Does HER2 status influence in the benefit of ramucirumab and paclitaxel as second line treatment of advanced gastro-esophageal adenocarcinoma? Data from the AGAMENON-SEOM registry
Por:
Valcarcel, S, Gallego, J, Jimenez-Fonseca, P, Diez, M, de Castro, E, Hernandez, R, Arrazubi, V, Custodio, A, Cano, J, Montes, A, Macias, I, Visa, L, Calvo, A, Tocino, R, Lago, N, Limon, M, Granja, M, Gil, M, Pimentel, P, Macia-Rivas, L, Perez, C, Mangas, M, Carnicero, A, Cerda, P, Gonzalez, L, Navalon, F, Rambla, M, Richard, M and Carmona-Bayonas, A
Publicada:
1 jul 2023
Ahead of Print:
1 ago 2022
Resumen:
Purpose This study aimed to compare ramucirumab-paclitaxel versus chemotherapy in second-line (2L) advanced gastroesophageal cancer (aGEC) based on HER2 status and analyze prognostic factors. Methods The study includes patients from the AGAMENON-SEOM registry with aGEC and known HER2 status who received 2L between 2016 and 2021. The Kaplan-Meier method was used to calculate progression-free survival (PFS) and overall survival (OS) and multivariable Cox regression analysis was done to adjust for confounding variables. Results Of the 552 patients who met the selection criteria, 149 (26.9%) had HER2-positive aGEC, 89 were treated with chemotherapy, and 60 with ramucirumab-paclitaxel, and 403 had an HER2-negative aGEC, 259 were treated with chemotherapy, and 144 with ramucirumab-paclitaxel. In the whole sample, 2L PFS was 3.0 months (95% CI 2.8-3.2), 2L OS, 5.7 months (5.2-6.3), and ramucirumab-paclitaxel versus chemotherapy was associated with increased PFS (HR 0.64, 95% CI 0.53-0.78, p < 0.0001) and OS (HR 0.68, 0.55-0.83, p = 0.0002). Median PFS of ramucirumab- paclitaxel versus chemotherapy was 3.5 vs 2.8 months (HR 0.67, 0.54-0.83, p = 0.0004) in HER2-negative, and 4.7 vs 2.7 months (HR 0.57, 0.40-0.82, p = 0.0031) in HER2-positive aGEC, respectively. Median OS for ramucirumab-paclitaxel versus chemotherapy was 6.6 vs 5 months (HR 0.67, 0.53-0.85, p = 0.0007) in HER2-negative, and 7.4 vs 5.6 months (HR 0.70, 0.53-1.04, p = 0.083) in HER2-positive aGEC, respectively. ECOG-PS, tumor burden, Lauren subtype, and neutrophil-lymphocyte ratio were prognostic factors. Conclusions In patients with an aGEC from the AGAMENON-SEOM registry, 2L treatment with ramucirumab-paclitaxel was superior to chemotherapy in PFS, OS and response rate, independent of HER2 status.
Filiaciones:
Valcarcel, S:
Hosp Univ Cent Asturias, Med Oncol Dept, ISPA, Ave Roma Sn, Oviedo 33011, Spain
:
Hosp Gen Univ Elche, Med Oncol Dept, Elche, Spain
Jimenez-Fonseca, P:
Hosp Univ Cent Asturias, Med Oncol Dept, ISPA, Ave Roma Sn, Oviedo 33011, Spain
Diez, M:
Hosp Univ Vall dHebron, Med Oncol Dept, Barcelona, Spain
de Castro, E:
Hosp Univ Marques de Valdecilla, Med Oncol Dept, IDIVAL, Santander, Spain
Hernandez, R:
Hosp Univ Canarias, Med Oncol Dept, Tenerife, Spain
Arrazubi, V:
Hosp Univ Navarra, Inst Invest Sanitaria Navarra IdiSNA, Med Oncol Dept, Pamplona, Spain
Custodio, A:
Hosp Univ La Paz, Med Oncol Dept, CIBERONC CB16-12-00398, Madrid, Spain
Cano, J:
Hosp Gen Univ Ciudad Real, Med Oncol Dept, Ciudad Real, Spain
Montes, A:
Complejo Hosp Univ Ourense, Med Oncol Dept, Orense, Spain
Macias, I:
Hosp Univ Parc Tauli, Med Oncol Dept, Sabadell, Spain
Visa, L:
Hosp Univ El Mar, Med Oncol Dept, Barcelona, Spain
Calvo, A:
Hosp Univ Gregorio Maranon, Med Oncol Dept, Madrid, Spain
Tocino, R:
Complejo Asistencial Univ Salamanca IBSAL, Med Oncol Dept, Salamanca, Spain
Lago, N:
Complejo Hosp Univ A Coruna, Med Oncol Dept, Coruna, Spain
Limon, M:
Hosp Univ Virgen del Rocio, Med Oncol Dept, Seville, Spain
Granja, M:
Hosp Univ Clin San Carlos Madrid, Med Oncol Dept, Madrid, Spain
Gil, M:
Hosp Gen Univ Valencia, Med Oncol Dept, Ciberonc CB16-12-0035, Valencia, Spain
Pimentel, P:
Hosp Santa Lucia, Med Oncol Dept, Cartagena, Spain
Macia-Rivas, L:
Hosp Univ Cent Asturias, Pharm Dept, Oviedo, Spain
Perez, C:
Hosp Univ Nuestra Senora de La Candelaria, Med Oncol Dept, Tenerife, Spain
Mangas, M:
Hosp Galdakao Usansolo, Med Oncol Dept, Galdakao Usansolo, Spain
Carnicero, A:
Hosp San Pedro, Med Oncol Dept, Logrono, Spain
Cerda, P:
Hosp Santa Creu & Sant Pau, Med Oncol Dept, Barcelona, Spain
Gonzalez, L:
Hosp Gen Univ Alicante, Med Oncol Dept, Alicante, Spain
Navalon, F:
Hosp Univ Son Llatzer, Med Oncol Dept, Mallorca, Spain
Rambla, M:
Hosp Univ Virgen de La Macarena, Med Oncol Dept, Seville, Spain
Richard, M:
Catalan Inst Oncol ICO, Med Oncol Dept, Lhospitalet De Llobregat, Spain
Carmona-Bayonas, A:
Univ Murcia, Hosp Univ Morales Meseguer, Hematol & Med Oncol Dept, CP13-00126,PI17-0050 ISCIII & FEDER, Murcia, Spain
|