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1. Results of a multicenter retrospective cohort study evaluating the safety and efficacy of FTD/TPI plus ramucirumab in advanced gastric cancer (HGCSG2302).

Author

Yoshikawa, Ayumu, Nakamura, Takeaki, Sawada, Kentaro, Ishiguro, Atsushi, Motoo, Iori, Sonoda, Yuki, Suzuki, Kazuhiro, Nakatsumi, Hiroshi, Hosokawa, Ayumu, Ishii, Takahiro, Ito, Ken, Nakamura, Michio, Hatanaka, Kazuteru, Meguro, Takashi, Sogabe, Susumu, Sasaki, Yusuke, Nakano, Shintaro, Muranaka, Tetsuhito, Yuki, Satoshi, and Komatsu, Yoshito

Published
2025
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2. A multicenter, prospective phase II trial of second-line aflibercept plus FOLFIRI in patients with metastatic colorectal cancer refractory to anti-EGFR agents (HGCSG1801): Updated analyses.

Author

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

Published
2025
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3. 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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4. 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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5. 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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8. HGCSG1801: A multicenter, prospective, phase II trial of second-line FOLFIRI plus aflibercept in patients with metastatic colorectal cancer (mCRC) refractory to anti-EGFR antibodies.

Author

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

Published
2024
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9. Study protocol for HGCSG1801: A multicenter, prospective, phase II trial of second-line FOLFIRI plus aflibercept in patients with metastatic colorectal cancer refractory to anti-EGFR antibodies

Author

Nakatsumi, Hiroshi, primary, Komatsu, Yoshito, additional, Muranaka, Tetsuhito, additional, Yuki, Satoshi, additional, Kawamoto, Yasuyuki, additional, Harada, Kazuaki, additional, Dazai, Masayoshi, additional, Tateyama, Miki, additional, Sasaki, Yusuke, additional, Miyagishima, Takuto, additional, Tsuji, Yasushi, additional, Katagiri, Masaki, additional, Nakamura, Michio, additional, Sogabe, Susumu, additional, Hatanaka, Kazuteru, additional, Meguro, Takashi, additional, Kobayashi, Tomoe, additional, Ishiguro, Atsushi, additional, Muto, Osamu, additional, Shindo, Yoshiaki, additional, Kotaka, Masahito, additional, Ando, Takayuki, additional, Takagi, Ryo, additional, Sakamoto, Naoya, additional, and Sakata, Yu, additional

Published
2022
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10. O15-2 HGCSG1902: Multicenter, prospective, observational study for patients with dysgeusia caused by chemotherapy

Author

Yokoyama, Tatsuya, primary, Ito, Ken, additional, Yuki, Satoshi, additional, Nakatsumi, Hiroshi, additional, Ando, Takayuki, additional, Sawada, Kentaro, additional, Yagisawa, Masataka, additional, Ishiguro, Atsushi, additional, Dazai, Masayoshi, additional, Iwanaga, Ichiro, additional, Hatanaka, Kazuteru, additional, Sato, Atsushi, additional, Matsumoto, Ryusuke, additional, Shindo, Yoshiaki, additional, Tateyama, Miki, additional, Muranaka, Tetsuhito, additional, Katagiri, Masaki, additional, Yokota, Isao, additional, Sakata, Yuh, additional, and Komatsu, Yoshito, additional

Published
2022
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11. Study protocol for HGCSG1801 : A multicenter, prospective, phase II trial of second-line FOLFIRI plus aflibercept in patients with metastatic colorectal cancer refractory to anti-EGFR antibodies

Author

Nakatsumi, Hiroshi, Komatsu, Yoshito, Muranaka, Tetsuhito, Yuki, Satoshi, Kawamoto, Yasuyuki, Harada, Kazuaki, Dazai, Masayoshi, Tateyama, Miki, Sasaki, Yusuke, Miyagishima, Takuto, Tsuji, Yasushi, Katagiri, Masaki, Nakamura, Michio, Sogabe, Susumu, Hatanaka, Kazuteru, Meguro, Takashi, Kobayashi, Tomoe, Ishiguro, Atsushi, Muto, Osamu, Shindo, Yoshiaki, Kotaka, Masahito, Ando, Takayuki, Takagi, Ryo, Sakamoto, Naoya, Sakata, Yu, Nakatsumi, Hiroshi, Komatsu, Yoshito, Muranaka, Tetsuhito, Yuki, Satoshi, Kawamoto, Yasuyuki, Harada, Kazuaki, Dazai, Masayoshi, Tateyama, Miki, Sasaki, Yusuke, Miyagishima, Takuto, Tsuji, Yasushi, Katagiri, Masaki, Nakamura, Michio, Sogabe, Susumu, Hatanaka, Kazuteru, Meguro, Takashi, Kobayashi, Tomoe, Ishiguro, Atsushi, Muto, Osamu, Shindo, Yoshiaki, Kotaka, Masahito, Ando, Takayuki, Takagi, Ryo, Sakamoto, Naoya, and Sakata, Yu

