Evidence map›Paper›PMID 27141384›Full record

ArticleOncoimmunology2016

Phase Ib study of poly-epitope peptide vaccination to thymidylate synthase (TSPP) and GOLFIG chemo-immunotherapy for treatment of metastatic colorectal cancer patients.

Pierpaolo Correale, Cirino Botta, Elodia Claudio Martino, Cristina Ulivieri, Giuseppe Battaglia, Tommaso Carfagno, Maria Grazia Rossetti, Antonella Fioravanti, Giacomo Maria Guidelli, Sara Cheleschi and 7 more

Open access · goldAbstract read
In one paragraph

Article in Oncoimmunology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
3.2field-weighted citation impact, top 8% 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

21 citing papers in PubMed, 26 citations in OpenAlex.

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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

17 authors at 2 institutions in 1 country.

Pierpaolo CorrealeUnit of Radiotherapy, Department of Oncology, University of Siena , Italy.
Cirino BottaMedical Oncology Unit, Department of Experimental and Clinical Medicine, "Magna Graecia" University of Catanzaro , Italy.
Elodia Claudio MartinoUnit of Radiotherapy, Department of Oncology, University of Siena , Italy.
Cristina UlivieriDepartment of Science of Life, University of Siena , Italy.
Giuseppe BattagliaUnit of Radiotherapy, Department of Oncology, University of Siena , Italy.
Tommaso CarfagnoUnit of Radiotherapy, Department of Oncology, University of Siena , Italy.
Maria Grazia RossettiUnit of Pharmacy, Siena University Hospital , Italy.
Antonella FioravantiUnit of Rheumatology, Department of Clinical Medicine and Immunologic Sciences, University of Siena , Italy.
Giacomo Maria GuidelliUnit of Rheumatology, Department of Clinical Medicine and Immunologic Sciences, University of Siena , Italy.
Sara CheleschiUnit of Rheumatology, Department of Clinical Medicine and Immunologic Sciences, University of Siena , Italy.
Claudia GandolfoMicrobiology and Virology Unit, Department of Medical Biotechnology, University of Siena , Italy.
Francesco CarboneUnit of Radiology, Department of Oncology, University of Siena , Italy.
Tatiana Cosima BaldariDepartment of Science of Life, University of Siena , Italy.
Pierfrancesco TassoneMedical Oncology Unit, Department of Experimental and Clinical Medicine, "Magna Graecia" University of Catanzaro , Italy.
Pierosandro TagliaferriMedical Oncology Unit, Department of Experimental and Clinical Medicine, "Magna Graecia" University of Catanzaro , Italy.
Luigi PirtoliUnit of Radiotherapy, Department of Oncology, University of Siena , Italy.
Maria Grazia CusiMicrobiology and Virology Unit, Department of Medical Biotechnology, University of Siena , Italy.
University of Siena · ITMagna Graecia University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Thymidylate synthase (TS) is a tumor-associated enzyme critical for DNA replication and main 5'-fluorouracil (5'-FU) target. TSPP/VAC1 is a multi-arm trial phase-Ib trial program aimed to investigate the toxicity and biomodulatory activity of a poly-epitope-peptide vaccine to TS (TSPP) in cancer patients (pts). Here, we present the results of the TSPP/VAC1/arm C trial aimed to evaluate TSPP in combination with chemo-immunotherapy in pretreated metastatic colo-rectal cancer (mCRC) pts. Twenty-nine pts, 14 males and 15 females, received poly-chemotherapy with gemcitabine [GEM; 1,000 mg/sqm, day-1], oxaliplatin [OX; 80 mg/sqm, day-2], levofolinate [100 mg/sqm, days 1-2], bolus/infusional 5'-FU [400 mg/800 mg/sqm, days 1-2], sargramostim [50 μg, days 3-7/q30], and interleukin-2 [sc. 0.5 MIU twice a day, days 8-14/18-30] [GOLFIG-regimen]. Seventeen pts received sc. TSPP injections at escalating dosage [3 pts, 100 µg (DL-1); 3 pts, 200 µg (DL-2) and 11pts, 300 µg (DL-3)] one week after each chemotherapy cycle (concomitant module), while 10 out 12 pts received TSPP (300 µg) after 12 GOLFIG courses [dose level (DL)-0] (sequential module). TSPP MTD was not achieved. Adverse events consisted in swelling/erythema at injection sites (17 cases), G1-2 haematological (16 cases) and gastro-enteric events (12), fever, rhinitis, conjunctivitis, and poly-arthralgia and rise in auto-antibodies [ANA, ENA, c-ANCA, p-ANCA in the DL1-3 pts]. Both treatment-modules showed immunomodulating and antitumor activity (disease-control-rate, DL1-3 and DL0 were 70.6% and 83.3%, respectively) with a better survival recorded in the second group [median OS DL1-3 vs. DL0 = 8 vs. 16 mo,

Indexed as

Colon cancerCTLsepitope peptidesGOLFIG chemo-immunotherapypeptide vaccinethymidylate synthase

Identifiers

PMID27141384
PMCPMC4839351
OpenAlexW2309445729

What OpenQuestion holds

Textmetadata
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.