Evidence map›Paper›PMID 30604155›Full record

Trial reportInternational journal of clinical oncology2019

Efficacy and safety of ramucirumab plus modified FOLFIRI for metastatic colorectal cancer.

Tomoyasu Yoshihiro, Hitoshi Kusaba, Akitaka Makiyama, Kazuma Kobayashi, Masato Uenomachi, Mamoru Ito, Yasuhiro Doi, Kenji Mitsugi, Tomomi Aikawa, Kotoe Takayoshi and 6 more

Abstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–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

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
  6. Current Targeted Therapy for Metastatic Colorectal Cancer.International journal of molecular sciences · 2023
    Review
  7. InoperableMolecular and clinical oncology · 2022
    Article
  8. Article
  9. Observational
  10. Review
  11. Article
  12. Review
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

16 authors.

Tomoyasu YoshihiroDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Hitoshi KusabaDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Akitaka MakiyamaDepartment of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Kitakyushu, Fukuoka, Japan.
Kazuma KobayashiDepartment of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Masato UenomachiDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Mamoru ItoDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Yasuhiro DoiDepartment of Medical Oncology, Hamanomachi Hospital, Fukuoka, Japan.
Kenji MitsugiDepartment of Medical Oncology, Hamanomachi Hospital, Fukuoka, Japan.
Tomomi AikawaDepartment of Gastrointestinal and Medical Oncology, National Kyushu Cancer Center, Fukuoka, Japan.
Kotoe TakayoshiDepartment of Gastrointestinal and Medical Oncology, National Kyushu Cancer Center, Fukuoka, Japan.
Taito EsakiDepartment of Gastrointestinal and Medical Oncology, National Kyushu Cancer Center, Fukuoka, Japan.
Hozumi ShimokawaDepartment of Medical Oncology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Kenji TsuchihashiDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Hiroshi AriyamaDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Koichi AkashiDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Eishi BabaDepartment of Comprehensive Clinical Oncology, Faculty of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. e-baba@intmed1.med.kyushu-u.ac.jp.ORCID http://orcid.org/0000-0001-9428-6772

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDose modification of chemotherapy for metastatic colorectal cancer (MCRC) is often needed, especially in second-line and later-line treatments due to adverse events of previous treatment and poor patient condition. No study has focused on ramucirumab plus modified dose of FOLFIRI for MCRC, and whether low relative dose intensity (RDI) affects treatment efficacy has not been clarified.

methodsMCRC patients who received ramucirumab plus FOLFIRI, which consisted of 150 mg/m

resultsA total of 43 patients were assessed. Median age was 63 years, and 22 patients (51%) were women. Twenty-six patients (60%) were given ramucirumab plus FOLFIRI as second-line therapy, and 17 (40%) as third or later-line. The median relative dose intensity (RDI) of irinotecan was 60.6%, which is lower than that in the pivotal phase 3 study (RAISE), and other agents showed the same trend. Median progression-free survival was 4.8 [95% confidence interval (CI) 3.2-5.7] months for all patients, 5.4 (95% CI 3.5-7.2) months for second-line patients, and 2.8 (95% CI 1.6-5.8) months for third or later-line patients. Median overall survival was 17.3 (95% CI 11.5-22.4) months for all patients. Patients with irinotecan RDI less than 60% showed similar treatment efficacy. Hematological toxicities of grade 3 or worse were observed in 21 patients, but all were manageable.

conclusionLow RDI did not compromise the treatment efficacy of ramucirumab plus modified FOLFIRI for MCRC patients.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCamptothecinColorectal NeoplasmsFemaleFluorouracilHematologic DiseasesHumansLeucovorinMaleMiddle AgedProgression-Free SurvivalRamucirumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCamptothecinFluorouracilLeucovorinRamucirumabColorectal cancerIrinotecanRamucirumabRelative dose intensity

Identifiers

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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.