Challenges in first line chemotherapy and targeted therapy in advanced gastric cancer

Expert Review of Anticancer Therapy

Volumn 14, Issue 8, 2014, Pages 887-900

  Garrido, Marcelo ^a   Fonseca, Paula J ^b   Vieitez, Jose María ^b   Frunza, Madalina ^b   Lacave, Angel J ^b,c  

^a PONTIFICIA UNIVERSIDAD CATÓLICA DE CHILE   (Chile)

^b Asturias Central University Hospital   (Spain)

^c Sanatorio Nuestra Señora de Covadonga   (Spain)

Author keywords

5 fluorouracil; advanced gastric cancer; chemotherapy; cisplatin; docetaxel; targeted agents; trastuzumab

Indexed keywords

BEVACIZUMAB; CAPECITABINE; CATUMAXOMAB; CETUXIMAB; CISPLATIN; CRIZOTINIB; DOCETAXEL; DOXORUBICIN; EPIRUBICIN; EVEROLIMUS; FIGITUMUMAB; FLUOROURACIL; FOLINIC ACID; GIMERACIL PLUS OTERACIL POTASSIUM PLUS TEGAFUR; IRINOTECAN; LAPATINIB; METHOTREXATE; MITOMYCIN; OXALIPLATIN; PACLITAXEL; PANITUMUMAB; PROTEIN TYROSINE KINASE INHIBITOR; RAMUCIRUMAB; RILOTUMUMAB; SORAFENIB; SUNITINIB; TIVANTINIB; TRASTUZUMAB; TRASTUZUMAB EMTANSINE; UNINDEXED DRUG; ANTINEOPLASTIC AGENT;

ADVANCED CANCER; ANEMIA; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CONTINUOUS INFUSION; DIARRHEA; DRUG APPROVAL; DRUG DOSAGE FORM COMPARISON; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG MECHANISM; DRUG MEGADOSE; DRUG RESPONSE; DRUG SAFETY; DRUG TARGETING; DRUG TOLERABILITY; GASTROINTESTINAL TOXICITY; HAND FOOT SYNDROME; HEMATOLOGIC DISEASE; HUMAN; LOW DRUG DOSE; MULTIPLE CYCLE TREATMENT; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PHARMACOLOGICAL BLOCKING; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; REVIEW; STOMACH CANCER; STOMATITIS; SURVIVAL RATE; SURVIVAL TIME; THROMBOSIS; TREATMENT DURATION; VOMITING; MOLECULARLY TARGETED THERAPY; PATHOLOGY; STOMACH NEOPLASMS;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; HUMANS; MOLECULAR TARGETED THERAPY; STOMACH NEOPLASMS; SURVIVAL RATE;

EID: 84905025438     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/14737140.2014.915194     Document Type: Review

References (83)

