Real-world treatment outcomes from nationwide ONCO-colon Turkey registry in RAS wi̇ld-type patients treated with biologics first-line metastatic colorectal cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e15561-e15561
Author(s):  
Umut Kefeli ◽  
Cagatay Arslan ◽  
Mahmut Emre Yildirim ◽  
Abdurrahman Isikdogan ◽  
Nuri Karadurmus ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Response Rate ◽  
Wild Type ◽  
First Line ◽  
Real World Data ◽  
Mutant Type ◽  
Anti Vegf

e15561 Background: Efficacy of anti-angiogenic and anti-EGFR agents has been demonstrated metastatic colorectal cancer (mCRC). Real-world evidence is especially important to detect the findings of patients outside of clinical trials. It complements together with clinical trials. However, there are a few studies that evaluated these treatments with biologics in the real-world setting. Recognizing the change that has occurred over the years will also shed light on future approaches. Therefore, we aimed to investigate the real-world data of patients with RAS-wild type mCRC. Methods: Medical records from 28 centers were collected for patients diagnosed with RAS wild-type mCRC between January 2016 and April 2019 and were included into the study. Histopathological, molecular and clinical characteristics of the patients were recorded. The treatment duration, response rate, progression-free survival and safety results were determined. Also, changes over the years were compared. Patients were compared according to the first-line biological treatments as anti-EGFR group (Group A and B) (panitumumab and cetuximab) and anti-VEGF group (group C). Results: Patients with KRAS mutant type were 43,6% and 6.1% patients were NRAS mutant type. A total of 1064 patients with documented RAS wild-type status were evaluated. 33%, 37% and 30% of all first line patients were treated with regimen including panitumumab, cetuximab and anti-VEGF, respectively. The median follow-up time was 24 (1-59) months. Median age was 61 (17-88) years. Thirty-five percent of the patients were female. Twenty percent of the patients had a right-sided colon tumor. Patients received median 6 cycles of treatment. Also, responded patients received median 6 cycles of treatment as maintenance treatment with biologics plus fluoropyrimidine. Overall response rate was 46,4%, 41,9% and 41,5% in A, B and C group respectively (p = 0,170). The median OS was 26, 27, and 23 months in A, B and C group respectively (p = 0.044). The median PFS of the patients in first-line setting that received panitumumab, cetuximab and bevacizumab were 11.6 (SE:0,6; 95% CI: 10.4-12.7), 11.0 (SE:0,5; 95% CI: 9.9-12.0), and 9.6 (SE:0,4; 95% CI: 8.8-10.4) months respectively (p = 0.012). In univariate analysis, female gender (p = 0.030), left sided tumors(p = 0.001), ECOG performance status (PS) 0-1 (p = 0.001), normal CEA level at initial diagnosis(p = 0.001) and treatment with anti-EGFR agents(p = 0.016) were found as favorable factors. PS 0-1 and normal CEA level at initial diagnosis were found as independent prognostic factors in multivariate analysis (p = 0.049, p = 0.031 respectively). Conclusions: This analysis of real-world data confirms the comparable efficacy of anti-EGFR agents in RAS-wild type mCRC. However, anti-EGFR treatment provides PFS and OS advantage when compared with anti-VEGF treatment in these patients.

Cetuximab with irinotecan or oxaliplatin for first-line metastatic colorectal cancer: Effectiveness in the EREBUS cohort compared to pivotal trials.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e14542-e14542
Author(s):  
Annie Fourrier-Réglat ◽  
Magali Rouyer ◽  
Pernelle Noize ◽  
Emmanuelle Bignon ◽  
Alise Le Monies ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Treatment Initiation ◽  
Response Rate ◽  
Real Life ◽  
Wild Type ◽  
First Line ◽  
Multicenter Cohort Study ◽  
Baseline Characteristics ◽  
One Year

e14542 Background: Cetuximab (CTX) has demonstrated improved survival outcomes in metastatic colorectal cancer (mCRC) but information from real-life use is sparse. Here, CTX survival and safety outcomes in real-life are compared to those observed in OPUS and CRYSTAL trials. Methods: EREBUS is a French multicenter cohort study that included over two years (2009-2010) patients with unresectable mCRC and wild-type KRAS initiating CTX as 1st-line therapy in 65 centres and followed for 12 months from treatment initiation. Results: We included 389 patients treated with a combination of CTX with irinotecan-based (56.0%) or CTX with oxaliplatin-based (37.8%) chemotherapy. The main characteristics, safety, response rate, and one year survival of this cohort are presented in the Table below in parallel with results obtained in pivotal trials. Conclusions: Despite differences in baseline characteristics between real-life and pivotal trials (such as ECOG status), the response rate and PFS were comparable in mCRC patients with wt KRAS treated with 1st-line CTX. The nature of adverse events was in-line with the trials but the frequency was lower probably owing to under-notification in real-life. [Table: see text]

