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PATINA

Breast Cancer

PATINA

Manufactured by: Pfizer
Product name: Ibrance® (palbociclib)

About the PATINA Trial

The PATINA trial was a Phase 3, randomized, open-label study evaluating the addition of palbociclib to standard anti-HER2 therapy and endocrine therapy in patients with HER2-positive, hormone receptor-positive metastatic breast cancer. The trial’s primary endpoint was progression-free survival (PFS), with secondary endpoints including overall survival (OS) and safety. The addition of palbociclib significantly improved PFS compared to anti-HER2 and endocrine therapy alone, supporting the strategy of incorporating CDK4/6 inhibition into the treatment of this molecular subtype. The safety profile was manageable and consistent with previously reported data on palbociclib, with no unexpected adverse events. These findings were presented at the 2024 San Antonio Breast Cancer Symposium (SABCS) and were highlighted by key opinion leaders such as Ilana Schlam and the Oncology Brothers, who provided further insights into the clinical implications for integrating CDK4/6 inhibitors in HER2+/HR+ metastatic disease.

Table of Contents

Major Presentations and Milestones

PATINA Trial design, results, and conclusions

PATINA Sentiments and Criticisms

PATINA Temporal Sentiment Arc

Professional Resources : Interactive Tweet History, Influence Diagram, Sentiment Table, AI Chatbot

FDA approval signal (tweeted): Erika P. Hamilton, MD noted: “T-DXd + pertuzumab approved for 1st L HER-2+ #bcsm!” and framed the downstream clinical question as “debates around induction length, maintenance, re-induction etc.” https://x.com/ErikaHamilton9/status/2000621940491657511

PATINA Trial: Major Presentations and Milestones

Primary speakers driving the story

Online discussion around PATINA was catalyzed by Paolo Tarantino, MD (who signposted the trial’s late addition to the San Antonio program) and then rapidly consolidated around Otto Metzger, MD (Dana-Farber Cancer Institute), who presented the phase 3 results at the San Antonio Breast Cancer Symposium (SABCS 2024). The early narrative emphasized a “practice-changing” maintenance strategy in HR+/HER2+ metastatic breast cancer after induction THP, with multiple KOLs highlighting the absolute PFS gain (≈15 months) and the practical implications for sequencing in the emerging DESTINY-Breast09 era.

As the presentation landed, Sara Tolaney, MD (Dana-Farber Cancer Institute) posted a concise summary of the key efficacy results and follow-up, reinforcing how quickly the community interpreted the trial as actionable for routine care.

By SABCS 2025, the conversation broadened from “PFS magnitude” to CNS outcomes and implementation in a rapidly shifting 1L HER2+ landscape (DB-09, HER2CLIMB-05, and PATINA). Stephanie Graff, MD, FACP, FASCO highlighted the CNS progression signal with palbociclib.

PATINA Trial Design, Results, and Conclusions

Trial Design:

PATINA (AFT-38) is a phase 3 trial in HR+/HER2+ metastatic breast cancer evaluating whether adding palbociclib to standard anti-HER2 plus endocrine maintenance improves outcomes after induction therapy. As summarized by Ilana Schlam, MD, patients (n=518) received induction THP and then were treated with HP + endocrine therapy ± palbociclib. https://x.com/IlanaSchlam/status/1867267431405678599

Primary Results (PFS):

Multiple KOLs converged on the same core efficacy message: a clinically large improvement in PFS with palbociclib added to maintenance anti-HER2 + endocrine therapy. Paolo Tarantino, MD quoted: “44 vs 29 months, HR 0.74, p=0.007.” https://x.com/PTarantinoMD/status/1867270082625196056

Ilana Schlam, MD contextualized the magnitude and population: “PFS was 29 vs 44 months with palbo” in “n=518 HR+/HER2+ mBC” after THP induction. https://x.com/IlanaSchlam/status/1867267431405678599

Erika Hamilton, MD emphasized the absolute delta and maintenance framing: “Wow, #PATINA shows 15 month improved PFS … when palbociclib is added to ET +HER-2 antibodies in maintenance 1st line setting after chemo induction.” https://x.com/ErikaHamilton9/status/1867234802593849710

Overall Survival (immature):

Community posts repeatedly cautioned that OS was not yet definitive. Oncology Brothers summarized: “OS not mature yet.” https://x.com/OncBrothers/status/1867296019551015341

CNS progression (SABCS 2025 focus):

