Abstract 4479
Background
Gemcitabine with platinum is regarded as the standard of care in patients with unresectable and/or metastatic disease with good performance status (PS). There is no standard of care for poor PS patients. A report from M.D.A.C.C. stated a median OS of only one month in GBC patients with poor PS. Erlotinib and capecitabine, both have shown efficacy in metastatic GBC. There has been no RCT to date in GBC patients with poor PS. With limited data showing the activity of erlotinib and capecitabine, we conducted this RCT to evaluate the efficacy and toxicity of these drugs in this patient cohort.
Methods
This is an ongoing open-label, phase II/III RCT (phase II part of the study is complete).The primary objective is to determine if erlotinib (150 mg/d PO )+ BSC or capecitabine (625 mg/m2 BD PO) + BSC has an OS benefit compared to BSC alone in patients with unresectable/metastatic GBC with ECOG PS III. A total of 51 patients with histopathologically confirmed GBC, age >/=18 years, with adequate organ functions (S. bilirubin < = 3.5 g/dl, AST/ALT within 5 times the normal limit and eGFR > 50 ml/min/1.73m2) were randomised. Patients were followed up q2wk in first month and q4wk thereafter. Toxicity was assessed using CTCAE v4.1. Radiological response evaluation (as per RECIST v1.1) was done at 8-10 weeks/earlier if clinically indicated, QoL assessment (using EORTC QLQ-C30 BIL21 ) was done at baseline and at 6-8 weeks. Intervention was continued until progression/unacceptable toxicity. Serial evaluation for OS in all three arms was done. Initially the study was started as a phase II RCT, an interim pre-planned analysis was done after completion of phase II.
Results
The median OS in capecitabine +BSC arm (n = 19) was 209 days, relotinib +BSC arm(n = 14) was 105 days and BSC alone arm was 71 days (p value 0.022). Only 2 patients had grade III diarrhea with erlotinib. There were no drug-related SAEs.
Conclusions
There is a statistically significant OS benefit of capecitabine+BSC or erlotinib+BSC over BSC alone in unresectable/metastatic GBC patients with ECOG PS III. Results will be updated upon completion of phase III.
Clinical trial identification
CTRI/2019/04/018860.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
All India Institute of Academic Sciences.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1058 - Assessment of CPS+EG, Neo-Bioscore and modified Neo-Bioscore in breast cancer patients treated with preoperative systemic therapy: a multicenter cohort study
Presenter: LING XU
Session: Poster Display session 2
Resources:
Abstract
1156 - The concordance of treatment decision guided by Oncotype and the PREDICT tool in early stage breast cancer
Presenter: Hadar Goldvaser
Session: Poster Display session 2
Resources:
Abstract
3447 - Influence of first treatment delay on survival among breast cancer subtypes
Presenter: Irene Zarcos Pedrinaci
Session: Poster Display session 2
Resources:
Abstract
3505 - Clinical features of early-stage (I-III) triple-negative breast cancer (TNBC) patients with tumors exhibiting low-overall change in molecular profile after neoadjuvant therapy.
Presenter: Nour Abuhadra
Session: Poster Display session 2
Resources:
Abstract
5442 - Meta-analysis in HER2+ early breast cancer therapies and cost-effectiveness in a Brazilian perspective
Presenter: Marcos Magalhaes
Session: Poster Display session 2
Resources:
Abstract
1570 - Anti-mullerian hormone (AMH) levels and antral follicle counts (AFC) may predict ovarian reserves before systemic chemotherapy (SC) in women with breast cancer(BC); a prospective clinical study
Presenter: Cetin Ordu
Session: Poster Display session 2
Resources:
Abstract
2698 - Prognosis of selected triple negative apocrine breast cancer patients who did not receive adjuvant chemotherapy.
Presenter: Giuseppe Cancello
Session: Poster Display session 2
Resources:
Abstract
3104 - Novel Blood Based Circulating Tumor Cell Biomarker For Breast Cancer Detection
Presenter: Chun-Yu Liu
Session: Poster Display session 2
Resources:
Abstract
4631 - Multi-Gene Prognostic Signatures and Prediction of Pathological Complete Response of ER-Positive HER2-Negative Breast Cancer Patients to Neo-Adjuvant Chemotherapy
Presenter: Claudia Mazo
Session: Poster Display session 2
Resources:
Abstract
4632 - Impact of menopause status on breast cancer outcomes and amenorrhea incidence during adjuvant tailored dose dense chemotherapy
Presenter: Andri Papakonstantinou
Session: Poster Display session 2
Resources:
Abstract