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 ResearchConceptsDose-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 treatmentPre-operative chemoradiotherapy with or without induction chemotherapy for operable locally-advanced esophageal cancer
Peters G, Talcott W, Peters N, Dhanasopan A, Lacy J, Cecchini M, Kortmansky J, Stein S, Lattanzi S, Park H, Boffa D, Johung K, Jethwa K. Pre-operative chemoradiotherapy with or without induction chemotherapy for operable locally-advanced esophageal cancer. Journal Of Gastrointestinal Oncology 2023, 14: 1181-1192. PMID: 37435226, PMCID: PMC10331751, DOI: 10.21037/jgo-22-1005.Peer-Reviewed Original ResearchProgression-free survivalMedian progression-free survivalOverall survivalIC-CRTInduction chemotherapySingle-institution retrospective cohort studyPre-operative chemoradiotherapyAdvanced esophageal cancerAdvanced esophageal carcinomaPathologic complete responseRetrospective cohort studyKaplan-Meier methodSubset of patientsProportional hazards regressionCycles of inductionAdenocarcinoma histologyCRT cohortCohort studyComplete responsePathologic responseTreatment cohortsDistant metastasisHazards regressionEsophageal cancerEsophageal carcinoma
2022
Hybrid-control arm construction using historical trial data for an early-phase, randomized controlled trial in metastatic colorectal cancer
Li C, Ferro A, Mhatre SK, Lu D, Lawrance M, Li X, Li S, Allen S, Desai J, Fakih M, Cecchini M, Pedersen KS, Kim TY, Reyes-Rivera I, Segal NH, Lenain C. Hybrid-control arm construction using historical trial data for an early-phase, randomized controlled trial in metastatic colorectal cancer. Communications Medicine 2022, 2: 90. PMID: 35856081, PMCID: PMC9287310, DOI: 10.1038/s43856-022-00155-y.Peer-Reviewed Original ResearchMetastatic colorectal cancerExperimental armColorectal cancerMetastatic colorectal cancer (mCRC) trialsMetastatic colorectal cancer patientsPhase Ib/IITrial dataHistorical trial dataColorectal cancer trialsDisease control rateObjective response ratePhase 3 trialProgression-free survivalColorectal cancer patientsStandardized mortality ratioEarly phase trialsEarly phase clinical developmentLogistic regression modelsMultiple experimental armsPrimary endpointOverall survivalPrior linesEfficacy signalsSafety profileCombination therapy
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