2024
Neurofilament light chains: A biomarker for vincristine-related neuropathy.
McNally G, Xu M, Voorhees T, Baiocchi R, Bond D, Epperla N, Maddocks K, Sawhala Y, Ramaswamy B, Lustberg M. Neurofilament light chains: A biomarker for vincristine-related neuropathy. Journal Of Clinical Oncology 2024, 42: 12114-12114. DOI: 10.1200/jco.2024.42.16_suppl.12114.Peer-Reviewed Original ResearchChemotherapy-induced peripheral neuropathyPatient-reported outcomesNF-L levelsPeripheral neuropathyTime point 3Cancer Institute Common Terminology Criteria for Adverse EventsNational Cancer Institute Common Terminology Criteria for Adverse EventsCommon Terminology Criteria for Adverse EventsAggressive non-Hodgkin's lymphomaSymptoms of chemotherapy-induced peripheral neuropathyDose-adjusted EPOCHNon-Hodgkin's lymphomaNF-LVincristine-induced neurotoxicityTime pointsLight chainClinician-reported outcome measuresNeurofilament light chainEuropean Organization for Research and TreatmentCycle fourLymphoma treatmentLong-term qualityBlood-based biomarkersChemotherapy typeAdverse events
2023
Retrospective cohort study of CDK4/6-inhibitor-induced alopecia in breast cancer patients
Minta A, Rose L, Park C, Ramaswamy B, Stover D, Gatti-Mays M, Cherian M, Williams N, Sudheendra P, Wesolowski R, Sardesai S, Lustberg M, Loprinzi C, Ruddy K, Cathcart-Rake E, Trovato S, Dulmage B. Retrospective cohort study of CDK4/6-inhibitor-induced alopecia in breast cancer patients. Supportive Care In Cancer 2023, 31: 717. PMID: 37991653, DOI: 10.1007/s00520-023-08160-0.Peer-Reviewed Original ResearchConceptsBreast cancer patientsTherapeutic responseAdverse eventsClinical characteristicsCancer patientsCommon cutaneous adverse eventsCutaneous adverse eventsPoor systemic absorptionRetrospective cohort studyComparison of pretreatmentEIA patientsEndocrine monotherapyClinical improvementCohort studyRetrospective cohortOncologic treatmentTopical antiandrogenCombination therapySystemic absorptionAndrogenetic alopeciaDean scaleMethodsThis studyPatientsAlopeciaScore gradeMitigating long-term and delayed adverse events associated with cancer treatment: implications for survivorship
Lustberg M, Kuderer N, Desai A, Bergerot C, Lyman G. Mitigating long-term and delayed adverse events associated with cancer treatment: implications for survivorship. Nature Reviews Clinical Oncology 2023, 20: 527-542. PMID: 37231127, PMCID: PMC10211308, DOI: 10.1038/s41571-023-00776-9.Peer-Reviewed Original ResearchConceptsAdverse eventsEvidence-based clinical practice guidelinesChemotherapy-associated adverse eventsNon-pharmacological treatment strategiesAdverse effectsClinical practice guidelinesAdverse treatment effectsCourse of therapyTotality of evidenceQuality of lifeTerms of survivalRisk assessment toolOptimal therapyCancer survivorsRisk factorsOncology practiceTreatment strategiesPractice guidelinesUnderlying biological mechanismsAppropriate managementAnticancer treatmentCancer treatmentEffective interventionsTreatment effectsChemotherapyPhase Ib study of HSP90 inhibitor, onalespib (AT13387), in combination with paclitaxel in patients with advanced triple-negative breast cancer
Williams N, Quiroga D, Johnson C, Brufsky A, Chambers M, Bhattacharya S, Patterson M, Sardesai S, Stover D, Lustberg M, Noonan A, Cherian M, Bystry D, Hill K, Chen M, Phelps M, Grever M, Stephens J, Ramaswamy B, Carson W, Wesolowski R. Phase Ib study of HSP90 inhibitor, onalespib (AT13387), in combination with paclitaxel in patients with advanced triple-negative breast cancer. Therapeutic Advances In Medical Oncology 2023, 15: 17588359231217976. PMID: 38152697, PMCID: PMC10752118, DOI: 10.1177/17588359231217976.Peer-Reviewed Original ResearchAdvanced triple-negative breast cancerTriple-negative breast cancerProgression-free survivalDuration of responseOverall response ratePrior taxane therapyAdverse eventsTaxane therapyCombination therapyBreast cancerMedian DORMedian progression-free survivalNon-hematologic adverse eventsPhase Ib studyPhase Ib trialPhase II doseAcceptable toxicity profileDose-limiting toxicityDrug interaction profileIb trialIntravenous paclitaxelPaclitaxel efficacyExpansion cohortCombination regimenMetastatic disease