Is oxaliplatin a good partner for EGFR monoclonal antibodies as first-line treatment in KRAS wild-type metastatic colorectal cancer? A meta-analysis.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e14645-e14645
Author(s):  
Feng Wen ◽  
Qiu Li ◽  
Ruilei Tang ◽  
Yaxiong Sang ◽  
Meng Li ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Monoclonal Antibodies ◽  
Metastatic Colorectal Cancer ◽  
Response Rate ◽  
Meta Analysis ◽  
Fixed Effect ◽  
Line Treatment ◽  
Wild Type ◽  
First Line ◽  
First Line Treatment

e14645 Background: This meta-analysis was performed to determine whether the addition of monoclonal antibodies (mAbs) of epidermal growth factor receptor (EGFR) to oxaliplatin-based chemotherapy treatment improves efficacy in KRAS wild-type metastatic colorectal cancer (mCRC), and whether infusional 5-fluorouracil (5-FU) and oxaliplatin is a preferred combination for EGFR mAbs. Methods: Oxaliplatin (including treatment), EGFR mAbs, first-line treatment, KRAS wild-type, and mCRC were used as key words. The PRIME, OPUS, COIN, and NORDIC VII trials were identified by two independent authors. Time-to-event outcomes of overall survival (OS) and progression-free survival (PFS) were analyzed using HRs (Hazard Ratios) with fixed effect, and response rate (RR) using odd ratios (OR) with fixed effect. Results: A total of 1,767 patients who were KRAS wild-type were included in this meta-analysis, with 866 patients in the mAbs and chemotherapy combination group and 901 patients in the chemotherapy alone group. The addition of mAbs to oxaliplatin-based chemotherapy in patients with KRAS wild-type mCRC as first-line treatment resulted in significant improvements in PFS (HR=0.88; 95% confidence interval (CI), 0.79 to 0.99; P=0.03) and response rate (RR) (OR = 1.38; 95% CI, 1.14 to 1.66; P = 0.009) compared with chemotherapy alone, but the difference in OS was not significant (HR=0.96; 95% CI, 0.85 to 1.08; P=0.48). However, the differences neither in OS nor in PFS were not significant when mAbs were added to bolus 5-FU or capecitabine-based regimens compared with chemotherapy alone, whereas PFS improved with an infusional 5-FU and oxaliplatin combination (P=0.06; PFS, HR=0.76; 95% CI, 0.65 to 0.86; P=0.0002), and even OS was marginally significant. Conclusions: Oxaliplatin and infusional 5-FU regimen tends to be a better backbone combination with EGFR mAbs as first-line treatment in KRAS wild-type mCRC.

Observational study of the first-line chemotherapy including cetuximab in patients with metastatic colorectal cancer: CORAL trial.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 539-539
Author(s):  
Kei Muro ◽  
Michio Itabashi ◽  
Hiroki Hashida ◽  
Toshiki Masuishi ◽  
Masanori Kotake ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Treatment Time ◽  
Wild Type ◽  
First Line ◽  
Mutant Type ◽  
Skin Symptoms ◽  
Grade 3 ◽  
Line Chemotherapy

539 Background: The combination therapy of Cetuximab (Cmab) + chemotherapy is one option as the first-line chemotherapy for KRAS wild-type metastatic colorectal cancer (mCRC). The efficacy of Cmab+FOLFIRI has been shown by CRYSTAL trail. There has been little experience of Cmab as the first-line chemotherapy in Japan, the data on Cmab combined with other drugs are insufficient, and efficacy according to the ESMO guideline groups (groups 1, 2, 3) has not yet been reported. Methods: The subjects were mCRC patients with PS 0-2 who received the first-line chemotherapy including Cmab, either in combination with chemotherapy or as monotherapy. Treatment duration, reason of discontinuation of the first-line chemotherapy (PD, conversion to surgery, adverse events), the second-line treatment, time to treatment failure, progression-free survival, response rate (RR), changes in paraneoplastic symptoms, skin symptoms (incidence, degree, prevention), and incidence and degree of other adverse events were investigated. Results: The 578 patients from the 158 institutes between January 2012 and June 2013 were enrolled. There were PS0/1/2 at 409/144/25, male/female at 368/210, median age of 65 (31-88) and groups 1/2/3 at 172/231/175. KRAS was wild type/mutant type/undetermined in 95.5%/2.4%/2.1%. Chemotherapies combined with Cmab were oxaliplatin-based/irinotecan-based/others (377/176/25). In evaluable cases, RR in groups 1/2/3 were 68.3%/50.8%/41.7%. In the frequency of skin symptoms reported up to 8 weeks/16 weeks, acneform rash was observed in 70.1%/62.1% (all grades) and in 1.2%/5.7% (grade 3 or higher), while paronychia was in 32.1%/40.6% (all grades) and in 2.6%/9.4% (grade 3 or higher). Liver resection rate and survivals are to be examined in the future. Conclusions: This is the first report on the first-line chemotherapy using Cmab, with RR as efficacy and skin symptoms as safety. Efficacy of the patients with the first-line chemotherapy using Cmab is different among 3 groups. This study is sponsored by the Public Health Research Center Foundation CSPOR in Japan. Clinical trial information: UMIN000007275.

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