Download the ESMO 2012 Abstract Book - Oxford Journals

patients. We have developed a randomized trial comparing the efficacy and toxicities
of CCRT versus NAC-RT for locally advanced nasopharyngeal cancer.
Patients and methods: A total of 175 patients were included in the study. The 87
patients received concurrent radio-chemotherapy daily 70 Gy/7 weeks with cisplatin
100 mg/m 2 q 3 weeks then followed by adjuvant chemotherapy for 3 cycles (q 3
weeks), consisting of cisplatin 80 mg/m 2 on day 1 and 5-FU 1,000 mg/m 2 on day 1-4.
The 88 patients received neoadjuvant chemotherapy for 3 cycles (q 3 weeks)
consisting of docetaxel 75 mg/m 2 on day 1, cisplatin 75 mg/m 2 on day 1, and 5-FU
750 mg/m 2 on days 1- 4 followed by concurrent radiotherapy daily 70 Gy/7 weeks
with carboplatin AUC 1.5 weekly for 6 weeks.
Results: The number of patients who completed treatment for the CCRT group was
34 (39.1%) and for the NAC-RT group was 54 (61.4%). The most common reasons
for study discontinuation were adverse events and patient’s willingness. The grade 3
and 4 treatment-related adverse events were two times higher in the CCRT group
(p < 0.06), mostly mucositis / stomatitis and nausea / vomiting. There was no
difference in hematologic adverse events between groups. The 1-year progression-free
survival rate was 91.8% and 89.3% in the CCRT and NAC-RT group, respectively.
No evidence of disease at the time of this interim analysis was found in 76.5% in the
CCRT group and 85.2% in the NAC-RT group.
Conclusion: Induction chemotherapy with docetaxel / cisplatin and 5-fluoro-uracil
followed by concurrent radio-chemotherapy was tolerable and provided well control
of disease. These interim early results revealed no difference in PFS but less side
effects and increase number of the patients with no evidence of disease in the
NAC-RT arm.
Disclosure: All authors have declared no conflicts of interest.
1036P INDUCTION THERAPY WITH CETUXIMAB, DOCETAXEL,
CISPLATIN, AND FLUOROURACIL IN PATIENTS WITH
RESECTABLE NON METASTATIC STAGE III OR IV
SQUAMOUS CELL CARCINOMA OF THE OROPHARYNX. A
GERCOR PHASE II STUDY
B. Chibaudel 1 ,R.Lacave 2 , J. Belloc 3 , A. Banal 4 , S. Albert 5 , F. Chabolle 6 ,
M. Lefevre 7 , P. Soussan 8 , R. Moukoko 9 , J. Lacau Saint Guily 10
1 Department of Medical Oncology, Hôpital Saint Antoine, Paris, FRANCE,
2 Laboratoire d’Histologie et Biologie Tumorale, Hôpital Tenon, PARIS, FRANCE,
3 Oto-Rhino-Laryngologie, Hôpital Simone Veil, Eaubonne, FRANCE, 4 Chirurgie
de la Face et du Cou, Centre René Huguenin, Saint-Cloud, FRANCE,
5 Oto-Rhino-Laryngologie et Chirurgie Cervico-Faciale, Hôpital Bichat Claude
Bernard, Paris, FRANCE, 6 Oto- Rhino-Laryngologie et Chirurgie Cervico-Faciale,
Hôpital Foch, Suresnes, FRANCE, 7 Anatomie et Cyto Pathologie, Hôpital Tenon,
Paris, FRANCE, 8 Virologie, Hôpital Tenon, Paris, FRANCE, 9 Groupe Coopérateur
Multidisciplinaire en Oncologie, GERCOR, Paris, FRANCE, 10 Oto-
Rhino-Laryngologie et Chirurgie Cervico-Faciale, Hôpital Tenon, Paris, FRANCE
Background: Docetaxel/cisplatin/5-FU (TPF) has been reported to be more active
than cisplatin/5-FU in Squamous Cell Carcinoma (SCC) of the head and neck (HN).
A clinical Complete Response (CR) rate of 8.5% was achieved after TPF induction
therapy (IT) in patients (pts) with unresectable pharyngolaryngeal SCC (Vermorken
et al, NEJM 2007). EGFR is overexpressed in up to 90% of HN cancers. Cetuximab
(Cet) was active in combination with radiotherapy and with cisplatin. The aim of this
multicenter single-arm phase II study was to evaluate Cet with TPF as IT in
oropharyngeal SCC.
