In a trial conducted by the Tata Memorial Hospital in Mumbai, India, investigators sought to solidify the impact of concomitant chemoradiation in women with FIGO stage IIIB squamous cell cervical cancer.
In this study, 850 women were randomized to either chemoradiotherapy or radiotherapy from 2003 to 2011. In the chemoradiation arm, disease-free survival at 5 years was significantly higher than in the radiotherapy arm (52.3% vs 43.8%; HR, 0.81; 95% CI, 0.68-0.98; P
= .03). Overall survival at 5 years was 54% in the chemoradiation arm and 46% in the radiotherapy arm (HR, 0.82; 95% CI, 0.68-0.98; P
This was the largest trial of stage IIIB cervical cancer to date to report outcomes, said lead investigator Umesh Mahantshetty, MD.
Results of this historic trial were presented at the 2017 International Meeting of the European Society of Gynaecological Oncology (ESGO).
In an interview with OncLive
during the meeting, Mahantshetty, radiation oncologist, Tata Memorial Hospital, Mumbai, discussed these results and shared his insight on the state of cervical cancer treatment in developing countries.
OncLive: Please provide an overview of this trial.
Tata Memorial Hospital treats a lot of cervical cancer patients every year, and most of the patients present at an advanced stage. The trial is about finding out whether chemoradiation would be beneficial in these women with more advanced disease. If you look at the literature, the evidence for practice of chemoradiation for locally advanced cervical cancer, it is not very robust. That is why in the early 2000s, we decided that we would do a phase III randomized trial to find out if chemoradiation is beneficial in advanced disease, especially stage III disease. And if it is beneficial, what is the magnitude of benefit in these patients? Since this was started in 2001, we took some time to recruit 850 patients in this trial, and [at ESGO 2017] we presented the final results of this randomized trial.
What were the findings?
The aim was to find whether chemoradiation would help in FIGO stage IIIB cervical cancer. And in this 850-patient randomized trial we actually showed an absolute benefit of 8% and 8.5% in disease-free survival and overall survival, respectively. This is the largest trial of stage IIIB cervical cancer to report the outcome. What is important is that this treatment was better in patients with stage IIIB, but also the other factors like hemoglobin, radiation doses, and overall treatment time did help to improve the outcome.
Cervical cancer is a leading cause of cancer death in Indian women. How do these results contribute to lowering this?
Cervical cancer is one of the major health problems not only in India, but in most of the developing countries. The major unmet need is to treat them optimally so that the outcome is best for them in their particular setting in the environment in which they are in. We are doing these pragmatic trials to figure out how best to improve outcomes in these women, especially in developing countries. This is a significant finding because such trials have never been done in this advanced disease or in a developing country center like the Tata Hospital in India, where we conducted this trial.
This trial definitely opens up avenues to do more research in developing countries. The advances in brachytherapy, even in a limited setting such as a developing country, can be implemented with some advances so that the outcomes are better. Tata Memorial Hospital is collaborating with agencies like the International Atomic Energy Agency, and WHO to find out how we can better implement simple treatment techniques that can improve the outcome of these women with advanced disease.
Did you face any significant challenges in conducting this trial?
This was a big challenge for Tata Memorial Hospital to run this trial because in developing countries, doing a trial of such magnitude costs a lot in terms of infrastructure [and] following the patients. We are also challenged in terms of compliance to the treatment, as well as follow-up of these women who come from far, remote places—most of them come from a rural background.
For us as an institution, there were a lot of lessons to learn from this trial, and whatever we implemented in this trial is now more or less routine. We have implemented a lot of these strategies in routine care, for example—emphasizing compliance to follow-up after the treatment is completed by various medical staff, including the physicians, has helped us to come up with some good outcome data.
Mahantshetty U, Shrivastava S, Engineer R, et al. Cisplatin chemo-radiation versus radiation in FIGO stage IIIb squamous cell carcinoma of the uterine cervix (cracx trial: nct00193791). Presented at the 2017 International Meeting of the European Society of Gynaecological Oncology (ESGO) in Vienna, Austria.