ABSTRACT
Background: Cisplatin based Concurrent chemo-radiation (CTRT) is the corner stone for treatment of locally advanced head and neck carcinoma. Epidermal growth factor receptor(EGFR) expression by squamous cell carcinoma which is associated with cancer development and progression,leads to emergence of anti-EGFR agents as a therapeutic option. In this study we compare cisplatin based CTRT against gefitinib based CTRT in terms of disease control and acute toxicity profile. Material and Methods: Stage III and IV squamous cell carcinoma of Head and neck region (excluding nasopharynx) were randomised into two groups. Control group received conventionally fractionated radiotherapy of 66Gy in 33fractions, over six and half weeks with concurrent weekly cisplatin. Study group received same dose of radiation with concurrent daily oral Gefitinib. All patients were followed up weekly during the treatment and then 6-8 weeks after completion of treatment and thereafter 3 monthly. Results: Overall response rate (complete response + partial response) was comparable for both arms (75% vs 76.2%, p value-0.881). Radiation with cisplatin was associated with significantly higher skin (28.6% vs 15%,p value-0.037) and mucosal (23.8% vs 5%,p-value-0.047) toxicities. Gefitinib containing arm showed significantly higher grade 3 diarrhoea (10% vs 0%, p-value-0.01) and skin rash (6% vs 0%, p -value-<0.001).With a median follow-up of 12.5 months Disease free survival (DFS) was not significantly different between the arms(12 vs 13 months). Conclusion: Gefitinib based CTRT is non-inferior to cisplatin based CTRT for the treatment of locally advanced head and neck carcinoma with acceptable toxicity profile.
ABSTRACT
Background: Cisplatin-based concurrent chemoradiation is the standard treatment for carcinoma cervix. However, there is a need to explore alternative chemotherapeutic agents to further improve the treatment outcome. In this study, weekly paclitaxel and cisplatin-based chemoradiation was compared with weekly cisplatin-based chemoradiation in terms of disease control and toxicity profile. Materials and Methods: Sixty-four patients with FIGO stage IB2-IIIB squamous cell carcinoma of the uterine cervix were divided (by simple random sampling) into two groups: control arm patients who received radiotherapy (50 Gy in 25 fractions over 5 weeks) with concurrent weekly cisplatin (40 mg/m 2 ) and study arm patients received same radiation dose with weekly cisplatin (30 mg/m2 ) and paclitaxel (40 mg/m2 ). After that, all patients received brachytherapy 21 Gy/three fractions, one fraction/week. All patients were followed up weekly during treatment, then 4–6 weeks after treatment completion, and thereafter monthly for at least 6 months. Results: The overall treatment response (complete+ partial response) was numerically higher in the cisplatin- containing control arm, but not significant (93% vs. 80%, P-value = 0.406). High-grade early rectal (60% vs. 25%, P-value = 0.014) and acute gastrointestinal toxicity (66% vs. 6%, P-value <0.001) were significantly higher in the cisplatin and paclitaxel-containing arm. Hematological, renal, late rectal, and bladder toxicities were also numerically higher in the study arm, but not statistically significant. Conclusion: There was no significant benefit of weekly paclitaxel and cisplatin as an alternative to weekly cisplatin-based chemoradiation in the treatment of carcinoma cervix.