{"doi":"10.1200/jco.2004.22.14_suppl.3532","title":"Oxaliplatin (L-OHP) combined with irinotecan (CPT-11), leucovorin (LV) and fluorouracil (5-FU) compared with irinotecan, leucovorin and fluorouracil as first-line treatment for metastatic colorectal cancer (MCC): Preliminary results of a multicenter randomized phase III trial","abstract":null,"journal":null,"year":null,"id":607575,"datarank":0.16479184330021646,"base_score":1.0986122886681096,"endowment":1.0986122886681096,"self_citation_contribution":0.16479184330021646,"citation_network_contribution":0.0,"self_endowment_contribution":0.16479184330021646,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":2,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Oxaliplatin (L-OHP) combined with irinotecan (CPT-11), leucovorin (LV) and fluorouracil (5-FU) compared with irinotecan, leucovorin and fluorouracil as first-line treatment for metastatic colorectal cancer (MCC): Preliminary results of a multicenter randomized phase III trial","abstract":"3532 Background: In a phase II trial conducted from our group the 4-drug regimen (5FU+LV+CPT-11+L-OHP) was highly active and well tolerated (JCO 2002;20:2661–2667). A randomized trial was conducted to compare in terms of overall survival (OS) the 4-drug regimen (Arm-A) with the “standard” 3-drug (5FU+LV+CPT-11) FOLFIRI regimen (Arm-B) as first-line treatment in MCC Methods: Assuming OS 17months for Arm-B and 21 months for Arm-A, 276 pts were needed to show a significant difference (two-tailed log-rank test; a=0.05, b=0.8). For Arm-A CPT-11 150mg/m2 30–90 min infusion was given on d1, L-OHP 65mg/m2 2h infusion on d2, simultaneously but in different lines with LV 200mg/m2 on days 2+3 followed by 5-FU 400 mg/m2/d iv bolus and 600 mg/m2/d 22h infusion on days 2+3. For Arm-B CPT-11 180mg/m2 30–90 min infusion was given on d1, LV 200 mg/m2 on days 1+2 followed by 5-FU 400 mg/m2/d iv bolus and 600 mg/m2/d 22h infusion on days 1+2. Cycles were repeated every 2 weeks until disease progression, unacceptable toxicity or consent withdrawal. Results: As of today 203 pts and 1673 cy of therapy were evaluable for safety and efficacy. 101 pts on Arm-A: M/F: 62/39, PS 0/1/2: 59/30/12, median age 65 (25–75).102 pts on Arm-B: M/F: 57/45, PS 0/1/2: 47/39/16, median age 66 (42–80). In an intention-to-treat analysis the response rate was 45% (95%CI 35,45%–55,27%) in Arm-A and 31% (95%CI 22,68%–41,24%) in Arm-B (p=0,055). In addition 32% of pts presented stable disease in Arm-A and 23% in Arm-B (p=0,147). Disease progression was observed in 23% of pts in Arm-A and 45% in Arm-B(p=0,001). Median TTP was 8.9 and 6.1 months (p=0,0958) and OS 21.1 and 16.5 months in Arm-A and Arm-B, respectively (Log rank=0,0956). Conclusions: These preliminary results show promising efficacy with acceptable safety for the 4-drug combination. Updated data will be presented. No significant financial relationships to disclose.","is_dataset_classified":null,"base_score":1.0986122886681096,"endowment":1.0986122886681096,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"23304386","pmcid":null,"openalex_id":"https://openalex.org/W4251039869","authors":[],"funders":[],"total_grants":0,"fwci":null,"citation_percentile":null,"influential_citations":0,"citation_trend":[],"oa_status":"closed","license":null,"oa_locations":[{"url":"http://ascopubs.org/doi/pdfdirect/10.1200/jco.2004.22.90140.3532","host_type":"publisher"},{"url":"https://doi.org/10.1200/jco.2004.22.14_suppl.3532","host_type":"journal"}],"fields_of_study":["Colorectal Cancer Treatments and Studies","Gastric Cancer Management and Outcomes","Lung Cancer Treatments and Mutations"],"mesh_terms":[],"keywords":["Irinotecan","Fluorouracil","Medicine","Oxaliplatin","Colorectal cancer","Internal medicine","Oncology","Chemotherapy","Cancer"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Good health and well-being"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-07-30T06:38:21.039415Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}