Methods: Main inclusion criteria were: previously untreated histologically proven
oropharyngeal SCC, non-metastatic stage III or IV disease (UICC 2002), surgically
resectable, age 18-75 years, ECOG Performance Status (PS) 0-1. Pts received Cet iv
/1-2h (400 mg/m 2 loading dose, then weekly 250 mg/m 2 ) followed by docetaxel iv
75mg/m 2 /1h and cisplatin iv 75mg/m 2 /1h (day 1); and 5-FU iv 750mg/m 2 /day
continuously (days 1-5), every 3 weeks for 3 courses. After completion of IT, the
treatment of the primitive tumor was at the investigator’s discretion. The primary
endpoint was the clinical and radiological CR of primitive tumor at 3 months.
Correlative studies investigated several EGFR-related biomarkers and HPV analyses
in tumor and blood samples.
Results: Among 42 pts enrolled from 07/2008 to 11/2011 in 9 centers, 41 pts were
treated. The main pts characteristics were: male 81%, mean age 56y, PS0 79%, tonsil
area 88%, stage III/IV 76%/24%. The planned 9 infusions were given in 31 (76%)
pts. A clinical and radiological CR of the primitive tumor at 3 months was achieved
in 9 (22%) pts, and a clinical CR in 17 (41%) pts. The most frequent G3-4 toxicities
were: neutropenia (39%), febrile neutropenia (20%), diarrhea (10%), and mucositis
(12%). Any grade acnea-like syndrome was observed in 18 (44%) pts. One toxic
death occurred secondary to chemo-induced colitis with colonic perforation.
Conclusions: The combination of cetuximab with TPF is highly active. A systematic
therapy with granulocyte colony-stimulating factor is necessary to prevent febrile
neutropenia.
Disclosure: All authors have declared no conflicts of interest.
Annals of Oncology
1037P DOCETAXEL, CARBOPLATIN AND FLUORO-URACIL (TCF)
INDUCTION THERAPY IN LOCALLY ADVANCED HEAD AND
NECK SQUAMOUS CELL CARCINOMA (HNSCC) PATIENTS
WITH CONTRAINDICATION FOR CISPLATIN BASED
COMBINATION (TPF)
E. Saada 1 , F.R. Ferrand 1 , M. Fekih 2 , D. Hamdan 1 , F. Janot 1 , S. Temam 2 ,
M. Julieron 1 , A.M. Leridant 1 , A. Schilf 1 , J. Guigay 1
1 Head and Neck Departement, Institut Gustave Roussy, Villejuif, FRANCE, 2 Head
and Neck, Institut Gustave Roussy, Villejuif, FRANCE
Background: TPF regimen is a standard induction combination for fit locally
advanced HNSCC patients (pts). TCF with carboplatin may be an option in frail pts
with contraindication for cisplatin, but data are missing about safety and efficacy of
such an approach.
Method: Retrospective study of monocentric cohort of HNSCC patients treated from
2007 to 2011 with TCF induction regimen at Gustave Roussy Institute. TCF regimen
combined Docetaxel 75mg/m 2 , Carboplatin AUC4, and 5FU: 750 mg/m 2 /day for
5days.
