A parallel dose-escalation study of weekly and twice-weekly bortezomib in combination with gemcitabine and cisplatin in the first-line treatment of patients with advanced solid tumors

Clinical Cancer Research

Volumn 13, Issue 12, 2007, Pages 3642-3651

  Voortman, Jens ^a   Smit, Egbert F ^a   Honeywell, Richard ^a   Kuenen, Bart C ^a   Peters, Godefridus J ^a   Van De Velde, Helgi ^b   Giaccone, Giuseppe ^a  

^a VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^b JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

BORTEZOMIB; CISPLATIN; GEMCITABINE;

ABDOMINAL PAIN; ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; BLURRED VISION; BONE PAIN; CANCER PATIENT; CANCER SURVIVAL; CLINICAL ARTICLE; CONJUNCTIVITIS; CONSTIPATION; COUGHING; DIARRHEA; DISEASE ACTIVITY; DIZZINESS; DRUG DOSE ESCALATION; DRUG TOLERABILITY; DRY SKIN; DYSPNEA; EPISTAXIS; FEMALE; FLU LIKE SYNDROME; HEADACHE; HEARTBURN; HICCUP; HOT FLUSH; HUMAN; INJECTION SITE REACTION; LUNG NON SMALL CELL CANCER; MALE; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; PERIORBITAL EDEMA; PRIORITY JOURNAL; RASH; RESPIRATORY TRACT INFECTION; SENSORY NEUROPATHY; SIDE EFFECT; STOMATITIS; TASTE DISORDER; THROMBOCYTOPENIA; TINNITUS; TREATMENT RESPONSE; VOMITING; WEIGHT REDUCTION; XEROSTOMIA;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BORONIC ACIDS; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; PYRAZINES;

EID: 34250770091     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-07-0061     Document Type: Article

References (42)

