Phase II study comparing the utility of concomitant chemotherapy, teletherapy and brachitherapy of high dose rate in uterine neck escamocelular carcinoma patients

Abstract

Listen

Translate article

5131 Background: Cervical carcinoma is a health problem in the No-development countries. An Alert of NCI in February 1999 indicate that the best therapeutic option is chemotherapy and radiotherapy combination Methods: a Phase II study of concomitant administration of: Cisplatino 30 ml /mt2, days 1, 8, 15. With 5 FU 750 ml /m2, days 1 to 5. and Teletherapy up to 3420cGy in 180cGy fractions 5 times a week and it will continue until completing 5400 cGy. A weekly application of high dose rate brachitherapy will be made, until completing a total of 5 inserts. Results: 55 patients have been studied with an age average of 47,4, the predominant histological grade was 43,6%, stage II B and 49% stage III B. They all received the complete treatment plan, without delay for the administration of the chemotherapy, radiotherapy and Brachitherapy. Haematological toxicity was mild and only 1,8% of febrile neutropenia was observed. Non-Haematological toxicity was considered mild in most of the patients, it is important to note that 2 cases of irreversible renal impairment, and 2 cases of deep vein thrombosis. Neuropathy and alopecia were mild. 47 patients had a complete response, 3 patients remained in stable illness and only 5 patients (9%) showed a progression of the illness. 36 months after follow-up 32,7% of the patients relapsed. It was found that most of them presented local and regional relapse. In 77% of the patients that relapsed, 2 relapses were in Bone 1 in Lung and 1 in central Nervous System. Deaths were caused by tumour progression, of which 1 was lung and 7 local-regional relapses. There are 32 illness-free patients alive under follow-up (58,1%) and 7 patients alive in progression. Conclusions: This is a chemotherapy scheme, well tolerated with secondary effects mild, therefore the treatment is considered to be safe and effective. The response rate was high although due to the reduced number of patients the global survival and the illness-free period cannot be determined at this moment. We expect to continue recruiting patients. No significant financial relationships to disclose.