Weekly and every 2 weeks cetuximab maintenance therapy after platinum-based chemotherapy plus cetuximab as first-line treatment for non-small cell lung cancer: randomized non-comparative phase IIIb NEXT trial

Targeted Oncology

Volumn 10, Issue 2, 2015, Pages 255-265

  Heigener, David F ^a   Pereira, José Rodrigues ^b   Felip, Enriqueta ^c   Mazal, Juraj ^d   Manzyuk, Lyudmila ^e   Tan, Eng Huat ^f   Merimsky, Ofer ^g   Sarholz, Barbara ^h   Esser, Regina ^h   Gatzemeier, Ulrich ^a  

^a LungenClinic Grosshansdorf   (Germany)

^b IM IN JK) Inst Do C   (Brazil)

^c HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^d Fakultna nemocnica s poliklinikou FD Roosevelta Banska Bystrica   (Slovakia)

^e N N BLOKHIN RUSSIAN CANCER RESEARCH CENTER   (Russian Federation)

^f DIVISION OF MEDICAL ONCOLOGY   (Singapore)

^g TEL AVIV SOURASKY MEDICAL CENTER   (Israel)

^h MERCK KGAA   (Germany)

Author keywords

Cetuximab; Chemotherapy; Every 2 weeks; Maintenance therapy; NSCLC

Indexed keywords

ALANINE AMINOTRANSFERASE; CARBOPLATIN; CETUXIMAB; CISPLATIN; DOCETAXEL; GEMCITABINE; NAVELBINE; PACLITAXEL; ANTINEOPLASTIC AGENT;

ACNE; ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; CONSTIPATION; CONTROLLED STUDY; COUGHING; DEATH; DERMATITIS; DISEASE COURSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; FAINTNESS; FATIGUE; FEMALE; HEART DISEASE; HUMAN; HYPOKALEMIA; HYPOMAGNESEMIA; INFUSION RELATED REACTION; LEUKOPENIA; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NON SMALL CELL LUNG CANCER; PARONYCHIA; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; SURVIVAL RATE; THORAX PAIN; THROMBOCYTOPENIA; TREATMENT WITHDRAWAL; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VOMITING; BRAZIL; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; EUROPE; ISRAEL; KAPLAN MEIER METHOD; LUNG NEOPLASMS; MAINTENANCE CHEMOTHERAPY; MIDDLE AGED; MORTALITY; PATHOLOGY; PHASE 2 CLINICAL TRIAL; SINGAPORE; TIME FACTOR; TREATMENT OUTCOME;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BRAZIL; CARCINOMA, NON-SMALL-CELL LUNG; CETUXIMAB; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; EUROPE; FEMALE; HUMANS; ISRAEL; KAPLAN-MEIER ESTIMATE; LUNG NEOPLASMS; MAINTENANCE CHEMOTHERAPY; MALE; MIDDLE AGED; SINGAPORE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84930657452     PISSN: 17762596     EISSN: 1776260X     Source Type: Journal    
DOI: 10.1007/s11523-014-0336-7     Document Type: Article

References (30)

1. Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O’Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U (2009) Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet 373(9674):1525–1531. doi:10.1016/S0140-6736(09)60569-9
2. Lynch TJ, Patel T, Dreisbach L, McCleod M, Heim WJ, Hermann RC, Paschold E, Iannotti NO, Dakhil S, Gorton S, Pautret V, Weber MR, Woytowitz D (2010) Cetuximab and first-line taxane/carboplatin chemotherapy in advanced non-small-cell lung cancer: results of the randomized multicenter phase III trial BMS099. J Clin Oncol 28(6):911–917. doi:10.1200/JCO.2009.21.9618
3. Butts CA, Bodkin D, Middleman EL, Englund CW, Ellison D, Alam Y, Kreisman H, Graze P, Maher J, Ross HJ, Ellis PM, McNulty W, Kaplan E, Pautret V, Weber MR, Shepherd FA (2007) Randomized phase II study of gemcitabine plus cisplatin or carboplatin, with or without cetuximab, as first-line therapy for patients with advanced or metastatic non-small-cell lung cancer. J Clin Oncol 25(36):5777–5784. doi:10.1200/JCO.2007.13.0856
4. Rosell R, Robinet G, Szczesna A, Ramlau R, Constenla M, Mennecier BC, Pfeifer W, O’Byrne KJ, Welte T, Kolb R, Pirker R, Chemaissani A, Perol M, Ranson MR, Ellis PA, Pilz K, Reck M (2008) Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer. Ann Oncol 19(2):362–369. doi:10.1093/annonc/mdm474
5. Chen P, Wang L, Liu B, Zhang HZ, Liu HC, Zou Z (2011) EGFR-targeted therapies combined with chemotherapy for treating advanced non-small-cell lung cancer: a meta-analysis. Eur J Clin Pharmacol 67(3):235–243. doi:10.1007/s00228-010-0965-4
6. Ibrahim EM, Abouelkhair KM, Al-Masri OA, Chaudry NC, Kazkaz GA (2011) Cetuximab-based therapy is effective in chemotherapy-naive patients with advanced and metastatic non-small-cell lung cancer: a meta-analysis of randomized controlled trials. Lung 189(3):193–198. doi:10.1007/s00408-011-9286-3
7. Lin H, Jiang J, Liang X, Zhou X, Huang R (2010) Chemotherapy with cetuximab or chemotherapy alone for untreated advanced non-small-cell lung cancer: a systematic review and meta-analysis. Lung Cancer 70:57–62. doi:10.1016/j.lungcan.2010.01.009
8. Thatcher N, Lynch TJ, Butts CA, Rosell R, Shepherd FA, Pujol J-L, Vansteenkiste J, Emig M, Groos J, Pirker R (2009) Cetuximab plus platinum-based chemotherapy as 1st-line treatment in patients with non-small cell lung cancer (NSCLC): a meta-analysis of randomized phase II/III trials. J Thorac Oncol 4(9):S297, abstr A293.297
9. Bokemeyer C, Bondarenko I, Makhson A, Hartmann JT, Aparicio J, de Braud F, Donea S, Ludwig H, Schuch G, Stroh C, Loos AH, Zubel A, Koralewski P (2009) Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. J Clin Oncol 27(5):663–671. doi:10.1200/JCO.2008.20.8397
10. Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D’Haens G, Pinter T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P (2009) Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 360(14):1408–1417. doi:10.1056/NEJMoa0805019
11. Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R (2008) Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med 359(11):1116–1127. doi:10.1056/NEJMoa0802656
12. Tabernero J, Ciardiello F, Rivera F, Rodriguez-Braun E, Ramos FJ, Martinelli E, Vega-Villegas ME, Rosello S, Liebscher S, Kisker O, Macarulla T, Baselga J, Cervantes A (2010) Cetuximab administered once every second week to patients with metastatic colorectal cancer: a two-part pharmacokinetic/pharmacodynamic phase I dose-escalation study. Ann Oncol 21(7):1537–1545. doi:10.1093/annonc/mdp549
13. Martin-Martorell P, Rosello S, Rodriguez-Braun E, Chirivella I, Bosch A, Cervantes A (2008) Biweekly cetuximab and irinotecan in advanced colorectal cancer patients progressing after at least one previous line of chemotherapy: results of a phase II single institution trial. Br J Cancer 99(3):455–458. doi:10.1038/sj.bjc.6604530
14. Pfeiffer P, Nielsen D, Bjerregaard J, Qvortrup C, Yilmaz M, Jensen B (2008) Biweekly cetuximab and irinotecan as third-line therapy in patients with advanced colorectal cancer after failure to irinotecan, oxaliplatin and 5-fluorouracil. Ann Oncol 19(6):1141–1145. doi:10.1093/annonc/mdn020
15. Van Cutsem E, Tejpar S, Vanbeckevoort D, Peeters M, Humblet Y, Gelderblom H, Vermorken JB, Viret F, Glimelius B, Gallerani E, Hendlisz A, Cats A, Moehler M, Sagaert X, Vlassak S, Schlichting M, Ciardiello F (2012) Intrapatient cetuximab dose escalation in metastatic colorectal cancer according to the grade of early skin reactions: the randomized EVEREST study. J Clin Oncol 30(23):2861–2868. doi:10.1200/JCO.2011.40.9243
