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

Abstract

First-line treatment with cetuximab plus gemcitabine/platinum is well tolerated and can be administered safely in patients with advanced NSCLC. Differences in response rate, progression-free survival, and overall survival suggest that the addition of cetuximab to platinum/gemcitabine may improve clinical outcomes. Larger studies are in progress to address this hypothesis.

Meta-analysis of Six Randomized Control Trials of Chemotherapy Plus Anti-HER Monoclonal Antibody for Advanced Gastric and Gastroesophageal Cancer

“…Over the past decade, the EGFR has been primary focus for biologically targeted therapies, with the most active treatments being monoclonal antibodies. Cetuximab is an FDA approved MoAb agent for use in advance or metastatic disease and exhibit efficacy in NSCLC and metastatic colorectal cancer (mCRC) (Butts et al, 2007;Rosell et al, 2008;Van Cutsem et al, 2009). However, No significant increase of OS was observed for panitumumab-FOLFOX4 versus FOLFOX4 in mCRC (median OS, 23.9 v 19.7 months, respectively; HR, 0.83; 95% CI, 0.67 to 1.02; P=.072) (Douillard et al, 2010b).…”

Cetuximab and Other Anti–Epidermal Growth Factor Receptor Monoclonal Antibodies in the Treatment of Non-Small Cell Lung Cancer

“…In fact, this statistically significant higher incidence of febrile neutropenia, probably related to the chemotherapy regimen choice and not confirmed with other chemotherapy combinations, is difficult to accept considering the palliative role of therapy in advanced NSCLC. [24]. A nonplatinum-based regimen, docetaxel plus gemcitabine, was administered in combination with cetuximab to 69 patients and resulted in an OR rate of 18%, an SD rate of 52%, a median time to progression of 4.5 months, an MST of 8 months, and a 1-year survival rate of 35%.…”

Improving Outcomes in Advanced Lung Cancer : Maintenance Therapy in Non-Small-Cell Lung Carcinoma = تحسين النتائج في سرطان الرئة المتقدم : العلاج المستدام في سرطان الرئة ذي الخلية غير الصغيرة

“…73 The US (BMS-099) 74 trial looked at unselected patients with NSCLC to taxane plus cetuximab, and reached its primary endpoint of enhanced median OS (9.7 versus 8.4 months) but not PFS. A review by Pirker et al (FLEX 71 , BMS 099 74 , BMS 100 75 , LUCAS 76 [see Table 4]) confirmed the consistent benefit of adding cetuximab to chemotherapy in patients with advanced NSCLC of all histological subtypes in terms of OS (P <0.01), PFS (P <0.03), and OS rate (OR 1.463, P <0.001). 77 The Southwest Oncology Group trial is a phase II study that combined cetuximab to carboplatin, paclitaxel and bevacizumab for 6 cycles, followed by bevacizumab weekly until disease progression.…”