{"doi":"10.1200/jco.24.00081","title":"Addition of Metastasis-Directed Therapy to Systemic Therapy for Oligometastatic Pancreatic Ductal Adenocarcinoma (EXTEND): A Multicenter, Randomized Phase II Trial","abstract":"<jats:sec>\n            <jats:title>PURPOSE</jats:title>\n            <jats:p>The EXTEND trial tested the hypothesis that adding comprehensive metastasis-directed therapy (MDT) to chemotherapy would improve progression-free survival (PFS) over chemotherapy alone among patients with oligometastatic pancreatic ductal adenocarcinoma (PDAC).</jats:p>\n          </jats:sec>\n          <jats:sec>\n            <jats:title>METHODS</jats:title>\n            <jats:p>\n              EXTEND (ClinicalTrials.gov identifier:\n              <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"https://www.clinicaltrials.gov/ct2/show/NCT03599765\">NCT03599765</jats:ext-link>\n              ) is a multicenter, phase II basket trial randomly assigning patients with ≤five metastases 1:1 to MDT plus systemic therapy versus systemic therapy. Disease progression was defined by radiologic criteria (RECIST v1.1), clinical progression, or death. The primary end point was PFS in the per-protocol population, evaluated after all patients achieved at least 6 months of follow-up. Exploratory end points included systemic immune response measures.\n            </jats:p>\n          </jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS</jats:title>\n            <jats:p>\n              Between March 19, 2019, and February 13, 2023, 41 patients were randomly assigned and 40 were eligible for the primary analysis of PFS (19 patients in the MDT arm; 21 patients in the control arm). At a median follow-up time of 17 months, the median PFS time was 10.3 months (95% CI, 4.6 to 14.0) in the MDT arm versus 2.5 months (95% CI, 1.7 to 5.1) in the control arm. PFS was significantly improved by the addition of MDT to systemic therapy (\n              <jats:italic>P</jats:italic>\n              = .030 for stratified log-rank test) with a hazard ratio of 0.43 (95% CI, 0.20 to 0.94). No grade ≥3 or greater adverse events related to MDT were observed. Systemic immune activation events were associated with MDT and correlated with improved PFS.\n            </jats:p>\n          </jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION</jats:title>\n            <jats:p>This study supports the addition of MDT to systemic therapy for patients with oligometastatic PDAC. Induction of systemic immunity is a possible mechanism of benefit. These results warrant confirmatory trials to refine treatment strategy and provide external validation.</jats:p>\n          </jats:sec>","journal":"Journal of Clinical Oncology","year":2024,"id":608383,"datarank":0.6190701577567639,"base_score":4.127134385045092,"endowment":4.127134385045092,"self_citation_contribution":0.6190701577567639,"citation_network_contribution":0.0,"self_endowment_contribution":0.6190701577567639,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":61,"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":[{"id":516555,"name":"Alexander D. Sherry","orcid":"0000-0001-5115-1691","position":1,"is_corresponding":false},{"id":1562523,"name":"Bryan M. Fellman","orcid":null,"position":2,"is_corresponding":false},{"id":1484040,"name":"Suyu Liu","orcid":"0000-0003-4966-8047","position":3,"is_corresponding":false},{"id":419866,"name":"Tharakeswara Bathala","orcid":"0000-0001-8342-4519","position":4,"is_corresponding":false},{"id":268280,"name":"Cara Haymaker","orcid":"0000-0002-1317-9287","position":5,"is_corresponding":false},{"id":1221880,"name":"Marina Nayeli Medina-Rosales","orcid":"0000-0001-5174-8885","position":6,"is_corresponding":false},{"id":90418,"name":"Alexandre Reuben","orcid":"0000-0003-4510-0382","position":7,"is_corresponding":false},{"id":428202,"name":"Emma B. Holliday","orcid":"0000-0002-4362-461X","position":8,"is_corresponding":false},{"id":380273,"name":"Grace L. Smith","orcid":"0000-0002-3171-2911","position":9,"is_corresponding":false},{"id":698289,"name":"Sonal S. Noticewala","orcid":"0000-0002-3153-0317","position":10,"is_corresponding":false},{"id":654530,"name":"Sarah Nicholas","orcid":null,"position":11,"is_corresponding":false},{"id":1562524,"name":"Tracy R. Price","orcid":"0009-0005-3375-409X","position":12,"is_corresponding":false},{"id":1279932,"name":"Rachael Martin","orcid":"0000-0002-3866-6823","position":13,"is_corresponding":false},{"id":1059262,"name":"L Perles","orcid":"0000-0002-5326-1998","position":14,"is_corresponding":false},{"id":573504,"name":"Sunyoung S. Lee","orcid":"0000-0002-5954-5991","position":15,"is_corresponding":false},{"id":590666,"name":"Michael S. Lee","orcid":"0000-0001-8407-3423","position":16,"is_corresponding":false},{"id":333696,"name":"Brandon G. Smaglo","orcid":"0000-0002-8814-8004","position":17,"is_corresponding":false},{"id":868765,"name":"Ryan