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1. Three-year outcomes of preoperative chemoradiotherapy plus nivolumab in microsatellite stable and microsatellite instability-high locally advanced rectal cancer

Author

Tsukada, Yuichiro, Bando, Hideaki, Inamori, Koji, Wakabayashi, Masashi, Togashi, Yosuke, Koyama, Shohei, Kotani, Daisuke, Yuki, Satoshi, Komatsu, Yoshito, Homma, Shigenori, Taketomi, Akinobu, Uemura, Mamoru, Kato, Takeshi, Fukui, Makoto, Nakamura, Naoki, Kojima, Motohiro, Kawachi, Hiroshi, Kirsch, Richard, Yoshida, Tsutomu, Sato, Akihiro, Nishikawa, Hiroyoshi, Ito, Masaaki, and Yoshino, Takayuki

Published
2024
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4. Different efficacy of tyrosine kinase inhibitors by KIT and PGFRA mutations identified in circulating tumor DNA for the treatment of refractory gastrointestinal stromal tumors

Author

Hashimoto, Tadayoshi, Nakamura, Yoshiaki, Komatsu, Yoshito, Yuki, Satoshi, Takahashi, Naoki, Okano, Naohiro, Hirano, Hidekazu, Ohtsubo, Koushiro, Ohta, Takashi, Oki, Eiji, Nishina, Tomohiro, Yasui, Hisateru, Kawakami, Hisato, Esaki, Taito, Machida, Nozomu, Doi, Ayako, Boku, Shogen, Kudo, Toshihiro, Yamamoto, Yoshiyuki, Kanazawa, Akiyoshi, Denda, Tadamichi, Goto, Masahiro, Iida, Naoko, Ozaki, Hiroshi, Shibuki, Taro, Imai, Mitsuho, Fujisawa, Takao, Bando, Hideaki, Naito, Yoichi, and Yoshino, Takayuki

Published
2024
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5. Clinical features associated with NeoRAS wild-type metastatic colorectal cancer A SCRUM-Japan GOZILA substudy

Author

Osumi, Hiroki, Shinozaki, Eiji, Nakamura, Yoshiaki, Esaki, Taito, Yasui, Hisateru, Taniguchi, Hiroya, Satake, Hironaga, Sunakawa, Yu, Komatsu, Yoshito, Kagawa, Yoshinori, Denda, Tadamichi, Shiozawa, Manabu, Satoh, Taroh, Nishina, Tomohiro, Goto, Masahiro, Takahashi, Naoki, Kato, Takeshi, Bando, Hideaki, Yamaguchi, Kensei, and Yoshino, Takayuki

Published
2024
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7. English version of Japanese Clinical Practice Guidelines 2022 for gastrointestinal stromal tumor (GIST) issued by the Japan Society of Clinical Oncology

Author

Hirota, Seiichi, Tateishi, Ukihide, Nakamoto, Yuji, Yamamoto, Hidetaka, Sakurai, Shinji, Kikuchi, Hirotoshi, Kanda, Tatsuo, Kurokawa, Yukinori, Cho, Haruhiko, Nishida, Toshirou, Sawaki, Akira, Ozaka, Masato, Komatsu, Yoshito, Naito, Yoichi, Honma, Yoshitaka, Takahashi, Fumiaki, Hashimoto, Hironobu, Udo, Midori, Araki, Minako, and Nishidate, Sumito

Published
2024
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8. Baseline ctDNA gene alterations as a biomarker of survival after panitumumab and chemotherapy in metastatic colorectal cancer

Author

Shitara, Kohei, Muro, Kei, Watanabe, Jun, Yamazaki, Kentaro, Ohori, Hisatsugu, Shiozawa, Manabu, Takashima, Atsuo, Yokota, Mitsuru, Makiyama, Akitaka, Akazawa, Naoya, Ojima, Hitoshi, Yuasa, Yasuhiro, Miwa, Keisuke, Yasui, Hirofumi, Oki, Eiji, Sato, Takeo, Naitoh, Takeshi, Komatsu, Yoshito, Kato, Takeshi, Mori, Ikuo, Yamanaka, Kazunori, Hihara, Masamitsu, Soeda, Junpei, Misumi, Toshihiro, Yamamoto, Kouji, Yamashita, Riu, Akagi, Kiwamu, Ochiai, Atsushi, Uetake, Hiroyuki, Tsuchihara, Katsuya, and Yoshino, Takayuki

Published
2024
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9. Trastuzumab Deruxtecan in Advanced Solid Tumors With Human Epidermal Growth Factor Receptor 2 Amplification Identified by Plasma Cell-Free DNA Testing: A Multicenter, Single-Arm, Phase II Basket Trial

