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CRITICS – combined modality treatment for localized gastric cancer

Prof. Marcel Verheij

Lordick- Verheij

CRITICS – combined modality treatment for localized gastric cancer

Professor Marcel Verheij

Professor And Chairman, Department of Radiotherapy, Amsterdam, The Netherlands

Video transcript

Q. Hello, we are here in Barcelona at the ESMO World Congress of GI Cancer and we have heard interesting data today about gastric and gastroesophageal cancer. I am happy to have Professor Marcel Verheij from Amsterdam with me as an interview partner. He is one of the principal investigators of the CRITICS study that has been presented at ASCO.

Hello Marcel, do you want to tell us quickly how the design of the CRITICS study was and what the major findings were?

A. Yes. The CRITICS study started in 2007. At that time there were two different approaches in order to improve the surgical results in gastric cancer; that was post-operative chemoradiotherapy according to the intergroup study and perioperative chemotherapy according to the MAGIC trial. At that time there was also discussion around what would be the optimal type of surgery: limited or extensive lymph node dissection?

Those three elements formed the rationale for the CRITICS study where we combined optimal surgery with optimal systemic therapy or local regional therapy. Patients were up-front randomised, in order to avoid selection and to mimic daily practice, to receive pre-operative chemotherapy followed by optimal surgery and then continued with post-operative chemotherapy and the other arm, the experimental arm, patients also started with pre-operative chemotherapy then they went to optimal surgery and then they received post-operative chemoradiotherapy.

The primary endpoint was overall survival, secondary endpoints progression free survival, toxicity, quality of life and translational research.

Q. We have seen already at ASCO that unfortunately survival was not improved in the chemoradiation arm compared to the perioperative chemotherapy alone arm. Do you think these are definitive negative results and how do you think it counts that the addition of radiation therapy did not have an additional …?

A. In these primary endpoint and also the secondary endpoint there was no difference in overall survival or progression free survival. The results were comparable with previous studies. What we did observe and that is also in agreement with other studies is that a large proportion of patients are not able to finish the entire treatment protocol. That was mainly due to patients who could not complete the post-operative part of the treatment.

We therefore think that the largest part of the efficacy of the treatment is given in the pre-operative phase. Apparently in the post-operative phase, once you have had pre-operative chemotherapy and optima surgery, no large differences in post-operative chemotherapy versus post-operative chemoradiotherapy remain for the whole group.

I believe that based on these data we should switch our attention to the pre-operative phase of treatment.

Q. Any plans for future studies which do this shift to pre-operative?

A. Yes.

Q. Is there already time to talk about?

A. Yes, we have already a design in place for a Phase 2 study in order to identify the optimal pre-operative regimen in resectable gastric cancer. We want to compare pre-operative chemotherapy versus pre-operative chemotherapy plus chemoradiation versus pre-operative chemoradiotherapy and no adjuvant post-operative treatment.

Q. If I understand you right, you believe that an explanation for the negative results is that it was too difficult to administer full treatment post-operatively; can I say that?

A. It is certainly an important element of the study. On the other hand it seems that we now have two treatment options in the post-operative phase. We can either continue with post-operative chemotherapy or apply post-operative chemoradiotherapy. We are currently analysing subgroups of patients because there may be subgroups of patients who benefit from one specific treatment versus the other specific post-operative treatment.

Q. What is their hypothesis? Which subgroups could be the positive patients or the poor responders to pre-operative chemotherapy?

A. Based on the ARTIST study we could anticipate the differential effect in node-positive patients. Based on our own retrospective data there may also be a specific benefit for patients who underwent an R1 resection, so these are among the subgroups of patients we are interested in specifically.

Q. Is there analysis that are currently ongoing and you will report on that in the next meetings?

A. Yes.

Q. Do you also plan to do a subgroup analysis on those who receive full treatment? Would that be interesting to look at?

A. Yes. That is also analysis we are currently doing.

Q. There will be some news in the future?

A. There will be.

Q. We are looking forward to seeing more data from the CRITICS trial. Thank you very much again that you were here to give this interview.

A. You are welcome.

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