Abstract 203P
Background
The HER2 REAL (NCT04857619) retrospective study explored treatment practices and survival outcomes in HER2+ u/mBC patients (pts) in routine clinical care in APAC and Brazil.
Methods
Pts diagnosed since wider access to trastuzumab emtansine (T-DM1) or 01/01/2017, whichever was earlier with ≥12 months (mo) of follow-up data from the index date (u/mBC diagnosis) and treated with ≥1 (line of treatment) LOT were enrolled based on medical chart review from 6 countries. We present treatment patterns and final survival outcomes.
Results
Of the 763 pts screened, 684 were analyzed (AU: 62, BR: 120, HK: 92, KR: 157, SG: 105, TW: 148) with median (range) age of 55 (20–91) yrs. Overall, 363 (53.1%) pts were hormone receptor-positive; 156 (22.8%) had visceral only, 126 (18.4%) non-visceral only, and 31 (4.5%) had CNS only metastases. The top regimen overall in LOT1 was trastuzumab (TRA) + pertuzumab (PTZ) + chemotherapy (CT; 321/670 [47.9%]) and in LOT2 was T-DM1 (254/596 [42.6%]). CT alone was the most common regimen in LOT3 (132/381 [34.6%]) and LOT4 (106/217 [48.8%]; Table). For TRA+PTZ+CT in LOT1, OS ranged from 36 to 49 mo for all countries with a median (95% CI) follow-up time of 30.1 (1–167) mo. Median PFS ranged from 8.8 (7.3–14.6) to 15.5 (12.5–22.3) mo for TRA+PTZ+CT in LOT1 and from 6.0 (4.6–8.2) to 7.1 (4.4–28.3) mo for T-DM1 in LOT2 for all 6 countries. Treatment discontinuation was mostly due to disease progression. Table: 203P
| LOT n (%) | Median duration of LOT (range), mo | Real-world treatment patterns, n (%) | Attrition rate n (%) | |||||||
| TRA+PTZ+CT | T-DM1 | TRA+ CT | TRA+PTZ+CT+HT | CT-alone | HT-alone | Anti-HER2+ HT | Anti-HER2+ HT+CT* | |||
| LOT1, 670 (98.0) | 8.3 (4.4, 15.5) | 321 (47.9) | 44 (6.6) | 103 (15.4) | 66 (9.9) | 60 (9.0) | 22 (3.3) | 25 (3.7) | 30 (4.5) | 65 (9.7) |
| LOT2, 596 (87.1) | 5.1 (2.6, 10.5) | 44 (7.4) | 254 (42.6) | 54 (9.1) | - | 84 (14.1) | 24 (4.0) | 55 (9.2) | 21 (3.5) | 110 (18.5) |
| LOT3, 381 (55.7) | 3.5 (1.6, 7.0) | 22 (5.8) | 42 (11.0) | 64 (16.8) | - | 132 (34.6) | 24 (6.3) | 24 (6.3) | 10 (2.6) | 81 (21.3) |
| LOT4, 217 (31.7) | 2.8 (1.4, 4.9) | 12 (5.5) | 18 (8.3) | 36 (16.6) | - | 106 (48.8) | 15 (6.9) | 5 (2.3) | 11 (5.1) | 52 (24.0) |
*excluding TRA+PTZ+CT+HT; HT, hormone therapy.
Conclusions
In this retrospective series of HER2+ u/mBC pts from APAC and Brazil, <50% received guideline-recommended therapies. The unexpected short PFS and OS outcomes indicate substandard treatment sequencing practices. Poor outcomes and high attrition rates in later lines highlight the need for better treatment alternatives in earlier lines of therapy. Optimization of standard of care practices in these regions is urgently needed to improve survival outcomes in this pt population.
Clinical trial identification
NCT04857619.
Editorial acknowledgement
The authors. would also like to thank Dr. Debasri Mukherjee and Dr. Soma Das of Fortrea Scientific Pvt Ltd for medical writing support that was funded by AstraZeneca International.
Legal entity responsible for the study
AstraZeneca International.
Funding
AstraZeneca International.
Disclosure
C.H. Barrios: Financial Interests, Institutional, Research Grant: Nektar, Pfizer, Polyphor, Amgen, Daiichi Sankyo, Sanofi, Exelixis, Regeneron, Novartis, GSK, Janssen, OBI Pharma, Lilly, Seagen, Roche, BMS, MSD, AstraZeneca, Novocure, Aveo Oncology, Takeda, PharmaMar, Gilead Sciences, Servier, Tolmar, Nanobiotix, Dizal; Financial Interests, Other, CRO: TRIO, Labcorp, ICON, IQVIA, Parexel, Nuvisan, PSI, Worldwide, Latinaba, Fortrea, PPD, Syneos Health; Financial Interests, Personal, Stocks/Shares, Ownership or Stocks: Tummi, MEDSir; Financial Interests, Personal, Advisory Board, Advisory Boards and Consulting: Boehringer-Ingelheim, GSK, Novartis, Pfizer, Roche/Genentech, Eisai, Bayer, MSD, AstraZeneca, Zodiac, Lilly, Sanofi, Daiichi. S.C. Lee: Financial Interests, Personal, Advisory Board, Advisory board, speaker invitations: Pfizer, Novartis, AstraZeneca, Roche, MSD; Financial Interests, Personal, Advisory Board, Advisory Board: Eli Lilly; Financial Interests, Personal, Advisory Board: Gilead; Financial Interests, Institutional, Research Grant: Pfizer, ACT Genomics, Eisai, Taiho, MSD, Karyopharm, ASLAN Pharmaceuticals, Adagene; Financial Interests, Institutional, Invited Speaker: Roche, Novartis, Daiichi Sankyo, BMS, AstraZeneca; Financial Interests, Personal, Invited Speaker: AstraZeneca. R. K.c. Ngan: Financial Interests, Personal, Other, Personal fees: Novartis, AstraZeneca, Sanofi, Pfizer, ZaiLab, Eisai, Lilly, Fosun Pharma, Roche, Nuance (China), Bristol Myers Squibb, Astellas, Merck, Sharp & Dohme. S. Im: Financial Interests, Personal, Advisory Board, no payment: AstraZeneca, Novartis, Eisai, Roche, Hanmi, Pfizer, Lilly, MSD, GSK, Daiichi Sankyo; Financial Interests, Institutional, Advisory Board: Bertis; Financial Interests, Personal, Advisory Board: Idience; Financial Interests, Institutional, Research Grant: AstraZeneca, Pfizer, Roche, Eisai, Dae Woong; Financial Interests, Institutional, Invited Speaker, Clinical Trial Budget: AstraZeneca, Eisai, Hanmi, Novartis, Roche, Pfizer, Daiichi Sankyo, MSD, Lilly; Financial Interests, Institutional, Research Grant, Clinical Trial Budget: Boryung Pharm. R. Hui: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, BMS, Eisai, Eli Lilly, Janssen, Merck Sereno, MSD, Novartis, Oncosec, Pfizer, Roche, Seagen, Takeda, Zai Lab; Financial Interests, Personal, Other, Speaker Honorarium: AstraZeneca, Eli Lilly, Janssen, MSD, Novartis; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Institutional, Research Grant: BMS, Corvus, Eisai, Eli Lilly, Janssen, MSD, Novartis, Oncosec, Roche, Seagen. T. Tung: Financial Interests, Institutional, Full or part-time Employment: AstraZeneca. All other authors have declared no conflicts of interest.