Author

Yagisawa, Masataka, Taniguchi, Hiroya, Satoh, Taroh, Kadowaki, Shigenori, Sunakawa, Yu, Nishina, Tomohiro, Komatsu, Yoshito, Esaki, Taito, Sakai, Daisuke, Doi, Ayako, Kajiwara, Takeshi, Ono, Hiromi, Asano, Masatoshi, Hirano, Nami, Odegaard, Justin, Fujii, Satoshi, Nomura, Shogo, Bando, Hideaki, Sato, Akihiro, Yoshino, Takayuki, and Nakamura, Yoshiaki

Published
2024
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11. Correlation of enriched specific subset of immune cells nearby tumor associated macrophage (TAM) with pathologic complete response (pCR) of concurrent chemoradiotherapy followed by nivolumab in locally advanced rectal cancer (LARC).

Author

Imai, Mitsuho, Bando, Hideaki, Tsukada, Yuichiro, Inamori, Koji, Kato, Takeshi, Komatsu, Yoshito, Uemura, Mamoru, Yuki, Satoshi, Taketomi, Akinobu, Fujisawa, Takao, Nakamura, Yoshiaki, Kojima, Motohiro, Koyama, Shohei, Song, Sanghoon, Ock, Chan-Young, Nishikawa, Hiroyoshi, Ito, Masaaki, and Yoshino, Takayuki

Published
2024
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12. QUATTRO-II randomized trial: CAPOXIRI+bevacizumab vs. FOLFOXIRI+bevacizumab as first-line treatment in patients with mCRC

Author

Bando, Hideaki, Kotani, Daisuke, Satake, Hironaga, Hamaguchi, Tetsuya, Shiozawa, Manabu, Kotaka, Masahito, Masuishi, Toshiki, Yasui, Hisateru, Kagawa, Yoshinori, Komatsu, Yoshito, Oki, Eiji, Yamamoto, Yoshiyuki, Kawakami, Hisato, Misumi, Toshihiro, Taniguchi, Hiroya, Yamazaki, Kentaro, Muro, Kei, Yoshino, Takayuki, Kato, Takeshi, and Tsuji, Akihito

Published
2024
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13. Trastuzumab deruxtecan in patients with HER2-positive advanced colorectal cancer (DESTINY-CRC02): primary results from a multicentre, randomised, phase 2 trial

Author

Raghav, Kanwal, Siena, Salvatore, Takashima, Atsuo, Kato, Takeshi, Van den Eynde, Marc, Pietrantonio, Filippo, Komatsu, Yoshito, Kawakami, Hisato, Peeters, Marc, Andre, Thierry, Lonardi, Sara, Yamaguchi, Kensei, Tie, Jeanne, Castro, Cristina Gravalos, Hsu, Hung-Chih, Strickler, John H, Kim, Tae-You, Cha, Yongjun, Barrios, Daniel, Yan, Qi, Kamio, Takahiro, Kobayashi, Kojiro, Boran, Aislyn, Koga, Makito, Allard, John D, and Yoshino, Takayuki

Published
2024
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14. Doublet chemotherapy, triplet chemotherapy, or doublet chemotherapy combined with radiotherapy as neoadjuvant treatment for locally advanced oesophageal cancer (JCOG1109 NExT): a randomised, controlled, open-label, phase 3 trial

Author

Komatsu, Yoshito, Akiyama, Yuji, Takahashi, Masanobu, Amagai, Kenji, Matsushita, Naoyuki, Hara, Hiroki, Sato, Hiroshi, Kojima, Takashi, Minashi, Keiko, Matsubara, Hisahiro, Kikuchi, Yuji, Kato, Ken, Narumiya, Kosuke, Kitagawa, Yuko, Kubota, Yutaro, Watanabe, Masayuki, Ueno, Masaki, Ozawa, Soji, Ogata, Takashi, Bamba, Takeo, Ichikawa, Hiroshi, Watanabe, Masaya, Tsubosa, Yasuhiro, Takeuchi, Hiroya, Abe, Tetsuya, Koike, Masahiko, Tsunoda, Shigeru, Doki, Yuichiro, Miyata, Hiroshi, Hirano, Motohiro, Ikeda, Hiroko, Goto, Masahiro, Minami, Hironobu, Masuzawa, Toru, Tsuda, Masahiro, Okada, Morihito, Mukai, Hidenori, Kajiwara, Takeshi, Shibuya, Yuichi, Morita, Masaru, Baba, Eishi, Baba, Hideo, Inomata, Masafumi, Sasaki, Ken, Machida, Ryunosuke, Ito, Yoshinori, Daiko, Hiroyuki, Kawakubo, Hirofumi, Takegawa, Naoki, and Nakamura, Kenichi

