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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Self-citation
Final results of STAR-01: A randomized phase III trial comparing preoperative chemoradiation with or without oxaliplatin in locally advanced rectal cancer.
Aschele, C., Lonardi, S., Cionini, L., Pinto, C., Cordio, S. S., Rosati, G., Bianchi, A. S., Tagliagambe, A., Frisinghelli, M., Zagonel, V., et al. (2016) · Journal of Clinical Oncology · doi:10.1200/jco.2016.34.15_suppl.3521 · Cited by 42
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Preoperative concomitant chemoradiotherapy with oxaliplatin and 5-fluorouracil in locally advanced rectal carcinoma
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A phase II study of oxaliplatin with 5-FU/folinic acid and concomitant radiotherapy as a preoperative treatment in patients with locally advanced rectal cancer.
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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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