Response to PD-1 and PD-L1 based immunotherapy in MSS advanced colorectal cancer is impacted by metastatic disease sites.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 72-72
Author(s):  
Marwan Fakih ◽  
Jaideep Singh Sandhu ◽  
Chongkai Wang ◽  
Ching Ouyang
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Disease Control ◽  
Metastatic Disease ◽  
Cox Regression ◽  
Lung Metastases ◽  
Therapy Response ◽  
Progression Free Survival ◽  
Liver Involvement ◽  
The Impact

72 Background: Microsatellite stable (MSS) metastatic colorectal cancer (mCRC) has been associated with immunotherapy resistance. However, the impact of metastatic diseases sites on clinical outcome with checkpoint inhibition has not be adequately investigated. Methods: Following IRB approval (14361), we performed a retrospective study to assess the response and progression-free survival (PFS) to PD-1 or PD-L1 based therapy in patients with MSS mCRC who progressed following standard chemotherapy and targeted therapy. Patients were included if they received an FDA approved anti-PD1 or anti-PD-L1 agent, alone or in combination with other investigational agents. Exclusion criteria included concurrent cytotoxic therapy. Response and PFS were determined by RECIST guidelines. Results: 97 patients with refractory MSS mCRC satisfied the inclusion criteria were evaluable for analysis. 57, 17, 13, and 10 received nivolumab, atezolizumab, pembrolizumab, and durvalumab, respectively. 47, 8, 10, 10, 17 received concurrent VEGFR, MEK, CTLA-4, radiation, or other targeted therapies. Among tested variables, including age, gender, primary tumor location, ECOG status, RAS, BRAF, APC, TP53, TMB, and sites of metastasis, only ECOG status (0 vs. 1) and metastatic disease to the liver were associated with disease control (partial response and stable disease; p = 0.005 and < 0.001 respectively). Disease control rates in patients without liver metastases (n = 43) was 56% (95% CI: 40-71%), compared with 2% (95% CI: 0.1-10%) in patients with liver metastases (n = 54) (p < 0.001). Also, liver involvement was predictive for PFS based on multivariate Cox regression model (p < 0.001). The median PFS in patients with liver involvement was 1.5 vs 4.5 months for no liver involvement (HR = 4.41, p = < 0.001). Amongst patients without liver metastases, 35% (15/43) remained without progression at 6 months. These patients were characterized by lung metastases (n = 8) and/or lymph node metastases (n = 4). Conclusions: The presence of liver metastases is MSS mCRC is predictive for lack of benefit from PD-1/PD-L1 inhibitors. Patients without liver metastases can derive a meaningful clinical benefit, with 35% being progression-free at 6 months. Future PD-1/PD-L1 drug development should consider metastatic sites of disease in study design and development.

A single institute retrospective trial of concurrent chemotherapy with SIR-Sphere versus SIR-Sphere alone in patients with chemotherapy-resistant colorectal cancer liver metastases.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 770-770 ◽  
Author(s):  
May Thet Cho ◽  
Jonathan Kessler ◽  
John Park ◽  
Gagandeep Singh ◽  
Yi-Jen Chen ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Disease Control ◽  
Progression Free Survival ◽  
Concurrent Chemotherapy ◽  
Colorectal Cancer Liver Metastases ◽  
Free Survival ◽  
Kaplan Meier ◽  
Grade 3 ◽  
The Impact

