Table A1.
Summary of studies reporting effectiveness of T-DM1 post-pertuzumab.
| Publication | Local Pertuzumab Funding Date | Study Period | Proxy for Disease Control Achieved in Prior Line of Treatment in the Metastatic Setting | Compared Subgroups | Outcomes on T-DM1 (Pertuzumab Experienced vs. Naive) | |
|---|---|---|---|---|---|---|
| Pertuzumab Experienced | Pertuzumab Naïve | |||||
| Fabi et al., 2017 [7] | June 2014 (Italy) | April 2012 to June 2016 | Overall response rate (%) 1L PFS in months |
51.7% 8.0 |
63.9% 12.0 |
mPFS 5 vs. 11 mos HR = 2.0; 1.1–3.6 |
| Noda-Narita et al., 2019 [6] | August, 2013 (Japan) | 1 April 2014 to 28 February 2017 | Total duration of HER2-targeted therapy prior to T-DM1, in months | 15.1 | 31.0 | mPFS 2.8 vs. 7.8 mos HR = 3.1 [1.46–6.54] |
| Ethier et al., 2021 [18] | December 2013 (Canada) | May 2014 to December 2017 | Median time from mBC diagnosis to T-DM1 initiation, in days | 1030 | 1525 | mOS 12 vs. 19 mos HR = 1.3 [1.2–1.8] * |
| Daniels et al., 2021 [14] | July 2015 (Australia) | 1 October 2015 to 31 May 2019 | Median duration of HER2 therapy prior to T-DM1 | 10.4 | NA | Median T-DM1 duration 6.5 mos mOS 18.9 mos vs. NR |
| Conte et al., 2020 [10] | June 2014 (Italy) | 15 November 2013 to 31 May 2018 | N (%) patiens with prior duration of treatment with pertuzumab < 1 year | 74% (44/59) | NA | mPFS 6.3 mos † |
| Pizzuti et al., 2020 [8] | June 2014 (Italy) | December 2003 through November 2017 | PFS1 only reported for overall 1L not by prior pertuzumab experiend in the T-DM1 group | NA | NA | mPFS 5.6 vs. 8 mos |
| Vici et al., 2017 [9] | June 2014 (Italy) | February 2013 through July 2016 | Not reported | NA | NA | mPFS 4.0 vs. 6.0 mos mOS 17.0 vs. 22.0 mos |
| Dzimitrowicz et al., 2016 [11] | June 2012 (U.S.) | 1 March 2013, and 15 July 2015 | Not reported | NA | NA | Median duration of treatment 4 mos † |
| Gong et al., 2020 [12] | December 2013 (Canada) | (2012–2017) | Not reported | NA | NA | mOS 15.4 mos ‡ |
| Michel et al., 2020 [13] | March 2013 (Germany) | Up to June 2019 | Not reported | NA | NA | mPFS 3.5 mos † mOS 22.5 mos † |
| Lupichuk et al., 2019 [28] | December 2013 (Canada) | Up to 1 March 2018 | Not reported | NA | NA | mEFS 5.5 vs. 18.9 mos EFS HR 2.4 [1.5–3.8] * mOS 14.1 vs. 23.2 mos OS HR 1.7 [1.0–2.9] * |
| Migeotte et al., 2021 [39] | 2014 (Belgium) | Up to 31 December 2016 | Not reported | NA | NA | mPFS 3.6 vs. 9.5 mos |
* Inverse of the HR reported. † Pertuzumab-experienced. ‡ Includes pertuzumab-naive and -experienced.