| Title: | A randomized phase II trial of erlotinib vs. S-1 as a third- or fourth-line therapy for patients with wild-type EGFR non-small cell lung cancer (HOT1002) |
| Other Titles: | A randomized phase II trial of erlotinib versus S-1 as a third- or fourth-line therapy for patients with wild-type EGFR non-small cell lung cancer (HOT1002) |
| Authors: | Ikezawa, Yasuyuki Browse this author |
| Asahina, Hajime Browse this author →KAKEN DB |
| Oizumi, Satoshi Browse this author →KAKEN DB |
| Watanabe, Masahiro Browse this author |
| Takamura, Kei Browse this author |
| Kawai, Yasutaka Browse this author |
| Yamada, Noriyuki Browse this author |
| Harada, Toshiyuki Browse this author |
| Kinoshita, Ichiro Browse this author →KAKEN DB |
| Fujita, Yuka Browse this author |
| Miyauchi, Eisaku Browse this author |
| Ogi, Takahiro Browse this author |
| Amano, Toraji Browse this author |
| Furuta, Megumi Browse this author |
| Sakakibara-Konishi, Jun Browse this author →KAKEN DB |
| Nishihara, Hiroshi Browse this author →KAKEN DB |
| Dosaka-Akita, Hirotoshi Browse this author →KAKEN DB |
| Isobe, Hiroshi Browse this author →KAKEN DB |
| Nishimura, Masaharu Browse this author →KAKEN DB |
| Keywords: | Erlotinib |
| S-1 |
| Non-small cell lung cancer |
| Third-line therapy |
| Fourth-line therapy |
| Issue Date: | Nov-2017 |
| Publisher: | Springer |
| Journal Title: | Cancer chemotherapy and pharmacology |
| Volume: | 80 |
| Issue: | 5 |
| Start Page: | 955 |
| End Page: | 963 |
| Publisher DOI: | 10.1007/s00280-017-3432-4 |
| PMID: | 28905108 |
| Abstract: | Purpose: A high proportion of patients with wild-type EGFR non-small cell lung cancer (NSCLC) receive third-line therapy and beyond, with no prospective randomized trials addressing the issue. This study aimed to select the most suitable regimen as a third- or fourth-line therapy for wild-type EGFR NSCLC. Methods: This multicenter, randomized phase II study in Japan included patients with recurrent or advanced NSCLC with wild-type or unknown EGFR, who progressed after two or three previous chemotherapies. The patients were randomly assigned to erlotinib (150 mg/day, days 1-21) or S-1 (80-120 mg/day, days 1-14) every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was disease control rate (DCR). The secondary endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), toxicity, and quality of life (QOL). Results: From 2011 to 2016, 37 patients were randomly assigned to receive erlotinib (E arm, n = 19) and S-1 (S arm, n = 18). This study was terminated prematurely because of poor patient accrual. DCR/ORR were 42.1%/15.8% in the E arm and 66.7%/16.7% in the S arm. Median PFS/OS were 1.6 months/8.0 months in the E arm and 3.3 months/12.2 months in the S arm. In both groups, the most commonly reported grade 3-4 toxicities were fatigue, anorexia, and nausea. One grade 5 pneumonitis occurred in the S arm. No significant difference was seen in QOL. Conclusions: S-1 as a third- or fourth-line therapy for wild-type EGFR NSCLC showed numerically better clinical outcomes than erlotinib. Clinical trial registration no. UMIN000005308. |
| Rights: | The final publication is available at link.springer.com |
| Type: | article (author version) |
| URI: | http://hdl.handle.net/2115/71783 |
| 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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