Abstract

Background: The first-line chemotherapy for patients with RAS and BRAF wild-type metastatic colorectal cancer (mCRC) commonly involves cytotoxic regimens, such as FOLFOX and FOLFIRI, combined with epidermal growth factor receptor (EGFR) antibodies. When progression occurs following anti-EGFR antibody-combined chemotherapy, anti-angiogenic inhibitors can be used as second-line treatment. Although randomized controlled trials have shown that anti-angiogenic inhibitors [bevacizumab, ramucirumab, and aflibercept (AFL)] carry survival benefit when combined with FOLFIRI as second-line chemotherapy, such trials did not provide data on patients with mCRC refractory to anti-EGFR antibody-combined chemotherapy. Therefore, our group planned a multicenter, nonrandomized, single-arm, prospective, phase II study to investigate the safety and efficacy of FOLFIRI plus AFL as a second-line chemotherapy for patients with mCRC refractory to oxaliplatin-based chemotherapy combined with anti-EGFR antibodies. Methods: FOLFIRI (irinotecan 180 mg/m(2), l-leucovorin 200 mg/m(2), bolus 5-FU 400 mg/m(2), and infusional 5-FU 2400 mg/m(2)/46 h) and AFL (4 mg/kg) will be administered every 2 weeks until progression or unacceptable toxicities occur. The primary endpoint will be the 6-month progression-free survival (PFS) rate, whereas the secondary endpoints will include overall survival, PFS, response rate, disease control rate, adverse events, and relative dose intensity for each drug. A sample size of 41 participants will be required. This study will be sponsored by the Non-Profit Organization Hokkaido Gastrointestinal Cancer Study Group and will be supported by a grant from Sanofi. Discussion: There is only an observational study reporting data on FOLFIRI plus AFL for patients with mCRC who previously received anti-EGFR antibodies; therefore, a prospective clinical trial is needed. This study will prospectively evaluate the efficacy and safety of FOLFIRI plus AFL in patients with mCRC who are

Published
2022

12. HGCSG1902: Multicenter, prospective, observational study for patients with dysgeusia caused by chemotherapy for gastrointestinal cancer.

Author

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

Published
2022
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13. HGCSG1902 Multicenter, Prospective, Observational Study of Chemotherapy-induced Dysgeusia in Gastrointestinal Cancer

Author

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

Published
2021
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14. MO26-5 HGCSG 1603: A phase 2 trial of ramucirumab plus irinotecan as second-line treatment for advanced gastric cancer

Author

Sawada, Kentaro, primary, Kawamoto, Yasuyuki, additional, Yuki, Satoshi, additional, Nakamura, Michio, additional, Muto, Osamu, additional, Sogabe, Susumu, additional, Shindo, Ysohiaki, additional, Ishiguro, Atsushi, additional, Sato, Atsushi, additional, Tsuji, Yasushi, additional, Dazai, Masayoshi, additional, Okuda, Hiroyuki, additional, Sasaki, Takahide, additional, Harada, Kazuaki, additional, Nakano, Shintaro, additional, Nakatsumi, Hiroshi, additional, Sekiguchi, Mari, additional, Sakata, Yuh, additional, Sakamoto, Naoya, additional, and Komatsu, Yoshito, additional

Published
2021
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15. A Phase I Trial of Oxaliplatin, Irinotecan, and S-1 Combination Therapy (OX-IRIS) as Chemotherapy for Unresectable Pancreatic Cancer (HGCSG 1403)

Author

Kawamoto, Yasuyuki, Nakatsumi, Hiroshi, Harada, Kazuaki, Muranaka, Tetsuhito, Ishiguro, Atsushi, Kobayashi, Yoshimitsu, Hayashi, Hideyuki, Yuki, Satoshi, Sawada, Kentaro, Yagisawa, Masataka, Nakano, Shintaro, Sakamoto, Naoya, Komatsu, Yoshito, Kawamoto, Yasuyuki, Nakatsumi, Hiroshi, Harada, Kazuaki, Muranaka, Tetsuhito, Ishiguro, Atsushi, Kobayashi, Yoshimitsu, Hayashi, Hideyuki, Yuki, Satoshi, Sawada, Kentaro, Yagisawa, Masataka, Nakano, Shintaro, Sakamoto, Naoya, and Komatsu, Yoshito

