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Forschungsdatenbank PMU-SQQUID

Preoperative oxaliplatin, capecitabine, and external beam radiotherapy in patients with newly diagnosed, primary operable, cT₃NxM0, low rectal cancer: a phase II study.
Ofner, D; Devries, AF; Schaberl-Moser, R; Greil, R; Rabl, H; Tschmelitsch, J; Zitt, M; Kapp, KS; Fastner, G; Keil, F; Eisterer, W; Jäger, R; Offner, F; Gnant, M; Thaler, J;
Strahlenther Onkol. 2011; 187(2): 100-107.
Originalarbeiten (Zeitschrift)

PMU-Autor/inn/en

Fastner Gerd
Greil Richard
Mlineritsch Brigitte
Moik Martin
Öfner-Velano Dietmar
Pleyer Lisa
Russ Gudrun
Sedlmayer Felix

Abstract

Purpose: In patients with locally advanced rectal cancer (LARC), preoperative chemoradiation is known to improve local control, and down-staging of the tumor serves as a surrogate for survival. Intensification of the systemic therapy may Lead to higher down-staging rates and, thus, enhance survival. This phase II study investigated the efficacy and safety of preoperative capecitabine and oxaliplatin in combination with radiotherapy. Patients and Methods: Patients with LARC of the mid and lower rectum, T3NxMO staged by MRI received radiotherapy (total dose 45 Gy) in combination with oral capecitabine (825 mg/m(2) twice a day on radiotherapy days; weeks 1-4) and oxaliplatin 50 mg/m2 intravenously (days 1, 8, 15, and 22). Efficacy was evaluated as rate of tumor down-categorization at the T level. Results: A total of 59 patients were enrolled (19 women, 40 men; median age of 61 years) and all were evaluable for efficacy and toxicity. Down-categorization at the T level was observed in 53% with pathological complete response in 6 patients (10%). Actual total radiotherapy, oxaliplatin and capecitabine doses received were 97%, 90%, and 93% of the protocol-specified preplanned doses, respectively. Grade 3/4 toxicity was observed in 15 patients (25%). The most frequent was diarrhea (12%). Conclusions: Preoperative chemoradiation with capecitabine and oxaliplatin is feasible in patients with MRI-proven cT3 LARC. The only clinically relevant toxicity was diarrhea. Overall, efficacy of the multimodality treatment was good, but not markedly exceeding that of 5-FU- or capecitabine-based chemoradiation approaches.


Useful keywords (using NLM MeSH Indexing)

Adenocarcinoma/drug therapy*

Adenocarcinoma/pathology

Adenocarcinoma/radiotherapy*

Adenocarcinoma/surgery

Administration, Oral

Adult

Aged

Antineoplastic Combined Chemotherapy Protocols/therapeutic use*

Antineoplastic Combined Chemotherapy Protocols/toxicity

Combined Modality Therapy

Deoxycytidine/administration*

dosage

Deoxycytidine/adverse effects

Deoxycytidine/analogs*

derivatives

Dose-Response Relationship, Drug

Drug Administration Schedule

Feasibility Studies

Female

Fluorouracil/administration*

dosage

Fluorouracil/adverse effects

Fluorouracil/analogs*

derivatives

Humans

Infusions, Intravenous

Male

Middle Aged

Neoadjuvant Therapy/methods*

Neoplasm Invasiveness/pathology

Neoplasm Staging

Organoplatinum Compounds/administration*

dosage

Organoplatinum Compounds/adverse effects

Radiotherapy, Conformal

Rectal Neoplasms/drug therapy*

Rectal Neoplasms/pathology

Rectal Neoplasms/radiotherapy*

Rectal Neoplasms/surgery

Treatment Outcome


Find related publications in this database (Keywords)

Rectal cancer
Chemoradiation
Capecitabine
Oxaliplatin