Evidence map›Paper›PMID 36463643›Full record

Trial reportBreast (Edinburgh, Scotland)2022

Effect of palbociclib plus endocrine therapy on time to chemotherapy across subgroups of patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer: Post hoc analyses from PALOMA-2 and PALOMA-3.

Hope S Rugo, Seock-Ah Im, Anil A Joy, Yaroslav Shparyk, Janice M Walshe, Bethany Sleckman, Sherene Loi, Kathy Puyana Theall, Sindy Kim, Xin Huang and 4 more

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Breast (Edinburgh, Scotland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01740427 phase3completednot on this map

A randomized, multicenter, double-blind phase 3 study of pd-0332991 (oral cdk 4/6 inhibitor) plus letrozole versus placebo plus letrozole for the treatment of postmenopausal women with er (+), her2 (-) breast cancer who have not received any prior systemic anti cancer treatment for advanced disease

TypeinterventionalSponsorPfizerRan2013 to 2023Enrolled666ConditionsBreast NeoplasmsArmsPD-0332991, Letrozole, Placebo
NCT01942135 phase3completednot on this map

Multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of fulvestrant (faslodex (registered)). with or without pd-0332991 (palbociclib) +/- goserelin in women with hormone receptor-positive, her2-negative metastatic breast cancer whose disease progressed after prior endocrine therapy

TypeinterventionalSponsorPfizerRan2013 to 2022Enrolled521ConditionsMetastatic Breast CancerArmsPalbociclib, Fulvestrant, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
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  4. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 11 institutions in 7 countries.

Hope S RugoUniversity of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, Department of Medicine (Hematology/Oncology), 1825 4th Street, 3rd Floor, Box 1710, San Francisco, CA, 94158, USA. Electronic address: hope.rugo@ucsf.edu.
Seock-Ah ImSeoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, 101 Daehak-ro, Jonro-gu, Seoul 03080, Republic of Korea. Electronic address: moisa@snu.ac.kr.
Anil A JoyCross Cancer Institute, University of Alberta, 11560 University Ave NW, Edmonton, AB T6G1Z2, Canada. Electronic address: Anil.Joy@albertahealthservices.ca.
Yaroslav ShparykLviv State Oncologic Regional Treatment and Diagnostic Center, Lviv, Ukraine. Electronic address: yshparyk@ukr.net.
Janice M WalsheCancer Trials Ireland, St Vincent's University Hospital, Elm Park, Dublin 4, Ireland. Electronic address: Janice.Walshe@svuh.ie.
Bethany SleckmanMercy Hospital St. Louis, 607 S New Ballas Road, Suite 3300, St. Louis, MO, 63141, USA. Electronic address: bethany.sleckman@mercy.net.
Sherene LoiPeter MacCallum Cancer Centre, University of Melbourne, Australia. Electronic address: Sherene.Loi@petermac.org.
Kathy Puyana TheallPfizer Oncology, 300 Technology Square, Cambridge, MA 02139, USA. Electronic address: Kathy.Theall@pfizer.com.
Sindy KimPfizer Inc, 10555 Science Center Dr, San Diego, CA 92121, USA. Electronic address: Sindy.Kim@pfizer.com.
Xin HuangPfizer Inc, 10555 Science Center Dr, San Diego, CA 92121, USA. Electronic address: Xin.Huang@pfizer.com.
Eustratios BananisPfizer Inc, 235 E 42nd St, New York, NY, 10017, USA. Electronic address: stratis.bananis@pfizer.com.
Reshma MahtaniMiami Cancer Institute, Baptist Health South Florida, Member, Memorial Sloan Kettering Cancer Alliance, 1228 South Pine Island Road, Plantation, FL, 33324, USA. Electronic address: rmahtani@baptisthealth.net.
Richard S FinnDavid Geffen School of Medicine, 2825 Santa Monica Blvd, Suite 200, Santa Monica, CA, 90404, USA. Electronic address: RFinn@mednet.ucla.edu.
Véronique DiérasUnicancer Centre Eugène Marquis, Avenue de la Bataille Flandres-Dunkerque, CS 44229, 35042, Rennes Cedex, France. Electronic address: v.dieras@rennes.unicancer.fr.
Pfizer (United States) · USBaptist Hospital of Miami · USCancer Trials Ireland · IECentre Eugène Marquis · FRKyiv City Clinical Oncology Center · UAMercy Hospital · USPeter MacCallum Cancer Centre · AUSanta Monica College · USSeoul National University Hospital · KRUCSF Helen Diller Family Comprehensive Cancer Center · USUniversity of Alberta · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious analyses from the PALOMA-2 and PALOMA-3 studies showed that palbociclib (PAL) plus endocrine therapy (ET) prolongs time to first subsequent chemotherapy (TTC) versus placebo (PBO) plus ET in the overall population of patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative (HR+/HER2-) advanced breast cancer (ABC). Here, we evaluated TTC in relevant patient subgroups.

methodsThese post hoc analyses evaluated TTC by subgroup using data from 2 randomized, phase 3 studies of women with HR+/HER2- ABC. In PALOMA-2, postmenopausal patients previously untreated for ABC were randomized 2:1 to receive PAL (125 mg/day, 3/1-week schedule) plus letrozole (LET; 2.5 mg/day; n = 444) or PBO plus LET (n = 222). In PALOMA-3, premenopausal or postmenopausal patients whose disease had progressed after prior ET were randomized 2:1 to receive PAL (125 mg/day, 3/1-week schedule) plus fulvestrant (FUL; 500 mg; n = 347) or PBO plus FUL (n = 174).

resultsFirst subsequent chemotherapy was received by 35.5% and 56.2% in PALOMA-2 and PALOMA-3 after progression on palbociclib plus ET or placebo plus ET. Across all subgroups analyzed, the median progression-free survival (PFS) was longer in the PAL plus ET arm than the PBO plus ET arm. TTC was longer with PAL plus ET versus PBO plus ET across the same patient subgroups in both studies.

conclusionsAcross all subgroups, PAL plus ET versus PBO plus ET had longer median PFS and resulted in prolonged TTC in both the PALOMA-2 and PALOMA-3 studies. Pfizer Inc (NCT01740427, NCT01942135).

Indexed as

Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsErb-b2 Receptor Tyrosine KinasesFemaleFulvestrantHumansPiperazinesPyridinesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesFulvestrantpalbociclibPiperazinesPyridinesAdvanced breast cancerChemotherapyPalbociclibProgression-free survivalSafety

Identifiers

PMID36463643
PMCPMC9720565
OpenAlexW4309348334

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.