Published
2024
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17. Efficacy of Pembrolizumab Monotherapy in Japanese Patients with Advanced Gastric or Gastroesophageal Junction Cancer

Author

Muro, Kei, Shitara, Kohei, Yamaguchi, Kensei, Yoshikawa, Takaki, Satake, Hironaga, Hara, Hiroki, Sugimoto, Naotoshi, Machida, Nozomu, Goto, Masahiro, Kawakami, Hisato, Amagai, Kenji, Omuro, Yasushi, Esaki, Taito, Hironaka, Shuichi, Nishina, Tomohiro, Komatsu, Yoshito, Matsubara, Hisahiro, Shiratori, Shinichi, Han, Shirong, Satoh, Taroh, and Ohtsu, Atsushi

Published
2023
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18. Safety and Efficacy of Encorafenib, Binimetinib, and Cetuximab for BRAFV600E-Mutant Metastatic Colorectal Cancer: Results of the Japanese Expanded Access Program

Author

Kotani, Daisuke, Takashima, Atsuo, Kato, Takeshi, Satoh, Taroh, Masuishi, Toshiki, Komatsu, Yoshito, Shiozawa, Manabu, Esaki, Taito, Izawa, Naoki, Takeuchi, Shinji, Bando, Hideaki, Iwasa, Satoru, Hasegawa, Hiroko, Yamaguchi, Toshifumi, Taniguchi, Hiroya, Ushida, Yasunori, Oizaki, Toshiya, Inoue, Chiaki, and Yoshino, Takayuki

Published
2024
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25. A randomised phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel for locally advanced pancreatic cancer (JCOG1407)

Author

Ozaka, Masato, Nakachi, Kohei, Kobayashi, Satoshi, Ohba, Akihiro, Imaoka, Hiroshi, Terashima, Takeshi, Ishii, Hiroshi, Mizusawa, Junki, Katayama, Hiroshi, Kataoka, Tomoko, Okusaka, Takuji, Ikeda, Masafumi, Sasahira, Naoki, Miwa, Haruo, Mizukoshi, Eishiro, Okano, Naohiro, Mizuno, Nobumasa, Yamamoto, Tomohisa, Komatsu, Yoshito, Todaka, Akiko, Kamata, Ken, Furukawa, Masayuki, Fujimori, Nao, Katanuma, Akio, Takayama, Yukiko, Tsumura, Hidetaka, Fukuda, Haruhiko, Ueno, Makoto, and Furuse, Junji

Published
2023
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27. Multicenter, prospective, observational study of chemotherapy-induced dysgeusia in gastrointestinal cancer

Author

Ito, Ken, Yuki, Satoshi, Nakatsumi, Hiroshi, Kawamoto, Yasuyuki, Harada, Kazuaki, Nakano, Shintaro, Saito, Rika, Ando, Takayuki, Sawada, Kentaro, Yagisawa, Masataka, Ishiguro, Atsushi, Dazai, Masayoshi, Iwanaga, Ichiro, Hatanaka, Kazuteru, Sato, Atsushi, Matsumoto, Ryusuke, Shindo, Yoshiaki, Tateyama, Miki, Muranaka, Tetsuhito, Katagiri, Masaki, Yokota, Isao, Sakata, Yuh, Sakamoto, Naoya, and Komatsu, Yoshito

Published
2022
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28. A multicenter, prospective, phase II trial of second‐line aflibercept plus FOLFIRI in patients with metastatic colorectal cancer refractory to an anti‐EGFR antibody: HGCSG1801.

Author

Nakatsumi, Hiroshi, Komatsu, Yoshito, Harada, Kazuaki, Kawamoto, Yasuyuki, Yuki, Satoshi, Sawada, Kentaro, Ishiguro, Atsushi, Sogabe, Susumu, Ando, Takayuki, Sasaki, Yusuke, Yoshikawa, Ayumu, Nakamura, Michio, Dazai, Masayoshi, Tateyama, Miki, Muto, Osamu, Kotaka, Masahito, Sagawa, Tamotsu, Muranaka, Tetsuhito, Hatanaka, Kazuteru, and Takagi, Ryo

Subjects
JAPANESE people, FEBRILE neutropenia, COLORECTAL cancer, CANCER chemotherapy, OVERALL survival
Abstract

