Armando Orlandi: PATRICIA Trial Final OS Results
Armando Orlandi, Medical Director at the Agostino Gemelli University Hospital Foundation IRCCS, shared on LinkedIn about a recent paper by T. Pascual et al. published on ScienceDirect:
“PATRICIA Trial Final OS Results: Confirming the PATINA Success Story
The final overall survival analysis from the SOLTI-1303-PATRICIA trial, just published in ESMO Open, provides compelling validation of the CDK4/6i + anti-HER2 strategy, reinforcing the groundbreaking PATINA trial results across different treatment settings.
From Primary to Final Analysis
- Primary endpoint: 6-month PFS (initially met)
- Final OS data: median follow-up 60.5 months, 56 deaths (78.9%)
- Overall median OS: 29.8 months (95% CI: 20.9-38.0)
- 4-year OS rates: 13.3% (cohort A), 35.7% (cohort B1), 32.3% (cohort B2)
PATINA Confirmation Across Treatment Lines
PATINA (1st-line maintenance):
- PFS: 44.3 vs 29.1 months (HR 0.52)
- Phase III randomized design
PATRICIA (heavily pretreated):
- Median OS: 29.8 months in heavily pretreated patients (2-4 prior regimens)
- PAM50 luminal subtypes: OS 38.0 vs 26.8 months
- Key insight: CDK4/6 + anti-HER2 efficacy spans from 1st-line to late-line settings
Biomarker-Driven Strategy Validated
Both trials demonstrate:
- Superior outcomes in hormone receptor-positive disease
- Importance of patient selection (PAM50 luminal in PATRICIA)
- Durable benefit of non-chemotherapy combinations
- Consistent safety profile across treatment lines
Building the Evidence
PATRICIA Strengths in Context:
- Validates PATINA concept in different patient population
- Long-term OS data supports durability of approach
- Genomic profiling identifies optimal candidates
- Chemotherapy-sparing strategy across disease stages
Translational Synergy
Together, PATINA and PATRICIA create a compelling narrative: CDK4/6i + anti-HER2 + endocrine therapy represents a paradigm shift from chemotherapy-dependent approaches to targeted, biomarker-driven strategies in HER2+/HR+ breast cancer.
Clinical Integration
These complementary studies establish CDK4/6i+ anti-HER2 combinations as a validated therapeutic backbone, with PATINA proving first-line efficacy and PATRICIA demonstrating activity even in heavily pretreated patients.The convergence of these results strongly supports incorporating this strategy across the treatment continuum for appropriately selected patients.”
Title: Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
Authors: T. Pascual, G. Villacampa, M. Oliveira, S. Escrivá-de-Romaní, S. Pernas, L. Paré, B. Adamo, E. Martínez, J. Cortés, A. Perelló, M. Galan, M. Melé, L. Villanueva, M. Gonzalez-Rodriguez, P. Tolosa, B. González-Farré, P. Galván, J. Canes, P. Nuciforo, J.M. Ferrero-Cafiero, X. González-Farré, P. Villagrasa, A. Prat, E. Ciruelos
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