Abstract

Lessons Learned Because S-1 is orally administered, OX-IRIS does not necessitate the continuous infusion of 5-FU and is more convenient. The recommended dose of OX-IRIS was determined to be level -1 (oxaliplatin, 65 mg/m(2); irinotecan, 100 mg/m(2); S-1, 80 mg/m(2)), which has manageable safety and promising anticancer activities. Background OX-IRIS is a new combination therapy of oxaliplatin, irinotecan, and S-1 for unresectable pancreatic ductal adenocarcinoma (PDAC), which may be beneficial because S-1 is administered orally and continuous infusion of 5-fluorouracil (5-FU) is not needed. Methods Patients who had not received prior therapy for unresectable PDAC were enrolled. Adenocarcinoma or adenosquamous histology was required. Oxaliplatin and irinotecan were administered on days 1 and 15; S-1 was administered orally twice a day on days 1-14, followed by 14 days of rest (one cycle). Primary endpoints were dose-limiting toxicity (DLT) and maximum tolerated dose (MTD). Secondary endpoints were safety, overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Results In level 0 (oxaliplatin, 85 mg/m(2); irinotecan, 100 mg/m(2); S-1, 80 mg/m(2)), two of five patients experienced DLT. In level -1 (oxaliplatin, 65 mg/m(2); irinotecan, 100 mg/m(2); S-1, 80 mg/m(2)), DLT could not be evaluated in two of eight patients because one cycle was not completed; one of the remaining six patients experienced DLT. Anemia, thrombocytopenia, fatigue, nausea, anorexia, diarrhea, and peripheral sensory neuropathy were seen frequently in levels 0 and -1. ORR was 30% in levels 0 and -1. Median progression-free survival and median overall survival were 4.1 months (95% confidence interval [CI], 0.0-8.9 months) and 13.7 months (95% CI, 4.8-22.6 months), respectively. Conclusion MTD of OX-IRIS therapy was estimated to be level 0, and the recommended dose (RD) for future trial was level -1.

Published
2021

16. 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, Komatsu, Yoshito, 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

Abstract

Background It is unclear whether the UGT1A1 status, single heterozygous (SH) or wild type (WT), is associated with the efficacy and toxicity of irinotecan monotherapy in advanced gastric cancer (AGC). We investigated the association between clinical outcomes (efficacy and safety) and UGT1A1 status in patients who received irinotecan monotherapy. Methods We evaluated AGC patients who received irinotecan monotherapy between January 2011 and December 2017. Efficacy was assessed according to overall survival (OS) and progression-free survival (PFS). Toxicity was graded using the Common Toxicity Criteria for Adverse Events (version 4.0). Results A total of 100 patients were evaluated (62 and 38 patients with UGT1A1 WT and SH, respectively). In the WT and SH groups, the irinotecan dose was reduced in 19 (30.6%) and 18 (47.2%) patients (p = 0.135), respectively; treatment was delayed due to adverse events (AEs) in 19 (30.6%) and 13 (34.2%) patients (p = 0.826), respectively; the median PFS was 3.15 and 3.25 months (HR, 0.734; 95% CI 0.465-1.158;p = 0.184), respectively; and the median OS was 10.4 and 7.26 months (HR, 1.137; 95% CI 0.752-1.721;p = 0.543), respectively. Severe hematological AEs (Grade >= 3) were significantly more frequent in the SH group than in the WT group (63% vs. 36%;p = 0.008), while severe non-hematological AEs was not significantly different (16.0% vs. 6.5%;p = 0.173). Conclusion There was no significant difference in the efficacy of irinotecan monotherapy between UGT1A1 WT and UGT1A1 SH, but UGT1A1 SH was associated with a high frequency of severe hematological toxicity.

Published
2021

17. A Phase I Trial of Oxaliplatin, Irinotecan, and S-1 Combination Therapy (OX-IRIS) as Chemotherapy for Unresectable Pancreatic Cancer (HGCSG 1403)

Author

Kawamoto, Yasuyuki, primary, Nakatsumi, Hiroshi, additional, Harada, Kazuaki, additional, Muranaka, Tetsuhito, additional, Ishiguro, Atsushi, additional, Kobayashi, Yoshimitsu, additional, Hayashi, Hideyuki, additional, Yuki, Satoshi, additional, Sawada, Kentaro, additional, Yagisawa, Masataka, additional, Nakano, Shintaro, additional, Sakamoto, Naoya, additional, and Komatsu, Yoshito, additional

Published
2021
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19. HGCSG 1301: A multicenter, double-blind, randomized controlled phase II trial comparing Hange-shashin-to versus placebo to prevent diarrhea in patients with metastatic colorectal cancer treated with IRIS/Bev as second-line therapy—Updated analysis of antitumor efficacy.

