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| © 2009 Elsevier Ltd. All rights reserved. |
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Joint ECCO 15 - 34TH ESMO
Multidisciplinary Congress
BERLIN, 20 - 24 SEPTEMBER 2009
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Abstract P-8516:
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| A phase 2 randomized trial of radiotherapy (RT) plus panitumumab compared to chemoradiotherapy in patients with unresected, locally advanced squamous cell carcinoma of the head and neck (SCCHN): interim pooled safety analysis |
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Citation: European Journal of Cancer Supplements, Vol 7 No 2, September 2009, Page 475
J. Giralt1, J.M. Trigo2, S. Nuyts3, M. Ozsahin4, A.B. Markowitz5, J. Daisne6, K. Skladowski7, C. Lonchay8, P. Holeckova9, M. Smitt10
1Hospital Vall d'Hebron Passeig, Department of Radiotherapy, Barcelona, Spain
2Hospital Virgen de la Victoria, Medical Oncology, Málaga, Spain
3University Hospitals Gasthuisberg, Radiotherapy, Leuven, Belgium
4Centre Hospitalier Universitaire Vaudois, Service de Radio-Oncologie, Lausanne, Switzerland
5University of Texas Medical Branch, Comprehensive Cancer Center, Galveston Texas, USA
6Clinique Ste. Elisabeth, Radiotherapy, Namur, Belgium
7Centrum Onkologii Instytut M. Sklodowskiej-Curie, Radiation Oncology, Gliwice, Poland
8Grand Hôpital de Charleroi, Oncology Department, Charleroi, Belgium
9University Hospital Na Bulovce, Institut of Radiation Oncology, Prague 8, Czech Republic
10Amgen Inc., Oncology, Thousand Oaks CA, USA
Background: Panitumumab (pmab), a fully human monoclonal antibody against the epidermal growth factor receptor (EGFR), is indicated as monotherapy for treatment of metastatic colorectal cancer. This ongoing study is designed to assess the efficacy and safety of pmab in combination with radiotherapy (PRT) compared to chemoradiotherapy (CRT) as initial treatment of unresected, locally advanced SCCHN (ClinicalTrials.gov Identifier: NCT00547157).
Methods: This is a phase 2, open-label, randomized, multicenter study. Eligible patients (pts) were randomized 2:3 to receive cisplatin 100 mg/m2 on days 1 and 22 of RT or pmab 9.0 mg/kg on days 1, 22, and 43. Accelerated RT (70 to 72 Gy – delivered over 6 to 6.5 weeks) was planned for all pts and was delivered either by intensity-modulated radiation therapy (IMRT) modality or by three-dimensional conformal (3D-CRT) modality. The primary endpoint is local-regional control (LRC) rate at 2 years. Key secondary endpoints include PFS, OS, and safety. An external, independent data monitoring committee conducts planned safety and efficacy reviews during the course of the trial.
Results: Pooled data from this planned interim safety analysis includes the first 52 of the 150 planned pts; 44 (84.6%) are male; median (range) age is 57 (33–77) years; ECOG PS 0: 65%, PS 1: 35%; 20 (39%) pts received IMRT, and 32 (61%) pts received 3D-CRT. Fifty (96%) pts completed RT, and 50 pts received RT per protocol without a major deviation. The median (range) total RT dose administered was 72 (64–74) Gy. The most common grade ≥ 3 adverse events graded using the CTCAE version 3.0 are shown (Table).
Conclusions: After the interim safety analysis, CONCERT-2 continues per protocol. Study enrollment is estimated to be completed by October 2009.
Table: Most common grade ≥ 3 adverse events1 – safety analysis set (n = 51)
| Adverse Event | Any Grade n (%) | Grade 3 n (%) | Grade 4 n (%) |
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| Dysphagia | 36 (71) | 16 (31) | 3 (6) |
| Mucosal inflammation | 35 (69) | 20 (39) | 3 (6) |
| Odynophagia | 21 (41) | 9 (18) | 0 (0) |
| Radiation-induced skin injury2 | 18 (35) | 9 (18) | 1 (2) |
| Stomatitis | 10 (20) | 5 (10) | 0 (0) |
| Anorexia | 7 (14) | 2 (4) | 0 (0) |
| Febrile neutropenia | 5 (10) | 3 (6) | 2 (4) |
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| 1Three patients experienced any grade 5 AE: 1 cardiac arrest; 1 death; 1 sudden death. 2Any skin toxicities determined to be caused by radiation therapy. |
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