Phase I Study of Lenalidomide in Solid Tumors

Miller, Antonius A.; Case, Doug; Harmon, Michele; Savage, Paul; Lesser, Glenn J.; Hurd, David D.; Melin, Susan A.

doi:10.1097/01.jto.0000268679.33238.67

Cited by 21 publications

(19 citation statements)

References 19 publications

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“…Overall, in phase I studies of single-agent lenalidomide in patients with pancreatic cancer, no responses were noted [32,33,40].…”

Section: Pancreatic Cancermentioning

confidence: 99%

“…In a phase I study of lenalidomide (5, 10, 25 mg/day) in 20 patients with solid tumors, one patient (25 mg/day) developed grade 3 motor neuropathy [40]. One patient with nonsmall-cell lung cancer (NSCLC) had a PR, and three patients had SD (NSCLC, n = 2; epithelioid hemangioendothelioma, n = 1).…”

Section: Lung Cancermentioning

confidence: 99%

“…One patient with nonsmall-cell lung cancer (NSCLC) had a PR, and three patients had SD (NSCLC, n = 2; epithelioid hemangioendothelioma, n = 1). Responders with NSCLC had received prior gemcitabine, carboplatin, and docetaxel [40].…”

Section: Lung Cancermentioning

confidence: 99%

“…Phase I studies of lenalidomide included patients with breast cancer but did not report clinical efficacy [38,40].…”

Section: Breast Cancermentioning

confidence: 99%

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Lenalidomide in solid tumors

Segler

Tsimberidou

2012

Cancer Chemother Pharmacol

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“…Overall, in phase I studies of single-agent lenalidomide in patients with pancreatic cancer, no responses were noted [32,33,40].…”

Section: Pancreatic Cancermentioning

confidence: 99%

Section: Lung Cancermentioning

confidence: 99%

Section: Lung Cancermentioning

confidence: 99%

“…Phase I studies of lenalidomide included patients with breast cancer but did not report clinical efficacy [38,40].…”

Section: Breast Cancermentioning

confidence: 99%

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Lenalidomide in solid tumors

Segler

Tsimberidou

2012

Cancer Chemother Pharmacol

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“…As with thalidomide, the exact moleculartargetsoflenalidomideremainunclear,butstudies invitroandanimalmodelssuggestimmunomodulatoryactivitythroughmodificationofthecellularandhumoralcomponentsoftheimmunesystem,antiangiogeniceffects,interferencewithsignaltransductionpathways,anddirectantitumor activity [8][9][10][11][12].Evidencefromexploratoryclinicalstudiessuggestsanevolvingroleoflenalidomideincancermanagement [13][14][15]andparticularlyinprostatecancer [16,17].…”

Section: Rationale For the Administration And Dosing Of Lenalidomide mentioning

confidence: 99%

Long-Term Disease Stabilization in a Patient with Castration-Resistant Metastatic Prostate Cancer by the Addition of Lenalidomide to Low-Dose Dexamethasone and Celecoxib

Marschner

Zaiss²

2012

Onkologie

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Background: Treatment of castrationresistant prostate cancer (CRPC) remains a challenge considering that most patients are elderly men with significant comorbidities. Alternative treatment strategies to cytotoxic therapy should be explored. There is evidence that the continuous administration of cyclooxygenase 2 (COX2) inhibitors and the immunomodulatory agents thalidomide or lenalidomide can result in longterm disease stabilization. Case Report: A 70-year-old patient with castrationresistant metastatic prostate cancer was treated with a combination of lowdose dexamethasone, celecoxib and subsequently lenalidomide. The patient had longterm disease stabilization for 33 months and a very good performance status despite moderate side effects, i.e. moderate Cushing’s syndrome and mild laboratory hematologic toxicity. Conclusion: The addition of lenalidomide to low-dose dexamethasone and celecoxib resulted in an impressive longterm disease stabilization of CRPC in this patient, allowing him to lead an active life with a good quality of life.

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Severe Hypoglycemia Caused by Lenalidomide

2017

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Lenalidomide is commonly used for multiple myeloma as either induction or maintenance therapy. The agent is associated with a host of adverse effects, but hypoglycemia has only been reported in one phase I trial in patients with solid tumors. We describe a 74-year-old woman who experienced grade 3 hypoglycemia (blood glucose level 35 mg/dl) likely related to lenalidomide. Her medical history was significant for refractory myeloma and type 2 diabetes mellitus. Lenalidomide was started as maintenance therapy following autologous bone marrow transplantation. Approximately 3 years later, she developed refractory hypoglycemia necessitating hospital admission despite stopping antihyperglycemic agents 4 weeks prior to admission. Lenalidomide was withheld during her admission and restarted 2 days prior to discharge. Work-up for causes of persistent hypoglycemia was negative, and her glucose levels improved over her 26-day hospitalization. She was readmitted approximately one month later for hypoglycemia, and lenalidomide was permanently discontinued. Again, work-up for causes of hypoglycemia was negative, and her glucose levels stabilized over her hospitalization. After discontinuation of lenalidomide, hypoglycemia did not recur, and within 1 year the patient required reinitiation of antihyperglycemic medications to control her glucose levels. Given the resolution of hypoglycemia with lenalidomide discontinuation and return of hyperglycemia after restarting the agent, it is likely that lenalidomide was the cause of the patient's hypoglycemia. Use of the Naranjo adverse drug reaction probability scale indicated a definite relationship (score of 9) between the patient's development of grade 3 hypoglycemia and lenalidomide therapy. Although this adverse drug reaction had been previously reported with lenalidomide during phase I trials in patients with solid tumors, only grade 1 or 2 hypoglycemia was reported in three patients. To our knowledge, this is the first reported case of grade 3 hypoglycemia caused by lenalidomide. KEY WORDS lenalidomide, hypoglycemia, multiple myeloma.

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Phase I Study of Lenalidomide in Solid Tumors

Abstract: The recommended dose of lenalidomide for further studies in patients with solid tumors is 25 mg/day for 4 weeks followed by a 2-week rest period.

Cited by 21 publications

References 19 publications

Lenalidomide in solid tumors

Lenalidomide in solid tumors

Long-Term Disease Stabilization in a Patient with Castration-Resistant Metastatic Prostate Cancer by the Addition of Lenalidomide to Low-Dose Dexamethasone and Celecoxib

Severe Hypoglycemia Caused by Lenalidomide

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