1. Ferlay J, Shin HR, Bray F, et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010;127:2893-917
2. Anderson WF, Camargo MC, Fraumeni JF Jr, et al. Age-specific trends in incidence of noncardia gastric cancer in US adults. JAMA 2010;303:1723-8
3. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med 2006;3:e442
4. Wagner AD, Grothe W, Haerting J, et al. Chemotherapy in advanced gastric cancer: A systematic review and meta-analysis based on aggregate data. J Clin Oncol 2006;24: 2903-9
5. Pyrhönen S, Kuitunen T, Nyandoto P, Kouri M. Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer. Br J Cancer 1995;71:587-91
6. Murad AM, Santiago FF, Petroianu A, et al. Modified therapy with 5-fluorouracil, doxorubicin, and methotrexate in advanced gastric cancer. Cancer 1993;72:37-41
7. Glimelius B, Ekström K, Hoffman K, et al. Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol 1997;8:163-8
8. Wagner AD, Unverzagt S, Grothe W, et al. Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev 2010;17: CD004064 versus best supportive care and consistently demonstrated a significant benefit in overall survival in favor of the group receiving chemotherapy.
9. Glimelius B, Hoffman K, Haglund U, et al. Initial or delayed chemotherapy with best supportive care in advanced gastric cancer. Ann Oncol 1994;5:189-90
10. Lacave AJ, Barón Duarte F.J. Quimioterapia del cáncer de estómago. Neoplasia 1989;6: 65-70
11. Sulkes A, Smyth J, Sessa C, et al. Docetaxel (Taxotere) in advanced gastric cancer: Results of a phase II clinical trial. EORTC Early Clinical Trials Group. Br J Cancer 1994;70: 380-3
12. Einzig AI, Neuberg D, Remick SC, et al. Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy: The Eastern Cooperative Oncology Group (ECOG) results of protocol E1293. Med Oncol 1996;13:87-93
13. Kruijtzer CM, Boot H, Beijnen JH, et al. Weekly oral paclitaxel as first-line treatment in patients with advanced gastric cancer. Ann Oncol 2003;14:197-204
14. Köhne CH, Catane R, Klein B, et al. Irinotecan is active in chemonaive patients with metastatic gastric cancer: A phase II multicentric trial. Br J Cancer 2003;89: 997-1001
15. Koizumi W, Saigenji K, Ujiie S, et al. A pilot phase II study of capecitabine in advanced or recurrent gastric cancer. Oncology 2003;64:232-6
16. Jeung HC, Rha SY, Kim HK, et al. Multi-institutional phase II study of S-1 monotherapy in advanced gastric cancer with pharmacokinetic and pharmacogenomic evaluations. Oncologist 2007;12:543-54
17. Oh SY, Kwon HC, Lee S, et al. A Phase II study of oxaliplatin with low-dose leucovorin and bolus and continuous infusion 5-fluorouracil (modified FOLFOX-4) for gastric cancerpatients with malignant ascites. Jpn J Clin Oncol 2007;37:930-5
18. Ajani JA, Takimoto C, Becerra CR, et al. A phase II clinical and pharmacokinetic study of intravenous exatecan mesylate (DX-8951f) in patients with untreated metastatic gastric cancer. Invest New Drugs 2005;23: 479-84
19. Lacave AJ, Wils J, Diaz-Rubio E, et al. Cis-Platinum as second-line chemotherapy in advanced gastric adenocarcinoma. A phase II study of the EORTC Gastrointestinal Tract Cancer Cooperative Group. Eur J Cancer Clin Oncol 1985;21: 1321-4
20. Lacave AJ, Barón FJ, Antón LM, et al. Combination chemotherapy with cisplatin and 5-fluorouracil 5-day infusion in the therapy of advanced gastric cancer: A phase II trial. Ann Oncol 1991;2:751-4
21. MacDonald JS, Schein PS, Woolley PV, et al. 5-Fluorouracil, doxorubicin, and mitomycin (FAM) combination chemotherapy for advanced gastric cancer. Ann Intern Med 1980;93:533-6
22. Wils JA, Klein HO, Wagener DJ, et al. Sequential high-dose methotrexate and fluorouracil combined with doxorubicin-A step ahead in the treatment of advanced gastric cancer: A trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. J Clin Oncol 1991;9:827-31
23. Webb A, Cunningham D, Scarffe JH, et al. Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer. J Clin Oncol 1997;15:261-7
24. Vanhoefer U, Rougier P, Wilke H, et al. Final results of a randomized phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin versus etoposide, leucovorin, and fluorouracil versus infusional fluorouracil and cisplatin in advanced gastric cancer: A trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group. J Clin Oncol 2000;8;2648-57
