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
5747 - The routine use of sentinel lymph node biopsy in high risk DCIS lesions is not justified
Presenter: Fanny Preat
Session: Poster Display session 2
Resources:
Abstract
1837 - Oncological impact of re-excision for positive margin status after breast conserving surgery in invasive breast cancer
Presenter: Kenjiro Jimbo
Session: Poster Display session 2
Resources:
Abstract
4347 - Pneumonitis and fibrosis after breast cancer radiation.
Presenter: Jarle Karlsen
Session: Poster Display session 2
Resources:
Abstract
2280 - Prognosis of mastectomy with reconstruction after neoadjuvant chemotherapy: a nationwide study in Korean Breast Cancer Society
Presenter: Sungmin Park
Session: Poster Display session 2
Resources:
Abstract
804 - A negative prognosis of radiotherapy-induced lower lymphocyte to monocyte ratio in patients with breast cancer
Presenter: Chang-ik Yoon
Session: Poster Display session 2
Resources:
Abstract
2701 - Patient data to monitor clinical patterns in early and advanced breast cancer in Europe
Presenter: Francesco Giusti
Session: Poster Display session 2
Resources:
Abstract
1437 - A critical appraisal of quality indicators of breast cancer treatment in Belgium
Presenter: Didier Verhoeven
Session: Poster Display session 2
Resources:
Abstract
1534 - Predictors of adherence among post-menopausal women receiving adjuvant endocrine therapy for breast cancer in Ontario, Canada
Presenter: Phillip Blanchette
Session: Poster Display session 2
Resources:
Abstract
4363 - Evaluation of endocrine therapy and patients preferences in early breast cancer: results of Elena study
Presenter: Emilia Montagna
Session: Poster Display session 2
Resources:
Abstract
2679 - Baseline Quality of life (QoL) and chemotherapy related toxicities (CRT) in localized breast cancer (BC) patients (pts): the French multicentric prospective CANTO cohort study
Presenter: Idlir Licaj
Session: Poster Display session 2
Resources:
Abstract