FOLFOX plus panitumumab or FOLFOX alone as additive therapy following R0/1 resection of RAS wild-type colorectal cancer liver metastases: The PARLIM trial (AIO KRK 0314).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3553-3553
Author(s):  
Dominik Paul Modest ◽  
Meinolf Karthaus ◽  
Stefan Kasper ◽  
Nicolas Moosmann ◽  
Verena Keitel ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Primary Endpoint ◽  
Specific Treatment ◽  
Progression Free Survival ◽  
Favourable Outcome ◽  
Wild Type ◽  
Open Label ◽  
Colorectal Cancer Liver Metastases ◽  
Colorectal Cancer Patients

3553 Background: This trial investigates the addition of panitumumab to chemotherapy with fluorouracil/ folinic acid and oxaliplatin (FOLFOX) in a 2:1 randomized, controlled, open label, phase II trial in RAS wild-type colorectal cancer patients with R0/1-resected liver metastases. Methods: The primary endpoint was progression-free survival (PFS) two years after randomisation. The experimental arm (12 wks of biweekly mFOLFOX6 plus panitumumab followed by 12 wks of panitumumab alone) was considered active if the 2-year-PFS rate was ≥65%. Based on historical data, a 2-year-PFS rate of 50% was estimated in the control arm (12 wks of biweekly FOLFOX). The trial was performed with a power of 80% and an alpha of 0.05. Secondary endpoints included overall survival (OS) and toxicity. The trial is registered with ClinicalTrials.gov, NCT01384994. Results: The full analysis set consists of 70 patients (pts) in the experimental arm and 36 pts in the control arm. The 2-year-PFS rate was 34.3% with FOLFOX plus panitumumab and failed to meet the primary endpoint. The 2-year-PFS rate in the control arm was 25%. In the experimental arm, a more favourable outcome was observed with regard to PFS (HR: 0.72, 95%CI 0.45-1.17; P = 0.18) and OS (HR: 0.76 (95% CI 0.34-1.71, P = 0.51) which did, however, not reach the level of significance. Updated data including toxicity and subgroup analyses might be presented at the meeting Conclusions: The PARLIM trial clearly failed to demonstrate a PFS rate of 65% after resection of colorectal liver metastases 2 years after randomisation, potentially indicating that the generally high frequency of recurrence and the choice of primary endpoint did not correspond in this study population. However, a trend for improved PFS and OS by the addition of panitumumab to 12 wks of FOLFOX followed by 12 wks panitumumab maintenance therapy may support future trials with ant-EGFR antibodies in this specific treatment setting. Clinical trial information: NCT01384994.

LM02-trial perioperative treatment with panitumumab and FOLFIRI in patients with wild-type RAS, potentially resectable colorectal cancer liver metastases.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16046-e16046
Author(s):  
Gudrun Piringer ◽  
Thomas Gruenberger ◽  
Irene Kuehrer ◽  
Dietmar Oefner ◽  
Klaus Kaczirek ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Liver Metastases ◽  
Objective Response ◽  
Progression Free Survival ◽  
Preoperative Therapy ◽  
Wild Type ◽  
Colorectal Cancer Liver Metastases ◽  
Common Grade ◽  
Grade 3

