Drug Database
DO

docetaxel (TPU 004DO / TPU004DO)

✓ Approved

Shandong Luoxin Pharma · TUBB · Small Molecule

What is docetaxel?

docetaxel is a small molecule developed by Shandong Luoxin Pharma. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesTPU 004DO, TPU004DO
CompanyShandong Luoxin Pharma
Drug ClassSmall Molecule
Molecular TargetTUBB
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Shandong Luoxin Pharma

Mechanism of Action

Molecular Targets

docetaxel acts on 1 molecular target:

TUBBtubulin beta class I (TUBB1, CSCSC1)
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Therapeutic Indications

docetaxel is developed for 6 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Breast cancer✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Gastric cancer✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Non-small cell lung cancer stage IV✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Non-small cell lung cancer metastatic✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Prostate cancer✓ Approved

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Related Research Articles

PubMedBreast cancer research and treatment2026-11-10

Dose-dense neoadjuvant bi-weekly nab-paclitaxel followed by epirubicin-cyclophosphamide versus bi-weekly docetaxel followed by epirubicin-cyclophosphamide in patients with HR+/HER2- early breast cancer: a multicentre, randomised, phase III trial.

Zhang Mingkun M, Qin Yuan Y, Wan Junhao J, Tian Zelin Z et al.

Dose-dense adjuvant chemotherapy prolongs survival in breast cancer and has been translated into neoadjuvant settings. Although weekly nanoparticle albumin-bound (nab)-paclitaxel yields superior pathological complete response (pCR) rates relative to solvent-based paclitaxel, data supporting its incorporation into a dose-dense neoadjuvant regimen-particularly for hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) tumours-remain limited. This trial therefore evaluated whether a bi-weekly dose-dense nab-paclitaxel schedule improves the proportion of residual cancer burden (RCB) 0/Ⅰ compared with a comparable dose-dense docetaxel regimen, each followed by dose-dense epirubicin plus cyclophosphamide. This was a multicentre, randomised, phase III trial done at three hospitals in China. HR⁺/HER2⁻ patients (cT1-3/N0-1/M0) were randomised 1:1 using dynamic allocation with Pocock minimisation on Ki-67 and TNM stage. The experimental arm received nab-paclitaxel 260 mg/m² intravenously on day 1 every two weeks for four cycles; the control arm received docetaxel 100 mg/m² on the identical schedule. Both cohorts subsequently received epirubicin 90 mg/m² plus cyclophosphamide 600 mg/m² intravenously on day 1 every two weeks for four cycles. Primary endpoints were RCB 0/Ⅰ rate; secondary endpoints encompassed disease free survival (DFS), overall survival (OS), and safety. Between December 2019 and December 2020, 388 patients (194 per arm) were enrolled. The nab-paclitaxel arm attained an RCB 0/Ⅰ rate of 20.1% (95% CI 14.41-26.72), significantly exceeding the docetaxel arm's 11.34% (95% CI 6.92-15.81; χ²=5.62, P = 0.018). pCR was achieved in 15.98% (95% CI 10.81-21.16) of the nab-paclitaxel group versus 10.31% (95% CI 6.01-14.60) of the docetaxel group (χ²=2.73, P = 0.098). Multivariate analysis confirmed a statistically significant favourable impact of nab-paclitaxel on RCB 0/Ⅰ. Five-year DFS was comparable (90.21% vs. 87.11%; HR: 1.14, 95% CI 0.64-2.05; P = 0.656), as was five-year OS (96.34% vs. 95.31%; HR: 0.64, 95% CI 0.29-1.42; P = 0.274), indicating no significant survival disparity. Grade 3/4 adverse event incidence was similar (30% vs. 38%). The most frequent all-grade toxicities (neutropenia, nausea, myalgia) occurred at comparable rates; however, grade 3/4 peripheral sensory neuropathy was observed exclusively in the nab-paclitaxel cohort. No treatment-related mortality was reported. A bi-weekly dose-dense nab-paclitaxel regimen followed by dose-dense epirubicin-cyclophosphamide constitutes a feasible and efficacious neoadjuvant strategy for early stage HR+/HER2- breast cancer, delivering a higher RCB 0/Ⅰ rate without compromising overall safety. The increased incidence of high-grade peripheral neuropathy mandates vigilant monitoring, yet the regimen represents a valuable addition to contemporary neoadjuvant options. ClinicalTrials.gov ID: NCT04182568, Date of registration: 2019-08-21.

PMID 43003936
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PubMedUrologic oncology2026-11-10

Comparison of novel salvage therapies for BCG-unresponsive NMIBC against gemcitabine/docetaxel: A reconstructed individual patient data analysis.

Almohtasib Jamil J, Kaul Sumedh S, Perez-Londono Agustin A, Ghali Fady F et al.

