Date Log
Submitted
February 19, 2023
Published
February 19, 2023
A retrospective study on incedence of adverse effects of paclitaxel in cancer patients at tertiary care hospital
Corresponding Author(s) : J. Anantha Lakshmi
anu_manas0108@Yahoo.com
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 11 No. 1 (2023): 2023 Volume -11 - Issue 1
Abstract
Paclitaxel is a chemotherapeutic agent widely used for the effective treatment of various types of cancer. Paclitaxel was approved by the United States Food and Drug Administration for the treatment of various cancers such as ovarian cancer, breast cancer, advanced non-small cell lung cancer and acquired immunodeficiency syndrome (AIDS) – related Kaposi’s sarcoma. Now a days Paclitaxel is used both as single and combination chemotherapy. However it is generally not tolerated well as it has serious adverse drug reactions such as hyper sensitivity reactions, neuropathy, haematological toxicity, myalgia etc. To prevent the adverse drug reactions the patient must be treated with corticosteroids, antihistamines, and H2 antagonist prior to administration of Paclitaxel. Although Paclitaxel treatment is associated with several ADRs, it is still used by oncologist to treat different types of cancer because of its high efficacy. To report the adverse effects of paclitaxel and to review the management prescribed by the physician. A Retrospective study was conducted on the adverse effects of paclitaxel in cancer patients in Apollo hospital. A total number of 100 sample size was studied and their Demographic details along with relevant subjective and objective information was collected from the patient files from medical record department (MRD). Patients were followed up until complete chemotherapy cycle. Parameters collected were tabulated in MS-Excel sheet and the ADR’s along with recovery status were analysed. Total 68 ADRs were reported and 32 were not reported in which 95 were female and 5 were male where age between 51-60 are mostly effected with cancer as per our study and 260 mg of paclitaxel was most commonly used. Patients showed shortness of breath followed by nausea and vomiting majorly. 68% ADRs were reported on administration of paclitaxel drug, where vomiting and shortness of breath are majorly reported allergic reactions, back pain chest heaviness ,dyspepsia, fever, mental deposits, malignant ascites are most minorly reported. Ondansetron is most commonly used drug for vomiting whereas Hydrocortisone and Pheniramine are most commonly used drugs for shortness of breath. Adverse effects are reported mainly based on Paclitaxel drug but they are not based on dose of the drug.
Keywords
Paclitaxel, chemotherapeutic agent, Adverse effects, carcinoma
J. Anantha Lakshmi, N. Hari Priya, Venkata Sampath, Ch.Gayathri, Ch. Kavya, & S. Sai Sirisha. (2023). A retrospective study on incedence of adverse effects of paclitaxel in cancer patients at tertiary care hospital. International Journal of Allied Medical Sciences and Clinical Research, 11(1), 34–41. https://doi.org/10.61096/ijamscr.v11.iss1.2023.34-41
Download Citation
Endnote/Zotero/Mendeley (RIS)BibTeX
References
-
1. Postma TJ, Vermorken JB, Liefting AJM, Pinedo HM, Heimans JJ. Paclitaxel-induced neuropathy. Ann Oncol. 1995 May 1;6(5):489-94. doi: 10.1093/oxfordjournals.annonc.a059220.
2. Ball HG, Blessing JA, Lentz SS, Mutch DG. A phase II trial of paclitaxel in patients with advanced or recurrent adenocarcinoma of the endometrium: a Gynecologic Oncology Group study. Gynecol Oncol. 1996 Aug 1;62(2):278-81. doi: 10.1006/gyno.1996.0227.
3. Shade RJ, Pisters KMW, Huber MH, Fossella F, Perez-Soler R, Shin DM et al. Phase I study of paclitaxel administered by ten-day continuous infusion. Investig New Drugs. 1998 Sep;16(3):237-43. doi: 10.1023/A:1006157226693.
4. Szebeni J, Alving CR, Muggia FM. Complement activation by cremophor EL as a possible contributor to hypersensitivity to paclitaxel: an in vitro study. JNCI J Natl Cancer Inst. 1998 Feb 18;90(4):300-6. doi: 10.1093/jnci/90.4.300.
5. Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil– based paclitaxel in women with breast cancer. J Clin Oncol. 2005 Nov 1;23(31):7794-803. doi: 10.1200/JCO.2005.04.937.
6. Yamaguchi K, Tada M, Horikoshi N, Otani T, Takiuchi H, Saitoh S et al. Phase II study of paclitaxel with 3-h infusion in patients with advanced gastric cancer. Gastric Cancer. 2002 Jun;5(2):90-5. doi: 10.1007/s101200200015.
