Some advanced epithelial ovarian cancer patients can avoid a lymphadenectomy without impacting survival outcomes
Prof Jean-Marc Classe - Nantes Université, Nantes, France
The question is about surgery for advanced ovarian cancer. Surgery for advanced ovarian cancer is primary surgery or surgery after interval neoadjuvant chemotherapy. This is very important. In this field, patients with lymph nodes suspicious to be involved must undergo a lymphadenectomy. The question is for the patient with no lymph nodes suspicious at the CT scan before surgery or during surgery when you perform the palpation. For these patients if you perform a systematic lymphadenectomy you find lymph nodes involved in one half of the patients. But the question is is it possible to avoid the surgery of lymph nodes in order to reduce the morbidity? Is it going to decrease the survival?
So we have already the response, the reply just for the patients treated with primary surgery. For these patients the LION trial presented at ASCO 2017 showed that, no, in primary surgery patients with no suspicious nodes can avoid a lymphadenectomy. The survival is exactly the same as without lymphadenectomy. With or without it’s the same survival. This is the LION trial.
But in the LION trial it didn’t add patients treated with neoadjuvant chemotherapy, only primary surgery. So in the CARACO trial we performed a trial based on exactly the same question, patients with an epithelial ovarian cancer, primary or interval surgery, complete surgery and randomisation to lymphadenectomy or to no lymphadenectomy.
When we go to the design of the trial it’s a superiority trial – we need to demonstrate the superiority of the lymphadenectomy – with the primary endpoint of progression free survival and secondary endpoints of overall survival, morbidity, quality of life and so on. The results show that there is no difference in survival, no PFS survival, no overall survival when you perform lymphadenectomy or no lymphadenectomy.
So it’s in addition with the information from the LION trial, now we can conclude that for patients treated with primary surgery or with interval surgery, with no lymph nodes suspicious before surgery, you can avoid the morbidity, the pain, the duration of surgery of these patients.
The impact is really a change in the routine practices of surgeons. Today all around the world surgeons treat patients with advanced ovarian cancer and no suspicious lymph nodes but neoadjuvant chemotherapy they must perform a lymphadenectomy because they didn’t add any information with the high level of evidence. With this trial whatever the place where you are, you are going to avoid a lymphadenectomy for these patients.
The impact is in the trial we have a table with surgical characteristics and we found one hour more of surgery in the group of lymphadenectomy and in the table about the morbidity we found statistically significantly more transfusion, MRH, urinary injury. So you can avoid all this morbidity and duration of surgery because the survival is exactly the same without lymphadenectomy for these patients. So it’s an important issue.
Now, how could the surgical practices change? The first step is the communication of the trial. The second step is the publication of the manuscript because into the manuscript you will have a lot more explication, more details. After, societies all over the world, ASCO, ASCO guidelines for the Unites States and we have the same in Europe, are going to change. But we must wait for the manuscript before any change because an abstract gives the results, gives some details but no more detail. We need more detail. So frequently there is no change before the manuscript publication but it’s still very good information for patients.
