State Key Laboratory of Oncology in South China

facilityđź“Ť Guangzhou, China
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Alpha-gal Syndrome Publications
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Alpha-gal Syndrome Researchers

Associated Institutions

Sun Yat-sen University
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Publications

CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients: promising findings from a prospective, open-label, randomized, phase III trial.

Shi Y, Li J, Xu J, Sun Y, Wang L, et al.
Cancer communications (London, England) •

The 5-fluorouracil/leucovorin plus oxaliplatin (FOLFOX) regimen is the standard first-line treatment for metastatic colorectal cancer (mCRC), however, the optimal second-line regimen for KRAS wild-type mCRC patients is still investigational. In this study, we aimed to determine the clinical efficacy and safety of CMAB009 plus irinotecan compared to irinotecan-only as a second-line regimen for treating KRAS wild-type mCRC patients. Patients with KRAS wild-type mCRC who had previously failed to respond to FOLFOX treatment were randomly assigned in a 2:1 ratio, to receive CMAB009 plus irinotecan or irinotecan-only. Patients receiving irinotecan-only were permitted to switch to CMAB009 therapy on disease progression and were grouped as the sequential-CMAB009 arm. The primary endpoints were overall response rate (ORR) and median progression-free survival (PFS). The secondary endpoints were median overall survival (OS), disease control rate (DCR), clinical benefit rate (CBR), and duration of response (DOR). The CMAB009 plus irinotecan arm demonstrated significantly improved ORR (33.2% vs. 12.8%; P < 0.001) and longer median PFS (169 days vs. 95 days; P < 0.001) as compared to the irinotecan-only arm. Patients receiving CMAB009 plus irinotecan also demonstrated improved DCR (80.1% vs. 65.2%, P < 0.001), CBR (30.0% vs. 14.6%, P < 0.001), and DOR (210 days vs. 109 days; P < 0.001) as compared to irinotecan-only. However, patients treated with CMAB009 had an increased risk of skin rash (66.9% vs. 5.5%, P < 0.001) and paronychia (9.8% vs. 0.0%, P < 0.001). Anti-drug antibodies (ADA) were detected in 3.6% of patients, and only 0.9% of patients who received CMAB009 experienced hypersensitivity reactions. In patients receiving sequential-CMAB009 therapy after failure with irinotecan, their median PFS was 84 days (95% CI 65 to 113 days). The median OS was 425 days for patients receiving CMAB009 plus irinotecan and 401 days for those with sequential-CMAB009 (P = 0.940). Treatment with CMAB009 plus irinotecan was found to be a superior second-line regimen in comparison to irinotecan-only in KRAS wild-type mCRC patients. Further, switching to CMAB009 can be considered as an efficient third-line of treatment after treatment failure with second-line irinotecan-only. Trial registration ClinicalTrials.gov: NCT01550055, retrospectively registered on March 9, 2012.

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[Efficacy of cetuximab combined with chemotherapy on advanced colorectal cancer: a report of 53 cases].

Guo GF, Xia LP, Zhang B, Jiang WQ, Liu MZ, et al.
Ai zheng = Aizheng = Chinese journal of cancer •

Studies showed that cetuximab combined with chemotherapy was effective on advanced colorectal cancer (ACRC) in recent years, however, few reports based on large case cohort are available in China. This study was to analyze the efficacy of cetuximab combined with chemotherapy for 53 chinese patients with ACRC. Clinical data of 53 patients with ACRC, treated with cetuximab combined with chemotherapy in Sun Yat-sen Cancer Center from March 2005 to April 2008, were analyzed for short-term efficacy and safety. The efficacy of the regimen used as first-line and non-first-line treatment was compared by Chi-square test; the effect of the regimen on prognosis was analyzed by multivariate Cox proportional hazards model. Of the 53 patients with colorectal adenocarcinoma, 40 were men and 13 were women, with a median age of 55 years. A total of 572 weeks (median, 8 weeks) of cetuximab treatment were completed. The overall response rate (RR) of the regimen was 39.6% and the disease control rate 66.0%. The disease control rates were similar when the regimen was used as first-line and non-first-line treatment (80.3% vs. 60.5%, P=0.177). For all 53 patients, clinical stage was an independent prognostic factor (P=0.002, OR>1). The most common Grade 3 to 4 adverse events included acne-like rash (7.5%), neutropenia (18.9%), and diarrhea (5.6%). No hypersensitive reaction or treatment-related death was observed. Only one patient discontinued treatment because of Grade 4 diarrhea and neutopenia. Cetuximab combined with chemotherapy can achieve relatively high disease control rate for ACRC patients, with less adverse events. Whether cetuximab has better effect in first-line treatment than in non-first-line treatment needs further study.

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