Clinical Outcome of the ACCORD 12/0405 PRODIGE 2 Randomized Trial in Rectal Cancer
Open accessAbstract
Purpose: The ACCORD 12 trial investigated the value of two different preoperative chemoradiotherapy (CT-RT) regimens in T3-4 Nx M0 resectable rectal cancer. Clinical results are reported after follow-up of 3 years. Patients and Methods: Between November 2005 and July 2008, a total of 598 patients were randomly assigned to preoperative CT-RT with CAP45 (45-Gy RT for 5 weeks with concurrent capecitabine) or CAPOX50 (50-Gy RT for 5 weeks with concurrent capecitabine and oxaliplatin). Total mesorectal excision was planned 6 weeks after CT-RT. The primary end point was sterilization of the operative specimen, which was achieved in 13.9% versus 19.2% of patients, respectively (P = .09). Clinical results were analyzed for all randomly assigned patients according to the intention-to-treat principle. Results: At 3 years, there was no significant difference between CAP45 and CAPOX50 (cumulative incidence of local recurrence, 6.1% v 4.4%; overall survival, 87.6% v 88.3%; disease-free survival, 67.9% v 72.7%). Grade 3 to 4 toxicity was reported in four patients in the CAP45 group and in two patients in the CAPOX50 group. Bowel continence, erectile dysfunction, and social life disturbance were not different between groups. In multivariate analysis, the sterilization rate (Dworak score) of the operative specimen was the main significant prognostic factor (hazard ratio, 0.32; 95% CI, 0.21 to 0.50). Conclusion: At 3 years, no significant difference in clinical outcome was achieved with the intensified CAPOX regimen. When compared with other recent randomized trials, these results indicate that concurrent administration of oxaliplatin and RT is not recommended.
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Adding OX to pyrimidine fluoride demonstrated no efficacy in regard to pCR ratio, localized control ratio and survival.
“but demonstrated no efficacy in regard to pCR ratio, localized control ratio and survival [120, 122–124]”
From Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2016 for the treatment of colorectal cancer (2018) · cites this paper as [124]
The Introduction reports no significant improvement in pathologic complete response, and the Discussion reports no significant benefit for local recurrence or survival at three years. But the trial changed both radiation dose and oxaliplatin use, so it cannot isolate oxaliplatin’s effect; “no efficacy” is also stronger than the reported absence of a significant benefit. Page numbers are unavailable in our copy. (LLM, conf=0.85)
Experimental — accuracy not yet measuredIn randomized controlled trials, adding OX to pyrimidine fluoride as combination chemotherapy in preoperative chemoradiotherapy increased harmful phenomena in three tests.
“OX increased harmful phenomena in three tests”
From Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2016 for the treatment of colorectal cancer (2018) · cites this paper as [124]
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- Authors
- Gérard, J.-P., Azria, D., Gourgou-Bourgade, S., Martel-Lafay, I., Hennequin, C., Etienne, P.-L., Vendrely, V., François, E., de La Roche, G., Bouché, O., Mirabel, X., Denis, B., Mineur, L., Berdah, J.-F., Mahé, M.-A., Bécouarn, Y., Dupuis, O., Lledo, G., Seitz, J.-F., Bedenne, L., Juzyna, B., & Conroy, T.
- Affiliations
- American Society of Clinical Oncology (US)
- Jean-Pierre Gérard and Eric François, Centre Antoine Lacassagne, Nice; David Azria and Sophie Gourgou-Bourgade, Centre Val d'Aurelle, Montpellier; Isabelle Martel-Lafay, Centre Léon Bérard; Gérard Lledo, Hôpital Privé Jean-Mermoz, Lyon; Christophe Hennequin, Hôpital Saint-Louis; Béata Juzyna, Bureau d'Etudes Cliniques et Thérapeutiques Groupe Tumeurs Digestives Unicancer, Paris; Pierre-Luc Etienne, Clinique Armoricaine de Radiologie, St Brieuc; Véronique Vendrely, Hôpital Saint André; Yves Bécouarn,...
- Centre Léon Bérard (FR)
- Corresponding author
- Gérard, Jean-Pierre
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2012-12-20
- Volume
- 30
- Issue
- 36
- Pages
- 4558-4565
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2158709109
- Cited by
- 430
- References
- 18
- Citations by year
- 2026: 11 · 2025: 17 · 2024: 21 · 2023: 17 · 2022: 26 · 2021: 33 · 2020: 44 · 2019: 39 · 2018: 41 · 2017: 41 · 2016: 30 · 2015: 51 · 2014: 30 · 2013: 23 · 2012: 6
- FWCI
- 17.39
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Institut National Du Cancer
- Topics
- Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
- Health Sciences › Medicine › Surgery › Colorectal and Anal Carcinomas
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Gastric Cancer Management and Outcomes
- Keywords
- rectal cancer, neoadjuvant chemoradiotherapy, oxaliplatin, capecitabine, total mesorectal excision, local recurrence, overall survival, disease-free survival, radiation toxicity, fecal continence, erectile dysfunction
- MeSH terms
- Capecitabine, Oxaliplatin, Aged, Antineoplastic Combined Chemotherapy Protocols, Leucovorin, Deoxycytidine, Female, Fluorouracil, Humans, Male, Middle Aged, Neoplasm Staging, Organoplatinum Compounds, Radiotherapy Dosage, Rectal Neoplasms, Treatment Outcome, Disease-Free Survival, Neoadjuvant Therapy, Chemoradiotherapy, Adjuvant
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