Cited by 764Colorectal Cancer Surgical TreatmentsColorectal and Anal CarcinomasGastric Cancer Management and Outcomes

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Primary Tumor Response to Preoperative Chemoradiation With or Without Oxaliplatin in Locally Advanced Rectal Cancer: Pathologic Results of the STAR-01 Randomized Phase III Trial

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Aschele, Carlo, Cionini, Luca, Lonardi, Sara, Pinto, Carmine, Cordio, Stefano, Rosati, Gerardo, Artale, Salvatore, Tagliagambe, Angiolo, Ambrosini, Giovanni, Rosetti, Paola, Bonetti, Andrea, Negru, Maria Emanuela, Tronconi, Maria Chiara, Luppi, Gabriele, Silvano, Giovanni, Corsi, Domenico Cristiano, Bochicchio, Anna Maria, Chiaulon, Germana, Gallo, Maurizio, Boni, Luca·2011·Journal of Clinical Oncology

DOI 10.1200/jco.2010.34.4911

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Abstract

Purpose: To investigate oxaliplatin combined with fluorouracil-based chemoradiotherapy as preoperative treatment for locally advanced rectal cancer. Patients and Methods: Seven hundred forty-seven patients with resectable, locally advanced (cT3-4 and/or cN1-2) adenocarcinoma of the mid-low rectum were randomly assigned to receive pelvic radiation (50.4 Gy in 28 daily fractions) and concomitant infused fluorouracil (225 mg/m 2 /d) either alone (arm A, n = 379) or combined with oxaliplatin (60 mg/m 2 weekly × 6; arm B, n = 368). Overall survival is the primary end point. A protocol-planned analysis of response to preoperative treatment is reported here. Results: Grade 3 to 4 adverse events during preoperative treatment were more frequent with oxaliplatin plus fluorouracil and radiation than with radiation and fluorouracil alone (24% v 8% of treated patients; P < .001). In arm B, 83% of the patients treated with oxaliplatin had five or more weekly administrations. Ninety-one percent, compared with 97% in the control arm, received ≥ 45 Gy (P < .001). Ninety-six percent versus 95% of patients underwent surgery with similar rates of abdominoperineal resections (20% v 18%, arm A v arm B). The rate of pathologic complete responses was 16% in both arms (odds ratio = 0.98; 95% CI, 0.66 to 1.44; P = .904). Twenty-six percent versus 29% of patients had pathologically positive lymph nodes (arm A v arm B; P = .447), 46% versus 44% had tumor infiltration beyond the muscularis propria (P = .701), and 7% versus 4% had positive circumferential resection margins (P = .239). Intra-abdominal metastases were found at surgery in 2.9% versus 0.5% of patients (arm A v arm B; P = .014). Conclusion: Adding oxaliplatin to fluorouracil-based preoperative chemoradiotherapy significantly increases toxicity without affecting primary tumor response. Longer follow-up is needed to assess the impact on efficacy end points.

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Authors: Aschele, C., Cionini, L., Lonardi, S., Pinto, C., Cordio, S., Rosati, G., Artale, S., Tagliagambe, A., Ambrosini, G., Rosetti, P., Bonetti, A., Negru, M. E., Tronconi, M. C., Luppi, G., Silvano, G., Corsi, D. C., Bochicchio, A. M., Chiaulon, G., Gallo, M., & Boni, L.
Affiliations: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT)
ORCID: Aschele, Carlo
Lonardi, Sara
Pinto, Carmine
Rosati, Gerardo
Bonetti, Andrea
Tronconi, Maria Chiara
Luppi, Gabriele
Silvano, Giovanni
Corsi, Domenico Cristiano
Bochicchio, Anna Maria
Boni, Luca
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2011-07-10
Volume: 29
Issue: 20
Pages: 2773-2780
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2010.34.4911
OpenAlex: W2123712900
Cited by: 763
References: 29
Citations by year: 2026: 8 · 2025: 23 · 2024: 24 · 2023: 21 · 2022: 37 · 2021: 42 · 2020: 60 · 2019: 60 · 2018: 59 · 2017: 72 · 2016: 61 · 2015: 83 · 2014: 62 · 2013: 64 · 2012: 69
FWCI: 33.33
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
Funders: Amgen
Sanofi
Topics: Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
Health Sciences › Medicine › Surgery › Colorectal and Anal Carcinomas
Health Sciences › Medicine › Oncology › Gastric Cancer Management and Outcomes
Keywords: locally advanced rectal cancer, neoadjuvant chemoradiotherapy, oxaliplatin, 5-fluorouracil, pelvic radiotherapy, pathological complete response, circumferential resection margin, lymph node metastasis, treatment toxicity, abdominoperineal resection, overall survival
MeSH terms: Oxaliplatin, Adenocarcinoma, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Female, Fluorouracil, Humans, Italy, Male, Middle Aged, Organoplatinum Compounds, Rectal Neoplasms, Survival Analysis, Dose Fractionation, Radiation, Neoadjuvant Therapy, Medication Adherence, Drug-Related Side Effects and Adverse Reactions

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Primary Tumor Response to Preoperative Chemoradiation With or Without Oxaliplatin in Locally Advanced Rectal Cancer: Pathologic Results of the STAR-01 Randomized Phase III Trial

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