Additional weekly Cetuximab to concurrent chemoradiotherapy in locally advanced non-small cell lung carcinoma: efficacy and safety outcomes of a randomized, multi-center phase II study investigating.
BACKGROUND
Modest benefits from concurrent chemoradiotherapy in patients with locally advanced NSCLC warrant further clinical investigations to identify more effective treatment regimens. Cetuximab, a monoclonal antibody against the epidermal growth factor receptor has shown activity in NSCLC. We report on the safety and efficacy of the combination of daily dose Cisplatin and concurrent radiotherapy with or without weekly Cetuximab.


METHODS
Patients received high dose accelerated radiotherapy (66 Gy in 24 fractions) and concurrent daily Cisplatin (6 mg/m(2)) without (Arm A) or with (Arm B) weekly Cetuximab (400 mg/m(2) loading dose one week prior to radiotherapy followed by weekly 250 mg/m(2)). The primary endpoint of the trial was objective local control rate (OLCR) determined at 6-8 weeks after treatment. Toxicity was reported as well.


RESULTS
Between February 2009 and May 2011, 102 patients were randomized. Median follow up was 29 months. The OLCR was 84% in Arm A and 92% in Arm B (p=0.36). The one-year local progression free interval (LPFI) and overall survival (OS) were 69% and 82% for Arm A and 73% and 71% for Arm B, respectively (LPFI p=0.39; OS p=0.99). Toxicity compared equally between both groups.


CONCLUSIONS
The addition of Cetuximab to radiotherapy and concurrent Cisplatin did not improve disease control in patients with locally advanced NSCLC but increased treatment related toxicity.
Department of Thoracic Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: m.vd.heuvel@nki.nl.
Michel M
MM
van den Heuvel
Department of Thoracic Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: w.uyterlinde@nki.nl.
Wilma
W
Uyterlinde
Biometrics Department, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: a.vincent@nki.nl.
Andrew D
AD
Vincent
Pathology Department, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: je.d.jong@nki.nl.
Jeroen
J
de Jong
Pulmonary Medicine, Amphia Ziekenhuis Breda, The Netherlands. Electronic address: jaerts@amphia.nl.
Joachim
J
Aerts
Department of Radiation Oncology, Verbeeten Institute, Tilburg, The Netherlands. Electronic address: Koppe.f@bvi.nl.
Frederike
F
Koppe
Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: j.knegjens@nki.nl.
Joost
J
Knegjens
Pulmonary Medicine, Haga Ziekenhuis The Hague, The Netherlands. Electronic address: H.Codrington@hagaziekenhuis.nl.
Henk
H
Codrington
Pulmonary Medicine, Academic Medical Centre, Amsterdam, The Netherlands. Electronic address: p.kunst@adrz.nl.
Peter W E
PW
Kunst
Department of Radiation Oncology, Academic Medical Center, Amsterdam, The Netherlands. Electronic address: e.m.dieleman@amc.nl.
Edith
E
Dieleman
Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: m.verheij@nki.nl.
Marcel
M
Verheij
Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: j.belderbos@nki.nl.
José
J
Belderbos
D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000532:radiotherapy*; D000068818:Cetuximab; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D061067:Antibodies, Monoclonal, Humanized; D000068818:Cetuximab; D002945:Cisplatin
Cetuximab; Concurrent chemoradiotherapy; NSCLC