An open-label, multicentre biomarker-oriented AIO phase II trial of sunitinib for patients with chemo-refractory advanced gastric cancer

European Journal of Cancer

Volumn 47, Issue 10, 2011, Pages 1511-1520

  Moehler, M ^a   Mueller, A ^a   Hartmann, J T ^b   Ebert, M P ^c   Al Batran, S E ^d   Reimer, P ^e   Weihrauch, M ^f   Lordick, F ^g   Trarbach, T ^h   Biesterfeld, S ^a   Kabisch, M ^a   Wachtlin, D ^a   Galle, P R ^a  

^a UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

^b UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^c UNIVERSITY OF HEIDELBERG   (Germany)

^d Clinic Northwest   (Germany)

^e UNIVERSITY OF WÜRZBURG   (Germany)

^f UNIVERSITY OF COLOGNE   (Germany)

^g KLINIKUM BRAUNSCHWEIG   (Germany)

^h UNIVERSITY HOSPITAL ESSEN   (Germany)

Author keywords

Advanced gastric cancer; Biomarkers; Objective response; Sunitinib; Tyrosine kinase inhibitor

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; PLATELET DERIVED GROWTH FACTOR ALPHA RECEPTOR; SUNITINIB; TUMOR MARKER; VASCULOTROPIN A; VASCULOTROPIN C; VASCULOTROPIN D; VASCULOTROPIN RECEPTOR 3;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; ADVANCED GASTRIC CANCER; AGED; ANEMIA; ANOREXIA; ARTICLE; BILIRUBIN BLOOD LEVEL; CANCER CONTROL; CANCER GROWTH; CANCER MORTALITY; COUGHING; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DYSGEUSIA; FATIGUE; FEMALE; HAND FOOT SYNDROME; HEADACHE; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PARESTHESIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN BLOOD LEVEL; PROTEIN EXPRESSION; SIDE EFFECT; STOMACH CANCER; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; DISEASE PROGRESSION; FEMALE; GENE EXPRESSION REGULATION, NEOPLASTIC; HUMANS; IMMUNOHISTOCHEMISTRY; INDOLES; MALE; MIDDLE AGED; MUTATION; PROSPECTIVE STUDIES; PROTEIN-TYROSINE KINASES; PYRROLES; STOMACH NEOPLASMS; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

EID: 79958803154     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2011.04.006     Document Type: Article

References (52)