16. Brodowicz T, Ciuleanu TE, Radosavljevic D, Shacham-Shmueli E, Vrbanec D, Plate S, Mrsic-Krmpotic Z, Dank M, Purkalne G, Messinger D, Zielinski CC (2013) FOLFOX4 plus cetuximab administered weekly or every second week in the first-line treatment of patients with KRAS wild-type metastatic colorectal cancer: a randomized phase II CECOG study. Ann Oncol 24(7):1769–1777. doi:10.1093/annonc/mdt116
17. (2002) In: Sobin LH, Wittekind C (eds) TNM classification of malignant tumours, sixth edition. Wiley-Liss, New York, pp 99–103
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, European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92(3):205–216. doi:10.1093/jnci/92.3.205
19. Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, Esteban E, Molinier O, Brugger W, Melezinek I, Klingelschmitt G, Klughammer B, Giaccone G (2010) Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol 11(6):521–529. doi:10.1016/S1470-2045(10)70112-1
20. Perol M, Chouaid C, Perol D, Barlesi F, Gervais R, Westeel V, Crequit J, Lena H, Vergnenegre A, Zalcman G, Monnet I, Le Caer H, Fournel P, Falchero L, Poudenx M, Vaylet F, Segura-Ferlay C, Devouassoux-Shisheboran M, Taron M, Milleron B (2012) Randomized, phase III study of gemcitabine or erlotinib maintenance therapy versus observation, with predefined second-line treatment, after cisplatin-gemcitabine induction chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol 30(28):3516–3524. doi:10.1200/JCO.2011.39.9782
21. Ciuleanu T, Brodowicz T, Zielinski C, Kim JH, Krzakowski M, Laack E, Wu YL, Bover I, Begbie S, Tzekova V, Cucevic B, Pereira JR, Yang SH, Madhavan J, Sugarman KP, Peterson P, John WJ, Krejcy K, Belani CP (2009) Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet 374(9699):1432–1440. doi:10.1016/S0140-6736(09)61497-5
22. Paz-Ares LG, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C (2013) PARAMOUNT: final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol 31(23):2895–2902. doi:10.1200/JCO.2012.47.1102
23. Barlesi F, Scherpereel A, Rittmeyer A, Pazzola A, Ferrer Tur N, Kim JH, Ahn MJ, Aerts JG, Gorbunova V, Vikstrom A, Wong EK, Perez-Moreno P, Mitchell L, Groen HJ (2013) Randomized phase III trial of maintenance bevacizumab with or without pemetrexed after first-line induction with bevacizumab, cisplatin, and pemetrexed in advanced nonsquamous non-small-cell lung cancer: AVAPERL (MO22089). J Clin Oncol 31(24):3004–3011. doi:10.1200/JCO.2012.42.3749
24. Pirker R, Pereira JR, von Pawel J, Krzakowski M, Ramlau R, Park K, de Marinis F, Eberhardt WE, Paz-Ares L, Storkel S, Schumacher KM, von Heydebreck A, Celik I, O’Byrne KJ (2012) EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol 13(1):33–42. doi:10.1016/S1470-2045(11)70318-7
25. Belani CP, Schreeder MT, Steis RG, Guidice RA, Marsland TA, Butler EH, Ramalingam SS (2008) Cetuximab in combination with carboplatin and docetaxel for patients with metastatic or advanced-stage nonsmall cell lung cancer: a multicenter phase 2 study. Cancer 113(9):2512–2517. doi:10.1002/cncr.23902
26. Herbst RS, Kelly K, Chansky K, Mack PC, Franklin WA, Hirsch FR, Atkins JN, Dakhil SR, Albain KS, Kim ES, Redman M, Crowley JJ, Gandara DR (2010) Phase II selection design trial of concurrent chemotherapy and cetuximab versus chemotherapy followed by cetuximab in advanced-stage non-small-cell lung cancer: Southwest Oncology Group study S0342. J Clin Oncol 28(31):4747–4754. doi:10.1200/JCO.2009.27.9356
27. Robert F, Blumenschein G, Herbst RS, Fossella FV, Tseng J, Saleh MN, Needle M (2005) Phase I/IIa study of cetuximab with gemcitabine plus carboplatin in patients with chemotherapy-naive advanced non-small-cell lung cancer. J Clin Oncol 23(36):9089–9096. doi:10.1200/JCO.2004.00.1438
28. Socinski MA, Saleh MN, Trent DF, Dobbs TW, Zehngebot LM, Levine MA, Bordoni R, Stella PJ (2009) A randomized, phase II trial of two dose schedules of carboplatin/paclitaxel/cetuximab in stage IIIB/IV non-small-cell lung cancer (NSCLC). Ann Oncol 20(6):1068–1073. doi:10.1093/annonc/mdn745
29. Thienelt CD, Bunn PA Jr, Hanna N, Rosenberg A, Needle MN, Long ME, Gustafson DL, Kelly K (2005) Multicenter phase I/II study of cetuximab with paclitaxel and carboplatin in untreated patients with stage IV non-small-cell lung cancer. J Clin Oncol 23(34):8786–8793. doi:10.1200/JCO.2005.03.1997
30. Redman MW, Crowley JJ, Herbst RS, Hirsch FR, Gandara DR (2012) Design of a phase III clinical trial with prospective biomarker validation: SWOG S0819. Clin Cancer Res: J Am Assoc Cancer Res 18(15):4004–4012. doi:10.1158/1078-0432.CCR-12-0167