Aflibercept (AFL) plus FOLFIRI prolongs overall survival (OS) in patients with metastatic colorectal cancer (mCRC). However, there is limited evidence on the efficacy and safety of AFL plus FOLFIRI previously treated with anti‐epidermal growth factor receptor (EGFR) agents. Therefore, we conducted a prospective open‐label phase II trial evaluating the efficacy and safety of AFL plus FOLFIRI in Japanese patients with mCRC failing a prior oxaliplatin‐based chemotherapy plus an anti‐EGFR agent. AFL (4 mg/kg iv) followed by FOLFIRI (irinotecan 180 mg/m2, leucovorin 200 mg/m2 iv, bolus 5‐fluorouracil [5‐FU] 400 mg/m2, and infusional 5‐FU 2400 mg/m2/46 h) was given every 2 weeks until progression or unacceptable toxicities. The primary endpoint was progression‐free survival (PFS) rate at 6 months. Forty three patients were enrolled between November 2019 and October 2022. The primary endpoint was met: 6‐month PFS rate was 58.8% (90% confidence interval [CI], 45.7%–72.0%). Median PFS and OS were 7.3 months (95% CI, 5.5–11.0 months) and 18.8 months (95% CI, 12.9–26.6 months), respectively. The overall response rate was 20.9% (95% CI, 10.0–36.0%) and disease control rate was 88.4% (95% CI, 74.9–96.1%). The main grade ≥3 adverse events included hypertension (62.8%), neutropenia (55.8%), leukopenia (25.6%), febrile neutropenia (11.6%), fatigue (9.3%), anorexia (9.3%), proteinuria (9.3%), and diarrhea (7.0%). No deaths and no new safety signals with a causal relation to the study treatment were observed. This study suggests that AFL plus FOLFIRI shows a high response rate and a manageable safety profile in Japanese patients with mCRC who failed prior oxaliplatin‐based chemotherapy plus an anti‐EGFR agent. [ABSTRACT FROM AUTHOR]

Published
2024
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29. Plain language summary of the FOENIX-CCA2 study: futibatinib for people with advanced bile duct cancer.

Author

Goyal, Lipika, Meric-Bernstam, Funda, Hollebecque, Antoine, Valle, Juan W, Morizane, Chigusa, Karasic, Thomas B, Abrams, Thomas A, Furuse, Junji, Kelley, Robin Katie, Cassier, Philippe A, Klümpen, Heinz-Josef, Chang, Heung-Moon, Chen, Li-Tzong, Tabernero, Josep, Oh, Do-Youn, Mahipal, Amit, Moehler, Markus, Komatsu, Yoshito, Ahn, Daniel H, and Epstein, Robert S

Abstract

What is this summary about? This summary describes the results from a phase 2 study called FOENIXCCA2. The study evaluated treatment with futibatinib in people with a rare form of advanced bile duct cancer called intrahepatic cholangiocarcinoma (or iCCA), where the tumors have changes in the structure of a gene called FGFR2. These changes include FGFR2 gene fusions. Bile duct cancer often returns after surgery or cannot be treated by surgery because the tumor has spread, so it requires treatment with chemotherapy. People live for a median of 1 year after their first chemotherapy treatment and 6 months after their second treatment. This study included people whose cancer had grown/spread after one or more chemotherapy treatments. The aims of the study were to see if futibatinib could shrink the size of tumors and stop the cancer from growing/spreading and to see how long people lived when treated with futibatinib. Clinicians also looked at side effects from taking futibatinib and at how it affected people's quality of life. What were the results? Futibatinib treatment shrank tumors in over 80% of people who received treatment. Tumors shrank by at least 30% in 42% of people. Futibatinib stopped tumors from growing/spreading for a median of 9.7 months. People who took the medicine lived for a median of 21.7 months, and 72% of people were still alive after 1 year. Side effects from taking futibatinib were like those reported for similar medicines, and clinicians considered the side effects to be manageable by adjusting the dose of futibatinib or treating the side effects. Most people reported that their quality of life stayed the same or improved during the first 9 months of taking futibatinib. What do the results mean? The results support the use of futibatinib for treating people with advanced bile duct cancer. Based on the results of this study, futibatinib is now approved in the US, Europe, and Japan. Futibatinib is approved for treating adults with advanced bile duct cancer who have received previous treatment for their cancer, and whose tumors have a gene fusion or other change in the FGFR2 gene. Clinical Trial Registration:NCT02052778 (FOENIX-CCA2) [ABSTRACT FROM AUTHOR]

Published
2024
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30. Cardiovascular safety of pimitespib in patients with advanced solid tumors: An open‐label, nonrandomized, phase 1 study.

