Efficacy and safety of bevacizumab in elderly patients with metastatic colorectal cancer: results from the Czech population-based registry

Slavíček, Lubomír; Pavlík, Tomáš; Tomášek, Jiří; Bortlíček, Zbyněk; Büchler, Tomáš; Melichar, Bohuslav; Vyzula, Rostislav; Prausová, Jana; Fínek, Jindřich; Májek, Ondřej; Dušek, Ladislav

doi:10.1186/1471-230x-14-53

Cited by 15 publications

(21 citation statements)

References 24 publications

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“…Bevacizumab-containing CTX outcomes from routine clinical practice were monitored and/or reported in mCRC patients registries such as prospective US BRiTE registry (n = 1,953) 9 or retrospective Czech (n = 3,187) and French (n = 1,322) registries. 10 , 18 These large first-line setting registries confirmed similarity of clinical benefit between younger and older patients, previously reported in randomized clinical trials and pooled analysis.…”

Section: Discussionsupporting

confidence: 82%

Bevacizumab plus chemotherapy in elderly patients with previously untreated metastatic colorectal cancer: single center experience

Ocvirk¹,

Moltara

Mesti

et al. 2016

Radiology and Oncology

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BackgroundMetastatic colorectal cancer (mCRC) is mainly a disease of elderly, however, geriatric population is underrepresented in clinical trials. Patient registries represent a tool to assess and follow treatment outcomes in this patient population. The aim of the study was with the help of the patients’ register to determine the safety and efficacy of bevacizumab plus chemotherapy in elderly patients who had previously untreated metastatic colorectal cancer.Patients and methodsThe registry of patients with mCRC was designed to prospectively evaluate the safety and efficacy of bevacizumab-containing chemotherapy as well as selection of patients in routine clinical practice. Patient baseline clinical characteristics, pre-specified bevacizumab-related adverse events, and efficacy data were collected, evaluated and compared according to the age categories.ResultsBetween January 2008 and December 2010, 210 patients with mCRC (median age 63, male 61.4%) started bevacizumab-containing therapy in the 1st line setting. Majority of the 210 patients received irinotecan-based chemotherapy (68%) as 1st line treatment and 105 patients (50%) received bevacizumab maintenance therapy. Elderly (≥ 70 years) patients presented 22.9% of all patients and they had worse performance status (PS 1/2, 62.4%) than patients in < 70 years group (PS 1/2, 35.8%). Difference in disease control rate was mainly due to inability to assess response in elderly group (64.6% in elderly and 77.8% in < 70 years group, p = 0.066). The median progression free survival was 10.2 (95% CI, 6.7–16.2) and 11.3 (95% CI, 10.2–12.6) months in elderly and < 70 years group, respectively (p = 0.58). The median overall survival was 18.5 (95% CI, 12.4–28.9) and 27.4 (95% CI, 22.7–31.9) months for elderly and < 70 years group, respectively (p = 0.03). Three-year survival rate was 26% and 37.6% in elderly vs. < 70 years group (p = 0.03). Overall rates of bevacizumab-related adverse events were similar in both groups: proteinuria 21/22 %, hypertension 25/19 %, haemorrhage 2/4 % and thromboembolic events 10/6 %, for elderly and < 70 years group, respectively.ConclusionsIn routine clinical practice, the combination of bevacizumab and chemotherapy is effective and well-tolerated regimen in elderly patients with metastatic colorectal cancer.

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Section: Discussionsupporting

confidence: 82%

Bevacizumab plus chemotherapy in elderly patients with previously untreated metastatic colorectal cancer: single center experience

Ocvirk¹,

Moltara

Mesti

et al. 2016

Radiology and Oncology

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“…The adverse events from bevacizumab treatment observed in this study are consistent with those published in post-registrational trials, including BEAT, BRiTE and ARIES [ 11 - 13 ]. We confirmed that severe (grade 3–5) events, including arterial thromboembolic events, proteinuria, gastrointestinal perforation and wound-healing complications were rare with incidence and spectrum of adverse events comparable across all age groups [ 14 ]. Taken together, the adverse events related to bevacizumab are acceptable and well tolerated.…”

Section: Discussionsupporting

confidence: 66%

“…However, the parameters of our analysis that confer substantial reliability to the presented results are, for example, unselective multicenter input of evaluated data and the proportion of tumors with wtKRAS vs mtKRAS, mirroring the proportion of KRAS mutation previously detected in the Czech Republic during a one year survey [ 9 ]. We excluded a potential bias caused by inclusion patients with known KRAS status only, as no difference was observed between PFS of mCRC patients treated in the first-line with bevacizumab and OX- or IRI-based chemotherapy with KRAS-known (11.5 months, 95% CI 11.0-12.1) and KRAS-unknown (11.6 months, 95% CI 11.0-12.2) which is further underlined by KRAS-unselected published data on first-line bevacizumab in mCRC patients based on CORECT registry [ 14 ]. An existing limitation of the present study is that we had no data specifying the type of KRAS mutation, NRAS mutation or data on BRAF mutation.…”

