Helbling, D.; Bodoky, G.; Gautschi, O.; Sun, H.; Bosman, F.; Gloor, Beat; Burkhard, R.; Winterhalder, R.; Madlung, Axel; Rauch, Daniel; Saletti, P.; Widmer, L.; Borner, M.; Baertschi, D.; Yan, P.; Benhattar, J.; Leibundgut, Elisabeth O.; Bougel, S.; Koeberle, D. (2013). Neoadjuvant chemoradiotherapy with or without panitumumab in patients with wild-type KRAS, locally advanced rectal cancer (LARC): a randomized, multicenter, phase II trial SAKK 41/07. Annals of oncology, 24(3), pp. 718-725. Oxford University Press 10.1093/annonc/mds519
|
Text
mds519.pdf - Published Version Available under License Publisher holds Copyright. Download (179kB) | Preview |
BACKGROUND
We conducted a randomized, phase II, multicenter study to evaluate the anti-epidermal growth factor receptor (EGFR) mAb panitumumab (P) in combination with chemoradiotherapy (CRT) with standard-dose capecitabine as neoadjuvant treatment for wild-type KRAS locally advanced rectal cancer (LARC).
PATIENTS AND METHODS
Patients with wild-type KRAS, T3-4 and/or N+ LARC were randomly assigned to receive CRT with or without P (6 mg/kg). The primary end-point was pathological near-complete or complete tumor response (pNC/CR), defined as grade 3 (pNCR) or 4 (pCR) histological regression by Dworak classification (DC).
RESULTS
Forty of 68 patients were randomly assigned to P + CRT and 28 to CRT. pNC/CR was achieved in 21 patients (53%) treated with P + CRT [95% confidence interval (CI) 36%-69%] versus 9 patients (32%) treated with CRT alone (95% CI: 16%-52%). pCR was achieved in 4 (10%) and 5 (18%) patients, and pNCR in 17 (43%) and 4 (14%) patients. In immunohistochemical analysis, most DC 3 cells were not apoptotic. The most common grade ≥3 toxic effects in the P + CRT/CRT arm were diarrhea (10%/6%) and anastomotic leakage (15%/4%).
CONCLUSIONS
The addition of panitumumab to neoadjuvant CRT in patients with KRAS wild-type LARC resulted in a high pNC/CR rate, mostly grade 3 DC. The results of both treatment arms exceeded prespecified thresholds. The addition of panitumumab increased toxicity.
Actions (login required)
 |
Edit item |