Naeem Haider, Shaharyar, Shahid Rasul, Ehsanur Rehman, Zafar Allaudin, Aun Muhammad.
A phase II study of cisplatin and 5-fluorouracil combination chemotherapy and concurrent thoracic radiation in squamous cell carcinoma of lung.
Pak J Med Sci Jan ;23(5):698-702.

Objective: To evaluate the efficacy and toxicity of cisplatin, 5-fluorouracil combination chemotherapy and concurrent thoracic radiation in squamous cell carcinoma of lung. Methodology: 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". Radiation 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. Results: 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%). Conclusion: 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.

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