Final results of AGITG ATTAX3 study: Randomized phase II study of weekly docetaxel (T), cisplatin, and fluoropyrimidine (F) with or without panitumumab (P) in advanced esophagogastric (OG) cancer.

Medientyp: E-Artikel
Titel: Final results of AGITG ATTAX3 study: Randomized phase II study of weekly docetaxel (T), cisplatin, and fluoropyrimidine (F) with or without panitumumab (P) in advanced esophagogastric (OG) cancer
Beteiligte: Tebbutt, Niall C.; Price, Timothy Jay; Sjoquist, Katrin Marie; Veillard, Anne-Sophie; Hall, Merryn; Ferraro, Danielle Angela; Wong, Nicole; Pavlakis, Nick; Strickland, Andrew; Varma, Suresh Chandra; Cooray, Prasad; Young, Rosemary; Underhill, Craig; Shannon, Jennifer Anne; Ganju, Vinod; Gebski, Val
Erschienen: American Society of Clinical Oncology (ASCO), 2013
Erschienen in: Journal of Clinical Oncology
Sprache: Englisch
DOI: 10.1200/jco.2013.31.15_suppl.4081
ISSN: 0732-183X; 1527-7755
Schlagwörter: Cancer Research ; Oncology
Entstehung:
Anmerkungen:
Beschreibung: <jats:p> 4081 </jats:p><jats:p> Background: This randomized phase II study evaluated the efficacy and safety of P, a fully human mAb against the epidermal growth factor receptor combined with T-based chemotherapy in advanced OG cancer. Methods: Eligible pts had histologically confirmed metastatic OG cancer (adeno-carcinoma and squamous cell carcinoma) were ≥18 years of age, PS 0-2, with adequate renal, haematologic and liver function with measurable disease. All pts provided informed consent. Selection was not based on kras determination. Pts received T 30mg/m<jats:sup>2</jats:sup> d1,8, C 60mg/m<jats:sup>2</jats:sup> d1 and F; investigator choice of 5FU infusion 160mg/m<jats:sup>2</jats:sup>/d or capecitabine 500mg/m<jats:sup>2</jats:sup>bd continuous ±P 9 mg/kg d1 q3w. Treatment was administered for 8 cycles or until PD. The primary endpoint was response rate according to RECIST (1.1) assessed q6w. Planned enrolment target was 100 pts. Stratification variables included histology, PS and choice of F. Results: From April 2010 to November 2011, 77 pts were enrolled from 15 institutions. A safety alert from the REAL3 study (also involving P in OG cancer) prompted an unplanned review of data from ATTAX3 by the IDMC. The IDMC found no evidence of adverse outcomes associated with P, but as it did not appear that P would significantly improve efficacy, they recommended cessation of the study to new enrolment. Previously enrolled pts were treated and followed according to protocol. Median follow up is 24m. Treatment arms were well balanced; median age 59, 64y, male 77%, 87%, PS0-1 95%,90%, adenocarcinoma 90%,90%, capecitabine 67%, 66% for TCF/TCF-P, respectively. Common grade 3/4 toxicities include infection 18%,24%, febrile neutropenia 10%, 5%, anorexia 10%, 24%, nausea 18%,30%, stomatitis 3%,5%, diarrhoea 15%,24% , acneiform rash 0%, 8%, fatigue 18%, 30%, hypomagnesemia 10%, 16% for TCF/TCF-P. Efficacy outcomes are summarized in Table. Conclusions: The addition of P to T-based chemotherapy in advanced OG cancer did not improve efficacy and was associated with an increase in some toxicities. Clinical trial information: ACTRN12609000109202. [Table: see text] </jats:p>
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