25. Ajani JA, Moiseyenko VM, Tjulandin S, et al. Clinical benefit with docetaxel plus fluorouracil and cisplatin compared with cisplatin and fluorouracil in a phase III trial of advanced gastric or gastroesophageal cancer adenocarcinoma: The V-325 Study Group. J Clin Oncol 2007;25:3205-9
26. Roth AD, Fazio N, Stupp R, et al. Docetaxel, cisplatin, and fluorouracil; docetaxel and cisplatin; and epirubicin, cisplatin, and fluorouracil as systemic treatment for advanced gastric carcinoma: A randomized phase II trial of the Swiss Group for Clinical Cancer Research. J Clin Oncol 2007;25:3217-23
27. Kang YK, Kang WK, Shin DB, et al. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: A randomised phase III noninferiority trial. Ann Oncol 2009;20: 666-73
28. Jiménez P, Vieitez JM, Estrada E, et al. A phase II study with capecitabine and cisplatin in patients with locally advanced unresectable and/or metastatic gastric cancer. J Clin Oncol 2008;26(4suppl):LBA59
29. Fonseca PJ, Vieitez JM, Estrada E, et al. A phase II Study with Capecitabine (Xeloda-) and Cisplatin as first-line therapy in patients with locally advanced unresectable and/or metastatic gastric cancer. ICACT; 2008; Abstract 91
30. Giordano KF, Jatoi A, Stella PJ, et al. Docetaxel and capecitabine in patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction: A phase II study from the North Central Cancer Treatment Group. Ann Oncol 2006;17: 652-6
31. 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;9:215-21
32. Ajani JA, Rodriguez W, Bodoky G, et al. Multicenter phase III comparison of cisplatin/S-1 with cisplatin/infusional fluorouracil in advanced gastric or gastroesophageal adenocarcinoma study: The FLAGS trial. J Clin Oncol 2010;28: 1547-53
33. Cunningham D, Starling N, Rao S, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 2008;358:36-46
34. Al-Batran SE, Hartmann JT, Probst S, et al. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: A study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol 2008;26:1435-42
35. Al-Batran SE, Hartmann JT, Hofheinz R, et al. Biweekly fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) for patients with metastatic adenocarcinoma of the stomach or esophagogastric junction: A phase II trial of the Arbeitsgemeinschaft Internistische Onkologie. Ann Oncol 2008;19:1882-7
36. Garrido M, Melgoza G, Galindo H, et al. Treatment of advanced gastric cancer with oxaliplatin plus 5-fluorouracil/leucovorin (FOLFOX-4 chemotherapy). Rev Med Chil 2007;135:1380-7
37. Luo HY, Xu RH, Wang F, et al. Phase II Trial of XELOX as first-line treatment for patients with advanced gastric cancer. Chemotherapy 2010;56:94-100
38. Dank M, Zaluski J, Barone C, et al. Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol 2008;19:1450-7
39. Farhat FS. A general review of the role of irinotecan (CPT11) in the treatment of gastric cancer. Med Oncol 2007;24:137-46
40. Louvet C, Guimbaud R, Bonnetain F, et al. Final results of the intergroup FFCD-GERCOR-FNCLCC 03-07 phase III study comparing two sequences of chemotherapy in advanced gastric cancers. Ann Oncol 2010;21(Supplement 8): Viii250-63
41. Grávalos C, Gómez-Mart?́n C, Rivera F, et al. Phase II study of trastuzumab and cisplatin as first-line therapy in patients with HER2-positive advanced gastric or gastroesophageal junction cancer. Clin Transl Oncol 2011;13:179-84
42. Iqbal S, Goldman B, Fenoglio-Preiser CM, et al. Southwest Oncology Group study S0413: A phase II trial of lapatinib (GW572016) as first-line therapy in patients with advanced or metastatic gastric cancer. Ann Oncol 2011;22:2610-15
43. Lenz H-J, Zhang W, Kemner AM, et al. Lapatinib + capecitabine in advanced gastric cancer: An open-label phase II study of non-ErbB2-targeted disease. Ann Oncol 2010;21(3):474-80
44. 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;376:687-97
45. Bang YJ. A randomized, open-label, phase III study of lapatinib in combination with weekly paclitaxel versus weekly paclitaxel alone in the second-line treatment of HER2 amplified advanced gastric cancer (AGC) in Asian population: Tytan study. J Clin Oncol 2013;31(4suppl):11
