The safety and efficacy of trabectedin for advanced leiomyosarcoma or liposarcoma appeared comparable among older and younger patients, according to a multicenter, open-label study presented at the Connective Tissue Oncology Society Annual Meeting.
Elderly patients with soft tissue sarcoma may have limited treatment options due to comorbidities and increased risk for toxicity.“There are few published data regarding the utility and toxicity of palliative systemic therapy in elderly patients with advanced soft tissue sarcomas,” Robin L. Jones, BSc, MB, MRCP, MD (Res), consultant medical oncologist at The Royal Marsden NHS Foundation Trust, told HemOnc Today. “Therefore, this analysis is important as it will serve as a useful benchmark for oncologists treating elderly patients with advanced soft tissue sarcomas.”
Jones and colleagues used data from an expanded access program — created to provide access to trabectedin for patients not expected to benefit from other treatment options — to evaluate the safety and efficacy of trabectedin (Yondelis, Janssen) among patients aged 65 years or older.
The expanded access program included 1,803 patients treated between 2005 and 2010. Of them, 330 (median age, 70 years; 53.4% women) were aged at least 65 years, and 1,453 (median age, 51 years; 59.7% women) were aged younger than 65 years.
All patients had unresectable advanced soft tissue sarcoma and had relapsed or progressed following standard chemotherapy or were intolerant to standard chemotherapy.
Overall, researchers determined a similar proportion of older and younger patients received therapy for 12 months or longer (7.4% for both) and received at least two cycles (81.7% vs. 84.3%). Median number of cycles received was three in each group.
A similar proportion of older and younger patients also experienced dose delay (33.6% vs. 36.2%) or reduction (47.2% vs. 46%).
Median OS was 11.47 months (95% CI, 10.02-14.98) for older patients and 12.25 months (95% CI, 11.07-14.13) for younger patients.
Older patients also demonstrated similar rates of overall response (3.9% vs. 5.4%) and clinical benefit (43.1% vs. 40.1%) as their younger counterparts.
Treatment-emergent adverse events occurred among 78% of older patients and 77.5% of younger patients. Serious treatment-emergent adverse events occurred among 43.7% of older patients compared with 38.2% of younger patients. Toxicities observed in the older group appeared comparable to previously reported events, and those that occurred in the younger group.
Most patients who discontinued treatment did so due to disease progression; only 9.1% of older patients and 8.1% of younger patients discontinued due to an adverse event.
“For the elderly population, further prospective trials are required incorporating geriatric assessment tools,” Jones said. “We need to develop markers that can identify elderly patients most likely to benefit from palliative systemic therapy.” – by Alexandra Todak .