Randomised phase II trial of docetaxel and sunitinib in patients with metastatic gastric cancer who were previously treated with fluoropyrimidine and platinum

British Journal of Cancer

Volumn 106, Issue 9, 2012, Pages 1469-1474

  Yi, J H ^a,b   Lee, J ^a,c   Park, S H ^a   Park, J O ^a   Yim, D S ^c   Park, Y S ^a   Lim, H Y ^a   Kang, W K ^a  

^a Sungkyunkwan University School of Medicine   (South Korea)

^b Yonsei University College of Medicine   (South Korea)

^c The Catholic University of Korea   (South Korea)

Author keywords

docetaxel; Gastric cancer; second line chemotherapy; sunitinib

Indexed keywords

DOCETAXEL; FLUOROPYRIMIDINE; N DEETHYLSUNITINIB; PLATINUM; SUNITINIB;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTICLE; CANCER CONTROL; CANCER GROWTH; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; DIARRHEA; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DRUG TREATMENT FAILURE; FEBRILE NEUTROPENIA; FEMALE; HAND FOOT SYNDROME; HAZARD RATIO; HUMAN; INOPERABLE CANCER; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; METASTASIS; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUROPATHY; NEUTROPENIA; OPEN STUDY; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZATION; STEADY STATE; STOMACH CANCER; STOMATITIS; THROMBOCYTOPENIA; TREATMENT RESPONSE;

ADENOCARCINOMA; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BONE NEOPLASMS; FEMALE; FLUOROURACIL; HUMANS; INDOLES; LIVER NEOPLASMS; LUNG NEOPLASMS; LYMPHATIC METASTASIS; MALE; MIDDLE AGED; PLATINUM; PYRROLES; SALVAGE THERAPY; STOMACH NEOPLASMS; SURVIVAL RATE; TAXOIDS; TISSUE DISTRIBUTION; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84860234330     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2012.100     Document Type: Article

References (34)

