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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

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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  • Medientyp: E-Artikel
  • Titel: 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
  • Beteiligte: 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
  • Erschienen: American Society of Clinical Oncology (ASCO), 2011
  • Erschienen in: Journal of Clinical Oncology
  • Sprache: Englisch
  • DOI: 10.1200/jco.2010.34.4911
  • ISSN: 0732-183X; 1527-7755
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:sec><jats:title>Purpose</jats:title><jats:p> To investigate oxaliplatin combined with fluorouracil-based chemoradiotherapy as preoperative treatment for locally advanced rectal cancer. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> 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<jats:sup>2</jats:sup>/d) either alone (arm A, n = 379) or combined with oxaliplatin (60 mg/m<jats:sup>2</jats:sup> 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. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> 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 &lt; .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 &lt; .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). </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> 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. </jats:p></jats:sec>
  • Zugangsstatus: Freier Zugang