Table 4 Studies of mTOR inhibitors in endometrial cancer

From: Everolimus as second- or third-line treatment of advanced endometrial cancer: ENDORAD, a phase II trial of GINECO

Study

Population ( N)

Treatment

Best overall response (%)

Median duration of non-progressive disease (months)

Median PFS (months)

Median OS (months)

Disc. due to AEs (%)

Everolimus

Current study

Recurrent/metastatic disease refractory to 1 or 2 chemotherapy regimens (44)

10 mg per day PO

CR: 0

PR: 9

SD: 27

PD: 57

NA: 6

Response: 3.1

SD: 4.3

2.8

8.1

35

Slomovitz et al, 2010

Progressive/recurrent disease treated with 1 or 2 chemotherapy regimens (35)

10 mg per day PO

CR: 0

PR: 0

SD: 43a

PD: 57a

4.5

NA

NA

40

Temsirolimus

NCIC IND160 (Oza et al, 2011a)

Metastatic or locally advanced chemotherapy-naive disease (33)

25 mg IV weekly

CR: 0

PR: 24/14b

SD: 69

PD: 15

Response: 5.1

SD: 9.7

7.33

NA

27

 

Metastatic or locally advanced disease treated with 1 chemotherapy regimen (27)

25 mg IV weekly

CR: 0

PR: 7/4b

SD: 48

PD: 48

Response: 4.9

SD: 3.8

3.25

NA

 

Fleming et al, 2011

Advanced, persistent, or recurrent disease previously treated with ⩽1 chemotherapy regimen (20)c

25 mg IV weekly

CR: 10

PR: 20

SD: 55

PD: 15

NA

NA

NA

18

Ridaforolimus

NCIC IND 192 (Mackay et al, 2011)

Recurrent or metastatic disease; only adjuvant chemotherapy permitted (34)

40 mg per dayd PO 5 days per week

CR: 0

PR: 7d

SD: 53

PD: 40

PR: 7.9 and 17.3e

SD: 7.1

NA

NA

38

Oza et al, 2011b

Advanced or metastatic disease treated with 1 or 2 lines of chemotherapy (64)

40 mg per day PO 5 days per week

CR+PR: 8/0b

SD: 56/35b

PD: 23/25b

NA

5.6/3.6b

9.6

33

Colombo et al, 2007; ARIAD Pharmaceuticals Inc., 2012

Advanced disease with documented progression despite previous chemotherapy (45)

12.5 mg IV 5 consecutive days every other week

CR: 0

PR: 10

SD: 19

NA

NA

NA

NA

  1. Abbreviations: AE, adverse event; CR=complete response; IV=intravenous; mTOR=mammalian target of rapamycin; NA=not available; NCIC=National Cancer Institut Canada; OS=overall survival; PD=progressive disease; PFS=progression-free survival; PO=orally; PR=partial response; SD=stable disease.
  2. aAt 8 weeks.
  3. bPresented as response as assessed by investigator/response as assessed by independent review.
  4. cIncludes only those patients treated with temsirolimus alone.
  5. dBoth patients who experienced PR were chemotherapy naive.
  6. eDuration of response in the two patients who experienced PR.
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