Preoperative Radiotherapy of Advanced Rectal Cancer With Capecitabine and Oxaliplatin With or Without Cetuximab: A Pooled Analysis of Three Prospective Phase I-II Trials
- Departments of Radiation Therapy and Oncology, Goethe University, Frankfurt am Main (Germany)
- Departments of Haematology and Oncology, Martin-Luther University Halle-Wittenberg (Germany)
- Department of Radiation Oncology, Martin-Luther University Halle-Wittenberg (Germany)
- Departments of General and Visceral Surgery, Georg-August University, Goettingen (Germany)
- Department of Radiation Oncology, University of Regensburg, Regensburg (Germany)
- Department of Radiation Oncology, Friedrich-Alexander University, Erlangen (Germany)
- WiSP, Research Institute Pharma GmbH, Langenfeld (Germany)
Purpose: A pooled analysis of three prospective trials of preoperative radiochemotherapy (RCT) for rectal cancer by using oxaliplatin and capecitabine with or without cetuximab was performed to evaluate the impact of additional cetuximab on pathologic complete response (pCR) rates and tumor regression (TRG) grades. Methods and Materials: Of 202 patients, 172 patients met the inclusion criteria (primary tumor stage II/III, M0). All patients received concurrent RCT, and 46 patients received additional cetuximab therapy. A correlation of pretreatment clinicopathologic factors and cetuximab treatment with early pCR rates (TRG > 50%) was performed with univariate and multivariate analyses. Toxicity data were recorded for all patients. Results: Of 172 patients, 24 (14%) patients achieved a pCR, and 84 of 172 (71%) patients showed a TRG of >50% in the surgical specimen assessment after preoperative treatment. Age, gender, and T/N stages, as well as localization of the tumor, were not associated with pCR or good TRG. The pCR rate was 16% after preoperative RCT alone and 9% with concurrent cetuximab therapy (p = 0.32). A significantly reduced TRG of >50% was found after RCT with cetuximab compared to RCT alone (p = 0.0035). This was validated by a multivariate analysis with all available clinical factors (p = 0.0037). Acute toxicity and surgical complications were not increased with additional cetuximab. Conclusions: Triple therapy with RCT and cetuximab seems to be feasible, with no unexpected toxicity. Early response assessment (TRG), however, suggests subadditive interaction. A longer follow-up (and finally randomized trials) is needed to draw any firm conclusions with respect to local and distant failure rates.
- OSTI ID:
- 21436190
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 78, Issue 2; Other Information: DOI: 10.1016/j.ijrobp.2009.07.1718; PII: S0360-3016(09)02826-0; Copyright (c) 2010 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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