1. Abrams TJ, Lee LB, Murray LJ, Pryer NK, Cherrington JM (2003a) SU11248 inhibits KIT and platelet-derived growth factor receptor beta in preclinical models of human small cell lung cancer. Mol Cancer Ther 2: 471-478
2. Abrams TJ, Murray LJ, Pesenti E, Holway VW, Colombo T, Lee LB, Cherrington JM, Pryer NK (2003b) Preclinical evaluation of the tyrosine kinase inhibitor SU11248 as a single agent and in combination with 'standard of care' therapeutic agents for the treatment of breast cancer. Mol Cancer Ther 2: 1011-1021
3. Bang YJ, Kang WK, Kang YK, Kim HC, Jacques C, Zuber E, Daglish B, Boudraa Y, Kim WS, Heo DS, Kim NK (2002) 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 32: 248-254 (Pubitemid 43102808)
4. Bang YJ, Kang YK, Kang WK, Boku N, Chung HC, Chen JS, Doi T, Sun Y, Shen L, Qin S, Ng WT, Tursi JM, Lechuga MJ, Lu DR, Ruiz-Garcia A, Sobrero A (2010) Phase II study of sunitinib as second-line treatment for advanced gastric cancer. Invest New Drugs 29(6): 1449-1458
5. Barone C, Basso M, Schinzari G, Pozzo C, Trigila N, D'Argento E, Quirino M, Astone A, Cassano A (2007) Docetaxel and oxaliplatin combination in second-line treatment of patients with advanced gastric cancer. Gastric Cancer 10: 104-111 (Pubitemid 46955936)
6. Britten CD, Kabbinavar F, Hecht JR, Bello CL, Li J, Baum C, Slamon D (2008) A phase I and pharmacokinetic study of sunitinib administered daily for 2 weeks, followed by a 1-week off period. Cancer Chemother Pharmacol 61: 515-524 (Pubitemid 350275988)
7. Christensen JG HC, Hollister BA (2008) Antitumor efficacy of sunitinib malate in concurrent and sequential combinations with standard chemotherapeutic agents in non-small cell lung cancer (NSCLC) nonclinical models. Proceedings of the 99th Annual Meeting of the American Association for Cancer Research, Philadelphia: PA, USA
8. de Jonge MJ, Dumez H, Kitzen JJ, Beuselinck B, Verweij J, Courtney R, Battista A, Brega N, Schoffski P (2011) Phase I safety and pharmacokinetic study of SU-014813 in combination with docetaxel in patients with advanced solid tumours. Eur J Cancer 47: 1328-1335
9. Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG (2006) Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet 368: 1329-1338 (Pubitemid 44528723)
10. Garcia-Donas J, Esteban E, Leandro-Garcia LJ, Castellano DE, del Alba AG, Climent MA, Arranz JA, Gallardo E, Puente J, Bellmunt J, Mellado B, Martinez E, Moreno F, Font A, Robledo M, Rodriguez-Antona C (2011) Single nucleotide polymorphism associations with response and toxic effects in patients with advanced renal-cell carcinoma treated with first-line sunitinib: a multicentre, observational, prospective study. Lancet Oncol 12: 1143-1150
11. Giuliani F, Gebbia V, De Vita F, Maiello E, Di Bisceglie M, Catalano G, Gebbia N, Colucci G (2003) 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: 4219-4222 (Pubitemid 37474923)
12. Glimelius B, Ekstrom K, Hoffman K, Graf W, Sjoden PO, Haglund U, Svensson C, Enander LK, Linne T, Sellstrom H, Heuman R (1997) Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol 8: 163-168 (Pubitemid 27112884)
13. Ilson DH (2007) Docetaxel, cisplatin, and fluorouracil in gastric cancer: does the punishment fit the crime? J Clin Oncol 25: 3188-3190 (Pubitemid 47325599)
14. Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D (2011) Global cancer statistics. CA Cancer J Clin 61: 69-90
15. Jung KW, Park S, Kong HJ, Won YJ, Lee JY, Park EC, Lee JS (2011) Cancer statistics in Korea: incidence, mortality, survival, and prevalence in 2008. Cancer Res Treat 43: 1-11
16. Kim JA, Lee J, Han B, Park SH, Park JO, Park YS, Lim HY, Kang WK (2011) Docetaxel/cisplatin followed by FOLFIRI versus the reverse sequence in metastatic gastric cancer. Cancer Chemother Pharmacol 68: 177-184
17. Lee JL, Ryu MH, Chang HM, Kim TW, Yook JH, Oh ST, Kim BS, Kim M, Chun YJ, Lee JS, Kang YK (2008) A phase II study of docetaxel as salvage chemotherapy in advanced gastric cancer after failure of fluoropyrimidine and platinum combination chemotherapy. Cancer Chemother Pharmacol 61: 631-637
