Onkologikoa Foundation, San Sebastían and Catalan Institute of Oncology-IDIBELL, L’Hospitalet de Llobregat, Barcelona, Spain
Ander Urruticoechea , Mohammed Rizwanullah , Seock-Ah Im , Antonio Carlos Sánchez Ruiz , Istvan Lang , Gianluca Tomasello , Hannah Douthwaite , Tanja Badovinac Crnjevic , Sarah Heeson , Jennifer Eng-Wong , Montserrat Munoz
Background: In PHEREXA (NCT01026142), adding P to H + X did not significantly improve independent review facility-assessed progression-free survival (IRF-PFS; primary endpoint) in patients with HER2-positive MBC who received a prior taxane and progressed during or after H-based therapy (hazard ratio [HR] 0.82; 95% confidence interval [CI] 0.65–1.02; p= .0731). An 8-month increase in median OS to 36.1 months was observed with P, but due to hierarchical testing of IRF-PFS, and subsequently of OS, statistical significance could not be claimed. No new safety signals were identified. We now report the final prespecified analysis. Methods: Randomization arms were A: intravenous H 8 mg/kg→6 mg/kg every 3 weeks (q3w) + oral X 1250 mg/m2 twice daily (2 weeks on, 1 week off q3w) and B: intravenous P 840 mg→420 mg q3w + intravenous H per Arm A + oral X 1000 mg/m2 (same schedule as Arm A). Treatment was given until disease progression, unmanageable toxicity, or patient request for discontinuation. OS and investigator-assessed PFS (INV-PFS) were assessed in the intent-to-treat population (all randomly assigned patients); adverse events (AEs), in the safety population (patients who received ≥1 dose of study drug). Results are descriptive. Results: At clinical cutoff (20-Sep-17), median time on study, including follow-up, was 23 months in Arm A and 33 months in Arm B. Efficacy is shown in the table. There was a small increase in AE incidence with longer follow-up, and no new symptomatic left ventricular systemic dysfunction (0 patients in Arm A and 5 [2.2%] in Arm B). Conclusions: While final OS results of PHEREXA are descriptive, median OS of 37.3 months in Arm B, with a 9.1-month increase versus Arm A, shows that clinical efficacy of H + P is maintained with longer follow-up. There were no new safety signals and no evidence of late cardiac toxicity. Clinical trial information: NCT01026142
Arm A H + X n = 224 | Arm B P + H + X n = 228 | |
---|---|---|
OS | ||
Events, n (%) | 136 (60.7) | 134 (58.8) |
Median, months | 28.1 | 37.2 |
∆, months | 9.1 | |
HR (95% CI) | 0.76 (0.60–0.98) | |
INV- PFS | ||
Events, n (%) | 182 (81.3) | 201 (88.2) |
Median, months | 9.0 | 11.8 |
∆, months | 2.8 | |
HR (95% CI) | 0.83 (0.68–1.02) |
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Abstract Disclosures
2016 ASCO Annual Meeting
First Author: Ander Urruticoechea
2022 ASCO Gastrointestinal Cancers Symposium
First Author: Daisuke Takahari
2023 ASCO Annual Meeting
First Author: Qamar J. Khan
2023 ASCO Annual Meeting
First Author: Qiao Li