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The following is a summary of “Ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line oxaliplatin-based chemotherapy in patients with advanced HER2-negative gastric or gastro-oesophageal junction cancer (ARMANI): a randomized, open-label, multicentre, phase 3 trial,” published in the November 2024 issue of Oncology by Randon et al.     

Paclitaxel plus ramucirumab is a recommended second-line therapy for people with advanced human epidermal growth factor receptor 2 (HER2)-negative gastric or gastro-esophageal junction cancer (GEJC).  

Researchers conducted a prospective study to assess whether switch maintenance with paclitaxel plus ramucirumab improves outcomes compared to continuing first-line oxaliplatin-based therapy in patients with advanced HER2-negative gastric or GEJC.  

They enrolled individuals aged 18 years or older with advanced HER2-negative gastric or GEJC who had disease control after 3 months of leucovorin, fluorouracil, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CAPOX). Patients were randomly assigned (1:1) to switch maintenance with paclitaxel 80 mg/m² on days 1, 8, and 15 plus ramucirumab 8 mg/kg on days 1 and 15 (every 28 days) or continuation of oxaliplatin-based therapy for 12 weeks followed by fluoropyrimidine monotherapy. The primary endpoint was progression-free survival (PFS).  

The results showed 280 participants (180 males [64%], 100 females [36%]), the median PFS was 6.6 months (95% CI, 5.9–7.8) in the switch maintenance group and 3.5 months (95% CI, 2.8–4.2) in the control group (HR, 0.61; 95% CI, 0.48–0.79; P=.0002). Restricted mean PFS at 24 months was 8.8 months (95% CI, 7.7–9.9) in the switch maintenance group and 6.1 months (95% CI, 5.0–7.2) in the control group (P=.0010). Grade 3–4 neutropenia occurred in 37 patients (26%) in the switch maintenance group and 13 (10%) in the control group, with no treatment-related deaths.  

They concluded that switch maintenance with paclitaxel plus ramucirumab is a potential strategy for people with advanced HER2-negative gastric or GEJC who are not eligible for immunotherapy or targeted agents.  

Source: thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00580-1/abstract