Author

Naoki, Katsuhiko, Igawa, Satoshi, Uojima, Haruki, Tsumura, Hideyasu, Sengoku, Norihiko, Karayama, Masato, Shimomura, Akihiko, Ohtake, Tohru, Shio, Yutaka, Hosokawa, Ayumu, Komatsu, Yoshito, and Kumagai, Yuji

Subjects
DRUG side effects, JAPANESE people, INTESTINAL cancer, STOMACH cancer, HEART beat, GASTROINTESTINAL stromal tumors, GASTROINTESTINAL tumors
Abstract

Background: Pimitespib (TAS‐116), a first‐in‐class, oral, selective heat‐shock protein 90 inhibitor, is approved as fourth‐line treatment for gastrointestinal stromal tumors in Japan. This phase 1 study evaluated the cardiac safety of pimitespib. Methods: In this open‐label, nonrandomized, multicenter study, Japanese patients (aged ≥20 years) with refractory, advanced solid tumors received placebo on day −1, then pimitespib 160 mg daily on days 1–5 of the cardiac safety evaluation period. Electrocardiograms were conducted at baseline, and on days −2, −1, 1, and 5; and blood samples were collected on days 1 and 5. Patients then received once‐daily pimitespib for 5 days every 3 weeks. The primary end point was the time‐matched difference in QT interval corrected for heart rate using the Fridericia correction (QTcF) between pimitespib and placebo. Pharmacokinetics, safety, and preliminary efficacy were also assessed. Results: Of the 22 patients in the cardiac safety‐evaluable population, no clinically relevant QTc prolongation was observed; the upper bound of the one‐sided 95% confidence interval for the time‐matched difference in change from baseline in QTcF was <20 msec at all time points on days 1 and 5. Pimitespib pharmacokinetic parameters were consistent with previous data, and the time‐matched difference in change from baseline in QTcF showed no marked increase as plasma concentrations increased. The safety profile was acceptable; 40% of patients experienced grade 3 or greater adverse drug reactions, mostly diarrhea (20%). The median progression‐free survival was 3.1 months. Conclusions: In Japanese patients with refractory, advanced solid tumors, pimitespib was not associated with clinically relevant QTc prolongation, and there were no cardiovascular safety concerns. Plain Language Summary: Pimitespib is a new anticancer drug that is being used to treat cancer in the stomach or intestines (gastrointestinal stromal tumors).This study demonstrated that pimitespib had no marked effect on heart rhythm or negative effects on the heart or blood vessels and had promising anticancer effects in Japanese patients with advanced solid tumors who were unable to tolerate or benefit from standard treatment. [ABSTRACT FROM AUTHOR]

Published
2024
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31. Phase II trial of niraparib for BRCA-mutated biliary tract, pancreatic and other gastrointestinal cancers: NIR-B.

Author

Kawamoto, Yasuyuki, Morizane, Chigusa, Komatsu, Yoshito, Kondo, Shunsuke, Ueno, Makoto, Kobayashi, Satoshi, Furukawa, Masayuki, Lee, Lingaku, Satoh, Taroh, Sakai, Daisuke, Ikeda, Masafumi, Imaoka, Hiroshi, Miura, Arisa, Hatanaka, Yutaka, Yokota, Isao, Nakamura, Yoshiaki, and Yoshino, Takayuki

