Abstract 3183
Background
Elderly patients often cannot tolerate the usual combination of two cytotoxic agents. Recently, bevacizumab plus trifluridine/tipiracil (FTD/TPI) was shown to be a good candidate regimen for vulnerable patients. We aimed to assess the efficacy and safety of bevacizumab plus FTD/TPI in elderly patients with metastatic colorectal cancer.
Methods
Patients aged 70 years or older, with previously untreated unresectable, metastatic colorectal cancer, who were not deemed to be candidates for oxaliplatin-based or irinotecan-based chemotherapy regimens, were included in this trial. The treatment consisted of FTD/TPI (35 mg/m2, twice daily on Days 1–5 and Days 8–12) with bevacizumab (5mg/kg intravenously on Day 1 and 15), administrated every 4 weeks until disease progression. The primary endpoint was progression-free survival (PFS). Based on a previous report, we estimated the expected PFS as 9 months and the lower limit of interest as 5 months. As this research was designed to have a statistical power of 80% and one-sided type I error of 0.10, we calculated that 32 patients were required and planned enrolling 35 patients. The secondary endpoints were response rate (ORR), overall survival (OS), and adverse events (AEs).
Results
Between 2017 January and 2018 March, 39 patients (17 male; 22 female), with a median age of 77.5 years (range: 70–88), ECOG performance status 0 (79.5%) or 1 (20.5%), and RAS WT/MT/Unknown 23.1/41.0/35.9% were enrolled. The median PFS was 8.0 months (80% CI 6.7–11.2), and the median OS was not reached. The best response was 40.5% (15/37; 95% CI: 24.8–57.9), and the disease control rate was 86.5% (32/37; 95% CI: 71.2–95.5). The most frequently occurring grade 3 or 4 AEs were neutropenia (71.8%), leucopenia (48.7%), hypertension (20.5%), anemia (17.9%), anorexia (12.8%), febrile neutropenia (10.3%), and fatigue (10.3%). No treatment-related deaths occurred.
Conclusions
In this Phase 2 KSCC 1602 trial of bevacizumab plus FTD/TPI, the primary endpoint of PFS was achieved. This combination therapy showed favorable survival outcomes with an acceptable safety profile for elderly patients with previously untreated metastatic colorectal cancer.
Clinical trial identification
UMIN000025241.
Editorial acknowledgement
Legal entity responsible for the study
Kyushu Study group of Clinical Cancer.
Funding
Taho Pharmaceutical.
Disclosure
A. Makiyama: Advisory / Consultancy, Speaker Bureau / Expert testimony: Eli Lily Pharmaceutical; Speaker Bureau / Expert testimony: Chugai Pharmaceutical; Speaker Bureau / Expert testimony: Taiho Pharmaceutical; Speaker Bureau / Expert testimony: Takeda Pharmaceutical. M. Kotaka: Honoraria (self): Yakult Honsya; Honoraria (self): Chugai pharmaceutical. H. Baba: Research grant / Funding (institution): Taiho pharmaceutical; Research grant / Funding (institution): Chugai pharmaceutical. M. Mori: Research grant / Funding (institution): Taiho Pharmaceutical Co, Ltd. All other authors have declared no conflicts of interest.
Resources from the same session
1619 - Meta-analysis of KRAS Mutation as prognostic factor in patients (pts.) with resection of colorectal (CRC) liver metastases: Tumor burden and Sideness analysis.
Presenter: Maria Romina Luca
Session: Poster Display session 2
Resources:
Abstract
2104 - Clinical implications of regorafenib-induced hypothyroidism in metastatic colorectal cancer refractory to standard therapies: A prospective evaluation
Presenter: Jwa Hoon Kim
Session: Poster Display session 2
Resources:
Abstract
2143 - Clinical impact of BRAF V600E mutations in patients (pts) with resectable solitary colorectal liver metastases (CRLM)
Presenter: Shin Kobayashi
Session: Poster Display session 2
Resources:
Abstract
3136 - Trifluridine/tipiracil in metastatic colorectal cancer: an updated multicentre real-world analysis on efficacy, safety and predictive factors.
Presenter: Chara Stavraka
Session: Poster Display session 2
Resources:
Abstract
4234 - Correlation between p53 expression and clinical outcome in RAS/BRAF wild type metastatic colorectal cancer patients receiving later-line irinotecan-cetuximab
Presenter: Eleonora Lai
Session: Poster Display session 2
Resources:
Abstract
4287 - Safety and effectiveness of aflibercept + FOLFIRI for the treatment of patients with metastatic colorectal cancer (mCRC): OZONE secondary analyses
Presenter: Ian Chau
Session: Poster Display session 2
Resources:
Abstract
1820 - A Phase Ib study of the safety and efficacy of atezolizumab (atezo) + bevacizumab (bev) + cobimetinib (cobi) in patients (pts) with metastatic colorectal cancer (mCRC)
Presenter: Johanna Bendell
Session: Poster Display session 2
Resources:
Abstract
5644 - Development and validation of a metastasis-associated immune prognostic model for concurrent metastatic colorectal cancer
Presenter: Zhiwen Luo
Session: Poster Display session 2
Resources:
Abstract
5697 - Prognostic role of blood cell count-based immuno-inflammatory parameters in the Valentino trial
Presenter: Giovanni Fuca
Session: Poster Display session 2
Resources:
Abstract
4704 - Evaluation of safety, immunogenicity and preliminary efficacy of PolyPEPI1018 vaccine in subjects with metastatic colorectal cancer (mCRC) with a predictive biomarker
Presenter: Joleen Hubbard
Session: Poster Display session 2
Resources:
Abstract