A Multicenter Phase II Trial of Carboplatin and Cetuximab for Treatment of Advanced Nonsmall Cell Lung Cancer

REFERENCES

• Jemal, A.; Siegel, R.; Ward, E.; Hao, Y.; Xu, J.; Murray, T.; Thun, M.J. Cancer statistics, 2008. CA Cancer J Clin 2008, 58, 71–96.
   PubMed Web of Science ®Google Scholar
• Govindan, R.; Page, N.; Morgensztern, D.; Read, W.; Tierney, R.; Vlahiotis, A.; Spitznagel, E.L.; Piccirillo, J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol 2006, 24, 4539–4544.
   PubMed Web of Science ®Google Scholar
• Yang, P.; Allen, M.S.; Aubry, M.C.; Wampfler, J.A.; Marks, R.S.; Edell, E.S.; Thibodeau, S.; Adjei, A.A.; Jett, J.; Deschamps, C. Clinical features of 5,628 primary lung cancer patients: experience at Mayo clinic from 1997 to 2003. Chest 2005, 128, 452–462.
   PubMed Web of Science ®Google Scholar
• Pfister, D.G.; Johnson, D.H.; Azzoli, C.G.; Sause, W.; Smith, T.J.; Baker, S.; Olak, J.; Stover, D.; Strawn, J.R.; Turrisi, A.; Somerfield, M.R. American society of clinical oncology treatment of unresectable non-small cell lung cancer guideline: update 2003. J Clin Oncol 2004, 22, 330–353.
   PubMed Web of Science ®Google Scholar
• Schiller, J.; Harrington, D.; Belani, C.; Langer, C, Sandler, A.; Krook, J.; Zhu, J.; Johnson, D. Comparison of four chemotherapy regimens for advanced non-small cell lung cancer. N Engl J Med 2002, 346, 92–98.
   PubMed Web of Science ®Google Scholar
• Treat, J.; Belani, C.P.; Edelman, M.J.; Socinski, M.A.; Ansari, R.H.; Obasaju, C.K.; Bloss, J.D., Marinucci, D.M.; Catalano, R.B.; Comis, R.L. A randomized phase III trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin in advanced (stage IIIB, IV) non-small cell lung cancer (NSCLC): update of the alpha oncology trial (A1-99002L). J Clin Oncol 2005, 23, abstract 7025, 627s.
   Web of Science ®Google Scholar
• Scagliotti, G.V.; 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. Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. J Clin Oncol 2002, 20, 4285–4291.
   PubMed Web of Science ®Google Scholar
• Scagliotti, G.V.; Selvaggi, G.; Novello, S.; Hirsch, FR. The biology of epidermal growth factor receptor in lung cancer. Clin Cancer Res 2004, 10, 4227s–4232s.
   PubMed Web of Science ®Google Scholar
• Mendelsohn, J.; Baselga, J. Status of epidermal growth factor receptor antagonists in the biology and treatment of cancer. J Clin Oncol 2003, 21, 2787–2799.
   PubMed Web of Science ®Google Scholar
• Shepherd, F.A.; Rodrigues Pereira, J.; Ciuleanu, T.; Tan, E.H.; Hirsh, V.; Thongprasert, S.; Campos, D.; Maoleekoonpiroj, S.; Smylie, M.; Martins, R.; van Kooten, M.; Dediu, M.; Findlay, B.; Tu, D.; Johnston, D.; Bezjak, A.; Clark, G.; Santabarbara, P.; Seymour, L. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005, 353, 123–132.
   PubMed Web of Science ®Google Scholar
• Kurai, J.; Chikumi, H.; Hashimoto, K.; Yamaguchi, K.; Yamasaki, A.; Sako, T.; Touge, H.; Makino, H.; Takata, M.; Miyata, M.; Nakamoto, M.; Burioka, N.; Shimizu, E. Antibody-dependent cellular cytotoxicity mediated by cetuximab against lung cancer cell lines. Clin Cancer Res 2007, 13, 1552–1561.
   PubMed Web of Science ®Google Scholar
• Robert, F.; Blumenschein, G.; Herbst, R.S.; Fossella, F.V.; Tseng, J.; Saleh, M.N.; Needle, M. Phase I/IIa study of cetuximab with gemcitabine plus carboplatin in patients with chemotherapy-naive advanced non-small-cell lung cancer. J Clin Oncol 2005, 23, 9089–9096.
   PubMed Web of Science ®Google Scholar
• Thienelt, C.D.; Bunn, P.A., Jr.; Hanna, N.; Rosenberg, A.; Needle, M.N.; Long, M.E.; Gustafson, D.L.; Kelly, K. 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 2005, 23, 8786–8793.
   PubMed Web of Science ®Google Scholar
• Rosell, R.; Robinet, G.; Szczesna, A.; Ramlau, R.; Constenla, M.; Mennecier, B.C.; Pfeifer, W.; KJ, O.B.; Welte, T.; Kolb, R.; Pirker, R.; Chemaissani, A.; Perol, M.; Ranson, M.R., Ellis, P.A.; Pilz, K.; Reck, M. 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 2007, 19, 362–369.