Author

Ishiguro, Atsushi, primary, Nakatsumi, Hiroshi, additional, Muranaka, Tetsuhito, additional, Kawamoto, Yasuyuki, additional, Yuki, Satoshi, additional, Tateyama, Miki, additional, Sato, Atsushi, additional, Miyagishima, Takuto, additional, Nakamura, Michio, additional, Dazai, Masayoshi, additional, Okuda, Hiroyuki, additional, Takahashi, Yasuo, additional, Kobayashi, Tomoe, additional, Kato, Takashi, additional, Hatanaka, Kazuteru, additional, Amano, Toraji, additional, Sakata, Yuh, additional, and Komatsu, Yoshito, additional

Published
2020
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20. A retrospective multicenter study evaluating the efficacy and safety of irinotecan in patients with advanced gastric cancer: Analysis of albumin-bilirubin (ALBI) grade.

Author

Motoo, Iori, primary, Komatsu, Yoshito, additional, Yuki, Satoshi, additional, Nakano, Shintaro, additional, Nakatsumi, Hiroshi, additional, Kawamoto, Yasuyuki, additional, Muranaka, Tetsuhito, additional, Sawada, Kentaro, additional, Ando, Takayuki, additional, Miyagishima, Takuto, additional, Harada, Kazuaki, additional, Kobayashi, Yoshimitsu, additional, Hatanaka, Kazuteru, additional, Ishiguro, Atsushi, additional, Tanimoto, Aya, additional, Honda, Takuya, additional, Dazai, Masayoshi, additional, Sasaki, Takahide, additional, and Sakamoto, Naoya, additional

Published
2020
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21. The impact of single-hetero UGT1A1 on clinical outcomes of irinotecan monotherapy in gastric cancer after fluoropyrimidine, platinum, and taxanes: Multicenter retrospective study.

Author

Ito, Ken, primary, Komatsu, Yoshito, additional, Yuki, Satoshi, additional, Nakano, Shintaro, additional, Nakatsumi, Hiroshi, additional, Kawamoto, Yasuyuki, additional, Muranaka, Tetsuhito, additional, Sawada, Kentaro, additional, Ando, Takayuki, additional, Kajiura, Shinya, additional, Miyagishima, Takuto, additional, Harada, Kazuaki, additional, Kobayashi, Yoshimitsu, additional, Hatanaka, Kazuteru, additional, Ishiguro, Atsushi, additional, Honda, Takuya, additional, Dazai, Masayoshi, additional, Sasaki, Takahide, additional, and Sakamoto, Naoya, additional

Published
2020
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22. Regorafenib as second-line therapy for imatinib-resistant gastrointestinal stromal tumor (GIST).

Author

Takahashi, Tsuyoshi, primary, Nishida, Toshirou, additional, Kudo, Toshihiro, additional, Boku, Narikazu, additional, Honma, Yoshitaka, additional, Komatsu, Yoshito, additional, Nakatsumi, Hiroshi, additional, Matsumoto, Koji, additional, Onoe, Takuma, additional, Oki, Eiji, additional, Nakamoto, Masako, additional, Fukutani, Miki, additional, Nomura, Shogo, additional, Sato, Akihiro, additional, Naito, Yoichi, additional, and Doi, Toshihiko, additional

Published
2020
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23. Regorafenib as second line therapy for imatinib-resistant gastrointestinal stromal tumor (GIST): A phase II study

Author

Naito, Yoichi, primary, Doi, Toshihiko, additional, Takahashi, Tsuyoshi, additional, Kudo, Toshihiro, additional, Boku, Narikazu, additional, Honma, Yoshitaka, additional, Komatsu, Yoshito, additional, Nakatsumi, Hiroshi, additional, Matsumoto, Koji, additional, Onoe, Takuma, additional, Oki, Eiji, additional, Tsuda, Yasuo, additional, Nakamoto, Masako, additional, Fukutani, Miki, additional, Nomura, Shogo, additional, Sato, Akihiro, additional, and Nishida, Toshirou, additional

Published
2019
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24. Update result of HGCSG 1403: Phase I trial of oxaliplatin/irinotecan/S-1 (OX-IRIS) as first-line chemotherapy for unresectable pancreatic cancer.

