Title: A Comparative Randomise Study of Chemotherapy versus Chemoradiation in Unresectable Locally Advanced Gallbladder Carcinoma
Authors: Dr Kamlesh Kumar Harsh, Dr Satya Narayan, Dr Sitaram Maharia, Dr Rajkumar Nirwan, Dr SL Jakhar, Dr Neeti Sharma, Dr HS Kumar
DOI: https://dx.doi.org/10.18535/jmscr/v5i1.132
Abstract
INTRODUCTION
Gall bladder (GB) carcinoma is most common biliary tract malignancy worldwide. (1) The incidence is increasing globally and also in India. Recently, the Indian Council of medical research (ICMR) has reported that incidence rates of GB cancer in women in Northern India (more than 9 per 100000 per year) are one of the highest in the world. Cholelithiasis is frequently associated with GB cancer in up to 40%-90% patients and is the most common associated factor independent of age or sex. (2) Surgery is potentially curative treatment in early stage of GB cancer. But vague presenting symptoms often delay the diagnosis of GB cancer, thus contributing to its overall progression and poor outcome. Overall mean survival is six months, while 5- year survival rate is only 5%. (3) Palliative therapy is the treatment which alleviates the distressing symptoms caused by advanced cancer. Palliative chemotherapy or radiotherapy helps to improve quality of life, reduces risk of complications and also has some survival benefit. In an effort to improve survival rates and quality of life, neoadjuvant or concurrent chemotherapy has been used. Radiation therapy is safe and tolerable as palliative therapy in unresectable GB cancer to relieve symptoms like abdominal pain and obstructive jaundice. It acts by shrinking tumors that are blocking passage ways for blood or bile or are pressing on nerves. (4)
The goal of the study was to evaluate the efficacy and safety of chemotherapy alone as Gemcitabine and Cisplatin versus continuous daily Capecita-bine with radiotherapy in patients with previously untreated locally advanced unresectable GB carcinoma. The primary end point was radiologic response and symptomatic evaluation. The secondary end point included overall survival and tolerability.
