Abstract 2667
Background
For the past 20 years, the improvement in OS has been achieved in mCRC. Active agents including anti-VEGF and anti-EGFR antibodies have contributed to this progress. Late-line treatment with regorafenib (REGO) or trifluridine/tipiracil (FTD/TPI) has also been demonstrated to be effective and these drugs are widely used as standard CT. However, no study has reported to what extent the availability of these two drugs changes the total OS of patients that is measured from the initiation of first-line CT.
Methods
We retrospectively enrolled consecutive mCRC pts at 3 institutions who received first-line CT between Jan 2005 and Sep 2016. We divided the pts into 3 groups according to the availability of drugs at the initiation of first-line CT; pts who started CT between Jan 2005 and Dec 2006 (cohort A: only cytotoxic drugs were available), between Jan 2007 and Dec 2011 (cohort B: anti-VEGF and anti-EGFR antibody were available), or between Jan 2012 and Sep 2016 (cohort C: REGO and FTD/TPI were available). Treatment outcomes were compared among the cohort A, B, and C.
Results
A total of 1,426 pts were analyzed. Pts characteristics of the cohort A (165 pts), B (626 pts), and C (635 pts) were as follows: median age, 62/64/65 years; ECOG PS ≥ 2, 8.5%/8.8%/8.2%; right-sided primary, 26.1%/29.4%/29.9%; tumor grade Grade 3, 10.1%/13.1%/11.9%; KRAS mutation, 28.6%/38.4%/41.1%; and number of metastatic sites ≥2, 63.6%/61.3%/58.1%. In the cohort A, B, and C, 1.2%, 10.7%, and 31.2% of the pts received at least one of late-line treatment with REGO or FTD/TPI. Median OS of the cohort A, B, and C was 18.6 month (M), 25.3 M, and 27.2 M. Hazard ratio (HR) of death was 0.82 (95% confidential interval [CI], 0.68-0.98; p = 0.0309) for the cohort B vs A, and 0.71 (95% CI, 0.59-0.86; p = 0.0004) for the cohort C vs A, and 0.87 (95% CI 0.77-0.99; p = 0.0356) for the cohort C vs B.
Conclusions
This real-world data analysis indicates that late-line treatment with REGO or FTD/TPI could contribute to the prolongation of OS from the initiation of first-line CT for mCRC pts.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
T. Masuishi: Honoraria (self): Taiho Pharmaceutical, Merck Serono, Chugai Pharma, Yakult Honsha, Takeda, Eli Lilly, Bayer Yakuhin, Sanofi; Research grant / Funding (self): Yakult Honsha. Y. Kawamoto: Honoraria (self): Taiho Pharmaceutical, Daiichi Sankyo, Takeda Pharmaceutical, Chugai Pharmaceutical, Merck Biopharma, Eli Lilly. S. Yuki: Honoraria (self): Chugai Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Bristol-Myers Squibb Co., Ltd., Eli Lilly Japan K.K., Bayer Yakuhin Co., Ltd., Taiho Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Sanofi K.K., Pharma International Inc., Yakult H. Y. Komatsu: Honoraria (self): Taiho, Chugai, Yakult, Daiichi Sankyo, Bayer, Merck, Takeda; Research grant / Funding (institution): Taiho, Chugai, Yakult, Daiichi Sankyo, Bayer, Merck, Takeda. K. Muro: Honoraria (self): Takeda, Chugai Pharma, Yakult Honsha, Merck Serono, Taiho Pharmaceutical, Lilly, Ono Pharmaceutical, Bayer; Research grant / Funding (self): Ono Pharmaceutical, MSD, Daiichi Sankyo, Shionogi, Kyowa Hakko Kirin, Gilead Sciences, Merck Serono, Pfizer, Sanofi. T. Yamanaka: Honoraria (self): Chugai, Takeda, Taiho, Boehringer-Ingelheim, Bayer, Pfizer; Advisory / Consultancy: Gilead Sciences, Daiichi-Sankyo, Sysmex, Huya Biosciences; Honoraria (institution): Chugai, Takeda, Taiho, Boehringer-Ingelheim, Bayer, Daiichi-Sankyo, Ono, Merck Serono, Astellas, Eli Lilly. K. Yamazaki: Honoraria (self): Chugai Pharma, Daiichi Sankyo, Yakult Honsha, Takeda, Bayer, Merck Serono, Bristol-Myers Squibb Japan, Taiho Pharmceutical, Lilly, Sanofi, Ono Pharmaceutical, MSD; Research grant / Funding (institution): Taiho Pharmaceutical. All other authors have declared no conflicts of interest.
Resources from the same session
5203 - Novel fusion genes identified from matched primary and recurred breast cancers by RNA-sequencing
Presenter: Soojeong Choi
Session: Poster Display session 2
Resources:
Abstract
5873 - Association between PIK3CA mutation status and development of brain metastases in HR+/HER2- metastatic breast cancer
Presenter: Donna Fitzgerald
Session: Poster Display session 2
Resources:
Abstract
3588 - The role of AXL as mechanism of resistance to trastuzumab and a prognostic factor in breast cancer HER2 positive: a translational approach.
Presenter: Anna Adam-Artigues
Session: Poster Display session 2
Resources:
Abstract
5640 - Untargeted assessment of tumor fractions in plasma for monitoring and prognostication from metastatic breast cancer patients undergoing systemic treatment
Presenter: Marija Balic
Session: Poster Display session 2
Resources:
Abstract
2616 - Clinical application of mutational analysis in breast cancer patients: the relevance of PIK3CA analysis for precision medicine.
Presenter: Juan Miguel Cejalvo
Session: Poster Display session 2
Resources:
Abstract
3870 - A retrospective gene expression analysis of surgically-removed Breast Cancer Brain Metastasis (BCBM)
Presenter: Meritxell Mallafré-Larrosa
Session: Poster Display session 2
Resources:
Abstract
1240 - Endocrine therapy alone versus targeted combination strategy as first line treatment in elderly patients with hormone receptor-positive advanced breast cancer: meta-analysis of Phase II and III randomized clinical trials
Presenter: Claudia Omarini
Session: Poster Display session 2
Resources:
Abstract
5535 - Alpelisib (ALP) + fulvestrant (FUL) for patients with hormone receptor–positive (HR+), HER2− advanced breast cancer (ABC): management and time course of key adverse events of special interest (AESIs) in SOLAR-1
Presenter: Hope Rugo
Session: Poster Display session 2
Resources:
Abstract
3093 - Changes in Hormone-Receptor status in Luminal breast cancers between primary tumor and metastases: results of the observational cohort GIM-13 AMBRA Study
Presenter: Marina Cazzaniga
Session: Poster Display session 2
Resources:
Abstract
1378 - MONARCH 3: Updated time to chemotherapy and disease progression following abemaciclib plus aromatase inhibitor (AI) in HR+, HER2- advanced breast cancer (ABC)
Presenter: Miguel Martín
Session: Poster Display session 2
Resources:
Abstract