ASSESSMENT OF TOXICITY OF NEOADJUVANT CHEMOTHERAPY FOR LOCALLY ADVANCED BREAST CANCER
Introduction. In the structure of malignancies in women breast cancer (BC) takes 1st place. In locally advanced breast cancer (LABC) treatment begins with neoadjuvant chemotherapy (CTX), the standard protocols are CMF, FAC, AC. In the trial, we used cytostatic Arglabin isolated from plants endemic to Central Kazakhstan - wormwood smooth, as monotherapy and as addition to AC-protocol.
The objective of the trial - to assess the toxicity of different protocols of neoadjuvant CTX of LABC.
Methods: 93 patients with LABC (T2N1-2M0, T3N0-2M0) at the age from 35 to 75 years were included in the trial. With 2 stage - 60 patients, with the third stage - 33 patients. All patients were randomized into 3 groups: The control group (n=36) received 4 courses of neoadjuvant chemotherapy according to AC-protocol (doxorubicin 50 mg/m 2 , cyclophosphan-500 mg/m 2 on day 1, repeated every three weeks) followed by radical mastectomy, 4 courses of adjuvant chemotherapy (АС), radiotherapy and hormone therapy if indicated. Investigative group 1 (n=30) received the same CTX but in combination with Arglabin at a dose of 370 mg/m 2 for 7 days. Investigative group 2 (n=27) received Arglabin as monotherapy.
Evaluation of hematological toxicity was performed according to WHO recommendations after 4 cycles of chemotherapy. Statistical processing was performed by methods of parametric statistics to estimate the significance of differences (Student's performance) between the control and test groups. Statistical analysis was used mathematical statistics procedures, implemented in applications «STATISTICA 10" and EXCEL.
Results. The most severe hematologic toxicity was in the control group receiving chemotherapy according to AC-protocol, neutropenia was observed at (19,5 ± 3,3)% of patients; patients receiving AC-protocol + Arglabin, - (10,8 ± 2,8)%; patients receiving Arglabin only - (0,9 ± 0,9)%.
Anemia I degree detected in patients of the control group and the test group 1, it was observed in (5,6 ± 1,9)% and (5,0 ± 2,0)%, respectively, and less pronounced in patients of the study group 2 (19 ± 1,3%). Thrombocytopenia I degree is expressed in patients of all groups equally with low rates.
Conclusion: Arglabin do not cause neutropenia. Addition of Arglabin to AC-protocol causes a leveling of the toxic effect CTX protocols.
Yuriy M. Fomenko 1, http://orcid.org/0000-0002-7693-4171
Valentina B. Sirota 1, http://orcid.org/0000-0001-6777-6864
Gaukhar Kh. Tuleuova 2, http://orcid.org/0000-0003-2069-0750
Nailya A. Kabildina 1, http://orcid.org/0000-0002-5616-1829
Regina A. Nurseitova 1, http://orcid.org/0000-0001-7627-6124
1 Karaganda State Medical University, Karaganda, Kazakhstan
2 International research and production holding “Phytochemistry”, Karaganda, Kazakhstan
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