Multiple novel salvage therapies for bacillus Calmette-Guerin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) have been introduced in recent years with FDA approval based on a historical benchmark of valrubicin. However, intravesical gemcitabine/docetaxel (gem/doce) has replaced valrubicin as the contemporary standard of care. We therefore, examined the complete response (CR) rates, durability of response (DOR), and disease-free survival (DFS) of novel therapies against gem/doce. We identified registration trials of FDA approved therapies for BCG-unresponsive NMIBC: nadofaragene, pembrolizumab, nogapendekin alfa inbakicept (NAI), TAR-200, and valrubicin. We used observational data for gem/doce as a benchmark. We reconstructed individual patient data (IPD) datasets for each trial by digitizing Kaplan-Meier plots using WebPlotDigitizer, and estimated IPDs using the Guyot algorithm. DOR and DFS were estimated using the Kaplan-Meier method and compared across treatments using the log-rank test. Among carcinoma in situ (CIS) cohorts, gem/doce (88%), and TAR-200 (82%) had the highest 3-month CR rates, exceeding NAI (71%), nadofaragene (53%), pembrolizumab (41%), and valrubicin (21%). Among responders, there were no statistically significant differences in DOR for each novel therapy compared against gem/doce. In papillary-only cohorts, gem/doce had a higher DFS compared to pembrolizumab (P = 0.012), and there was no statistically significant difference with nadofaragene or TAR-200. None of the recently FDA-approved therapies demonstrated a greater CR rate, DOR, or DFS compared to gem/doce. Notwithstanding limitations related to heterogeneity across trials, these findings suggest that none of the novel intravesical therapies should be considered prior to gem/doce based on oncologic control, coupled with the low cost of gem/doce, and highlight the need to rigorously examine the comparative effectiveness and sequencing of novel therapeutics.

PMID 43009427
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PubMedAnnals of surgical oncology2026-11-10

Poor Imaging Response to FLOT is Associated with Worse Pathologic Features and Survival in Gastroesophageal Adenocarcinoma.

Park Jin-Soo JS, Allison Frances F, Allen Jonathan J, Jang Raymond R et al.

Little is known about the outcomes of patients with gastroesophageal adenocarcinoma (GEA) who respond poorly to neoadjuvant FLOT (5-fluorouracil, leucovorin, oxaliplatin, docetaxel) on imaging. We aimed to determine whether imaging non-response to FLOT was associated with worse pathologic features, recurrence patterns, and survival outcomes. Patients with GEA who received neoadjuvant FLOT from January 2017 to April 2025 were retrospectively analyzed. Staging and re-staging computed tomography and positron emission tomography were used to determine tumor response, stratifying the cohort into FLOT responders or non-responders (FNRs). Pathologic features, overall survival (OS) and event-free survival (EFS) were compared between the two groups. Survival data from 193 patients were analyzed: 116 (60.1%) were responders and 77 (39.9%) were FNR; 24 patients in the FNR group developed metastases and were not included in pathologic analysis (n = 169). FNRs had worse performance status, more advanced ypT and ypN stage, less pathologic tumor regression, and higher rates of lymphovascular and perineural invasion than responders. Imaging response to FLOT was significantly associated with pathologic tumor regression grade (p < 0.001). Median OS was lower in the FNR group (24.6 vs. 67 months, log rank p < 0.001), as was median EFS (13 vs. 32 months, log rank p < 0.001). FLOT non-response was a prognostic factor for OS (hazard ratio 1.989; 95% confidence interval 1.079-3.669; p = 0.028) on multivariable analysis. In the 81 patients who experienced recurrence after resection, there was no difference in OS and EFS with imaging response. Patients with GEA with poor response to FLOT on imaging demonstrated significantly worse pathologic features and OS and EFS.

PMID 43004099
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PubMedJournal of clinical oncology : official journal of the American Society of Clinical Oncology2026-11-10

Treatment of Stage IB to III Nasopharyngeal Carcinoma: CSCO-ASCO Guideline Update.

Chen Yu-Pei YP, Ismaila Nofisat N, Huang Shao Hui SH, Jiang Wei W et al.

To update the 2021 CSCO-ASCO guideline on chemotherapy in combination with radiotherapy for the definitive treatment of non-metastatic nasopharyngeal carcinoma (NPC), incorporating new evidence on radiotherapy techniques and target-volume de-escalation, chemotherapy regimens and their sequencing, adjuvant therapy, and immunotherapy for patients with stage IB-III disease. A multidisciplinary Expert Panel reviewed evidence published since the prior guideline, including randomized controlled trials, systematic reviews, meta-analyses, and relevant prospective and retrospective studies. Outcomes of interest included overall survival, failure-free or progression-free survival, locoregional and distant disease control, acute and late toxicities, and patient-reported quality of life. Recommendations were developed using the ASCO guideline development process and Expert Panel consensus. The updated evidence supports: IMRT with image guidance and MRI-based target delineation as core components of definitive treatment; selected response-adapted target delineation following induction chemotherapy; elective nodal de-escalation in appropriately selected patients; risk-adapted chemotherapy sequencing according to stage and biologic risk; cisplatin-based concurrent chemoradiotherapy; gemcitabine-cisplatin (GP) or docetaxel-cisplatin-fluorouracil (TPF) as preferred induction regimens; and selected adjuvant chemotherapy options, including metronomic capecitabine for patients with higher residual post-chemoradiotherapy risk. Several randomized trials evaluating PD-1 inhibitors have demonstrated improved disease-control outcomes, but overall survival data remain immature. This guideline update provides recommendations on radiotherapy technique, dose, imaging, and target delineation; sequencing of additional chemotherapy with radiotherapy; concurrent chemotherapy options; induction chemotherapy regimens and timing; adjuvant chemotherapy options; and the role of immunotherapy. At present, the Panel makes no recommendation for or against routine addition of immunotherapy to induction-concurrent chemoradiotherapy; applicability of the trial evidence, benefits and harms, local approval and access, and patient preferences should guide individualized decisions.Additional information is available at www.ascopubs.org/topics/asco-guidelines/head-neck-cancer.

