997P - Results of TPEx (docetaxel, cisplatin, cetuximab) regimen use in first line patients with recurrent/metastatic squamous cell carcinoma of the head...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer agents
Head and Neck Cancers
Therapy
Biological therapy
Presenter Caroline Even
Citation Annals of Oncology (2014) 25 (suppl_4): iv340-iv356. 10.1093/annonc/mdu340
Authors C. Even1, B. Bobillot2, L. Mayache-Badis1, F.R. Ferrand1, N. Lezghed1, F. Bidault3, A. Auperin2, S. Temam1, F. Janot1, A. Schilf1, J. Guigay4
  • 1Head And Neck Department, Gustave Roussy, 94805 - Villejuif/FR
  • 2Department Of Biostatistics, Gustave Roussy, 94805 - Villejuif/FR
  • 3Department Of Radiodiagnostic, Gustave Roussy, 94805 - Villejuif/FR
  • 4Medical Oncology, Institute Gustave Roussy, Villejuif at present Centre Antoine Lacassagne, 06189 - Nice/FR

Abstract

Aim

According to the ESMO guidelines, 5FU, platinum and cetuximab is the standard in first line for patients (pts) with R/M SCCHN (PFEx; Vermorken, 2008). In 2012, the multicenter phase II TPEx GORTEC 2008-03 evaluating TPEx (4 cycles (cy) and maintenance with cetuximab every 2 weeks in case of response or stable disease) demonstrated that this regimen is effective and might be a relevant substitute for PFEx in fit pts (Guigay, ASCO, 2012) . We report here the retrospective analysis of pts treated with TPEx at Gustave Roussy.

Methods

Thirty patients with R/M SCCHN were treated between February 2011 and October 2013 in first line chemotherapy with TPEx (docetaxel : 75mg/m2/3 weeks, cisplatin : 75mg/m2/3 weeks and cetuximab 400mg/m2 on day 1 cy 1 then 250 mg/m2 weekly). G-CSF support was delivered as primary prophylaxis.

Results

Population included 20 male/10 female, median age 56.8 years [range 33-76], PS 0 or 1 except 1 pt (PS = 2), with oral cavity, oropharynx, larynx, hypopharynx localization (n= 10, 11, 7, 2 respectively). Pts received a median of 4 [1-7] cy. TPEx was modified in 18 pts mainly for toxicity; dose-intensity/cy was 94.6% for cisplatin, 90.9 % for docetaxel and 93% for cetuximab. We reported Gr 3 vomiting (n = 1), Gr 3 mucositis (n = 1), Gr 3 skin rash (n = 1), Gr 3 diarrhea (n = 1), Gr 2 neuropathy (n = 6), Gr 4 neutropenia (n= 3), Gr 3 hypersensitivity to cetuximab at cy 1 (n = 1). 25 pts received a maintenance (cetuximab every 2 weeks (n = 18), docetaxel and cetuximab (n = 2), carboplatin and cetuximab (n = 4), docetaxel (n = 1)). The median duration of maintenance was 2.8 months [maximum 9 months]; 3 pts are still in maintenance (after 1,3 and 5 months respectively). 5 pts did not receive maintenance (because of progression (n = 3); hypersensitivity to cetuximab (n = 1); death (n = 1)). Best response was complete response (n = 6), partial response (n = 20), stable disease (n = 2), progressive disease (n = 1), 1 pt (PS = 2) was not evaluated because she died from infectious pneumonia after cy 1. The objective response rate was 87%, the median PFS and OS were 6.0 and 13.6 months respectively with a median follow-up of 21.3 months [range 5.6–26.5].

Conclusions

In real life, TPEx is effective with an 87% ORR and an OS > 13 months. These data confirm the results of the phase II, with tolerable side effects in fit pts. A GORTEC multicentric randomized phase III trial (TPEx vs PFeX) will be conducted.

Disclosure

J. Guigay: Research funding from Novartis, Merck Serono, GSK and honoraria from Merck Serono All other authors have declared no conflicts of interest.