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

Autor: 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, J. Albiński, R. Banaś, E. Chmielowska, W. Bal, J. Baszczyk-Mnich, M. Bialas, T. Borowiec, M. Bujko, A. Cencelewicz, K. Chomik, M. Chwaliński, I. Ciepela, D. Dupla, A. Florek, A. Górnicki, K. Jeziorski, W. Józwicki, J. Kobiela, M. Koda, P. Kołodziej, P. Kruszewski, M. Kryj, G. Kuciel-Lisiecka, R. Kwiatkowski, A. Lachowski, P. Liszka-Dalecki, A. Majewski, W. Majewski, T. Majsak, D. Maka, M. Malka, A. Mazurkiewicz, J. Morawiec, E. Nogal, M. Olejniczak, D. Olkowski, K. Ostrowska-Cichocka, M. Pietruszka, G. Piotrkowski, M. Plewicka, D. Porzuczek-Zuziak, J. Reszke, A. Rychter, J. Sadowski, A. Salata, K. Serkies, E. Srutek, B. Szóstak, T. Tuziak, D. Tyralik, J. Skoczylas, E. Wachua, P. Wandzel, B. Winkler-Spytkowska, P. Wojtasik, K. Wroński, M. Zemal, I. Zygulski
Rok vydání: 2016
Předmět:
Zdroj: Annals of Oncology. 27:834-842
ISSN: 0923-7534
DOI: 10.1093/annonc/mdw062
Popis: 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/m2/day and leucovorin 20 mg/m2/day during the first and fifth week of irradiation along with five infusions of oxaliplatin 50 mg/m2 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 ClinicalTrials.gov number NCT00833131.
Databáze: OpenAIRE
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