Section: Discussionmentioning

confidence: 93%

Efficacy of bevacizumab and chemotherapy in the first-line treatment of metastatic colorectal cancer: broadening KRAS-focused clinical view

et al. 2015

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BackgroundThe aim of the present retrospective study was to analyze clinical outcome and risk factors associated with treatment outcomes according to KRAS status in patient with metastatic colorectal cancer (mCRC) treated with bevacizumab (bev) plus chemotherapy in the first-line setting.MethodsWe performed observational study on 1622 patients with mCRC treated with bev plus oxaliplatin- or irinotecan-based chemotherapy, and correlated treatment outcomes with KRAS mutation status. The primary endpoint was progression-free survival (PFS) and additionally overall survival (OS). Adverse events of bevacizumab and risk factors including location of metastases were evaluated.ResultsMutation in KRAS was present in 40.6% of mCRC cases. The median PFS in patients with wild-type KRAS (wtKRAS) vs mutant KRAS was 11.5 vs 11.4 months, respectively. The median OS was 30.7 vs 28.4 months (p = 0.312). Patients with KRAS mutation had lung metastases more frequently than wtKRAS individuals (32.0% vs 23.8%; p = 0.001). We observed no difference in clinical outcome between hepatic and extrahepatic metastatic disease.ConclusionKRAS mutation does not interfere with clinical benefit from first-line treatment with bevacizumab plus chemotherapy in mCRC patients.Electronic supplementary materialThe online version of this article (doi:10.1186/s12876-015-0266-6) contains supplementary material, which is available to authorized users.

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“…Three studies reported the presence of primary metastases at diagnosis. The proportion of patients with the presence of synchronous metastasis ranged from 58.0 to 81.2%, and it was similar across the different age groups (Kozloff et al 2010; Slavicek et al 2014; Parakh et al 2015).…”

Section: Resultsmentioning

confidence: 82%

Effect of age on the effectiveness of the first-line standard of care treatment in patients with metastatic colorectal cancer: systematic review of observational studies

Dagher

Sabidó

Zöllner

2019

J Cancer Res Clin Oncol

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Purpose Most metastatic colorectal cancer (mCRC) patients are elderly. This systematic review identifies and describes observational studies evaluating the influence of age on first-line treatment effectiveness in real-world practice. Methods Medline and EMBASE were searched up to May 2016. The included studies were those that investigated first-line treatment of mCRC and reported age groups and overall survival (OS), progression-free survival (PFS) or overall response rate (ORR) were included. Studies published before 2008 were excluded. Study quality was assessed using the Newcastle–Ottawa Scale. Data were evaluated by age group (< 70 vs. ≥ 70 years; 65–75 vs. ≥ 75 years) and outcome. A pooled survival median was calculated for patients (cutoff = 70 years). Results In total, 11 articles with 11,063 patients were included. Four studies using a cutoff of 70 years of age reported OS and PFS, and two studies reported ORRs. In terms of OS, all studies showed a higher OS for those < 70 years of age than for those ≥ 70 years of age. PFS did not find differences by age. For ORRs, one study favoured the younger group, while the second study did not differ by age. Based on three studies, the pooled medians for < 70 years of age and ≥ 70 years of age were the same for PFS (10.2) and were 27.0 and 22.9 for OS, respectively. All included studies were of high or acceptable quality. Conclusions The results suggest that age has no effect on PFS. For ORR, the results were inconsistent between studies. Younger patients in general had better OS, which might be partly explained by more aggressive treatment. This treatment seemed not to be guided by performance status or number of metastatic sites. Electronic supplementary material The online version of this article (10.1007/s00432-019-02948-6) contains supplementary material, which is available to authorized users.

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Efficacy and safety of bevacizumab in elderly patients with metastatic colorectal cancer: results from the Czech population-based registry

Cited by 15 publications

References 24 publications

Bevacizumab plus chemotherapy in elderly patients with previously untreated metastatic colorectal cancer: single center experience

Bevacizumab plus chemotherapy in elderly patients with previously untreated metastatic colorectal cancer: single center experience

Efficacy of bevacizumab and chemotherapy in the first-line treatment of metastatic colorectal cancer: broadening KRAS-focused clinical view

Effect of age on the effectiveness of the first-line standard of care treatment in patients with metastatic colorectal cancer: systematic review of observational studies

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