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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
Open accessAbstract
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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“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 [122]
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“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 [122]
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Metadata
- 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
- Venue
- Journal of Clinical Oncology
- Published
- 2011-07-10
- Volume
- 29
- Issue
- 20
- Pages
- 2773-2780
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- 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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