Author

Nakano, Shintaro, primary, Kawamoto, Yasuyuki, additional, Yuki, Satoshi, additional, Yagisawa, Masataka, additional, Sawada, Kentaro, additional, Muranaka, Tetsuhito, additional, Nakatsumi, Hiroshi, additional, Saiki, Takuro, additional, Ishiguro, Atsushi, additional, Harada, Kazuaki, additional, Kobayashi, Yoshimitsu, additional, Iwanaga, Ichiro, additional, Hatanaka, Kazuteru, additional, Sakata, Yuh, additional, and Komatsu, Yoshito, additional

Published
2019
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25. Impact of tumor growth rate during preceding treatment on tumor response to nivolumab or irinotecan in advanced gastric cancer.

Author

Kato, Kyoko, primary, Masuishi, Toshiki, additional, Fushiki, Kunihiro, additional, Nakano, Shintaro, additional, Kawakami, Takeshi, additional, Kawamoto, Yasuyuki, additional, Narita, Yukiya, additional, Tsushima, Takahiro, additional, Nakatsumi, Hiroshi, additional, Kadowaki, Shigenori, additional, Todaka, Akiko, additional, Yuki, Satoshi, additional, Tajika, Masahiro, additional, Machida, Nozomu, additional, Komatsu, Yoshito, additional, Muro, Kei, additional, and Yasui, Hirofumi, additional

Published
2019
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26. A retrospective analysis of neoadjuvant chemotherapy followed by surgery or definitive chemoradiotherapy in patients with advanced esophageal squamous cell carcinoma.

Author

Nakatsumi, Hiroshi, primary, Komatsu, Yoshito, additional, Nakano, Shintaro, additional, Sawada, Kentaro, additional, Muranaka, Tetsuhito, additional, Kawamoto, Yasuyuki, additional, Yuki, Satoshi, additional, Uchinami, Yusuke, additional, Taguchi, Hiroshi, additional, Shirato, Hiroki, additional, Ebihara, Yuma, additional, Shichinohe, Toshiaki, additional, Hirano, Satoshi, additional, and Sakamoto, Naoya, additional

Published
2019
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27. HGCSG 1603: Phase II study of ramucirumab and irinotecan combination therapy as second-line treatment in patients with metastatic or advanced gastric cancer.

Author

Ishiguro, Atsushi, primary, Kawamoto, Yasuyuki, additional, Yuki, Satoshi, additional, Kobayashi, Yoshimitsu, additional, Harada, Kazuaki, additional, Sogabe, Susumu, additional, Tsuji, Yasushi, additional, Nakano, Shintaro, additional, Sawada, Kentaro, additional, Muranaka, Tetsuhito, additional, Nakatsumi, Hiroshi, additional, Dazai, Masayoshi, additional, Sasaki, Takahide, additional, Eto, Kazunori, additional, Nakamura, Michio, additional, Muto, Osamu, additional, Sakata, Yuh, additional, Sakamoto, Naoya, additional, and Komatsu, Yoshito, additional

Published
2019
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29. HGCSG 1403: phase I trial of oxaliplatin /irinotecan /S-1 (OX-IRIS) for unresectable pancreatic cancer

Author

Kawamoto, Yasuyuki, primary, Yuki, Satoshi, additional, Hayashi, Hideyuki, additional, Nakano, Shintaro, additional, Sawada, Kentaro, additional, Muranaka, Tetsuhito, additional, Nakatsumi, Hiroshi, additional, Saiki, Takuro, additional, Ishiguro, Atsushi, additional, Harada, Kazuaki, additional, Kobayashi, Yoshimitsu, additional, Iwanaga, Ichiro, additional, Hatanaka, Kazuteru, additional, Sakata, Yuh, additional, Sakamoto, Naoya, additional, and Komatsu, Yoshito, additional

Published
2018
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30. Predictive value of tumor growth rate during previous treatment for tumor response to regorafenib (REGO) and trifluridine/tipiracil (TFTD) in metastatic colorectal cancer (mCRC).

Author

Kawakami, Takeshi, primary, Masuishi, Toshiki, additional, Kawamoto, Yasuyuki, additional, Omae, Katsuhiro, additional, Muranaka, Tetsuhito, additional, Nakatsumi, Hiroshi, additional, Yuki, Satoshi, additional, Komatsu, Yoshito, additional, Yamazaki, Kentaro, additional, Onozawa, Yusuke, additional, Yasui, Hirofumi, additional, Tajika, Masahiro, additional, Kadowaki, Shigenori, additional, Taniguchi, Hiroya, additional, and Muro, Kei, additional

Published
2018
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32. A retrospective cohort study evaluating the safety and efficacy of TAS-102 in patients with metastatic colorectal cancer (HGCSG1503): Analysis of cases of prior regorafenib.

