Contribution of oxaliplatin to treatment of localized rectal cancer

Study author, year	RT dose, Gy	Chemotherapy during RT	Adjuvant chemotherapy	Long-term outcomes
STAR-01 Aschele C, 2016^[1]	50.4	FU (225 mg/m²/day) +/– oxaliplatin (60 mg/m² weekly)	FU-based adjuvant therapy was encouraged but not specified	No SS difference in OS
ACCORD/PRODIGE1 Gerard JP, 2010, 2012^[2,3]	45	Capecitabine (800 mg twice daily, 5 days/week) versus	Left to discretion of participating institutes + not reported	No SS difference in OS
	50	Capecitabine (800 mg twice daily, 5 days/week) + oxaliplatin (50 mg/m² weekly)
PETACC-6 Schmoll HJ, 2018^[4]	45 (optional boost to 50.4)	Capecitabine (825 mg/m² twice daily) versus	Capecitabine (1000 mg/m² twice daily, days 1 to 15, every 21 days for 6 months) versus	No SS difference in DFS, OS, or locoregional control
		Capecitabine + oxaliplatin (50 mg/m² weekly)	Same capecitabine dose + oxaliplatin (130 mg/m² every 3 weeks for 6 months)
CAO/ARO Rodel C, 2012, 2015^[5,6]	50.4	FU infusion (1000 mg/m²/day, days 1 to 5 and 29 to 33) versus	Bolus FU (500 mg/m² days 1 to 5 monthly for 4 months) versus	Three-year DFS 75.9 versus 71.2%, HR 0.79 (95% CI 0.64-0.98)
		FU infusion (250 mg/m²/day, days 1 to 14 and 22 to 35) + oxaliplatin (50 mg/m² weekly)	FOLFOX (day 1 and 15 every 28 days for 4 months)
NSABP R-04 Allegra CJ, 2015^[7]	50.4	FU infusion (225 mg/m²/day) +/– oxaliplatin (50 mg/m² weekly) or	FU-based adjuvant therapy was encouraged but not specified	No difference in OS, DFS, or locoregional control
		Capecitabine (825 mg/m² twice daily) +/– oxaliplatin (50 mg/m² weekly)

RT: radiation therapy; FU: fluorouracil; SS: statistically significant; OS: overall survival; DFS: disease-free survival; FOLFOX: short-term infusional FU plus leucovorin and oxaliplatin HR: hazard ratio.

Prepared with data from:

Aschele C, Lonardi S, Cionini L, et al. Final results of STAR-01: A randomized phase III trial comparing preoperative chemoradiation with or without oxaliplatin in locally advanced rectal cancer. J Clin Oncol 2016; 34:3521.
Gérard JP, Azria D, Gourgou-Bourgade S, et al. Comparison of two neoadjuvant chemoradiotherapy regimens for locally advanced rectal cancer: results of the phase III trial ACCORD 12/0405-Prodige 2. J Clin Oncol 2010; 28:1638.
Gérard JP, Azria D, Gourgou-Bourgade S, et al. Clinical outcome of the ACCORD 12/0405 PRODIGE 2 randomized trial in rectal cancer. J Clin Oncol 2012; 30:4558.
Schmoll H-J, Stein A, Van Cutsem E, et al. Pre- and postoperative capecitabine without or with oxaliplatin in locally advanced rectal cancer: PETACC 6 trial by EORTC GITCG and ROG, AIO, AGITG, BGDO, and FFCD. J Clin Oncol 2020; :JCO2001740.
Rödel C, Liersch T, Becker H, et al. Preoperative chemoradiotherapy and postoperative chemotherapy with fluorouracil and oxaliplatin versus fluorouracil alone in locally advanced rectal cancer: initial results of the German CAO/ARO/AIO-04 randomised phase 3 trial. Lancet Oncol 2012; 13:679.
Rödel C, Graeven U, Fietkau R, et al. Oxaliplatin added to fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer (the German CAO/ARO/AIO-04 study): final results of the multicentre, open-label, randomised, phase 3 trial. Lancet Oncol 2015; 16:979.
Allegra CJ, Yothers G, O'Connell MJ, et al. Neoadjuvant 5-FU or Capecitabine Plus Radiation With or Without Oxaliplatin in Rectal Cancer Patients: A Phase III Randomized Clinical Trial. J Natl Cancer Inst 2015.

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Contribution of oxaliplatin to treatment of localized rectal cancer