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
| Autor: | Lucas Widmer, Elisabeth Oppliger Leibundgut, Daniela Baertschi, D. Helbling, Axel Madlung, H. Sun, F. Bosman, Markus Borner, R. Burkhard, Daniel Rauch, Ralph Winterhalder, Dieter Koeberle, György Bodoky, Beat Gloor, Piercarlo Saletti, O. Gautschi, Pu Yan, S. Bougel, Jean Benhattar |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Diarrhea Male Oncology medicine.medical_specialty Colorectal cancer medicine.medical_treatment DNA Mutational Analysis Phases of clinical research 610 Medicine & health Adenocarcinoma medicine.disease_cause Deoxycytidine Gastroenterology Proto-Oncogene Proteins p21(ras) Capecitabine Proto-Oncogene Proteins Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Panitumumab Neoadjuvant therapy Aged Neoplasm Staging Aged 80 and over Rectal Neoplasms business.industry Surrogate endpoint Antibodies Monoclonal Chemoradiotherapy Hematology Middle Aged medicine.disease Neoadjuvant Therapy Treatment Outcome ras Proteins Female Fluorouracil KRAS business medicine.drug |
| Zdroj: | 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 |
| ISSN: | 0923-7534 |
| DOI: | 10.1093/annonc/mds519 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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