Real-world study on the effect of nab-paclitaxel treatment on clinical outcomes and laboratory parameters in patients across metastatic tumor sites

Abstract

Objectives: PacliALLTM is the first and only indigenously developed brand of nab-paclitaxel in India that has shown bioequivalence to the global reference (Abraxane®). However, real-world Evidence is scarce about the use of it in different tumor sites beyond approved indications. This study assessed the effects of nab-paclitaxel (PacliALLTM) on clinical outcomes in patients diagnosed with different metastatic cancers in a tertiary care hospital in India. Material and Methods: In this retrospective study, data on demographics, medical history, and laboratory investigations were collected from medical records of patients with metastatic cancer. Patients on nab-paclitaxel were included, and data on laboratory findings, including hematological, liver, and kidney function tests and prognostic outcomes, were evaluated. Results: The study population consisted of 73 patients with metastatic cancer (mean age- 54.6 years). Primary sites of cancer in most patients were the oral cavity (40.8%), followed by breast and ovary (15.3%, each). The Eastern Cooperative Oncology Group score was 0 in 84.3% and 1 in 14.3% of patients. Weekly analyses showed no significant differences in hemoglobin, neutrophil, creatinine, random blood glucose (RBG), and serum glutamic-oxaloacetic transaminase levels. A significant proportion of patients reported anemia and RBG >125 mg/dL at baseline (97.1% and 63.4%, respectively) and week 17 (85.1% and 88.1%, respectively). Most patients had a partial response at week 17 (76.8%), respectively. No serious adverse reactions were reported, requiring a change in treatment. Conclusion: Nab-paclitaxel showed manageable tolerability and favorable response rates in metastatic cancer patients. It is widely used beyond approved indications in a significant proportion of patients across various tumor sites.