From the MInT trial we know that there is a patient population with a very excellent prognosis; those patients present with an age-adjusted IPI of zero and have no bulky disease, meaning that their maximum tumour diameter was less than 7.5cm. From the MInT trial we know that their three year progression free survival was 95% therefore we wanted to investigate whether we could maintain efficacy and reduce toxicity by reduction of CHOP cycles.
What was your method?
We included patients at the age of 18-60 for front line treatment of aggressive lymphoma if they had limited stage disease, age-adjusted IPI of zero and no bulky disease. We randomised those patients to receive either six cycles of R-CHOP or four cycles of R-CHOP plus two cycles of R. We included 592 patients and we had 588 patients for final analysis. It was a multicentre international trial which took part in Germany, Italy, Israel, Norway and Denmark and we had 138 centres. We randomised a long, long time, from December 2005 to October 2016.
What were the primary endpoints?
The primary endpoint was three year progression free survival; secondary endpoints were event free survival, overall survival, response rate and toxicity.
What did you find?
We found that three year progression free survival is excellent after four cycles of R-CHOP and it is definitely non-inferior to six cycles of R-CHOP. Also event free survival and overall survival are not different. We could reduce toxicity, both haematological toxicity and non-haematological toxicity by about a third and the relapse pattern is similar in both arms. So, to sum it up, four cycles are enough in this patient population.
The trial was funded by the Deutsche Krebshilfe, a non-profit organisation, the German Cancer Aid.