Evidence map›Paper›PMID 16570038›Full record

Trial reportBritish journal of cancer2006

Phase I/II study of S-1 combined with irinotecan for metastatic advanced gastric cancer.

M Inokuchi, T Yamashita, H Yamada, K Kojima, W Ichikawa, Z Nihei, T Kawano, K Sugihara

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
7.3field-weighted citation impact, top 3% 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

20 citing papers in PubMed, 67 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Randomized phase III study comparing the efficacy and safety of irinotecan plus S-1 with S-1 alone as first-line treatment for advanced gastric cancer (study GC0301/TOP-002).Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2011
    Trial
  5. Trial
  6. Article
  7. Article
  8. Current Development of Anti-Cancer Drug S-1.Journal of clinical and diagnostic research : JCDR · 2016
    Review
  9. Article
  10. Peritoneal carcinomatosis.World journal of gastroenterology · 2013
    Review
  11. Article
  12. Review
  13. Article
  14. Pilot study of a combination of S-1 and paclitaxel for patients with peritoneal metastasis from gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2010
    Article
  15. Article
  16. Article
  17. Salvage gastrectomy following a combination of biweekly paclitaxel and S-1 for stage IV gastric cancer.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2008
    Article
  18. Article
  19. Article
  20. 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

8 authors at 4 institutions in 2 countries.

M InokuchiDepartment of Esophagogastric Surgery, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo, and Mutsugi Clinic, Tokyo 113-8519, Japan. m-inokuchi.srg2@tmd.ac.jp
T Yamashita
H Yamada
K Kojima
W Ichikawa
Z Nihei
T Kawano
K Sugihara
Tokyo Medical and Dental University · JPHitotsubashi University · JPIstituti Clinici Scientifici Maugeri · ITSaitama Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A dose-escalation study of irinotecan (CPT-11) combined with S-1, an oral dihydropyrimidine dehydrogenase inhibitory fluoropyrimidine, was performed to determine the maximum-tolerated dose (MTD), recommended dose (RD), dose-limiting toxicities (DLTs), and objective response rate (RR) in advanced gastric cancer (AGC). S-1 was administered orally at 80 mg m-2 day-1 from day 1 to 14 of a 28-day cycle and CPT-11 was given intravenously on day 1 and 8 at an initial dose of 70 mg m-2 day-1, stepping up to 100 mg m-2. The treatment was repeated every 4 weeks, unless disease progression was observed. In the phase I portion, the MTD of CPT-11 was presumed to be 100 mg m-2, because 66.6% of patients (two of three) developed DLTs. All three patients at the initial RD of CPT-11 (90 mg m-2) experienced grade 4 haematological or grade 3 nonhaematological toxicities at second course, followed by the dose reduction of CPT-11 from the third course. Considering safety and the ability to continue treatment, the final RD was determined to be 80 mg m-2. In the phase II portion, 42 patients including seven patients in the final RD phase I portion were evaluated. The median treatment course was five (range: 1-13). The incidences of severe (grade 3-4) haematological and nonhaematological toxicities were 19 and 10%, respectively, but all were manageable. The RR was 62% (26 of 42, 95% confidence interval: 47.2-76.6%), and the median survival time was 444 days. Our phase I/II trial showed S-1 combined with CPT-11 is effective for AGC and is well tolerated, with acceptable toxicity.

Indexed as

Administration, OralAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCamptothecinDisease ProgressionDose-Response Relationship, DrugDrug Administration ScheduleDrug CombinationsFemaleHumansInjections, IntravenousIrinotecanMaleMaximum Tolerated DoseMiddle AgedCamptothecinDrug CombinationsIrinotecanOxonic AcidS 1 (combination)Tegafur

Identifiers

PMID16570038
PMCPMC2361252
OpenAlexW2004703251

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.