1. King RW, Deshaies RJ, Peters JM, Kirschner MW. How proteolysis drives the cell cycle. Science 1996;274:1652-9.
2. Palombella VJ, Rando OJ, Goldberg AL, Maniatis T. The ubiquitin-proteasome pathway is required for processing the NF-κB1 precursor protein and the activation of NF-κB. Cell 1994;78:773-85.
3. Read MA, Neish AS, Luscinskas FW, Palombella VJ, Maniatis T, Collins T. The proteasome pathway is required for cytokine-induced endothelial-leukocyte adhesion molecule expression. Immunity1995;2:493-506.
4. Twombly R. First proteasome inhibitor approved for multiple myeloma. J Natl Cancer Inst 2003;95:845.
5. Adams J. The proteasome: a suitable antineoplastic target. Nat Rev Cancer 2004;4:349-60.
6. Beg AA, Baltimore D. An essential role for NF-κB in preventing TNF-α-induced cell death. Science 1996;274:782-4.
7. 2-M phase arrest and apoptosis. Mol Cancer Ther 2002;1:841-9.
8. Fernandez Y, Verhaegen M, Miller TP, et al. Differential regulation of noxa in normalmelanocytes andmelanoma cells by proteasome inhibition: therapeutic implications. Cancer Res 2005;65:6294-304.
9. Perez-Galan P, Roue G, Villamor N, Montserrat E, Campo E, Colomer D. The proteasome inhibitor bortezomib induces apoptosis in mantle-cell lymphoma through generation of ROS and Noxa activation independent of p53 status. Blood 2006;107:257-64.
10. Ludwig H, Khayat D, Giaccone G, Facon T. Proteasome inhibition and its clinical prospects in the treatment of hematologic and solid malignancies. Cancer 2005;104:1794-807.
11. Adams J, Palombella VJ, Sausville EA, et al. Proteasome inhibitors: a novel class of potent and effective antitumor agents. Cancer Res 1999;59:2615-22.
12. Fanucchi MP, Fossella FV, Belt R, et al. Randomized phase II study of bortezomib alone and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer. J Clin Oncol 2006;24:5025-33.
13. Richardson PG, Sonneveld P, Schuster MW, et al. Bortezomib or high-dose dexamethasone for relapsed multiplemyeloma. N Engl J Med 2005;352:2487-98.
14. Sandler AB, Nemunaitis J, Denham C, et al. Phase III trial of gemcitabine plus cisplatin versus cisplatin alone in patients with locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 2000;18:122-30.
15. Lehmann J, Retz M, Steiner G, et al. [Gemcitabine/cisplatin vs. MVAC. 5 year survival outcome of the phase III study of chemotherapy of advanced urothelial carcinoma in Germany]. Urologe A 2003;42:1074-86.
16. Aghajanian C, Dizon DS, Sabbatini P, Raizer JJ, Dupont J, Spriggs DR. Phase I trial of bortezomib and carboplatin in recurrent ovarian or primary peritoneal cancer. JClin Oncol 2005;23:5943-9.
17. Mortenson MM, Schlieman MG, Virudachalam S, Bold RJ. Effects of the proteasome inhibitor bortezomib alone and in combination with chemotherapy in the A549 non-small-cell lung cancer cell line. Cancer Chemother Pharmacol 2004;54:343-53.
18. Kamat AM, Karashima T, Davis DW, et al. The proteasome inhibitor bortezomib synergizes with gemcitabine to block the growth of human 253JB-V bladder tumors in vivo. Mol Cancer Ther 2004;3:279-90.
19. Teicher BA, Ara G, Herbst R, Palombella VJ, Adams J. The proteasome inhibitor PS-341in cancer therapy. Clin Cancer Res 1999;5:2638-45.
20. Davies AM, McCoy J, Lara PN, et al. Bortezomib + gemcitabine (Gem)/carboplatin (Carbo) results in encouraging survival in advanced non-small cell lung cancer (NSCLC): Results of a phase II Southwest Oncology Group (SWOG) trial [abstract 7017]. Int J Clin Oncol 2006;24:18S.
21. Imai J, Yashiroda H, Maruya M, Yahara I, Tanaka K. Proteasomes and molecular chaperones: cellular machinery responsible for folding and destruction of unfolded proteins. Cell Cycle 2003;2:585-90.
22. Fahy BN, Schlieman MG, Mor tenson MM, Virudachalam S, Bold RJ. Targeting BCL-2 overexpression in various human malignancies through NFβB inhibition by the proteasome inhibitor bortezomib. Cancer Chemother Pharmacol 2005;56:46-54.
23. Mack PC, Davies AM, Lara PN, Gumerlock PH, Gandara DR. Integration of the proteasome inhibitor PS-341 (Velcade) into the therapeutic approach to lung cancer. Lung Cancer 2003;41 Suppl 1:S89-96.
24. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-16.
25. van Moorsel CJ, Kroep JR, Pinedo HM, et al. Pharmacokinetic schedule finding study of the combination of gemcitabine and cisplatin in patients with solid tumors. Ann Oncol 1999;10:441-8.
26. Honeywell R, van Groeningen CJ, Laan AC, et al. Analysis of deoxycytidine accumulation in gemcitabine treated patients. Nucleosides Nucleotides Nucleic Acids 2006;25:1225-32.
27. Honeywell R, Laan AC, van Groeningen CJ, et al. The determination of gemcitabine and 2′-deoxycytidine in human plasma and tissue by APCI tandemmass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2007;847:142-52.
28. Voortman J, Giaccone G. Severe reversible cardiac failure after bortezomib treatment combinedwith chemotherapy in a non-small cell lung cancer patient: a case report. BMC Cancer 2006;6:129.
29. Kroep JR, Smit EF, Giaccone G, et al. Pharmacology of the paclitaxel-cisplatin, gemcitabine-cisplatin, and paclitaxel-gemcitabine combinations in patients with advanced non-small cell lung cancer. Cancer Chemother Pharmacol 2006;58:509-16.
30. Scagliotti G. Proteasome inhibitors in lung cancer. Crit Rev Oncol Hematol 2006;58:177-89.
31. Scagliotti GV, DeMarinis F, Rinaldi M, et al. Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. J Clin Oncol 2002;20:4285-91.
32. Zatloukal P, Petruzelka L, Zemanova M, et al. Gemcitabine plus cisplatin vs. gemcitabine plus carboplatin in stage IIIb and IV non-small cell lung cancer: a phase III randomized trial. Lung Cancer 2003;41:321-31.
33. Lonial S, Waller EK, Richardson PG, et al. Risk factors and kinetics of thrombocytopenia associated with bortezomib for relapsed, refractory multiplemyeloma. Blood 2005;106:3777-84.
34. Richardson PG, Briemberg H, Jagannath S, et al. Frequency, characteristics, and reversibility of peripheral neuropathy during treatment of advanced multiple myeloma with bortezomib. J Clin Oncol 2006;24:3113-20.
35. Ropper AH, Gorson KC. Neuropathies associated with paraproteinemia. N Engl J Med 1998;338:1601-7.
36. Ryan DP, Appleman LJ, Lynch T, et al. Phase I clinical trial of bortezomib in combination with gemcitabine in patients with advanced solid tumors. Cancer 2006;107:2482-9.
37. Lightcap ES, McCormack TA, Pien CS, Chau V, Adams J, Elliott PJ. Proteasome inhibition measurements: clinical application. Clin Chem 2000;46:673-83.
38. Mazzanti P, Massacesi C, Rocchi MB, et al. Randomized, multicenter, phase II study of gemcitabine plus cisplatin versus gemcitabine plus carboplatin in patients with advanced non-small cell lung cancer. Lung Cancer 2003;41:81-9.
39. Gebbia V, Galetta D, Caruso M, et al. Gemcitabine and cisplatin versus vinorelbine and cisplatin versus ifosfamide+gemcitabine followed by vinorelbine and cisplatin versus vinorelbine and cisplatin followed by ifosfamide and gemcitabine in stage IIIB-IV non small cell lung carcinoma: a prospective randomized phase III trial of the Gruppo Oncologico Italia Meridionale. Lung Cancer 2003;39:179-89.
40. Cardenal F, Lopez-Cabrerizo MP, Anton A, et al. Randomized phase III study of gemcitabine-cisplatin versus etoposide-cisplatin in the treatment of locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 1999;17:12-8.
41. Greco FA, Spigel DR, Barton JH, et al. Weekly bortezomib in the treatment of patients (pts) with previously treated multiple myeloma: a phase II trial of the Minnie Pearl Cancer Research Network [abstract 7547]. J Clin Oncol 2006;24:18S.
42. Suvannasankha A, Smith GG, Juliar BE, Abonour R. Weekly bortezomib/methylprednisolone is effective and well tolerated in relapsed multiple myeloma. Clin Lymphoma Myeloma 2006;7:131-4.