Evidence map›Paper›PMID 27336466›Full record

ArticlePloS one2016

Phase I Trial of Consolidative Radiotherapy with Concurrent Bevacizumab, Erlotinib and Capecitabine for Unresectable Pancreatic Cancer.

Awalpreet S Chadha, Heath D Skinner, Jillian R Gunther, Mark F Munsell, Prajnan Das, Bruce D Minsky, Marc E Delclos, Deyali Chatterjee, Huamin Wang, Marilyn Clemons and 9 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–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

9 citing papers in PubMed.

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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

19 authors.

Awalpreet S ChadhaDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Heath D SkinnerDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Jillian R GuntherDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Mark F MunsellDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Prajnan DasDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Bruce D MinskyDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Marc E DelclosDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Deyali ChatterjeeDepartment of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Huamin WangDepartment of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Marilyn ClemonsDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Geena GeorgeDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Pankaj K SinghDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Matthew H KatzDepartment of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Jason B FlemingDepartment of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Milind M JavleDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Robert A WolffDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Gauri R VaradhacharyDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Christopher H CraneDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Sunil KrishnanDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposeTo determine the safety, tolerability and maximum tolerated dose (MTD) of addition of erlotinib to bevacizumab and capecitabine-based definitive chemoradiation (CRT) in unresectable pancreatic cancer.

methodsSeventeen patients with CT-staged, biopsy-proven unresectable pancreatic cancer were enrolled between 3/2008 and 10/2010. Prior chemotherapy was permitted. Two patients each were enrolled at dose levels (DLs) 1-4 and 9 patients at DL 5. All patients received 50.4 Gy (GTV only) in 28 fractions with concurrent capecitabine, bevacizumab and erlotinib. Dose of each drug was escalated in 5 DLs using the continual reassessment method. Bevacizumab was escalated from 5mg/Kg q2weeks (DLs 1-4) to 10mg/Kg q2weeks (DL 5); daily erlotinib from 100mg/day (DLs 1-2) to 150 mg/Kg (DLs 3-5); and capecitabine from 400mg/m2 twice daily on days of radiation (DL 1) to 650mg/m2 (DLs 2-3) to 825 mg/m2 (DLs 4-5). Reassessment for potential resection was performed 6-8 weeks later.

resultsSixteen patients received gemcitabine-based chemotherapy prior to CRT. With a median clinical follow-up of 10 months, no grade 3 toxicities were observed in DLs 1-4. Three (33%) patients at DL 5 developed a grade 3 acute toxicity (2 diarrhea, 1 rash). No grade 4 or 5 toxicities were seen. DL 4 was selected as the MTD; therefore, the recommended doses in combination with radiation are: bevacizumab, 5mg/Kg q2weeks; erlotinib, 150 mg/Kg daily; and capecitabine, 825mg/m2 BID. Median survival was 17.4 months. Of the five patients who underwent resection, 4 were originally deemed locally advanced and 1 was borderline resectable. Three patients had excellent pathological response (2 complete response and 20% viable tumor) at surgery, and the 2 patients with complete response are still alive at 61 and 67 months of follow up with no local or distant failures.

conclusionsThis chemoradiation regimen at the recommended dose levels is safe and tolerable for patients with unresectable pancreatic cancer and merits further evaluation.

Indexed as

ChemoradiotherapyAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiomarkers, TumorCapecitabineCombined Modality TherapyDisease ProgressionErlotinib HydrochlorideFemaleHumansKaplan-Meier EstimateMaleMaximum Tolerated DoseNeoplasm MetastasisNeoplasm StagingPancreatic NeoplasmsBevacizumabBiomarkers, TumorCapecitabineErlotinib HydrochlorideRepressor ProteinsSAMD4A protein, human

Identifiers

PMID27336466
PMCPMC4919049

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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.