This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Brændengen, M. Articles by Glimelius, B. Search for Related Content PubMed PubMed Citation Articles by Brændengen, M. Articles by Glimelius, B. Pubmed/NCBI databases Compound via MeSH Substance via MeSH Hazardous Substances DB FLUOROURACIL LEUCOVORIN Social Bookmarking                            What's this?

Randomized Phase III Study Comparing Preoperative Radiotherapy With Chemoradiotherapy in Nonresectable Rectal Cancer

Morten Brændengen, Kjell M. Tveit, Åke Berglund, Elke Birkemeyer, Gunilla Frykholm, Lars Påhlman, Johan N. Wiig, Per Byström, Krzysztof Bujko, Bengt Glimelius

From the Departments of Medical Oncology and Surgery, Norwegian Radium Hospital; Ullevål University Hospital, Cancer Centre, Oslo, Norway; University of Oslo, Oslo; Division of Hematology and Oncology, Stavanger University Hospital, Stavanger; Department of Oncology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Oncology and Pathology, Karolinska Institutet, Stockholm; Department of Oncology, Radiology, and Clinical Immunology, University of Uppsala; Department of Surgery, Uppsala University Hospital, Uppsala, Sweden; and the Department of Radiotherapy, M. Sklodowska-Curie Memorial, Warsaw, Poland

Corresponding author: Morten Braendengen, MD, Ullevål University Hospital, Cancer Centre, 0407 Oslo, Norway; e-mail: morten.braendengen{at}ulleval.no

Purpose Preoperative chemoradiotherapy is considered standard treatment for locally advanced rectal cancer, although the scientific evidence for the chemotherapy addition is limited. This trial investigated whether chemotherapy as part of a multidisciplinary treatment approach would improve downstaging, survival, and relapse rate.

Patients and Methods The randomized study included 207 patients with locally nonresectable T4 primary rectal carcinoma or local recurrence from rectal carcinoma in the period 1996 to 2003. The patients received either chemotherapy (fluorouracil/leucovorin) administered concurrently with radiotherapy (50 Gy) and adjuvant for 16 weeks after surgery (CRT group, n = 98) or radiotherapy alone (50 Gy; RT group, n = 109).

Results The two groups were well balanced according to pretreatment characteristics. An R0 resection was performed in 82 patients (84%) in the CRT group and in 74 patients (68%) in the RT group (P = .009). Pathologic complete response was seen in 16% and 7%, respectively. After an R0 + R1 resection, local recurrence was found in 5% and 7%, and distant metastases in 26% and 39%, respectively. Local control (82% v 67% at 5 years; log-rank P = .03), time to treatment failure (63% v 44%; P = .003), cancer-specific survival (72% v 55%; P = .02), and overall survival (66% v 53%; P = .09) all favored the CRT group. Grade 3 or 4 toxicity, mainly GI, was seen in 28 (29%) of 98 and six (6%) of 109, respectively (P = .001). There was no difference in late toxicity.

Conclusion CRT improved local control, time to treatment failure, and cancer-specific survival compared with RT alone in patients with nonresectable rectal cancer. The treatments were well tolerated.

Supported by the Swedish Cancer Society, Stockholm Cancer Society, and the Norwegian Cancer Society and through the regional agreement on medical training and clinical research between Stockholm county council and the Karolinska Institutet.

Presented in part at the 13th Annual European Cancer Conference, October 30–November 3, 2005, Paris, France.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				M. I. Koukourakis, A. Giatromanolaki, H. Sheldon, F. M. Buffa, G. Kouklakis, I. Ragoussis, E. Sivridis, A. L. Harris, and for the Tumour and Angiogenesis Research Group Phase I/II Trial of Bevacizumab and Radiotherapy for Locally Advanced Inoperable Colorectal Cancer: Vasculature-Independent Radiosensitizing Effect of Bevacizumab Clin. Cancer Res., November 15, 2009; 15(22): 7069 - 7076. [Abstract] [Full Text] [PDF]

				M. Kusters, V. Valentini, F. A. Calvo, R. Krempien, G. A. Nieuwenhuijzen, H. Martijn, G. B. Doglietto, E. del Valle, F. Roeder, M. W. Buchler, et al. Results of European pooled analysis of IORT-containing multimodality treatment for locally advanced rectal cancer: adjuvant chemotherapy prevents local recurrence rather than distant metastases Ann. Onc., November 4, 2009; (2009) mdp501v1. [Abstract] [Full Text] [PDF]