2024
Sorafenib or anthracycline‐based chemotherapy for progressive desmoid tumors
Costa P, Arora A, Fernandez Y, Yi I, Bakkila B, Tan H, Coelho P, Campoverde L, Hardy N, Bialick S, Freire A, D’Amato G, Chang Y, Mesenger J, Subhawong T, Haims A, Hurwitz M, Olino K, Turaga K, Deshpande H, Trent J. Sorafenib or anthracycline‐based chemotherapy for progressive desmoid tumors. Cancer 2024, 131: e35647. PMID: 39543805, DOI: 10.1002/cncr.35647.Peer-Reviewed Original ResearchProgression-free survivalAnthracycline-containing regimensAnthracycline-based therapyDesmoid tumorsAdverse eventsOne-year progression-free survivalMulti-institutional retrospective analysisAnthracycline-containing regimenCommon grade 1Desmoid tumor patientsGrade 3 eventsAnthracycline-based chemotherapyHand-foot syndromeSecondary end pointsActivity of sorafenibProgressive desmoid tumorsYear of treatmentMedian TTRBaseline characteristicsTumor patientsLocal invasionTreatment responseSorafenibAnthracyclinesEnd pointsPreliminary efficacy and safety of fruquintinib as maintenance therapy after first-line treatment in metastatic colorectal cancer (mCRC): A multicenter, randomized, open-label clinical trial (the FRONT study).
Xu X, Yu Y, Liu Q, Wang Y, Cui Y, Li W, Li Q, Feng Y, Liang L, Yu S, Lv M, Liu T. Preliminary efficacy and safety of fruquintinib as maintenance therapy after first-line treatment in metastatic colorectal cancer (mCRC): A multicenter, randomized, open-label clinical trial (the FRONT study). Journal Of Clinical Oncology 2024, 42: 126-126. DOI: 10.1200/jco.2024.42.3_suppl.126.Peer-Reviewed Original ResearchProgression-free survivalMetastatic colorectal cancerDisease control rateFirst-line treatmentMedian progression-free survivalSafety of fruquintinibHand-foot syndromeFull analysis setMaintenance therapyPer-protocol setOral mucositisFR groupLeft-sided metastatic colorectal cancerOutcomes of progression-free survivalRight-sided metastatic colorectal cancerResponse to first-line treatmentClinical trialsFirst-line standard treatmentInteractive web response systemOpen-label clinical trialFirst-line therapyWeb response systemDiscontinuation of treatmentModerate dose levelsRandomized clinical trials
2018
Extended outcomes of intraperitoneal and systemic chemotherapy for gastric cancer with peritoneal metastases.
Chan D, Syn N, Neogh C, Phua N, . E, Ho J, Sundar R, Tan C, Ngoi N, Chee C, Shabbir A, So J, Yong W. Extended outcomes of intraperitoneal and systemic chemotherapy for gastric cancer with peritoneal metastases. Journal Of Clinical Oncology 2018, 36: 125-125. DOI: 10.1200/jco.2018.36.4_suppl.125.Peer-Reviewed Original ResearchConversion gastrectomyPeritoneal metastasisGastric cancerIP paclitaxelMedian OSPeritoneal cytologyDay 1Positive peritoneal washing cytologyTreated with 8 cyclesSurvival rateNegative peritoneal cytologyPeritoneal washing cytologyRecurrent gastric adenocarcinomaHand-foot syndromeMedian follow-upOverall survival rateWeek of restTime of reportingMedian no.Tumor perforationSystemic chemotherapyFebrile neutropeniaIncreasing drug concentrationPeritoneal diseasePeritoneal dissemination
2016
Phase I study of safety and tolerability of sunitinib in combination with sirolimus in patients with refractory solid malignancies and determination of VEGF (VEGF-A) and soluble VEGF-R2 (sVEGFR2) in plasma
Li J, Kluger H, Devine L, Lee JJ, Kelly WK, Rink L, Saif MW. Phase I study of safety and tolerability of sunitinib in combination with sirolimus in patients with refractory solid malignancies and determination of VEGF (VEGF-A) and soluble VEGF-R2 (sVEGFR2) in plasma. Cancer Chemotherapy And Pharmacology 2016, 77: 1193-1200. PMID: 27103123, DOI: 10.1007/s00280-016-3033-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansIndolesMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPyrrolesSirolimusSunitinibTOR Serine-Threonine KinasesVascular Endothelial Growth Factor AVascular Endothelial Growth Factor Receptor-2Young AdultConceptsRenal cell carcinomaComplete responseFourth cohortVEGF productionOral small-molecule inhibitorApparent pharmacokinetic interactionMedian age 57Prior systemic therapyRefractory solid malignanciesResidual renal massTolerability of sunitinibHand-foot syndromeHalf of patientsLymph node dissectionCombination of sunitinibPhase 1 studyDose of sunitinibOral mTOR inhibitorDose/scheduleUnknown compensatory mechanismsCycle 1Multiple receptor tyrosine kinasesAnti-tumor activityEpithelial growth factor receptor (EGFR) signalingTumor cell proliferation