Huey","orcid":"0000-0002-7887-8484","position":18,"is_corresponding":false},{"id":678034,"name":"Jason Willis","orcid":"0000-0001-8238-8552","position":19,"is_corresponding":false},{"id":505235,"name":"Dan Zhao","orcid":"0000-0001-7066-9058","position":20,"is_corresponding":false},{"id":307383,"name":"Lorenzo Cohen","orcid":"0000-0003-4372-9208","position":21,"is_corresponding":false},{"id":60605,"name":"Cullen M. Taniguchi","orcid":"0000-0002-8052-3316","position":22,"is_corresponding":false},{"id":227744,"name":"Eugene J. Koay","orcid":"0000-0001-7675-3461","position":23,"is_corresponding":false},{"id":344388,"name":"Matthew H. G. Katz","orcid":"0000-0003-3870-6968","position":24,"is_corresponding":false},{"id":395090,"name":"Robert A. Wolff","orcid":"0000-0002-6614-1610","position":25,"is_corresponding":false},{"id":1381717,"name":"Prajnan Das","orcid":"0000-0002-8253-4190","position":26,"is_corresponding":false},{"id":1388696,"name":"Shubham Pant","orcid":"0000-0001-9055-8494","position":27,"is_corresponding":false},{"id":254922,"name":"Albert C. Koong","orcid":"0000-0001-9824-1643","position":28,"is_corresponding":false},{"id":236011,"name":"Chad Tang","orcid":"0000-0002-5915-1327","position":29,"is_corresponding":false},{"id":355311,"name":"Ethan B. Ludmir","orcid":"0000-0002-5472-5344","position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Addition of Metastasis-Directed Therapy to Systemic Therapy for Oligometastatic Pancreatic Ductal Adenocarcinoma (EXTEND): A Multicenter, Randomized Phase II Trial","abstract":"<jats:sec>\n            <jats:title>PURPOSE</jats:title>\n            <jats:p>The EXTEND trial tested the hypothesis that adding comprehensive metastasis-directed therapy (MDT) to chemotherapy would improve progression-free survival (PFS) over chemotherapy alone among patients with oligometastatic pancreatic ductal adenocarcinoma (PDAC).</jats:p>\n          </jats:sec>\n          <jats:sec>\n            <jats:title>METHODS</jats:title>\n            <jats:p>\n              EXTEND (ClinicalTrials.gov identifier:\n              <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"https://www.clinicaltrials.gov/ct2/show/NCT03599765\">NCT03599765</jats:ext-link>\n              ) is a multicenter, phase II basket trial randomly assigning patients with ≤five metastases 1:1 to MDT plus systemic therapy versus systemic therapy. Disease progression was defined by radiologic criteria (RECIST v1.1), clinical progression, or death. The primary end point was PFS in the per-protocol population, evaluated after all patients achieved at least 6 months of follow-up. Exploratory end points included systemic immune response measures.\n            </jats:p>\n          </jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS</jats:title>\n            <jats:p>\n              Between March 19, 2019, and February 13, 2023, 41 patients were randomly assigned and 40 were eligible for the primary analysis of PFS (19 patients in the MDT arm; 21 patients in the control arm). At a median follow-up time of 17 months, the median PFS time was 10.3 months (95% CI, 4.6 to 14.0) in the MDT arm versus 2.5 months (95% CI, 1.7 to 5.1) in the control arm. PFS was significantly improved by the addition of MDT to systemic therapy (\n              <jats:italic>P</jats:italic>\n              = .030 for stratified log-rank test) with a hazard ratio of 0.43 (95% CI, 0.20 to 0.94). No grade ≥3 or greater adverse events related to MDT were observed. Systemic immune activation events were associated with MDT and correlated with improved PFS.\n            </jats:p>\n          </jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION</jats:title>\n            <jats:p>This study supports the addition of MDT to systemic therapy for patients with oligometastatic PDAC. Induction of systemic immunity is a possible mechanism of benefit. These results warrant confirmatory trials to refine treatment strategy and provide external validation.</jats:p>\n          </jats:sec>","is_dataset_classified":null,"base_score":0.0,"endowment":0.0,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"21097893","pmcid":null,"openalex_id":null,"authors":[],"funders":[],"total_grants":0,"fwci":null,"citation_percentile":null,"influential_citations":0,"citation_trend":[],"oa_status":"green","license":null,"oa_locations":[{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11540734/pdf/nihms-2024905.pdf","host_type":"repository"},{"url":"https://ascopubs.org/doi/pdfdirect/10.1200/JCO.24.00081","host_type":"publisher"},{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11540734/","host_type":"repository"}],"fields_of_study":[],"mesh_terms":[],"keywords":[],"sdg_mappings":[],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-07-30T12:45:00.156880Z","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":[]}