PMID- 38137901 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231225 IS - 2075-1729 (Print) IS - 2075-1729 (Electronic) IS - 2075-1729 (Linking) VI - 13 IP - 12 DP - 2023 Dec 5 TI - Real-World Data on Second-Line Therapy with Ramucirumab for Metastatic Gastric Cancer: A Two-Center Study on Romanian Population. LID - 10.3390/life13122300 [doi] LID - 2300 AB - (1) Background: Following the results of RAINBOW and REGARD trials, ramucirumab was approved as the standard second-line treatment for patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer, alone or in combination with paclitaxel. The present study aimed to evaluate the efficacy and safety of ramucirumab in the Romanian population during every-day clinical practice. (2) Methods: A two-center, retrospective, observational study evaluated patients with metastatic gastric and GEJ cancer treated with ramucirumab monotherapy or associated with paclitaxel. The patients were treated between 2018 and 2022 in two Romanian centers as follows: 18 patients underwent treatment with ramucirumab monotherapy, while 51 received the combined treatment regimen. Study endpoints included median progression-free survival (PFS), median overall survival (OS), and the evaluation of treatment-induced adverse events (AEs). (3) Results: In the study cohort (n = 69), the most frequent treatment-induced AE in the ramucirumab plus paclitaxel arm was hematological toxicity; the most common AE for patients treated with ramucirumab monotherapy was fatigue and headache. Overall, the median PFS was 4.7 months (95% CI: 3.4-5.9 months) and median OS was 18.23 months (95% CI: 15.6-20.7 months). PFS was correlated with the number of treatment cycle administrations, Eastern Cooperative Oncology Group performance status at treatment initiation, and metastatic site (visceral vs. peritoneal). OS was correlated with the number of treatment cycles administered and human epidermal growth factor receptor-2 status. (4) Conclusions: The results support the previously described toxicity profile for ramucirumab monotherapy or associated with paclitaxel and demonstrated a relatively superior median PFS. FAU - Galos, Diana AU - Galos D AD - Department of Medical Oncology, The Oncology Institute Prof. Dr. Ion Chiricuta, 400015 Cluj-Napoca, Romania. FAU - Balacescu, Loredana AU - Balacescu L AD - Department of Genetics, Genomics and Experimental Pathology, The Oncology Institute Prof. Dr. Ion Chiricuta, 400015 Cluj-Napoca, Romania. FAU - Vidra, Radu AU - Vidra R AUID- ORCID: 0000-0001-7968-908X AD - Postgraduate Program for Bio-Behavioral Integrative Medicine, Babes-Bolyai University, 400084 Cluj-Napoca, Romania. AD - Department of Medical Oncology, Regional Institute of Gastroenterology and Hepatology Prof. Dr. Octavian Fodor, 400162 Cluj-Napoca, Romania. FAU - Sur, Daniel AU - Sur D AUID- ORCID: 0000-0002-0926-4614 AD - Department of Medical Oncology, The Oncology Institute Prof. Dr. Ion Chiricuta, 400015 Cluj-Napoca, Romania. AD - Department of Medical Oncology, University of Medicine and Pharmacy "Iuliu Hatieganu", 400012 Cluj-Napoca, Romania. LA - eng PT - Journal Article DEP - 20231205 PL - Switzerland TA - Life (Basel) JT - Life (Basel, Switzerland) JID - 101580444 PMC - PMC10744814 OTO - NOTNLM OT - gastric cancer OT - gastroesophageal junction cancer OT - metastatic disease OT - paclitaxel OT - ramucirumab OT - second-line treatment COIS- The authors declare no conflict of interest. EDAT- 2023/12/23 12:44 MHDA- 2023/12/23 12:45 PMCR- 2023/12/05 CRDT- 2023/12/23 01:12 PHST- 2023/10/24 00:00 [received] PHST- 2023/11/24 00:00 [revised] PHST- 2023/12/01 00:00 [accepted] PHST- 2023/12/23 12:45 [medline] PHST- 2023/12/23 12:44 [pubmed] PHST- 2023/12/23 01:12 [entrez] PHST- 2023/12/05 00:00 [pmc-release] AID - life13122300 [pii] AID - life-13-02300 [pii] AID - 10.3390/life13122300 [doi] PST - epublish SO - Life (Basel). 2023 Dec 5;13(12):2300. doi: 10.3390/life13122300.