Affiliation:
1. Department of Medical and Hemato Oncology, Regency Hospital, Kanpur, Uttar Pradesh, India,
2. Department of Pediatric Oncology, Rama Hospital, Kanpur, Uttar Pradesh, India,
3. Department of Medical Affairs, Mankind Specialties, Mumbai, Maharashtra, India,
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.