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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

2016; Elsevier BV; Volume: 27; Issue: 5 Linguagem: Inglês

10.1093/annonc/mdw062

1569-8041

Krzysztof Bujko, Lucjan Wyrwicz, Andrzej Rutkowski, Małgorzata Malinowska, Lucyna Pietrzak, J Kryński, Wojciech Michalski, Janusz Olędzki, Jerzy Kuśnierz, Leszek Zajâc, M. Bednarczyk, Marek Szczepkowski, Wiesław Tarnowski, Ewa Kosakowska, Jakub Zwoliński, Mariola Winiarek, Katarzyna Wiśniowska, M. Partycki, K. Bęczkowska, Wojciech Polkowski, Roman Styliński, Ryszard Wierzbicki, Paweł Bury, M. Jankiewicz, Krzysztof Paprota, M. Lewicka, Bogumiła Ciseł, Magdalena Skórzewska, Jerzy Mielko, Marek Bębenek, Adam Maciejczyk, Bartosz Kapturkiewicz, A. Dybko, Łukasz Hajac, Andrzej Wojnar, Tadeusz Lesniak, J. Zygulska, D. Jantner, Ewa Chudyba, W. Zegarski, Manuela Las‐Jankowska, Michał Jankowski, L Kołodziejski, A. Radkowski, U. Żelazowska-Omiotek, B. Czeremszyńska, Lucyna Kępka, Jarosław Kołb-Sielecki, Z. Toczko, Zbys Fedorowicz, Adam Dziki, Adrian Danek, G Nawrocki, Rafał Sopyło, W. Markiewicz, Piotr Kędzierawski, Jerzy Wydmański, J. Albiński, Renata Banaś, E. Chmielowska, Wiesław Bal, J. Baszczyk-Mnich, Marcin Białas, T. Borowiec, Krzysztof Bujko, Anna Cencelewicz, Konstanty Chomik, Maciej Chwaliński, I. Ciepela, Dorota Dupla, Artur Florek, A. Górnicki, Krzysztof Jeziorski, Wojciech Jóźwicki, Jarek Kobiela, Masahiko Koda, P Kołodziej, Piotr Kruszewski, Mariusz Kryj, G. Kuciel-Lisiecka, Robert Kwiatkowski, Angela Lachowski, Piotr Liszka-Dalecki, Adam Majewski, Wojciech Majewski, T Majsak, Doualla-Bell Kotto Maka, Marcin Malka, Adam Mazurkiewicz, Jan Morawiec, E. Nogal, M. Olejniczak, D. Olkowski, Krystyna Ostrowska-Cichocka, Mariusz Pietruszka, G. Piotrkowski, M Plewicka, Dorota Porzuczek-Zuziak, Joanna Reszke, Anna Rychter, J. Sadowski, Andrzej Salata, Krystyna Serkies, Ewa Śrutek, Bartosz Szostak, T. Tuziak, Dariusz Tyralik, Jacek Skoczylas, E. Wachua, Piotr Wandzel, B. Winkler-Spytkowska, Piotr Wojtasik, Konrad Wroński, M. Zemal, Ireneusz Zygulski,

Colorectal Cancer Treatments and Studies

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 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.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.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.The trial is registered as ClinicalTrials.gov number NCT00833131.