Abstract 3500
Background
Chemotherapy is associated with a survival benefit in advanced gastric cancer. Several options exist, including EOX. The regimen docetaxel, cisplatin and 5-fluorouracil (DCF) is toxic and modifications have been developed. In our institution CTX was a standard treatment from 2004 to 2012 when it was replaced by EOX. Afterwards, a randomised trial with CTX was conducted.
Methods
SEED was a prospective, single-center, phase 2 trial in unresectable HER2-negative esophagogastric adenocarcinoma. Patients were randomised to either docetaxel 60 mg/m2, carboplatin AUC5 and capecitabine 1000 mg/m2 bd for 14 days q4w (CTX) or epirubicin 50 mg/m2, oxaliplatin 130 mg/m2 and capecitabine 625 mg/m2 bd for 21 days q3w (EOX). Treatment continued until progression, intolerance or a maximum of 9 cycles. The primary endpoint was 1-year-survival for patients treated with CTX. The trial sought to accept (lower boundary 55%) or reject (higher boundary 40%) CTX for further study without making direct comparisons to EOX. Secondary endpoints included OS, PFS and grade 3/4 toxicities.
Results
From 2014 to 2019 a total of 98 patients were randomised (49 in each arm). The median age was 63 (36 - 79). Male/female: 79/19; ECOG PS (0/1): 46/52; oesophageal/GEJ/gastric: 29/44/25; metastatic/non-metastatic: 96/2. As of 26 April 2019, 85 patients had died. The estimated 1-year survival was 32% (95% CI 19 - 46) for CTX and 39% (95% CI 25 - 52) for EOX. The median PFS and OS was 6.2 months (95% CI 5.2 - 7.2) and 9.2 months (95% CI 7.2 - 11.2), respectively, for CTX, and 5.2 months (95% CI 3.5 - 7.0) and 10.2 months (95% CI 7.9 - 12.4), respectively, for EOX. Grade 3/4 related toxicities in > 5% were neutropenia (78%), febrile neutropenia (25%), diarrhoea (8%) and fatigue (6%) for CTX, and neutropenia (49%), febrile neutropenia (10%), peripheral neuropathy (8%) and nausea (8%) for EOX. There were no treatment-related deaths.
Conclusions
CTX resulted in a 1-year-survival rate of 32% and so is rejected for further study. Also, CTX had a high rate of febrile neutropenia. CTX is not recommended for patients with esophagogastric cancer, except selected patients intolerant of other standard therapies, and then only with G-CSF support.
Clinical trial identification
NCT02177552.
Editorial acknowledgement
Legal entity responsible for the study
Lene Baeksgaard.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
2674 - Multicenter Phase I Trial of Trastuzumab Emtansine (T-DM1) in Combination with Non-Pegylated Liposomal Doxorubicin (NPLD) in HER2[+] Metastatic Breast Cancer (MBC). THELMA Study
Presenter: Elena López-Miranda
Session: Poster Display session 2
Resources:
Abstract
1398 - Phase 1 study of liposomal formulation of eribulin (E7389-LF) in patients (pts) with advanced solid tumors: primary results of dose-escalation part
Presenter: Noboru Yamamoto
Session: Poster Display session 2
Resources:
Abstract
5818 - Polo-like Kinase 1 inhibitor onvansertib synergizes with paclitaxel in breast cancer carrying p53 mutation
Presenter: Antonio Giordano
Session: Poster Display session 2
Resources:
Abstract
5927 - Phase 1b study of heat shock protein 90 inhibitor, onalespib in combination with paclitaxel in patients with advanced, triple negative breast cancer (NCT02474173).
Presenter: Robert Wesolowski
Session: Poster Display session 2
Resources:
Abstract
1695 - Impact of pertuzumab and T-DM1 on prognosis of HER2-positive metastatic breast cancer (MBC) and factors affecting their efficacy: results from the AGMT_MBC-Registry
Presenter: Simon Peter Gampenrieder
Session: Poster Display session 2
Resources:
Abstract
1742 - Clinical profile and outcome of HER2 positive breast cancer patients with brain metastases treated with HER2 targeted therapy: Real world experience.
Presenter: Prabhat Bhargava
Session: Poster Display session 2
Resources:
Abstract
1846 - Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer: results of single arm phase IV COMACHI study
Presenter: Norikazu Masuda
Session: Poster Display session 2
Resources:
Abstract
5385 - Anti HER-2 Therapies and Left Ventricular Dysfunction The Renaissance Study
Presenter: ANDRES DANIELE
Session: Poster Display session 2
Resources:
Abstract
3320 - Safety and efficacy of T-DM1 in 128 patients with advanced HER2+ breast cancer: The Royal Marsden experience.
Presenter: Nicolò Battisti
Session: Poster Display session 2
Resources:
Abstract
4540 - Use of trastuzumab emtansine (T-DM1; K) after pertuzumab + trastuzumab (PH) in patients with HER2-positive metastatic breast cancer (mBC): challenges in assessing effectiveness of treatment sequencing in the real world (RW)
Presenter: Thibaut Sanglier
Session: Poster Display session 2
Resources:
Abstract