46. Hecht JR, Bang YJ, Qin S, et al. Lapatinib in combination with capecitabine plus oxaliplatin (CapeOx) in HER2-positive advanced or metastatic gastric, esophageal, or gastroesophageal adenocarcinoma (AC): The TRIO-013/LOGiC Trial. J Clin Oncol 2013;31(18 Suppl):LBA4001
47. Pinto C, Di Fabio F, Siena S, et al. Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastroesophageal junction adenocancinoma (FOLCETUX study). Ann Oncol 2007;18:510-17
48. Lordick F, Luber B, Lorenzen S, et al. Cetuximab plus oxaliplatin/leucovorin/5-fluorouracil in first-line metastatic gastric cancer: A phase II study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Br J Cancer 2010;102: 500-5
49. Fahlke J, Ridwelsi K, Florschuetz A, et al. Cetuximab plus docetaxel-cisplatin (DC) as first-line treatment for locally advanced or metastatic gastric cancer: Preliminary results of a phase II study. J Clin Oncol 2009; 27(18S):LBAe15592
50. Pinto C, Di Fabio F, Barone C, et al. Phase II study of cetuximab in combination with cisplatin and docetaxel in patients with untreated advanced gastric or gastro-oesophageal junction adenocarcinoma (DOCETUX study). Br J Cancer 2009;101: 1261-8
51. Han SW, Oh DY, Im SA, et al. Phase II study and biomarker analysis of cetuximab combined with modified FOLFOX6 in advanced gastric cancer. Br J Cancer 2009;100:298-304
52. Kim C, Lee JL, Ryu MH, et al. A prospective phase II study of cetuximab in combination with XELOX (capecitabine and oxaliplatin) in patients with metastatic and/or recurrent advanced gastric cancer. Invest New Drugs 2011;29:366-73
53. Moehler M, Mueller A, Trarbach T, et al. Cetuximab with irinotecan, folinic acid and 5-fluorouracil as first-line treatment in advanced gastroesophageal cancer: A prospective multi-center biomarkeroriented phase II study. Ann Oncol 2011;22:1358-66
54. Chan JA, Blaszkowsky LS, Enzinger PC, et al. A multicenter phase II trial of single-agent cetuximab in advanced esophageal and gastric adenocarcinoma. Ann Oncol 2011;22:1367-73
55. Wöll E, Greil R, Eisterer W, et al. Oxaliplatin, irinotecan and cetuximab in advanced gastric cancer. A multicenter phase II trial (Gastric-2) of the Arbeitsgemeinschaft Medikamentose Tumortherapie (AGMT). Anticancer Res 2011;31:4439-43
56. Schønnemann KR, Yilmaz M, Bjerregaard JK, et al. Phase II study of biweekly cetuximab in combination with irinotecan as second-line treatment in patients with platinum-resistant gastrooesophageal cancer. Eur J Cancer 2012;48: 510-17
57. Tebbutt NC, Parry MM, Zannino D, et al. Docetaxel plus cetuximab as second-line treatment for docetaxel-refractory oesophagogastric cancer: The AGITG ATTAX2 trial. Br J Cancer 2013;108:771-4
58. Enzinger PC, Burtness B, Hollis D, et al. CALGB 80403/ECOG 1206: A randomized phase II study of three standard chemotherapy regimens (ECF, IC, FOLFOX) plus cetuximab in metastatic esophageal and GE junction cancer. J Clin Oncol 2010;28(15 Suppl):Abstr 4006
59. Rao S, Starling N, Cunningham D, et al. Matuzumab plus epirubicin, cisplatin and capecitabine (ECX) compared with epirubicin, cisplatin and capecitabine alone as first-line treatment in patients with advanced oesophago-gastric cancer: A randomised, multicentre open-label phase II study. Ann Oncol 2010;21:2213-19
60. Wang JW, Chi Y, Zheng Z, et al. Randomized, single-centered, phase II clinical trial of nimotuzumab plus cisplatin and S-1 as first-line therapy in patients with advanced gastric cancer. J Clin Oncol 2012; 30(15suppl):e14668
61. Lordick F, Kang YK, Chung HC, et al. Capecitabine and cisplatin with or without cetuximab for patients with previously untreated advanced gastric cancer (EXPAND): A randomised, open-label phase 3 trial. Lancet Oncol 2013;14:490-9
62. Waddell T, Chau I, Cunningham D, et al. Epirubicin, oxaliplatin, and capecitabine with or without panitumumab for patients with previously untreated advanced oesophagogastric cancer (REAL3): A randomised, open-label phase 3 trial. Lancet Oncol 2013;14:481-9
63. Shah MA, Ramanathan RK, Ilson DH, et al. Multicenter phase II study of irinotecan, cisplatin, and bevacizumab in patients with metastatic gastric or gastroesophageal junction adenocarcinoma. J Clin Oncol 2006;24:5201-6
