Evidence map›Paper›PMID 21052661›Full record

Trial reportEuropean journal of nuclear medicine and molecular imaging2011

Phase II study of radiopeptide 177Lu-octreotate and capecitabine therapy of progressive disseminated neuroendocrine tumours.

Phillip G Claringbold, Paul A Brayshaw, Richard A Price, J Harvey Turner

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in European journal of nuclear medicine and molecular imaging, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04194125 (Clinical Study of Radiopeptide 177Lu-DOTATOC in Combination With Capecitabine and Temozolomide in Advanced, Non-resectable and Progressive Neuroendocrine Tumors With Somatostatin Receptor Overexpression), which is not on this map. Cited by 87 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
87citing papers in PubMed, 4 pooled it
4.9field-weighted citation impact, top 5% 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.

NCT04194125 phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

Clinical Study of Radiopeptide 177Lu-DOTATOC in Combination With Capecitabine and Temozolomide in Advanced, Non-resectable and Progressive Neuroendocrine Tumors With Somatostatin Receptor Overexpression

TypeinterventionalSponsorUniversity of Warmia and MazuryRan2019 to 2022Enrolled25ConditionsNeuroendocrine TumorsArms177Lu-DOTATOC
3 · Its place in the literature

Who cites it

87 citing papers in PubMed, 4 syntheses or guidelines pooled it, 207 citations in OpenAlex.

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27 more citing papers are in PubMed but not listed here.

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

4 authors at 2 institutions in 1 country.

Phillip G ClaringboldDepartment of Oncology, Fremantle Hospital, Fremantle, WA, Australia.
Paul A Brayshaw
Richard A Price
J Harvey Turner
Fremantle Hospital · AUUniversity of Western Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn this phase II study we investigated the safety and efficacy of combination capecitabine and (177)Lu-octreotate for the treatment of disseminated, progressive, unresectable neuroendocrine tumours (NETs).

methodsEnrolled in the study were 33 patients with biopsy-proven NETs, positive (111)In-octreotide scintigraphy and progressive disease measurable by CT/MRI who were to receive four cycles of 7.8 GBq (177)Lu-octreotate 8-weekly, with 14 days of 1,650 mg/m(2) capecitabine per day.

resultsOf the 33 patients, 25 completed four cycles. Minimal transient myelosuppression at 3-4 weeks caused grade 3 thrombocytopenia in one patient but no neutropenia. Nephrotoxicity was absent. Critical organ radiation dosimetry provided median estimates of the dose per cycle to the kidneys of 2.4 Gy and to the liver of 4.8 Gy, and showed cumulative doses all below toxic thresholds. Objective response rates (ORR) were 24% partial response (PR), 70% stable disease (SD) and 6% progressive disease. Median progression-free survival and median overall survival had not been reached at a median follow-up of 16 months (range 5-33 months). Survival at 1 and 2 years was 91% (95% CI 75-98%) and 88% (95% CI 71-96%), respectively.

conclusionThe addition of capecitabine radiosensitizing chemotherapy does not increase the minimal toxicity of (177)Lu-octreotate radiopeptide therapy and led to an ORR of 24% PR and 70% minor response or SD in patients with progressive metastatic NETs. Tumour control and stabilization of disease was obtained in 94% of these patients.

Indexed as

AdultAgedAged, 80 and overCapecitabineDeoxycytidineDisease ProgressionEndocrine Gland NeoplasmsFemaleFluorouracilHumansMaleMiddle AgedNeoplasm StagingNeuroendocrine TumorsOctreotidePilot Projects177Lu-octreotateCapecitabineDeoxycytidineFluorouracilOctreotide

Identifiers

PMID21052661
OpenAlexW1988986189

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.