101P - Neoadjuvant chemotherapy for locally advanced breast cancer

Date 18 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Cytotoxic agents
Breast Cancer, Locally Advanced
Presenter Yuriy Fomenko
Citation Annals of Oncology (2016) 27 (suppl_9): ix30-ix34. 10.1093/annonc/mdw576
Authors Y. Fomenko1, V. Sirota1, U. Bitz2, S. Zhumakaeva1, I. Omarova3, N. Kabildina1
  • 1Department Of Oncology, Karaganda State Medical Academy, 100008 - Karaganda/KZ
  • 2Klinik Für Hämatologie, Onkologie Und Tumorimmunologie, Helios Klinikum Berlin Buch, 13125 - Berlin/DE
  • 3Department Of Chemotherapy, Karaganda Regional Cancer Center, 100000 - Karaganda/KZ

Abstract

Background

Neoadjuvant chemotherapy (CTX) is a standard therapy in locally advanced breast cancer. Arglabin is a sesquiterpene gamma-lactone isolated from Artemisia glabella, a species of wormwood endemic to the Karaganda region of Kazakhstan.

Methods

93 patients with locally advanced breast cancer (T2N1-2M0, T3N0-2M0) at the age from 30 to 75 years were included in the trial. All patients were randomized into 3 groups: The control group (n = 36) received 4 courses of neoadjuvant CTX according to AC-protocol (doxorubicin 50 mg/m2, cyclophosphan-500 mg/m2 on day 1, repeated every three weeks) followed by radical mastectomy, 4 courses of adjuvant chemotherapy (AC), radiotherapy and hormone therapy if indicated. Investigative group 1 (n = 30) received the same chemotherapy but in combination with Arglabin at a dose of 370 mg/m2 for 7 days. Investigative group 2 (n = 27) received Arglabin as monotherapy. Efficacy of the combined treatment was estimated by standard criteria of WHO.

Results

A complete response of a tumor was not observed in any patient. Partial responses were observed in 58,3% of patients in the control group, in 63,3% in investigative group 1 and 25,9% in investigative group 2 (p ≥ 0,05), stable disease was diagnosed in 38,9%, 33,3% and 51,9% (p ≥ 0,05). The axillary lymph node metastasis response in patients after neoadjuvant therapy was 39.6% in the control group, 63.7% in investigative group 1(p ≥ 0,05) and 2,9% in investigative group 2 (p ≤ 0.05). In the control group, tumor regression grade 3 and 4 were 25% of patients, 33.3% were after neoadjuvant chemotherapy AC + Arglabin and 14.8% after Arglabin monotherapy.

Conclusions

Addition of Arglabin to AC-protocol in neoadjuvant chemotherapy does not improve tumor response rates.

Clinical trial indentification

Legal entity responsible for the study

Karaganda State Medical University

Funding

Karaganda State Medical University

Disclosure

All authors have declared no conflicts of interest.