontotemporal Dementia/drug therapy ; Tissue Inhibitor of Metalloproteinase-1/therapeutic use ; Colonic Neoplasms/drug therapy ; Cell-Free Nucleic Acids/therapeutic use ; Biomarkers ; Antineoplastic Combined Chemotherapy Protocols/pharmacology ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Pyrrolidines ; Thymine
Chemical Substances	tipiracil (NGO10K751P) ; Bevacizumab (2S9ZZM9Q9V) ; Interleukin-8 ; Uracil (56HH86ZVCT) ; Trifluridine (RMW9V5RW38) ; Tissue Inhibitor of Metalloproteinase-1 ; Cell-Free Nucleic Acids ; Biomarkers ; Pyrrolidines ; Thymine (QR26YLT7LT)
Language	English
Publishing date	2024-01-09
Publishing country	France
Document type	Clinical Trial, Phase II ; Journal Article
ZDB-ID	2222136-0
ISSN	1776-260X ; 1776-2596
ISSN (online)	1776-260X
ISSN	1776-2596
DOI	10.1007/s11523-023-01027-8
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Article ; Online: Nanoparticle albumin-bound paclitaxel and ramucirumab versus paclitaxel and ramucirumab as second-line chemotherapy for unresectable advanced or recurrent gastric cancer: a multicenter, propensity score-matched analysis (CROSS SELL study).

Nakasya, Akio / Hagiwara, Yuya / Ikoma, Tatsuki / Kurioka, Yusuke / Matsumoto, Toshihiko / Yamamoto, Yoshiyuki / Tsuduki, Takao / Kajiwara, Takeshi / Moriwaki, Toshikazu / Nishina, Tomohiro / Yamashita, Natsumi / Hyodo, Ichinosuke

International journal of clinical oncology

2022 Volume 27, Issue 4, Page(s) 684–694

Abstract: Background: Paclitaxel plus ramucirumab (PTX + RAM) is the standard second-line chemotherapy for unresectable advanced or recurrent gastric cancer (AGC). Nanoparticle albumin-bound paclitaxel (nab-PTX) is an improved, more convenient form of PTX and is ... ...

Abstract	Background: Paclitaxel plus ramucirumab (PTX + RAM) is the standard second-line chemotherapy for unresectable advanced or recurrent gastric cancer (AGC). Nanoparticle albumin-bound paclitaxel (nab-PTX) is an improved, more convenient form of PTX and is non-inferior to PTX. Although some retrospective and single-arm phase II studies regarding nab-PTX + RAM have been reported, comparative studies are lacking. Here, we compared the efficacy and toxicity of nab-PTX + RAM and PTX + RAM using propensity score matching. Methods: Clinical data of 265 patients treated for AGC with nab-PTX + RAM or PTX + RAM were retrospectively collected. Nab-PTX was administered at dosages of 100 mg/m Results: In total, 190 (72%) patients were matched. The median PFS was 5.3 [95% confidence interval (CI) 4.4-6.3] and 4.7 (95% CI 3.2-5.3) months in the nab-PTX + RAM and PTX + RAM groups, respectively [hazard ratio (HR) = 0.76, 95% CI 0.56-1.03, p = 0.07]. The median OS was 11.5 (95% CI 9.2-15.0) and 9.9 (95% CI 8.0-12.7) months, respectively (HR = 0.78, 95% CI 0.56-1.07, p = 0.12). Grade 3 and 4 neutropenia was observed more frequently in the nab-PTX + RAM group (72% vs. 56%, p = 0.03). No treatment-related deaths occurred. Conclusions: Nab-PTX + RAM exhibited more favorable trends in terms of PFS and OS but was more myelosuppressive than PTX + RAM. As neutropenia is commonly manageable toxicity, nab-PTX + RAM presents a treatment alternative for AGC. Further studies including randomized, controlled studies are warranted.
MeSH term(s)	Albumin-Bound Paclitaxel/therapeutic use ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Humans ; Nanoparticles ; Neoplasm Recurrence, Local/etiology ; Paclitaxel ; Propensity Score ; Retrospective Studies ; Stomach Neoplasms/drug therapy ; Treatment Outcome ; Ramucirumab
Chemical Substances	Albumin-Bound Paclitaxel ; Antibodies, Monoclonal, Humanized ; Paclitaxel (P88XT4IS4D)
Language	English
Publishing date	2022-01-28
Publishing country	Japan
Document type	Journal Article ; Multicenter Study
ZDB-ID	1400227-9
ISSN	1437-7772 ; 1341-9625
ISSN (online)	1437-7772
ISSN	1341-9625
DOI	10.1007/s10147-022-02114-y
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Article ; Online: Clinical features and treatment of epidermal growth factor inhibitor-related late-phase papulopustular rash.

