{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T09:12:48Z","timestamp":1784279568424,"version":"3.55.0"},"reference-count":23,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2025,9,17]],"date-time":"2025-09-17T00:00:00Z","timestamp":1758067200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Importance<\/jats:title>\n                  <jats:p>The addition of agents targeting critical signal mediators of cancer cell proliferation such as cyclin-dependent kinases (CDK) potentiates the efficacy of platinum chemotherapy.<\/jats:p>\n                  <jats:p>Objective<\/jats:p>\n                  <jats:p>To determine the safety and efficacy of palbociclib combined with cisplatin (cis) or carboplatin (carbo) in advanced solid malignancies<\/jats:p>\n                  <jats:p>Design<\/jats:p>\n                  <jats:p>Enrollment on dose escalation (part I) proceeded using the Bayesian adaptive design Escalation with Overdose Control (EWOC).<\/jats:p>\n                  <jats:p>Setting<\/jats:p>\n                  <jats:p>Single institution investigator initiated trial.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Participants<\/jats:title>\n                  <jats:p>Patients with any advanced cancer after at least one prior therapy were enrolled on dose escalation to determine recommended phase II doses (RP2D). Expansion cohorts were then opened for pancreaticobiliary tract cancers.<\/jats:p>\n                  <jats:p>Intervention<\/jats:p>\n                  <jats:p>Escalating doses of palbociclib in combination with different doses of cisplatin or carboplatin.<\/jats:p>\n                  <jats:p>Main Outcomes and Measures<\/jats:p>\n                  <jats:p>Primary endpoint was objective response rate (ORR). Secondary endpoints included safety, overall survival (OS), and progression-free survival (PFS).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We enrolled 39 patients on dose escalation (part I) and 32 additional patients on dose expansion (part II). RP2D of palbociclib 100\u2009mg on Day 2-22\u2009+\u2009Cisplatin (cis) 60\u2009mg\/m2 IV on Day 1 Q4W (Arm A); and palbociclib 75\u2009mg on Day 2-22\u2009+\u2009Carboplatin (carbo) AUC 6 IV on Day 1 Q4W (Arm B). ORR for Part I were 12.5% (Arm A) and 25% (Arm B). Median PFS and OS for dose expansion were 2.1 and 4.9\u2009months, respectively. For PDAC, mPFS was 1.9\u2009months (95% CI: 1.7, 2.4), and OS was 3.7\u2009months (95% CI: 2.7, 5.7). Most common treatment-related adverse events (TRAEs\u2014all grade %): Arm A\u2014neutropenia (66%), thrombocytopenia (26%), nausea, fatigue, and anemia (20% each); Arm B\u2014neutropenia (64.7%), thrombocytopenia (53%), and anemia (29%). There were no grade 4-5 TRAEs.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions and Relevance<\/jats:title>\n                  <jats:p>The combination of palbociclib with cisplatin or carboplatin had an acceptable safety profile and clinical responses in some treatment refractory advanced cancers. There was no objective response, but about half of PDAC patients had disease stabilization. Additional efforts are needed to exploit CDK abnormalities in these patients. Clinical trial registration number: NCT02897375<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/oncolo\/oyaf284","type":"journal-article","created":{"date-parts":[[2025,9,19]],"date-time":"2025-09-19T23:18:46Z","timestamp":1758323926000},"source":"Crossref","is-referenced-by-count":2,"title":["Phase I study of palbociclib with cisplatin or carboplatin in the management of patients with advanced pancreatic cancer"],"prefix":"10.1093","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8079-4725","authenticated-orcid":false,"given":"Olatunji B","family":"Alese","sequence":"first","affiliation":[{"name":"Department of Hematology & Medical Oncology, Emory University School of Medicine , Atlanta, GA 30322,","place":["United States"]},{"name":"Winship Cancer Institute, Emory University , Atlanta, GA 30322,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert 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