2021
A Cardiac Rehabilitation Program for Breast Cancer Survivors: A Feasibility Study
Zvinovski F, Stephens JA, Ramaswamy B, Reinbolt RE, Noonan AM, VanDeusen JB, Wesolowski R, Stover DG, Williams NO, Sardesai SD, Mehta L, Foraker R, Gulati M, Lustberg M, Quick AM. A Cardiac Rehabilitation Program for Breast Cancer Survivors: A Feasibility Study. Journal Of Oncology 2021, 2021: 9965583. PMID: 34135964, PMCID: PMC8178006, DOI: 10.1155/2021/9965583.Peer-Reviewed Original ResearchBreast cancer survivorsSerious adverse eventsBrief Fatigue InventoryCancer survivorsQLQ-C30Risk factorsStudy protocolSingle-arm feasibility studyCardiovascular disease risk factorsVO2 maxCVD risk factorsCardiac rehabilitation programDisease risk factorsCardiac rehabilitation interventionsBreast cancer populationQuality of lifeSecondary endpointsAdverse eventsCR programPreliminary efficacyCancer patientsCancer populationFatigue InventoryOverall adherenceMean changeEmerging Pharmacological and Non-Pharmacological Therapeutics for Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy
Li Y, Lustberg MB, Hu S. Emerging Pharmacological and Non-Pharmacological Therapeutics for Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy. Cancers 2021, 13: 766. PMID: 33673136, PMCID: PMC7918689, DOI: 10.3390/cancers13040766.Peer-Reviewed Original ResearchChemotherapy-induced peripheral neuropathyPeripheral neuropathyPathogenesis of CIPNTreatment of CIPNFirst-line chemotherapeutic agentNon-pharmacological therapeuticsCommon adverse eventsNon-pharmacological strategiesQuality of lifeAdverse eventsClinical outcomesCancer survivorsEffective intervention strategiesClinical trialsSide effectsChemotherapeutic agentsEffective interventionsVinca alkaloidsNew targetsIntervention strategiesNeuropathyPrior failureClinical researchersPlatinum compoundsTherapeuticsAdverse Events and Perception of Benefit From Duloxetine for Treating Aromatase Inhibitor-Associated Arthralgias
Schnell PM, Lustberg MB, Henry NL. Adverse Events and Perception of Benefit From Duloxetine for Treating Aromatase Inhibitor-Associated Arthralgias. JNCI Cancer Spectrum 2021, 5: pkab018. PMID: 33842832, PMCID: PMC8023424, DOI: 10.1093/jncics/pkab018.Peer-Reviewed Original ResearchConceptsPatient-perceived benefitsAdverse eventsBrief Pain Inventory-Short FormAromatase Inhibitor–Associated ArthralgiaDuloxetine-treated patientsOriginal primary outcomeDouble-blind trialLow-grade toxicityEffect of duloxetineSubgroup of patientsAverage painComparable patientsAppropriate patientsPrimary outcomeMusculoskeletal symptomsBreast cancerPlaceboDuloxetineSide effectsFunctional assessmentPatientsSecondary analysisFavorable effectTreatmentPerceptions of benefitsPatient-reported sexual function of breast cancer survivors with genitourinary syndrome of menopause after fractional CO2 laser therapy
