Clin Cancer Res: The efficacy of mTOR inhibitor sapanisertib combined with fulvestrant in the treatment of postmenopausal women with advanced breast cancer with ER+/HER2- after progression on aromatase inhibitor

Recently, a phase II clinical study was published in the journal Clin Cancer Res, mainly to evaluate the mTOR inhibitor sapanisertib combined with fulvestrant in the treatment of postmenopausal women with advanced breast cancer with ER+/HER2- after aromatase inhibitor progression.
curative effect
.

Recently, a phase II clinical study was published in the journal Clin Cancer Res, mainly to evaluate the mTOR inhibitor sapanisertib combined with fulvestrant in the treatment of postmenopausal women with advanced breast cancer with ER+/HER2- after aromatase inhibitor progression.
curative effect
.

breast cancer

Postmenopausal women with estrogen receptor-positive (ER+)/HER2 advanced or metastatic breast cancer that progressed during or after aromatase inhibitor therapy were randomized to receive fulvestrant 500 mg alone, fulvestrant plus sapanisertib 4 mg QD, or Fulvestrant plus sapanisertib 30 mg QW until disease progression, unacceptable toxicity, withdrawal consent, or study termination
.

Postmenopausal women with estrogen receptor-positive (ER+)/HER2 advanced or metastatic breast cancer that progressed during or after aromatase inhibitor therapy were randomized to receive fulvestrant 500 mg alone, fulvestrant plus sapanisertib 4 mg QD, or Fulvestrant plus sapanisertib 30 mg QW until disease progression, unacceptable toxicity, withdrawal consent, or study termination
.

The study included 141 patients, 46, 47, and 48 patients in the fulvestrant alone, fulvestrant plus sapanisertib 4 mg QD, or fulvestrant plus sapanisertib 30 mg QW groups
.

The median age was 58 years (33–84)

The study included 141 patients, 46, 47, and 48 patients in the fulvestrant alone, fulvestrant plus sapanisertib 4 mg QD, or fulvestrant plus sapanisertib 30 mg QW groups

The median PFS was 3.

PFS

PFS

Subgroup analysis

Subgroup analysis

The median OS was 30.
5 months with fulvestrant alone, not yet reached with fulvestrant + sapanisertib QD (HR, 0.
71; 95% CI, 0.
36 1.
40; P = 0.
276), fulvestrant + sapanisertib QW group was 34.
2 months (HR, 0.
89; 95% CI, 0.
47 1.
68; P = 0.
470)
.

The median OS was 30.
5 months with fulvestrant alone, not yet reached with fulvestrant + sapanisertib QD (HR, 0.
71; 95% CI, 0.
36 1.
40; P = 0.
276), fulvestrant + sapanisertib QW group was 34.
2 months (HR, 0.
89; 95% CI, 0.
47 1.
68; P = 0.
470)
.

The median OS was 30.

The ORR of the three groups was 10.

                  Efficacy assessment

  Efficacy assessment

The most common adverse events were nausea, vomiting, and hyperglycemia, all of which occurred more frequently in the combination arm
.

The incidence of discontinuation due to adverse events was higher in the two combination arms than with fulvestrant alone (32%, 36%, and 4%, respectively)

The most common adverse events were nausea, vomiting, and hyperglycemia, all of which occurred more frequently in the combination arm

In conclusion, the study showed that the combination of mTOR inhibitor sapanisertib with fulvestrant did not actually improve the prognosis of postmenopausal women with advanced breast cancer who were ER+/HER2- after progression on aromatase inhibitor

Original source:

García-Sáenz JÁ, Martínez-Jáñez N, Cubedo R, Jerez Y, Lahuerta A, González-Santiago S, Ferrer N, Ramos M, Alonso-Romero JL, Antón A, Carrasco E, Chen J, Neuwirth R, Galinsky K, Vincent S, Leonard EJ, Slamon D.

García-Sáenz JÁ, Martínez-Jáñez N, Cubedo R, Jerez Y, Lahuerta A, González-Santiago S, Ferrer N, Ramos M, Alonso-Romero JL, Antón A, Carrasco E, Chen J, Neuwirth R, Galinsky K, Vincent S, Leonard EJ, Slamon D.
Sapanisertib Plus Fulvestrant in Post-Menopausal Women with Estrogen Receptor-Positive/HER2-Negative Advanced Breast Cancer After Progression on Aromatase Inhibitor.
Clin Cancer Res.
2022 Jan 3:clincanres.
2652.
2021.
doi: 10.
1158 /1078-0432.
CCR-21-2652.
Epub ahead of print.
PMID: 34980598.
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