1. J. Ferlay, D.M. Parkin, and E. Steliarova-Foucher Estimates of cancer incidence and mortality in Europe in 2008 Eur J Cancer 46 2010 765 781
2. D.M. Parkin, F. Bray, J. Ferlay, and P. Pisani Global cancer statistics, 2002 CA Cancer J Clin 55 2005 74 108 (Pubitemid 40372904)
3. A.D. Wagner, W. Grothe, and J. Haerting Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data J Clin Oncol 24 2006 2903 2909 (Pubitemid 46630593)
4. D. Cunningham, N. Starling, and S. Rao Capecitabine and oxaliplatin for advanced esophagogastric cancer N Engl J Med 358 2008 36 46
5. M. Dank, J. Zaluski, and C. Barone 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 19 2008 1450 1457
6. M. Moehler, S. Kanzler, and M. Geissler A randomized multicenter phase II study comparing capecitabine with irinotecan or cisplatin in metastatic adenocarcinoma of the stomach or esophagogastric junction Ann Oncol 21 2010 71 77
7. E. Van Cutsem, V.M. Moiseyenko, and S. Tjulandin Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group J Clin Oncol 24 2006 4991 4997 (Pubitemid 46631401)
8. D. Curran, C. Pozzo, and J. Zaluski Quality of life of palliative chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction treated with irinotecan combined with 5-fluorouracil and folinic acid: results of a randomised phase III trial Qual Life Res 18 2009 853 861
9. M. Moehler, P.R. Galle, I. Gockel, T. Junginger, and H. Schmidberger The multidisciplinary management of gastrointestinal cancer. Multimodal treatment of gastric cancer Best Pract Res Clin Gastroenterol 21 2007 965 981
10. M. Moehler, U. Haas, and J. Siebler Weekly treatment with irinotecan, folinic acid and infusional 5-fluorouracil (ILF) in patients with advanced gastric cancer Anticancer Drugs 14 2003 645 650 (Pubitemid 37303932)
11. D. Drescher, M. Moehler, and I. Gockel Coexpression of receptor-tyrosine-kinases in gastric adenocarcinoma - a rationale for a molecular targeting strategy? World J Gastroenterol 13 2007 3605 3609 (Pubitemid 47162268)
12. H. Zhang, J. Wu, L. Meng, and C.C. Shou Expression of vascular endothelial growth factor and its receptors KDR and Flt-1 in gastric cancer cells World J Gastroenterol 8 2002 994 998 (Pubitemid 35446408)
13. J.C. Becker, C. Muller-Tidow, H. Serve, W. Domschke, and T. Pohle Role of receptor tyrosine kinases in gastric cancer: new targets for a selective therapy World J Gastroenterol 12 2006 3297 3305 (Pubitemid 43933772)
14. K. Maeda, Y.S. Chung, and Y. Ogawa Prognostic value of vascular endothelial growth factor expression in gastric carcinoma Cancer 77 1996 858 863 (Pubitemid 26061277)
15. M. Katano, M. Nakamura, K. Fujimoto, K. Miyazaki, and T. Morisaki Prognostic value of platelet-derived growth factor-A (PDGF-A) in gastric carcinoma Ann Surg 227 1998 365 371 (Pubitemid 28131017)
16. Y. Takahashi, K.R. Cleary, and M. Mai Significance of vessel count and vascular endothelial growth factor and its receptor (KDR) in intestinal-type gastric cancer Clin Cancer Res 2 1996 1679 1684 (Pubitemid 26356351)
17. Doi T, Koizumi W, Siena S, et al. Efficacy, tolerability, and pharmacokinetics of gefitinib (ZD1839) in pretreated patients with metastatic gastric cancer. Proc Am Soc Clin Oncol 2003;22:Abstract 1036.
18. T. Dragovich, S. McCoy, and C.M. Fenoglio-Preiser Phase II trial of erlotinib in gastroesophageal junction and gastric adenocarcinomas: SWOG 0127 J Clin Oncol 24 2006 4922 4927 (Pubitemid 46630921)
19. M.A. Shah, R.K. Ramanathan, and D.H. Ilson Multicenter phase II study of irinotecan, cisplatin, and bevacizumab in patients with metastatic gastric or gastroesophageal junction adenocarcinoma J Clin Oncol 24 2006 5201 5206 (Pubitemid 46631363)
20. C. Pinto, F. Di Fabio, and S. Siena Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma (FOLCETUX study) Ann Oncol 18 2007 510 517 (Pubitemid 46359631)
21. S.W. Han, D.Y. Oh, and S.A. Im Phase II study and biomarker analysis of cetuximab combined with modified FOLFOX6 in advanced gastric cancer Br J Cancer 100 2009 298 304
22. T.J. Abrams, L.B. Lee, L.J. Murray, N.K. Pryer, and J.M. Cherrington SU11248 inhibits KIT and platelet-derived growth factor receptor beta in preclinical models of human small cell lung cancer Mol Cancer Ther 2 2003 471 478
23. D.B. Mendel, A.D. Laird, and X. Xin In vivo antitumor activity of SU11248, a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor and platelet-derived growth factor receptors: determination of a pharmacokinetic/pharmacodynamic relationship Clin Cancer Res 9 2003 327 337 (Pubitemid 36109749)
24. A.M. O'Farrell, T.J. Abrams, and H.A. Yuen SU11248 is a novel FLT3 tyrosine kinase inhibitor with potent activity in vitro and in vivo Blood 101 2003 3597 3605 (Pubitemid 36857948)
25. G.D. Demetri, A.T. van Oosterom, and C.R. Garrett Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial Lancet 368 2006 1329 1338 (Pubitemid 44528723)
26. R.J. Motzer, T.E. Hutson, and P. Tomczak Sunitinib versus interferon alfa in metastatic renal-cell carcinoma N Engl J Med 356 2007 115 124 (Pubitemid 46089672)