e16046 Background: Nearly half of patients with colorectal cancer develop liver metastases and only 20% are initially resectable. Surgical resection of liver metastases results in five-year survival rates of 24-48%. Perioperative FOLFOX therapy increases progression free survival. In advanced disease the addition of targeting therapies to chemotherapy results in an overall survival advantage. In this study the efficacy and safety of perioperative panitumumab and FOLFIRI therapy were investigated. Methods: Patients with previously untreated, wild-type RAS, potentially resectable colorectal cancer liver metastases were included. Chemotherapy consisted of irinotecan 180mg/m2 intravenously over 120 minutes and fluorouracil bolus 400mg/m2 intravenously, followed by a 46 h infusion of fluorouracil 2400mg/m2 repeated every 2 weeks. Panitumumab was given as an intravenous dose of 6mg/kg every 2 weeks. Preoperative 4 cycles and postoperative 8 cycles were administered. Primary objectives were the evaluation of efficacy and safety. Results: We enrolled 36 patients in 7 centers in Austria. ITT-analyses included 35 patients. There were 28 men and 7 women, the median age was 66 years. 91.4% completed the planned 4 cycles of preoperative therapy and 82.9% underwent liver resection. R0 resection rate was 82.7%. 20 patients started postoperative chemotherapy and 12 patients completed the planned 8 cycles. Objective response rate after preoperative therapy was 65.7% with one radiological complete remission and 22 partial remissions. In 20% and 5.7% of patients stable disease and progressive disease were documented, respectively. Three patients discontinued preoperative treatment due to adverse events without response evaluation. The most common grade 3 adverse events were diarrhea (n = 4), rash (n = 3) and leukopenia (n = 3) during preoperative therapy. One patient died due to sepsis and one had a pulmonary embolism grade 4. After surgery two patients died due to hepatic failure and one patient had a suture related complication grade 3. Most common grade 3/4 adverse events during postoperative therapy were rash (n = 2), stroke (n = 1) and intestinal obstruction (n = 1). Conclusions: Panitumumab in combination with FOLFIRI as preoperative therapy for operable colorectal liver metastases in RAS wild-type patients results in a radiological objective response rate in 65.7% of patients with a manageable grade 3 diarrhea rate of 14.3%. Progression-free survival and overall survival are still monitored. Clinical trial information: 2012_000265-20 .

A single-arm study on the efficacy and safety of regorafenib plus sintilimab as salvage-line treatments in non-MSI-H metastatic colorectal cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e15560-e15560
Author(s):  
Rui Liu ◽  
Xia Wang ◽  
Zhi Ji ◽  
Ting Deng ◽  
Le Zhang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Sample Size ◽  
Objective Response ◽  
Lymphocyte Activation ◽  
Progression Free Survival ◽  
Treatment Interruption ◽  
Wild Type ◽  
Open Label ◽  
Best Response

e15560 Background: PD-1 blockade is particularly ineffective in patients with microsatellite stable (MSS) or mismatch repair (MMR)-proficient colorectal cancer (CRC). Regorafenib (R) has been shown to modulate anti-tumor immunity through different mechanisms, including the reduction of tumor-associated macrophages (TAMs) and lymphocyte activation or immunosuppressive cells, such as forkhead box P3 (Foxp3)+ CD25+ regulatory T cells (Tregs). Synergy between R and anti–PD-1/PD-L1 antibodies has been demonstrated in pre-clinical models compared to that of either treatment alone. Accordingly, this study attempted to evaluate the combined activity of regorafenib with an immune checkpoint inhibitor. Methods: This trial was a prospective, open-label, monocentric, nonrandomized, single arm study. This study included patients with non MSI-H mCRC who received R (80 mg QD 3weeks/4) and sintilimab (S)(200 mg every 3 weeks).The primary endpoint was the confirmed objective response rate (ORR).The secondary endpoints were progression free survival (PFS),overall survival (OS),disease control rate (DCR) and safety. Results: As of January 8, 2021, 24 patients (median age 59 years) with mCRC were enrolled and received treatment with R+S. RAS wild type was 50% of all patients. In addition, 83.3% of patients received two prior lines of treatment, while 58.3% had liver metastases at enrollment. Of the 24 patients, the best response was observed to be stable disease(SD) in six patients (25%) and progressive disease (PD)in four patients (16.7%). Another nine (37.5%) patients have yet to be evaluated. In the 15 evaluated patients, the ORR(RECIST version 1.1) was 33.3% , the DCR was 73.3%. Additionally, among the 10 evaluated patients with liver metastases, the ORR was 30% , the DCR was 80%. Among the nine evaluated patients with wild-type populations of k-ras, the ORR and DCR was found to be 44.4% and 66.7%, which was higher than the mutation patients. The median PFS was 4.2 (95% CI, 2.5, NA) months, the median OS was not reached. The most common grade 3/4 adverse events were palmar-plantar erythro-dysesthesia syndrome (4.2%), erythra (4.2%). No death was related to the treatment. Moreover, four (16.7%) patients were subject to at least 1 dose modification or treatment interruption. Conclusions: In this study, the combination of R+S achieved a similar ORR with REGONIVO. Furthermore, this combination was well tolerated and had a manageable safety profile. However, due to the limited sample size, some biases may be present. As a result, we will continue to expand the sample size for future verification. Clinical trial information: NCT04745130.

