Prognostic factors affecting outcomes in patients with malignant GI bleeding treated with a novel endoscopically delivered hemostatic powder

Abstract

Background and aims: Endoscopic hemostatic techniques remain poorly effective for GI tumor bleeding. We assessed Tc-325 (Hemospray, Cook Medical, Bloomington, Ind, USA) for this indication and determined possible predictors of decreased recurrent bleeding and improved 6-month survival in affected patients.

Methods: This retrospective study identified 99 patients with active malignant GI bleeding (primary or metastatic) treated with Tc-325. Eleven patients were excluded because of incomplete data. Data on patient characteristics and possible predictive factors of early (72-hour) and delayed (7-, 14-, and 30-day) recurrent bleeding, as well as 6-month survival, were collected.

Results: Overall, 70.5% were male (age, 65 ± 14 years). Half had a high Eastern Cooperative Oncology Group (ECOG) score (3 or 4). An upper GI cancer was found in 56.8%, and 72.7% cancers were stage 4. Of those affected, 51.6% received at least 1 non-endoscopic additional definitive hemostatic treatment after Tc-325. Immediate hemostasis with Tc-325 was 97.7%, with recurrent bleeding noted in 15% (early) and 17% (delayed). Six-month survival was 53.4%. On multivariable analysis, no predictive factor for recurrent bleeding was identified, whereas ECOG score 0 to 2 (P = .001; hazard ratio [HR], 0.14; 95% confidence interval [CI], 0.04-0.47), cancer stage 1 to 3 (P = .04; HR, 0.31; 95% CI, 0.10-0.96), and receiving definite hemostatic treatment alone or in any combination with surgery, chemotherapy, radiotherapy, or radiologic embolization (P = .002; HR, 0.24; 95% CI, 0.09-0.59) were significant prognosticators of 6-month survival after adjusting for comorbidity, type of cancer bleeding, and presence of a coagulopathy.

Conclusion: Before definitive therapy can be offered, Tc-325 provides effective initial hemostasis of tumoral GI bleeding. Good performance status, non-end-stage cancer, and receiving definite hemostatic treatment are independent predictors of 6-month survival. (Clinical trial registration number: NCT03066700.).