Abstract

Due to the widespread use of cancer genetic testing in gastrointestinal cancer, the BRCA1/2 genetic mutation has been identified in biliary tract cancer as well as pancreatic cancer. Niraparib is a poly(ADP-ribose) polymerase (PARP) inhibitor, and PARP inhibitors exert their cytotoxicity against cancer cells in the context of homologous recombination deficiency, such as BRCA mutations, via the mechanism of synthetic lethality. The aim of this phase II NIR-B trial is to evaluate the efficacy and safety of niraparib for patients with unresectable advanced or recurrent biliary tract cancer, pancreatic cancer or other gastrointestinal cancers with germline or somatic BRCA1/2 mutations revealed by genetic testing. The primary end point is an investigator-assessed objective response rate in each cohort. Clinical Trial Registration:jRCT2011200023 (ClinicalTrials.gov) Plain Language Summary A clinical study to confirm the efficacy and safety of niraparib for people with advanced biliary tract, pancreatic and other abdominal cancers with the BRCA genetic mutation: the NIR-B trial. BRCA gene is involved in repairing DNA injury and plays an important role in cancer growth. Cells with a mutation in the BRCA gene cannot repair DNA using a method called homologous recombination repair. Niraparib is part of a class of drugs called 'PARP inhibitors' that inhibit enzymes called 'PARP' involved in repairing DNA injury, and has shown efficacy against cancers with BRCA gene mutations. BRCA gene mutations are infrequent but have been found in a variety of cancers. The NIR-B trial is a clinical trial to evaluate the efficacy and safety of niraparib for people with advanced biliary tract, pancreatic and other abdominal cancers with BRCA gene mutations. Executive summary Background Recent comprehensive genomic profiling testing has revealed therapeutic target molecules. It has been proven that the BRCA1/2 genetic mutation has been identified in biliary tract and pancreatic cancer. Niraparib is classified as a poly(ADP-ribose) polymerase (PARP) inhibitor, and PARP inhibitors exert cytotoxicity against cancer cells in the context of homologous recombination deficiency, such as BRCA mutations, by the mechanism of synthetic lethality. Niraparib has been shown to be selective for PARP1/2 as well as more cytotoxic than other PARP inhibitors owing to its PARP-trapping activity. NIR-B trial This NIR-B trial is a multicenter, open-label, single-arm, three-cohort and basket-type phase II study, with the aim to evaluate the efficacy and safety of niraparib for patients with unresectable advanced or recurrent biliary tract cancer, pancreatic cancer and other gastrointestinal cancers with germline or somatic BRCA1/2 mutations observed on genetic testing. Eligible patients will be enrolled at six trial sites in Japan. Patients with a body weight ≥77 kg and platelet count ≥150,000/mm3 will be administered 300 mg of niraparib orally once daily, while patients with a body weight <77 kg or platelet count <150,000/mm3 will be administered 200 mg of niraparib orally once daily. The primary end point is an investigator-assessed objective response rate (ORR) in each cohort with a threshold ORR of 10% and an expected ORR of 35%. The key secondary end points are progression-free survival, overall survival, disease control rate, duration of response and safety. Pretreatment tumor tissue and serial circulating tumor DNA will be collected and analyzed to investigate the resistance mechanisms and to provide a clinically meaningful biomarker that can be used to identify and implement treatment changes. The trial was initiated in January 2021, and enrollment is ongoing. [ABSTRACT FROM AUTHOR]

Published
2024
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34. Clinical Validation of Plasma-Based Genotyping for RAS and BRAF V600E Mutation in Metastatic Colorectal Cancer: SCRUM-Japan GOZILA Substudy

Author

Aoki, Yu, Nakamura, Yoshiaki, Denda, Tadamichi, Ohta, Takashi, Esaki, Taito, Shiozawa, Manabu, Yamaguchi, Kensei, Yamazaki, Kentaro, Sunakawa, Yu, Kato, Takeshi, Okano, Naohiro, Taniguchi, Hiroya, Sato, Taro, Oki, Eiji, Nishina, Tomohiro, Komatsu, Yoshito, Matsuhashi, Nobuhisa, Goto, Masahiro, Yasui, Hisateru, Ohtsubo, Koushiro, Moriwaki, Toshikazu, Takahashi, Naoki, Horita, Yosuke, Boku, Shogen, Wakabayashi, Masashi, Ikeno, Takashi, Mitani, Ryuta, Yuasa, Mihoko, and Yoshino, Takayuki

Published
2023
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36. Feasibility of edoxaban for asymptomatic cancer-associated thrombosis in Japanese patients with gastrointestinal cancer: ExCAVE study

Author

Nakamura, Michio, Ishiguro, Atsushi, Dazai, Masayoshi, Kawamoto, Yasuyuki, Yuki, Satoshi, Sogabe, Susumu, Hosokawa, Ayumu, Sawada, Kentaro, Muto, Osamu, Izawa, Naoki, Nakashima, Koji, Horie, Yoshiki, Yagisawa, Masataka, Kajiura, Shinya, Ando, Takayuki, Mitsuhashi, Yosuke, Sunakawa, Yu, Kikuchi, Yasuka, and Komatsu, Yoshito

Published
2022
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37. Circulating tumor DNA-guided treatment with pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer: a phase 2 trial

Author

Nakamura, Yoshiaki, Okamoto, Wataru, Kato, Takeshi, Esaki, Taito, Kato, Ken, Komatsu, Yoshito, and Yuki, Satoshi

Subjects
Metastasis -- Risk factors, Colorectal cancer -- Diagnosis -- Complications and side effects -- Development and progression, Pertuzumab -- Testing, Cancer -- Genetic aspects, Biological sciences, Health
Abstract