Tohyama, Mikiko / Hamada, Makoto / Harada, Daijiro / Kozuki, Toshiyuki / Nogami, Naoyuki / Monden, Nobuya / Kajiwara, Takeshi / Nishina, Tomohiro

The Journal of dermatology

2019 Volume 47, Issue 2, Page(s) 121–127

Abstract: Papulopustular rash, an acneiform rash, appears on the seborrheic region during the first to second week of treatment with an epidermal growth factor receptor inhibitor (EGFRi). The rash gradually disappears after the fourth week; however, it persists or ...

Abstract	Papulopustular rash, an acneiform rash, appears on the seborrheic region during the first to second week of treatment with an epidermal growth factor receptor inhibitor (EGFRi). The rash gradually disappears after the fourth week; however, it persists or newly develops in other regions during EGFRi treatment. Because Staphylococcus aureus is frequently isolated from late-phase papulopustular rash, we assessed the incidence of bacterial infection and treatment outcomes of patients with late-phase papulopustular rash. Sixty-four cases treated with an EGFRi over 4 weeks who presented with papulopustular rash were assessed retrospectively. The median duration of EGFR inhibitor treatment was 5 months. Grade 2 and 3 papulopustular rash was observed in 47 and eight cases, respectively. Bacterial culture was performed in 51 cases, 50 of which yielded positive results: methicillin-sensitive S. aureus in 29, methicillin-resistant S. aureus in 14, Staphylococcus species in five, Pseudomonas aeruginosa in three, and other in four cases. Of the S. aureus isolates, 42% were resistant to minocycline and 40% to levofloxacin. After treatment with topical and/or oral antibiotics without topical corticosteroids, the papulopustular rash rapidly improved by an average of 2.9 ± 3.4 weeks. However, use of a combination of antibiotics and a topical corticosteroid prolonged the recovery period to an average of 18.9 ± 11.4 weeks. In conclusion, folliculitis that develops over 4 weeks after the initiation of EGFRi treatment is typically caused by staphylococcal infection. Bacterial culture is necessary due to the high rate of antibiotic resistance. It is important to distinguish late- from early-phase papulopustular rash and to treat using different approaches.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Anti-Bacterial Agents/pharmacology ; Anti-Bacterial Agents/therapeutic use ; Antineoplastic Agents, Immunological/adverse effects ; Cetuximab/adverse effects ; Drug Resistance, Bacterial ; ErbB Receptors/antagonists & inhibitors ; Exanthema/diagnosis ; Exanthema/drug therapy ; Exanthema/immunology ; Exanthema/microbiology ; Female ; Folliculitis/diagnosis ; Folliculitis/drug therapy ; Folliculitis/immunology ; Folliculitis/microbiology ; Humans ; Incidence ; Male ; Middle Aged ; Neoplasms/drug therapy ; Neoplasms/immunology ; Panitumumab/adverse effects ; Pseudomonas Infections/diagnosis ; Pseudomonas Infections/drug therapy ; Pseudomonas Infections/immunology ; Pseudomonas Infections/microbiology ; Pseudomonas aeruginosa/drug effects ; Pseudomonas aeruginosa/immunology ; Pseudomonas aeruginosa/isolation & purification ; Staphylococcal Infections/diagnosis ; Staphylococcal Infections/drug therapy ; Staphylococcal Infections/immunology ; Staphylococcal Infections/microbiology ; Staphylococcus aureus/drug effects ; Staphylococcus aureus/immunology ; Staphylococcus aureus/isolation & purification ; Time Factors
Chemical Substances	Anti-Bacterial Agents ; Antineoplastic Agents, Immunological ; Panitumumab (6A901E312A) ; EGFR protein, human (EC 2.7.10.1) ; ErbB Receptors (EC 2.7.10.1) ; Cetuximab (PQX0D8J21J)
Language	English
Publishing date	2019-12-05
Publishing country	England
Document type	Journal Article
ZDB-ID	800103-0
ISSN	1346-8138 ; 0385-2407
ISSN (online)	1346-8138
ISSN	0385-2407
DOI	10.1111/1346-8138.15170
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Article ; Online: Clinical significance of circulating-tumour DNA analysis by metastatic sites in pancreatic cancer.

