# Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase 2 trial

Source: https://onco.cc/key-papers/paper-hensley-gemcitabine-docetaxel-leiomyosarcoma-jco-2002/  
OnCo record `paper-hensley-gemcitabine-docetaxel-leiomyosarcoma-jco-2002` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The combination of gemcitabine and docetaxel produced responses in more than half of patients with leiomyosarcoma, most of them uterine and many previously treated with doxorubicin, establishing a widely used second regimen for the disease.

## Summary

Phase 2 study of 34 patients with unresectable leiomyosarcoma (29 uterine) treated with fixed-dose-rate gemcitabine followed by docetaxel every three weeks with growth factor support.

Objective response was 53 percent including three complete responses, with responses in patients previously treated with doxorubicin; median time to progression was 5.6 months and myelosuppression was the main toxicity.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: Journal of Clinical Oncology
- Year: 2002
- DOI: 10.1200/JCO.2002.11.050
- Authors: Hensley ML, Maki R, Venkatraman E, et al.
- Findings: Objective response 53 percent (18 of 34).; Responses in patients with prior doxorubicin exposure.
- What it means: Gemcitabine-docetaxel is a standard first- or second-line option for leiomyosarcoma, especially uterine, and remains in use alongside doxorubicin-based regimens.
- Caveats: Single-arm study; randomised trials (GeDDiS) later found gemcitabine-docetaxel no better than doxorubicin first line.

## Sources

- J Clin Oncol 2002: https://doi.org/10.1200/JCO.2002.11.050
- PubMed: https://pubmed.ncbi.nlm.nih.gov/12065559/

## Connected records

- cancers: [Leiomyosarcoma](https://onco.cc/cancers/leiomyosarcoma/)
- drugs: [Docetaxel](https://onco.cc/drugs/docetaxel/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/)
- journals: [Journal of Clinical Oncology](https://onco.cc/journals/jco/)

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