Quick AM, Zvinovski F, Hudson C, Hundley A, Evans C, Stephens JA, Arthur E, Ramaswamy B, Reinbolt RE, Noonan AM, VanDeusen JB, Wesolowski R, Stover DG, Williams NO, Sardesai SD, Faubion SS, Loprinzi CL, Lustberg MB. Patient-reported sexual function of breast cancer survivors with genitourinary syndrome of menopause after fractional CO2 laser therapy. Menopause The Journal Of The North American Menopause Society 2021, 28: 642-649. PMID: 33534429, DOI: 10.1097/gme.0000000000001738.Peer-Reviewed Original ResearchConceptsFemale Sexual Function IndexBC survivorsSexual functionSingle-arm feasibility studyFemale Sexual Distress ScaleOverall FSFI scoreSymptoms of GSMBreast cancer survivorsPatient-reported outcomesSexual Function IndexFractional CO2 laser therapySexual Distress ScaleCO2 laser therapyFSDS-R scoresFractional CO2 laserFSFI scoreAdverse eventsGenitourinary syndromePatient demographicsVaginal drynessCancer survivorsDisease characteristicsFunction IndexLaser therapyDistress Scale
2020
Pilot study of fractional CO2 laser therapy for genitourinary syndrome of menopause in gynecologic cancer survivors
Quick AM, Dockter T, Le-Rademacher J, Salani R, Hudson C, Hundley A, Terstriep S, Streicher L, Faubion S, Loprinzi CL, Coleman JS, Wang KC, Lustberg M. Pilot study of fractional CO2 laser therapy for genitourinary syndrome of menopause in gynecologic cancer survivors. Maturitas 2020, 144: 37-44. PMID: 33358206, PMCID: PMC7773136, DOI: 10.1016/j.maturitas.2020.10.018.Peer-Reviewed Original ResearchConceptsGynecologic cancer survivorsFemale Sexual Functioning IndexVaginal Assessment ScaleCancer survivorsLaser therapyTreatment armsSexual functionFractional COMedian total FSFI scoreMedian UDI-6 scoreRandomized sham-controlled trialUDI-6 scoresUrinary Distress InventorySerious adverse eventsSham-controlled trialProportion of patientsMedian VAS scoreTotal FSFI scoreFractional CO2 laser therapyCO2 laser therapyLaser treatmentPreliminary evidenceAdenocarcinoma histologyUrinary symptomsAdverse eventsManagement of adverse events in patients with HER2+ metastatic breast cancer treated with tucatinib, trastuzumab, and capecitabine (HER2CLIMB).
Okines A, Paplomata E, Wahl T, Wright G, Sutherland S, Jakobsen E, Valdes F, Chan A, Clark A, Conlin A, Lustberg M, Specht J, Pluard T, Zhu X, Krop I, Gelmon K, Slamon D, Ramos J, An G, Hamilton E. Management of adverse events in patients with HER2+ metastatic breast cancer treated with tucatinib, trastuzumab, and capecitabine (HER2CLIMB). Journal Of Clinical Oncology 2020, 38: 1043-1043. DOI: 10.1200/jco.2020.38.15_suppl.1043.Peer-Reviewed Original ResearchAdverse eventsMedian timeControl armBreast cancerExposure-adjusted incidence ratesElevated liver enzymesMetastatic breast cancerCases of diarrheaMedian durationDose modificationTx groupIncidence rateLiver enzymesHigh incidenceDiarrheaTucatinibFirst onsetCapecitabineTrastuzumabHER2Significant inhibitionBilirubinLonger durationCycle 1Patients
2019
350P Phase Ib study of heat shock protein 90 inhibitor, onalespib in combination with paclitaxel in patients with advanced, triple negative breast cancer (NCT02474173)
Wesolowski R, Brufsky A, Chambers M, Bhattacharya S, Lustberg M, VanDeusen J, Sardesai S, Williams N, Noonan A, Phelps M, Grever M, Stephens J, Carson W, Ramaswamy B. 350P Phase Ib study of heat shock protein 90 inhibitor, onalespib in combination with paclitaxel in patients with advanced, triple negative breast cancer (NCT02474173). Annals Of Oncology 2019, 30: v126. DOI: 10.1093/annonc/mdz242.045.Peer-Reviewed Original ResearchTriple-negative breast cancerOverall response rateNegative breast cancerBreast cancerDay 1Cancer Therapy Evaluation ProgramCycle 1Clinical benefit rateCommon grade 3Dose level 1Dose-expansion studyHigher adverse eventsPhase Ib studySchedule of paclitaxelAcceptable safety profileProgression-free survivalHeat shock protein 90 inhibitorShock protein 90 inhibitorsNational Cancer InstituteEvaluable ptsPaclitaxel hypersensitivityStudy regimenAdverse eventsMethods PatientsSafety profileThe Global POLAR program: Two pivotal placebo-controlled studies of calmangafodipir used on top of modified FOLFOX6 to prevent chemotherapy-induced peripheral neuropathy (CIPN).