2014
A Phase II study of bevacizumab in combination with trastuzumab and docetaxel in HER2 positive metastatic breast cancer
Zhao M, Pan X, Layman R, Lustberg M, Mrozek E, Macrae E, Wesolowski R, Carothers S, Puhalla S, Shapiro C, Ramaswamy B. A Phase II study of bevacizumab in combination with trastuzumab and docetaxel in HER2 positive metastatic breast cancer. Investigational New Drugs 2014, 32: 1285-1294. PMID: 24894652, PMCID: PMC4303337, DOI: 10.1007/s10637-014-0122-5.Peer-Reviewed Original ResearchConceptsProgression-free survivalLeft ventricular ejection fractionClinical benefit rateHER2-positive MBCObjective response rateComplete responsePartial responseBreast cancerStable diseaseFree survivalGrade 3HER2-positive metastatic breast cancerResponse rateAdditional overall survival benefitsMedian progression-free survivalMetastatic breast cancer patientsPositive metastatic breast cancerVascular epithelial growth factorCommon grade 3Cycles of bevacizumabGrade 2 hypertensionMethods Eligible patientsPrior chemotherapy regimensCombination of bevacizumabHand-foot syndrome
2012
Phase I study of axitinib combined with paclitaxel, docetaxel or capecitabine in patients with advanced solid tumours
Martin LP, Kozloff MF, Herbst RS, Samuel TA, Kim S, Rosbrook B, Tortorici M, Chen Y, Tarazi J, Olszanski AJ, Rado T, Starr A, Cohen RB. Phase I study of axitinib combined with paclitaxel, docetaxel or capecitabine in patients with advanced solid tumours. British Journal Of Cancer 2012, 107: 1268-1276. PMID: 22996612, PMCID: PMC3494424, DOI: 10.1038/bjc.2012.407.Peer-Reviewed Original ResearchConceptsAdvanced solid tumorsCommon treatment-related adverse eventsSolid tumorsTreatment-related adverse eventsAntitumour activitySelective second-generation inhibitorPhase ICo-administered agentsVascular endothelial growth factor receptorHand-foot syndromeEndothelial growth factor receptorHuman xenograft tumor modelsEfficacy of chemotherapyXenograft tumor modelMultiple tumor typesAxitinib pharmacokineticsCapecitabine pharmacokineticsGrowth factor receptorStable diseaseStarting doseAdverse eventsPartial responseComplete responseTreatment regimenDocetaxel exposure
2011
P1-17-10: Cabozantinib (XL184) in Patients with Metastatic Breast Cancer: Results from a Phase 2 Randomized Discontinuation Trial.
Tolaney S, Nechushtan H, Berger R, Kurzrock R, Ron I, Schöffski P, Awada A, Yasenchak C, Burris H, Ramies D, Shen X, Winer E. P1-17-10: Cabozantinib (XL184) in Patients with Metastatic Breast Cancer: Results from a Phase 2 Randomized Discontinuation Trial. Cancer Research 2011, 71: p1-17-10-p1-17-10. DOI: 10.1158/0008-5472.sabcs11-p1-17-10.Peer-Reviewed Original ResearchMetastatic breast cancerObjective response rateStable diseasePartial responseBone scanBreast cancerBone metastasesNarcotic useDiscontinuation trialClinical activityWk 12Common related adverse eventsOverall disease control ratePost-baseline tumour assessmentPrior anti-VEGF therapyBone marker analysesFatigue/astheniaPrior treatment regimensPrior treatment statusDisease control rateHand-foot syndromeProgression-free survivalRelated adverse eventsAnti-VEGF therapyInvasive ductal carcinomaEscalation Trial of Clofarabine Followed by Escalating Dose of Fractionated Cyclophosphamide in Adults with Relapsed or Refractory Acute Leukemias,
Zeidan A, Carraway H, Yun H, Greer J, Karp J. Escalation Trial of Clofarabine Followed by Escalating Dose of Fractionated Cyclophosphamide in Adults with Relapsed or Refractory Acute Leukemias,. Blood 2011, 118: 3615. DOI: 10.1182/blood.v118.21.3615.3615.Peer-Reviewed Original ResearchRefractory acute leukemiaAbsolute lymphocyte countAbsolute neutrophilic countDose level 1Dose-limiting toxicityOverall response rateAdverse cytogeneticsWhite blood cellsM2/dayClinical responseAcute leukemiaDay 1One-year disease-free survivalPhase I dose-escalation trialMedian absolute lymphocyte countElevated liver function testsAllogeneic stem cell transplantI dose-escalation trialTotal white blood cellsSecond-generation purine nucleoside analogDose level 3Dose level 4Dose of CYGrade 3 pneumoniaHand-foot syndromeA phase II trial of gemcitabine (G), carboplatin (C), and sorafenib (S) in patients (pts) with transitional cell carcinoma (TCC): Preliminary safety and outcome.