770 Background: The use of selective internal radiation therapy (SIRT) with SIR-Spheres in chemotherapy-resistant colorectal cancer liver metastases (CRC-L) has been associated with favorable progression free survival (PFS) and overall survival (OS) when given alone or concurrently with chemotherapy. However, no prospective studies exist for concurrent SIRT and chemotherapy (SIRT-CT) vs. SIRT alone. We conducted a single institute retrospective trial to compare the effect of SIRT-CT to SIRT alone on liver PFS in patients with CRC-L. Methods: Patients (pts) with CRC-L treated with SIR-Spheres at City of Hope between 2009 and 2014 were identified. CRL-L patients treated with SIRT-CT or with SIRT were excluded if they received, following radioembolization, any chemotherapy/targeted regimen on which they did not previously progress. This strategy was adopted to minimize the impact of post-SIRT systemic therapy bias on SIRT-CT/SIRT liver PFS outcome. Pts characteristics included demographics, liver involvement pattern, and lines of prior chemotherapy. Liver PFS, response rate, and toxicities were compared between SIRT-CT and SIRT arms. Kaplan-Meier estimation was used for PFS analysis. Results: 48 CRC-L pts were treated with SIR-spheres; 27 satisfied the post-SIR-spheres systemic treatment criteria (14 SIRT-CT, 13 SIRT) and were included on this study. Pts characteristics included: age (median = 62; range 52-80), sex (18 males), primary site (colon: 23), hepatic disease burden (23 bilobar), 5-FU resistance/intolerance (25/2), and extrahepatic disease (22). Pts characteristics were similar between treatment arms, except for median prior therapies (SIRT-CT = 3, SIRT = 2). No SIRT-CT or SIRT associated ≥ grade 3 toxicities were noted. Disease control rates were 84% (2/13 PR; 9/13 SD) and 14% (2/14 SD on the SIRT-CT and SIRT arms, respectively (p = 0.001). Median PFS in the liver was 176 days in the SIRT-CT group vs. 91 days in the SIRT group (p = 0.0006). Conclusions: In patients with 5-FU refractory CRC-L, SIRT-CT is associated with an increased disease control rate and a prolonged DFS in comparison with SIRT alone.

scholarly journals Diagnostic and Prognostic Value of B4GALT1 Hypermethylation and Its Clinical Significance as a Novel Circulating Cell-Free DNA Biomarker in Colorectal Cancer

Cancers ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 1598 ◽  
Author(s):  
Francesco Picardo ◽  
Antonella Romanelli ◽  
Laura Muinelo-Romay ◽  
Tommaso Mazza ◽  
Caterina Fusilli ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Lung Metastases ◽  
Methylation Status ◽  
Therapy Response ◽  
Progression Free Survival ◽  
Prognostic Impact ◽  
Aberrant Expression ◽  
Predictive Values ◽  
Methylation Specific Pcr ◽  
Specific Pcr

Epigenetic modifications of glyco-genes have been documented in different types of cancer and are tightly linked to proliferation, invasiveness, metastasis, and drug resistance. This study aims to investigate the diagnostic, prognostic, and therapy-response predictive value of the glyco-gene B4GALT1 in colorectal cancer (CRC) patients. A Kaplan–Meier analysis was conducted in 1418 CRC patients (GEO and TCGA datasets) to assess the prognostic and therapy-response predictive values of the aberrant expression and methylation status of B4GALT1. Quantitative methylation-specific PCR (QMSP) and droplet digital quantitative methylation-specific PCR (dd-QMSP) were respectively used to detect hypermethylated B4GALT1 in metastasis and plasma in four cohorts of metastatic CRC cases (mCRC). Both the downregulated expression and promoter hypermethylation of B4GALT1 have a negative prognostic impact on CRC. Interestingly a low expression level of B4GALT1 was significantly associated with poor cetuximab response (progression-free survival (PFS) p = 0.01) particularly in wild-type (WT)-KRAS patients (p = 0.03). B4GALT1 promoter was aberrantly methylated in liver and lung metastases. The detection of hypermethylated B4GALT1 in plasma of mCRC patients showed a highly discriminative receiver operating characteristic (ROC) curve profile (area under curve (AUC) value 0.750; 95% CI: 0.592–0.908, p = 0.008), clearly distinguishing mCRC patients from healthy controls. Based on an optimal cut-off value defined by the ROC analysis, B4GALT1 yield a 100% specificity and a 50% sensitivity. These data support the potential value of B4GALT1 as an additional novel biomarker for the prediction of cetuximab response, and as a specific and sensitive diagnostic circulating biomarker that can be detected in CRC.