Lustberg M, Pfeiffer P, Qvortrup C, Muro K, Bengtson M, Nittve M, Sonesson C, Nagahama F, Sonehara Y, Carlsson C. The Global POLAR program: Two pivotal placebo-controlled studies of calmangafodipir used on top of modified FOLFOX6 to prevent chemotherapy-induced peripheral neuropathy (CIPN). Journal Of Clinical Oncology 2019, 37: tps3616-tps3616. DOI: 10.1200/jco.2019.37.15_suppl.tps3616.Peer-Reviewed Original ResearchChemotherapy-induced peripheral neuropathyChronic chemotherapy-induced peripheral neuropathyMetastatic colorectal cancerProportion of patientsFree survivalSafety endpointCumulative doseHigh-risk stage IIAdditional safety endpointsProgressive-free survivalCommon adverse eventsPlacebo-controlled studyDisease-free survivalOxaliplatin-induced neuropathyTreatment of patientsManganese superoxide dismutase activitySuperoxide dismutase mimeticFOLFOX6 chemotherapyMFOLFOX6 chemotherapyOXA treatmentPrimary endpointAdverse eventsFirst doseOverall survivalMS patientsThe Global POLAR program: Calmangafodipir used on top of modified FOLFOX6 (5-FU/FA and oxaliplatin) to prevent chemotherapy induced peripheral neuropathy (CIPN).
Pfeiffer P, Qvortrup C, Muro K, Lustberg M, Nagahama F, Sonehara Y, Bengtson M, Nittve M, Sonesson C, Carlsson C. The Global POLAR program: Calmangafodipir used on top of modified FOLFOX6 (5-FU/FA and oxaliplatin) to prevent chemotherapy induced peripheral neuropathy (CIPN). Journal Of Clinical Oncology 2019, 37: tps722-tps722. DOI: 10.1200/jco.2019.37.4_suppl.tps722.Peer-Reviewed Original ResearchMetastatic colorectal cancerProportion of patientsFree survivalSafety endpointCumulative doseHigh-risk stage IIAdditional safety endpointsProgressive-free survivalCommon adverse eventsOxaliplatin-induced neuropathyDisease-free survivalPatient reported symptomsTreatment of patientsManganese superoxide dismutase activitySuperoxide dismutase mimeticFOLFOX6 chemotherapyMFOLFOX6 chemotherapyOXA treatmentPrimary endpointAdverse eventsFirst doseOverall survivalMS patientsPeripheral neuropathyTreatment breaks
2018
Fractional CO2 laser therapy for genitourinary syndrome of menopause (GSM) in survivors of breast cancer (BC).
Quick A, Zvinovski F, Hudson C, Hundley A, Evans C, Suresh A, Stephens J, Carpenter K, Ramaswamy B, Reinbolt R, Noonan A, VanDeusen J, Wesolowski R, Stover D, Williams N, Sardesai S, Smith K, Faubion S, Loprinzi C, Lustberg M. Fractional CO2 laser therapy for genitourinary syndrome of menopause (GSM) in survivors of breast cancer (BC). Journal Of Clinical Oncology 2018, 36: 202-202. DOI: 10.1200/jco.2018.36.34_suppl.202.Peer-Reviewed Original ResearchVaginal Assessment ScaleSerious adverse eventsFractional CO2 laser therapyCO2 laser therapyFemale Sexual Function IndexUrogenital Distress InventoryVaginal drynessBC survivorsBreast cancerLaser therapyStudy treatmentSingle-arm feasibility studySecondary efficacy endpointsFinal efficacy analysisSexual Function IndexER/PRFractional CO2 laser treatmentFractional CO2 laserEndocrine therapySham laserEfficacy endpointFSFI scoreAdverse eventsGenitourinary syndromePrimary efficacy
2014
Treatment‐Related Mortality With Everolimus in Cancer Patients
Wesolowski R, Abdel‐Rasoul M, Lustberg M, Paskell M, Shapiro C, Macrae E. Treatment‐Related Mortality With Everolimus in Cancer Patients. The Oncologist 2014, 19: 661-668. PMID: 24794158, PMCID: PMC4041666, DOI: 10.1634/theoncologist.2013-0355.Peer-Reviewed Original ResearchConceptsFatal adverse eventsTreatment-related mortalityCancer patientsAdverse eventsOverall incidenceSan Antonio Breast Cancer SymposiumRole of everolimusControl group patientsMultiple solid tumorsEverolimus administrationGroup patientsCancer SymposiumSubgroup analysisControl armOdds ratioEverolimusFatal eventsClinical OncologyPatientsSolid tumorsPubMed databaseTumor typesIncidenceAmerican SocietySignificant differences