   PubMed Web of Science ®Google Scholar
• Green, M.R.; Kreisman, H.; Doll, D.C.; Lyss, A.P.; Clamon, G.H.; Goutsou, M.; Perry, M.C.; Propert, K.J. Carboplatin in non-small cell lung cancer: an update on the cancer and leukemia group B experience. Semin Oncol 1992, 19, 44–49.
   PubMedGoogle Scholar
• Kreisman, H.; Ginsberg, S.; Propert, K.J.; Richards, F.; Graziano, S.; Green, M. Carboplatin or iproplatin in advanced non-small cell lung cancer: a cancer and leukemia group B study. Cancer Treat Rep 1987, 71, 1049–1052.
   PubMedGoogle Scholar
• Bonomi, P.D.; Finkelstein, D.M.; Ruckdeschel, J.C.; Blum, R.H.; Green, M.D.; Mason, B.; Hahn, R., Tormey, D.C.; Harris, J.; Comis, R.; . Combination chemotherapy versus single agents followed by combination chemotherapy in stage IV non-small-cell lung cancer: a study of the Eastern Cooperative Oncology Group. J Clin Oncol 1989, 7, 1602–1613.
   PubMed Web of Science ®Google Scholar
• Therasse, P.; Arbuck, S.G.; Eisenhauer, E.A.; Wanders, J.; Kaplan, R.S.; Rubinstein, L.; Verweij, J.; Van Glabbeke, M.; van Oosterom, A.T.; Christian, M.C.; Gwyther, S.G. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000, 92, 205–216.
   PubMed Web of Science ®Google Scholar
• Calvert, A.; Newell, D.; Gumbrell, L.; O'Reilly, S.; Burnell, M.; Boxall, F. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 1989, 7, 1748–1756.
   PubMed Web of Science ®Google Scholar
• ERBITUX (cetuximab) package insert ImClone Systems Incoporated and Bristol-Meyers Squibb Company. ER-B0001-2005.
   Google Scholar
• Cella, D.; Bonomi, A.; Lloyd, S.; Tulsky, D.; Kaplan, E.; Bonomi, P. Reliability and validity of the of the functional assessment of cancer therapy-lung (FACT-L) quality of life instrument. Lung Cancer 1995, 12, 199–200.
   PubMed Web of Science ®Google Scholar
• Soni, M.K.; Cella, D.; Masters, G.A.; Burch, S.P.; Heyes, A.; Silberman, C. The validity and clinical utility of symptom monitoring in advanced lung cancer: a literature review. Clin Lung Cancer 2002, 4, 153–160.
   PubMedGoogle Scholar
• Hanfelt, J.J.; Slack, R.S.; Gehan, E.A. A modification of Simon's optimal design for phase II trials when the criterion is median sample size. Control Clin Trials 1999, 20, 555–566.
   PubMedGoogle Scholar
• Cella, D.; Eton, D.T.; Fairclough, D.L.; Bonomi, P.; Heyes, A.E.; Silberman, C.; Wolf, M.K.; Johnson, D.H. What is a clinically meaningful change on the functional assessment of cancer therapy-lung (FACT-L) questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) study 5592. J Clin Epidemiol 2002, 55, 285–295.
   PubMed Web of Science ®Google Scholar
• Delbaldo, C.; Michiels, S.; Syz, N.; Soria, J.C.; Le Chevalier, T.; Pignon, J.P. Benefits of adding a drug to a single-agent or a 2-agent chemotherapy regimen in advanced non-small-cell lung cancer: a meta-analysis. JAMA 2004, 292, 470–484.
   PubMed Web of Science ®Google Scholar
• Hanna, N.; Lilenbaum, R.; Ansari, R.; Lynch, T.; Govindan, R.; Janne, P.A.; Bonomi, P. Phase II trial of cetuximab in patients with previously treated non-small-cell lung cancer. J Clin Oncol 2006, 24, 5253–5258.
   PubMed Web of Science ®Google Scholar
• Butts, C.A.; Bodkin, D.; Middleman, E.L.; Englund, C.W.; Ellison, D.; Alam, Y.; Kreisman, H.; Graze, P.; Maher, J.; Ross, H.J.; Ellis, P.M.; McNulty, W.; Kaplan, E.; Pautret, V.; Weber, M.R.; Shepherd, F.A. Randomized phase II study of gemcitabine plus cisplatin or carboplatin [corrected], with or without cetuximab, as first-line therapy for patients with advanced or metastatic non small-cell lung cancer. J Clin Oncol 2007, 25, 5777–5784.
   PubMed Web of Science ®Google Scholar
• Pirker, R.; Pereira, J.R.; Szczesna, A.; von Pawel, J.; Krzakowski, M.; Ramlau, R.; Vynnychenko, I.; Park, K.; Yu, C.T.; Ganul, V.; Roh, J.K.; Bajetta, E.; O'Byrne, K.; de Marinis, F.; Eberhardt, W.; Goddemeier, T.; Emig, M.; Gatzemeier, U. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet 2009, 373, 1525–1531.
