<p>Factors Associated With Regorafenib Adherence With Metastatic Colorectal Cancer</p>

3550 Background: In the early 2000s, classic LV5FU2 (C) (folinic acid, 5FU bolus, then 5FU infusion on D1 and D2) was replaced with simplified LV5FU2 (S) (folinic acid and 5FU bolus on D1 only), considered as effective and less toxic. No trial proved this assertion. The LV5FU2 companion in the FOLFIRI or FOLFOX regimen was C or S. The FFCD 2001-02 study compared in a 2 x 2 factorial design, in not-pretreated elderly patients (75+) with metastatic colorectal cancer, C or S, with or without irinotecan. No significant differences in PFS and OS were observed in the comparison with or without irinotecan. The median OS was 15.2 months in C versus 11.4 months in S, HR = 0.71 (0.55–0.92) and objective response rate was 37.1% in C vs S 25.6% in S, p = 0.004. The aim of this study was to present the factors associated with these differences. Methods: Prognostic factors associated with OS were studied using a Cox model. The multivariate analysis used the significantly different items from the univariate analysis and the differences observed at the inclusion. For each of these items, a subgroup analysis was performed. The second- and third-line treatments were analysed. Results: The 282 patients from the intent-to-treat study were included in the model. In OS, the prognostic factors were C versus S, number of metastatic sites, alkaline phosphatases (AP) and CEA. The interaction test in each subgroup for OS was not significant but C was significantly better in the following subgroup: age > 80 years, male, Karnofsky 100%, 1-2 Charlson index, AP ≤ 2N, leucocyte count > 11,000, CEA > 2N, CA 19-9 ≤2N. No differences were observed in the NCI toxicities but 130 serious adverse events in S versus 102 in C. A second-line was used for 55% patients in C, 46% in S, 81% of them with oxaliplatin or irinotecan in C, 76% after S. The third-line administration (20%) and targeted therapy (15%) were similar in C and S. Conclusions: C-LV5FU2 was superior both in subgroups with better and lower prognostics and this difference cannot be explained by an imbalance between the populations. The toxicity was not higher and a second-line was more often possible after C. The switch from C to S without scientific proof was perhaps a mistake in our practices. Clinical trial information: NCT00303771.

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Factors associated with Trifluridine/Tipiracil (TAS-102) effectiveness in patients with refractory metastatic colorectal cancer: real-life data from the Czech Republic.

10.21203/rs.2.16737/v1 ◽

2019 ◽

Author(s):

Peter Grell ◽

Josef Dvorak ◽

Michal Vocka ◽

Stanislav John ◽

Helena Pitauerova ◽

...

Keyword(s):

Colorectal Cancer ◽

Czech Republic ◽

Clinical Practice ◽

High Risk ◽

Metastatic Colorectal Cancer ◽

Scoring System ◽

Risk Group ◽

Real Life ◽

The Czech Republic ◽

Factors Associated

Abstract Background: Trifluridine/tipiracil (TAS-102) is effective in refractory metastatic colorectal cancer (mCRC). Currently, no predictive biomarkers are established and used in clinical practice. Methods: We analyzed data of 160 patients treated with TAS-102 in real clinical practice in the Czech Republic. Different factors associated with progression-free survival (PFS) and overall survival (OS) were evaluated. Results: Median PFS was 3.3 months, and median OS 10.2 months. Factors significantly associated with PFS and/or OS were: ECOG performance status (PS), time from diagnosis of mCRC > 24 months, initiation of treatment > 3 months from last fluoropyrimidine, number of metastatic sites, baseline CRP level, WBC count, neutrophils count, monocytes count, neutrophil to lymphocyte ratio, development of neutropenia, thrombocytopenia, diarrhea, required dose reduction and cycle delay. We developed a scoring system TAScore from factors available at the beginning of treatment. One point each was assigned to the following factors (PS, diagnosis of mCRC > 24 months, initiation of TAS-102 > 3 months from fluoropyrimidine, baseline CRP, WBC, monocytes count < 0.5 × 10 9 /L) and patients were divided into 3 groups: high risk group (0 to 1 point), intermediate (2 to 3), favorable with 4 or more points. OS according to risk group was: 5.7 months for high risk, 8.7 for intermediate, 12.8 for favorable (P < 0.001). TAScore was also associated with PFS (P < 0.001). Conclusions : TAS-102 is effective in patients with refractory mCRC. We propose simple scoring system TAScore to help with precise patient selection at the beginning of TAS-102 treatment.

