After 30 years, a new approach to lung cancer in early stages is making its way

The results of the international clinical trial CheckMate-816 confirm Spanish research: the administration of chemo-immunotherapy before surgery improves survival. The FDA has already approved it on a fast track basis.

"There are rarely changes so drastic that they modify an oncologist's 'textbook'." This is how Mariano Provencio, head of the Medical Oncology Service at the Puerta de Hierro Hospital in Madrid and president of the Spanish Lung Cancer Group (GECP), results of the international and multicenter clinical trial, CheckMate-816, which will be officially presented at the American Congress of Medical Oncology (ASCO) next June in Chicago. Results that may represent an absolute change in the approach to lung cancer in early and intermediate stages. This work, in which Puerta de Hierro and the Valle de Hebron Hospital in Barcelona have participated, would have shown that The combination of chemotherapy and immunotherapy before surgery offers better survival results than the administration of chemo alone in this group of patients. Specifically, "in stage III A [those who would have a worse prognosis], the new strategy means reaching 81% of patients alive at three years compared to 30% with the previous approach with chemotherapy alone," highlights Provencio.

"For more than 30 years there has been no progress in the treatment of lung cancer in early and intermediate stages, and specifically in III A, which amounts to 20% of the patients. These are those patients who have a localized tumor, it is locally advanced, they have lymph nodes...", explains the president of the GECP.

Confirmation of the Spanish study

The origin of the CheckMate-816 test is in previous work carried out in Spain, the NADIM study (with 46 patients) who led the GECP and in which the translational research was carried out at Puerta de Hierro. Their results were published two years ago in the journal The Lancet, "obtaining a great international impact," he points out.

These conclusions, as he points out, reflected that by administering chemo and immunotherapy before surgery in these patients, "the two-year survival free of relapse was 77%. Last year we presented the three-year overall survival data, which is 80%. 81%, much more than the 30% we had," says the president of the GECP.

When the data began to be known, CheckMate-816 was launched, of which Provencio is also one of the authors. The sample for the research was made up of 380 patients from all over the world, including Spaniards, and expanded it from stage IB (very initial) to III A, in which only the NADIM had been focused..

"When our results came out, there were many people in the world who said, 'well, it is a selected population, we will have to see, we will have to wait for it to be compared with the standard, we will have to do a randomized study...' Well, now We have it and we Spaniards were right. The Spanish study is confirmed in the American multinational work," celebrates the head of Medical Oncology at Puerta de Hierro.

Pathological response

He himself reports that in the Spanish trial "a rate of complete pathological responses, that is, complete disappearance of the tumor, of 63% was obtained, which is a lot, because with normal chemo you do not obtain more than 2, 4 or 6%" and , although in multinational American research "the rate of pathological responses is around 25%, it is still a lot: 2% versus 25%," he clarifies.

Furthermore, both after CheckMate-816 and in the Spanish study, "the percentage of operated [after chemoimmuno treatment] is around 90% and the rate of complete resections is around 100%, which is outrageous" .

Although the findings of this trial will not be officially presented until ASCO, The American Medicines Agency (FDA) has decided to approve this new treatment scheme on a fast track basis. (fast track)so it could soon begin to be administered there. In the case of Europe, the regulatory agency (EMA) will know these same results in the coming weeks.

"The change is really so dramatic and so spectacular for patients that I believe that ethically in Spain and Europe they should approve it quickly as well. The authorities do not have to approach it from a very regulatory point of view, thinking about drugs; This is very different, because the prognosis of the patients changes radically and it is a completely different type of approach," explains Provencio. And he adds: "We already use those three cycles of chemo and adding immunotherapy, I don't know what could cost more, but if we avoid that percentage of relapses and subsequent deaths, we are avoiding a lot. later money as well," he concludes.

Source: The World