18. Mendel DB, Laird AD, Xin X, Louie SG, Christensen JG, Li G, Schreck RE, Abrams TJ, Ngai TJ, Lee LB, Murray LJ, Carver J, Chan E, Moss KG, Haznedar JO, Sukbuntherng J, Blake RA, Sun L, Tang C, Miller T, Shirazian S, McMahon G, Cherrington JM (2003) 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: 327-337 (Pubitemid 36109749)
19. Moehler M, Mueller A, Hartmann JT, Ebert MP, Al-Batran SE, Reimer P, Weihrauch M, Lordick F, Trarbach T, Biesterfeld S, Kabisch M, Wachtlin D, Galle PR (2011) An open-label, multicentre biomarker-oriented AIO phase II trial of sunitinib for patients with chemo-refractory advanced gastric cancer. Eur J Cancer 47: 1511-1520
20. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Oudard S, Negrier S, Szczylik C, Pili R, Bjarnason GA, Garcia-del-Muro X, Sosman JA, Solska E, Wilding G, Thompson JA, Kim ST, Chen I, Huang X, Figlin RA (2009) Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 27: 3584-3590
21. Nguyen S, Rebischung C, Van Ongeval J, Flesch M, Bennamoun M, Andre T, Ychou M, Gamelin E, Carola E, Louvet C (2006) Epirubicin-docetaxel in advanced gastric cancer: two phase II studies as second and first line treatment. Bull Cancer 93: E1-E6
22. Nishiyama M, Wada S (2009) Docetaxel: its role in current and future treatments for advanced gastric cancer. Gastric Cancer 12: 132-141
23. O'Farrell AM, Abrams TJ, Yuen HA, Ngai TJ, Louie SG, Yee KW, Wong LM, Hong W, Lee LB, Town A, Smolich BD, Manning WC, Murray LJ, Heinrich MC, Cherrington JM (2003) SU11248 is a novel FLT3 tyrosine kinase inhibitor with potent activity in vitro and in vivo. Blood 101: 3597-3605 (Pubitemid 36857948)
24. Park SH, Lim DH, Park K, Lee S, Oh SY, Kwon H, Kang JH, Hwang IG, Lee J, Park JO, Park YS, Lim HY, Kang WK (2011) A multicenter, randomized phase III trial comparing second-line chemotherapy (SLC) plus best supportive care (BSC) with BSC alone for pretreated advanced gastric cancer (AGC). J Clin Oncol 29(Suppl): Abstract 4004
25. Park SH, Kang WK, Lee HR, Park J, Lee KE, Lee SH, Park JO, Kim K, Kim WS, Chung CW, Im YH, Lee MH, Park CH, Park K (2004) Docetaxel plus cisplatin as second-line therapy in metastatic or recurrent advanced gastric cancer progressing on 5-fluorouracil-based regimen. Am J Clin Oncol 27: 477-480 (Pubitemid 39371942)
26. Pyrhonen S, Kuitunen T, Nyandoto P, Kouri M (1995) Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with nonresectable gastric cancer. Br J Cancer 71: 587-591
27. Raymond E, Dahan L, Raoul JL, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen JS, Horsch D, Hammel P, Wiedenmann B, Van Cutsem E, Patyna S, Lu DR, Blanckmeister C, Chao R, Ruszniewski P (2011) Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med 364: 501-513
28. Robert F, Sandler A, Schiller JH, Liu G, Harper K, Verkh L, Huang X, Ilagan J, Tye L, Chao R, Traynor AM (2010) Sunitinib in combination with docetaxel in patients with advanced solid tumors: a phase I doseescalation study. Cancer Chemother Pharmacol 66: 669-680
29. Tanaka M, Ma E, Tanaka H, Ioka A, Nakahara T, Takahashi H (2011) Trends of stomach cancer mortality in eastern Asia in 1950-2004: Comparative study of Japan, Hong Kong and Singapore using age, period and cohort analysis. Int J Cancer 130(4): 930-936
30. Van Cutsem E, Haller D, Ohtsu A (2002) The role of chemotherapy in the current treatment of gastric cancer. Gastric Cancer 5(Suppl 1): 17-22 (Pubitemid 36608899)
31. Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Risse ML, Ajani JA (2006) 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: 4991-4997 (Pubitemid 46631401)
32. van Erp NP, Eechoute K, van der Veldt AA, Haanen JB, Reyners AK, Mathijssen RH, Boven E, van der Straaten T, Baak-Pablo RF, Wessels JA, Guchelaar HJ, Gelderblom H (2009) Pharmacogenetic pathway analysis for determination of sunitinib-induced toxicity. J Clin Oncol 27: 4406-4412
33. Wagner AD, Grothe W, Haerting J, Kleber G, Grothey A, Fleig WE (2006) Chemotherapy in advanced gastric cancer: a systematic review and metaanalysis based on aggregate data. J Clin Oncol 24: 2903-2909 (Pubitemid 46630593)
34. Zhong H, Zhang Y, Ma S, Ying JE, Yang Y, Yong D, Hang X, Sun Q, Zhong B, Wang D (2008) Docetaxel plus oxaliplatin (DOCOX) as a second-line treatment after failure of fluoropyrimidine and platinum in Chinese patients with advanced gastric cancer. Anticancer Drugs 19: 1013-1018