Abstract
To the Editor:
Ferris et al. report promising results from a large, phase 3 trial in which nivolumab outperformed standard therapy in patients with platinum-refractory squamous-cell cancer of the head and neck. However, the monotherapies that were identified as standard treatment led to varied overall survival. Moreover, the median difference of 1.7 months in overall survival between docetaxel and nivolumab treatment was equal to the difference between docetaxel and cetuximab. This finding is further reflected in the nonsignifican difference between nivolumab and docetaxel in the hazard ratio for death.
Therefore, we believe that it is not correct to conclude that nivolumab is superior to all three drugs that are used in patients with platinumrefractory squamous-cell cancer of the head and neck. Because the overall survival benefit was especially prominent in patients who had not received cetuximab previously, this subgroup is likely to be biologically different from patients who were pretreated with cetuximab. Since the comparison between nivolumab and docetaxel is likely to be underpowered in this study, we believe that this cohort should be expanded to detect the true additive value of nivolumab in this line of treatment.
Ferris et al. report promising results from a large, phase 3 trial in which nivolumab outperformed standard therapy in patients with platinum-refractory squamous-cell cancer of the head and neck. However, the monotherapies that were identified as standard treatment led to varied overall survival. Moreover, the median difference of 1.7 months in overall survival between docetaxel and nivolumab treatment was equal to the difference between docetaxel and cetuximab. This finding is further reflected in the nonsignifican difference between nivolumab and docetaxel in the hazard ratio for death.
Therefore, we believe that it is not correct to conclude that nivolumab is superior to all three drugs that are used in patients with platinumrefractory squamous-cell cancer of the head and neck. Because the overall survival benefit was especially prominent in patients who had not received cetuximab previously, this subgroup is likely to be biologically different from patients who were pretreated with cetuximab. Since the comparison between nivolumab and docetaxel is likely to be underpowered in this study, we believe that this cohort should be expanded to detect the true additive value of nivolumab in this line of treatment.
| Original language | English |
|---|---|
| Pages (from-to) | 595-596 |
| Number of pages | 2 |
| Journal | New England Journal of Medicine |
| Volume | 376 |
| Issue number | 6 |
| DOIs |
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| Publication status | Published - 9 Feb 2017 |
Research programs
- EMC MM-03-86-08