Toxicity profile of Doxorubicin-Cyclophosphamide and Doxorubicin-Cyclophosphamide followed by Paclitaxel regimen and its associated factors among women with breast cancer in Ethiopia: A prospective cohort study.

Abstract

Management of patients with breast cancer undergoing chemotherapy is complicated by a very high rate of adverse drug reactions which is even more challenging in developing countries like Ethiopia where the toxicity profile of chemotherapy is lacking. The present study aimed at evaluating the toxicity profile of Doxorubicin-Cyclophosphamide (AC) and Doxorubicin-Cyclophosphamide→Paclitaxel (AC→T) regimens among 146 patients with breast cancer in Ethiopia. This prospective cohort study, with the median of six months' follow-up, was conducted from January 1 to September 30, 2017 GC at the only nationwide oncology center, Tikur Anbessa Specialized Hospital (TASH), Addis Ababa, Ethiopia. Seventy-one patients received AC, while 75 received AC-T regimen. The toxicity with the highest grade during any cycle was considered as the toxicity grade for that patient. SPSS version 22 was used for analysis. The overall frequent non-hematological adverse drug reactions reported for both regimens were fatigue 144 (98.7%), dysgeusia 142 (97.3%), skin hyperpigmentation 141 (96.6%), nausea 136 (93.2%), vomiting 129 (88.4%), gastritis 122 (83.6%), peripheral neuropathy 108 (74%), and myalgia/arthralgia 110 (75.3%). Neutropenia 107 (73.3%), leukopenia 102 (69.9%), and anemia 51 (34.9%) were the most frequent overall grade hematological toxicities reported. However, those received AC regimen suffered more from grade 2 and above leukopenia (35.2% vs. 17.3%, P = 0.014), anemia (16.9% vs. 2.7%, P = 0.004), and alkaline phosphatase increment (11.3% vs. 2.7%, P = 0.039) than AC-T regimen. On the contrary, those received AC-T regimen suffered more from severe arthralgia/myalgia (2.8% vs. 2%, P = 0.001), peripheral neuropathy (1.4% vs. 36%, P = 0.000), and gastritis (14.1% vs. 29.3%, P = 0.026) than AC regimen. Pretreatment blood cell counts, having stage IV breast tumor, older age, and lower body surface area were significant predictors of grade 2 to above hematological toxicities. Older age, arthralgia/myalgia, and skin hyperpigmentation occurred during the cohort were significant predictors of grade 2 to above oral mucositis, peripheral neuropathy, and fatigue, respectively. Patients who received the AC regimen suffered more from hematological abnormalities, while those on the AC-T regimen experienced more of non-hematological toxicities. Overall, we report high incidences of AC and AC-T regimens-induced toxicities in Ethiopian women with breast cancer, and they may require prior support based on pretreatment blood counts, age and body surface area, and close follow-up during chemotherapy.