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Ann Oncol. 2015 Aug;26(8):1722-8. doi: 10.1093/annonc/mdv223. Epub 2015 May 8.

Chemoradiation, surgery and adjuvant chemotherapy versus induction chemotherapy followed by chemoradiation and surgery: long-term results of the Spanish GCR-3 phase II randomized trial†.

Author information

1
Department of Medical Oncology, Valencian Institute of Oncology, Valencia, Spain cfmartos@fivo.org.
2
Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, USA.
3
Department of Medical Oncology, Parc Taulí Hospital, Sabadell.
4
Department of Medical Oncology, Clinic Hospital, Barcelona.
5
Department of Medical Oncology, La Fe University Hospital, Valencia.
6
Department of Medical Oncology, Del Mar Hospital, Barcelona.
7
Department of Medical Oncology, General University Hospital, Valencia.
8
Department of Medical Oncology, Arnau de Vilanova Hospital, Lleida.
9
Department of Medical Oncology, Navarra Hospital, Pamplona.
10
Department of Medical Oncology, General Hospital, Alicante.
11
Department of Medical Oncology, Lozano Blesa Hospital, Zaragoza.
12
Department of Medical Oncology, Miguel Servet Hospital, Zaragoza.
13
Department of Medical Oncology, Pesset Hospital, Valencia.
14
Department of Medical Oncology, Santa Creu y Sant Pau Hospital, Barcelona, Spain.
15
Division of Radiation Oncology, MD Anderson Hospital, Houston, USA.

Abstract

BACKGROUND:

The primary results of our phase II randomized trial suggested that compared with conventional preoperative chemoradiation (CRT), the addition of chemotherapy (CT) before CRT and surgery allows most patients receive their planned treatment with a better toxicity profile without compromising the pathological complete response and complete resection rates. We now report the 5-year outcomes.

PATIENTS AND METHODS:

Patients with distal or middle third, T3-T4 and/or N+ rectal adenocarcinoma selected by magnetic resonance imaging, were randomly assigned to arm A-preoperative CRT followed by surgery and four cycles of postoperative adjuvant capecitabine and oxaliplatin (CAPOX)-or arm B-four cycles of CAPOX followed by CRT and surgery. The following 5-year actuarial outcomes were assessed: the cumulative incidence of local relapse (LR) and distant metastases (DM), disease-free (DFS) and overall survival (OS).

RESULTS:

A total of 108 eligible patients were randomly assigned to arm A (n = 52) or arm B (n = 56). With a median follow-up of 69.5 months, 5-year DFS was 64% in arm A and 62% in arm B (P = 0.85) and 5-year OS was 78% in arm A and 75% in arm B (P = 0.64). The 5-year cumulative incidence of LR was 2% and 5% (P = 0.61) and 5-year cumulative incidence of DM was 21% and 23%; (P = 0.79) in arms A and B, respectively.

CONCLUSION:

Both treatment approaches yield similar outcomes. Given the lower acute toxicity and improved compliance with induction CT compared with adjuvant CT, integrating effective systemic therapy before CRT and surgery is a promising strategy and should be examined in phase III trials.

KEYWORDS:

induction chemotherapy; locally advanced rectal cancer; phase II randomized trial, adjuvant chemotherapy

PMID:
25957330
DOI:
10.1093/annonc/mdv223
[Indexed for MEDLINE]

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