. Author manuscript; available in PMC: 2019 Nov 20.

Published in final edited form as: Am Soc Clin Oncol Educ Book. 2018 May 23;38:978–997. doi: 10.1200/EDBK_199765

Table 6.

Effect of ESR1 Mutations on Clinical Outcome in Patients Receiving Endocrine Therapies in PALOMA3 Trial

Variable	ESR1-Mutated		Odds Ratio or Hazard Ratio (95% CI); p Value Statistical Consideration
Variable	Palbociclib + Fulvestrant	Placebo + Fulvestrant
Patients, n	63	28
ORR, %	17.5	3.6	5.94^* (0.78–270.5); .06
Median PFS, mo (95% CI)	9.4 (5.3–11.1)	3.6 (2.0–5.5)	0.43^** (0.25–0.74); .002
	ESR1 Wild Type
	Palbociclib + Fulvestrant	Placebo + Fulvestrant
Patients, n	177	92
ORR,%	21.5	14.1	1.66^* (0.81–3.61); .14
Median PFS, mo (95% CI)	9.5 (9.2–NE)	5.4 (3.5–7.4)	0.49^** (0.35–0.70); ≤.001
	ESR1 Status Available
	ESR1 Wild Type	ESR1-Mutated
Patients, n	261	91
Median PFS (95% CI)	9.2 (7.4–10.9)	7.3 (3.7–9.1)	1.46^** (1.06–2.02); .02

Odds ratio (univariate analysis).

^**

Hazard ratio (univariate analysis).

Abbreviations: ORR, overall response rate; NE, not evaluable.