TY - JOUR
T1 - Is there still room for large registrative trials in unselected cancer patients? the case of anti-epidermal growth factor receptor antibodies in advanced non-small-cell lung cancer
AU - Di Maio, Massimo
PY - 2011/9
Y1 - 2011/9
N2 - Necitumumab, a monoclonal antibody directed against EGFR, is currently under development as a treatment for advanced NSCLC. Two Phase III randomized trials are ongoing, testing the addition of necitumumab to first-line platinum-based chemotherapy. In the same setting, cetuximab produced a statistically significant but clinically modest benefit in the whole study population, and no solid data have been produced about predictive factors of efficacy. Will the difference in structure between the two antibodies be enough to obtain a clinically relevant advantage, making real progress in the treatment of advanced NSCLC? Large Phase III trials in unselected patients risk demonstrating statistically significant results with debatable clinical relevance in the whole population, and the study of predictive factors is often left to subgroup analysis performed after the conduction of the trial. We do not need further 'me-too' drugs, or drugs that produce a small benefit in the unselected population. On the contrary, the oncologic community needs drugs to be used with a proper selection of patients, to obtain larger, relevant benefits in molecularly characterized subgroups. Final results of randomized trials with necitumumab in advanced NSCLC are expected in a couple of years.
AB - Necitumumab, a monoclonal antibody directed against EGFR, is currently under development as a treatment for advanced NSCLC. Two Phase III randomized trials are ongoing, testing the addition of necitumumab to first-line platinum-based chemotherapy. In the same setting, cetuximab produced a statistically significant but clinically modest benefit in the whole study population, and no solid data have been produced about predictive factors of efficacy. Will the difference in structure between the two antibodies be enough to obtain a clinically relevant advantage, making real progress in the treatment of advanced NSCLC? Large Phase III trials in unselected patients risk demonstrating statistically significant results with debatable clinical relevance in the whole population, and the study of predictive factors is often left to subgroup analysis performed after the conduction of the trial. We do not need further 'me-too' drugs, or drugs that produce a small benefit in the unselected population. On the contrary, the oncologic community needs drugs to be used with a proper selection of patients, to obtain larger, relevant benefits in molecularly characterized subgroups. Final results of randomized trials with necitumumab in advanced NSCLC are expected in a couple of years.
KW - Advanced non-small cell lung cancer
KW - Clinical trial methodology
KW - Necitumumab
KW - Predictive factors
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U2 - 10.1517/14712598.2011.599799
DO - 10.1517/14712598.2011.599799
M3 - Article
C2 - 21806477
AN - SCOPUS:80051496809
VL - 11
SP - 1131
EP - 1133
JO - Expert Opinion on Biological Therapy
JF - Expert Opinion on Biological Therapy
SN - 1471-2598
IS - 9
ER -