Mehnert J, Mortazavi A, Stein M, Donadio A, Zelterman D, McDonough J, Rowen E, Hoimes C, Gibney G, Kelly W. A phase II trial of gemcitabine (G), carboplatin (C), and sorafenib (S) in patients (pts) with transitional cell carcinoma (TCC): Preliminary safety and outcome. Journal Of Clinical Oncology 2011, 29: 278-278. DOI: 10.1200/jco.2011.29.7_suppl.278.Peer-Reviewed Original ResearchTransitional cell carcinomaAdvanced transitional cell carcinomaPR/CRDose reductionOral tyrosine kinase inhibitorECOG PS 0Grade 3/4 neutropeniaHand-foot syndromePhase II trialProgression-free intervalMedian age 64Tyrosine kinase inhibitorsAnti-angiogenic propertiesECOG 0Evaluable diseaseMaintenance SNeutropenic feverNonhematologic toxicityHematologic toxicityMaintenance therapyPrimary endpointSecondary endpointsStable diseaseII trialPS 0Quality of Life of Older Patients With Early-Stage Breast Cancer Receiving Adjuvant Chemotherapy: A Companion Study to Cancer and Leukemia Group B 49907
Kornblith AB, Lan L, Archer L, Partridge A, Kimmick G, Hudis C, Winer E, Casey R, Bennett S, Cohen HJ, Muss HB. Quality of Life of Older Patients With Early-Stage Breast Cancer Receiving Adjuvant Chemotherapy: A Companion Study to Cancer and Leukemia Group B 49907. Journal Of Clinical Oncology 2011, 29: 1022-1028. PMID: 21300923, PMCID: PMC3068052, DOI: 10.1200/jco.2010.29.9859.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAgedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineChemotherapy, AdjuvantCyclophosphamideDeoxycytidineDisease-Free SurvivalDoxorubicinFemaleFluorouracilHumansMethotrexateNeoplasm StagingQuality of LifeRisk AssessmentRisk FactorsSurveys and QuestionnairesSurvival AnalysisTime FactorsTreatment OutcomeUnited StatesConceptsEarly-stage breast cancerSystemic adverse effectsStandard chemotherapyBreast cancerCapecitabine treatmentOlder patientsOverall survivalStandard treatmentBetter QOLAdverse effectsHand-foot syndromePhase III trialsLife Questionnaire C30Completion of treatmentQuality of lifeAdjuvant chemotherapyLife substudyIII trialsCancer QualityImproved survivalLess nauseaGood appetiteHospital AnxietyDepression ScaleMonths postbaseline
2009
A phase I study of sunitinib in combination with sirolimus in adults with advanced refractory malignancies
Li J, Kluger H, Saif M, Murren J, Lee J, Kelly W, Rink L, Devine L, Sznol M. A phase I study of sunitinib in combination with sirolimus in adults with advanced refractory malignancies. Journal Of Clinical Oncology 2009, 27: 3554-3554. DOI: 10.1200/jco.2009.27.15_suppl.3554.Peer-Reviewed Original ResearchEarly discontinuationDose reductionDose levelsOral small-molecule inhibitorReceptor tyrosine kinasesAdvanced refractory malignanciesApparent PK interactionsHand-foot syndromeOral mTOR inhibitorDose/scheduleSoft tissue sarcomasDose of sirolimusMultiple receptor tyrosine kinasesAnti-tumor activityTumor cell proliferationDose cohortsECOG PSSunitinib doseInterstitial pneumonitisProgressive diseaseDose escalationTargeted agentsRefractory malignanciesTissue sarcomasPK interactions
2007
Phase I trial of intravenous 17-allylaminogeldanamycin (A) and oral sorafenib (B) in pretreated advanced malignancy: Plasma Hsp90α induction correlates with clinical benefit
Vaishampayan U, Sausville E, Horiba M, Quinn M, Heilbrun L, Burger A, Ivy P, Li J, Lorusso P. Phase I trial of intravenous 17-allylaminogeldanamycin (A) and oral sorafenib (B) in pretreated advanced malignancy: Plasma Hsp90α induction correlates with clinical benefit. Journal Of Clinical Oncology 2007, 25: 3531-3531. DOI: 10.1200/jco.2007.25.18_suppl.3531.Peer-Reviewed Original ResearchAdvanced malignanciesClinical benefitGrade 3 hand-foot syndromeAdequate organ functionGrade 2 nauseaGrade 3 fatigueResponse-evaluable patientsHand-foot syndromePhase II dosePhase I trialSystemic cancer therapyDose cohortsEvaluable patientsInevaluable patientsNCI-CTEPOral sorafenibStable diseaseB. PatientsClinical responseFoot syndromeLatter patientsMajor toxicityPartial responsePerformance statusStable patients
