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Volumn 24, Issue 6, 2013, Pages 1567-1573

A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma

(14)  Roy, A C a   Park, S R b   Cunningham, D a   Kang, Y K c   Chao, Y d   Chen, L T e   Rees, C f   Lim, H Y g   Tabernero, J h   Ramos, F J h   Kujundzic, M i   Cardic, M B j   Yeh, C G k   de Gramont, A l  


Author keywords

Docetaxel; Irinotecan; Liposomal irinotecan; Oesophago gastric cancer; Phase II; Second line

Indexed keywords

ANTINEOPLASTIC AGENT; DOCETAXEL; IRINOTECAN; PEP 02; UNCLASSIFIED DRUG;

EID: 84878447869     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdt002     Document Type: Article
Times cited : (104)

References (27)
  • 3
    • 69149102489 scopus 로고    scopus 로고
    • Is there a role for second-line chemotherapy in advanced gastric cancer?
    • Wesolowski R, Lee C, Kim R. Is there a role for second-line chemotherapy in advanced gastric cancer? Lancet Oncol 2009; 10: 903-912.
    • (2009) Lancet Oncol , vol.10 , pp. 903-912
    • Wesolowski, R.1    Lee, C.2    Kim, R.3
  • 4
    • 84861724755 scopus 로고    scopus 로고
    • Gastrointestinal cancer: salvage chemotherapy in gastric cancer-more than a straw?
    • Lordick F. Gastrointestinal cancer: salvage chemotherapy in gastric cancer-more than a straw? Nat Rev Clin Oncol 2012; 9: 312-313.
    • (2012) Nat Rev Clin Oncol , vol.9 , pp. 312-313
    • Lordick, F.1
  • 5
    • 38049047178 scopus 로고    scopus 로고
    • Capecitabine and oxaliplatin for advanced esophagogastric cancer
    • Cunningham D, Starling N, Rao S et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 2008; 358: 36-46.
    • (2008) N Engl J Med , vol.358 , pp. 36-46
    • Cunningham, D.1    Starling, N.2    Rao, S.3
  • 6
    • 40749153540 scopus 로고    scopus 로고
    • S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial
    • Koizumi W, Narahara H, Hara T et al. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol 2008; 9: 215-221.
    • (2008) Lancet Oncol , vol.9 , pp. 215-221
    • Koizumi, W.1    Narahara, H.2    Hara, T.3
  • 7
    • 77956262693 scopus 로고    scopus 로고
    • Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial
    • Bang YJ, Van Cutsem E, Feyereislova A et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet 2010; 376: 687-697.
    • (2010) Lancet , vol.376 , pp. 687-697
    • Bang, Y.J.1    Van Cutsem, E.2    Feyereislova, A.3
  • 8
    • 80053341349 scopus 로고    scopus 로고
    • Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer-a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO)
    • Thuss-Patience PC, Kretzschmar A, Bichev D et al. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer-a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer 2011; 47: 2306-2314.
    • (2011) Eur J Cancer , vol.47 , pp. 2306-2314
    • Thuss-Patience, P.C.1    Kretzschmar, A.2    Bichev, D.3
  • 9
    • 84862981823 scopus 로고    scopus 로고
    • Salvage chemotherapy for pretreated gastric cancer: a randomized phase III trial comparing chemotherapy plus best supportive care with best supportive care alone
    • Kang JH, Lee SI, Lim do H et al. Salvage chemotherapy for pretreated gastric cancer: a randomized phase III trial comparing chemotherapy plus best supportive care with best supportive care alone. J Clin Oncol 2012; 30: 1513-1518.
    • (2012) J Clin Oncol , vol.30 , pp. 1513-1518
    • Kang, J.H.1    Lee, S.I.2    Lim do, H.3
  • 10
    • 84878442878 scopus 로고    scopus 로고
    • Randomized phase III study of irinotecan (CPT-11) versus weekly paclitaxel (wPTX) for advanced gastric cancer (AGC) refractory to combination chemotherapy (CT) of fluoropyrimidine plus platinum (FP): WJOG4007 trial
    • Ueda S, Hironaka S, Yasui H et al. Randomized phase III study of irinotecan (CPT-11) versus weekly paclitaxel (wPTX) for advanced gastric cancer (AGC) refractory to combination chemotherapy (CT) of fluoropyrimidine plus platinum (FP): WJOG4007 trial. ASCO Meeting Abstr 2012; 30: 4002.
