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Aim: To evaluate the role of oxaliplatin in neoadjuvant chemotherapy delivered after short-course irradiation., Background: Using oxaliplatin in the above setting is uncertain., Patients and Methods: A subgroup of 136 patients managed by short-course radiotherapy and 3 cycles of consolidation chemotherapy within the framework of a randomised study was included in this post-hoc analysis. Sixty-seven patients received FOLFOX4 (oxaliplatin group) while oxaliplatin was omitted in the second period of accrual in 69 patients because of protocol amendment (fluorouracil-only group)., Results: Grade 3+ acute toxicity from neoadjuvant treatment was observed in 30% of patients in the oxaliplatin group vs. 16% in the fluorouracil-only group ( p  = 0.053). The corresponding proportions of patients having radical surgery or achieving complete pathological response were 72% vs. 77% (odds ratio [OR] = 0.88; 95% confidence interval [CI]: 0.39-1.98; p  = 0.75) and 15% vs. 7% (OR = 2.25; 95% CI: 0.83-6.94; p  = 0.16), respectively. The long-term outcomes were similar in the two groups. Overall and disease-free survival rates at 5 years were 63% vs. 56% ( p  = 0.78) and 49% vs. 44% ( p  = 0.59), respectively. The corresponding numbers for cumulative incidence of local failure or distant metastases were 33% vs. 38% (hazard ratio [HR] = 0.89; 95% CI: 0.52-1.52; p  = 0.68) and 33% vs. 33% (HR = 0.78; 95% CI: 0.43-1.40; p  = 0.41), respectively., Conclusion: Our findings do not support adding oxaliplatin to three cycles of chemotherapy delivered after short-course irradiation., Competing Interests: None, (© 2020 Greater Poland Cancer Centre. Published by Elsevier B.V. All rights reserved.)

Purpose: To present an interim analysis of the trial comparing two neoadjuvant therapies for unresectable rectal cancer., Methods: Patients with fixed cT3 or cT4 or locally recurrent rectal cancer without distant metastases were randomized to either 5 × 5 Gy and 3 courses of FOLFOX4 (schedule I) or 50.4 Gy delivered in 28 fractions given simultaneously with 5-Fu, leucovorin and oxaliplatin (schedule II). Surgery in both groups was performed 12 weeks after the beginning of radiation and 6 weeks after neoadjuvant treatment., Results: 49 patients were treated according to schedule I and 48 according to schedule II. Grade III+ acute toxicity was observed in 26% of patients in group I and in 25% in group II. There were two toxic deaths, both in group II. The microscopically radical resection (primary endpoint) rate was 73% in group I and 71% in group II. Overall and severe postoperative complications were recorded in 27% and 9% of patients vs. 16% and 7%, respectively. Pathological complete response was observed in 21% of the patients in group I and in 9% in group II., Conclusions: The interim analysis revealed no major differences in acute toxicity and local efficacy between the two evaluated strategies., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)