SWOG S0722: Phase II study of mTOR inhibitor everolimus (RAD001) in advanced Malignant Pleural Mesothelioma (MPM)

Sai Hong Ignatius Ou, James Moon, Linda L Garland, Philip C. Mack, Joseph R. Testa, Anne S. Tsao, Antoniette J. Wozniak, David R. Gandara

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

INTRODUCTION:: The PI3K/Akt/mammalian target of rapamycin pathway is activated in a majority of malignant pleural mesotheliomas (MPM). We evaluated the activity of everolimus, an oral mammalian target of rapamycin inhibitor, in patients with unresectable MPM. METHODS:: MPM patients who had received at least one but no more than two prior chemotherapy regimens, which must have been platinum-based, were treated with 10 mg of everolimus daily. The primary endpoint was 4-month progression-free survival (PFS) by RECIST 1.1. RESULTS:: A total of 59 evaluable patients were included in the analysis. The median duration of treatment was 2 cycles (56 days). Overall response rate was 2% [95% confidence interval (CI): 0-12%] by RECIST 1.1 and 0% (0-10%) by modified RECIST for MPM. The 4-month PFS rate was 29% (95% CI: 17-41%) by RECIST 1.1, and 27% (95% CI: 16-39%) by modified RECIST. The median PFS was 2.8 months (95% CI: 1.8-3.4) by RECIST 1.1. The median overall survival was 6.3 months (95% CI: 4.0-8.0). There was no difference in PFS among patients who received one or two prior chemotherapy regimens (p = 0.74). There was no difference in overall survival between patients with epithelioid histology versus other types (p = 0.47). The most common toxicities were fatigue (59%), hypertriglyceridemia (44%), anemia (42%), oral mucositis (34%), nausea (32%), and anorexia (32%). The most common grade 3 to 4 toxicities were fatigue (10.2%), anemia (6.8%), and lung infection (6.8%). CONCLUSION:: Everolimus has limited clinical activity in advanced MPM patients. Additional studies of single-agent everolimus in advanced MPM are not warranted.

Original languageEnglish (US)
Pages (from-to)387-391
Number of pages5
JournalJournal of Thoracic Oncology
Volume10
Issue number2
DOIs
StatePublished - Feb 6 2015

Fingerprint

Disease-Free Survival
Confidence Intervals
Sirolimus
Fatigue
Anemia
Drug Therapy
Stomatitis
Survival
Hypertriglyceridemia
Anorexia
Platinum
Phosphatidylinositol 3-Kinases
Nausea
Malignant Mesothelioma
Everolimus
Response Evaluation Criteria in Solid Tumors
Histology
Survival Rate
Lung
Infection

Keywords

  • Everolimus
  • Malignant pleural mesothelioma
  • Modified RECIST
  • mTOR inhibitor

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

SWOG S0722 : Phase II study of mTOR inhibitor everolimus (RAD001) in advanced Malignant Pleural Mesothelioma (MPM). / Ou, Sai Hong Ignatius; Moon, James; Garland, Linda L; Mack, Philip C.; Testa, Joseph R.; Tsao, Anne S.; Wozniak, Antoniette J.; Gandara, David R.

In: Journal of Thoracic Oncology, Vol. 10, No. 2, 06.02.2015, p. 387-391.

Research output: Contribution to journalArticle

Ou, Sai Hong Ignatius ; Moon, James ; Garland, Linda L ; Mack, Philip C. ; Testa, Joseph R. ; Tsao, Anne S. ; Wozniak, Antoniette J. ; Gandara, David R. / SWOG S0722 : Phase II study of mTOR inhibitor everolimus (RAD001) in advanced Malignant Pleural Mesothelioma (MPM). In: Journal of Thoracic Oncology. 2015 ; Vol. 10, No. 2. pp. 387-391.
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AU - Mack, Philip C.

AU - Testa, Joseph R.

AU - Tsao, Anne S.

AU - Wozniak, Antoniette J.

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