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

Author:

Brændengen Morten1,Tveit Kjell M.1,Berglund Åke1,Birkemeyer Elke1,Frykholm Gunilla1,Påhlman Lars1,Wiig Johan N.1,Byström Per1,Bujko Krzysztof1,Glimelius Bengt1

Affiliation:

1. 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...

Abstract

PurposePreoperative 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 MethodsThe 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).ResultsThe 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.ConclusionCRT 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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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