Long Term Real-World Outcomes of Trifluridine/Tipiracil in Metastatic Colorectal Cancer—A Single UK Centre Experience

In the UK, Trifluridine-tipiracil (Lonsurf) is used to treat metastatic colorectal cancer in the third-line setting, after prior exposure to fluoropyrimidine-based regimes. Current data on the real-world use of Lonsurf lack long-term follow-up data. A retrospective evaluation of patients receiving Lonsurf at our Cancer Centre in 2016–2017 was performed, all with a minimum of two-year follow-up. Fifty-six patients were included in the review. The median number of cycles of Lonsurf administered was 3. Median follow-up was 6.0 months, with all patients deceased at the time of analysis. Median progression-free survival (PFS) was 3.2 months, and overall survival (OS) was 5.8 months. The median interval from Lonsurf discontinuation to death was two months, but seven patients received further systemic treatment and median OS gained was 12 months. Lonsurf offered a slightly better PFS but inferior OS to that of the RECOURSE trial, with PFS similar to real-world data previously presented. Interestingly, 12.5% had a PFS > 9 months, and this cohort had primarily left-sided and RAS wild-type disease. A subset received further systemic treatment on Lonsurf discontinuation with good additional OS benefit. Lonsurf may alter the course of disease for a subset of patients, and further treatment on progression can be considered in carefully selected patients.

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Initial experience of TAS-102 chemotherapy in Australian patients with chemorefractory metastatic colorectal cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.3_suppl.71 ◽

2021 ◽

Vol 39 (3_suppl) ◽

pp. 71-71

Author(s):

Azim Jalali ◽

Hui-Li Wong ◽

Rachel Wong ◽

Margaret Lee ◽

Lucy Gately ◽

...

Keyword(s):

Colorectal Cancer ◽

Overall Survival ◽

Febrile Neutropenia ◽

Metastatic Colorectal Cancer ◽

Real World ◽

Performance Status ◽

Progression Free Survival ◽

Median Number ◽

Ecog Performance Status ◽

Number Of Patients

71 Background: For patients with refractory metastatic colorectal cancer (mCRC) treatment with Trifluridine/Tipiracil, also known as TAS-102, improves overall survival. In Australia, TAS-102 was initially made available locally through patients self-funding, later via an industry sponsored Medicine Access Program (MAP) and then via the Pharmaceutical Benefits Scheme (PBS). This study aims to investigate the efficacy and safety of TAS-102 in real world Australian population. Methods: A retrospective analysis of prospectively collected data from the Treatment of Recurrent and Advanced Colorectal Cancer (TRACC) registry was undertaken. The characteristics and outcomes of patients receiving TAS-102 were assessed and compared to all TRACC patients and those enrolled in the registration study (RECOURSE). Results: Across 13 sites, 107 patients were treated with TAS-102 (non-PBS n = 27, PBS n = 80), The median number of patients per site was 7 (range: 1-17). The median age was 60 years (range: 31-83), compared to 67 for all TRACC patients and 63 for RECOURSE. Comparing registry TAS-102 and RECOURSE patients, 75% vs 100% were ECOG performance status 0-1, 74% vs 79% had initiated treatment more than 18 months from diagnosis of metastatic disease and 39% vs 49% were RAS wild type. Median time on treatment was 10.4 weeks (range: 1.7-32). Median clinician assessed progression-free survival was 3.3 compared to RECIST defined PFS of 2 months in RECOURSE study, while median overall survival was the same at 7.1 months. Two patients (2.3%) had febrile neutropenia and there were no treatment-related deaths in the real-world series, where TAS102 dose at treatment initiation was at clinician discretion. In the RECOURSE study there was a 4% febrile neutropenia rate and one treatment-related death. Conclusions: TRACC registry patients treated with TAS102 were younger than both TRACC patients overall and those from the RECOURSE trial. Less strict application of RECIST criteria and less frequent imaging may have contributed to an apparently longer PFS. However overall survival outcomes achieved with TAS102 in real world patients were comparable to findings from this pivotal trial with an acceptable rate of major adverse events.

