ASTRON (OGSG 2401): A multicenter prospective trial of ferric carboxymaltose without erythropoiesis-stimulating agents for iron deficiency anemia in patients with gastric/colorectal cancer receiving chemotherapy.

Abstract

12045 Background: Iron deficiency anemia (IDA) during chemotherapy for patients with gastrointestinal cancer worsens quality of life (QoL) and may compromise treatment continuity. Ferric carboxymaltose (FCM) enables high-dose intravenous iron supplementation; however, prospective data without concomitant erythropoiesis-stimulating agents (ESAs) remain limited. We conducted a multicenter prospective trial to evaluate intravenous FCM without concomitant ESAs or red blood cell (RBC) transfusion support. Methods: This was a multicenter prospective single-arm study. Key eligibility criteria included unresectable or recurrent gastric or colorectal cancer, ongoing chemotherapy, hemoglobin (Hb) <10.0 g/dL, and transferrin saturation (TSAT) <20%. FCM was administered as three 500 mg doses at ≥7-day intervals (total 1500 mg), with all doses completed within 29 days of the first infusion (Day 1). The primary endpoint was Hb improvement rate at week 8, defined as an Hb increase ≥1.0 g/dL from baseline without RBC transfusion. The improvement rate was tested against a threshold of 18% using a one-sided exact binomial test (α=0.05). QoL (FACT-An and EQ-5D-5L) was analyzed using linear mixed-effects models. Results: Fifty-two patients were enrolled; 51 received FCM. Median age was 72 years (range 45–90). Primary tumors were gastric (71.2%) and colorectal (28.8%); ECOG PS 0/1/2 was 50.0%/46.2%/3.8%. Disease status was unresectable in 55.8% and postoperative recurrence in 44.2%. The primary tumor was present in 40.4%. Most patients (90.4%) were receiving cytotoxic chemotherapy. Baseline median Hb was 9.15 g/dL (IQR 8.50–9.50), TSAT 8.55% (IQR 5.77–12.80), and ferritin 37.6 ng/mL (IQR 17.1–179.0). The week-8 Hb improvement rate was 72.5% (37/51; 95% CI 58.3–84.1; p<0.001). Hb improvement rates at weeks 4 and 12 were 58.8% (30/51) and 76.5% (39/51), respectively. FACT-An total score improved at week 8 (mixed-model estimate +4.93; 95% CI 0.23–9.62; p=0.040). EQ-5D also improved at week 8 (estimate +6.72; 95% CI 0.98–12.46; p=0.022). Planned protocol treatment was completed in 49/52 patients (94.2%). No treatment-related serious adverse events or deaths were observed. Conclusions: FCM achieved an Hb improvement rate of 72.5% and improved QoL in patients with gastric or colorectal cancer and IDA receiving chemotherapy, with high protocol completing and no treatment-related serious adverse events. These findings support FCM as an effective and feasible option for managing IDA during chemotherapy without ESAs. Clinical trial information: jRCTs051240288.