Evidence map›Paper›PMID 34521387›Full record

Trial reportBMC cancer2021

Prospective observational study on Pazopanib in patients treated for advanced or metastatic renal cell carcinoma in countries in Asia Pacific, North Africa, and Middle East regions: PARACHUTE study.

Mustafa Erman, Bivas Biswas, Pongwut Danchaivijitr, Lingwu Chen, Yoke Fui Wong, Tarek Hashem, Chun Sen Lim, Bulent Karabulut, Hsiao-Jen Chung, Chandrasekhar Chikatapu and 3 more

Erratum issuedAbstract readClinical Trial, Phase IVObservational Study
In one paragraph

Trial report in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Mustafa ErmanMedical Oncology, Hacettepe University, Ankara, Turkey.
Bivas BiswasMedical Oncology, Tata Medical Center, Kolkata, West Bengal, India.
Pongwut DanchaivijitrMedical Oncology, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Lingwu ChenMedical Oncology, The First Affiliated Hospital of Sun Yat-sen, Guangzhou, Guangdong Province, China.
Yoke Fui WongRadiotherapy and Oncology, National Cancer Institute, Putrajaya, Malaysia.
Tarek HashemMedical Oncology, Dr Tarek Hashem's Clinic, Cairo, Egypt.
Chun Sen LimClinical Oncology, Sultan Ismail Hospital, Johor Bahru, Malaysia.
Bulent KarabulutMedical Oncology, Ege University, Izmir, Turkey.
Hsiao-Jen ChungDepartment of Urology, Taipei Veterans General Hospital and Department of Urology, College of Medicine and Shu-Tien Urological Research Cente, National Yang Ming Chiao Tung University, Taipei, Taiwan.
Chandrasekhar ChikatapuOncology, Novartis Healthcare Pvt Ltd, Hyderabad, Telangana, India.
Sara InglesOncology, Novartis Pharma AG, Basel, Switzerland.
Khemaies SlimaneOncology, Novartis Pharma SAS, Rueil-Malmaison, France.
Ravindran KanesvaranDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore. ravindran.kanesvaran@singhealth.com.sg.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical effectiveness and safety data of pazopanib in patients with advanced or mRCC in real-world setting from Asia Pacific, North Africa, and Middle East countries are lacking.

methodsPARACHUTE is a phase IV, prospective, non-interventional, observational study. Primary endpoint was the proportion of patients remaining progression free at 12 months. Secondary endpoints were ORR, PFS, safety and tolerability, and relative dose intensity (RDI).

resultsOverall, 190 patients with a median age of 61 years (range: 22.0-96.0) were included. Most patients were Asian (70%), clear-cell type RCC was the most common (81%), with a favourable (9%), intermediate (47%), poor (10%), and unknown (34%) MSKCC risk score. At the end of the observational period, 78 patients completed the observational period and 112 discontinued the study; 60% of patients had the starting dose at 800 mg. Median RDI was 82%, with 52% of patients receiving < 85%. Of the 145 evaluable patients, 56 (39%) remained progression free at 12 months, and the median PFS was 10 months (95% CI: 8.48-11.83). 19% of patients (21/109) were long-term responders (on pazopanib for ≥18 months). The best response per RECIST 1.1 was CR/PR in 24%, stable disease in 44%, and PD in 31%. Most frequent (> 10%) TEAEs related to pazopanib included diarrhoea (30%), palmar-plantar erythrodysesthesia syndrome (15%), and hypertension (14%).

conclusionsResults of the PARACHUTE study support the use of pazopanib in patients with advanced or mRCC who are naive to VEGF-TKI therapy. The safety profile is consistent with that previously reported by pivotal and real-world evidence studies.

Indexed as

AdultAfrica, NorthernAgedAged, 80 and overAngiogenesis InhibitorsAntineoplastic AgentsAsiaCarcinoma, Renal CellFemaleHumansIndazolesKidney NeoplasmsMaleMiddle AgedMiddle EastProgression-Free SurvivalAngiogenesis InhibitorsAntineoplastic AgentsIndazolespazopanibPyrimidinesSulfonamidesPARACHUTEPazopanibReal-world studyRenal cell carcinoma

Identifiers

PMID34521387
PMCPMC8442269

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.