Germline ATM mutations on survival in metastatic pancreatic cancer patients.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16746-e16746
Author(s):  
Arjan Gower ◽  
Gillian Gresham ◽  
Nanor Haladjian ◽  
John Lee ◽  
Camille Ng ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Metastatic Disease ◽  
Cox Regression ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Underlying Mechanism ◽  
First Line ◽  
Increased Risk ◽  
Atm Protein ◽  
The Impact

e16746 Background: Ataxia telangiectasia mutated (ATM) protein is a DNA damage repair enzyme and regulates normal cell-cycle mechanisms. Germline ATM mutations are associated with increased risk for developing pancreatic cancer (PC), occurring in approximately 2% of PC patients (pts). The role of germline ATM mutations in PC is not well defined. The objective of this study was to compare survival outcomes in patients with germline ATM mutations compared to somatic ATM mutations in PC. Methods: Tumor genomic profiling was completed in 144 PC patients at a single institution in the US, where pts were included in the analysis if they had either germline ATM mutations or somatic ATM mutations. Clinical outcomes were compared between pts with germline ATM mutations and pts with somatic ATM mutations only. Adjusted Cox regression models were fit to evaluate the impact of ATM mutation on overall survival (OS), calculated from treatment (tx) initiation to death, and progression free survival (PFS) calculated from tx initiation to first progression. Results: From 144 PC pts evaluated, 7 pts (4.9%) had germline ATM mutations, all of whom presented with metastatic disease, and 14 pts (9.7%) with somatic ATM mutations only, of whom 10 presented with metastatic disease and 4 who initially presented with locally advanced PC. The majority of pts (15/21), including all 7 pts with germline ATM mutations and 8 with somatic ATM mutations, were treated with first line gemcitabine and abraxane. Median OS was not reached in patients with germline mutations, and 11 months for patients with somatic mutations. Pts with germline ATM mutations had significantly higher OS (HR: 0.12, 95% CI 0.03-0.62, p = 0.01) and PFS (HR:0.26, 95%CI 0.07-0.91, p = 0.04) compared to patients with somatic ATM mutations only after adjusting for age, sex, and first-line tx. Conclusions: Pts with germline ATM mutations may experience greater survival benefit from tx compared to those with only somatic ATM mutations. Further research into the underlying mechanism is warranted.

scholarly journals Transarterial chemoembolization alone or followed by bevacizumab for treatment of colorectal liver metastases

2021 ◽  
pp. HEP40
Author(s):  
Giammaria Fiorentini ◽  
Donatella Sarti ◽  
Michele Nardella ◽  
Riccardo Inchingolo ◽  
Massimiliano Nestola ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Disease Control ◽  
Transarterial Chemoembolization ◽  
Tumor Response ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Kras Mutations ◽  
Colorectal Cancer Liver Metastases ◽  
Mutational Status

Aims: Bevacizumab (B) in association with systemic chemotherapy is commonly used for the treatment of colorectal cancer liver metastases. The aim of this study was to monitor tumor response, overall survival (OS) and progression-free survival (PFS) of patients with colorectal cancer liver metastases treated with transarterial chemoembolization (TACE) + B compared with TACE alone and to correlate the results with KRAS mutational status. Patients & methods: This was an observational multicentric case–control study (NCT03732235) on the efficacy and safety of B administered after TACE. Results: The disease control rate was significantly higher for the TACE + B than the TACE alone group (p < 0.001). KRAS wild-type patients had a significantly better disease control rate than those with KRAS mutations in the TACE + B group. Median OS and PFS were similar for the TACE + B and TACE groups, whereas median time to progression was significantly higher for the TACE + B group (p < 0.01). Conclusion: The combination of TACE with B may improve tumor response and delay disease progression.

scholarly journals Effect of oxaliplatin plus 5-fluorouracil or capecitabine on circulating and imaging biomarkers in patients with metastatic colorectal cancer: a prospective biomarker study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Reem D. Mahmood ◽  
Danielle Shaw ◽  
Tine Descamps ◽  
Cong Zhou ◽  
Robert D. Morgan ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Metastatic Colorectal Cancer ◽  
Targeted Therapies ◽  
Progression Free Survival ◽  
Cytotoxic Chemotherapy ◽  
Imaging Biomarker ◽  
Imaging Biomarkers ◽  
Pre Treatment ◽  
The Impact