scholarly journals Chemotherapy Plus Cetuximab versus Chemotherapy Alone for Patients with KRAS Wild Type Unresectable Liver-Confined Metastases Colorectal Cancer: An Updated Meta-Analysis of RCTs

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
W. Lv ◽  
G. Q. Zhang ◽  
A. Jiao ◽  
B. C. Zhao ◽  
Y. Shi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
R0 Resection ◽  
Cochrane Central Register ◽  
Wild Type ◽  
Resection Rate ◽  
Colorectal Cancer Liver Metastases ◽  
Number Of Patients

Purpose. Our study analyses clinical trials and evaluates the efficacy of adding cetuximab in systematic chemotherapy for unresectable colorectal cancer liver-confined metastases patients. Materials and Methods. Search EMBASE, PubMed, and the Cochrane Central Register of Controlled Trials for RCTs comparing chemotherapy plus cetuximab with chemotherapy alone for KRAS wild type patients with colorectal cancer liver metastases (CRLMs). We calculated the relative risks (RRs) with 95% confidence interval and performed meta-analysis of hazard ratios (HRs) for the R0 resection rate, the overall response rate (ORR), the progression-free survival (PFS) and overall survival (OS). Results. 1173 articles were retrieved and 4 RCTs were available for our study. The four studies involved 504 KRAS wild type patients with CRLMs. The addition of cetuximab significantly improved all the 4 outcomes: the R0 resection rate (RR 2.03, p=0.004), the ORR (RR 1.76, p<0.00001), PFS (HR 0.63, p<0.0001), and also OS (HR 0.74, p=0.04); the last outcome is quite different from the conclusion published before. Conclusions. Although the number of patients analysed was limited, we found that the addition of cetuximab significantly improves the outcomes in KRAS wild type patients with unresectable colorectal cancer liver-confined metastases. Cetuximab combined with systematic chemotherapy perhaps suggests a promising choice for KRAS wild type patients with unresectable liver metastases.

scholarly journals Safety and efficacy of panitumumab in combination with trifluridine/tipiracil for pre-treated patients with unresectable, metastatic colorectal cancer with wild-type RAS: The phase 1/2 APOLLON study

2021 ◽  
Author(s):  
Takeshi Kato ◽  
Yoshinori Kagawa ◽  
Yasutoshi Kuboki ◽  
Makio Gamoh ◽  
Yoshito Komatsu ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Therapeutic Option ◽  
Phase 1 ◽  
Progression Free Survival ◽  
Phase 2 ◽  
Wild Type ◽  
Open Label ◽  
Safety And Efficacy ◽  
Multicentre Phase

Abstract Background We aimed to assess the safety and efficacy of combination treatment with panitumumab plus trifluridine/tipiracil (FTD/TPI) in patients with wild-type RAS metastatic colorectal cancer (mCRC) who were refractory/intolerant to standard therapies other than anti-epidermal growth factor receptor therapy. Methods APOLLON was an open-label, multicentre, phase 1/2 trial. In the phase 1 part, 3 + 3 de-escalation design was used to investigate the recommended phase 2 dose (RP2D); all patients in the phase 2 part received the RP2D. The primary endpoint was investigator-assessed progression-free survival (PFS) rate at 6 months. Secondary endpoints included PFS, overall survival (OS), overall response rate (ORR), disease control rate (DCR), time to treatment failure (TTF), and safety. Results Fifty-six patients were enrolled (phase 1, n = 7; phase 2, n = 49) at 25 Japanese centres. No dose-limiting toxicities were observed in patients receiving panitumumab (6 mg/kg every 2 weeks) plus FTD/TPI (35 mg/m2 twice daily; days 1–5 and 8–12 in a 28-day cycle), which became RP2D. PFS rate at 6 months was 33.3% (90% confidence interval [CI] 22.8–45.3). Median PFS, OS, ORR, DCR, and TTF were 5.8 months (95% CI 4.5–6.5), 14.1 months (95% CI 12.2–19.3), 37.0% (95% CI 24.3–51.3), 81.5% (95% CI 68.6–90.8), and 5.8 months (95% CI 4.29–6.21), respectively. Neutrophil count decreased (47.3%) was the most common Grade 3/4 treatment-emergent adverse event. No treatment-related deaths occurred. Conclusion Panitumumab plus FTD/TPI exhibited favourable anti-tumour activity with a manageable safety profile and may be a therapeutic option for pre-treated mCRC patients.

