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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 +12 more·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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  • In 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 [122]

    The Compliance and Acute Toxicity section reports more grade 3–4 adverse events when oxaliplatin was added to preoperative fluorouracil and radiotherapy (24% versus 8%). The Discussion says increased acute toxicity was seen in two randomized phase III trials, not three; the claimed number of tests is unsupported. (LLM, conf=0.87)

    Experimental — accuracy not yet measured

  • 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 [122]

    The Pathology Findings report a 16% pathologic complete response rate in both arms, supporting the claim that adding oxaliplatin did not improve pCR. This report analyzes response to preoperative treatment; although Data Management and Statistics names survival as the trial’s primary endpoint, it does not report a survival comparison or a local-control rate. Those parts of the claim are not supported by this paper. (LLM, conf=0.88)

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Research works printed but not linked: 1

  1. [13]13. Sobin LH, Wittekind CH (eds): International Union Against Cancer (UICC) TNM classification of malignant tumours, 5th ed. New York, NY, John Wiley & Sons, 1997

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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
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
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 › Pulmonary and Respiratory Medicine › 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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