AIMS AND BACKGROUND: In 1990 the National Institutes of Health Consensus Conference recommended adjuvant combined therapy for @entity1 with radically resected @entity5 at high risk for relapse (ie, stage II-III). The purpose of our prospective non-randomized study was to verify the feasibility and effectiveness of postoperative radiochemotherapy in terms of improvement in disease-free and overall survival in this @entity1 subgroup. STUDY DESIGN: From January 1990 to October 1998, 191 consecutive @entity1 with radically resected @entity5 were treated. A total of 159 @entity1 with a 24-month follow-up were assessable for @entity137 and survival. Anterior resection was performed in 129 (81%) and abdomino-perineal resection in 30 (19%) @entity1 . Fifty-four (34%) stage II and 105 (66%) stage III @entity1 entered the study. Within 45-60 days of surgery, all @entity1 received @entity1487 chemotherapy at the dose of 500 mg/m2 as an i.v. bolus on days 1-5, every 4 weeks, for 6 cycles. Chemotherapy cycles III and IV were administered at the same daily dose on radiotherapy days 1-3 and 29-31. Radiotherapy consisted of 45 Gy/25 fractions plus a boost dose of 5.4 Gy. RESULTS: After a median follow-up of 57 months (range, 25-123), overall recurrent disease was reported in 58 (36%) @entity1 : local, systemic, and both local and systemic relapses in 12 (8%), 37 (23%) and 9 (6%) cases, respectively. According to local extension, recurrence rates were 15% and 48% in stage II and III, respectively. Five-year overall and disease-free survival were 71% and 66%, respectively. Overall survival was 87% in stage II and 62% in stage III @entity1 , and disease-free survival was 84% and 56% in stage II and III disease, respectively. According to univariate and multivariate analyses, significant prognostic factors for @entity5 control were: stage (II vs III, P <0.001), the number of involved nodes (< or = 3 vs > 3, P <0.0001), and no extracapsular node invasion (P <0.0001). The recommended dose of the combined radiochemotherapy regimen was generally well tolerated. The incidence of any > or = grade 3 acute @entity137 (according to the WHO scale) was 13% @entity294 , 11% proctitis, 5% perineal @entity1909 and 4% myelosuppression. Four (3%) @entity1 had radiotherapy-related severe late @entity137 which required surgery. CONCLUSIONS: The study provided recurrence rates and survival similar to other adjuvant radiochemotherapy regimens published in the literature. However, in view of the low 5-year survival rate recorded in stage III @entity1 , a different approach should be investigated.

Adjuvant radiochemotherapy in high-risk XXXX results of a prospective non-randomized study.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity5 :: ('MESH:D009369', 'Disease') :: ['better tumor', 'stage II-III rectal cancer', 'rectal cancer'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity1909 :: ('MESH:D003872', 'Disease') :: ['dermatitis'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['5-fluorouracil']
@entity5 :: (MESH:D009369,Disease) :: ['rectal cancer']
