Evidence map›Paper›PMID 36308367›Full record

Trial reportAsian Pacific journal of cancer prevention : APJCP2022

Triplet (FOLFOXIRI) Versus Doublet (FOLFOX or FOLFIRI) Regimen as First Line Treatment in Metastatic Colorectal Carcinoma, a Prospective Phase II, Randomized Controlled Trial.

Khaled Ahmed Khalil, Hanan Selim Musallam, Mohamed Abdulla Hassan, Inas Abdou Mahmoud

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

Trial report in Asian Pacific journal of cancer prevention : APJCP, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 17% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. 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

4 authors at 1 institution in 1 country.

Khaled Ahmed KhalilDepartment of Clinical Oncology, Kasr El Ainy Hospital, Cairo University, Cairo, Egypt.
Hanan Selim MusallamDepartment of Clinical Oncology, Kasr El Ainy Hospital, Cairo University, Cairo, Egypt.
Mohamed Abdulla HassanDepartment of Clinical Oncology, Kasr El Ainy Hospital, Cairo University, Cairo, Egypt.
Inas Abdou MahmoudDepartment of Clinical Oncology, Kasr El Ainy Hospital, Cairo University, Cairo, Egypt.
Cairo University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe outcomes of treatment of metastatic colorectal cancer (mCRC) is still unsatisfactory. Several trials approved that, the upfront treatment with triplet regimen included fluorouracil, leucovorin, irinotecan and oxaliplatin improved the outcomes of patients with metastatic disease as compared to standard doublet regimen. The objective of our study is evaluating the impact of upfront treatment with triplet (FOLFOXIRI) regimen on both oncological outcomes (response rate and survival) and patients' tolerability in comparison to the standard doublet regimen.

methodsWe randomly enrolled 64 patients with a newly diagnosed unresectable mCRC to receive either FOLFOXIRI (experimental arm) or FOLFIRI or FOLFOX4 (control arm) biweekly up to 12 cycles. The primary endpoints are overall response rate (RR) and patients' tolerability. The secondary endpoints are the progression free and overall survival.

resultThere was a significantly increase in RR (59% vs 37%) and complete remission rate (CR) (6.3% and 3.1%, respectively (P = 0.045) for the triplet therapy group compared to control group.  Consequently, an increased rate of secondary resection of metastasis (21.9% vs 3.1% respectively; P=0.023). The FOLFOXIRI regimen was associated with higher rate of grade 3/4 toxicity but not statistically significant except febrile neutropenia (6.2%; P=0.03). There was numerical prolongation in the median PFS in the FOLFOXIRI group on compared to control group but not significantly (9 versus 8 months; P=0.11). The median OS was 20 and 22 months in FOLFOXIRI arm and control arm respectively with no statistically significant difference (P=0.57).

conclusionFOLFOXIRI had a higher efficacy and higher conversion rate to secondary resection over the doublet regimen as an upfront treatment option, coupled with a manageable adverse event, but failed to improve the survival outcomes.

Indexed as

Colorectal NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCamptothecinFluorouracilHumansLeucovorinOrganoplatinum CompoundsProspective StudiesBevacizumabCamptothecinFluorouracilLeucovorinOrganoplatinum CompoundsEfficacyFOLFOXIRImCRCstandard doubletToxicity

Identifiers

PMID36308367
PMCPMC9924351
OpenAlexW4307805721

What OpenQuestion holds

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LicenceCC BY-NC
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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.