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Factors associated with the efficiency of maintenance therapy in patients with metastatic colorectal cancer

Colorectal Oncology ◽

10.17650/2220-3478-2016-6-2-8-17 ◽

2016 ◽

Vol 6 (2) ◽

pp. 8-17

Author(s):

M. Yu. Fedyanin ◽

A. A. Tryakin ◽

E. M. Polyanskaya ◽

I. A. Pokataev ◽

O. V. Sheina ◽

...

Keyword(s):

Colorectal Cancer ◽

Maintenance Therapy ◽

Metastatic Colorectal Cancer ◽

Factors Associated

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Real-world time on treatment and overall survival in patients with metastatic colorectal cancer receiving cetuximab in second line after failing irinotecan or oxaliplatin-based regimens.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e15568 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e15568-e15568

Author(s):

Wambui Gathirua-Mwangi ◽

Tony Yang ◽

Taha Khan ◽

Yixun Wu ◽

Manuel Afable

Keyword(s):

Colorectal Cancer ◽

Overall Survival ◽

Metastatic Colorectal Cancer ◽

Real World ◽

Index Date ◽

Growth Factor Receptor ◽

Community Setting ◽

Second Line ◽

Cox Models ◽

Factors Associated

e15568 Background: Anti-epidermal growth factor receptor agents are increasingly used in later lines of therapy for the treatment of metastatic colorectal cancer (mCRC). However, the real-world time on treatment (TOT) and overall survival (OS) of patients with mCRC receiving cetuximab in second-line (2L) setting have not been described. Therefore, we sought to evaluate TOT, OS and identify factors associated with longer TOT and OS based on retrospective observational data. Methods: A total of 1,011 patients were selected from the nationwide Flatiron electronic health record database (January 2013-August 2020) who were: 1) diagnosed with mCRC, 2) received 2L treatment with cetuximab containing regimens, and 3) had failed oxaliplatin/irinotecan-based regimens in first-line (1L). TOT was defined as the time from initiation of cetuximab in 2L (index date), to the last date showing evidence of cetuximab administration. End of therapy was defined if patients progressed to third-line of therapy, or having a death record. OS was calculated from the index date to the date of death or censored to last visit date available. The Kaplan-Meier estimates, and stepwise Cox models were adapted to calculate hazard ratios (HR) and 95% confidence intervals (CI) for associated factors. Results: Majority of patients receiving 2L treatment with cetuximab containing regimens were: less than 65 years old (58%), male (60%), had a median body mass index (BMI) of 26.6 kg/m², received FOLFOX regimens in 1L (61%) and were treated in the community setting (96%). The most common 2L regimens were cetuximab+FOLFIRI (46%) and cetuximab+Irinotecan (29%). Overall, the median TOT (mTOT) for patients receiving 2L cetuximab was 3.94 months (median Interquartile range (mIQR) 3.51-4.40), and median OS (mOS) was 14.36 months (mIQR 13.01-15.70). Of all cetuximab containing regimens, receiving cetuximab+FOLFIRI in 2L (mTOT = 4.43 months, mIQR 3.71-5.36), KRAS wild-type (vs. KRAS+), and receiving 2L cetuximab after prior therapy with 1L CapeOX (vs. FOLFOX) were associated with a longer mTOT. Living in the South region (vs. Midwest) was associated with a shorter mTOT. Having a higher BMI (obese vs. underweight HR = 0.46, 95% CI 0.32-0.66) was associated with a longer mOS, while receiving cetuximab+FOLFOX in 2L (mOS = 10.97 months, mIQR 5.55-14.06) or being older (≥65 vs. < 65 years; HR = 1.24, 95% CI 1.05-1.46) were associated with a shorter mOS. Conclusions: In this real-world retrospective analysis we show TOT and OS overall in mCRC patients who received cetuximab containing regimens in 2L. These patients were mostly male, < 65 years, and majority received FOLFOX regimens in 1L therapy. Key factors associated with TOT and OS were treatment regimens received in 1L and 2L. In addition, KRAS status and region were associated with TOT, while BMI and age were associated with OS only.

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Determinants of choice in offering drug holidays during first-line therapy for metastatic colorectal cancer

Future Oncology ◽

10.2217/fon-2020-0270 ◽

2020 ◽

Vol 16 (32) ◽

pp. 2645-2660

Author(s):

Silvio Ken Garattini ◽

Marta Bonotto ◽

Luca Porcu ◽

Elena Ongaro ◽

Lorenzo Gerratana ◽

...

