P-265 - Survival benefit of oral tegafur/uracil and leucovorin metronomic chemotherapy as a first line therapy for patients with recurrent or metastatic col...

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Cytotoxic agents
Colon and Rectal Cancer
Biological therapy
Presenter A. Ramesh
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors A. Ramesh, S. Srinivasan, S. Suresh
  • Sri Ramachandra University and Hospital, Chennai/IN



This phase II trial was performed to evaluate the efficacy and tolerability of tegafur/uracil (UFT) and oral leucovorin (LV), Cyclophosphamide and oral etoposide patients with recurrent or metastatic colorectal cancer who had received one prior chemotherapy.


We did an open-label, single-group, at our University Hospital in India. We enrolled patients aged at least 18 years with histologically confirmed, locally advanced inoperable, or metastatic and recurrent measurable colorectal cancer with documented progression. Patients received Tablet Tegafur uracil two times per day per orally daily and Tablet leucovorin 15 mg two times per day orally daily for 4 weeks. They also received Tab Cyclophosphamide 50 mg and tablet Etoposide 50 mg orally daily for 3 weeks and 1 week gap. Next cycle due on 28 days. Treatment continued until disease progression or occurrence of unacceptable toxic effects. The primary endpoint was objective tumour response, defined by a complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (version 1.0) criteria. Treatment was administered on an outpatient basis every 28 days and consisted of at least two cycles and continue until disease progression.


A total of 30 patients were enrolled in this study. The median age of the patients was 55 years (range: 29 to 75 years). The observed overall response rate was 70%. The patients who discontinued treatment had progressive disease. The estimated median overall survival time was 23.5 months. Two patients (7%) experienced toxicities with a worst grade of 3, and one patient (4%) experienced toxicities with a worst grade of 4 mainly gastrointestinal with vomiting and diarrhoea. There was 1 treatment-related death. No patients experienced grade 3 or 4 hematological adverse events.


Although the response rate to oral chemotherapy was good and longer then reported in literature, a favorable survival time was observed. Lower hematological adverse event rate of U may introduce second line therapy safely colorectal cancer patients and contribute longer survival, low cost and tolerable. This is a very attractive option in limited resource countries.

Oral low dose metronomic therapy is considered to be a promising regimen for patients with unresectable metastatic, recurrent lesion from a standpoint of clinical efficacy and safety.