Comparative efficacy of 5flourouracil/calcium leucovorine versus 5flourouracil/calcium leucovorine plus oxaliplatin in the adjuvant treatment of colonic carcinoma in Kashmir.
OBJECTIVE
This prospective, randomized comparative study conducted in Kashmir evaluated the clinical profile of colonic carcinoma and the efficacy, side effects and survival advantage of adjuvant treatment with 5FU/CLV versus FOLFOX7.


METHODS
Between 2007 and 2009, the clinical profiles of 50 patients enrolled and randomized equally into Arm A receiving 5FU/CLV alone (Mayo Clinic Regimen) and Arm B receiving the FOLFOX7 regimen (including oxaliplatin) were evaluated.


RESULTS
Majority of the patients were in the 5(th) and 6(th) decade of life (males 70% versus females 30%), and most were from urban dwellings. Consumption of red meat, obesity and physical inactivity were common risk factors. A family history of colonic carcinoma was reported in 12% of the patients. Event-free and disease-free survival for the two arms were: Arm A - 12.8 ± 5 months and 14.2 ± 6 months; Arm B - 13.0 ± 6.7 months and 13.1 ± 6 months, respectively. Treatment-related morbidity was significant in Arm B whereas general well being and surrogate laboratory markers including a hemogram, favored Arm A.


CONCLUSIONS
The clinical profile, risk factors and familial predisposition of Kashmiri colonic carcinoma patients matches that of colon cancer patients elsewhere. There was no added survival advantage by adding oxaliplatin to 5FU and CLV. Although the interim results showed that the Mayo Clinic Regimen has a better total survival advantage compared with the FOLFOX7 regimen, the results were not statistically significant. The Mayo Clinic Regimen was better than the FOLFOX7 regimen in terms of the toxicity profile. However, this finding needs to be studied further. The main idea of conducting this study was to reveal that there is no added advantage of adding oxaliplatin to 5FU and CLV, thereby (a) reducing the toxicity (b) and lowering cost of therapy.
Department of Medical Oncology, Sher-i-Kashmir Institute of Medical Sciences Soura, Srinagar, India.
Hamid Deva
HD
Shaiq
Department of Medicine, GMC, Srinagar, India.
Sheikh Aejaz
SA
Aziz
Department of Medicine, King Khalid University/Aseer Central Hospital, Abha, KSA.
Imran R
IR
Rangreze
Department of Surgical Gastroenterology, SKIMS, Srinagar, India.
Omar J
OJ
Shah
Department of Medicine, SKIMS, Soura, Kashmir, J & K, India.
Shehla Shafi
SS
Khan
Colonic carcinoma; FOLFOX7; Mayo clinic regimen; disease-free survival; event-free survival