7. McGuire WP, Blessing JA, Moore D, Lentz SS, Photopulos G. Paclitaxel has moderate activity in squamous cervix cancer. A Gynecologic Oncology Group study. J Clin Oncol. 1996 Mar;14(3):792-5. doi: 10.1200/JCO.1996.14.3.792.
8. Kim TY, Kim DW, Chung JY, Shin SG, Kim SC, Heo DS et al. Phase I and pharmacokinetic study of Genexol-PM, a cremophor-free, polymeric micelle-formulated paclitaxel, in patients with advanced malignancies. Clin Cancer Res. 2004 Jun 1;10(11):3708-16. doi: 10.1158/1078-0432.CCR-03-0655.
9. Winer EP, Berry DA, Woolf S, Duggan D, Kornblith A, Harris LN et al. Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: cancer and leukemia group B trial 9342. J Clin Oncol. 2004 Jun 1;22(11):2061-8. doi: 10.1200/JCO.2004.08.048.
10. Trimble EL, Adams JD, Vena D, Hawkins MJ, Friedman MA, Fisherman JS et al. Paclitaxel for platinum-refractory ovarian cancer: results from the first 1,000 patients registered to National Cancer Institute Treatment Referral Center 9103. J Clin Oncol. 1993 Dec;11(12):2405-10. doi: 10.1200/JCO.1993.11.12.2405.
11. Saville MW, Lietzau J, Pluda JM, Wilson WH, Humphrey RW, Feigel E et al. Treatment of HIV-associated Kaposi’s sarcoma with paclitaxel. Lancet. 1995 Jul 1;346(8966):26-8. doi: 10.1016/S0140-6736(95)92654-2.
12. Varghese J, Mateti UV, Shetty J, Philip ML, Naga Raju B. Incidence and cost of chemotherapy- induced adverse drug reactions among cancer patients in a charitable hospital. J Rep Pharma Sci [serial online]; 2021.
References
1. Postma TJ, Vermorken JB, Liefting AJM, Pinedo HM, Heimans JJ. Paclitaxel-induced neuropathy. Ann Oncol. 1995 May 1;6(5):489-94. doi: 10.1093/oxfordjournals.annonc.a059220.
2. Ball HG, Blessing JA, Lentz SS, Mutch DG. A phase II trial of paclitaxel in patients with advanced or recurrent adenocarcinoma of the endometrium: a Gynecologic Oncology Group study. Gynecol Oncol. 1996 Aug 1;62(2):278-81. doi: 10.1006/gyno.1996.0227.
3. Shade RJ, Pisters KMW, Huber MH, Fossella F, Perez-Soler R, Shin DM et al. Phase I study of paclitaxel administered by ten-day continuous infusion. Investig New Drugs. 1998 Sep;16(3):237-43. doi: 10.1023/A:1006157226693.
4. Szebeni J, Alving CR, Muggia FM. Complement activation by cremophor EL as a possible contributor to hypersensitivity to paclitaxel: an in vitro study. JNCI J Natl Cancer Inst. 1998 Feb 18;90(4):300-6. doi: 10.1093/jnci/90.4.300.
5. Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil– based paclitaxel in women with breast cancer. J Clin Oncol. 2005 Nov 1;23(31):7794-803. doi: 10.1200/JCO.2005.04.937.
6. Yamaguchi K, Tada M, Horikoshi N, Otani T, Takiuchi H, Saitoh S et al. Phase II study of paclitaxel with 3-h infusion in patients with advanced gastric cancer. Gastric Cancer. 2002 Jun;5(2):90-5. doi: 10.1007/s101200200015.
7. McGuire WP, Blessing JA, Moore D, Lentz SS, Photopulos G. Paclitaxel has moderate activity in squamous cervix cancer. A Gynecologic Oncology Group study. J Clin Oncol. 1996 Mar;14(3):792-5. doi: 10.1200/JCO.1996.14.3.792.
8. Kim TY, Kim DW, Chung JY, Shin SG, Kim SC, Heo DS et al. Phase I and pharmacokinetic study of Genexol-PM, a cremophor-free, polymeric micelle-formulated paclitaxel, in patients with advanced malignancies. Clin Cancer Res. 2004 Jun 1;10(11):3708-16. doi: 10.1158/1078-0432.CCR-03-0655.
