Evidence map›Paper›PMID 39067037›Full record

Trial reportJNCI cancer spectrum2024

Docetaxel-oxaliplatin-capecitabine/5-fluorouracil (DOX/F) followed by docetaxel versus oxaliplatin-capecitabine/5-fluorouracil (CAPOX/FOLFOX) in HER2-negative advanced gastric cancers.

Anant Ramaswamy, Prabhat Bhargava, Biswajit Dubashi, Anuj Gupta, Akhil Kapoor, Sujay Srinivas, Omshree Shetty, Poonam Jadhav, Veena Desai, Vanita Noronha and 32 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in JNCI cancer spectrum, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Synchronous metastatic malignancy of the prostate and stomach: A case report.International journal of surgery case reports · 2025
    Article
  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

42 authors.

Anant RamaswamyDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.ORCID 0000-0002-8169-4264
Prabhat BhargavaDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Biswajit DubashiDepartment of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
Anuj GuptaDepartment of Medical Oncology, Homi Bhabha Cancer Hospital, Varanasi, India.
Akhil KapoorDepartment of Medical Oncology, Homi Bhabha Cancer Hospital, Varanasi, India.
Sujay SrinivasDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Omshree ShettyDepartment of Molecular Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Poonam JadhavDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Veena DesaiDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Vanita NoronhaDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.ORCID 0000-0002-0191-2744
Amit JoshiDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Nandini MenonDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Vijay M PatilConsultant Medical Oncologist, P.D. Hinduja Hospital & Medical Research Centre, Mumbai, India.
Bal Krishna MishraDepartment of Medical Oncology, Homi Bhabha Cancer Hospital, Varanasi, India.
Bipinesh SansarDepartment of Medical Oncology, Homi Bhabha Cancer Hospital, Varanasi, India.
Arpita SinghDepartment of Medical Oncology, Homi Bhabha Cancer Hospital, Varanasi, India.
Swapnil PatelDepartment of Surgical Oncology, Homi Bhabha Cancer Hospital, Varanasi, India.
Satyendra Narayan SinghDepartment of Radiology, Homi Bhabha Cancer Hospital, Varanasi, India.
Ipsita DhalDepartment of Pathology, Homi Bhabha Cancer Hospital, Varanasi, India.
Kunal Ranjan VinayakDepartment of Palliative Medicine, Homi Bhabha Cancer Hospital, Varanasi, India.
Vikash PalDepartment of Medical Oncology, Homi Bhabha Cancer Hospital, Varanasi, India.
Sarika MandavkarDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Sadhana KannanDepartment of Statistics, Advanced Centre for Treatment, Research and Education in Cancer, Homi Bhabha National Institute (HBNI), Mumbai, India.
Deepali ChauguleDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Rajshree PatilDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Manali ParulekarDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Chaitali NashikkarTata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Suman Kumar AnkathiDepartment of Radiodiagnosis, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Rajiv Kumar KaushalDepartment of Pathology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Aekta ShahDepartment of Pathology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Prasanth GanesanDepartment of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
Smita KayalDepartment of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
Ramesh AnanthakrishnanDepartment of Radiodiagnosis, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
Noorzia SyedDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Debdeep SamaddarDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Venkatesh KapuDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Anokhi ShahDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
D KaaviyaDepartment of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
R SuganiyaDepartment of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
Nirmala Devi SrinivasanDepartment of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
Kumar PrabhashDepartment of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.
Vikas OstwalDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.ORCID 0000-0002-0067-4748

Funding

Nag Foundation Grant to the instituteTMC Research Administrative Council (TRAC) Tata Memorial Centre
6 · The paper itself

Abstract

backgroundWe evaluated whether the addition of docetaxel (D) to a combination comprising 5-fluorouracil/leucovorin (5-FU/LV) or capecitabine (C) plus oxaliplatin (O) (DOF/DOX) improved overall survival (OS) compared with 6 months of 5-fluorouracil (5-FU) or capecitabine in combination with oxaliplatin (FOLFOX/CAPOX) alone in advanced HER2-negative gastroesophageal junction and gastric adenocarcinomas (G/GEJ).

methodsThis study was an investigator-initiated, open-label, multi-institutional, randomized phase III trial in adult patients with HER2-negative advanced G/GEJs. The primary endpoint of the study was a comparison of median OS by Kaplan-Meier method. Next-generation sequencing was performed on tissue.

resultsOf the 324 patients randomly assigned between July 2020 and November 2022, 305 patients were evaluable for analysis (FOLFOX/CAPOX: 156; DOF/DOX: 149). With a median follow-up time of 19.2 months (95% Confidence Interval [CI] = 16.5 months to 21.9 months) for the entire cohort, the median OS was 10.1 months (95% CI = 9.2 to 10.9) for FOLFOX/CAPOX and 8.9 months (95% CI = 7.3 to 10.5) for DOF/DOX, and this difference was not statistically significant (P = .70). An increased proportion of grade 3 or grade 4 neutropenia (21% vs 3%; P < .001) and grade 2/3 neuropathy (17% vs 7%; P = .005) was seen in patients receiving DOF/DOX. Genomic profiling revealed a low incidence of microsatellite instability (1%) and a high incidence of BRCA1 (8.4%) and BRCA2 (7.5%) somatic alterations.

conclusionFOLFOX or CAPOX chemotherapy for 6 months remains one of the standards of care in advanced HER2-negative gastroesophageal junction and gastric adenocarcinomas, with no additional survival benefit seen with the addition of docetaxel. Genomic profiling of patients revealed a higher than previously known incidence of somatic BRCA alterations, which requires further evaluation.CTRI (Clinical Trial Registry of India: CTRI/2020/03/023944).

Indexed as

AdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsCapecitabineDocetaxelFluorouracilOxaliplatinStomach NeoplasmsAdultAgedErb-b2 Receptor Tyrosine KinasesEsophageal NeoplasmsEsophagogastric JunctionFemaleHumansKaplan-Meier EstimateLeucovorinCapecitabineDocetaxelERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesFluorouracilLeucovorinOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID39067037
PMCPMC11316615

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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.