دورية أكاديمية
أعرض في EDS

Randomized study of etirinotecan pegol versus irinotecan as second-line treatment for metastatic colorectal cancer.

التفاصيل البيبلوغرافية
العنوان: Randomized study of etirinotecan pegol versus irinotecan as second-line treatment for metastatic colorectal cancer.
المؤلفون: Lenz HJ; USC Norris Comprehensive Cancer Center, 1441 Eastlake Ave Rm 3456, Los Angeles, CA, 90089-9173, USA. lenz@med.usc.edu., Philip P; Barbara Ann Karmanos Cancer Institute, 4th Fl, HWCRC 4100 John R Detroit, Detroit, MI, 48201, USA.; Wayne State University, Detroit, MI, USA., Saunders M; Christie Hospital NHS Foundation Trust, Wilmslow Road, Manchester, M20 4BX, UK., Kolevska T; Kaiser Permanente Medical Center, 2nd Floor, Hallway C, 975 Sereno Drive, Vallejo, CA, 94589, USA., Mukherjee K; Chittaranjan National Cancer Institute, 37 Shyama Prasad Mukherjee Road, Bhawanipur, Kolkata, West Bengal, 700026, India., Samuel L; ANCHOR Unit Clinic D, Aberdeen Royal Infirmary, Aberdeen, AB25 2ZN, UK., Bondarde S; Shatabdi Super Specialty Hospital, Suyojit City Center, Mumbai Naka, Nashik, 422 005, India., Dobbs T; Tennessee Cancer Specialists, 1415 Old Weisgarser Road, Knoxville, TN, 37909-1292, USA., Tagliaferri M; Nektar Therapeutics, 455 Mission Bay Boulevard South, San Francisco, CA, 94158, USA., Hoch U; Nektar Therapeutics, 455 Mission Bay Boulevard South, San Francisco, CA, 94158, USA., Hannah AL; Nektar Therapeutics, 455 Mission Bay Boulevard South, San Francisco, CA, 94158, USA., Berkowitz M; UCLA Geffen School of Medicine, 201 S. Buena Vista Street, Suite 200, Burbank, CA, 91505, USA.
المصدر: Cancer chemotherapy and pharmacology [Cancer Chemother Pharmacol] 2017 Dec; Vol. 80 (6), pp. 1161-1169. Date of Electronic Publication: 2017 Oct 17.
نوع المنشور: Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial
اللغة: English
بيانات الدورية: Publisher: Springer Verlag Country of Publication: Germany NLM ID: 7806519 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-0843 (Electronic) Linking ISSN: 03445704 NLM ISO Abbreviation: Cancer Chemother Pharmacol Subsets: MEDLINE
أسماء مطبوعة: Publication: Berlin : Springer Verlag
Original Publication: Berlin, New York, Springer International.
مواضيع طبية MeSH: Antineoplastic Agents/*therapeutic use , Camptothecin/*analogs & derivatives , Colorectal Neoplasms/*drug therapy , Heterocyclic Compounds, 4 or More Rings/*therapeutic use , Polyethylene Glycols/*therapeutic use, Adult ; Aged ; Aged, 80 and over ; Camptothecin/therapeutic use ; Colorectal Neoplasms/pathology ; Disease-Free Survival ; Female ; Humans ; Irinotecan ; Male ; Middle Aged ; Neoplasm Metastasis
مستخلص: Purpose: Etirinotecan pegol (EP) is a long-acting topoisomerase-I inhibitor designed to provide sustained exposure to SN-38 (active metabolite of irinotecan). This phase II study compared EP versus irinotecan as second-line treatment for KRAS-mutant, irinotecan-naïve, metastatic colorectal cancer (mCRC).
Methods: Patients were randomized to EP 145 mg/m 2 or irinotecan 350 mg/m 2 Q21d until disease progression/unacceptable toxicity. The primary endpoint was progression-free survival (PFS) with response determined by central radiologic review (RECIST version 1.1).
Results: The study was terminated before completing accrual due to evolving standards of care. Eighty-three patients were randomized. Median PFS was longer with EP versus irinotecan (4.0 versus 2.8 months, respectively; HR 0.65; 95% CI 0.40-1.04; P = 0.07). Six-month PFS rates were 32.8 and 15.4%, respectively. Median OS was 9.6 and 8.4 months in EP and irinotecan arms, respectively (HR 0.91; 95% CI 0.56-1.49). ORRs were 10 and 5%, respectively (P = 0.676); median DOR was significantly longer in EP arm (7.9 versus 1.4 months; P = 0.018). The most common grade-3/4 adverse events for EP and irinotecan were diarrhea (21 vs 20%), neutropenia (10 vs 22%), abdominal pain (14 vs 5%), nausea (14 vs 2%), and vomiting (12 vs 7%), respectively.
Conclusion: EP is active and safe for second-line treatment of KRAS-mutant, irinotecan-naïve mCRC.
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معلومات مُعتمدة: P30 CA022453 United States CA NCI NIH HHS
فهرسة مساهمة: Keywords: Chemotherapy; Etirinotecan pegol; Irinotecan; KRAS mutant; Metastatic colorectal cancer
المشرفين على المادة: 0 (Antineoplastic Agents)
0 (Heterocyclic Compounds, 4 or More Rings)
3WJQ0SDW1A (Polyethylene Glycols)
7673326042 (Irinotecan)
LJ16641SFT (etirinotecan pegol)
XT3Z54Z28A (Camptothecin)
تواريخ الأحداث: Date Created: 20171019 Date Completed: 20171201 Latest Revision: 20210109
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC6863159
DOI: 10.1007/s00280-017-3438-y
PMID: 29043412
قاعدة البيانات: MEDLINE
الوصف
تدمد:1432-0843
DOI:10.1007/s00280-017-3438-y