Umemoto, Kumiko / Sunakawa, Yu / Ueno, Makoto / Furukawa, Masayuki / Mizuno, Nobumasa / Sudo, Kentaro / Kawamoto, Yasuyuki / Kajiwara, Takeshi / Ohtsubo, Koushiro / Okano, Naohiro / Matsuhashi, Nobuhisa / Itoh, Shinji / Matsumoto, Toshihiko / Shimizu, Satoshi / Otsuru, Toru / Hasegawa, Hiroko / Okuyama, Hiroyuki / Ohama, Hideko / Moriwaki, Toshikazu /

Ohta, Takashi / Odegaard, Justin I / Nakamura, Yoshiaki / Bando, Hideaki / Yoshino, Takayuki / Ikeda, Masafumi / Morizane, Chigusa

British journal of cancer

2023 Volume 128, Issue 8, Page(s) 1603–1608

Abstract: Background: Liquid biopsy is an alternative to tissue specimens for tumour genotyping. However, the frequency of genomic alterations with low circulating-tumour DNA (ctDNA) shedding is shown in pancreatic ductal adenocarcinoma (PDAC). We, therefore, ... ...

Abstract	Background: Liquid biopsy is an alternative to tissue specimens for tumour genotyping. However, the frequency of genomic alterations with low circulating-tumour DNA (ctDNA) shedding is shown in pancreatic ductal adenocarcinoma (PDAC). We, therefore, investigated the prevalence of KRAS mutations and ctDNA fraction by the metastatic site in patients with PDAC. Methods: This study enrolled previously treated PDAC patients from a plasma genomic profiling study; ctDNA analysis was performed using Guardant360 at disease progression before initiating subsequent treatment. Results: In 512 patients with PDAC, KRAS mutations were detected in 57%. The frequency of KRAS mutation in ctDNA differed depending on the metastatic organ; among patients with single-organ metastasis (n = 296), KRAS mutation detection rate was significantly higher in patients with metastasis to the liver (78%). In addition, the median maximum variant allele frequency (VAF) was higher with metastasis to the liver (1.9%) than with metastasis to the lungs, lymph nodes, peritoneum or with locally advanced disease (0.2%, 0.4%, 0.2% and 0.3%, respectively). Conclusion: The prevalence of KRAS mutations and maximum VAF were higher in patients with metastasis to the liver than in those with metastasis to other sites. This study indicated the clinical utility of ctDNA analysis, especially in PDAC with liver metastases.
MeSH term(s)	Humans ; Circulating Tumor DNA/genetics ; Clinical Relevance ; Proto-Oncogene Proteins p21(ras)/genetics ; Pancreatic Neoplasms/pathology ; Carcinoma, Pancreatic Ductal/pathology ; Mutation ; Biomarkers, Tumor/genetics
Chemical Substances	Circulating Tumor DNA ; Proto-Oncogene Proteins p21(ras) (EC 3.6.5.2) ; Biomarkers, Tumor
Language	English
Publishing date	2023-02-13
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	80075-2
ISSN	1532-1827 ; 0007-0920
ISSN (online)	1532-1827
ISSN	0007-0920
DOI	10.1038/s41416-023-02189-y
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Article ; Online: A Phase II Trial of Trifluridine/Tipiracil in Combination with Cetuximab Rechallenge in Patients with RAS Wild-Type mCRC Refractory to Prior Anti-EGFR Antibodies: WJOG8916G Trial.

Targeted oncology

2023 Volume 18, Issue 3, Page(s) 369–381

Abstract: Background: Trifluridine/tipiracil (FTD/TPI) improved the overall survival in patients with metastatic colorectal cancer (mCRC) who had previously received standard chemotherapies; however, the clinical outcomes remain poor.: Objective: A multicenter ...