27. M. Moehler, C. Frings, and A. Mueller VEGF-D expression correlates with colorectal cancer aggressiveness and is downregulated by cetuximab World J Gastroenterol 14 2008 4156 4167
28. Bang YJ, Kang YK, Kang WK, et al. Phase II study of sunitinib as second-line treatment for advanced gastric cancer. Invest New Drugs 2010(May 12) [Epub ahead of print].
29. H. Choi, C. Charnsangavej, and S.C. Faria Correlation of computed tomography and positron emission tomography in patients with metastatic gastrointestinal stromal tumor treated at a single institution with imatinib mesylate: proposal of new computed tomography response criteria J Clin Oncol 25 2007 1753 1759 (Pubitemid 46797957)
30. R.J. Motzer, M.D. Michaelson, and B.G. Redman Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma J Clin Oncol 24 2006 16 24 (Pubitemid 46630489)
31. F. Giuliani, V. Gebbia, and F. De Vita Docetaxel as salvage therapy in advanced gastric cancer: a phase II study of the Gruppo Oncologico Italia Meridionale (G.O.I.M.) Anticancer Res 23 2003 4219 4222 (Pubitemid 37474923)
32. J.C. Jo, J.L. Lee, and M.H. Ryu Docetaxel monotherapy as a second-line treatment after failure of fluoropyrimidine and platinum in advanced gastric cancer: experience of 154 patients with prognostic factor analysis Jpn J Clin Oncol 37 2007 936 941
33. S. Hironaka, S. Zenda, and N. Boku Weekly paclitaxel as second-line chemotherapy for advanced or recurrent gastric cancer Gastric Cancer 9 2006 14 18
34. Y. Kodera, S. Ito, and Y. Mochizuki A phase II study of weekly paclitaxel as second-line chemotherapy for advanced gastric Cancer (CCOG0302 study) Anticancer Res 27 2007 2667 2671 (Pubitemid 47227980)
35. J.H. Chun, H.K. Kim, and J.S. Lee Weekly irinotecan in patients with metastatic gastric cancer failing cisplatin-based chemotherapy Jpn J Clin Oncol 34 2004 8 13 (Pubitemid 43118052)
36. J.T. Hartmann, D. Quietzsch, and T. Daikeler Mitomycin C continuous infusion as salvage chemotherapy in pretreated patients with advanced gastric cancer Anticancer Drugs 10 1999 729 733 (Pubitemid 30015674)
37. Y.J. Bang, E. Van Cutsem, and A. Feyereislova 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 376 2010 687 697
38. H.J. Burstein, A.D. Elias, and H.S. Rugo Phase II study of sunitinib malate, an oral multitargeted tyrosine kinase inhibitor, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane J Clin Oncol 26 2008 1810 1816
39. M.A. Socinski, S. Novello, and J.R. Brahmer Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer J Clin Oncol 26 2008 650 656 (Pubitemid 351264362)
40. P. Laurent-Puig, A. Cayre, and G. Manceau Analysis of PTEN, BRAF, and EGFR status in determining benefit from cetuximab therapy in wild-type KRAS metastatic colon cancer J Clin Oncol 27 2009 5924 5930
41. A. Bardelli, and S. Siena Molecular mechanisms of resistance to cetuximab and panitumumab in colorectal cancer J Clin Oncol 28 2010 1254 1261
42. S.H. Lee, J.W. Lee, and Y.H. Soung BRAF and KRAS mutations in stomach cancer Oncogene 22 2003 6942 6945 (Pubitemid 37386695)
43. V.S. Li, C.W. Wong, and T.L. Chan Mutations of PIK3CA in gastric adenocarcinoma BMC Cancer 5 2005 29
44. E. Lieto, F. Ferraraccio, and M. Orditura Expression of vascular endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR) is an independent prognostic indicator of worse outcome in gastric cancer patients Ann Surg Oncol 15 2008 69 79
45. 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 biomarker-oriented phase II study. Ann Oncol 2010.
46. S.S. Sundar, and T.S. Ganesan Role of lymphangiogenesis in cancer J Clin Oncol 25 2007 4298 4307 (Pubitemid 47548571)
47. P. Gao, G.Y. Zhou, and Q.H. Zhang Lymphangiogenesis in gastric carcinoma correlates with prognosis J Pathol 218 2009 192 200
48. M. Kodama, Y. Kitadai, and M. Tanaka Vascular endothelial growth factor C stimulates progression of human gastric cancer via both autocrine and paracrine mechanisms Clin Cancer Res 14 2008 7205 7214
49. F.H. Han, H.M. Li, D.H. Zheng, Y.L. He, and W.H. Zhan The effect of the expression of vascular endothelial growth factor (VEGF)-C and VEGF receptor-3 on the clinical outcome in patients with gastric carcinoma Eur J Surg Oncol 36 2010 1172 1179
50. H.Y. Seo, J.M. Park, and K.H. Park Prognostic significance of serum vascular endothelial growth factor per platelet count in unresectable advanced gastric cancer patients Jpn J Clin Oncol 40 2010 1147 1153
51. M.S. Al-Moundhri, A. Al-Shukaili, and M. Al-Nabhani Measurement of circulating levels of VEGF-A, -C, and -D and their receptors, VEGFR-1 and -2 in gastric adenocarcinoma World J Gastroenterol 14 2008 3879 3883
52. O. Lyros, A. Mueller, and F. Heidel Analysis of anti-proliferative and chemosensitizing effects of sunitinib on human esophagogastric cancer cells: synergistic interaction with vandetanib via inhibition of multi-receptor tyrosine kinase pathways Int J Cancer 127 2010 1197 1208