| General information |
| Database: | DB01007 |
| Objective: | Thisphase II study investigated the efficacy and safety of everolimus, an inhibitor of mammalian target of rapamycin (mTOR), in locally advanced or metastatic thyroid cancer. |
| Authors: | Lim SM, et al |
| Title: | A multicenter, phase II trial of everolimus in locally advanced or metastatic thyroid cancer of all histologic subtypes. |
| Journal: | Ann Oncol |
| Year: | 2013 |
| PMID: | 24050953 |
| Trial Design |
| Clinical Trial Id: | NCT01164176 |
| Agent: | everolimus
|
| Target: | Serine/threonineprotein kinase mTOR
|
| Cancer Type: | thyroid cancer |
| Cancer Subtype: | advanced thyroid cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | A multicenter, phase II trial |
| Key Patients Feature: | Patients with thyroid cancer of any histology that was resistant or not appropriate for (131)I |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received everolimus 10 mg daily orally until unacceptable toxicity or disease progression. |
| Primary End Point: | disease control rate [partial response (PR) + stable response more than and equal to 12 weeks]. |
| Secondary End Point: | response rates, clinical benefit (PD + durable stable disease (SD)], progression free survival (PFS), overall survival, duration of response, and safety. |
| Patients Number: | 38 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 5% |
| Disease Control Rate: | 81% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 47 weeks [95% confidence interval (CI) 14.978.5]. |
| Median OS A vs. C: | NR(not reached) |
| Adverse Event(agent arm): | the most common events included mucositis (84%), anorexia (44%), and aspartate transaminase (AST)/alanine transaminase (ALT) elevation (26%) (Table 3). The most common grade 3 AEs were mucositis (15%) and diarrhea (10%). One patient (2%) discontinued treatment because of treatmentrelated toxicity. She suffered from everolimusrelated interstitial pneumonitis G4 which required broadspectrum IV antibiotics and corticosteroid. She recovered from pneumonitis 2 weeks after hospitalization. One patient (2%) suffered from infection G5 resulting from acute pyelonephritis which was not considered by the investigator to be related. |
| Conclusions: | Everolimus had a limited activity with low response rate in locally advanced or metastatic thyroid cancer. Reasonable clinical benefit rate and safety profile may warrant further investigation. |