Main Article Content
Background: Paclitaxel is a chemotherapy drug which widely used in the standard oncologic treatment of gynecologic cancer. Drug related problems are usually reported among the group of patients who received Paclitaxel, especially side effects during drug administration called an infusion reactions. Previous studies shown that Cremophor EL (CrEL), a lipid-based solvent formulation of injectable paclitaxel, can trigger hypersensitivity reactions.
Objective: To compare the presenting with infusion reactions between original and generic drugs used in gynecologic cancer patients at Ramathibodi Hospital.
Methods: Retrospective medical record study with enrollment from January 1, 2013 to December 31, 2015, of 446 gynecologic cancer patients received the first cycle of paclitaxel from the Division of Gynecologic Oncology at Ramathibodi Hospital. The infusion reactions during the course of treatment with original drug and generic drug were collected and analyzed.
Results: Original and generic drugs treatment were 227 (51%) and 219 (49%) patients, respectively. Eighty-four (18.83%) patients had infusion reactions after receiving paclitaxel injection, 43 patients of original drug; and 41 patents of generic drug. Among these, mild and severe reactions were 80 and 4 patients, respectively. There was no significant difference in the incidence of severe reactions between the two groups of paclitaxel used.
Conclusion: The study shown that the infusion reactions of paclitaxel between original and generic drugs were equivalent when used in first-line gynecologic cancer therapy.
2. Adams JD, Flora KP, Goldspiel BR, Wilson JW, Arbuck SG, Finley R. Taxol: a history of pharmaceutical development and current pharmaceutical concerns. J Natl Cancer Inst Monogr. 1993;15:141-147.
3. Lassus M, Scott D, Leyland-Jones B. Allergic reactions associated with cremophor containing antineoplastics. Proc Am Soc Clin Oncol. 1985;4:268.
4. Gelderblom H, Verweij J, Nooter K, Sparreboom A. Cremophor EL: the drawbacks and advantage of vehicle detection for drug formulation. Eur J Cancer. 2001;37(13):1590-1598.
5. Vogel WH. Infusion reactions: diagnosis, assessment, and management. Clin J Oncol Nurs. 2010;14(2):E10-E21. doi:10.1188/10.CJON.E10-E21.
6. National Cancer Institute. Common Terminology Criteria for Adverse Events, version 4.0; 2009. https://www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed March 13, 2018.
7. Kintzel PE. Prophylaxis for paclitaxel hypersensitivity reactions. Ann Pharmacother. 2001;35(9):1114-1117.
8. Nathpong I, Chomporn S. Chemotherapy Protocol. Bangkok, Thailand; Treatment Guideline Gynecologic Oncology; 2007.
9. Rungnirattisai S. The comparative study on product attributes, satisfaction and prescription of physicians toward generic and original drug. Master’s Project, M.B.A. (Marketing). Bangkok: Graduate School, Srinakharinwirot University; 2011.
10. Industrial Medicine. Quality of generic drugs. https://newsser.fda.moph.go.th/drug_gpiip/publish/downloads/Generic%20Drug1.pdf. Accessed March 13, 2018.
11. Lang I, Rubovszky G, Horvath Z, et al. A comparative analysis on the efficacy and safety of Intaxel® and Taxol® in advanced metastatic breast cancer. J Clin Diagn Res. 2013;7(6):1120-1124. doi:10.7860/JCDR/2013/4742.3027.
12. Ratanajarusiri T, Sriuranpong V, Sitthideatphaiboon P, et al. A difference in the incidences of hypersensitivity reactions to original and generic taxanes. Chemotherapy. 2017;62(2):134-139. doi:10.1159/000450748.
13. Gautam R, Sankalp Y, Raj K. Paclitaxel induced acute ST elevation myocardial infarction: a rare case report. J Clin Diagn Res. 2016:10(10):XD01-XD02. doi:10.7860/JCDR/2016/21396.8614.
14. McEvoy GK. AHFS Drug Information. United States of America: American Society of Health-System Pharmacists; 2009:1199.
15. Dash HK. Cremophor® ELP - Solubilizer for the Pharmaceutical Industry. Solan, India: Fresenius Kabi Oncology; 2003.