Abstract Background Patients with metastatic colorectal cancer are treated with cytotoxic chemotherapy supplemented by molecularly targeted therapies. There is a critical need to define biomarkers that can optimise the use of these therapies to maximise efficacy and avoid unnecessary toxicity. However, it is important to first define the changes in potential biomarkers following cytotoxic chemotherapy alone. This study reports the impact of standard cytotoxic chemotherapy across a range of circulating and imaging biomarkers. Methods A single-centre, prospective, biomarker-driven study. Eligible patients included those diagnosed with colorectal cancer with liver metastases that were planned to receive first line oxaliplatin plus 5-fluorouracil or capecitabine. Patients underwent paired blood sampling and magnetic resonance imaging (MRI), and biomarkers were associated with progression-free survival (PFS) and overall survival (OS). Results Twenty patients were recruited to the study. Data showed that chemotherapy significantly reduced the number of circulating tumour cells as well as the circulating concentrations of Ang1, Ang2, VEGF-A, VEGF-C and VEGF-D from pre-treatment to cycle 2 day 2. The changes in circulating concentrations were not associated with PFS or OS. On average, the MRI perfusion/permeability parameter, Ktrans, increased in response to cytotoxic chemotherapy from pre-treatment to cycle 2 day 2 and this increase was associated with worse OS (HR 1.099, 95%CI 1.01–1.20, p = 0.025). Conclusions In patients diagnosed with colorectal cancer with liver metastases, treatment with standard chemotherapy changes cell- and protein-based biomarkers, although these changes are not associated with survival outcomes. In contrast, the imaging biomarker, Ktrans, offers promise to direct molecularly targeted therapies such as anti-angiogenic agents.

Impact of FOLFOXIRI plus bevacizumab on resectability and survival in patients with initially unresectable liver metastases from colorectal cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 621-621 ◽  
Author(s):  
M. Shimada ◽  
M. Nishioka ◽  
J. Hanaoka ◽  
H. Mori ◽  
T. Ikemoto ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Hepatic Resection ◽  
Lung Metastases ◽  
Disease Free Survival ◽  
Conversion Rates ◽  
Median Period ◽  
Unresectable Liver Metastases ◽  
Grade 3 ◽  
The Impact

621 Background: Prognosis in patients with unresectable liver metastases from colorectal cancer is known to be very poor. However, thanks to progress of chemotherapy including molecular-target agents, “conversion” (from unresectable to resectable) has been sometimes seen. The aim of this preliminary study is to clarify the impact of FOLFOXIRI plus bevacizumab (Bev) on conversion and prognosis in patients with initially unresectable liver metastases from colorectal cancer. Methods: Seven patients with initially unresectable liver metastases from colorectal cancer, who received FOLFOXIRI (LOHP 85mg/m2 D1, CPT-11 150mg/m2 D1, LV 200mg/m2 D1, and 5FU 2,400mg/m2 infusion over 46 hours, D1) plus Bev 5mg/kg bolus every 2 weeks, were included in this study. Resectability, disease-free survival (DFS), and overall survival (OS) after hepatic resection were investigated in detail. In addition, completeness and adverse effects were examined in this regimen. Results: All 7 patients tolerated the regimen well, and no adverse effect of grade 3-4 was observed. Five out of 7 patients (71%) became resectable (conversion), except for 2 with multiple lung metastases and bone metastasis prior to chemotherapy. Our historical conversion rates were, 0% (0/7) in 5FU/LV regimen from 1994 to 2003, 25% (7/27) other regimens such as FOLFIRI and FOLFOX except for FOLFOXIRI plus Bev from 2004. In 5 patients who became resectable, CR was not observed, however, all had PR after 6 cycles of chemotherapy (RR 100%). All 5 patients could undergo curative (R0) hepatic resection, furthermore, all had pathological major response (grade 2). Follow-up period ranged from 8 to 18 months, with a median period of 14 months, and 2 patients relapsed (lung recurrence and peritoneal dissemination), and one died of lung metastases (1.5-year OS and DFS are 80 % and 60%). Conclusions: Our preliminary data suggested the feasibility of this new therapeutic combination in patients with initially unresectable liver metastases from colorectal cancer, and a high conversion rate and better prognosis. [Table: see text]