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Primary Tumor ◽

Treatment Interruption ◽

First Line ◽

Factors Associated ◽

Primary Rectal Cancer ◽

First Line Therapy ◽

Line Therapy

Background: ‘Drug holidays’ (DH) for metastatic colorectal cancer (mCRC) were introduced to preserve quality of life. We studied factors associated to a DH offer in first line. Materials & methods: We retrospectively analyzed 754 consecutive patients treated with chemotherapy for mCRC in two Italian institutions between 2005 and 2017. Associations between baseline clinical-pathological factors and DH (56 or more days of treatment interruption) were investigated. Results: In 754 patients, previous metastasectomy, previous thermoablation and previous surgery of primary tumor were independently associated with DH. Excluding procedures or clinical trials: primary rectal cancer and resection of primary tumor were significantly associated to DH. Conclusions: DH was offered to patients with lower burden of disease, but further investigations are needed to safely guide a holiday strategy.

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Factors associated with the initiation of chemotherapy within 90 days of death in metastatic colorectal cancer patients: a population-based study

Supportive Care in Cancer ◽

10.1007/s00520-020-05655-y ◽

2020 ◽

Author(s):

Atul Batra ◽

Geoff McKinnon ◽

Alkarim Billawala ◽

Dropen Sheka ◽

Shiying Kong ◽

...

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Cancer Patients ◽

Population Based ◽

Population Based Study ◽

Factors Associated ◽

Colorectal Cancer Patients

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Observational cohort study of first-line bevacizumab with oxaliplatin or irinotecan and fluoropyrimidines in metastatic colorectal cancer: HGCSG0802—Analysis of early tumor shrinkage (ETS).

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.4_suppl.753 ◽

2016 ◽

Vol 34 (4_suppl) ◽

pp. 753-753 ◽

Cited By ~ 1

Author(s):

Satoshi Yuki ◽

Hiroshi Nakatsumi ◽

Kentaro Sawada ◽

Takashi Kato ◽

Takashi Meguro ◽

...

Keyword(s):

Colorectal Cancer ◽

Multivariate Analysis ◽

Metastatic Colorectal Cancer ◽

Univariate Analysis ◽

First Line ◽

Factors Associated ◽

Early Tumor Shrinkage ◽

Significant Difference ◽

Early Tumor ◽

Line Chemotherapy

753 Background: It was reported that early tumor shrinkage (ETS) was associated with better overall survival (OS) in patients (pts) with metastatic colorectal cancer (mCRC) receiving first line chemotherapy. We investigated association of ETS with progression-free survival (PFS) and OS in pts with mCRC treated with first-line bevacizumab (BV)-based chemotherapy (HGCSG0802). Methods: The objective of HGCSG0802 was to evaluate PFS, OS, response rate (RR), safety and so on. The key eligibility criteria were evaluable lesions, older than 20 years old, ECOG PS 0-2. This analysis evaluated the association of ETS at 8 weeks from the start of chemotherapy with pts characteristics, PFS and OS. To identify factors associated with ETS, if there were clinical variables with p < 0.2 in univariate analysis, we planned a multivariate analysis using the logistic regression model. To identify predictive and prognostic factors, a multivariate analysis was performed using Cox proportional hazard model with backward elimination for variables with p < 0.2 in univariate analysis. Results: Of 108 pts (the full analysis set), 99 pts were evaluable for ETS. Sixty-eight pts (68.7%) had ETS ≥20%. The pts characteristics between ETS ≥20% (ETS) and <20% (Non-ETS) were well balanced. In univariate analysis to identify factors associated with ETS, there were no clinical variables with p < 0.2. The median PFS and OS were 7.3/18.3 months in Non-ETS versus 10.0/25.2 months in ETS (HR 0.529; p=0.006 and HR 0.627; p=0.107). In multivariate analysis for PFS and OS, although there was no significant difference between ETS and Non-ETS for OS (HR 0.709; p=0.186), there was significant difference for PFS (HR 0.524; p=0.006). Conclusions: ETS was observed in 68.7% (68/99) and non-ETS in 31.3% (31/99) of patients with metastatic colorectal cancer received bevacizumab combined first line chemotherapy. In univariate analysis, it could not identify any factors associated with ETS. In the results of multivariate analysis, ETS showed an independent predictive impact, but not prognostic impact. Clinical trial information: UMIN000018935.

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