PMID 43008242
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PubMedOncology and therapy2026-11-10

Durable Treatment-Free Remission in BRCA1-Associated Metastatic Triple-Negative Breast Cancer with Brain and Radiologically Diagnosed Hepatic Metastases: A Case Report.

Alaklabi Sabah S, AlAyoubi Leenah L, Alsuhaibani Mohanned M, Tulbah Asma A et al.

Metastatic triple-negative breast cancer (TNBC) is associated with aggressive clinical behavior and poor survival, particularly in patients with brain and visceral metastases. We describe an exceptionally durable treatment-free remission in a young woman with metastatic TNBC and a subsequently identified pathogenic germline BRCA1 variant. We retrospectively reviewed the patient's clinical course, radiological and histopathological findings, systemic and local treatments, genetic testing, and long-term follow-up. In 2008, the patient was diagnosed with grade 3 triple-negative invasive ductal carcinoma and hepatic lesions considered metastatic based on computed tomography (CT), magnetic resonance imaging (MRI), and multidisciplinary assessment. Following six cycles of fluorouracil, doxorubicin, and cyclophosphamide (FAC), the hepatic lesions regressed. In 2009, she developed a solitary, histologically confirmed left frontal brain metastasis, which was surgically resected and treated with postoperative radiotherapy. Subsequent breast and hepatic disease progression was treated with 15 cycles of docetaxel plus bevacizumab, resulting in a marked radiological response. Following isolated locoregional progression in 2011, without radiologically active distant disease, she underwent modified radical mastectomy with axillary dissection followed by locoregional radiotherapy. A pathogenic germline BRCA1 variant was identified in 2020. She has received no systemic anticancer therapy since December 2010 and remained in complete clinical and radiological remission as of June 2026, more than 17 years after diagnosis of the brain metastasis. This case documents an exceptionally prolonged treatment-free remission in metastatic TNBC despite a history of radiologically diagnosed hepatic metastases and a histologically confirmed brain metastasis. Although the contributions of tumor biology and individual treatments cannot be established, the clinical course highlights the heterogeneity of metastatic TNBC and the importance of individualized multidisciplinary management.

PMID 43004051
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PubMedArchivio italiano di urologia, andrologia : organo ufficiale [di] Societa italiana di ecografia urologica e nefrologica2026-11-09

Electromotive drug administration accelerates intravesical tissue uptake of gemcitabine and docetaxel into porcine bladders: an ex vivo proof-of-concept study.

Carando Roberto R, Salvadori Danilo D, Natuzzi Fedele F, Kouros Michail M et al.

Intravesical alternatives to bacillus Calmette-Guérin (BCG) are needed to treat patients with non-muscle-invasive bladder cancer (NMIBC) not responding to BCG or high-risk NMIBC. Electromotive drug administration (EMDA) enhances the penetration of mitomycin C into the bladder wall and could be used also with other drugs. We aimed to investigate whether EMDA accelerates intravesical delivery of gemcitabine and docetaxel as compared to passive diffusion (PD). We instilled fifteen porcine bladders with gemcitabine and docetaxel using EMDA or PD. Drug concentrations in the mucosa, muscle, and adventitious layers of the bladder were quantified using reversed-phase high-performance liquid chromatography. Docetaxel mean total tissue penetration increased from 2.9% with PD to 6.4% with EMDA after pretreatment with gemcitabine. When no gemcitabine pretreatment was done, docetaxel absorption was statistically significantly higher with EMDA than with PD. Hyaluronic acid did not improve or worsen penetration and no statistically significant difference was observed between the treatment arm with saline (95% confidence intervals of the mean [95% CI] vs PD: 5.92-19.91) and hyaluronic acid/chondroitin sulphate solution (95% CI vs PD: 7.67-23.32). For gemcitabine, no statistically significant difference was observed among treatment arms. Total gemcitabine tissue penetration was similar in both treatment arms, but EMDA shortened the time needed to achieve similar tissue concentrations compared to passive diffusion, reducing the gemcitabine uptake time by 70 minutes and the docetaxel uptake time by 40 minutes. EMDA accelerates gemcitabine and docetaxel uptake and enhances intravesical delivery of docetaxel.

PMID 43001838
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