Evidence map›Paper›PMID 35596182›Full record

Trial reportBMC cancer2022

Health-related quality of life scores of metastatic pancreatic cancer patients responsive to first line chemotherapy compared to newly derived EORTC QLQ-C30 reference values.

Suvina Amin, Seongjung Joo, Sandra Nolte, Hyun Kyoo Yoo, Nikunj Patel, Hilary F Byrnes, Sara Costa-Cabral, Colin D Johnson

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02184195 (A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT02184195 phase3completednot on this map

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

TypeinterventionalSponsorAstraZenecaRan2014 to 2023Enrolled154ConditionsGermline BRCA1/2 Mutations and, Metastatic Adenocarcinoma of the PancreasArmsOlaparib, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Pancreatic cancer.Nature reviews. Disease primers · 2026
    Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
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

8 authors.

Suvina AminAstraZeneca, One Medimmune Way, Gaithersburg, MD, 20878, USA.
Seongjung JooMerck & Co, Inc, Kenilworth, NJ, 07033, USA.
Sandra NolteICON Clinical Research GmbH, Konrad-Zuse-Platz 11, 81829, Munich, Germany.
Hyun Kyoo YooAstraZeneca, City house, 130 Hills road, Cambridge, CB2 1RE, UK.
Nikunj PatelAstraZeneca, One Medimmune Way, Gaithersburg, MD, 20878, USA.
Hilary F ByrnesICON plc, 731 Arbor Way, Suite 100, Blue Bell, PA, 19422, USA. Hilary.Byrnes@iconplc.com.
Sara Costa-CabralMapi Research Trust, 27, Rue de la Villette, 3rd & 4th Floors, 69003, Lyon, France.
Colin D JohnsonUniversity of Southampton, University Road, Southampton, SO17 BJ, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetastatic pancreatic cancer (mPC) and its treatments significantly impact health-related quality of life (HRQoL). POLO, a randomized, double-blind, placebo-controlled phase 3 trial evaluated the efficacy of olaparib as maintenance therapy in germline BRCA mutated mPC patients who had not progressed during ≥16 weeks of first-line platinum-based chemotherapy. HRQoL was assessed using the EORTC QLQ-C30. To enhance score interpretation, we derived reference values for treatment-naïve mPC patients from the literature.

methodsA targeted literature review identified EORTC QLQ-C30 baseline values in treatment-naïve mPC patients. Reference values were calculated by deriving means from studies meeting inclusion criteria, with scores from 0 to 100 (higher scores indicate better QoL/functioning but worse symptoms). For POLO patients, means were calculated using pooled baseline data across study arms.

resultsFour studies met inclusion criteria. Depending on the specific scale, sample sizes ranged from n = 466 to n = 639. Compared to newly derived reference values, POLO patients reported markedly better HRQoL scores at baseline across most scales, with eight scales showing differences of ≥10 points. POLO patients' HRQoL scores were often close to or better than general population norm data.

conclusionsThis is the first study to systematically derive EORTC QLQ-C30 reference values for mPC. POLO patients had better HRQoL scores than those in the literature and similar to general population data. Comparatively high HRQoL of POLO patients are likely due to effects of prior first-line treatment and resolution of chemotherapy-related symptoms, response shift, or a combination. Newly derived reference values can enhance interpretation of mPC patients' HRQoL.

trial registrationThe POLO trial was registered on 9 July 2014 with ClinicalTrials.gov as NCT02184195.

Indexed as

Pancreatic NeoplasmsQuality of LifeHumansReference ValuesSurveys and QuestionnairesEORTC QLQ-C30Health-related quality of lifePancreatic carcinomaPatient-reported outcomeReference values

Identifiers

PMID35596182
PMCPMC9123808

What OpenQuestion holds

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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 OpenQuestion graph.