Post-Marketing Surveillance of a generic Oxaliplatin (Alvoxal®) in Iranian Patients with Cancer

Abstract Purpose This phase IV study aimed to evaluate the safety profile of a generic oxaliplatin (Alvoxal®, NanoAlvand, Iran) in Iranian patients diagnosed with either colorectal or other, different types of cancer. Methods Patients with colorectal cancer, gastric cancer, or other malignancies receiving oxaliplatin as a part of their treatment were included in this open-label, multicenter, observational phase IV study. This study aimed to assess the safety profile of oxaliplatin in patients diagnosed with different cancers. Findings A total of 483 patients from 16 cities in Iran were enrolled. The most common malignancy was colorectal cancer (55.49%), followed by gastric cancer (28.16%). Based on the results, 405 patients experienced at least one adverse event (AE). Most of these AEs were grade 1 or 2, and the most commonly reported AE was anemia (60.66%). During the study, 26 serious adverse events (SAEs) occurred in 15 (3.11%) patients, which were perhaps related to oxaliplatin. There were no remarkable differences in the incidences of AEs in the system organ classes (SOCs) of blood and lymphatic system disorders, gastrointestinal disorders, or nervous system disorders among patients with different malignancies (colorectal cancer, gastric cancer, and other malignancies) or between genders. The results of this open-label, multicenter, observational, post-marketing surveillance (PMS) study demonstrated no unexpected safety findings from the use of this generic oxaliplatin product (Alvoxal®) in Iranian patients diagnosed with different types of cancer. Implications This phase IV study provides data on the safety profile of a number of chemotherapy regimens containing a generic oxaliplatin product given to Iranian patients diagnosed with different types of cancer.