The applicability of circulating tumor DNA (ctDNA) genotyping to inform enrollment of patients with cancer in clinical trials has not been established. We conducted a phase 2 trial to evaluate the efficacy of pertuzumab plus trastuzumab for metastatic colorectal cancer (mCRC), with human epidermal growth factor receptor 2 (HER2) amplification prospectively confirmed by tumor tissue or ctDNA analysis (UMIN000027887). HER2 amplification was confirmed in tissue and/or ctDNA in 30 patients with mCRC. The study met the primary endpoint with a confirmed objective response rate of 30% in 27 tissue-positive patients and 28% in 25 ctDNA-positive patients, as compared to an objective response rate of 0% in a matched real-world reference population treated with standard-of-care salvage therapy. Post hoc exploratory analyses revealed that baseline ctDNA genotyping of HER2 copy number and concurrent oncogenic alterations adjusted for tumor fraction stratified patients according to efficacy with similar accuracy to tissue genotyping. Decreased ctDNA fraction 3 weeks after treatment initiation associated with therapeutic response. Pertuzumab plus trastuzumab showed similar efficacy in patients with mCRC with HER2 amplification in tissue or ctDNA, showing that ctDNA genotyping can identify patients who benefit from dual-HER2 blockade as well as monitor treatment response. These findings warrant further use of ctDNA genotyping in clinical trials for HER2-amplified mCRC, which might especially benefit patients in first-line treatment. The multicenter phase 2 TRIUMPH trial shows the utility of ctDNA genotyping as a screening platform to select patients with HER2-amplified metastatic colorectal cancer who benefit from dual-HER2 blockade with trastuzumab and pertuzumab, Author(s): Yoshiaki Nakamura [sup.1] [sup.2] , Wataru Okamoto [sup.1] [sup.2] [sup.3] , Takeshi Kato [sup.4] , Taito Esaki [sup.5] , Ken Kato [sup.6] , Yoshito Komatsu [sup.7] , Satoshi Yuki [...]

Published
2021
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38. Combination therapy of capecitabine, irinotecan, oxaliplatin, and bevacizumab as a first‐line treatment for metastatic colorectal cancer: Safety lead‐in results from the QUATTRO-II study

Author

Kotani, Daisuke, Yoshino, Takayuki, Kotaka, Masahito, Kawazoe, Akihito, Masuishi, Toshiki, Taniguchi, Hiroya, Yamazaki, Kentaro, Yamanaka, Takeharu, Oki, Eiji, Muro, Kei, Komatsu, Yoshito, Bando, Hideaki, Satake, Hironaga, Kato, Takeshi, and Tsuji, Akihito

Published
2021
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40. Combination therapy of bevacizumab with either S-1 and irinotecan or mFOLFOX6/CapeOX as first-line treatment of metastatic colorectal cancer (TRICOLORE): Exploratory analysis of RAS status and primary tumour location in a randomised, open-label, phase III, non-inferiority trial

Author

Denda, Tadamichi, Takashima, Atsuo, Gamoh, Makio, Iwanaga, Ichiro, Komatsu, Yoshito, Takahashi, Masanobu, Nakamura, Masato, Ohori, Hisatsugu, Sakashita, Akiko, Tsuda, Masahiro, Kobayashi, Yoshimitsu, Baba, Hideo, Kotake, Masanori, Ishioka, Chikashi, Yamada, Yasuhide, Sato, Atsushi, Yuki, Satoshi, Morita, Satoshi, Takahashi, Shin, Yamaguchi, Tatsuro, and Shimada, Ken

Published
2021
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42. Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): a multicentre, open-label, phase 2 trial

Author

Siena, Salvatore, Di Bartolomeo, Maria, Raghav, Kanwal, Masuishi, Toshiki, Loupakis, Fotios, Kawakami, Hisato, Yamaguchi, Kensei, Nishina, Tomohiro, Fakih, Marwan, Elez, Elena, Rodriguez, Javier, Ciardiello, Fortunato, Komatsu, Yoshito, Esaki, Taito, Chung, Ki, Wainberg, Zev, Sartore-Bianchi, Andrea, Saxena, Kapil, Yamamoto, Eriko, Bako, Emarjola, Okuda, Yasuyuki, Shahidi, Javad, Grothey, Axel, and Yoshino, Takayuki

Published
2021
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43. Safety and efficacy of panitumumab in combination with trifluridine/tipiracil for pre-treated patients with unresectable, metastatic colorectal cancer with wild-type RAS: The phase 1/2 APOLLON study

Author

Kato, Takeshi, Kagawa, Yoshinori, Kuboki, Yasutoshi, Gamoh, Makio, Komatsu, Yoshito, Yasui, Hirofumi, Satake, Hironaga, Oki, Eiji, Tanioka, Hiroaki, Kotaka, Masahito, Makiyama, Akitaka, Denda, Tadamichi, Goto, Masahiro, Yoshino, Takayuki, Yamazaki, Kentaro, Soeda, Junpei, Shibuya, Kazunori, Iwata, Masaru, Oba, Koji, and Yamaguchi, Kensei

Published
2021
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45. Trastuzumab Deruxtecan in Human Epidermal Growth Factor Receptor 2–Expressing Biliary Tract Cancer (HERB; NCCH1805): A Multicenter, Single-Arm, Phase II Trial.

