Induction Docetaxel, Cisplatin and 5 Fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy Versus Concomitant Chemoradiotherapy in Unresectable Locally Advanced Head and Neck Cancer: A Phase III Randomized Study
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Induction Docetaxel, Cisplatin and 5 Fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy Versus Concomitant Chemoradiotherapy in Unresectable Locally Advanced Head and Neck Cancer: A Phase III Randomized Study,RAMY R. GHALI, EMAN EL-SHARAWY, AZZA M. ADEL and SAMER A. IBRAHIM
Abstract
Objective: This phase III randomized trial was designed to assess feasibility (on the basis of efficacy and toxicity) of induction docetaxel, cisplatin, and 5-fluorouracil (TPF) fol-lowed by CT/RT versus concomitant chemoradiotherapy (CT/ RT) alone in patients with unresectable locally advanced squamous cell carcinoma of the head and neck (SSCHN).
Patients and Methods: Sixty patients were randomly assigned into 2 arms; Arm A: 30 patients received CT/RT in the form of radiotherapy to the primary tumor and neck nodes concomitant with cisplatin 100mg/m2 on day 1, 22 and 43 of radiotherapy. Arm B: 30 patients received induction TPF regimen (docetaxel: 75mg/m2, cisplatin: 75mg/m2 both on day 1, and 5-fluorouracil: 750mg/m2/day over 96h). Cycles were repeated every 3 weeks to a maximum of three cycles, after which patients received the same RT regimen as in arm A with cisplatin 30mg/m2 weekly starting day 1 of radiother-apy. Concomitant chemoradiotherapy commenced 3-5 weeks after the end of induction chemotherapy.
Results: From August 2007 to September 2009, 60 patients with stage III-IV M0 SCCHN, ECOG-PS of 0 to 1, were randomly assigned to each of the study arms. Induction TPF, the ORR was 63.33% (19/30 assessable patients) (95% CI : 13.653-23.439) and the CR was 23.33% (CI:3.5-12.27) (7/30 assessable patients). Two patients (6.67%) progressed during TPF. Following CT/RT, the CR rate was 13.33% (95% CI: 1.128-9.216) in arm A and 42.86% (95% CI 6.848-17.589) in arm B p-value=0.0105 indicating a better activity for arm B. The Corresponding PR rates were 53.33% and 32.14% for arm A and B respectively. The overall response rate was 66% and 75% for both groups respectivly, progressive disease was more in arm A (8 compared to 3 patients in both groups respectivly). There were no early deaths in both arms. During induction TPF, the most common grade 3-4 hematologic toxicity was neutropenia (36.67%), with 3.33% experiencing febrile neutropenia. The rate of grade 3-4 anemia and throm-bocytopenia was 3.33%. Grade 3-4 non-hematologic toxic effects as alopecia occurred in 86.67%, stomatitis/mucositis (6.67%), and nausea (6.67%). Grade 3-4 hematologic toxic effects during CT/RT were not statistically significant between both arms (p-value=0.344). The most relevant non-hematologic toxic effects (mucositis/stomatitis, skin toxicity, and dysphagia) which constituted 46.66% and 39.28% respectively but this difference was not statistically significant (p-value=0.571).
Conclusion: Treatment of unresectable locally advanced squamous cell carcinoma of head neck cancer with induction TPF chemotherapy followed by concomitant CT/RT yields significantly more patients with complete response and is not on the expense of higher toxicity than concomitant chemora-diotherapy alone.