https://scholars.lib.ntu.edu.tw/handle/123456789/543458
標題: | Efficacy, Tolerability, and Biomarker Analyses of Once-Every-2-Weeks Cetuximab Plus First-Line FOLFOX or FOLFIRI in Patients With KRAS or All RAS Wild-Type Metastatic Colorectal Cancer: The Phase 2 APEC Study | 作者: | ANN-LII CHENG Cornelio G. Shen L. Price T. Yang T.-S. Chung I.J. Dai G.-H. Lin J.-K. Sharma A. KUN-HUEI YEH Ma B. Zaatar A. Guan Z. Masood N. Srimuninnimit V. Yau T. Gibbs P. Wang X. Doval D.C. Oh S.-T. Shim B.Y. Gorospe C. Wang H.-M. Sirachainan E. Hill A. Suh K.W. Beier F. Chatterjee S. Lim R. |
公開日期: | 2017 | 出版社: | Elsevier Inc. | 卷: | 16 | 期: | 2 | 起(迄)頁: | e73-e88 | 來源出版物: | Clinical Colorectal Cancer | 摘要: | The nonrandomized phase 2 APEC trial investigated first-line once-every-2-weeks cetuximab plus chemotherapy (investigator's choice of FOLFOX or FOLFIRI) studied patients with KRAS/RAS wild-type metastatic colorectal cancer. We observed an activity and safety profile similar to that reported in prior first-line pivotal studies involving weekly cetuximab, suggesting that once-every-2-weeks cetuximab is effective and tolerable as first-line therapy. Background In patients with KRAS wild-type (wt) metastatic colorectal cancer (mCRC), outcomes with first-line chemotherapies are improved by adding weekly cetuximab. The APEC study investigated first-line once-every-2-weeks cetuximab plus chemotherapy for patients with KRAS wt mCRC; additional biomarker subgroups were also analyzed. Patients and Methods APEC was a nonrandomized phase 2 trial conducted in the Asia-Pacific region. Patients (n = 289) received once-every-2-weeks cetuximab with investigator's choice of chemotherapy (FOLFOX or FOLFIRI). The primary end point was best confirmed overall response rate (BORR); progression-free survival (PFS) and overall survival (OS) were secondary end points. Early tumor shrinkage (ETS) and depth of response (DpR) were also evaluated. Results In the KRAS wt population, BORR was 58.8%, median PFS 11.1 months, and median OS 26.8 months. Expanded RAS mutational analysis revealed that patients with RAS wt mCRC had better outcomes (BORR = 64.7%; median PFS = 13.0 months; median OS = 28.4 months). The data suggest that ETS and DpR may be associated with survival outcomes in the RAS wt population. Although this study was not designed to formally assess differences in outcome between treatment subgroups, efficacy results appeared similar for patients treated with FOLFOX and FOLFIRI. There were no new safety findings; in particular, grade 3/4 skin reactions were within clinical expectations. Conclusion The observed activity and safety profile is similar to that reported in prior first-line pivotal studies involving weekly cetuximab, suggesting once-every-2-weeks cetuximab is effective and tolerable as first-line therapy and may represent an alternative to weekly administration. ? 2016 The Author(s) |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85001720473&doi=10.1016%2fj.clcc.2016.08.005&partnerID=40&md5=2736a9757e9b20a578394b86b784b3d8 https://scholars.lib.ntu.edu.tw/handle/123456789/543458 |
ISSN: | 1533-0028 | DOI: | 10.1016/j.clcc.2016.08.005 | SDG/關鍵字: | biological marker; cetuximab; fluorouracil; folinic acid; irinotecan; oxaliplatin; antineoplastic agent; camptothecin; cetuximab; fluorouracil; folinic acid; KRAS protein, human; platinum complex; protein p21; Ras protein; tumor marker; Article; continuous infusion; dermatitis; diarrhea; drug efficacy; drug safety; drug tolerability; drug withdrawal; fatigue; hand foot syndrome; heart disease; human; hyperglycemia; hypokalemia; hypophosphatemia; infusion related reaction; intestine obstruction; leukopenia; metastatic colorectal cancer; mucosa inflammation; multicenter study; multiple cycle treatment; neutropenia; oncogene K ras; oncogene ras; overall survival; paronychia; peripheral neuropathy; phase 2 clinical trial; progression free survival; rash; sensory neuropathy; sepsis; skin manifestation; stomatitis; treatment outcome; treatment response; vomiting; aged; analogs and derivatives; clinical trial; colorectal tumor; disease free survival; drug administration; female; genetics; male; metabolism; metastasis; middle aged; pathology; survival rate; Aged; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Camptothecin; Cetuximab; Colorectal Neoplasms; Disease-Free Survival; Drug Administration Schedule; Female; Fluorouracil; Humans; Leucovorin; Male; Middle Aged; Neoplasm Metastasis; Organoplatinum Compounds; Proto-Oncogene Proteins p21(ras); ras Proteins; Survival Rate |
顯示於: | 腫瘤醫學研究所 |
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