Evidence map›Paper›PMID 37649318›Full record

Trial reportCancer medicine2023

Safety and efficacy of neoadjuvant chemoradiotherapy with moderately hypofractionated intensity-modulated radiotherapy for resectable pancreatic cancer: A prospective, open-label, phase II study.

Toshihiko Masui, Kazuyuki Nagai, Takayuki Anazawa, Yosuke Kasai, Akitada Yogo, Michio Yoshimura, Takashi Mizowaki, Norimitsu Uza, Akihisa Fukuda, Shigemi Matsumoto and 5 more

Open access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 20% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

15 authors at 1 institution in 1 country.

Toshihiko MasuiDepartment of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.ORCID 0000-0002-4001-4824
Kazuyuki NagaiDepartment of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Takayuki AnazawaDepartment of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Yosuke KasaiDepartment of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Akitada YogoDepartment of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Michio YoshimuraDepartment of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Takashi MizowakiDepartment of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.ORCID 0000-0002-8135-8746
Norimitsu UzaDepartment of Gastroenterology and Hepatology, Kyoto University, Kyoto, Japan.
Akihisa FukudaDepartment of Gastroenterology and Hepatology, Kyoto University, Kyoto, Japan.
Shigemi MatsumotoDepartment of Real World Data Research and Development, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Masashi KanaiDepartment of Clinical Oncology, Kyoto University, Kyoto, Japan.ORCID 0000-0002-6954-4474
Hiroyoshi IsodaDepartment of Diagnostic Imaging and Nuclear Medicine, Kyoto University, Kyoto, Japan.
Yoshiya KawaguchiDepartment of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Shinji UemotoDepartment of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Etsuro HatanoDepartment of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Kyoto University · JP

Funding

Japan Society for the Promotion of Science 21K08732
6 · The paper itself

Abstract

backgroundResectable pancreatic cancer (RPC) is potentially resectable on admission, and the impact of neoadjuvant therapy on these tumors is controversial. Moreover, the safety and efficacy of neoadjuvant chemoradiotherapy with moderately hypofractionated intensity-modulated radiation therapy (NACIMRT) for RPC have not been studied. Here, we conducted a phase II study to evaluate the safety and efficacy of hypofractionated NACIMRT for RPC.

methodsA total of 54 RPC patients were enrolled and treated according to the study protocol. We used moderately hypofractionated (45 Gy in 15 fractions) IMRT with gemcitabine to shorten the duration of radiotherapy and reduce gastrointestinal toxicity. The primary endpoint was overall survival (OS), and we subsequently analyzed the microscopically margin-negative resection (R0) rate, disease-free survival (DFS), and histologic effects and safety of NACIMRT.

resultsMedian OS for the cohort was 40.0 months. Forty-two patients (77.8%) underwent pancreatectomy after NACIMRT. Median DFS was 20.3 months. The R0 resection rate was 95.2% (40/42) per protocol and 85.2% (46/54) for the cohort. There were no intervention-related deaths during the study period. Local treatment response, as assessed by the CAP classification, showed no residual tumor in 4.8% of patients. Overall, 23.9% of patients experienced CTCAE grade 3 or 4 during NACIMRT. Adjuvant therapy was initiated in 88% of patients undergoing resection. Postoperative complications grade ≥3b on the Clavien-Dindo scale occurred in 4.8% of patients. CA19-9 level at enrollment was an independent prognostic factor for OS and DFS.

conclusionsThis is the first prospective study of hypofractionated IMRT as neoadjuvant therapy for RPC. Hypofractionated NACIMRT for RPC could be safely introduced with a high induction rate of adjuvant chemotherapy, with an overall survival of 40.0 months.

Indexed as

Chemoradiotherapy, AdjuvantNeoadjuvant TherapyPancreatic NeoplasmsRadiotherapy, Intensity-ModulatedAdultAgedDeoxycytidineFemaleGemcitabineHumansMaleMiddle AgedPancreatectomyProspective StudiesRadiation Dose HypofractionationTreatment OutcomeDeoxycytidineGemcitabinechemoradiotherapyIMRTintensity-modulated radiotherapyneoadjuvant therapypancreatic cancersurgery

Identifiers

PMID37649318
PMCPMC10557863
OpenAlexW4386305548

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.