Evidence map›Paper›PMID 23129742›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Randomized phase III trial of induction chemotherapy with docetaxel, cisplatin, and fluorouracil followed by surgery versus up-front surgery in locally advanced resectable oral squamous cell carcinoma.

Lai-ping Zhong, Chen-ping Zhang, Guo-xin Ren, Wei Guo, William N William, Jian Sun, Han-guang Zhu, Wen-yong Tu, Jiang Li, Yi-li Cai and 16 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 180 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
180citing papers in PubMed, 10 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.

NCT06016413 phase2not yet recruitingnot on this mapstarted 2023, after this paper: background citation

A Prospective, Single-arm, Phase II Study of Adelbelimab Combined With Carboplatin and Nab-paclitaxel in Neoadjuvant Therapy for Patients With Resectable Locally Advanced Squamous Cell Carcinoma of the Head and Neck

TypeinterventionalSponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRan2023 to 2026Enrolled30ConditionsHead and Neck Squamous Cell CarcinomaArmsNab paclitaxel, Carboplatin, adelbelimumab
NCT07145931 phase2not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Tislelizumab Combined With Chemotherapy for Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Therapy for Head and Neck Squamous Cell Carcinoma Invading the Skull Base: A Prospective, Single-arm, Phase II Clinical Study

TypeinterventionalSponsorSun Yat-sen UniversityRan2025 to 2029Enrolled24ConditionsHead and Neck Cancer Squamous Cell Carcinoma, Skull Base--Cancer, Neoadjuvant Chemoimmunotherapy, Objective Response RateArmsNeoadjuvant chemoimmunotherapy, Tislelizumab Nab paclitaxel
3 · Its place in the literature

Who cites it

180 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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  7. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 107 randomized trials and 19,805 patients, on behalf of MACH-NC Group.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2021
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  18. Neoadjuvant Chemoimmunotherapy for the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Clinical Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
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  20. Pilot Phase II Trial of Neoadjuvant Immunotherapy in Locoregionally Advanced, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
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120 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Lai-ping ZhongNinth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Chen-ping Zhang
Guo-xin Ren
Wei Guo
William N William
Jian Sun
Han-guang Zhu
Wen-yong Tu
Jiang Li
Yi-li Cai
Li-zhen Wang
Xin-dong Fan
Zhong-he Wang
Yong-jie Hu
Tong Ji
Wen-jun Yang
Wei-min Ye
Jun Li
Yue He
Yan-an Wang
Li-qun Xu
Bo-song Wang
Merrill S Kies
J Jack Lee
Jeffrey N Myers
Zhi-yuan Zhang

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
6 · The paper itself

Abstract

purposeTo evaluate induction chemotherapy with docetaxel, cisplatin, and fluorouracil (TPF) followed by surgery and postoperative radiotherapy versus up-front surgery and postoperative radiotherapy in patients with locally advanced resectable oral squamous cell carcinoma (OSCC). PATIENTS AND

methodsA prospective open-label phase III trial was conducted. Eligibility criteria included untreated stage III or IVA locally advanced resectable OSCC. Patients received two cycles of TPF induction chemotherapy (docetaxel 75 mg/m(2) on day 1, cisplatin 75 mg/m(2) on day 1, and fluorouracil 750 mg/m(2) on days 1 to 5) followed by radical surgery and postoperative radiotherapy (54 to 66 Gy) versus up-front radical surgery and postoperative radiotherapy. The primary end point was overall survival (OS). Secondary end points included local control and safety.

resultsOf the 256 patients enrolled onto this trial, 222 completed the full treatment protocol. There were no unexpected toxicities, and induction chemotherapy did not increase perioperative morbidity. The clinical response rate to induction chemotherapy was 80.6%. After a median follow-up of 30 months, there was no significant difference in OS (hazard ratio [HR], 0.977; 95% CI, 0.634 to 1.507; P = .918) or disease-free survival (HR, 0.974; 95% CI, 0.654 to 1.45; P = .897) between patients treated with and without TPF induction. Patients in the induction chemotherapy arm with a clinical response or favorable pathologic response (≤ 10% viable tumor cells) had superior OS and locoregional and distant control.

conclusionOur study failed to demonstrate that TPF induction chemotherapy improves survival compared with up-front surgery in patients with resectable stage III or IVA OSCC.

Indexed as

AdultAgedAlopeciaAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCisplatinCombined Modality TherapyDocetaxelFemaleFluorouracilFollow-Up StudiesHematologic DiseasesHumansInduction ChemotherapyKaplan-Meier EstimateMaleCisplatinDocetaxelFluorouracilTaxoids

Identifiers

PMID23129742
PMCPMC5569675

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.