Evidence map›Paper›PMID 32725346›Full record

Trial reportInternational journal of colorectal disease2020

A prospective, single-arm, multicenter trial of neoadjuvant chemotherapy with mFOLFOX6 plus panitumumab without radiotherapy for locally advanced rectal cancer.

Kenichiro Toritani, Jun Watanabe, Yusuke Suwa, Kazuya Nakagawa, Hirokazu Suwa, Atsushi Ishibe, Mitsuyoshi Ota, Chikara Kunisaki, Takeharu Yamanaka, Itaru Endo

Abstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of colorectal disease, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 33% 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. 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

10 authors at 4 institutions in 1 country.

Kenichiro ToritaniDepartment of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan.ORCID https://orcid.org/0000-0001-5184-8819
Jun WatanabeDepartment of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan. nabe-jun@comet.ocn.ne.jp.ORCID https://orcid.org/0000-0002-7187-3664
Yusuke SuwaDepartment of Surgery, Gastroenterological Center, Yokohama City University Medical Center, 4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.
Kazuya NakagawaDepartment of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Hirokazu SuwaDepartment of Surgery, Yokosuka Kyosai Hospital, Yokosuka, Japan.
Atsushi IshibeDepartment of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Mitsuyoshi OtaDepartment of Surgery, Yokohama Minato Red Cross hospital, Yokohama, Japan.
Chikara KunisakiDepartment of Surgery, Gastroenterological Center, Yokohama City University Medical Center, 4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.
Takeharu YamanakaDepartment of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.
Itaru EndoDepartment of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Yokohama City University · JPYokohama City University Medical Center · JPYokohama Municipal Minato Red Cross Hospital · JPYokosuka Kyosai Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe present study evaluated the safety and efficacy of neoadjuvant chemotherapy with modified 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus panitumumab in clinical stage III rectal cancer with KRAS wild-type.

methodsWe conducted a prospective multicenter phase II trial. KRAS wild-type clinical stage III rectal cancer patients were enrolled. Patients received 6 cycles of mFOLFOX6 with 6 mg/kg panitumumab as neoadjuvant chemotherapy. The primary outcome was the response rate (RR) defined by RECIST. Lateral lymph node dissection (LLDN) was performed when patients had a locally advanced tumor < 9 cm from the anal margin.

resultsA total of 50 patients were enrolled. Twelve (24.0%) experienced grade 3-4 adverse events during neoadjuvant chemotherapy. The RR was 88.0% (complete response 2.0%, partial response 86.0%), which met the primary outcome. All patients underwent laparoscopic surgery and achieved R0 resection. Seven patients underwent resection of other adjacent organs, and 43 underwent LLND. Twelve patients (24.0%) experienced grade 3-4 postoperative complications, and 4 (8.0%) had pathological complete response (pCR). Thirteen patients (26.0%) had lymph node metastasis. Forty-five patients (90.0%) received postoperative adjuvant chemotherapy. The 3-year relapse-free survival (RFS) and overall survival (OS) rates were 79.0% and 93.7%, respectively.

conclusionsNeoadjuvant chemotherapy of mFOLFOX6 plus panitumumab without radiotherapy resulted in a low pCR rate but a high PR rate, low local recurrence rate, and good long-term outcome, suggesting that this treatment strategy may be a viable option for patients unable or unwilling to receive radiotherapy. The trial was registered with the UMIN Clinical Trials Registry, number 000006039.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsNeoadjuvant TherapyRectal NeoplasmsFluorouracilHumansLeucovorinNeoplasm StagingPanitumumabProspective StudiesTreatment OutcomeFluorouracilLeucovorinPanitumumabLaparoscopic surgerymFOLFOX6Neoadjuvant chemotherapyPanitumumabRectal cancer

Identifiers

PMID32725346
OpenAlexW3045818183

What OpenQuestion holds

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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.