Abstract 1394P
Background
Real world data for second (2nd) line treatment and effectiveness depending on HER2 expression in gastric cancer are lacking. The objectives of this analysis were to evaluate 2nd line treatments effectiveness, and to explore HER2 expression potential effect on paclitaxel + ramucirumab (RAMUPACLI).
Methods
Patients (pts) in the Spanish AGAMENON-SEOM registry who received 2nd line treatment were included. Survival was estimated using the Kaplan-Meier method. A Bayesian Cox regression was performed, estimating the posterior probability distribution of all hazard ratio values. Non-informative priors were used (normal, mean=0, sd=10). Statistical analysis was carried out using R v4.04 statistical software
Results
3088 pts. from 34 Spanish centers were included (2010-2020). The lines of treatment received were: 2 (1595, 54%), 3 (30%) and >3 (11%). Median age was 63 years (20-88) and 72% were male. 27% had HER2+ tumors. 67% had ≥2 metastatic sites, 48% (adenopathy) and 43% (liver involvement). Most frequently used 2nd line regimen were paclitaxel (23%), PACLIRAMU (20%), irinotecan (15%), docetaxel (12%) and FOLFIRI (11%). ORR was 13%, PFS 3.19 (2.96-3.32) months (mo) and OS 5.85 mo (5.42-6.25). For those HER+ treated with PACLIRAMU (n=60), PFS was 4.73 mo (3.39-6.18) and OS 7.66 mo (6.18-12.03). In HER2(-) treated with PACLIRAMU (n=153), PFS was 3.62 mo (3.16-4.83) and OS 6.90 mo (5.82-8.52). For HER2+, the posterior probability of benefit (HR <1) with PACLIRAMU vs paclitaxel was 81% for OS (HR0.83; 95%CrI, 0.56-1.23). and 99% for PFS (HR0.63; 95%CrI, 0.43-0.92). For HER2(-), the posterior probability of benefit with PACLIRAMU vs paclitaxel was 100% for OS (HR0.65; 95%CrI, 0.51-0.82). and 100% for PFS (HR0.67; 95%CrI, 0.54-0.83). Table: 1394P
| 2nd line regimen | N/events | PFS (months), median (95% CI) |
| Paclitaxel | 261 / 257 | 2.76 (2.53-2.99) |
| PACLIRAMU | 224 / 207 | 3.75 (3.39-5.16) |
| Irinotecan | 172 / 164 | 2.63 (2.40-3.29) |
| Docetaxel | 139 / 137 | 2.76 (2.24-3.48) |
| FOLFIRI | 123 / 117 | 2.96 (2.70-4.01) |
Conclusions
In the Spanish AGAMENON-SEOM registry, 2nd line treatment effectiveness and the additional benefit of ramucirumab to paclitaxel regardless of HER2 status were confirmed.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Section of the Spanish Society of Medical Oncology (SEOM) on Outcomes Assessment and Clinical Practice.
Disclosure
N. Martinez Lago: Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Personal, Expert Testimony: Lilly; Financial Interests, Personal, Expert Testimony: Leopharma; Financial Interests, Personal, Advisory Board: PIERRE FABRE; Financial Interests, Personal, Advisory Board: AAA - Novartis; Financial Interests, Personal, Advisory Board: Merck. A. Carmona-Bayonas: Financial Interests, Advisory Role: Bristol; Financial Interests, Advisory Role: Pfizer; Financial Interests, Advisory Role: MSD; Financial Interests, Advisory Role: Mylan; Financial Interests, Advisory Role: Baxter; Financial Interests, Invited Speaker: HRA pharma; Financial Interests, Invited Speaker: LeoPharma; Financial Interests, Invited Speaker: Rovi; Financial Interests, Invited Speaker: Sanofi. A. Ramchandani: Financial Interests, Advisory Role: GSK; Financial Interests, Advisory Role: ArtraZeneca; Financial Interests, Advisory Role: Clovis; Financial Interests, Invited Speaker: Pharmamar; Financial Interests, Invited Speaker: Roche. A. Martin Carnicero: Financial Interests, Advisory Board: Bristol; Financial Interests, Advisory Board: Novartis; Financial Interests, Advisory Board: Sanofi; Financial Interests, Advisory Board: Ipsen; Financial Interests, Invited Speaker: Merck; Financial Interests, Invited Speaker: MSD; Financial Interests, Invited Speaker: Amgen; Financial Interests, Invited Speaker: AAA; Financial Interests, Invited Speaker: Roche; Financial Interests, Invited Speaker: Grunenthal; Financial Interests, Invited Speaker: Archimedes Pharma; Financial Interests, Expert Testimony: Kyowa Kirin. M. Granja Ortega: Financial Interests, Advisory Role: Servier; Financial Interests, Expert Testimony: Sanofi; Financial Interests, Invited Speaker: Amgen; Financial Interests, Invited Speaker: Celgene. R. Hernandez: Financial Interests, Advisory Role: Amgen; Financial Interests, Invited Speaker: Servier; Financial Interests, Invited Speaker: Lilly; Financial Interests, Invited Speaker: Roche; Financial Interests, Invited Speaker: Merck; Financial Interests, Invited Speaker: Ipsen. A. Azkarate: Financial Interests, Invited Speaker: Roche; Financial Interests, Advisory Board: MSD; Financial Interests, Invited Speaker: BMS. J.C. Camara: Financial Interests, Advisory Role: Servier; Financial Interests, Advisory Role: Sanofi; Financial Interests, Advisory Role: Amgen; Financial Interests, Advisory Role: Roche; Financial Interests, Invited Speaker: Merck; Financial Interests, Invited Speaker: Angelini Pharma. A. Fernandez Montes: Financial Interests, Advisory Role: BMS; Financial Interests, Invited Speaker: MSD; Financial Interests, Advisory Role: MSD; Financial Interests, Invited Speaker: Servier; Financial Interests, Invited Speaker: Lilly; Financial Interests, Advisory Role: Lilly; Financial Interests, Advisory Role: AstraZeneca; Financial Interests, Invited Speaker: Pierre Fabre; Financial Interests, Invited Speaker: Merck. E. Martinez de Castro: Financial Interests, Advisory Role: BMS; Financial Interests, Advisory Role: Pfizer; Financial Interests, Advisory Role: Amgen; Financial Interests, Advisory Role: Servier; Financial Interests, Invited Speaker: Angellini; Financial Interests, Invited Speaker: Roche; Financial Interests, Invited Speaker: LeoPharma; Financial Interests, Invited Speaker: Rovi; Financial Interests, Invited Speaker: Sanofi. J. Gallego: Financial Interests, Advisory Role: Lilly; Financial Interests, Invited Speaker: Lilly; Financial Interests, Advisory Role: BMS; Financial Interests, Invited Speaker: Merck; Financial Interests, Invited Speaker: Novartis; Financial Interests, Advisory Role: Amgen; Financial Interests, Advisory Role: Bayer; Financial Interests, Advisory Role: Eisai. All other authors have declared no conflicts of interest.