Abstract 779P
Background
Systemic administration of cytotoxic drugs is the primary treatment strategy for patients with advanced carcinoma of cervix, but poor tolerance and side effects of the drugs led us to conduct this trial in patients who are ineligible for any type of intravenous chemotherapy.
Methods
In this prospective interventional study 60 patients with metastatic, recurrent and persistent cervical cancer, who are not eligible or not willing for intravenous chemotherapy, were enrolled in this trial. All 60 patients received at least two lines of therapy either as curative concurrent chemo-radiotherapy or palliative taxane-platin, gemcitabine-platin combination chemotherapy. Patients were randomly divided into two groups of 30 patients each with one group receiving low-dose oral capecitabine (500 mg twice a day) along with regular BSC (Group A) and the other group receiving best supportive care (Group B) only.
Results
Group A i.e; low-dose oral capecitabine and BSC group was better tolerated with none of the patients having thrombocytopenia or neutropenia. There were 3 complete responses (10%) and 8 partial responses (26.66%) and stable disease in 12 patients (40%) at the end of six months in group A as compared to group B. All the patients in group B had progressive disease with only 9 patients being alive (30%) and the rest of the 21 patients (70%) had died because of progressive disease at the end of six months, whereas in group A, 4 patients (13.33%) had progressive disease and 3 patients (10%) died while on treatment due to progressive disease. There was not much difference in the side effects profile of the treatment except dyspepsia which is more frequent in the group A (37.5%) as compared to group B (20%).
Conclusions
Metronomic, low-dose oral capecitabine was found to be very effective and well tolerated with significant clinical responses, better quality of life and symptom control without any considerable side effects in patients with metastatic, recurrent and persistent cervical cancer who are ineligible for intravenous chemotherapy. As this is a very small study the authors believe that more research is needed with more patients to know the beneficial effects of metronomic low-dose oral capecitabine.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
I. Madabhavi.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.