A phase II, open-label trial of bortezomib (VELCADE®) in combination with gemcitabine and cisplatin in patients with locally advanced or metastatic non-small cell lung cancer

Cancer Chemotherapy and Pharmacology

Volumn 77, Issue 5, 2016, Pages 949-956

  Kontopodis, E ^a   Kotsakis, A ^a   Kentepozidis, N ^a   Syrigos, K ^a   Ziras, N ^a   Moutsos, M ^a   Filippa, G ^a   Mala, A ^a   Vamvakas, L ^a   Mavroudis, D ^a   Georgoulias, V ^a   Agelaki, S ^a  

^a Hellenic Oncology Research Group (HORG)   (Greece)

Author keywords

Bortezomib; Cisplatin; Gemcitabine; Non small cell lung cancer

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BORTEZOMIB; CISPLATIN; GEMCITABINE; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE;

ADENOCARCINOMA; ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALLERGY; ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CANCER COMBINATION CHEMOTHERAPY; DIARRHEA; DISEASE COURSE; DISEASE SEVERITY; DRUG EFFICACY; DYSPNEA; EDEMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; HEARING DISORDER; HISTOPATHOLOGY; HUMAN; INFECTION; INTENTION TO TREAT ANALYSIS; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; METASTASIS; MONOTHERAPY; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEPHROTOXICITY; NEUROTOXICITY; NEUTROPENIA; NON SMALL CELL LUNG CANCER; OPEN STUDY; OTOTOXICITY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RASH; REPEATED DRUG DOSE; SIDE EFFECT; SQUAMOUS CELL CARCINOMA; SURVIVAL RATE; THROMBOCYTOPENIA; THROMBOEMBOLISM; TREATMENT RESPONSE; VISUAL DISORDER; VOMITING; ANALOGS AND DERIVATIVES; CANCER STAGING; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; DISEASE FREE SURVIVAL; DOSE RESPONSE; DRUG ADMINISTRATION; LUNG NEOPLASMS; MORTALITY; PATHOLOGY;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BORTEZOMIB; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; NEOPLASM STAGING;

EID: 84961201263     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-016-2997-7     Document Type: Article

References (30)

1. Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ (2009) Cancer statistics, 2009. CA Cancer J Clin 59 (4): 225-249. doi: 10.3322/caac.20006
2. Greenlee RT, Murray T, Bolden S, Wingo PA (2000) Cancer statistics, 2000. CA Cancer J Clin 50 (1): 7-33
3. Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR (2004) American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol 22 (2): 330-353
4. Azzoli CG, Temin S, Aliff T, Baker S Jr, Brahmer J, Johnson DH, Laskin JL, Masters G, Milton D, Nordquist L, Pao W, Pfister DG, Piantadosi S, Schiller JH, Smith R, Smith TJ, Strawn JR, Trent D, Giaccone G (2011) 2011 focused update of 2009 American Society of Clinical Oncology clinical practice guideline update on chemotherapy for stage IV non-small-cell lung cancer. J Clin Oncol 29 (28): 3825-3831. doi: 10.1200/JCO.2010.34.2774
5. Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH (2006) Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 355 (24): 2542-2550. doi: 10.1056/NEJMoa061884
6. Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C (2009) Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. J Clin Oncol 27 (8): 1227-1234. doi: 10.1200/JCO.2007.14.5466
7. Mack PC, Davies AM, Lara PN, Gumerlock PH, Gandara DR (2003) Integration of the proteasome inhibitor PS-341 (Velcade) into the therapeutic approach to lung cancer. Lung Cancer 41 (Suppl 1): S89-S96. doi: S0169500203001491
8. Schenkein DP (2004) Use of proteasome inhibition in the treatment of lung cancer. Clin Lung Cancer 6 (Suppl 2): S89-S96
9. Yang Y, Ikezoe T, Saito T, Kobayashi M, Koeffler HP, Taguchi H (2004) Proteasome inhibitor PS-341 induces growth arrest and apoptosis of non-small cell lung cancer cells via the JNK/c-Jun/ AP-1 signaling. Cancer Sci 95 (2): 176-180
10. Denlinger CE, Rundall BK, Keller MD, Jones DR (2004) Proteasome inhibition sensitizes non-small-cell lung cancer to gemcitabine-induced apoptosis. Ann Thorac Surg 78 (4): 1207-1214. doi: 10.1016/j.athoracsur.2004.04.029
11. Mortenson MM, Schlieman MG, Virudachalam S, Bold RJ (2004) 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 54 (4): 343-353. doi: 10.1007/s00280-004-0811-4
12. Aghajanian C, Soignet S, Dizon DS, Pien CS, Adams J, Elliott PJ, Sabbatini P, Miller V, Hensley ML, Pezzulli S, Canales C, Daud A, Spriggs DR (2002) A phase I trial of the novel proteasome inhibitor PS341 in advanced solid tumor malignancies. Clin Cancer Res 8 (8): 2505-2511
13. Fanucchi MP, Fossella FV, Belt R, Natale R, Fidias P, Carbone DP, Govindan R, Raez LE, Robert F, Ribeiro M, Akerley W, Kelly K, Limentani SA, Crawford J, Reimers HJ, Axelrod R, Kashala O, Sheng S, Schiller JH (2006) 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 24 (31): 5025-5033. doi: 10.1200/JCO.2006.06.1853
14. Johnson S, Algazy K, Miller D et al (2005) Phase 2 clinical/ pharmacodynamic trial of the proteasome inhibitor PS-341 in advanced NSCLC. Proc Am Soc Clin Oncol; Chicago, Abstr 810
15. Voortman J, Smit EF, Kuenen BC, Peters GJ, van de Velde H, Giaccone G (2005) A phase 1B, open-label, dose-escalation study of bortezomib in combination with gemcitabine and cisplatin in the first-line treatment of patients with advanced solid tumors. ECCO 2005, abstr 1468
16. Voortman J, Smit EF, Honeywell R, Kuenen BC, Peters GJ, van de Velde H, Giaccone G (2007) 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. Clin Cancer Res 13 (12): 3642-3651. doi: 10.1158/1078-0432.CCR-07-0061
17. Davies AM, Chansky K, Lara PN Jr, Gumerlock PH, Crowley J, Albain KS, Vogel SJ, Gandara DR (2009) Bortezomib plus gemcitabine/carboplatin as first-line treatment of advanced non-small cell lung cancer: a phase II Southwest Oncology Group Study (S0339). J Thorac Oncol 4 (1): 87-92. doi: 10.1097/JTO.0b013e3181915052
18. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92 (3): 205-216
19. National Cancer Institute (2006) Common Terminology Criteria for Adverse Events (CTCAE). Cancer Therapy Evaluation Program. Common toxicity criteria. Version 3. 0. DCTD, NCI, NIH, DHHS edn
20. Simon R (1989) Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10: 1-10
21. Collet D (1994) Modelling survival data in medical research, 3rd edn. Blackwell Scientific, Oxford
22. Cox DR (1970) The analysis of binary data, 1st edn. Methuen, London
23. Crino L, Scagliotti GV, Ricci S, De Marinis F, Rinaldi M, Gridelli C, Ceribelli A, Bianco R, Marangolo M, Di Costanzo F, Sassi M, Barni S, Ravaioli A, Adamo V, Portalone L, Cruciani G, Masotti A, Ferrara G, Gozzelino F, Tonato M (1999) Gemcitabine and cisplatin versus mitomycin, ifosfamide, and cisplatin in advanced non-small-cell lung cancer: a randomized phase III study of the Italian Lung Cancer Project. J Clin Oncol 17 (11): 3522-3530
24. Sandler AB, Nemunaitis J, Denham C, von Pawel J, Cormier Y, Gatzemeier U, Mattson K, Manegold C, Palmer MC, Gregor A, Nguyen B, Niyikiza C, Einhorn LH (2000) 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 18 (1): 122-130
25. Scagliotti GV, De Marinis F, Rinaldi M, Crino L, Gridelli C, Ricci S, Matano E, Boni C, Marangolo M, Failla G, Altavilla G, Adamo V, Ceribelli A, Clerici M, Di Costanzo F, Frontini L, Tonato M (2002) Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. J Clin Oncol 20 (21): 4285-4291
26. Smit EF, van Meerbeeck JP, Lianes P, Debruyne C, Legrand C, Schramel F, Smit H, Gaafar R, Biesma B, Manegold C, Neymark N, Giaccone G (2003) Three-arm randomized study of two cisplatin-based regimens and paclitaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group—EORTC 08975. J Clin Oncol 21 (21): 3909-3917
27. Scagliotti GV, Parikh P, von Pawel J, Biesma B, Vansteenkiste J, Manegold C, Serwatowski P, Gatzemeier U, Digumarti R, Zukin M, Lee JS, Mellemgaard A, Park K, Patil S, Rolski J, Goksel T, de Marinis F, Simms L, Sugarman KP, Gandara D (2008) Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advancedstage non-small-cell lung cancer. J Clin Oncol 26 (21): 3543-3551. doi: 10.1200/JCO.2007.15.0375
28. Richardson PG, Sonneveld P, Schuster MW, Irwin D, Stadtmauer EA, Facon T, Harousseau JL, Ben-Yehuda D, Lonial S, Goldschmidt H, Reece D, San-Miguel JF, Blade J, Boccadoro M, Cavenagh J, Dalton WS, Boral AL, Esseltine DL, Porter JB, Schenkein D, Anderson KC (2005) Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med 352 (24): 2487-2498. doi: 10.1056/NEJMoa043445
29. Lonial S, Waller EK, Richardson PG, Jagannath S, Orlowski RZ, Giver CR, Jaye DL, Francis D, Giusti S, Torre C, Barlogie B, Berenson JR, Singhal S, Schenkein DP, Esseltine DL, Anderson J, Xiao H, Heffner LT, Anderson KC (2005) Risk factors and kinetics of thrombocytopenia associated with bortezomib for relapsed, refractory multiple myeloma. Blood 106 (12): 3777-3784. doi: 10.1182/blood-2005-03-1173
30. Bringhen S, Larocca A, Rossi D, Cavalli M, Genuardi M, Ria R, Gentili S, Patriarca F, Nozzoli C, Levi A, Guglielmelli T, Benevolo G, Callea V, Rizzo V, Cangialosi C, Musto P, De Rosa L, Liberati AM, Grasso M, Falcone AP, Evangelista A, Cavo M, Gaidano G, Boccadoro M, Palumbo A (2010) Efficacy and safety of once-weekly bortezomib in multiple myeloma patients. Blood 116 (23): 4745-4753. doi: 10.1182/blood-2010-07-294983