scholarly journals Yttrium-90 radioembolization for colorectal cancer liver metastases in KRAS wild-type and mutant patients: Clinical and ccfDNA studies

2016 ◽  
Vol 37 (1) ◽  
pp. 57-65 ◽  
Author(s):  
E. Janowski ◽  
O. Timofeeva ◽  
S. Chasovskikh ◽  
M. Goldberg ◽  
A. Kim ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Wild Type ◽  
Colorectal Cancer Liver Metastases ◽  
Yttrium 90

scholarly journals Randomized Phase II Study of SOX+B-mab Versus SOX+C-mab in Patients With Previously Untreated Recurrent Advanced Colorectal Cancer With Wild-Type KRAS (MCSGO-1107 Study)

2021 ◽  
Author(s):  
Yujiro Nishizawa ◽  
Naotsugu Haraguchi ◽  
Hirotoshi Kim ◽  
Yoshihito Ide ◽  
Ken Nakata ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase Ii ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Wild Type ◽  
Open Label ◽  
Randomized Phase Ii ◽  
Early Tumor ◽  
Patient Prognosis ◽  
Clinical Trials Registry

Abstract Background: Although chemotherapy for metastatic colorectal cancer (mCRC) has improved, the standard chemotherapy regimens for patients with RAS wild-type mCRC remain debated.Methods: This randomized phase II, open-label, multicenter study compared the efficacy and safety of S-1 and oxaliplatin (SOX)+bevacizumab (B-mab) with SOX+cetuximab (C-mab) in patients with previously untreated recurrent advanced CRC with wild-type KRAS. Between February 2012 and October 2016, 45 patients were enrolled.Results: Overall response rates were 59.1% and 43.5% (p=0.29) and disease control rates were 90.9% and 91.3% (p=0.96) in the SOX+B-mab and SOX+C-mab groups, respectively. Median overall survival (OS) was 25.3 and 15.5 months (HR=0.607, p=0.167) and median progression-free survival (PFS) were 11.7 and 5.5 months (HR=0.558, p=0.077) in the SOX+B-mab and SOX+C-mab groups, respectively. The OS and PFS of patients with early tumor shrinkage (ETS) were not significantly different in the SOX+B-mab group. However, they were significantly better when ETS was ≥20 in the SOX+C-mab group (p=0.032 and p=0.003, respectively).Conclusions: The efficacy and safety of SOX+B-mab and SOX+C-mab for wild-type KRAS recurrent advanced CRC as first-line chemotherapy were almost the same. Consideration of the treatment strategy based on ETS may improve patient prognosis, especially in patients receiving the SOX+C-mab regimen.Trial registration: UMIN Clinical Trials Registry (UMIN000006706)Date of registration: NOV/11/2011URL of trial registry record:https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007920

Effective salvage therapy of liver-only colorectal cancer metastases with chronomodulated irinotecan-fluorouracil-oxaliplatin via hepatic artery infusion

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3585-3585
Author(s):  
M. Bouchahda ◽  
R. Adam ◽  
S. Giacchetti ◽  
X. M. Li ◽  
D. Castaing ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Hepatic Artery ◽  
Therapeutic Potential ◽  
Performance Status ◽  
Sensory Neuropathy ◽  
Progression Free Survival ◽  
Hepatic Artery Infusion ◽  
Colorectal Cancer Liver Metastases ◽  
Heavily Pretreated