    • (2012) ASCO Meeting Abstr , vol.30 , pp. 4002
    • Ueda, S.1    Hironaka, S.2    Yasui, H.3
  • 11
    • 33645047575 scopus 로고    scopus 로고
    • Development of a highly active nanoliposomal irinotecan using a novel intraliposomal stabilization strategy
    • Drummond DC, Noble CO, Guo Z et al. Development of a highly active nanoliposomal irinotecan using a novel intraliposomal stabilization strategy. Cancer Res 2006; 66: 3271-3277.
    • (2006) Cancer Res , vol.66 , pp. 3271-3277
    • Drummond, D.C.1    Noble, C.O.2    Guo, Z.3
  • 12
    • 70349994207 scopus 로고    scopus 로고
    • Phase I study of liposome encapsulated irinotecan (PEP02) in advanced solid tumor patients
    • Chen L, Chang T, Cheng A, Yang C, Shiah H, Chang J, Yeh G. Phase I study of liposome encapsulated irinotecan (PEP02) in advanced solid tumor patients. J Clin Oncol 2008; 29: 26.
    • (2008) J Clin Oncol , vol.29 , pp. 26
    • Chen, L.1    Chang, T.2    Cheng, A.3    Yang, C.4    Shiah, H.5    Chang, J.6    Yeh, G.7
  • 13
    • 0034594628 scopus 로고    scopus 로고
    • New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada
    • Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000; 92: 205-216.
    • (2000) J Natl Cancer Inst , vol.92 , pp. 205-216
    • Therasse, P.1    Arbuck, S.G.2    Eisenhauer, E.A.3
  • 14
    • 84878430836 scopus 로고    scopus 로고
    • Phase I study of biweekly liposome irinotecan (PEP02, MM-398) in metastatic colorectal cancer after first-line oxaliplatin-based chemotherapy
    • (abstr 613)
    • Chen LT, Shiah HS, Lin PC, Lee JC, Su WC, Wang YW, Yeh GC, Chang JY. Phase I study of biweekly liposome irinotecan (PEP02, MM-398) in metastatic colorectal cancer after first-line oxaliplatin-based chemotherapy. J Clin Oncol 2012; 30(4): (abstr 613).
    • (2012) J Clin Oncol , vol.30 , Issue.4
    • Chen, L.T.1    Shiah, H.S.2    Lin, P.C.3    Lee, J.C.4    Su, W.C.5    Wang, Y.W.6    Yeh, G.C.7    Chang, J.Y.8
  • 15
    • 0028853410 scopus 로고
    • Population pharmacokinetics and pharmacodynamics of irinotecan (CPT-11) and active metabolite SN-38 during phase I trials
    • Chabot GG, Abigerges D, Catimel G et al. Population pharmacokinetics and pharmacodynamics of irinotecan (CPT-11) and active metabolite SN-38 during phase I trials. Ann Oncol 1995; 6: 141-151.
    • (1995) Ann Oncol , vol.6 , pp. 141-151
    • Chabot, G.G.1    Abigerges, D.2    Catimel, G.3
  • 16
    • 0030883212 scopus 로고    scopus 로고
    • Clinical pharmacokinetics of irinotecan
    • Chabot GG. Clinical pharmacokinetics of irinotecan. Clin Pharmacokinet 1997; 33: 245-259.
    • (1997) Clin Pharmacokinet , vol.33 , pp. 245-259
    • Chabot, G.G.1
  • 17
    • 84867081102 scopus 로고    scopus 로고
    • A multinational phase II study of PEP02 (liposome irinotecan) for patients with gemcitabinerefractory metastatic pancreatic cancer
    • Ko AH, Tempero MA, Shan Y et al. A multinational phase II study of PEP02 (liposome irinotecan) for patients with gemcitabinerefractory metastatic pancreatic cancer. ASCO Meeting Abstr 2011; 29: 4069.
    • (2011) ASCO Meeting Abstr , vol.29 , pp. 4069
    • Ko, A.H.1    Tempero, M.A.2    Shan, Y.3
  • 18
    • 4243713419 scopus 로고    scopus 로고
    • Group trial CPT-11 at 320 mg/m2 caused excessive toxicity in patients ( pts) with advanced adenocarcinoma(ACA) of the stomach (S) or gastroesophageal junction (GJ): A North Central Cancer Treatment
    • Egner J, Goldberg RM, Sargent DJ et al. Group trial CPT-11 at 320 mg/m2 caused excessive toxicity in patients ( pts) with advanced adenocarcinoma(ACA) of the stomach (S) or gastroesophageal junction (GJ): A North Central Cancer Treatment. Proc Am Soc Clin Oncol 1999; 16: 207a.
    • (1999) Proc Am Soc Clin Oncol , vol.16
    • Egner, J.1    Goldberg, R.M.2    Sargent, D.J.3
  • 19
    • 0036654749 scopus 로고    scopus 로고
    • Docetaxel 75 mg/m(2) is active and well tolerated in patients with metastatic or recurrent gastric cancer: a phase II trial
