Post-hoc analysis suggests regional hyperthermia plus chemotherapy may improve survival in extremity soft tissue sarcoma
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Key Takeaway
Consider regional hyperthermia with chemotherapy for extremity soft tissue sarcoma, but do not base decisions solely on risk estimates.
This post-hoc analysis evaluated overall survival in patients with extremity soft tissue sarcoma treated with neoadjuvant chemotherapy either alone or combined with regional hyperthermia. The study population included patients analyzed from a randomized trial setting. The primary outcome assessed was overall survival, with secondary considerations including the absolute difference in five-year survival rates between the two groups.
Results indicated that survival in the group receiving chemotherapy combined with regional hyperthermia exceeded Sarculator predictions and showed improvement compared to the chemotherapy-only group. The absolute five-year survival difference favored the combined approach, although the statistical significance was not reached. The authors noted that the interaction between the Sarculator score and treatment was not significant, suggesting the treatment effect was consistent across risk groups.
The authors highlight limitations regarding the reliance on risk estimates alone for guiding treatment decisions. They emphasize that findings do not suggest that clinical decisions should be based on risk estimates in isolation. The study supports the use of regional hyperthermia combined with chemotherapy in patients with primary extremity soft tissue sarcoma, but this should be interpreted with caution given the study design and lack of statistical significance in the primary outcome.
View Original Abstract ↓
BACKGROUND: In the EORTC 62961-ESHO 95 randomized trial (European Organization for Research and Treatment 62961-European Society of Hyperthermia Oncology 95; ClinicalTrials.gov identifier NCT00003052), neoadjuvant chemotherapy (NAC) combined with regional hyperthermia (RHT) improved survival in patients with soft tissue sarcoma (tumor size >5 cm, grade 2 or 3, deep location). This study investigated the survival benefit of NAC + RHT in a subgroup of patients who had extremity soft tissue sarcoma (ESTS) according to risk predictions using the Sarculator nomogram.
METHODS: Overall survival (OS) was predicted with the Sarculator nomogram using baseline prognostic parameters. Kaplan-Meier analysis was used to estimate observed OS. A bivariable Cox model including the Sarculator score, treatment, and their interaction was fitted. Hazard ratios for OS were calculated for each decile of the Sarculator risk distribution.
RESULTS: Of 143 patients with ESTS, 135 were analyzed (NAC, n = 70; NAC + RHT, n = 65) with a median follow-up of 136 months (interquartile range, 110-183 months). Survival in the NAC + RHT group exceeded Sarculator predictions and improved compared with the group that received NAC alone (hazard ratio, 0.67; 95% confidence interval, 0.39-1.17; p = .081), with an absolute 5-year OS difference of 15.6% (95% confidence interval, 0.0%-31.4%). Risk stratification suggested greater benefit of NAC + RHT as predicted OS decreased. However, the interaction between Sarculator score and treatment was not significant (p = .495).
CONCLUSIONS: This analysis of ESTS from a randomized trial confirmed the previously reported OS benefit by adding RHT to NAC. Although patients with higher predicted risk seemed to benefit more from the combined treatment, these findings do not suggest that treatment decisions should be based on risk estimates alone, supporting the use of RHT combined with chemotherapy in patients who have primary ESTS.
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