3585 Background: Cell cycle and pharmacology genes are controlled by the molecular clock in normal liver but not in tumors (Filipski et al. JNCI 2005). As a result, circadian-based hepatic artery infusions of 3 main active drugs (ChronoHAI) could improve both tolerability and efficacy in patients (pts) with liver metastases from colorectal cancer. Methods: The therapeutic potential of 3-drug chronoHAI was evaluated in 28 heavily pretreated non hospitalized pts with metastatic colorectal cancer (MCC). They received 5-day (d) q21 d courses (c) with d1 irinotecan (160 mg/m2 from 2 to 8 am, peak at 5 am) and d2–5 oxaliplatin (20 mg/m2/d from 10 am to 10 pm, peak at 4 pm) and 5-fluorouracil (600 mg/m2/d from 10 pm to 10 am, peak at 4 am). 149 courses (c) were given (median, 5 ; 1–15) using a multichannel pump (Mélodie, Aguettant, F). Toxicity was assessed q21 d and response q3 c with CT scan. Results: Pt characteristics: prior chemotherapy lines 1/2/3/4+: 3/4/8/13 pts; WHO Performance Status 0/1/2/3 : 12/9/6/1 pts; median age: 63 years (32–73); liver only: 21 pts; liver and lung: 7 pts. Treatment was withdrawn for thrombosis (6 pts) and/or Grade (gr) 3 abdominal pain (3 pts). Grade 3–4 diarrhea and vomiting respectively occurred in 6 pts (21%) and 4 pts (14%) and were the main toxicities. Leucopenia, anemia and thrombocytopenia were respectively encountered in 5, 2 and 1 pt (< 18%). NCIC gr 3 sensory neuropathy occurred in 4 pts and alopecia in 3 pts. Of 25 pts with measurable lesions, disease progressed in 11 pts (exclusively outside the liver for 3 pts) and was controlled in 14 pts (56%), including 8 objective responses - 32% [95% C.L. 13.4 to 50.6]. Partial hepatectomy was performed in 3 pts with measurable disease (12%): R0 (2 PR) and R1 (1 SD). Median Progression free survival is 5 months [2.5 to 7.5] and median survival is 18.4 mo [10.5 to 26.3]. Five pts are alive at 2 to 51 mo. Conclusions: 3-drug chronoHAI is safe in heavily pretreated pts and achieves consistent activity against colorectal cancer liver metastases despite prior failure to oxaliplatin, irinotecan and fluorouracil. The addition of systemic molecular targeted therapy could be useful for preventing extra hepatic dissemination. Supported by ARTBC, Hôpital P. Brousse, Villejuif, France No significant financial relationships to disclose.

A randomized clinical trial of chemotherapy compared to chemotherapy in combination with cetuximab in k-RAS wild-type patients with operable metastases from colorectal cancer: The new EPOC study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3504-3504 ◽  
Author(s):  
John Neil Primrose ◽  
Stephen Falk ◽  
Meg Finch-Jones ◽  
Juan W. Valle ◽  
David Sherlock ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Liver Metastases ◽  
Egf Receptor ◽  
Primary Tumour ◽  
Data Monitoring Committee ◽  
Progression Free Survival ◽  
Study Data ◽  
Wild Type ◽  
Free Survival

