2023
NCI 7977: A Phase I Dose-Escalation Study of Intermittent Oral ABT-888 (Veliparib) Plus Intravenous Irinotecan Administered in Patients with Advanced Solid Tumors
Cecchini M, Walther Z, Wei W, Hafez N, Pilat M, Boerner S, Durecki D, Eder J, Schalper K, Chen A, LoRusso P. NCI 7977: A Phase I Dose-Escalation Study of Intermittent Oral ABT-888 (Veliparib) Plus Intravenous Irinotecan Administered in Patients with Advanced Solid Tumors. Cancer Research Communications 2023, 3: 1113-1117. PMID: 37377610, PMCID: PMC10292219, DOI: 10.1158/2767-9764.crc-22-0485.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsBenzimidazolesHumansIrinotecanNeoplasmsPoly(ADP-ribose) Polymerase InhibitorsConceptsDose-limiting toxicityHomologous recombination deficiencyPARP inhibitorsStable diseaseWeekly irinotecanObjective responseDay 1Day 3Solid tumorsPhase I dose-escalation studyTwice daily days 1I dose-escalation studyPhase I clinical trialDaily days 1Dose level 1Doses of veliparibGrade 3 neutropeniaMultiple-dose schedulesProgression-free survivalAdvanced solid tumorsDose-escalation studyEvaluable patientsNonoverlapping toxicitiesDose scheduleSystemic treatment
2020
A phase 1b expansion study of TAS‐102 with oxaliplatin for refractory metastatic colorectal cancer
Cecchini M, Kortmansky JS, Cui C, Wei W, Thumar JR, Uboha NV, Hafez N, Lacy J, Fischbach NA, Sabbath KD, Gomez CM, Sporn JR, Stein S, Hochster HS. A phase 1b expansion study of TAS‐102 with oxaliplatin for refractory metastatic colorectal cancer. Cancer 2020, 127: 1417-1424. PMID: 33351187, PMCID: PMC8085021, DOI: 10.1002/cncr.33379.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsDrug Administration ScheduleDrug CombinationsDrug Resistance, NeoplasmFemaleFluorouracilHumansIrinotecanLeucovorinMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinProgression-Free SurvivalPyrrolidinesResponse Evaluation Criteria in Solid TumorsThymineTrifluridineConceptsMetastatic colorectal cancerOverall response rateRefractory metastatic colorectal cancerProgression-free survivalTAS-102Colorectal cancerDay 1Primary endpointOverall survivalDose escalationDay 5Median progression-free survivalPhase 1b studyMedian overall survivalResponse Evaluation CriteriaTreat populationDose expansionPartial responseStandard dosesUnexpected side effectsStudy treatmentTumor shrinkageUnexpected toxicitiesSide effectsNovel antimetabolite
2017
Olaratumab for the treatment of soft tissue sarcoma.
Deshpande HA, Cecchini M, Ni Choileain S, Jones R. Olaratumab for the treatment of soft tissue sarcoma. Drugs Of Today 2017, 53: 247-255. PMID: 28492292, DOI: 10.1358/dot.2017.53.4.2560077.Peer-Reviewed Original ResearchConceptsSoft tissue sarcomasPhase II studyTissue sarcomasII studyMetastatic diseaseOverall survivalOngoing phase III studiesRandomized phase II studyPlatelet-derived growth factor receptor alphaProgression-free survivalPhase III studyStandard chemotherapy regimensGrowth factor receptor alphaUnited States FoodMechanism of actionChemotherapy regimensIII studyOngoing trialsSolid malignanciesReceptor alphaPhase IbDrug AdministrationSignificant improvementFDA approvalOlaratumab
2016
Chemotherapy induced neutropenia at 1-month mark is a predictor of overall survival in patients receiving TAS-102 for refractory metastatic colorectal cancer: a cohort study
Kasi PM, Kotani D, Cecchini M, Shitara K, Ohtsu A, Ramanathan RK, Hochster HS, Grothey A, Yoshino T. Chemotherapy induced neutropenia at 1-month mark is a predictor of overall survival in patients receiving TAS-102 for refractory metastatic colorectal cancer: a cohort study. BMC Cancer 2016, 16: 467. PMID: 27412464, PMCID: PMC4944251, DOI: 10.1186/s12885-016-2491-y.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAgedAntineoplastic AgentsChemotherapy-Induced Febrile NeutropeniaClinical Trials, Phase III as TopicCohort StudiesColorectal NeoplasmsDisease-Free SurvivalDose-Response Relationship, DrugDrug CombinationsDrug Resistance, NeoplasmFemaleHumansJapanKaplan-Meier EstimateMaleMiddle AgedPrognosisPyrrolidinesThymineTrifluridineUnited StatesUracilConceptsMetastatic colorectal cancerProgression-free survivalOverall survivalCohort studyGrade 2Median progression-free survivalRefractory metastatic colorectal cancerLonger progression-free survivalNeutrophil count decreaseCommon Terminology CriteriaBetter overall survivalKaplan-Meier methodChemotherapy-induced neutropeniaLog-rank testTerminology CriteriaAdverse eventsClinical characteristicsPatient demographicsStandard therapyTAS-102Colorectal cancerOutcome dataPatientsCount decreaseRegulatory approval