Good morning ladies and gentlemen. I would like to thank the ESMO Press Committee for inviting me here. I am planning to make a brief presentation to you about the results of this randomised controlled trial that is a single centre study from the largest cancer hospital in India which is the Tata Memorial Centre. We designed this study and initiated it in 2003 and this study compares neoadjuvant chemotherapy followed by radical surgery versus concomitant chemoradiation using cisplatin in patients with locally advanced cervical cancer.
Many of you know that cervical cancer is a common cancer in women worldwide and is particularly prevalent in the less developed regions of the world where there continues to be a substantial number of cases and deaths due to this disease. Unfortunately, many patients continue to present in locally advanced stages and these are defined as FIGO stages between IB-2 to IVA which means that the cancer has invaded the tissues that surround the cervix. Giving radiotherapy and simultaneous chemotherapy using cisplatin has been the standard treatment for close to twenty years now based on the results of several large high quality randomised trials and I will not go into those details today. However, despite adequate treatment, about 25-40% of patients relapse of their disease and therefore there is an alternative treatment strategy that involves giving neoadjuvant chemotherapy followed by radical surgery. An older set of trials suggests that this may be superior to radiotherapy alone but radiotherapy alone is no longer the current standard, so therefore we have conducted this trial to compare neoadjuvant chemotherapy and surgery to concomitant chemoradiation. I would like to add in passing that, despite lack of evidence, neoadjuvant chemotherapy and surgery continue to be practised in many parts of the world, particularly in Europe and in Asia.
This is the trial that we designed. We included patients with squamous cell carcinoma of the cervix in stages IB-2, 2A or 2B. They were in good performance status, no prior treatment, no distant metastases and adequate blood reports. These patients were randomised after stratification on stage in a 1:1 ratio to one of the two arms. The experimental arm was neoadjuvant chemotherapy using standard doses of paclitaxel and carboplatin given once every three weeks followed by a type 3 radical hysterectomy. The control treatment was standard radiotherapy with concomitant cisplatin chemotherapy, 40mg/m2 once a week for about five weeks.
These are the main results of our study and you can see that concomitant chemoradiation resulted in an improvement in the primary endpoint of disease free survival with a hazard ratio of 1.38 for the surgical arm and a p-value of 0.038. Five year disease free survival rates of 76.7% versus 69.3%, corresponding to a 38% excess risk of relapse or death due to cancer in the surgical arm.
We measured the acute and the late toxicities of treatment in both arms of the study and I will present more detailed data this evening at the plenary session. However, I would like to point out that at two years or later after completion of treatment the rate of only vaginal toxicity continued to be higher in the concomitant chemoradiation arm and there was no significant difference between the two arms with respect to rectal, bladder or other toxicities.
The conclusions of our study are that chemotherapy followed by surgery is not superior to radiotherapy and simultaneous chemotherapy in patients with locally advanced cervical cancer. This is a robust trial with 635 patients and we believe that this data is definitive. Chemotherapy followed by surgery should not be routinely practised, as I told you, it is practised in some parts of the world. This is the very first study to report on this comparison as has already been pointed out by the moderator. Another study by EORTC is likely to report in the next one to two years and concomitant chemoradiation should continue to be the standard treatment.
Thank you very much for your attention.