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 Anticancer agents
Head and Neck Cancers
Surgical Oncology
Therapy
Biological Therapy
Radiation Oncology
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.