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Efficacy, safety and prognostic factors in patients with refractory metastatic colorectal cancer treated with trifluridine/tipiracil plus bevacizumab in a real-world setting

10.21203/rs.3.rs-1251622/v1 ◽

2022 ◽

Author(s):

Nieves Martínez-Lago ◽

Teresa Calleja Chucla ◽

Beatriz Alonso de Castro ◽

Rafael Varela Ponte ◽

Cristina Reboredo Rendo ◽

...

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Real World ◽

Progression Free Survival ◽

Efficacy And Safety ◽

Free Survival ◽

Common Grade ◽

Third Line ◽

Grade 3

Abstract We evaluated the efficacy and safety of trifluridine/tipiracil (TAS-102) plus bevacizumab in treating refractory metastatic colorectal cancer (mCRC) in a retrospective, observational study. Patients refractory or intolerant to standard therapies received TAS-102 (30–35 mg/m2 twice daily on days 1–5 and days 8–12 every 28 days) plus bevacizumab 5 mg/kg on days 1 and 15. Clinical and pathological characteristics, overall response rate (ORR) and disease control rate (DCR), overall survival (OS) and progression-free survival (PFS) data were collected and analysed. Thirty-five patients were treated from July 2019 to October 2021 (median age 64 years). The majority of patients (68.6%) were receiving TAS-102 plus bevacizumab as third-line treatment. Patients received a median of 4 (range 2–15) cycles of treatment. Among 31 patients evaluable for response (88.6%), ORR and DCR were 3.2% and 51.6%, respectively. After a median 11.6 months’ follow-up, median PFS was 4.3 (95% confidence interval [CI] 3.4–5.1) months and median OS was 9.3 (95% CI 6.6–12.1) months. The most common grade 3–4 toxicities were neutropenia, asthenia and nausea/vomiting, and there were no treatment-related deaths. This real-world study confirms the efficacy and safety of TAS-102 plus bevacizumab in patients with refractory mCRC.

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Real-world genetic testing patterns in metastatic colorectal cancer: Balancing adoption challenges with performance efficiency.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.30_suppl.46 ◽

2018 ◽

Vol 36 (30_suppl) ◽

pp. 46-46

Author(s):

Adrianne Waldman Casebeer ◽

Charron Long ◽

Dana Angela Drzayich Jankus ◽

Patrick Racsa ◽

Teresa Rogstad ◽

...

Keyword(s):

Colorectal Cancer ◽

Genetic Testing ◽

Metastatic Colorectal Cancer ◽

Precision Medicine ◽

Real World ◽

Genetic Test ◽

Median Number ◽

Real World Data ◽

Ongoing Research ◽

Testing Patterns

46 Background: Evaluation of real-world data regarding genetic testing for metastatic colorectal cancer (mCRC) highlights the successes and challenges of precision medicine. Guidelines recommend genetic testing to inform mCRC treatment choice. However, there is a lack of real-world evidence regarding genetic testing patterns, including adoption and efficiency. Methods: This retrospective analysis identified adult patients with newly diagnosed mCRC (2015-2106), Medicare Advantage coverage with a pharmacy benefit (MAPD), and claims evidence of CRC-related genetic testing. Inclusion required diagnosis of colon/rectal cancer on ≥2 medical claims and new metastatic disease. Paid and unpaid claims identified genetic testing, which was classified as limited RAS, extended KRAS/NRAS, limited + extended, and BRAF. Efficiency was measured as time-to-testing and time-to-treatment once testing was performed. Results: The study included 4,408 patients with mCRC and MAPD, with a median age of 72 years. Evidence of limited +/- extended testing was noted for 667 (15.1%) of patients. Of these, 78.3% initiated CRC treatment. Limited, extended, and limited + extended testing was observed for 51.7%, 4.5% and 43.8% of patients, respectively. BRAF was observed for 46.4%, 23.3% and 63.7% of patients with limited, extended, or limited + extended testing, respectively. For the 69.2% of patients tested prior to treatment, the median number of days between mCRC diagnosis and first genetic test was 6 [range: 0-31] days, with 25 [13-46] days between testing and treatment. When treatment preceded testing, the median number of days from treatment to test was 72.0 [20-251]. Of patients with > 1 genetic test, most patients had all tests on the same day (96.9%) or within 7 days (97.8%) of diagnosis, with no differences by type of testing. Conclusions: Per guidelines, mCRC-related genetic testing was completed efficiently after diagnosis and prior to treatment initiation for most patients. Genetic testing rates remain low, perhaps indicating barriers to scaling precision medicine. Ongoing research to explore ways to expedite adoption of precision medicine, while maintaining its efficiency, is needed.

