An early switch from induction chemotherapy to maintenance ramucirumab-paclitaxel has shown improved outcomes in patients with advanced-stage gastric or gastro-esophageal junction cancer (G/GEJC), according to results from the phase III ARMANI trial. This approach is particularly relevant for patients ineligible for combination therapy incorporating antibodies targeting HER2, PD-1, or claudin-18.2, who often receive chemotherapy alone as a first-line treatment. Disease progression in these patients typically occurs within a few months, and the associated morbidities can preclude standard second-line treatment with ramucirumab plus paclitaxel.
The ARMANI trial involved 280 patients with unresectable HER2-negative G/GEJC who achieved disease control after 3 months of induction therapy with folinic acid, 5-fluorouracil, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CAPOX). Participants were randomized 1:1 to either continuous ramucirumab-paclitaxel (switch maintenance group) or a further 3 months of FOLFOX or CAPOX followed by single-agent fluoropyrimidine maintenance (control group). The primary endpoint of the study was progression-free survival (PFS).
The findings suggest that an early switch to ramucirumab-paclitaxel maintenance can offer a significant advantage in terms of PFS compared to continuing chemotherapy followed by fluoropyrimidine maintenance. This is particularly important given that many patients with advanced G/GEJC are not candidates for more targeted therapies and face limited treatment options after initial chemotherapy failure. The early switch strategy may provide a more effective and potentially less toxic approach to managing this challenging disease.