1005P - Induction chemotherapy (IC) with docetaxel, cisplatin and 5-fluorouracil (TPF) followed by chemoradiotherapy (CRT) concurrent with fractionated adm...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Head and Neck Cancers
Surgery and/or Radiotherapy of Cancer
Presenter Susumu Okano
Citation Annals of Oncology (2014) 25 (suppl_4): iv340-iv356. 10.1093/annonc/mdu340
Authors S. Okano1, M. Tahara2, T. Onoe3, T. Enokida2, T. Yamazaki2, S. Zenda4
  • 1Oto-rhino-laryngology, Jikei University School of Medicine, 105-8461 - Minato-ku, Tokyo/JP
  • 2Head And Neck Medical Oncology, National Cancer Center Hospital East, 2778577 - Kashiwa, Chiba/JP
  • 3Medical Oncology, Hyogo Cancer Center, 673-8558 - Akashi-shi, Hyogo/JP
  • 4Radiation Oncology, National Cancer Center Hospital East, JP-277-8577 - Kashiwa, Chiba/JP

Abstract

Aim

TPF followed by high-dose cisplatin CRT is not recommended due to concerns over toxicity. The aim of this study was to evaluate the feasibility of TPF as IC and fractionated administration of high-dose cisplatin CRT for the treatment of locally advanced SCCHN.

Methods

Key eligibility criteria included histologically proven SCCHN with previously untreated stage 3 or 4, PS 0-1, age 20 to 75 years, adequate organ function. IC consisted of a maximum of 3 cycles of docetaxel at a dose of 70 to 75 mg/m2 on day 1, cisplatin at 70 to 75mg/m2 on day1, and 5-fluorouracil at 750mg/m2 days 1 to 5, repeated every 3 weeks. Patients received a total of 70 Gy of radiotherapy concomitant with fractionated adminitration of high-dose cisplatin at a dose of 20mg/m2 on days 1 to 4, repeated every 3 weeks. Primary endpoint was the treatment completion rate of IC, which was defined as completion of 3 cycles IC. Sample size was calculated using Simon's two-stage design.

Results

From 2009 to 2014, 48 patients (pts) were accrued. Patient backgrounds were: median age 61 years, ECOG PS 0/1 (41/7) and oropharynx/hypopharynx/larynx (26/19/3). The treatment completion rate of IC was 91.6%. Grade 3 or 4 toxicities of TPF were neutropenia (83.3%) and febrile neutropenia (20.8%), anorexia (14.6%), mucositis (6.3%). 38 pts (79.1%) achieved response after IC. Forty-one pts subsequently received CRT and four received radiation alone. Thirty-four pts (70.8%) completed the three planned cycles of fractionated administration of high-dose cisplatin, but six (12.5%) did not because of hematological toxicity (n = 1) and acute renal failure (n = 1) and others (n = 4). Grade 3 or 4 toxicities of CRT were mucositis (51.2%) and dysphasia (31.7%), dermatitis (8.3%). 24pts (50%) achieved complete response. With a median follow-up of 36.1 months, 3-year overall survival was 75.4% (95% CI: 55.4-87.4).

Conclusions

TPF followed by fractionated administration of high-dose cisplatin CRT was tolerable with acceptable toxicities for pts with locally advanced SCCHN.

Disclosure

All authors have declared no conflicts of interest.