Cationic liposomal paclitaxel plus gemcitabine or gemcitabine alone in patients with advanced pancreatic cancer: A randomized controlled phase II trial

Annals of Oncology

Volumn 23, Issue 5, 2012, Pages 1214-1222

  Lohr J M ^a,b   Haas, S L ^a,b   Bechstein, W O ^c   Bodoky, G ^d   Cwiertka, K ^e   Fischbach, W ^f   Folsch U R ^g   Jager D ^h   Osinsky, D ⁱ   Prausova, J ^j   Schmidt, W E ^k   Lutz, M P ^l   Ambrus, M ^l   Bartos, J ^l   Bondar, V ^l   Brugger, W ^l   Chibisov, L ^l   Gauler, T ^l   Gog, C ^l   Graeven, U ^l   Greiner, L ^l   Herzog, P ^l   Marten A ^l   Matzdorff, A ^l   Myasoedov, D ^l   Pap, A ^l   Petruzelka, L ^l   Schmid, R ^l   Siffnerova, H ^l   Spurny, V ^l   Szanto, J ^l   Thurzo, L ^l   Vanasek, J ^l   Zeuzem, S ^l   more..

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b KAROLINSKA INSTITUTE   (Sweden)

^c UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^d Szent Laszlo Hospital   (Hungary)

^e UNIVERSITY HOSPITAL OLOMOUC   (Czech Republic)

^f KLINIKUM ASCHAFFENBURG   (Germany)

^g UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^h UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

ⁱ Institute of Oncology AMS of Ukraine   (United Kingdom)

^j CHARLES UNIVERSITY   (Czech Republic)

^k ST JOSEF HOSPITAL   (Germany)

^l Caritasklinik St Theresia ^*

more..

Author keywords

Cationic liposomes; EndoTAG 1; Liposomal paclitaxel; Pancreatic cancer; Vascular targeting

Indexed keywords

ENDOTAG; GEMCITABINE; PACLITAXEL; UNCLASSIFIED DRUG;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER CONTROL; CANCER SURVIVAL; CHILL; CONTROLLED STUDY; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FEVER; GASTROINTESTINAL DISEASE; HEMATOLOGIC DISEASE; HUMAN; INFUSION RELATED REACTION; LEUKOPENIA; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PANCREAS CANCER; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTOPENIA; TREATMENT OUTCOME; VOMITING;

EID: 84860463458     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdr379     Document Type: Article

References (42)

1. Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin 2010; 60: 277-300.
2. Hidalgo M. Pancreatic cancer. N Engl J Med 2010; 362: 1605-1617.
3. Löhr M. Is it possible to survive pancreatic cancer? Nat Clin Pract Gastroenterol Hepatol 2006; 3: 236-237.
4. Burris HA 3rd, Moore MJ, Andersen J et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol 1997; 15: 2403-2413.
5. Moore MJ, Goldstein D, Hamm J et al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2007; 25: 1960-1966.
6. O'Reilly E. Pancreatic adenocarcinoma: new strategies for success. Gastrointest Cancer Res 2009; 3: S11.
7. Nieto J, Grossbard ML, Kozuch P. Metastatic pancreatic cancer 2008: is the glass less empty? Oncologist 2008; 13: 562-576.
8. von Hoff DD, Ramanathan R, Borad M et al. SPARC correlation with response to gemcitabine (G) plus nab-paclitaxel (nab-P) in patients with advanced metastatic pancreatic cancer: a phase I/II study. J Clin Oncol 2009; 27 (15 Suppl): (Abstr 4525).
9. Saif MW, Syrigos K, Penney R, Kaley K. Docetaxel second-line therapy in patients with advanced pancreatic cancer: a retrospective study. Anticancer Res 2010; 30: 2905-2909.
10. Lam AP, Sparano JA, Vinciguerra V et al. Phase II study of paclitaxel plus the protein kinase C inhibitor bryostatin-1 in advanced pancreatic carcinoma. Am J Clin Oncol 2010; 33: 121-124.
11. Saif MW, Podoltsev NA, Rubin MS et al. Phase II clinical trial of paclitaxel loaded polymeric micelle in patients with advanced pancreatic cancer. Cancer Invest 2010; 28: 186-194.
12. Korc M. Pathways for aberrant angiogenesis in pancreatic cancer. Mol Cancer 2003; 2: 8.
13. Kleeff J, Beckhove P, Esposito I et al. Pancreatic cancer microenvironment. Int J Cancer 2007; 121: 699-705.
14. Abu Lila AS, Ishida T, Kiwada H. Targeting anticancer drugs to tumor vasculature using cationic liposomes. Pharm Res 2010; 27: 1171-1183.
15. Eichhorn ME, Strieth S, Krasnici S et al. Protamine enhances uptake of cationic liposomes in angiogenic microvessels. Angiogenesis 2004; 7: 133-141.
16. Thurston G, McLean JW, Rizen M et al. Cationic liposomes target angiogenic endothelial cells in tumors and chronic inflammation in mice. J Clin Invest 1998; 101: 1401-1413.
17. Campbell RB, Fukumura D, Brown EB et al. Cationic charge determines the distribution of liposomes between the vascular and extravascular compartments of tumors. Cancer Res 2002; 62: 6831-6836.
18. Schmitt-Sody M, Strieth S, Krasnici S et al. Neovascular targeting therapy: paclitaxel encapsulated in cationic liposomes improves antitumoral efficacy. Clin Cancer Res 2003; 9: 2335-2341.
19. Strieth S, Eichhorn ME, Werner A et al. Paclitaxel encapsulated in cationic liposomes increases tumor microvessel leakiness and improves therapeutic efficacy in combination with Cisplatin. Clin Cancer Res 2008; 14: 4603-4611.
20. Eichhorn ME, Ischenko I, Luedemann S et al. Vascular targeting by EndoTAG-1 enhances therapeutic efficacy of conventional chemotherapy in lung and pancreatic cancer. Int J Cancer 2010; 126: 1235-1245.
21. Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000; 92: 205-216.
22. Cunningham D, Chau I, Stocken DD et al. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol 2009; 27: 5513-5518.
23. Heinemann V, Boeck S, Hinke A et al. Meta-analysis of randomized trials: evaluation of benefit from gemcitabine-based combination chemotherapy applied in advanced pancreatic cancer. BMC Cancer 2008; 8: 82.
24. Sultana A, Smith CT, Cunningham D et al. Meta-analyses of chemotherapy for locally advanced and metastatic pancreatic cancer. J Clin Oncol 2007; 25: 2607-2615.
25. Bria E, Milella M, Gelibter A et al. Gemcitabine-based combinations for inoperable pancreatic cancer: have we made real progress? A meta-analysis of 20 phase 3 trials. Cancer 2007; 110: 525-533.
26. Conroy T, Desseigne F, Ychou M et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 2011; 364: 1817-1825.
27. Bayraktar S, Bayraktar UD, Rocha-Lima CM. Recent developments in palliative chemotherapy for locally advanced and metastatic pancreas cancer. World J Gastroenterol 2010; 16: 673-682.
28. Kulke MH, Tempero MA, Niedzwiecki D et al. Randomized phase II study of gemcitabine administered at a fixed dose rate or in combination with cisplatin, docetaxel, or irinotecan in patients with metastatic pancreatic cancer: CALGB 89904. J Clin Oncol 2009.
29. Lutz MP, Van Cutsem E, Wagener T et al. Docetaxel plus gemcitabine or docetaxel plus cisplatin in advanced pancreatic carcinoma: randomized phase II study 40984 of the European Organisation for Research and Treatment of Cancer Gastrointestinal Group. J Clin Oncol 2005; 23: 9250-9256.
30. Kosmidis P, Mylonakis N, Nicolaides C et al. Paclitaxel plus carboplatin versus gemcitabine plus paclitaxel in advanced non-small-cell lung cancer: a phase III randomized trial. J Clin Oncol 2002; 20: 3578-3585.
31. Albain KS, Nag SM, Calderillo-Ruiz G et al. Gemcitabine plus Paclitaxel versus Paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment. J Clin Oncol 2008; 26: 3950-3957.
32. Philip PA, Mooney M, Jaffe D et al. Consensus report of the national cancer institute clinical trials planning meeting on pancreas cancer treatment. J Clin Oncol 2009; 27: 5660-5669.
33. Bramhall SR, Schulz J, Nemunaitis J et al. A double-blind placebo-controlled, randomised study comparing gemcitabine and marimastat with gemcitabine and placebo as first line therapy in patients with advanced pancreatic cancer. Br J Cancer 2002; 87: 161-167.
34. Van Cutsem E, van de Velde H, Karasek P et al. Phase III trial of gemcitabine plus tipifarnib compared with gemcitabine plus placebo in advanced pancreatic cancer. J Clin Oncol 2004; 22: 1430-1438.
35. Philip PA, Benedetti J, Fenoglio-Preiser C et al. Phase III study of gemcitabine [G] plus cetuximab [C] versus gemcitabine in patients [pts] with locally advanced or metastatic pancreatic adenocarcinoma [PC]: SWOG S0205 study. J Clin Oncol (Meeting Abstracts) 2007; 25 (18S): (Abstr LBA4509).
36. Van Cutsem E, Vervenne WL, Bennouna J et al. Phase III trial of bevacizumab in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. J Clin Oncol 2009; 27: 2231-2237.
37. Kindler HL, Ioka T, Richel DJ et al. A double-blinded, placebo-controlled, randomized, phase III study of axitinib (AG-013736; A) plus gemcitabine (G) vs. G plus placebo (P) in advanced pancreatic cancer (PC) patients (pts). Eur J Cancer Suppl 2009; 7: 361.
38. Mahadevan D, Von Hoff DD. Tumor-stroma interactions in pancreatic ductal adenocarcinoma. Mol Cancer Ther 2007; 6: 1186-1197.
39. Apte MV, Park S, Phillips PA et al. Desmoplastic reaction in pancreatic cancer: role of pancreatic stellate cells. Pancreas 2004; 29: 179-187.
40. Bardeesy N, DePinho RA. Pancreatic cancer biology and genetics. Nat Rev Cancer 2002; 2: 897-909.
41. Strieth S, Eichhorn ME, Sauer B et al. Neovascular targeting chemotherapy: encapsulation of paclitaxel in cationic liposomes impairs functional tumor microvasculature. Int J Cancer 2004; 110: 117-124.
42. McDonald DM, Baluk P. Significance of blood vessel leakiness in cancer. Cancer Res 2002; 62: 5381-5385.