Evidence map›Paper›PMID 33928486›Full record

Trial reportInternational journal of clinical oncology2021

Safety and efficacy of panitumumab in combination with trifluridine/tipiracil for pre-treated patients with unresectable, metastatic colorectal cancer with wild-type RAS: The phase 1/2 APOLLON study.

Takeshi Kato, Yoshinori Kagawa, Yasutoshi Kuboki, Makio Gamoh, Yoshito Komatsu, Hirofumi Yasui, Hironaga Satake, Eiji Oki, Hiroaki Tanioka, Masahito Kotaka and 10 more

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in International journal of clinical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 43% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Observational
  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

20 authors at 15 institutions in 1 country.

Takeshi KatoNational Hospital Organization Osaka National Hospital, 2 Chome-1-14 Hoenzaka, Chuo Ward, Osaka, 540-0006, Japan.
Yoshinori KagawaKansai Rosai Hospital, 3 Chome-1-69 Inabaso, Amagasaki, Hyogo, 660-8511, Japan.
Yasutoshi KubokiNational Cancer Center Hospital East, 6 Chome-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Makio GamohOsaki Citizen Hospital, Furukawa Honami, 3 Chome, Osaki, 989-6183, Japan.
Yoshito KomatsuHokkaido University Hospital, 5 Chome Kita 14 Jonishi, Kita Ward, Sapporo, Hokkaido, 060-8648, Japan.
Hirofumi YasuiShizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi, Sunto District, Shizuoka, 411-0934, Japan.
Hironaga SatakeKobe City Medical Center General Hospital, 2 Chome-1-1 Minatojima Minamimachi, Chuo Ward, Kobe, Hyogo, 650-0047, Japan.
Eiji OkiKyushu University, Maidashi 3 Chome-1-3, Higashi Ward, Fukuoka, 812-0053, Japan.
Hiroaki TaniokaOkayama Rosai Hospital, 1 Chome-10-25 Chikkomidorimachi, Minami Ward, Okayama, 702-8055, Japan.
Masahito KotakaSano Hospital, 2 Chome-5-1 Shimizugaoka, Tarumi Ward, Kobe, Hyogo, 655-0031, Japan.
Akitaka MakiyamaJapan Community Healthcare Organization Kyushu Hospital, 1 Chome-8-1 Kishinoura, Yahatanishi Ward, Kitakyushu, Fukuoka, 806-8501, Japan.
Tadamichi DendaChiba Cancer Center, 666-2 Nitona-cho, Chuo Ward, Chiba, 260-8717, Japan.
Masahiro GotoOsaka Medical College Hospital, 2-7 Daigakumachi, Takatsuki, Osaka, 569-0096, Japan.
Takayuki YoshinoNational Cancer Center Hospital East, 6 Chome-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Kentaro YamazakiShizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi, Sunto District, Shizuoka, 411-0934, Japan.
Junpei SoedaTakeda Pharmaceutical Company, Ltd, Nihonbashi-Honcho 2 Chome-1-1, Chuo Ward, Tokyo, 103-8668, Japan.
Kazunori ShibuyaTakeda Pharmaceutical Company, Ltd, Nihonbashi-Honcho 2 Chome-1-1, Chuo Ward, Tokyo, 103-8668, Japan.
Masaru IwataTakeda Pharmaceutical Company, Ltd, Nihonbashi-Honcho 2 Chome-1-1, Chuo Ward, Tokyo, 103-8668, Japan.
Koji ObaUniversity of Tokyo, 7 Chome-3-1 Hongo, Bunkyo, Tokyo, 113-8654, Japan.
Kensei YamaguchiGastroenterological Chemotherapy Department, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3 Chome-8-31, Ariake, Koto, Tokyo, 135-8550, Japan. kensei.yamaguchi@jfcr.or.jp.ORCID http://orcid.org/0000-0001-6887-5709
Takeda (Japan) · JPNational Cancer Center Hospital East · JPShizuoka Cancer Center · JPChiba Cancer Center · JPGifu University Hospital · JPHokkaido University Hospital · JPJapanese Foundation For Cancer Research · JPKansai Medical University · JPKansai Rosai Hospital · JPKawasaki Medical School · JPKyushu University · JPOsaka Medical and Pharmaceutical University · JPOsaka National Hospital · JPOsaki Citizen Hospital · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe aimed to assess the safety and efficacy of combination treatment with panitumumab plus trifluridine/tipiracil (FTD/TPI) in patients with wild-type RAS metastatic colorectal cancer (mCRC) who were refractory/intolerant to standard therapies other than anti-epidermal growth factor receptor therapy.

methodsAPOLLON was an open-label, multicentre, phase 1/2 trial. In the phase 1 part, 3 + 3 de-escalation design was used to investigate the recommended phase 2 dose (RP2D); all patients in the phase 2 part received the RP2D. The primary endpoint was investigator-assessed progression-free survival (PFS) rate at 6 months. Secondary endpoints included PFS, overall survival (OS), overall response rate (ORR), disease control rate (DCR), time to treatment failure (TTF), and safety.

resultsFifty-six patients were enrolled (phase 1, n = 7; phase 2, n = 49) at 25 Japanese centres. No dose-limiting toxicities were observed in patients receiving panitumumab (6 mg/kg every 2 weeks) plus FTD/TPI (35 mg/m

conclusionPanitumumab plus FTD/TPI exhibited favourable anti-tumour activity with a manageable safety profile and may be a therapeutic option for pre-treated mCRC patients.

Indexed as

Colorectal NeoplasmsTrifluridineAntineoplastic Combined Chemotherapy ProtocolsHumansPanitumumabPyrrolidinesThyminePanitumumabPyrrolidinesThyminetipiracilTrifluridineAnti-EGFR antibodyOral nucleoside anti-tumour agentOutcomesPhase 1/2 clinical trialSalvage line

Identifiers

PMID33928486
PMCPMC8213662
OpenAlexW3157959900

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.