Long-course oxaliplatin-based preoperative chemoradiation versus 5 × 5 Gy and consolidation chemotherapy for cT4 or fixed cT3 rectal cancer: results of a randomized phase III study

K Bujko, L Wyrwicz, A Rutkowski, M Malinowska, L Pietrzak, J Kryński, W Michalski, J Olędzki, J Kuśnierz, L Zając, M Bednarczyk, M Szczepkowski, W Tarnowski, E Kosakowska, J Zwoliński, M Winiarek, K Wiśniowska, M Partycki, K Bęczkowska, W Polkowski, R Styliński, R Wierzbicki, P Bury, M Jankiewicz, K Paprota, M Lewicka, B Ciseł, M Skórzewska, J Mielko, M Bębenek, A Maciejczyk, B Kapturkiewicz, A Dybko, Ł Hajac, A Wojnar, T Leśniak, J Zygulska, D Jantner, E Chudyba, W Zegarski, M Las-Jankowska, M Jankowski, L Kołodziejski, A Radkowski, U Żelazowska-Omiotek, B Czeremszyńska, L Kępka, J Kolb-Sielecki, Z Toczko, Z Fedorowicz, A Dziki, A Danek, G Nawrocki, R Sopyło, W Markiewicz, P Kędzierawski, J Wydmański
Annals of Oncology: Official Journal of the European Society for Medical Oncology 2016, 27 (5): 834-42

BACKGROUND: Improvements in local control are required when using preoperative chemoradiation for cT4 or advanced cT3 rectal cancer. There is therefore a need to explore more effective schedules.

PATIENTS AND METHODS: Patients with fixed cT3 or cT4 cancer were randomized either to 5 × 5 Gy and three cycles of FOLFOX4 (group A) or to 50.4 Gy in 28 fractions combined with two 5-day cycles of bolus 5-Fu 325 mg/m(2)/day and leucovorin 20 mg/m(2)/day during the first and fifth week of irradiation along with five infusions of oxaliplatin 50 mg/m(2) once weekly (group B). The protocol was amended in 2012 to allow oxaliplatin to be then foregone in both groups.

RESULTS: Of 541 entered patients, 515 were eligible for analysis; 261 in group A and 254 in group B. Preoperative treatment acute toxicity was lower in group A than group B, P = 0.006; any toxicity being, respectively, 75% versus 83%, grade III-IV 23% versus 21% and toxic deaths 1% versus 3%. R0 resection rates (primary end point) and pathological complete response rates in groups A and B were, respectively, 77% versus 71%, P = 0.07, and 16% versus 12%, P = 0.17. The median follow-up was 35 months. At 3 years, the rates of overall survival and disease-free survival in groups A and B were, respectively, 73% versus 65%, P = 0.046, and 53% versus 52%, P = 0.85, together with the cumulative incidence of local failure and distant metastases being, respectively, 22% versus 21%, P = 0.82, and 30% versus 27%, P = 0.26. Postoperative and late complications rates in group A and group B were, respectively, 29% versus 25%, P = 0.18, and 20% versus 22%, P = 0.54.

CONCLUSIONS: No differences were observed in local efficacy between 5 × 5 Gy with consolidation chemotherapy and long-course chemoradiation. Nevertheless, an improved overall survival and lower acute toxicity favours the 5 × 5 Gy schedule with consolidation chemotherapy.

CLINICAL TRIAL NUMBER: The trial is registered as number NCT00833131.

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