Author

Ishiguro, Atsushi, primary, Yuki, Satoshi, additional, Nakatsumi, Hiroshi, additional, Saiki, Takuro, additional, Tsuji, Yasushi, additional, Hatanaka, Kazuteru, additional, Yoshita, Hiroki, additional, Minami, Shinya, additional, Ohta, Tomoyuki, additional, Eto, Kazunori, additional, Nakajima, Junta, additional, Nakamura, Michio, additional, Suzuki, Kazuhiro, additional, Koike, Masahiko, additional, Kato, Kanji, additional, Tateyama, Miki, additional, Asada, Chiaki, additional, Sekiguchi, Mari, additional, Sakata, Yuh, additional, and Komatsu, Yoshito, additional

Published
2018
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33. Study protocol of HGCSG1404 SNOW study: a phase I/II trial of combined chemotherapy of S-1, nab-paclitaxel and oxaliplatin administered biweekly to patients with advanced gastric cancer

Author

Kawamoto, Yasuyuki, primary, Komatsu, Yoshito, additional, Yuki, Satoshi, additional, Sawada, Kentaro, additional, Muranaka, Tetsuhito, additional, Harada, Kazuaki, additional, Nakatsumi, Hiroshi, additional, Fukushima, Hiraku, additional, Ishiguro, Atsushi, additional, Dazai, Masayoshi, additional, Hatanaka, Kazuteru, additional, Nakamura, Michio, additional, Iwanaga, Ichiro, additional, Uebayashi, Minoru, additional, Sogabe, Susumu, additional, Kobayashi, Yoshimitsu, additional, Miyagishima, Takuto, additional, Ono, Kota, additional, Sakamoto, Naoya, additional, and Sakata, Yuh, additional

Published
2017
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34. HGCSG 1201: Phase II study of trastuzumab with irinotecan in HER2-positive metastatic or advanced gastric cancer patients previously treated with trastuzumab

Author

Sasaki, Takahide, primary, Kawamoto, Yasuyuki, additional, Yuki, Satoshi, additional, Meguro, Takashi, additional, Hatanaka, Kazuteru, additional, Uebayashi, Minoru, additional, Iwanaga, Ichiro, additional, Nakamura, Michio, additional, Eto, Kazunori, additional, Okuda, Hiroyuki, additional, Abe, Masakazu, additional, Oba, Ayane, additional, Abe, Nobuhiko, additional, Sato, Atsushi, additional, Nakatsumi, Hiroshi, additional, Harada, Kazuaki, additional, Muranaka, Tetsuhito, additional, Yagisawa, Masataka, additional, Oba, Koji, additional, Sakata, Yuh, additional, and Komatsu, Yoshito, additional

Published
2017
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36. Comparison of efficacy and toxicity of FOLFIRINOX and gemcitabine with nab-paclitaxel in unresectable pancreatic cancer

Author

Muranaka, Tetsuhito, primary, Kuwatani, Masaki, additional, Komatsu, Yoshito, additional, Sawada, Kentaro, additional, Nakatsumi, Hiroshi, additional, Kawamoto, Yasuyuki, additional, Yuki, Satoshi, additional, Kubota, Yoshimasa, additional, Kubo, Kimitoshi, additional, Kawahata, Shuhei, additional, Kawakubo, Kazumichi, additional, Kawakami, Hiroshi, additional, and Sakamoto, Naoya, additional

Published
2017
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37. First report: A retrospective trial for evaluating the safety and efficacy of TAS-102 for patients with metastatic colorectal cancer: HGCSG1503

Author

Dazai, Masayoshi, primary, Yuki, Satoshi, additional, Nakatsumi, Hiroshi, additional, Tsuji, Yasushi, additional, Kobayashi, Yoshimitsu, additional, Hatanaka, Kazuteru, additional, Okuda, Hiroyuki, additional, Hosokawa, Ayumu, additional, Furukawa, Koichi, additional, Ogawa, Kohei, additional, Minami, Shinya, additional, Ishiguro, Atsushi, additional, Honda, Takuya, additional, Ohta, Tomoyuki, additional, Eto, Kazunori, additional, Kato, Takashi, additional, Nakajima, Junta, additional, Sasaki, Takahide, additional, Nakamura, Michio, additional, Shindo, Yoshiaki, additional, Sakata, Yuh, additional, and Komatsu, Yoshito, additional

Published
2017
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38. The Nationwide Cancer Genome Screening Project in Japan, SCRUM-Japan GI-screen: Efficient identification of cancer genome alterations in advanced esophageal cancer.