RAS mutational status and CEA production at initial presentation in metastatic colorectal cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 542-542
Author(s):  
May Thet Cho ◽  
Leanne Goldstein ◽  
Chie Akiba ◽  
S. Cecilia Lau ◽  
Milhan Telatar ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Metastatic Colorectal Cancer ◽  
Metastatic Disease ◽  
Hepatic Metastases ◽  
Small Sample ◽  
Eligibility Criteria ◽  
Mutational Status ◽  
Ras Status ◽  
The Impact

542 Background: Serial CEA testing is recommended in the surveillance of patients with resected stage II-IV colorectal cancer. However, the sensitivity of CEA in identifying metastatic disease has not been evaluated in the settings of RAS mutant (MT) and RAS/BRAF wild-type tumors (WT). In order to evaluate the impact of RAS mutational status on CEA production, we retrospectively evaluated a single-institute metastatic colorectal cancer (mCRC) population. Methods: We retrospectively reviewed, in a single center, all cases with mCRC with known RAS mutational status based on next generation sequencing (ONCO44 and ONCO48). These assays identify clinically relevant mutations in BRAF, KRAS, and NRAS. Additional eligibility criteria included the availability of CEA levels and imaging studies at first diagnosis of mCRC. Patient demographics, primary tumor location and sites of metastatic disease at 1st diagnosis were captured. CEA levels were stratified as normal or elevated based on a cut point of 5ng/ml. Results: 139 mCRC patients satisfied the eligibility criteria (75 RAS-MT, 59 RAS/BRAF-WT, and 5 BRAF-MT). BRAF-MT patients were excluded from the analysis due to their small sample size. Patients with RAS/BRAF-WT tumors were more likely to present with metastatic disease to the liver, but this did not reach statistical significance (p = 0.056). There was no difference in the incidence of normal CEA at presentation in RAS-MT (30%) and RAS/BRAF-WT (28%) cohorts. CEA production was dependent on the pattern of metastatic disease. Elevated CEA was associated with the presence of liver metastases versus no metastases among RAS-MT (92% vs 47% p <.0001) and RAS/BRAF-WT patients (82% vs 50% p = 0.0101). RAS status did not impact the likelihood of CEA production within the hepatic metastases and non-hepatic metastases groups. Conclusions: RAS status does not appear to influence CEA production in patients with mCRC. CEA elevations are highly associated with liver metastases and are less prevalent in patients without hepatic involvement. These findings confirm the limited predictive value of CEA for non-hepatic recurrence, irrespective of RAS status.

scholarly journals Effect of oxaliplatin plus 5-fluorouracil or capecitabine on circulating and imaging biomarkers in patients with metastatic colorectal cancer: a prospective biomarker study

2020 ◽  
Author(s):  
Reem Mahmood ◽  
Danielle Shaw ◽  
Tine Descamps ◽  
Cong Zhou ◽  
Robert D. Morgan ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Metastatic Colorectal Cancer ◽  
Targeted Therapies ◽  
Progression Free Survival ◽  
Cytotoxic Chemotherapy ◽  
Imaging Biomarker ◽  
Imaging Biomarkers ◽  
Pre Treatment ◽  
The Impact

Abstract Background: Patients with metastatic colorectal cancer are treated with cytotoxic chemotherapy supplemented by molecularly targeted therapies. There is a critical need to define biomarkers that can optimise the use of these therapies to maximise efficacy and avoid unnecessary toxicity. However, it is important to first define the changes in potential biomarkers following cytotoxic chemotherapy alone. This study reports the impact of standard cytotoxic chemotherapy across a range of circulating and imaging biomarkers.Methods: A single-centre, prospective, biomarker-driven study. Eligible patients included those diagnosed with colorectal cancer with liver metastases that were planned to receive first line oxaliplatin plus 5-fluorouracil or capecitabine. Patients underwent paired blood sampling and magnetic resonance imaging (MRI), and biomarkers were associated with progression-free survival (PFS) and overall survival (OS).Results: 20 patients were recruited to the study. Data showed that chemotherapy significantly reduced the number of circulating tumour cells as well as the circulating concentrations of Ang1, Ang2, VEGF-A, VEGF-C and VEGF-D from pre-treatment to cycle 2 day 2. The changes in circulating concentrations were not associated with PFS or OS. On average, the MRI perfusion/permeability parameter, Ktrans, increased in response to cytotoxic chemotherapy from pre-treatment to cycle 2 day 2 and this increase was associated with worse OS (HR 1.099, 95%CI 1.01-1.20, p=0.025).Conclusions: In patients diagnosed with colorectal cancer with liver metastases, treatment with standard chemotherapy changes cell- and protein-based biomarkers, although these changes are not associated with survival outcomes. In contrast, the imaging biomarker, Ktrans, offers promise to direct molecularly targeted therapies such as anti-angiogenic agents.

