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A Phase I Trial of Oxaliplatin, Irinotecan, and S-1 Combination Therapy (OX-IRIS) as Chemotherapy for Unresectable Pancreatic Cancer (HGCSG 1403)
| Title: | A Phase I Trial of Oxaliplatin, Irinotecan, and S-1 Combination Therapy (OX-IRIS) as Chemotherapy for Unresectable Pancreatic Cancer (HGCSG 1403) |
| Authors: | Kawamoto, Yasuyuki Browse this author | | Nakatsumi, Hiroshi Browse this author | | Harada, Kazuaki Browse this author | | Muranaka, Tetsuhito Browse this author | | Ishiguro, Atsushi Browse this author | | Kobayashi, Yoshimitsu Browse this author | | Hayashi, Hideyuki Browse this author | | Yuki, Satoshi Browse this author | | Sawada, Kentaro Browse this author | | Yagisawa, Masataka Browse this author | | Nakano, Shintaro Browse this author | | Sakamoto, Naoya Browse this author →KAKEN DB | | Komatsu, Yoshito Browse this author →KAKEN DB |
| Keywords: | Pancreatic cancer | | Combination therapy | | Oxaliplatin | | Irinotecan | | S-1 |
| Issue Date: | 4-Oct-2021 |
| Publisher: | John Wiley & Sons |
| Journal Title: | The Oncologist |
| Volume: | 26 |
| Issue: | 10 |
| Start Page: | e1675 |
| End Page: | e1682 |
| Publisher DOI: | 10.1002/onco.13838 |
| 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. |
| Type: | article |
| URI: | http://hdl.handle.net/2115/83684 |
| Appears in Collections: | 北海道大学病院 (Hokkaido University Hospital) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)
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