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The course of Erbitux (cetuximab), the antibody to EGFR, in lung cancer over the last years has been controversial but overall underwhelming. Added to carboplatin and Taxol (paclitaxel) or Taxotere (docetaxel) as first line therapy in a North American phase III randomized trial, it was associated with a marginal improvement in progression-free survival depending on who did the assessement, but no improvement in overall survival. The subsequent, larger randomized phase III trial called FLEX, of carboplatin/Navelbine (vinorelbine) with or without Erbitux, showed no improvement in overall survival but 5 week improvement in overall survival that was statistically significant but felt by most of the world to be clinically insignificant, especially when considering that the addition of Erbitux was associated with an extra weekly IV infusion, additional side effects, and another >$50K/yr in costs per patient. In the years since the FLEX trial was presented and published, Erbitux has failed to earn a place in the treatment of lung cancer.
However, that doesn't mean that the potential role of Erbitux doesn't remain a question. The Southwest Oncology Group (SWOG) conducted a single arm phase II trial (SWOG 0536) that added Erbitux to carbo/Taxol/Avastin (bevacizumab) and looked encouraging, with a median progression-free survival of 14 months and median overall survival of 14 months. While certainly encouraging, these results are not markedly superior to those seen with various recent doublet +/- Avastin combinations with some form of maintenance therapy that don't include Erbitux.
SWOG is now conducting the phase III follow up trial (SWOG 0819) in which previously untreated patients with advanced NSCLC and tissue available for molecular studies are randomized to carbo/Taxol/Avastin (in Avastin-eligible patients only) with or without Erbitux. Following first line therapy, patients continue Avastin (if eligible) +/- Erbitux as well. The schema is as shown below:
The trial has been ongoing for a few years now, but it needs a few more patients before it's ready to close and definitively answer the question of whether there might be a place for Erbitux after all in NSCLC. The study is available through hundreds of SWOG member sites throughout North America, with more details available here.
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