| Title: | Phase II Study of Continued Trastuzumab Plus Irinotecan in Patients with HER2-positive Gastric Cancer Previously Treated with Trastuzumab (HGCSG 1201) |
| Authors: | Yasuyuki, Kawamoto Browse this author →KAKEN DB |
| Satoshi, Yuki Browse this author |
| Takashi, Meguro Browse this author |
| Hatanaka, Kazuteru Browse this author |
| Uebayashi, Minoru Browse this author |
| Nakamura, Michio Browse this author |
| Okuda, Hiroyuki Browse this author |
| Iwanaga, Ichiro Browse this author |
| Kato, Takashi Browse this author |
| Nakano, Shintaro Browse this author |
| Sato, Atsushi Browse this author |
| Harada, Kazuaki Browse this author |
| Oba, Koji Browse this author |
| Sakata, Yuh Browse this author |
| Sakamoto, Naoya Browse this author →KAKEN DB |
| Komatsu, Yoshito Browse this author →KAKEN DB |
| Keywords: | gastric cancer |
| HER2 |
| trastuzumab |
| irinotecan |
| second-line treatment |
| Issue Date: | May-2022 |
| Publisher: | Oxford University Press |
| Journal Title: | The Oncologist |
| Volume: | 27 |
| Issue: | 5 |
| Start Page: | 340 |
| End Page: | e374 |
| Publisher DOI: | 10.1093/oncolo/oyab062 |
| Abstract: | Background The efficacy of irinotecan plus continuous trastuzumab beyond progression in patients with gastric cancer previously treated with trastuzumab plus standard first-line chemotherapy has not been reported. Methods Patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer who were previously treated with trastuzumab received trastuzumab every 3 weeks and irinotecan every 2 weeks. The primary endpoint was the overall response rate (ORR), and the secondary endpoints included progression-free survival (PFS), 6-month survival rates, safety, and subgroup analysis by HER2 status. Results Sixteen patients were enrolled in a 3-year pre-planned registration period. This study was prematurely closed due to poor patient accrual. The ORR and disease control rate were 6.7% (95% CI, 0.2-32.0) and 53.3% (95% CI, 26.6-78.7). The median PFS and overall survival (OS) were 2.4 months (95% CI, 0.0-5.2) and 9.7 months (95% CI, 8.2-11.2), respectively. The most frequently reported grades 3-4 adverse events were neutropenia (40%), anemia (27%), anorexia (33%), and fatigue (33%). Conclusion With only 16 patients enrolled, the present study has very low power to detect any clinical benefit of trastuzumab plus irinotecan beyond disease progression in patients with HER2-positive advanced gastric cancer who previously received trastuzumab. Trial Identifier: UMIN000007636. |
| Type: | article |
| URI: | http://hdl.handle.net/2115/85675 |
| 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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