RESUMO
BACKGROUND: Patients with recurrent and metastatic head and neck Squamous Cell Cancer (HNSCC) have poor prognosis with limited treatment options. In view of decimal prognosis, the treatment decision should include quality of life (QOL) issues, cost-effectiveness besides the response rates and survival. AIM: Present retrospective analysis was conducted to evaluate efficacy (disease-free survival), pharmacoeconomics, and toxicity profile of four (4) different regimens, viz. gefitinib alone, gefitinib with methotrexate, methotrexate alone, or 5-FU with cisplatin. MATERIALS AND METHODS: Case records between 2007 September and 2008 September were analyzed, 68 patients were found suitable for analysis. Patients received gefitinib (250 mg/day), methotrexate as 50 mg intramuscular weekly or a combination of the same or 5-FU 750 mg/m(2)/day for 4 days along with cisplatin 75 mg/m(2)/day on day 1 in 21-day cycle. RESULTS: A total of 68 patients received therapy. Fifty-one patients have clinically meaningful response (stable disease + complete + partial responses) (75%) and had symptomatic improvement. The median progression-free survival was significantly superior in responders (those who achieved partial or complete response) (8.4 months vs. 3.1 months, P=0.001). Methotrexate with gefitinib had maximum median survival and better overall QOL compared to the other treatment regimens. Weekly methotrexate is relatively cost-effective followed by methotrexate with gefitinib and gefitinib alone. 5-FU with cisplatin in our experience does not appear so attractive in view of high complication rates (when given in full doses) and prolonged hospital stay. CONCLUSION: Based on the results of this retrospective analysis, methotrexate weekly as single agent or in combination with gefitinib appears as an attractive alternative regimen for patients with metastatic HNSCC including those having poor performance status. A prospective study was planned and submitted to the local ethics committee based on above results to validate these results and compare methotrexate and gefitinib arm with 5-FU + cisplatin.
RESUMO
BACKGROUND: One of the most distressing complications of head and neck cancer patients on chemoradiotherapy is mucositis. There is no proper tool to predict its occurrence in these patients. AIM: This study was conducted to develop a risk-scoring system to predict probable incidence and severity of mucositis in head and neck cancer patients on chemoradiotherapy. MATERIALS AND METHODS: This is a retrospective analysis conducted at a tertiary care cancer center with approximately 2,000 new cases of head and neck cancer patients annually. We Hypothesized were age, comorbid conditions, leukocyte count, nutritional status, oral hygiene, tobacco use, erythrocyte sedimentation rate (ESR); Eastern cooperative oncology group (ECOG) performance status (PS) and TNM (tumor, node, metastasis) stage as possible risk factors. Receiver operating characteristic (ROC) curves were drawn to predict the cutoff values for risk factors, and a final scoring system was developed with sensitivity and specificity data. RESULTS: A total of 218 patients on chemoradiation receiving cisplatin 40 mg/m2 /week along with local radiation of 60-70 Gy depending on primary site were analyzed. Based on ROC analysis, the following cutoff values were selected: age > 40 years, ECOG PS > 2, WBC < 3000/µL, elevated ESR, albumin < 3 gm/dL and > stage III disease. The remaining factors were indicated as present or absent. A score of 1 was assigned for the above risk factors. For patients, the final score of 3 or less there is 17% probability of developing grade 3 or 4 mucositis, while patients having score of 6 or more have 76% probability. CONCLUSION: The current tool is fairly accurate in predicting development of mucositis in head and neck cancer patients on chemoradiotherapy. This will further help clinicians to adopt preventive strategies as well as better counseling.