   PubMed Web of Science ®Google Scholar
• Lynch, T.J.; Patel, T.; Dreisbach, L.; McCleod, M.; Heim, W.; Hermann, R.C.; Paschold, E.; Pautret, V.; Weber, M.R.; Hart, L.L. Overall survival (OS) results from the phase III trial BMS 099: cetuximab + taxane/carboplatin as 1st-line treatment for advanced NSCLC. J Thorac Oncol 2008, 3(11) ( Suppl. 4), S305.
   Google Scholar
• Shepherd, F.A.; Dancey, J.; Ramlau, R.; Mattson, K.; Gralla, R.; O'Rourke, M.; Levitan, N.; Gressot, L.; Vincent, M.; Burkes, R.; Coughlin, S.; Kim, Y.; Berille, J. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000, 18, 2095–2103.
   PubMed Web of Science ®Google Scholar
• Fossella, F.V.; DeVore, R.; Kerr, R.N.; Crawford, J.; Natale, R.R.; Dunphy, F.; Kalman, L.; Miller, V.; Lee, J.S.; Moore, M.; Gandara, D.; Karp, D.; Vokes, E.; Kris, M.; Kim, Y.; Gamza, F., Hammershaimb, L. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. The TAX 320 non-small cell lung cancer study group. J Clin Oncol 2000, 18, 2354–2362.
   PubMed Web of Science ®Google Scholar
• Rosell, R.; Robinet, G.; Szczesna, A.; Ramlau, R.; Constenla, M.; Mennecier, B.C.; Pfeifer, W.; O'Byrne, K.J.; Welte, T.; Kolb, R.; Pirker, R.; Chemaissani, A.; Perol, M.; Ranson, M.R.; Ellis, P.A.; Pilz, K.; Reck, M. 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 2008, 19, 362–369.
   PubMed Web of Science ®Google Scholar
• Borghaei, H.; Langer, C.J.; Millenson, M.; Ruth, K.J.; Litwin, S.; Tuttle, H.; Seldomridge, J.S.; Rovito, M.; Mintzer, D.; Cohen, R.; Treat, J. Phase II study of paclitaxel, carboplatin, and cetuximab as first line treatment, for patients with advanced non-small cell lung cancer (NSCLC): results of OPN-017. J Thorac Oncol 2008, 3, 1286–1292.
   PubMed Web of Science ®Google Scholar
• O'Neil, B.H.; Allen, R.; Spigel, D.R.; Stinchcombe, T.E.; Moore, D.T.; Berlin, J.D.; Goldberg, R.M. High incidence of cetuximab-related infusion reactions in Tennessee and North Carolina and the association with atopic history. J Clin Oncol 2007, 25, 3644–3648.
   PubMed Web of Science ®Google Scholar
• Chung, C.H.; Mirakhur, B.; Chan, E.; Le, Q.T.; Berlin, J.; Morse, M.; Murphy, B.A.; Satinover, S.M.; Hosen, J.; Mauro, D.; Slebos, R.J.; Zhou, Q.; Gold, D.; Hatley, T.; Hicklin, D.J.; Platts-Mills, T.A. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. N Engl J Med 2008, 358, 1109–1117.
   PubMed Web of Science ®Google Scholar
• Robinson, D.; Mauro, D.; Chung, C.; Fox, F.; Lundberg, M.; Oman, H.; Camacho, T.; Storms, M. Utility of cetuximab-cross reactive IgE as a predictive biomarker for cetuximab associated severe infusion reactions. AACR Meeting Abstracts 2008:B24, 2008.
   Google Scholar
• Hirsch, F.R.; Herbst, R.S.; Olsen, C.; Chansky, K.; Crowley, J.; Kelly, K.; Franklin, W.A.; Bunn, P.A.; Jr., Varella-Garcia, M.; Gandara, D.R. Increased EGFR gene copy number detected by fluorescent in situ hybridization predicts outcome in non-small-cell lung cancer patients treated with cetuximab and chemotherapy. J Clin Oncol 2008, 26, 3351–3357.
   PubMed Web of Science ®Google Scholar
• Khambata-Ford, S.; Harbison, C.T.; Hart, L.L.; Awad, M.; Xu, L.; Dakhil, S.; Hermann, R.C.; Lynch, T.J.; Weber, M. K-RAS mutations (MT) and EGFR-related markers as potential predictors of cetuximab benefit in 1st line advanced NSCLC: results from the BMS099 study. J Thorac Oncol 2008, 3(11) (Suppl. 4),S304.
   Google Scholar
• Gatzemeier, U.; von Pawel, J.; Vynnchenko, I.; Zatloukal, P.; DeMarinis, F.; O'Byrne, K.; Eberhardt, W.;Paz-Ares, L.; Emig, M.; Pirker, R. FLEX: cetuximab in combination with platinum-based chemotherapy (CT) improves survival versus CT alone in the 1st-line treatment of patients (pts) with advanced non-small cell lung cancer (NSCLC). J Thorac Oncol 2008, 3, S265— abstract 8.
   PubMedGoogle Scholar