Author

Ohba, Akihiro, Morizane, Chigusa, Kawamoto, Yasuyuki, Komatsu, Yoshito, Ueno, Makoto, Kobayashi, Satoshi, Ikeda, Masafumi, Sasaki, Mitsuhito, Furuse, Junji, Okano, Naohiro, Hiraoka, Nobuyoshi, Yoshida, Hiroshi, Kuchiba, Aya, Sadachi, Ryo, Nakamura, Kenichi, Matsui, Naoko, Nakamura, Yoshiaki, Okamoto, Wataru, Yoshino, Takayuki, and Okusaka, Takuji

Published
2024
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46. BIG BANG study (EPOC1703): multicentre, proof-of-concept, phase II study evaluating the efficacy and safety of combination therapy with binimetinib, encorafenib and cetuximab in patients with BRAF non-V600E mutated metastatic colorectal cancer

Author

Kotani, Daisuke, Bando, Hideaki, Taniguchi, Hiroya, Masuishi, Toshiki, Komatsu, Yoshito, Yamaguchi, Kensei, Nakajima, Takako, Satoh, Taroh, Nishina, Tomohiro, Esaki, Taito, Nomura, Shogo, Takahashi, Koji, Iida, Shinobu, Matsuda, Seiko, Motonaga, Shinya, Fuse, Nozomu, Sato, Akihiro, Fujii, Satoshi, Ohtsu, Atsushi, Ebi, Hiromichi, and Yoshino, Takayuki

Published
2020
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47. 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

Author

Fujitani, Kazumasa, Shitara, Kohei, Takashima, Atsuo, Koeda, Keisuke, Hara, Hiroki, Nakayama, Norisuke, Hironaka, Shuichi, Nishikawa, Kazuhiro, Kimura, Yutaka, Amagai, Kenji, Hosaka, Hisashi, Komatsu, Yoshito, Shimada, Ken, Kawabata, Ryohei, Ohdan, Hideki, Kodera, Yasuhiro, Nakamura, Masato, Nakajima, Takako Eguchi, Miyata, Yoshinori, Moriwaki, Toshikazu, Kusumoto, Tetsuya, Nishikawa, Kazuo, Ogata, Kazuhiro, Shimura, Masashi, Morita, Satoshi, and Koizumi, Wasaburo

Published
2021
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49. Clinical utility of circulating tumor DNA sequencing in advanced gastrointestinal cancer: SCRUM-Japan GI-SCREEN and GOZILA studies

Author

Nakamura, Yoshiaki, Taniguchi, Hiroya, Ikeda, Masafumi, Bando, Hideaki, Kato, Ken, Morizane, Chigusa, Esaki, Taito, Komatsu, Yoshito, Kawamoto, Yasuyuki, Takahashi, Naoki, Ueno, Makoto, Kagawa, Yoshinori, Nishina, Tomohiro, Kato, Takeshi, Yamamoto, Yoshiyuki, Furuse, Junji, Denda, Tadamichi, Kawakami, Hisato, Oki, Eiji, Nakajima, Takako, Nishida, Naohiro, Yamaguchi, Kensei, Yasui, Hisateru, Goto, Masahiro, Matsuhashi, Nobuhisa, Ohtsubo, Koushiro, Yamazaki, Kentaro, Tsuji, Akihito, Okamoto, Wataru, Tsuchihara, Katsuya, Yamanaka, Takeharu, Miki, Izumi, Sakamoto, Yasutoshi, Ichiki, Hiroko, Hata, Masayuki, Yamashita, Riu, Ohtsu, Atsushi, Odegaard, Justin I., and Yoshino, Takayuki

Published
2020
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50. Impact of single-heterozygous UGT1A1 on the clinical outcomes of irinotecan monotherapy after fluoropyrimidine and platinum-based combination therapy for gastric cancer: a multicenter retrospective study

Author

Nakano, Shintaro, Yuki, Satoshi, Kawamoto, Yasuyuki, Nakatsumi, Hiroshi, Ando, Takayuki, Kajiura, Shinya, Yoshikawa, Ayumu, Harada, Kazuaki, Hatanaka, Kazuteru, Tanimoto, Aya, Ishiguro, Atsushi, Honda, Takuya, Dazai, Masayoshi, Sasaki, Takahide, Sakamoto, Naoya, and Komatsu, Yoshito

Published
2020
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