Abstract

Objectives: Adjuvant chemotherapy is often considered following surgery for uterine leiomyosarcoma. However, due to the rarity of this malignancy, few trials exist documenting active cytotoxic agents in the adjuvant setting. A Phase III trial conducted by the GOG failed to show improved progression-free (PFS) or overall survival (OS) in patients randomized to doxorubicin or observation. The role of gemcitabine and docetaxel was evaluated in a prospective study; however, that trial lacked a control arm. Our objective was to compare survival outcomes among patients with uterine leiomyosarcoma who received adjuvant gemcitabine and docetaxel versus other chemotherapy regimens. Methods: This was a retrospective cohort study including 145 patients diagnosed with leiomyosarcoma from 1981 to 2013 at two tertiary care centers. Data collected included age, BMI, race, tumor grade, stage, residual disease, adjuvant treatment, PFS and OS. Variables were compared by Fisher's exact test or Wilcoxon rank-sum test. Kaplan– Meier curves were used to plot time to progression/recurrence or death. Cox proportional hazards regression was used to estimate hazard ratios for progression/recurrence or death by patient characteristics. Results: Among the cohort, 55 received adjuvant chemotherapy. Of these, 29 received gemcitabine/docetaxel and 26 received other chemotherapy. There were no significant differences in age, BMI, stage at diagnosis, or presence of residual disease between the two groups. However, patients receiving gemcitabine/docetaxel were significantly more likely to be Caucasian (85.7% vs. 61.5%, p = 0.008) and have a high grade tumor (96.6% vs. 61.5%, p = 0.02). Median PFS was 5.5 months in the gemcitabine/docetaxel group compared to 13 months in the other chemotherapy group (p= 0.30). The corresponding median OS was 23 months in the gemcitabine/docetaxel group compared to 39 months in the other chemotherapy group (p= 0.27). Conclusions: There was no significant difference in PFS or OS in patients with uterine leiomyosarcoma treated with adjuvant gemcitabine/docetaxel versus other chemotherapy regimens. Further evidence is needed to determine the role and best therapeutic regimens in the adjuvant setting.

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