Gefitinib vs gefitinib plus pemetrexed-carboplatin in EGFR-mutant lung cancer (Tata Memorial)
An Indian trial showed that adding standard chemotherapy to the cheap first-generation pill gefitinib doubled the time lung cancer stayed controlled and cut deaths by more than half.
Overview
350 patients were randomised (176 gefitinib, 174 gefitinib plus pemetrexed-carboplatin). Median progression-free survival was 16 months with the combination versus 8 months with gefitinib alone (hazard ratio for progression or death 0.51; P<0.001); median overall survival was not reached versus 17 months (hazard ratio for death 0.45; P<0.001); response rates were 75% versus 63%, at the cost of more grade 3 or worse toxicity (51% versus 25%). With the Japanese NEJ009 trial it established EGFR inhibitor plus chemotherapy as an option, and offered a low-cost alternative where osimertinib is unaffordable; the approach later re-emerged in FLAURA2.
- Median 16 vs 8 months with Gefitinib + pemetrexed-carboplatin compared with Gefitinib; about 8 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 49 percent lower chance of the event at any given time (hazard ratio 0.51).
- The p-value (<0.001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Untreated advanced EGFR-mutant non-small-cell lung cancer: gefitinib alone vs gefitinib plus pemetrexed and carboplatin. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (EGFR); the result should not be assumed for people whose cancer does not have it.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
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