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Patient demographics and management landscape of metastatic colorectal cancer in the third‐line setting: Real‐world data in an australian population

Asia-Pacific Journal of Clinical Oncology ◽

10.1111/ajco.13553 ◽

2021 ◽

Author(s):

Sandy Tun Min ◽

Aflah Roohullah ◽

Annette Tognela ◽

Azim Jalali ◽

Margaret Lee ◽

...

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Real World ◽

Real World Data ◽

Australian Population ◽

World Data ◽

Patient Demographics ◽

The Third ◽

Third Line ◽

Line Setting

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Nomogram of conditional survival probability of long-term Survival for Metastatic Colorectal Cancer: A Real-World Data Retrospective Cohort Study from SEER database

International Journal of Surgery ◽

10.1016/j.ijsu.2021.106013 ◽

2021 ◽

pp. 106013

Author(s):

Lingyu Han ◽

Weixing Dai ◽

Shaobo Mo ◽

Wenqiang Xiang ◽

Qingguo Li ◽

...

Keyword(s):

Colorectal Cancer ◽

Cohort Study ◽

Real World ◽

Retrospective Cohort Study ◽

Retrospective Cohort ◽

Conditional Survival ◽

Seer Database ◽

Real World Data ◽

Term Survival

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Cetuximab versus bevacizumab maintenance following prior 8-cycle modified FOLFOXIRI plus cetuximab in Asian postmenopausal women with treatment-naive KRAS and BRAF wild-type metastatic colorectal cancer

Journal of International Medical Research ◽

10.1177/0300060520930440 ◽

2020 ◽

Vol 48 (9) ◽

pp. 030006052093044

Author(s):

Baomin Chen ◽

Donghua Zheng ◽

Weiguang Yu ◽

Cuiping Huang ◽

Junxing Ye ◽

...

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Postmenopausal Women ◽

Induction Therapy ◽

Maintenance Treatment ◽

Progression Free Survival ◽

Wild Type ◽

Clinical Endpoints ◽

Treatment Naïve

Objective To assess the efficacy and safety of cetuximab (CE) versus bevacizumab (BE) maintenance treatment after prior 8-cycle modified 5-fluorouracil, folinate, oxaliplatin, and irinotecan (FOLFOXIRI) plus CE induction therapy in treatment-naive KRAS and BRAF wild-type (wt) metastatic colorectal cancer (mCRC). Methods From 2012 to 2017, prospectively maintained databases were reviewed to assess Asian postmenopausal women with treatment-naive KRAS and BRAF wt mCRC who underwent modified FOLFOXIRI plus CE induction therapy, followed by CE or BE maintenance until disease progression or death. Co-primary clinical endpoints were progression-free survival (PFS) and overall survival (OS). Results A total of 222 women were included (CE n = 110 and BE n = 112). At a median follow-up of 27.0 months (interquartile range, 6.5–38.6 months), median PFS was 21.9 months (95% confidence interval [CI] 16.4–24.4) and 17.7 months (95% CI 11.3–19.0) for CE and BE groups, respectively (hazard ratio [HR] 0.31, 95% CI 0.15–0.46); median OS was 26.0 months (95% CI 23.4–28.7) and 22.7 months (95% CI 21.2–24.3) for CE and BE groups, respectively (HR 0.22, 95% CI 0.11–0.37). Conclusions CE maintenance treatment is more poorly tolerated but has a slightly more modest survival benefit compared with BE maintenance treatment in mCRC.

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