At SABCS 2025, discussion increasingly centered on whether palbociclib might reduce CNS progression risk. Sara Tolaney, MD wrote: “Among pts w/no CNS mets at baseline, cumulative risk of CNS progression or death: 12.8% (palbo) vs 19.0% (control), p=0.0378 … caveat: no mandatory CNS imaging at baseline or in f/u.” https://x.com/stolaney1/status/1999247544233115957

Nicole Casasanta, MD provided additional CNS detail and a baseline-CNS subgroup snapshot: “At 36 mo, cum. incidence CNS progression/death 13.4% vs 19.9% for palbo vs control P =0.04,” while noting small baseline CNS numbers (“Palbo (n=11), Control (n=9)”). https://x.com/ncasasanta/status/2001099600392802502

Patient-reported outcomes / QoL:

Later in the evidence arc, PROs were emphasized as reassuring for long-term maintenance. Guilherme Nader Marta, MD posted that adding palbociclib “maintained HRQoL,” with “similar time to symptom progression (HR 0.89)” and stable FACT-B TOI and EQ-5D-5L scores over time. https://x.com/GuiNaderMarta/status/1980197881597534349

Key Conclusions:

Across tweets, PATINA was interpreted as establishing a compelling maintenance strategy after induction THP in HR+/HER2+ metastatic disease, with a consistent ~15-month median PFS improvement and emerging (but methodologically caveated) CNS signals. The practical clinical question shifted toward how to integrate PATINA-style maintenance into a first-line environment increasingly influenced by antibody–drug conjugates (e.g., T-DXd + pertuzumab) and tucatinib-based maintenance trials.

PATINA Sentiments and Criticisms

Positive Reception:

Paolo Tarantino, MD (SABCS 2024): “Otto Metzger (@Otto_DFCI) presents the practice-changing results from the #PATINA phase 3 trial… significantly and meaningfully improved PFS (44 vs 29 months, HR 0.74, p=0.007). 44 months!!!!!!!!!!!!!!!!!!!!!!!!” https://x.com/PTarantinoMD/status/1867270082625196056

Sara Tolaney, MD (SABCS 2024): “PFS 44.3 vs 29.1 mo, HR 0.74, p=0.0074… Amazing benefit!!!!” https://x.com/stolaney1/status/1867267861036904636

Hope Rugo, MD (SABCS 2024 anticipation): “Long awaited results and very exciting advance for our patients!! Almost all of my patients still on this well tolerated quadruplet Rx.” https://x.com/hoperugo/status/1867227709312504307

Critical Perspectives / Implementation Concerns:

Enrique Soto (SABCS 2024): “Pts have gotten through a tough chemo, if you add something toxic to their subsequent therapy, it should increase OS! … We NEED to stop saying toxicities are ‘manageable’, the palbo group had much more toxicities, it should be said like that, without spin” https://x.com/EnriqueSoto8/status/1867269383703474600

Suyog Cancer (commentary on design/selection): “So that is how smart trial design help you to get impressive PFS results. You select pts with good biology at the end of induction chemo…” https://x.com/SuyogCancer/status/1867393684821447139

Anis Toumeh, MD (ASCO 2025 context, comparing to evolving T-DXd strategies): “With PATINA mPFS of 44m, I am not sure this is straightforward from a change of practice standpoint.” https://x.com/AnisToumeh/status/1929542709519249891

Nuanced consensus emerging:

Even among supportive voices, the debate moved quickly to duration and tolerability of prolonged T-DXd-based induction and the need for maintenance. Erika Hamilton, MD asked: “do we think we are really going to give years and years of TDXd 1st line? … Feel like we should have a maintenance strategy after induction.” https://x.com/ErikaHamilton9/status/1867238639362879729

Eleonora Teplinsky, MD, FASCO (SABCS 2025): “Not everyone needs upfront T-DXd and the side effects of prolonged T-DXd are significant. A maintenance approach is critical. THP with maintenance tucatinib or palbociclib is an excellent option.” https://x.com/drteplinsky/status/1998803333126267270

PATINA Temporal Sentiment Arc

2024 (SABCS24: “practice-changing” reveal)

Primary/KOL tweets:

2025 (ASCO25/ESMO25: sequencing debates and QoL data)

Primary/KOL tweets:

Late 2025 (SABCS25: CNS protection and maintenance strategy consolidation)

Primary/KOL tweets:

Across the full arc, PATINA evolved from a SABCS 2024 “late-breaking practice change” story into a 2025–2026 implementation and sequencing debate: how to preserve long PFS while minimizing cumulative toxicity, and whether palbociclib-containing maintenance meaningfully changes CNS natural history in HR+/HER2+ metastatic disease.

PATINA Professional Resources