scholarly journals Prognostic role of docetaxel-induced suppression of free testosterone serum levels in metastatic prostate cancer patients

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Paula Kappler ◽  
Michael A. Morgan ◽  
Philipp Ivanyi ◽  
Stefan J. Brunotte ◽  
Arnold Ganser ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Metastatic Prostate Cancer ◽  
Cox Regression ◽  
Specific Antigen ◽  
Progression Free Survival ◽  
Serum Levels ◽  
Biologically Active ◽  
Free Form ◽  
Total Testosterone ◽  
The Impact

AbstractTo date, only few data concerning the biologically active, free form of testosterone (FT) are available in metastatic prostate cancer (mPC) and the impact of FT on disease, therapy and outcome is largely unknown. We retrospectively studied the effect of docetaxel on FT and total testosterone (TT) serum levels in 67 mPC patients monitored between April 2008 and November 2020. FT and TT levels were measured before and weekly during therapy. The primary endpoint was overall survival (OS). Secondary endpoints were prostate-specific antigen response and radiographic response (PSAR, RR), progression-free survival (PFS), FT/TT levels and safety. Median FT and TT serum levels were completely suppressed to below the detection limit during docetaxel treatment (FT: from 0.32 to < 0.18 pg/mL and TT: from 0.12 to < 0.05 ng/mL, respectively). Multivariate Cox regression analyses identified requirement of non-narcotics, PSAR, complete FT suppression and FT nadir values < 0.18 pg/mL as independent parameters for PFS. Prior androgen-receptor targeted therapy (ART), soft tissue metastasis and complete FT suppression were independent prognostic factors for OS. FT was not predictive for treatment outcome in mPC patients with a history of ART.

Lonsurf (trifluridine/tipiracil): Assessing the impact of dose related toxicities and progression free survival in (refractory) metastatic colorectal cancer

2021 ◽  
pp. 107815522110179
Author(s):  
Olivia R Court
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Dose Reduction ◽  
Progression Free Survival ◽  
Electronic Patient Records ◽  
Free Survival ◽  
Length Of Treatment ◽  
Common Grade ◽  
Grade 3 ◽  
The Impact

In the RECOURSE trial which lead to its accreditation, Lonsurf (trifluridine/tipiracil) was shown to extend progression free survival (PFS) by 1.8 months in metastatic colorectal cancer. This Trust audit aims to assess the average quantity of cycles of Lonsurf received by participants and the length of time it extends PFS. Similarly, to identify how many participants required a dose-reduction or experienced toxicities which necessitated supportive therapies. Quantitative data was collected retrospectively from all participants who had received ≥1 cycle of Lonsurf from The Clatterbridge Cancer Centre (CCC) from 2016 until June 2020. Participant electronic patient records were accessed to identify toxicity grading, length of treatment received, the date progression was identified, if dose reductions were applied and if supportive therapies were administered. Lonsurf extends PFS in patients with metastatic colorectal cancer at CCC by 3.0 months (95% CI: 2.73–3.27) and average treatment length was 2.4 months. However, 78 participants (41.5%) received a dose reduction due to toxicities. A total of 955 toxicities were recorded by participants; the most commonly reported toxicities irrespective of grade were fatigue (33.8%), diarrhoea (13.8%) and nausea (12.3%). The most common grade ≥3 toxicities were constipation and infection. The most frequently utilised supportive therapies were loperamide (49.6%) and domperidone (49.1%). Granulocyte colony stimulating factor (GCSF) was required by patients on 5 occasions (0.3%) in total. Lonsurf extends median PFS in patients with metastatic colorectal cancer by 3.0 months. The most common grade ≥3 toxicities which necessitated supportive therapies or a dose reduction were gastrointestinal and infection.

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