RE: A Randomized Phase II/III Study of Dalotuzumab in Combination With Cetuximab and Irinotecan in Chemorefractory, KRAS Wild-Type, Metastatic Colorectal Cancer

JNCI: Journal of the National Cancer Institute, Mar 2016

Wen-zhuo, He, Liang-ping, Xia

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RE: A Randomized Phase II/III Study of Dalotuzumab in Combination With Cetuximab and Irinotecan in Chemorefractory, KRAS Wild-Type, Metastatic Colorectal Cancer

JNCI J Natl Cancer Inst ( correspondence RE: A?Randomized Phase II/III Study of Dalotuzumab in Combination With Cetuximab and Irinotecan in Chemorefractory, KRAS Wild-Type, Metastatic Colorectal Cancer He?Wen-zhuo 0 1 2 3 4 Xia?Liang-ping 0 1 2 3 4 0 3. Loupakis F , Pollina L, Stasi I, et al. PTEN expression and KRAS mutations on 1 2. Artale S, Sartore-Bianchi A, Veronese SM, et al. Mutations of KRAS and BRAF 2 Affiliations of authors: VIP Region, Sun Yat-sen University Cancer Center , Guangzhou, Guangdong , P. R. China (HWz , XLp); State Key Laboratory of Oncology in 3 orefractory, KRAS Wild-Type, Metastatic Colorectal Cancer.J Natl Cancer Inst 4 South China; Collaborative Innovation Center for Cancer Medicine; Guangzhou , Guangdong , P. R. China, HWz, XLp of Dalotuzumab in Combination With Cetuximab and Irinotecan in Chem- Chemorefractory - Correspondence With great interest, we read the study by Sclafani et? al. about they selected mRNA expression of IGF-1 as a biomarker because the role of dalotuzumab in KRAS wild-type metastatic colorecmRNA might be significantly affected by tissue fixation, espe tal cancer (mCRC) patients ( 1 ). The study ended up with a con cially in formalin fixation (4). Third, even if mRNA expression clusion that dalotuzumab could not improve survival of KRAS analyses of formalin-fixed, paraffin-embedded samples are wild-type mCRC patients. The authors also suggested that fur acceptable, the authors need to further discuss why they chose ther biomarker-driven studies are warranted because insulin25% as cutoff point for IGF-1. Fourth, it is difficult to understand like growth factor type 1 (IGF-1) receptor ligands are promising why the authors performed subgroup analyses only between biomarkers. arms A? and C.? Given the fact that numerically better survival Indeed, the development of targeted therapies is increas was achieved in arm B than arm A, we would like to suggest the ingly dependent on our knowledge of biomarker. We have sevauthors provide detailed overall survival and progression-free eral concerns about the biomarker analyses of Prof. Sclafani?s survival results in patients with IGF-1-overexpressing tumors study. First, we would like to suggest the authors to further and low IGF-1 tumors in arm B, respectively. clarify the origin of tumor tissue used for biomarker analyses. In the past few years, more and more studies emphasized different expression of certain biomarkers between primary tumors and matched metastatic sites in various types of tumors, including colorectal cancer 2(,3). The discrepancy between pri mary and metastatic sites may weaken the predictive value of IGF-1. We noticed that the authors mentioned that data on source of tumor were not available. As the authors claimed in the discussion, perhaps it was difficult to distinguish source of tumor between right-side colon and left-side colon or rectum, but we believe it might be feasible to clarify primary or metastatic tumor based on formalin-fixed, paraffin-embedded tissue. Second, we would like to recommend the authors discuss why in primary and matched metastatic sites of colorectal cancer.J Clin Oncol. primary tumors and metastases in the prediction of benefit from cetuximab plus irinotecan for patients with metastatic colorectal cancer.J Clin Oncol. ation for targeted therapies in cancer.Nat Rev Clin Oncol. 2015;12(4):197?212. by 1. Sclafani F , Kim TY , Cunningham D , et? al. A Randomized Phase II /III Study


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Wen-zhuo, He, Liang-ping, Xia. RE: A Randomized Phase II/III Study of Dalotuzumab in Combination With Cetuximab and Irinotecan in Chemorefractory, KRAS Wild-Type, Metastatic Colorectal Cancer, JNCI: Journal of the National Cancer Institute, 2016, DOI: 10.1093/jnci/djv404