Evidence map›Paper›PMID 38902994›Full record

ArticleThe oncologist2024

A phase 1 study of biweekly nab-paclitaxel/oxaliplatin/S-1/LV for advanced upper gastrointestinal cancers: TCOG T1216 study.

Hui-Jen Tsai, Shih-Hung Yang, Chin-Fu Hsiao, Hsiang-Fong Kao, Yung-Yeh Su, Yan-Shen Shan, Chia-Jui Yen, Jeng-Shiun Du, Chiun Hsu, I-Chen Wu and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in The oncologist, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03162510 (An Phase I Dose-Escalation Study of Biweekly Abraxane in Combination With Oxaliplatin and Oral S-1/LV), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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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.

NCT03162510 phase1completednot on this map

An Phase I Dose-Escalation Study of Biweekly Abraxane in Combination With Oxaliplatin and Oral S-1/LV (SOLAR Regimen) as First-line Chemotherapy in Patients With Advanced Gastric, Pancreatic and Biliary Cancers

TypeinterventionalSponsorNational Health Research Institutes, TaiwanRan2018 to 2022Enrolled18ConditionsGastric Cancer in Situ, Pancreatic Cancers, Biliary CancersArmsOxaliplatin, Albumin-Bound Paclitaxel /nab-Paclitaxel, S-1, LV
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

11 authors.

Hui-Jen TsaiNational Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.
Shih-Hung YangDepartment of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
Chin-Fu HsiaoInstitute of Population Health Sciences, National Health Research Institutes, Zhunan, Taiwan.
Hsiang-Fong KaoDepartment of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
Yung-Yeh SuNational Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.
Yan-Shen ShanDepartment of Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Chia-Jui YenDepartment of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Jeng-Shiun DuDivision of Hematology and Oncology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Chiun HsuDepartment of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
I-Chen WuCenter for Cancer Research, Kaohsiung Medical University, Kaohsiung, Taiwan.
Li-Tzong ChenNational Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.

Funding

Taiwan Cooperative Oncology Group
6 · The paper itself

Abstract

backgroundOxaliplatin- and fluoropyrimidine-based triplet regimens have demonstrated feasibility and efficacy in the treatment of upper gastrointestinal (UGI) cancers. Herein, we evaluate the feasibility and preliminary efficacy of biweekly nab-paclitaxel plus oxaliplatin and S-1/leucovorin (SOLAR) in chemonaïve UGI cancers.

methodsA 3 + 3 phase 1 study was conducted to determine the maximal tolerated dose (MTD) of oxaliplatin in SOLAR (nab-paclitaxel [150 mg/m2 in D1], oxaliplatin [60, 75, or 85 mg/m2 in D1], and oral S-1/leucovorin [35 mg/m2 and 30 mg bid from D1 to D7]). The secondary endpoints were overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety.

resultsThirteen and 6 accruals were in the dose-escalation and MTD expansion cohorts, respectively. One of 6 patients at level III experienced dose-limiting toxicity (grade 3 diarrhea), which revealed that the MTD of oxaliplatin was 85 mg/m2. After a mean of 15.9 cycles of treatment, the most common treatment-related grade 3/4 toxicities were neutropenia (57.9%) and diarrhea (21.1%). The ORR was 63.2%. The median PFS and OS were 12.5 and 24.7 months, respectively.

conclusionThe current study revealed the MTD of oxaliplatin and demonstrated the preliminary efficacy of SOLAR in UGI cancers, which deserves further investigation. CLINICALTRIALS.GOV IDENTIFIER: NCT03162510.

Indexed as

AlbuminsAntineoplastic Combined Chemotherapy ProtocolsDrug CombinationsGastrointestinal NeoplasmsLeucovorinOxaliplatinOxonic AcidPaclitaxelTegafurAdultAgedFemaleHumansMaleMaximum Tolerated DoseMiddle Aged130-nm albumin-bound paclitaxelAlbuminsDrug CombinationsLeucovorinOxaliplatinOxonic AcidPaclitaxelS 1 (combination)Tegafurnab-paclitaxeloxaliplatinphase 1S-1/leucovorinupper gastrointestinal cancers

Identifiers

PMID38902994
PMCPMC11449045

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Registered trials

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.