Evidence map›Paper›PMID 27390847›Full record

Trial reportPloS one2016

A Phase Ib/II Study Evaluating the Combination of Weekly Docetaxel and Cisplatin Together with Capecitabine and Bevacizumab in Patients with Advanced Esophago-Gastric Cancer.

Baruch Brenner, Michal Sarfaty, Ofer Purim, Yulia Kundel, Limor Amit, Amir Abramovich, Udi Sadeh Gonik, Efraim Idelevich, Noa Gordon, Gal Medalia and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00845884 (A Phase I/II Study Evaluating the Combination of Weekly Docetaxel and Cisplatin Together With Capecitabine and Bevacizumab in Patients With Advanced Gastric Cancer), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 24% 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.

NCT00845884 phase1 / phase2unknown statusnot on this map

A Phase I/II Study Evaluating the Combination of Weekly Docetaxel and Cisplatin Together With Capecitabine and Bevacizumab in Patients With Advanced Gastric Cancer

TypeinterventionalSponsorRabin Medical CenterRan2009 to 2012Enrolled49ConditionsAdvanced Gastric CancerArmsDocetaxel, Cisplatin, Capecitabine, Bevacizumab
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

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

Baruch BrennerInstitute of Oncology, Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petach Tiqva, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.ORCID http://orcid.org/0000-0002-1596-9362
Michal SarfatyInstitute of Oncology, Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petach Tiqva, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Ofer PurimInstitute of Oncology, Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petach Tiqva, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Yulia KundelInstitute of Oncology, Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petach Tiqva, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Limor AmitInstitute of Oncology, Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petach Tiqva, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Amir AbramovichInstitute of Oncology, Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petach Tiqva, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Udi Sadeh GonikDepartment of Radiology, Beilinson Hospital, Rabin Medical Center, Petach Tiqva, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Efraim IdelevichInstitute of Oncology, Kaplan Medical Center, Rehovot, and Hebrew Univerity, Jerusalem, Israel.
Noa GordonInstitute of Oncology, Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petach Tiqva, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Gal MedaliaInstitute of Oncology, Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petach Tiqva, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Aaron SulkesInstitute of Oncology, Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petach Tiqva, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Tel Aviv University · ILKaplan Medical Center · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCurrent treatment options for advanced esophagogastric cancer (AEGC) are still unsatisfactory. The aim of this prospective phase Ib/II study was to evaluate the safety and efficacy of a novel regimen, AVDCX, consisting of weekly docetaxel and cisplatin together with capecitabine and bevacizumab, in AEGC.

methodsPatients with AEGC received treatment with different dose levels of AVDCX (cisplatin and docetaxel 25-35 mg/m2, days 1,8, capecitabine 1,600 mg/m2 days 1-14, bevacizumab 7.5 mg/kg, day 1, Q:21 days). The study's primary objectives were to establish the recommended phase II doses of docetaxel and cisplatin in AVDCX (phase Ib part) and to determine the tumor response rate (phase II part).

resultsThe study was closed early, after the accrual of 22 patients, due to accumulating toxicity-related deaths. The median age was 59 years and 77% of patients had gastric or gastroesophageal adenocarcinomas. Grade ≥3 adverse events were documented in 18 patients (82%), usually neutropenia (36%), fatigue (54%) or diarrhea (23%). There were three fatal toxicities (14%): mesenteric thromboembolism, gastric perforation and pancytopenic sepsis. The recommended phase II doses of cisplatin and docetaxel were determined to be 25 mg/m2 and 30 mg/m2, respectively. Twenty-one patients were evaluable for response: 12 (54%) had partial response (PR), 4 (18%) had stable disease (SD) and none had complete response (CR). Hence, the objective response rate (CR+PR) was 54% and the disease control rate (CR+PR+SD) was 72%. For the 17 patients treated at the MTD, the objective response rate was 41% and the disease control rate was 88%. The median overall survival (OS) for these patients was 13.9 months (range, 1.5-52.2 months) and the median progression-free survival was 7.6 months (range, 1.3-26.6 months). The 2-year OS rate reached 23.7%.

conclusionsAVDCX was associated with a high rate of regimen related fatal adverse events and is not appropriate for further development in AEGC patients.

trial registrationClinicalTrials.gov NCT00845884.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCapecitabineCisplatinDisease-Free SurvivalDocetaxelDrug Administration ScheduleEsophageal NeoplasmsFemaleHumansMaleMiddle AgedProspective StudiesStomach NeoplasmsBevacizumabCapecitabineCisplatinDocetaxelTaxoids

Identifiers

PMID27390847
PMCPMC4938513
OpenAlexW2472508010

What OpenQuestion holds

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LicenceCC BY
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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.