Author

Nakashima, Yuichiro, primary, Kojima, Takashi, additional, Hara, Hiroki, additional, Kato, Ken, additional, Kajiwara, Takeshi, additional, Hironaka, Shuichi, additional, Nakatsumi, Hiroshi, additional, Kato, Takeshi, additional, Moriwaki, Toshikazu, additional, Naruge, Daisuke, additional, Esaki, Taito, additional, Izawa, Naoki, additional, Kadowaki, Shigenori, additional, Tamura, Takao, additional, Miki, Izumi, additional, Sudo, Tomohisa, additional, Nomura, Shogo, additional, Shitara, Kohei, additional, Ohtsu, Atsushi, additional, and Yoshino, Takayuki, additional

Published
2017
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39. Study protocol of HGCSG1404 SNOW study : a phase I/II trial of combined chemotherapy of S-1, nab-paclitaxel and oxaliplatin administered biweekly to patients with advanced gastric cancer

Author

Kawamoto, Yasuyuki, Komatsu, Yoshito, Yuki, Satoshi, Sawada, Kentaro, Muranaka, Tetsuhito, Harada, Kazuaki, Nakatsumi, Hiroshi, Fukushima, Hiraku, Ishiguro, Atsushi, Dazai, Masayoshi, Hatanaka, Kazuteru, Nakamura, Michio, Iwanaga, Ichiro, Uebayashi, Minoru, Sogabe, Susumu, Kobayashi, Yoshimitsu, Miyagishima, Takuto, Ono, Kota, Sakamoto, Naoya, Sakata, Yuh, Kawamoto, Yasuyuki, Komatsu, Yoshito, Yuki, Satoshi, Sawada, Kentaro, Muranaka, Tetsuhito, Harada, Kazuaki, Nakatsumi, Hiroshi, Fukushima, Hiraku, Ishiguro, Atsushi, Dazai, Masayoshi, Hatanaka, Kazuteru, Nakamura, Michio, Iwanaga, Ichiro, Uebayashi, Minoru, Sogabe, Susumu, Kobayashi, Yoshimitsu, Miyagishima, Takuto, Ono, Kota, Sakamoto, Naoya, and Sakata, Yuh

Abstract

Background: In Japan, S-1 plus cisplatin (SP) regimen has become a standard therapy for patients with advanced gastric cancer. Moreover, the S-1 plus oxaliplatin regimen is now a standard treatment. Nab-paclitaxel was developed for chemotherapy of gastric cancer in Japanese clinical practice. Nab-paclitaxel, created with albumin-bound paclitaxel particles, has high transferability to tumour tissues and does not cause hypersensitivity reactions because of a different chemical composition compared with docetaxel and paclitaxel. A combination of S-1, nab-paclitaxel and oxaliplatin (which we named ‘SNOW regimen’) can be a promising triplet therapy for advanced gastric cancer. Although we have to pay attention to chemotherapy-induced neuropathy, we aim to investigate the recommended dose of this regimen in a phase I study. Furthermore, we will investigate its efficacy and toxicity in a phase II study. Methods: The phase I study is a dose-escalation study using a standard 3 plus 3 design, followed by expansion cohorts. The SNOW regimen involves 28-day cycles with escalated doses of nab-paclitaxel (100-175 mg/m2 on days 1 and 15) and fixed doses of oxaliplatin (65 mg/ m2 on days 1 and 15) and S-1 (80 mg/m2/day on day 1 to 14). The primary endpoints are assessment of dose limiting toxicities and determination of maximum tolerated dose to investigate the recommended dose in the subsequent phase II study. In the phase II study, the primary endpoint is objective response rate. Secondary endpoints are assessment of safety, progression-free survival, disease control rate, overall survival and time to treatment failure. Adverse events were monitored and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Discussion: Triplet therapies for advanced gastric cancer patients have been evaluated in clinical trials. The SNOW regimen can be a promising new triplet therapy. Trial registration: This study is performed at institutes

Published
2017

41. A multicenter prospective study on the efficacy and safety of denosumab in gastrointestinal cancer patients receiving short-term periodic steroid premedication for prevention of chemotherapy-induced nausea and vomiting: ESPRESSO-02/HGCSG1602.

Author

Nakamura, Michio, primary, Yagisawa, Masataka, additional, Sawada, Kentaro, additional, Muranaka, Tetsuhito, additional, Nakatsumi, Hiroshi, additional, Kawamoto, Yasuyuki, additional, Yuki, Satoshi, additional, Dazai, Masayoshi, additional, Ishiguro, Atsushi, additional, Kobayashi, Yoshimitsu, additional, Sogabe, Susumu, additional, Miyagishima, Takuto, additional, Iwanaga, Ichiro, additional, Tateyama, Miki, additional, Hatanaka, Kazuteru, additional, Ono, Kota, additional, Sakata, Yuh, additional, and Komatsu, Yoshito, additional

Published
2017
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42. North Japan multicenter phase II study of oxaliplatin-containing regimen as adjuvant chemotherapy for stage III colon cancer (NORTH/HGCSG1003).

