Abstract 3240
Background
TAGS, a randomised, double-blind, phase III study, showed that FTD/TPI significantly improved overall survival (OS) and progression-free survival (PFS) compared with placebo in heavily pretreated mGC patients (pts) receiving best supportive care. The aim of this analysis was to evaluate the effects of FTP/TPI in the European subpopulation of TAGS.
Methods
TAGS enrolled pts with histologically confirmed, non-resectable mGC, Eastern Cooperative Oncology Group (ECOG) performance status 0/1, and ≥2 prior chemotherapy regimens. Pts were randomised 2:1 to FTD/TPI (35 mg/m2 BID on days 1–5 and 8–12 every 28 days) or placebo. Primary endpoint was OS. Secondary endpoints included PFS, time to deterioration (TTD) of ECOG and safety; 507 pts were randomised to FTD/TPI (n = 337) or placebo (n = 170). Median follow-up was 10.7 months.
Results
277 pts (mean age 63.0 years; 75% male) were enrolled from 64 sites in Europe. Baseline characteristics were balanced between groups; 120 (67%) and 63 (65%) of pts in FTD/TPI and placebo groups had received ≥3 regimens of prior systemic therapy. FTP/TPI significantly prolonged OS (hazard ratio [HR] 0.59, 95% confidence interval [CI] 0.44-0.78), PFS (HR 0.46, 95% CI 0.35–0.61) and TTD to ECOG (HR 0.59, 95% CI 0.45–0.78; Table) compared with placebo. FTD/TPI had a predictable and manageable safety profile. Treatment-emergent adverse events (TEAEs) were reported in 172/180 (96%) FTD/TPI-treated and 92/97 (96%) placebo-treated pts. Efficacy and safety in European population of TAGS.Table:
801P
FTD/TPI | Placebo | HR (95% CI) | P-value (2-sided) | |
---|---|---|---|---|
(n = 180) | (n = 97) | |||
Efficacy outcomes, median (95% CI) | ||||
OS | 5.45 (4.34– 6.21) | 3.15 (2.43– 3.58) | 0.59 (0.44– 0.78) | 0.0002 |
PFS | 1.94 (1.91– 2.50) | 1.77 (1.74– 1.87) | 0.46 (0.35– 0.61) | <0.0001 |
TTD of ECOG | 3.84 (2.89– 4.50) | 2.10 (1.87– 2.53) | 0.59 (0.45– 0.78) | 0.0001 |
TEAEs, n (%) | ||||
Any | 172 (96.1) | 92 (95.8) | ||
Serious | 79 (44.1) | 49 (51.0) | ||
Grade ≥3 | 143 (79.9) | 62 (64.6) | ||
Treatment-related | 140 (78.2) | 55 (57.3) | ||
Leading to dose modification | 107 (59.8) | 26 (27.1) | ||
Leading to treatment discontinuation | 24 (13.4) | 19 (19.8) | ||
Leading to death | 19 (10.6) | 14 (14.6) |
Conclusions
FTD/TPI was effective and well tolerated in European patients, consistent with the overall population of TAGS.
Clinical trial identification
NCT02500043.
Editorial acknowledgement
Simone Tait of Springer Healthcare Communications, funded by Institut de Recherches Internationales Servier.
Legal entity responsible for the study
Taiho Oncology and Taiho Pharmaceutical.
Funding
Taiho Oncology and Taiho Pharmaceutical.