Results: Population included 34 pts, median age 59 years (44-78), all with Charlson
Comorbidity Index score ≥ 2, with oropharynx, hypopharynx, oral cavity, larynx
and paranasal sinuses HNSCC localization (32.3, 23.5, 17.6, 14.7 and 11.8%
respectively). TNM stage were: T1-2 : 4 pts (11.7%), T3-4: 27 pts (79.4%), rTx: 3
pts (8.8%); N0: 8 pts (23.5%), N1: 4 pts (11.8%), N2a-N2b: 6 pts (17.6%), N2c-N3:
13 pts (38.2%); M1: 1 pt (2.9%). TPF contraindications were respiratory disease
(di.) (11 pts: 32.3%), heart di. (6 pts: 17.6%), liver di. (3 pts: 8.8%), alcohol related
neuropathy (3 pts: 8.8%), hearing di. (5 pts: 14.7%), renal di. (5 pts: 14.7%), other
co-morbidities (3 pts: 8.8%).Patients received 2 to 4 cycles of TCF. GCSF was
delivered in 31 pts (91.2%). Cumulated incidence of Grade 3-4 toxicity was 37.2%,
and one toxic death occurred at C2. Five pts (14.7%) stopped treatment because of
toxicity. RECIST evaluation found complete response in 1 patient (2.9%), partial
response in 23 pts (67.6%), stable disease in 6 pts (17.7%), and progression disease
in 1 pt (2.9%). Subsequent treatment was surgery followed by radiotherapy (9 pts,
26.5%), radiotherapy or chemoradiotherapy (22 pts, 64.7%), chemotherapy (3 pts,
8.8%). Response after RT was: CR: 16 pts (64%), PR: 4 pts (16 %), SD: 3 pts (12
%), PD: 2 pts (8 %). Median recurrence-free survival was 8.7 months, median
overall survival (OS): 22.9 months. Personal history of cancer (HR = 4.6, p = 0.02),
tobacco (HR = 37.5, p = 0.04), alcohol intake (HR = 0.12, p = 0.01), hypertension (
HR = 4.4, p = 0.01), T4 stage ( HR = 0.1, p = 0.02), N2c-N3 stage (HR = 18.5, p =
0.003), BMI < 20 (HR = 9.6, p = 0.02) and lymphopenia (HR = 4.3, p = 0.01) were
associated with OS in multivariate analysis.
Conclusion: TCF induction regimen was manageable and provided objective
responses in 70% of frail HNSCC patients.
Disclosure: All authors have declared no conflicts of interest.
1038P INDUCTION CHEMOTHERAPY WITH DOCETAXEL,
CISPLATIN AND 5-FLUOROURACIL FOLLOWED BY
RADIOTHERAPY WITH CETUXIMAB FOR LOCALLY
ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD
AND NECK
F. Keil 1 , E. Selzer 2 , A. Berghold 3 , K. Kapp 4 , A. De Vries 5 , R. Greil 6 , S. Reinisch 7 ,
W. Anderhuber 8 , M. Burian 9 , G.V. Kornek 10
1 Internal Medicine, Hanusch Krankenhaus, Vienna, AUSTRIA, 2 University Clinic of
Radiation Therapy and Radiation Biology, Medical University Vienna, Vienna,
AUSTRIA, 3 Institute for Med. Informatics, Statistics and Documentation, Institute
for Med. Informatics, Statistics and Documentation, Graz, AUSTRIA, 4 Radiation
Therapy - Radiooncology, University Clinic, Graz, AUSTRIA, 5 Radiation Therapy,
LKH Feldkirch, Feldkirch, AUSTRIA, 6 Internal Medicine III, University Hospital
Salzburg, Salzburg, AUSTRIA, 7 Clinical Departement of General Hnc, Medical
University Graz, Graz, AUSTRIA, 8 Departement of HNC, LKH Leoben, Leoben,
AUSTRIA, 9 HNC Departement, Hospital of Barmherzigen Schwestern, Linz,
AUSTRIA, 10 Oncology, Medical University of Vienna, Vienna, AUSTRIA
Purpose: To determine the efficacy and feasibility of induction chemotherapy with
docetaxel, cisplatin and 5-fluorouracil followed by radiotherapy and cetuximab in
patients with locally advanced head and neck cancer.
Patients and methods: Forty-nine previously untreated patients (median age: 53
years) with local advanced stage III and IV squamous cell carcinoma of the head and
neck received three courses of induction chemotherapy consisting of docetaxel 75
mg/m 2 day 1, cisplatin 75 mg/m 2 day 1, and infusional 5-Fluorouracil 750 mg/m 2 /
day on days 1-5 followed by radiotherapy plus cetuximab at 250mg/m 2 /week (after
an initial loading dose of 400mg/m 2 ). Patients with an ECOG performance score of 0
or 1 without severe co-morbidities adequate hematopoietic, hepatic, and renal
functions were eligible.
Results: After completion of induction chemotherapy 44 of 49 patients received
radiotherapy plus cetuximab. In 45 patients ICT was delivered without delay or dose
ix340 | Abstracts Volume 23 | Supplement 9 | September 2012