9. Winer EP, Berry DA, Woolf S, Duggan D, Kornblith A, Harris LN et al. Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: cancer and leukemia group B trial 9342. J Clin Oncol. 2004 Jun 1;22(11):2061-8. doi: 10.1200/JCO.2004.08.048.
10. Trimble EL, Adams JD, Vena D, Hawkins MJ, Friedman MA, Fisherman JS et al. Paclitaxel for platinum-refractory ovarian cancer: results from the first 1,000 patients registered to National Cancer Institute Treatment Referral Center 9103. J Clin Oncol. 1993 Dec;11(12):2405-10. doi: 10.1200/JCO.1993.11.12.2405.
11. Saville MW, Lietzau J, Pluda JM, Wilson WH, Humphrey RW, Feigel E et al. Treatment of HIV-associated Kaposi’s sarcoma with paclitaxel. Lancet. 1995 Jul 1;346(8966):26-8. doi: 10.1016/S0140-6736(95)92654-2.
12. Varghese J, Mateti UV, Shetty J, Philip ML, Naga Raju B. Incidence and cost of chemotherapy- induced adverse drug reactions among cancer patients in a charitable hospital. J Rep Pharma Sci [serial online]; 2021.
2. Ball HG, Blessing JA, Lentz SS, Mutch DG. A phase II trial of paclitaxel in patients with advanced or recurrent adenocarcinoma of the endometrium: a Gynecologic Oncology Group study. Gynecol Oncol. 1996 Aug 1;62(2):278-81. doi: 10.1006/gyno.1996.0227.
3. Shade RJ, Pisters KMW, Huber MH, Fossella F, Perez-Soler R, Shin DM et al. Phase I study of paclitaxel administered by ten-day continuous infusion. Investig New Drugs. 1998 Sep;16(3):237-43. doi: 10.1023/A:1006157226693.
4. Szebeni J, Alving CR, Muggia FM. Complement activation by cremophor EL as a possible contributor to hypersensitivity to paclitaxel: an in vitro study. JNCI J Natl Cancer Inst. 1998 Feb 18;90(4):300-6. doi: 10.1093/jnci/90.4.300.
5. Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil– based paclitaxel in women with breast cancer. J Clin Oncol. 2005 Nov 1;23(31):7794-803. doi: 10.1200/JCO.2005.04.937.
6. Yamaguchi K, Tada M, Horikoshi N, Otani T, Takiuchi H, Saitoh S et al. Phase II study of paclitaxel with 3-h infusion in patients with advanced gastric cancer. Gastric Cancer. 2002 Jun;5(2):90-5. doi: 10.1007/s101200200015.
7. McGuire WP, Blessing JA, Moore D, Lentz SS, Photopulos G. Paclitaxel has moderate activity in squamous cervix cancer. A Gynecologic Oncology Group study. J Clin Oncol. 1996 Mar;14(3):792-5. doi: 10.1200/JCO.1996.14.3.792.
8. Kim TY, Kim DW, Chung JY, Shin SG, Kim SC, Heo DS et al. Phase I and pharmacokinetic study of Genexol-PM, a cremophor-free, polymeric micelle-formulated paclitaxel, in patients with advanced malignancies. Clin Cancer Res. 2004 Jun 1;10(11):3708-16. doi: 10.1158/1078-0432.CCR-03-0655.
9. Winer EP, Berry DA, Woolf S, Duggan D, Kornblith A, Harris LN et al. Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: cancer and leukemia group B trial 9342. J Clin Oncol. 2004 Jun 1;22(11):2061-8. doi: 10.1200/JCO.2004.08.048.
10. Trimble EL, Adams JD, Vena D, Hawkins MJ, Friedman MA, Fisherman JS et al. Paclitaxel for platinum-refractory ovarian cancer: results from the first 1,000 patients registered to National Cancer Institute Treatment Referral Center 9103. J Clin Oncol. 1993 Dec;11(12):2405-10. doi: 10.1200/JCO.1993.11.12.2405.
11. Saville MW, Lietzau J, Pluda JM, Wilson WH, Humphrey RW, Feigel E et al. Treatment of HIV-associated Kaposi’s sarcoma with paclitaxel. Lancet. 1995 Jul 1;346(8966):26-8. doi: 10.1016/S0140-6736(95)92654-2.
12. Varghese J, Mateti UV, Shetty J, Philip ML, Naga Raju B. Incidence and cost of chemotherapy- induced adverse drug reactions among cancer patients in a charitable hospital. J Rep Pharma Sci [serial online]; 2021.