2006
Phase I evaluation of AZD2171, a highly potent and selective inhibitor of VEGFR signaling, in combination with selected chemotherapy regimens in patients with advanced solid tumors
Lorusso P, Heath E, Valdivieso M, Pilat M, Wozniak A, Gadgeel S, Shields A, Puchalski T, Ewesuedo R. Phase I evaluation of AZD2171, a highly potent and selective inhibitor of VEGFR signaling, in combination with selected chemotherapy regimens in patients with advanced solid tumors. Journal Of Clinical Oncology 2006, 24: 3034-3034. DOI: 10.1200/jco.2006.24.18_suppl.3034.Peer-Reviewed Original ResearchVascular endothelial growth factor receptorDose-limiting toxicityArm 1Chemotherapy regimensArm 2Arm 4Grade 3 hand-foot syndromeSolid tumorsGrade 4 neutropenic feverGrade 3 diarrheaGrade 3 fatigueGrade 3 hypertensionHand-foot syndromePhase I evaluationPre-treated patientsAdvanced solid tumorsPhase I trialEndothelial growth factor receptorSolid tumor patientsDuration of responseSelective inhibitorEfficacy/toxicityGrowth factor receptorIdentical chemotherapyNeutropenic fever
2004
The role of the liposomal anthracyclines and other systemic therapies in the management of advanced breast cancer
Robert NJ, Vogel CL, Henderson IC, Sparano JA, Moore MR, Silverman P, Overmoyer BA, Shapiro CL, Park JW, Colbern GT, Winer EP, Gabizon AA. The role of the liposomal anthracyclines and other systemic therapies in the management of advanced breast cancer. Seminars In Oncology 2004, 31: 106-146. PMID: 15717740, DOI: 10.1053/j.seminoncol.2004.09.018.Peer-Reviewed Original ResearchConceptsConventional doxorubicinBreast cancerLiposomal anthracyclinesLiposomal doxorubicinHand-foot syndromeAdvanced breast cancerMultiple phase IIConventional anthracyclinesSystemic therapyProlong survivalStandard dosesContinuous infusionToxicity profileOptimal doseActive drugCytotoxic drugsHigh dosesIntermittent scheduleWeekly scheduleAnthracyclinesNormal tissuesTrastuzumabCancerDoxorubicinNausea
2003
Phase I and II study of exisulind in combination with capecitabine in patients with metastatic breast cancer.
Pusztai L, Zhen JH, Arun B, Rivera E, Whitehead C, Thompson WJ, Nealy KM, Gibbs A, Symmans WF, Esteva FJ, Booser D, Murray JL, Valero V, Smith TL, Hortobagyi GN. Phase I and II study of exisulind in combination with capecitabine in patients with metastatic breast cancer. Journal Of Clinical Oncology 2003, 21: 3454-61. PMID: 12972520, DOI: 10.1200/jco.2003.02.114.Peer-Reviewed Original ResearchMeSH Keywords3',5'-Cyclic-GMP PhosphodiesterasesAdultAgedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineCyclic Nucleotide Phosphodiesterases, Type 2Cyclic Nucleotide Phosphodiesterases, Type 5DeoxycytidineFemaleFluorouracilHumansImmunohistochemistryMiddle AgedNeoplasm MetastasisPhosphoric Diester HydrolasesProdrugsSulindacConceptsMetastatic breast cancerHand-foot syndromeAdverse eventsBreast cancerGrade 2Strong stainingPhase IContinuous daily therapyFrequent grade 2Dose-limiting toxicityOverall clinical benefitPercent of tumorsUnexpected adverse eventsPhase II testingBID dosePrevious anthracyclineStable diseaseDaily therapyTaxane chemotherapyLaboratory abnormalitiesMedian durationPartial responseClinical benefitTumor responseImmunohistochemical assessmentPhase II study of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer.