64. Shah MA, Jhawer M, Ilson DH, et al. Phase II study of modified docetaxel, cisplatin, and fluorouracil with bevacizumab in patients with metastatic gastroesophageal adenocarcinoma. J Clin Oncol 2011;29: 868-74
65. El-Rayes BF, Zalupski M, Bekai-Saab T, et al. A phase II study of bevacizumab, oxaliplatin, and docetaxel in locally advanced and metastatic gastric and gastroesophageal junction cancers. Ann Oncol 2010;21:1999-2004
66. Uronis HE, Bendell JC, Altomare I, et al. A phase II study of capecitabine, oxaliplatin, and bevacizumab in the treatment of metastatic esophagogastric adenocarcinomas. Oncologist 2013;18:271-2
67. A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer. Available from: Www.clinicaltrials.gov/ct2/show/NCT00887822
68. Ohtsu A, Shah MA, Van Cutsem E, et al. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: A randomized, double-blind, placebo-controlled phase III study. J Clin Oncol 2011;29:3968-76
69. Van Cutsem E, de Haas S, Kang YK, et al. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: A biomarker evaluation from the AVAGAST randomized phase III trial. J Clin Oncol 2012;30: 2119-27
70. Fuchs CS, Tomasek J, Yong CJ, et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): An international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet 2014;383(9911):31-9 • Established the first single drug biological treatment that has survival benefits in patients with advanced disease progressing after first-line chemotherapy.
71. A Study of Paclitaxel With or Without Ramucirumab in Metastatic Gastric Adenocarcinoma (RAINBOW). Available from: Http://clinicaltrials.gov/show/ NCT01170663
72. Sun W, Powell M, O'Dwyer PJ, et al. Phase II study of sorafenib in combination with docetaxel and cisplatin in the treatment of metastatic or advanced gastric and gastroesophageal junction adenocarcinoma: ECOG 5203. J Clin Oncol 2010;28: 2947-51
73. Yi JH, Lee J, Lee J, et al. Randomised phase II trial of docetaxel and sunitinib in patients with metastatic gastric cancer who were previously treated with fluoropyrimidine and platinum. Br J Cancer 2012;106:1469-74
74. Li J, Qin S, Xu J, et al. Apatinib for Chemotherapy Refractory Advanced Metastatic Gastric Cancer: Results From a Randomized, Placebo-Controlled, Parallel-Arm, Phase II Trial. J Clin Oncol 2013;31(26):3219-25
75. Murayama T, Inokuchi M, Takagi Y, et al. Relation between outcomes and localisation of p-mTOR expression in gastric cancer. Br J Cancer 2009;100:782-8
76. Ohtsu A, Ajani JA, Bai YX, et al. Everolimus for Previously Treated Advanced Gastric Cancer: Results of the Randomized, Double-Blind, Phase III GRANITE-1 Study. J Clin Oncol 2013; 31(31):3935-43
77. Danilkovitch-Miagkova A, Zbar B. Dysregulation of Met receptor tyrosine kinase activity in invasive tumors. J Clin Invest 2002;109:863-7
78. Lennerz JK, Kwak EL, Ackerman A, et al. MET amplification identifies a small and aggressive subgroup of esophagogastric adenocarcinoma with evidence of responsiveness to crizotinib. J Clin Oncol 2011;29:4803-10
79. Muro K, Ryu M-H, Yasui H, et al. A phase II study of tivantinib monotherapy in patients with previously treated advanced or recurrent gastric cancer. J Clin Oncol 2012; 30(15suppl):4082
80. Oliner K, Tang R, Anderson A, et al. Evaluation of MET pathway biomarkers in a phase II study of rilotumumab (AMG 102) or placebo in combination with epirubicin, cisplatin, and capecitabine (ECX) in patients with locally advanced or metastatic gastric or esophagogastric junction cancer. J Clin Oncol 2012; 30(15suppl):4005
81. First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET)-Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma (RILOMET-1). Available from: Http://clinicaltrials.gov/show/NCT01697072
82. Zeidler R, Mysliwietz J, Csánady M, et al. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer 2000;83:261-6
83. Heiss MM, Murawa P, Koralewski P, et al. The trifunctional antibody catumaxomab for the treatment of malignant ascites due to epithelial cancer: Results of a prospective randomized phase II/III trial. Int J Cancer 2010;127:2209-21