Disclosure
M. Alsina: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Laboratoire Servier; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Travel / Accommodation / Expenses: Lilly; Honoraria (self), Travel / Accommodation / Expenses: Roche; Honoraria (self), Travel / Accommodation / Expenses: Amgen; Travel / Accommodation / Expenses: Merck. J. Tabernero: Advisory / Consultancy: Amgen; Advisory / Consultancy: Bayer; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: Celgene; Advisory / Consultancy: Chugai Pharma; Advisory / Consultancy: Lilly; Advisory / Consultancy: MSD; Advisory / Consultancy: Merck Serono; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Roche; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Symphogen; Advisory / Consultancy: Taiho pharmaceutical; Advisory / Consultancy: Takeda; Advisory / Consultancy: Genentech/Roche; Advisory / Consultancy: Array Biopharma; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: BeiGene; Advisory / Consultancy: Servier. M. Squadroni: Research grant / Funding (self): Taiho Pharmaceutical; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Ipsen. T. Doi: Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Chugai Pharma; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Kyowa Hakko Kirin; Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Daiichi Sankyo; Advisory / Consultancy, Speaker Bureau / Expert testimony: Amgen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Sumitomo Dainippon; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Taiho Pharmaceutical; Research grant / Funding (self): Novartis; Research grant / Funding (self): Merck Serono; Research grant / Funding (self): Astellas Pharma; Research grant / Funding (self): MSD; Research grant / Funding (self): Janssen; Research grant / Funding (self): Boehringer Ingelheim; Research grant / Funding (self): Takeda; Research grant / Funding (self): Pfizer; Research grant / Funding (self): Lilly; Research grant / Funding (self): Celgene; Research grant / Funding (self): BMS; Research grant / Funding (self): AbbVie; Research grant / Funding (self): Quintiles. C. Faustino: Honoraria (self), Advisory / Consultancy: Merck Serono; Honoraria (self): Astellas; Honoraria (self), Advisory / Consultancy: Servier. K. Shitara: Honoraria (self), Honoraria (institution), Advisory / Consultancy: Astellas Pharma; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Travel / Accommodation / Expenses: Lilly; Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Takeda; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Honoraria (institution), Advisory / Consultancy: Ono Pharmaceutical; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: AbbVie; Honoraria (self): Yakult; Honoraria (institution): Dainippon Sumitomo Pharma; Honoraria (institution): Daiichi Sankyo; Honoraria (institution): Taiho Pharmaceutical; Honoraria (institution): Chugai Pharma; Honoraria (self), Honoraria (institution), Advisory / Consultancy: MSD; Honoraria (institution): Medi Science. E. Van Cutsem: Research grant / Funding (self): Amgen; Research grant / Funding (self): Bayer; Research grant / Funding (self): Boehringer Ingelheim; Research grant / Funding (self): Celgene; Research grant / Funding (self): Ipsen; Research grant / Funding (self): Lilly; Research grant / Funding (self): Merck; Research grant / Funding (self): Merck KgA; Research grant / Funding (self): Novartis; Research grant / Funding (self): Roche; Research grant / Funding (self): Sanofi; Research grant / Funding (self): Servier. N. Causse-Amellal: Full / Part-time employment: Laboratoire Servier. C. LEGER: Full / Part-time employment: Laboratoire Servier. D. Skanji: Full / Part-time employment: Laboratoire Servier. All other authors have declared no conflicts of interest.
Resources from the same session
3034 - Efficacy and safety of neoadjuvant chemotherapy plus trastuzumab and pertuzumab in non-metastatic HER2-positive breast cancer in real life: NEOPEARL STUDY
Presenter: Maria Agnese Fabbri
Session: Poster Display session 2
Resources:
Abstract
4772 - Real world comparison of the impact of adjuvant capecitabine in women with high-risk triple-negative breast cancer after neoadjuvant chemotherapy
Presenter: Maysa Vilbert
Session: Poster Display session 2
Resources:
Abstract
5627 - Influence of age on the indication of adjuvant chemotherapy in early breast cancer using Oncotype DX. An analysis of 240 patients treated in the Institut Catala d’Oncologia (ICO) hospitals
Presenter: Sabela Recalde
Session: Poster Display session 2
Resources:
Abstract
3917 - Impact of delayed neoadjuvant systemic chemotherapy on survival among breast cancer patients
Presenter: Mariana Chavez Mac Gregor
Session: Poster Display session 2
Resources:
Abstract
2246 - Clinical Confirmation of Higher Exposure to Niraparib in Tumor vs Plasma in Patients With Breast Cancer
Presenter: Laura Spring
Session: Poster Display session 2
Resources:
Abstract
581 - The rationale for the effectiveness of systemic treatment of breast cancer depending on the body weight index
Presenter: Mohammad Hojouj
Session: Poster Display session 2
Resources:
Abstract
5327 - Response to neoadjuvant chemotherapy in HER2 non-overexpressing breast cancer subtypes
Presenter: Silvia Mihaela Ilie
Session: Poster Display session 2
Resources:
Abstract
3613 - Pre-specified interim analysis of the SAFE trial (NCT2236806): a 4-arm randomized, double-blind, controlled study evaluating the efficacy and safety of cardiotoxicity prevention in non-metastatic breast cancer patients treated with anthracyclines with or without trastuzumab.
Presenter: Lorenzo Livi
Session: Poster Display session 2
Resources:
Abstract
3736 - Safety of hypofractionated whole breast irradiation after conservative surgery for patients aged less than 60 years: a multi-center comparative study.
Presenter: Icro Meattini
Session: Poster Display session 2
Resources:
Abstract
5085 - Usefulness of NT-ProBNP as a biomarker of cardiotoxicity in breast cancer patients treated with trastuzumab
Presenter: Isabel Blancas López-Barajas
Session: Poster Display session 2
Resources:
Abstract