Konference: 2009 34st Congress ESMO a 15th Congress ECCO - účast ČR
Kategorie: Nádory hlavy a krku
Téma: Poster Session III: Head and neck cancer
Číslo abstraktu: P-8516
Autoři: J. Giralt; J.M. Trigo; S. Nuyts; M. Ozsahin; A.B. Markowitz; J. Daisne; K. Skladowski; C. Lonchay; Mgr. et MUDr. Petra Holečková, Ph.D., MBA; M. Smitt
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 ¨C 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¨C77) 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¨C74) Gy. The most common grade ˇÝ 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.
Publikováno v: European Journal of Cancer Supplements, Vol 7 No 2, September 2009, Page 475
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 ¨C 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¨C77) 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¨C74) Gy. The most common grade ˇÝ 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.
Publikováno v: European Journal of Cancer Supplements, Vol 7 No 2, September 2009, Page 475
Datum přednesení příspěvku: 22. 9. 2009
