Safety and pharmacokinetics of second-line ramucirumab plus FOLFIRI in Japanese patients with metastatic colorectal carcinoma

Anticancer Research

Volumn 35, Issue 7, 2015, Pages 4003-4008

  Yoshino, Takayuki ^a   Yamazaki, Kentaro ^b   Gotoh, Masahiro ^c   Nasroulah, Federico ^d   Gao, Ling ^d   Yoshizuka, Naoto ^d   Ohtsu, Atsushi ^a  

^a NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^b SHIZUOKA CANCER CENTER   (Japan)

^c OSAKA MEDICAL COLLEGE HOSPITAL   (Japan)

^d ELI LILLY AND COMPANY   (United States)

Author keywords

FOLFIRI; Japanese patients; Metastatic colorectal carcinoma; Pharmacokinetics; Ramucirumab

Indexed keywords

BEVACIZUMAB; FLUOROPYRIMIDINE; FLUOROURACIL; IRINOTECAN; LEVOLEUCOVORIN; OXALIPLATIN; RAMUCIRUMAB; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; FOLINIC ACID; MONOCLONAL ANTIBODY;

ABDOMINAL PAIN; ACCUMULATION RATIO; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER FATIGUE; CANCER GROWTH; CANCER PATIENT; CANCER STAGING; CHEMOTHERAPY INDUCED ANEMIA; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CHRONOTHERAPY; CLINICAL ARTICLE; COLORECTAL CARCINOMA; CONTINUOUS INFUSION; DECREASED APPETITE; DIARRHEA; DOSE RESPONSE; DRUG CLEARANCE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; ELIMINATION HALF-LIFE; EPISTAXIS; FEMALE; HUMAN; HYPERTENSION; JAPANESE (PEOPLE); LIVER METASTASIS; LUNG METASTASIS; LYMPH NODE METASTASIS; MALAISE; MALE; METASTATIC COLORECTAL CANCER; MIDDLE AGED; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OPEN STUDY; PERIODONTAL DISEASE; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; PROTEINURIA; RECOMMENDED DRUG DOSE; SINGLE DRUG DOSE; STOMATITIS; THERAPY DELAY; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT OUTCOME; TREATMENT RESPONSE; VOLUME OF DISTRIBUTION AT STEADY-STATE; ANALOGS AND DERIVATIVES; ASIAN CONTINENTAL ANCESTRY GROUP; CLINICAL TRIAL; COLORECTAL NEOPLASMS; DISEASE COURSE;

AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ASIAN CONTINENTAL ANCESTRY GROUP; CAMPTOTHECIN; COLORECTAL NEOPLASMS; DISEASE PROGRESSION; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED;

EID: 84937118869     PISSN: 02507005     EISSN: 17917530     Source Type: Journal    
DOI: None     Document Type: Article

References (15)

1. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L and Rougier P: Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 355: 1041-1047, 2000.
2. Saltz LB, Cox J V, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, Maroun JA, Ackland SP, Locker PK, Pirotta N, Elfring GL and Miller LL: Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 343: 905-914, 2000.
3. Tournigand C, André T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, and Louvet C and de Gramont A: FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 22: 229-237, 2004.
4. Carmeliet P and Jain RK: Molecular mechanisms and clinical applications of angiogenesis. Nature 473: 298-307, 2011.
5. Bennouna J, Sastre J, Arnold D, Österlund P, Greil R, Van Cutsem E, von Moos R, Viéitez JM, Bouché O, Borg C, Steffens CC, Alonso-Orduña V, Schlichting C, Reyes-Rivera I, Bendahmane B, André T, Kubicka S and ML18147 Study Investigators: Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial. Lancet Oncol 14: 29-37, 2013.
6. Tabernero J, Van Cutsem E, Lakomý R, Prausová J, Ruff P, van Hazel GA, Moiseyenko VM, Ferry DR, McKendrick JJ, Soussan-Lazard K, Chevalier S and Allegra CJ: Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial. Eur J Cancer 50: 320-331, 2014.
7. Spratlin JL, Cohen RB, Eadens M, Gore L, Camidge DR, Diab S, Leong S, O'Bryant C, Chow LQ, Serkova NJ, Meropol NJ, Lewis NL, Chiorean EG, Fox F, Youssoufian H, Rowinsky EK and Eckhardt SG: Phase I pharmacologic and biologic study of ramucirumab (IMC-1121B), a fully human immunoglobulin G1 monoclonal antibody targeting the vascular endothelial growth factor receptor-2. J Clin Oncol 28: 780-787, 2010.
8. Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero and REGARD Trial Investigators: Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet 383: 31-39, 2014.
9. Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A and RAINBOW Study Group: Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol 15: 1224-1235, 2014.
10. Garon EB, Ciuleanu TE, Arrieta O, Prabhash K, Syrigos KN, Goksel T, Park K, Gorbunova V, Kowalyszyn RD, Pikiel J, Czyzewicz G, Orlov SV, Lewanski CR, Thomas M, Bidoli P, Dakhil S, Gans S, Kim JH, Grigorescu A, Karaseva N, Reck M, Cappuzzo F, Alexandris E, Sashegyi A, Yurasov S and Pérol M: Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet 384: 665-673, 2014.
11. Tabernero J, Yoshino T, Cohn AL, Obermannova R, Bodoky G, Garcia-Carbonero R, Ciuleanu TE, Portnoy DC, Van Cutsem E, Grothey A, Prausová J, Garcia-Alfonso P, Yamazaki K, Clingan PR, Lonardi S, Kim TW, Simms L, Chang SC, Nasroulah F; RAISE Study Investigators: Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol Apr 10 2015: doi: 10.1016/S1470-2045(15)70127-0 [Epub ahead of print].
12. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J: New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45: 228-247, 2009.
13. Wang D, Braiteh FS, Lee JJ, Denlinger CS, Shepard DR, Chaudhary A, Lin Y, Gao L, Asakiewicz CJ, Nasroulah F, LoRusso P: Phase II study evaluating the effect of concomitant ramucirumab (RAM) on the pharmacokinetics (PK) of irinotecan (IRI) and its metabolite SN-38 when coadministered with folinic acid (FA) and 5-fluorouracil (5-FU) (FOLFIRI) in patients (pts) with advanced malignant solid tumors. J Clin Oncol 33 (suppl 3): abstr 691, 2015.
14. Deng R, Jin F, Prabhu S and Iyer S: Monoclonal antibodies: what are the pharmacokinetic and pharmacodynamic considerations for drug development? Expert Opin Drug Metab Toxicol 8: 141-160, 2012.
15. Zhu AX, Finn RS, Mulcahy M, Gurtler J, Sun W, Schwartz JD, Dalal RP, Joshi A, Hozak RR, Xu Y, Ancukiewicz M, Jain RK, Nugent FW, Duda DG and Stuart K: A phase II and biomarker study of ramucirumab, a human monoclonal antibody targeting the VEGF receptor-2, as first-line monotherapy in patients with advanced hepatocellular cancer. Clin Cancer Res 19: 6614-6623, 2013.