|
|
|
| © 2009 Elsevier Ltd. All rights reserved. |
|
|
|
 |
|
|
|
Joint ECCO 15 - 34TH ESMO
Multidisciplinary Congress
BERLIN, 20 - 24 SEPTEMBER 2009
|
|
Abstract P-8514:
|
| SPECTRUM, a phase III trial for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) receiving chemotherapy with or without panitumumab: interim pooled safety analysis |
|
|
| |
Citation: European Journal of Cancer Supplements, Vol 7 No 2, September 2009, Page 474
J. Stöhlmacher1, I. Davidenko2, E. Winquist3, L. Licitra4, K. Skladowski5, T.E. Ciuleanu6, R.R. Kumar7, P. Foa8, J. Gansert9, J.B. Vermorken10
1Universitätsklinikum Carl Gustav Carus, Onkologische Tagesklinik / Onkologisches Forschungslabor, Dresden, Germany
2Krasnodar Regional Oncology Dispensary, Krasnodar, Russian Federation
3London Health Sciences Centre, Dept. of Oncology, London Ontario, Canada
4Istituto Nazionale Tumori, Head and Neck Department, Milano, Italy
5Instytut im. M. Sklodowskiej-Curie, I Klinika Radioterapii, Gliwice, Poland
6Oncology Institute "Ion Chiricuta", Medical Oncology, Cluj Napoca, Romania
7Regional Cancer Centre Medical College Campus, Clinical Oncology, Trivandrum, India
8San Paolo Hospital, Department of Oncology, Milano, Italy
9Amgen Inc., Oncology Therapeutics, Thousand Oaks CA, USA
10Universitair Ziekenhuis Antwerpen, Department of Oncology, Edegem, Belgium
Background: Panitumumab (pmab) is a fully human monoclonal antibody against the epidermal growth factor receptor (EGFR), a therapeutic target in patients (pts) with SCCHN. SPECTRUM is assessing the safety and efficacy of pmab + standard platinum-based chemotherapy (CT) in pts with recurrent and/or metastatic (R/M) disease (ClinicalTrials.gov ID: NCT00460265; sponsor: Amgen Inc).
Methods: This is a global, phase III, open-label study. As of March 2009, the trial has completed enrollment of 658 pts. Pts with R/M SCCHN were randomized (1:1) to receive cisplatin (100 mg/m2) IV on day 1+5 FU (1000 mg/m2) continuous IV daily on days 1–4 Q3W for up to 6 cycles ± pmab (9 mg/kg). Pts receiving pmab without disease progression after 6 cycles may continue pmab monotherapy until disease progression. Substitution of carboplatin (AUC 5) is allowed for specific toxicities. Primary endpoint is overall survival. Key secondary endpoints include progression-free survival, response rate, and safety. This trial is overseen by an independent Data Monitoring Committee (DMC).
AEs of Interesta (N = 446b)
| AE (MedDRA terms) | Any grade, n (%) | Grade 3/4, n (%) |
|---|
| Nausea | 248 (56) | 24 (5) |
| Skin and subcutaneous tissue SOCc | 207 (46) | 31 (7) |
| Neutropenia | 206 (46) | 141 (32) |
| Vomiting | 177 (40) | 23 (5) |
| Stomatitis/mucosal inflammation | 172 (39) | 40 (9) |
| Anemia | 166 (37) | 64 (14) |
| Diarrhea | 143 (32) | 15 (3) |
| Hypomagnesemia | 122 (27) | 27 (6) |
| Fatigue | 111 (25) | 18 (4) |
| Anorexia | 110 (25) | 16 (4) |
| Thrombocytopenia | 91 (20) | 29 (7) |
| Weight decreased | 91 (20) | 5 (1) |
| Leukopenia | 65 (15) | 34 (8) |
| Febrile neutropenia | 29 (7) | 27 (6) |
|
|
| aTreatment-related (CT ± pmab) grade 5 AEs included cardiac/vascular disorders (n = 8), febrile neutropenia/neutropenia-related complications (n = 4), multi-organ/hepatic or renal failure (n = 3), and 1 each of hemorrhagic diarrhea, tumor hemorrhage and aspiration pneumonia; bExcludes 5 pts who did not receive any protocol treatment; cSOC, System organ class |
Results: Pooled data from this interim safety analysis includes the first 451 pts of 650 planned pts; 99% received any study treatment; 86% are male; median age is 58 years (range 26–84); ECOG PS 0/1 = 33%/67%. Median follow-up time is 17.1 weeks; 85% have ended CT. 18 pts (4%) had a grade 5 adverse event (AE) considered to be treatment-related (CT ± pmab). Any AEs of interest occurring in ≥20% of pts or those with grade ≥3 in ≥5% of pts are shown (Table).
Conclusions: After an interim analysis by the DMC of the first 451 pts, SPECTRUM continues per protocol. Enrollment is complete and the study is ongoing.
|
|
|
|