Electronic Resource

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

التفاصيل البيبلوغرافية
العنوان: 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
المؤلفون: Helbling, D., Bodoky, G., Gautschi, O., Sun, H., Bosman, F., Gloor, B., Burkhard, R., Winterhalder, R., Madlung, A., Rauch, D., Saletti, P., Widmer, L., Borner, M., Baertschi, D., Yan, P., Benhattar, J., Leibundgut, E. O., Bougel, S., Koeberle, D.
نوع الوثيقة: Electronic Resource
مستخلص: 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
URL: http://doc.rero.ch/record/303769/files/mds519.pdf
الاتاحة: Open access content. Open access content
ملاحظة: English
Other Numbers: CHRRO oai:doc.rero.ch:303769
999837278
المصدر المساهم: RERO-LIBR NETWORK OF WESTERN SWITZERLAND
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رقم الانضمام: edsoai.ocn999837278
قاعدة البيانات: OAIster