Abstract	Background: Trifluridine/tipiracil (FTD/TPI) improved the overall survival in patients with metastatic colorectal cancer (mCRC) who had previously received standard chemotherapies; however, the clinical outcomes remain poor. Objective: A multicenter phase II study aimed to assess the efficacy and safety of FTD/TPI plus cetuximab rechallenge. Patients and methods: Patients with histologically confirmed RAS wild-type mCRC refractory to prior anti-epidermal growth factor receptor (anti-EGFR) antibody were enrolled and treated with FTD/TPI (35 mg/m Results: A total of 56 patients (median age 60 years; left-sided tumors 91%; objective partial or complete response during the prior anti-EGFR therapy 61%) were enrolled. The DCR was 54% (80% confidence interval [CI] 44-63; P = 0.12), with a partial response rate of 3.6%. Median progression-free survival (PFS) was 2.4 months (95% CI 2.1-3.7). In the circulating tumor DNA analysis, patients without any alterations of the six genes (n = 20) demonstrated higher DCR (75% vs. 39%; P = 0.02) and longer PFS (median 4.7 vs. 2.1 months; P < 0.01) than those with any gene alterations (n = 33). The most common grade 3/4 hematologic adverse event was neutropenia (55%). No treatment-related deaths occurred. Conclusions: FTD/TPI plus cetuximab rechallenge did not demonstrate clinically meaningful efficacy in all mCRC patients, but might be beneficial for the molecularly selected population.
MeSH term(s)	Humans ; Middle Aged ; Cetuximab/pharmacology ; Cetuximab/therapeutic use ; Colorectal Neoplasms/pathology ; Trifluridine/pharmacology ; Trifluridine/therapeutic use ; Circulating Tumor DNA ; Frontotemporal Dementia/chemically induced ; Frontotemporal Dementia/drug therapy ; Colonic Neoplasms/drug therapy ; Antineoplastic Combined Chemotherapy Protocols/pharmacology ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use
Chemical Substances	Cetuximab (PQX0D8J21J) ; tipiracil (NGO10K751P) ; Trifluridine (RMW9V5RW38) ; Circulating Tumor DNA
Language	English
Publishing date	2023-05-06
Publishing country	France
Document type	Clinical Trial, Phase II ; Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2222136-0
ISSN	1776-260X ; 1776-2596
ISSN (online)	1776-260X
ISSN	1776-2596
DOI	10.1007/s11523-023-00963-9
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Article ; Online: Clinical Outcomes Following Trifluridine/Tipiracil Treatment for Patients With Metastatic Colorectal Cancer Ineligible for Regorafenib Treatment.

Niisato, Yusuke / Moriwaki, Toshikazu / Fukuoka, Shota / Masuishi, Toshiki / Takashima, Atsuo / Kumekawa, Yosuke / Kajiwara, Takeshi / Yamazaki, Kentaro / Esaki, Taito / Makiyama, Akitaka / Denda, Tadamichi / Hatachi, Yukimasa / Suto, Takeshi / Sugimoto, Naotoshi / Shimada, Yasuhiro

Anticancer research

2021 Volume 41, Issue 4, Page(s) 2203–2207

Abstract: Background/aim: In later-line treatment of metastatic colorectal cancer (mCRC), trifluridine/tipiracil is often selected because regorafenib is difficult to use in patients with comorbidities such as thrombosis, hemorrhage, or cardiac events. However, ... ...

Abstract	Background/aim: In later-line treatment of metastatic colorectal cancer (mCRC), trifluridine/tipiracil is often selected because regorafenib is difficult to use in patients with comorbidities such as thrombosis, hemorrhage, or cardiac events. However, the safety and efficacy of trifluridine/tipiracil in these patients is not clear. Patients and methods: The clinical outcomes of trifluridine/tipiracil were retrospectively investigated in patients who were ineligible for regorafenib because of comorbidities. Results: Among the 27 patients who received trifluridine/tipiracil, many had comorbidities of deep venous thrombosis or hemorrhage. The median overall survival was 12.4 months, and the median progression-free survival was 2.8 months. The median overall survival was 7.7 months in 19 patients without subsequent regorafenib. Grade 3 or higher toxicities were found in 51% of patients. No treatment discontinuation because of comorbidities was observed. Conclusion: Trifluridine/tipiracil can be safely administered while maintaining efficacy in patients who were ineligible for regorafenib.
MeSH term(s)	Adenocarcinoma/drug therapy ; Adenocarcinoma/epidemiology ; Adenocarcinoma/pathology ; Adult ; Aged ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/epidemiology ; Colorectal Neoplasms/pathology ; Comorbidity ; Drug Combinations ; Female ; Humans ; Japan/epidemiology ; Male ; Middle Aged ; Neoplasm Metastasis ; Patient Selection ; Phenylurea Compounds/therapeutic use ; Progression-Free Survival ; Pyridines/therapeutic use ; Pyrrolidines/adverse effects ; Pyrrolidines/therapeutic use ; Retrospective Studies ; Salvage Therapy ; Survival Analysis ; Thymine/adverse effects ; Thymine/therapeutic use ; Treatment Outcome ; Trifluridine/adverse effects ; Trifluridine/therapeutic use
Chemical Substances	Drug Combinations ; Phenylurea Compounds ; Pyridines ; Pyrrolidines ; trifluridine tipiracil drug combination ; regorafenib (24T2A1DOYB) ; Thymine (QR26YLT7LT) ; Trifluridine (RMW9V5RW38)
Language	English
Publishing date	2021-04-01
Publishing country	Greece
Document type	Journal Article
ZDB-ID	604549-2
ISSN	1791-7530 ; 0250-7005
ISSN (online)	1791-7530
ISSN	0250-7005
DOI	10.21873/anticanres.14996
Database	MEDical Literature Analysis and Retrieval System OnLINE

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