This was a study that was planned by academic investigators from the gynaecologic oncology group of our centre. We started the study in 2003 and the accrual of patients went on until 2015 at which point we had 635 patients. This was a study that looked at an important therapeutic question in cervical cancer – whether to perform chemotherapy and surgery or radiation and simultaneous chemotherapy. At the time of planning the study we had hypothesised that chemotherapy followed by surgery would result in better outcomes compared to concomitant chemoradiation but, as you know, the results that I presented yesterday suggest that for disease free survival, which was the primary endpoint of our study, the outcome is better with concomitant chemoradiation.
There were a few standard elements from the data, including local toxicity which I noticed.
If you noticed the data that I presented yesterday the rates of severe grades of toxicities, bladder toxicity, rectal toxicity, vaginal toxicity, that we are concerned about with radiation was not significantly different between the two arms during treatment or within six weeks of completion of treatment. But the rates of any grade of long-term toxicity were significantly higher with concomitant chemoradiation in terms of rectal toxicity, bladder toxicity and vaginal toxicity. At two years the rates of bladder and rectal toxicities were comparable and low in both the arms but the rate of vaginal toxicity continued to be higher in the concomitant chemoradiation arm. So, yes, that is a concern. At the time that this study was going on we used the standard radiotherapy techniques but, as you know, radiation therapy has improved, we have better focus and more conformal radiation techniques. So hopefully this toxicity will continue to be minimised in the future.
I suppose the take home message of this would be that chemoradiation remains the best choice available.
Yes, chemoradiation remains the best choice for treatment of locally advanced cervical cancer. But in addition to that I would also like to say that we suggest that neoadjuvant chemotherapy and surgery not be offered as part of routine practice. The reason is that a considerable fraction of patients in the surgical arm anyway went on to receive radiation or chemoradiation. That is because they required it either as a part of crossover or because of adjuvant treatment. So if we are not achieving better outcomes with chemotherapy and surgery and we anyways require three modalities of treatment in at least 40% of patients it may be a good idea to have chemoradiation as the standard treatment.
We await the results of the EORTC study that has asked the same question. Their endpoint is overall survival and we hope that the results of that study will further clarify the situation in 2018.