phase II study of cisplatin and 5-fluorouracil combination chemotherapy and concurrent thoracic radiation in squamous cell carcinoma of lung

ABSTRACT

To evaluate the efficacy and toxicity of cisplatin, 5-fluorouracil combination chemotherapy and concurrent thoracic radiation in squamous cell carcinoma of lung. A prospective, non randomized, quasi-experimental, phase II study which was conducted in the Department of Clinical Oncology Mayo Hospital/KEMC Lahore. This study was conducted from September 2002 to May 2004. Twenty two patients of histopathologically confirmed squamous cell carcinoma of lung were enrolled. Stage III B or stage IV patients requiring radiation therapy for control of local symptoms were included. These patients were treated with chemotherapy and concurrent chest radiation. The treatment regimen included cisplatin 80mg/m2 on day one and day "28" and 5-FU 750mg/m2 day 1-4 and day "28-31". Radia-tion was started on day one and a tumor dose of 50 Gy was delivered in 25 fractions. Common Toxicity Criteria and RTOG criteria were used to assess toxicities. Miller's criteria were used for response evaluation. Responses were evaluated two weeks after the completion of concurrent chemoradiotherapy. All the twenty two patients completed the planned treatment. Complete response was not achieved in any patient. Partial response was seen in 15 patients [68.18%], stable disease in five patients [22.73%] and progressive disease was seen in two patients [9.09%]. CTC Grade-II nausea was seen in eight patients [36.36%], vomiting in five patients [22.73%] and mucositis in six patients [27.27%]. Grade-III neutropenia was observed in three patients [13.64%] and Grade-III mucositis and diarrhea in five patients [22.72%] each. Grade-IV neutropenia was seen in two patients [9.09%]. Cisplatin and 5-Fluorouracil combination chemotherapy concurrent with 50 Gy radiation is an effective and well tolerated treatment modality for this subset of lung cancer patients