Author

Shichinohe, Toshiaki, primary, Yuki, Satoshi, additional, Takahashi, Norihiko, additional, Nakatsumi, Hiroshi, additional, Kawamoto, Yasuyuki, additional, Kusumi, Takaya, additional, Ishiguro, Atsushi, additional, Sogabe, Susumu, additional, Iwanaga, Ichiro, additional, Hatanaka, Kazuteru, additional, Oomori, Kazuyoshi, additional, Nakamura, Michio, additional, Senmaru, Naoto, additional, Iwai, Kazuhiro, additional, Koike, Masahiko, additional, Sakamoto, Naoya, additional, Taketomi, Akinobu, additional, Hirano, Satoshi, additional, Ito, Yoichi M, additional, and Komatsu, Yoshito, additional

Published
2017
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43. Feasibility Study of Bolus 5-Fluorouracil+L-Leucovorin as Salvage Line Chemotherapy for Oral Fluorouracil-Resistant Unresectable Gastric Cancer: Hokkaido Gastrointestinal Cancer Study Group Study HGCSG1502

Author

Muranaka, Tetsuhito, primary, Komatsu, Yoshito, additional, Yagisawa, Masataka, additional, Sawada, Kentaro, additional, Harada, Kazuaki, additional, Kawamoto, Yasuyuki, additional, Nakatsumi, Hiroshi, additional, Yuki, Satoshi, additional, Ono, Kota, additional, Kawahata, Shuhei, additional, Kobayashi, Yoshimitsu, additional, Sogabe, Susumu, additional, Miyagishima, Takuto, additional, Hatanaka, Kazuteru, additional, Sasaki, Takahide, additional, Dazai, Masayoshi, additional, Iwanaga, Ichiro, additional, Ishiguro, Atsushi, additional, Nakamura, Michio, additional, Sakamoto, Naoya, additional, and Sakata, Yuh, additional

Published
2017
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46. Observational cohort study of first-line bevacizumab with oxaliplatin or irinotecan and fluoropyrimidines in metastatic colorectal cancer: HGCSG0802—Analysis of early tumor shrinkage (ETS).

Author

Yuki, Satoshi, primary, Nakatsumi, Hiroshi, additional, Sawada, Kentaro, additional, Kato, Takashi, additional, Meguro, Takashi, additional, Nakamura, Michio, additional, Iwanaga, Ichiro, additional, Ehira, Nobuyuki, additional, Sonoda, Norikazu, additional, Kudo, Mineo, additional, Kato, Kanji, additional, Sogabe, Susumu, additional, Amano, Toraji, additional, Ono, Kota, additional, Sakamoto, Keita, additional, Miyamoto, Noriyuki, additional, Kudo, Kohsuke, additional, Sakamoto, Naoya, additional, Sakata, Yuh, additional, and Komatsu, Yoshito, additional

Published
2016
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47. Phase II trial of bolus 5-FU/l-LV regimen as salvage line chemotherapy for oral fluorouracil resistant unresectable gastric cancer (HGCSG1502).

Author

Muranaka, Tetsuhito, primary, Yuki, Satoshi, additional, Sawada, Kentaro, additional, Kawamoto, Yasuyuki, additional, Nakatsumi, Hiroshi, additional, Dazai, Masayoshi, additional, Hayashi, Hideyuki, additional, Nakamura, Michio, additional, Ishiguro, Atsushi, additional, Sogabe, Susumu, additional, Kobayashi, Yoshimitsu, additional, Miyagishima, Takuto, additional, Iwanaga, Ichiro, additional, Tateyama, Miki, additional, Hatanaka, Kazuteru, additional, Kato, Takashi, additional, Sakamoto, Naoya, additional, Sakata, Yuh, additional, and Komatsu, Yoshito, additional

Published
2016
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50. P-086 - HGCSG 1201: Phase II study of trastuzumab with irinotecan in HER2-positive metastatic or advanced gastric cancer patients previously treated with trastuzumab

Author

Sasaki, Takahide, Kawamoto, Yasuyuki, Yuki, Satoshi, Meguro, Takashi, Hatanaka, Kazuteru, Uebayashi, Minoru, Iwanaga, Ichiro, Nakamura, Michio, Eto, Kazunori, Okuda, Hiroyuki, Abe, Masakazu, Oba, Ayane, Abe, Nobuhiko, Sato, Atsushi, Nakatsumi, Hiroshi, Harada, Kazuaki, Muranaka, Tetsuhito, Yagisawa, Masataka, Oba, Koji, Sakata, Yuh, and Komatsu, Yoshito

Published
2017
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