    • Bang YJ, Kang WK, Kang YK et al. Docetaxel 75 mg/m(2) is active and well tolerated in patients with metastatic or recurrent gastric cancer: a phase II trial. Jpn J Clin Oncol 2002; 32: 248-254.
    • (2002) Jpn J Clin Oncol , vol.32 , pp. 248-254
    • Bang, Y.J.1    Kang, W.K.2    Kang, Y.K.3
  • 20
    • 33748529958 scopus 로고    scopus 로고
    • Prophylaxis of irinotecan-induced diarrhea with neomycin and potential role for UGT1A1*28 genotype screening: a double-blind, randomized, placebo-controlled study
    • de Jong FA, Kehrer DF, Mathijssen RH et al. Prophylaxis of irinotecan-induced diarrhea with neomycin and potential role for UGT1A1*28 genotype screening: a double-blind, randomized, placebo-controlled study. Oncologist 2006; 11: 944-954.
    • (2006) Oncologist , vol.11 , pp. 944-954
    • de Jong, F.A.1    Kehrer, D.F.2    Mathijssen, R.H.3
  • 21
    • 34250629236 scopus 로고    scopus 로고
    • UGT1A1 polymorphism can predict hematologic toxicity in patients treated with irinotecan
    • Cote JF, Kirzin S, Kramar A et al. UGT1A1 polymorphism can predict hematologic toxicity in patients treated with irinotecan. Clin Cancer Res 2007; 13: 3269-3275.
    • (2007) Clin Cancer Res , vol.13 , pp. 3269-3275
    • Cote, J.F.1    Kirzin, S.2    Kramar, A.3
  • 22
    • 33745972934 scopus 로고    scopus 로고
    • The role of UGT1A1*28 polymorphism in the pharmacodynamics and pharmacokinetics of irinotecan in patients with metastatic colorectal cancer
    • Toffoli G, Cecchin E, Corona G et al. The role of UGT1A1*28 polymorphism in the pharmacodynamics and pharmacokinetics of irinotecan in patients with metastatic colorectal cancer. J Clin Oncol 2006; 24: 3061-3068.
    • (2006) J Clin Oncol , vol.24 , pp. 3061-3068
    • Toffoli, G.1    Cecchin, E.2    Corona, G.3
  • 23
    • 33744804311 scopus 로고    scopus 로고
    • Comprehensive analysis of UGT1A polymorphisms predictive for pharmacokinetics and treatment outcome in patients with nonsmall- cell lung cancer treated with irinotecan and cisplatin
    • Han JY, Lim HS, Shin ES et al. Comprehensive analysis of UGT1A polymorphisms predictive for pharmacokinetics and treatment outcome in patients with nonsmall- cell lung cancer treated with irinotecan and cisplatin. J Clin Oncol 2006; 24: 2237-2244.
    • (2006) J Clin Oncol , vol.24 , pp. 2237-2244
    • Han, J.Y.1    Lim, H.S.2    Shin, E.S.3
  • 25
    • 34250202527 scopus 로고    scopus 로고
    • Irinotecan pharmacokinetics/pharmacodynamics and UGT1A genetic polymorphisms in Japanese: roles of UGT1A1*6 and *28
    • Minami H, Sai K, Saeki M et al. Irinotecan pharmacokinetics/pharmacodynamics and UGT1A genetic polymorphisms in Japanese: roles of UGT1A1*6 and *28. Pharmacogenet Genomics 2007; 17: 497-504.
    • (2007) Pharmacogenet Genomics , vol.17 , pp. 497-504
    • Minami, H.1    Sai, K.2    Saeki, M.3
  • 26
    • 59849128188 scopus 로고    scopus 로고
    • Can UGT1A1 genotyping reduce morbidity and mortality in patients with metastatic colorectal cancer treated with irinotecan? An evidence-based review
    • Palomaki GE, Bradley LA, Douglas MP et al. Can UGT1A1 genotyping reduce morbidity and mortality in patients with metastatic colorectal cancer treated with irinotecan? An evidence-based review. Genet Med 2009; 11: 21-34.
    • (2009) Genet Med , vol.11 , pp. 21-34
    • Palomaki, G.E.1    Bradley, L.A.2    Douglas, M.P.3
  • 27
    • 84878431082 scopus 로고    scopus 로고
    • Study of MM-398 with or without 5-fluorouracil and leucovorin, versus 5-fluorouracil and leucovorin in patients with metastatic pancreatic cancer (NAPOLI 1). ClinicalTrials.gov Identifier: NCT01494506
    • Study of MM-398 with or without 5-fluorouracil and leucovorin, versus 5-fluorouracil and leucovorin in patients with metastatic pancreatic cancer (NAPOLI 1). ClinicalTrials.gov Identifier: NCT01494506.


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