3504 Background: Resection of liver metastases from colorectal cancer with or without neoadjuvant chemotherapy is the standard of care. The EPOC study (Nordlinger et al, Lancet 2008) randomised patients between surgery and surgery with chemotherapy and demonstrated an improvement in 3 year progression free survival (PFS) of 7·3% (from 28·1% to 35·4%). As a rational extension to the EPOC study data, the New EPOC study evaluates the benefit of cetuximab, an EGF receptor antibody, in addition to standard chemotherapy in patients with operable liver metastases. Methods: 272 patients were randomised between February 2007 and November 2012 into the New EPOC study. Eligible patients were required to be k-RAS wild type, have operable liver metastases and to be sufficiently fit for chemotherapy and surgery. Patients with the primary tumour in situ, and those who required short course rectal radiation were eligible. Patients were randomised to receive a fluoropyrimidine and oxaliplatin plus or minus cetuximab for 12 weeks before, then 12 weeks following surgery. Patients who had been treated with adjuvant oxaliplatin could receive irinotecan and 5 – fluorouracil. Results: Following a recommendation from the Independent Data Monitoring Committee on 19/11/2012, the New EPOC study was stopped when the study met a protocol pre-defined futility analysis. With 45.3% (96/212) of the expected events observed, progression free survival was significantly worse in the cetuximab arm (14.8 vs 24.2 months, HR (95%CI) 1.50037 (1.000707 to 2.249517) p< 0.048). The result of a pre-planned analysis excluding the 23 patients treated with irinotecan based chemotherapy was similar (15.2 vs 24.2 months, HR 1.565546 (1.014967-2.414793) P<0.043). Conclusions: Although the data are immature, the accumulation of more events is unlikely to change this result. In patients with resectable liver metastases and K-RAS wt tumours the addition of cetuximab to chemotherapy is not beneficial. Clinical trial information: ISRCTN22944367.

The Association of FCGR2A and FCGR3A polymorphisms with outcomes in cetuximab treated metastatic colorectal cancer patients: CCTG and AGITG CO.20 trial analysis.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 633-633
Author(s):  
Daniel Shepshelovich ◽  
Amanda Rose Townsend ◽  
Osvaldo Espin-Garcia ◽  
Lidija Latifovic ◽  
Christopher J. O'Callaghan ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Cancer Patients ◽  
Progression Free Survival ◽  
Wild Type ◽  
Genotype Combination ◽  
Trial Analysis ◽  
Germline Polymorphism ◽  
Intermediate Outcomes ◽  
Colorectal Cancer Patients

633 Background: We previously reported that the Fc-gamma receptor (FCGR) germline polymorphism in the FCGR2A gene (rs1801274; His (H) to Arg (R) substitution) but not FCGR3A (rs396991; Phe (F) to Val (V)) was associated with cetuximab benefit on overall survival (OS) in metastatic colorectal cancer patients (CCTG CO.17 trial). We performed a validation of these results in CO.20, a randomized trial of cetuximab+placebo vs. cetuximab+brivanib for metastatic, chemotherapy refractory, wild type K-RAS colorectal cancer. Methods: After genotyping DNA extracted from whole blood, the polymorphism relationships with OS and progression-free survival (PFS) were assessed using log-rank tests and hazard ratios (HR) from Cox proportional hazard models, adjusting for known prognostic factors. Results: Of 592/725 (82%) K-RAS wild type patients with available DNA and genotyping, those carrying the higher affinity FCGR2A H/H genotype (N = 165; 28%) had improved OS (HR 0.53; 95%CI:0.41-0.68) and PFS (HR 0.65; 95%CI:0.51-0.83) compared to those carrying the lower affinity R/R genotype (N = 128; 22%), corresponding to median absolute benefits of 3.7 (OS) and 3.3 months (PFS). The H/R genotype (N = 299; 50%) had intermediate outcomes. No significant associations were found between FCGR3A genotype and OS or PFS. No interaction between FCGR polymorphisms and treatment arm was observed. Patients carrying the double wild type combination of FCGR2A H/H and FCGR3A F/F genotypes (N = 45; 7.6%) had significantly better outcomes than other patients, particularly those carrying the rare (N = 11; 2%) R/R+ V/V genotype combination, corresponding to median absolute benefits of 12.5 (OS; HR 0.33 95%CI:0.16-0.68) and 4.5 (PFS; HR 0.45 95%CI:0.22-0.92) months. There were no significant associations between FCGR polymorphisms and either any grade of 3/4 toxicity or skin rash. Conclusions: In KRAS-wild type, cetuximab-treated patients, FCGR2A polymorphism was independently replicated to be associated with clinical outcome without affecting toxicity profiles. Additionally, in this large dataset, FCGR3A appears to modulate the relationship between FCGR2A polymorphism and outcome.

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