Evidence map›Paper›PMID 31679139›Full record

Observational studyEndocrine2020

Thyroid profile during the alternative Sunitinib dosing 2/1 schedule in metastatic renal cell carcinoma.

L Rizza, E Sbardella, D Gianfrilli, R Lauretta, M Tenuta, G Del Bene, F Longo, A Faggiano, A Lenzi, E Giannetta and 1 more

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Endocrine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 18% 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.

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

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Article
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

11 authors at 2 institutions in 1 country.

L Rizza *Endocrinology Unit, Department of Oncology and Medical Specialities, AO San Camillo-Forlanini, Rome, Italy.
E Sbardella *Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
D GianfrilliDepartment of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
R LaurettaInternal Medicine, Angiolini Hospital of Bagno di Romagna, Forlì Cesena, Italy.
M TenutaDepartment of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
G Del BeneDepartment of Radiological, Oncological and Anatomopathological Sciences, Sapienza University of Rome, Rome, Italy.
F LongoDepartment of Radiological, Oncological and Anatomopathological Sciences, Sapienza University of Rome, Rome, Italy.
A FaggianoDepartment of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
A LenziDepartment of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
E GiannettaDepartment of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
C PozzaDepartment of Experimental Medicine, Sapienza University of Rome, Rome, Italy. carlotta.pozza@uniroma1.it.
Sapienza University of Rome · ITAzienda Unità Sanitaria Locale Della Romagna · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeHypothyroidism is a common side effect of Sunitinib (SUN) treatment in metastatic renal cell carcinoma (mRCC) patients. We aimed to evaluate thyroid profile during the alternative 2/1 SUN treatment schedule and to assess the predictive value of hypothyroidism in terms of survival.

methodsWe performed a prospective observational study enrolling 42 consecutive mRCC patients starting first-line alternative SUN dosing 2/1 schedule. Thyroid function was assessed at baseline and during the first three SUN cycles (1 cycle = 6 weeks = 2 ON/1 OFF + 2 ON/1 OFF), and then after 6 and 12 months. Thyroid ultrasound was performed at baseline and after 3, 6, and 12 months.

resultsSubclinical hypothyroidism developed in 24% of patients during the first cycle; in other 24% in the second cycle and in 14% in the third cycle. The highest TSH values were reached during the second cycle, ON phase (6.58 ± 5.74 μI U/l). We observed a reduction in thyroid size, in echogenicity and in parenchymal perfusion in all patients. Progression-free survival (PFS) tended to be longer in patients with TSH ≥ 5 μI U/ml during the second cycle (p = 0.069). TSH level was an independent risk factor for PFS in men (p = 0.009) but not in women (p = 0.285).

conclusionsThis is the first study investigating functional and morphological effects on thyroid during the alternative 2/1 SUN schedule in mRCC patients. We detected an early onset of subclinical hypothyroidism, observing the association between TSH ≥ 5 μI U/ml and: (i) longer PFS in men; (ii) progressive decrease of thyroid size in absence of significant changes in autoimmune thyroid profile.

Indexed as

Antineoplastic AgentsCarcinoma, Renal CellKidney NeoplasmsFemaleHumansIndolesMalePyrrolesSunitinibThyroid GlandAntineoplastic AgentsIndolesPyrrolesSunitinibHypothyroidismTarget therapyTSHTyrosine kinase inhibitors

Identifiers

PMID31679139
OpenAlexW2987809121

What OpenQuestion holds

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Registered trials

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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.