Vol 25, No 6 (2020)
Original research articles
Published online: 2020-11-01

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Neoadjuvant chemotherapy with or without oxaliplatin after short-course radiotherapy in high-risk rectal cancer: A subgroup analysis from a prospective study

Ewa Kosakowska1, Lucyna Pietrzak2, Wojciech Michalski3, Lucyna Kepka4, Wojciech Polkowski5, Malgorzata Jankiewicz6, Bogumila Cisel5, Jacek Krynski1, Jacek Zwolinski1, Lucjan Wyrwicz7, Andrzej Rutkowski1, Roman Stylinski8, Grzegorz Nawrocki9, Rafal Sopylo9, Marek Szczepkowski10, Wieslaw Tarnowski11, Krzysztof Bujko2
DOI: 10.1016/j.rpor.2020.08.002
Rep Pract Oncol Radiother 2020;25(6):1017-1022.

Abstract

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.

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