Rivera E, Valero V, Arun B, Royce M, Adinin R, Hoelzer K, Walters R, Wade JL, Pusztai L, Hortobagyi GN. Phase II study of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer. Journal Of Clinical Oncology 2003, 21: 3249-54. PMID: 12947059, DOI: 10.1200/jco.2003.03.111.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerLiposomal doxorubicinBreast cancerOverall survivalDay 1Median cumulative anthracycline doseLeft ventricular ejection fractionPhase II clinical trialCommon grade 3Cumulative anthracycline doseFrequent nonhematologic toxicitiesPrevious anthracycline exposureHand-foot syndromeMedian overall survivalMedian response durationPhase II studyFront-line therapyVentricular ejection fractionOverall response rateAdjuvant chemotherapyAnthracycline doseAssessable patientsMeasurable diseaseNeutropenic complicationsNonhematologic toxicity
2001
Multicenter, Phase II study of capecitabine in taxane‐pretreated metastatic breast carcinoma patients
Blum J, Dieras V, Russo P, Horton J, Rutman O, Buzdar A, Osterwalder B. Multicenter, Phase II study of capecitabine in taxane‐pretreated metastatic breast carcinoma patients. Cancer 2001, 92: 1759-1768. PMID: 11745247, DOI: 10.1002/1097-0142(20011001)92:7<1759::aid-cncr1691>3.0.co;2-a.Peer-Reviewed Original ResearchConceptsMetastatic breast carcinomaTreatment-related adverse eventsHand-foot syndromeBreast carcinomaAdverse eventsGrade 3 treatment-related adverse eventsCommon treatment-related adverse eventsResponse rateGrade 4 adverse eventsMetastatic breast carcinoma patientsPrevious chemotherapy regimensPrior anthracycline chemotherapyTreatment-related deathsPhase II studyPhase II trialBreast carcinoma patientsSubgroup of patientsOverall response rateCurrent multicenterFluoropyrimidine carbamateOral capecitabineAnthracycline chemotherapyChemotherapy regimensII trialTaxane therapy
1999
Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer.
Blum J, Jones S, Buzdar A, LoRusso P, Kuter I, Vogel C, Osterwalder B, Burger H, Brown C, Griffin T. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. Journal Of Clinical Oncology 1999, 17: 485-93. PMID: 10080589, DOI: 10.1200/jco.1999.17.2.485.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerTreatment-related adverse eventsHand-foot syndromeBreast cancerAdverse eventsCommon treatment-related adverse eventsLarge multicenter phase II trialOnly treatment-related adverse eventMulticenter phase II studyMulticenter phase II trialComplete response durationPrior chemotherapeutic regimensPhase II studyPhase II trialMedian survival timeFavorable toxicity profileOverall response rateFluoropyrimidine carbamateMeasurable diseaseOral capecitabineAssessable diseaseII trialII studyMedian durationMetastatic disease
1998
Oral 5-FU analogues in the treatment of breast cancer.
Bunnell CA, Winer EP. Oral 5-FU analogues in the treatment of breast cancer. Oncology 1998, 12: 39-43. PMID: 9830624.Peer-Reviewed Original ResearchConceptsPhase II trialBreast cancer patientsBreast cancerII trialCancer patientsResponse rateOpen-label phase II trialRandomized phase II studyCombination of UFTHand-foot syndromePartial response ratePhase II studyTreatment-related toxicityAdvanced breast cancerMetastatic breast cancerOverall response rateTreatment of patientsPreliminary response dataAnthracycline useCommon toxicitiesSalvage therapyMetastatic settingII studyTherapeutic armamentariumGrade 3
1989
Low-Dose Continuous Infusion 5-Fluorouracil and Cisplatin
LoRusso P, Pazdur R, Redman B, Kinzie J, Vaitkevicius V. Low-Dose Continuous Infusion 5-Fluorouracil and Cisplatin. American Journal Of Clinical Oncology 1989, 12: 486-490. PMID: 2686394, DOI: 10.1097/00000421-198912000-00005.Peer-Reviewed Original ResearchConceptsContinuous infusionLow-dose continuous infusionMedian performance statusHand-foot syndromeSubclavian vein thrombosisDose continuous infusionMeasurable diseaseMedian durationMedian survivalPartial responsePerformance statusVein thrombosisComplete responseMedian ageGastric ulcerationPatientsSingle agentAntineoplastic activityCisplatinMonthsRest periodInfusionTrialsSurvivalToxicity
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