Adverse Drug Reactions in Non-Metastatic Breast Cancer Patients Treated with Anthracycline-Taxane and +/- Carboplatin and/or +/- Trastuzumab-based Regimens: A Prospective Cohort Study from Tertiary Care Teaching Hospital, South India

Background and objectives: Chemotherapy is the standard treatment for Nonmetastatic breast cancer. All the chemotherapeutic agents are capable of producing various Adverse Drug Reactions (ADR) in heterogeneous organs of the body. In this prospective cohort study, we assessed whether ADRs from three different chemotherapy regimens varies in patients with Non-metastatic breast cancer. Methods: Patients who satisfied eligibility criteria were enrolled and divided into three groups based on the chemotherapy regimen they had taken. The patients who received doxorubicin and cyclophosphamide (AC) followed by Docetaxel (T) were assigned to group AC-T, those who received AC followed by Docetaxel and carboplatin (Cb) were in group AC-TCb and those who received AC followed by Docetaxel and Trastuzumab (H) were assigned to group AC-TH. ADR reported by patients as well as from laboratory reports were Graded as per NCI CTCAE guidelines. Result and discussion: A total of 190 patients were enrolled of which, 84 patients (44.2%) received AC-T, 52 (27.4%) AC-TCb and 54 (28.4%) AC-TH regimen. Among thirteen system organ classification studied, general disorder was statistically significant (P value=0.012). Grade 3/4 hand-foot syndrome was present in 3 subjects from AC-T and 1 from AC-TCb. Vomiting, Grade 4 type was 1 from AC-T and AC-TCb had. One from AC-TCb had constipation, Grade 3. Mucositis Grade 4 type was observed from both AC-T and AC-TCb. One from AC-TCb had diarrhea, Grade 3. Although hematological reactions were a few but most of them belongs to severe type. 3 from AC-T, 1 from AC-TCb and 2 from AC-TH had anemia, Grade 3/4. 9 subjects from AC-T, 5 from AC-TCb and 4 from AC-TH had febrile neutropenia, Grade 3/4. 19 subjects from AC-T, 12 from AC-TCb and 11 from ACTH had neutropenia, Grade 3/4. 14 subjects from AC-T, 8 from AC-TCb and 7 from AC-TH had insomnia, Grade 3/4. One subject from AC-T had hearing impaired, Grade 4. Conclusion: All regimens tolerated by the subjects reasonably very well with majority of adverse effects were mild. Severe (Grade 3 or 4) adverse effects were rare.

Author(s): Faheema Kandoth, Sreejith K and Dinesan M

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