Outcomes of Elderly Patients with Advanced Soft Tissue Sarcoma Treated with First-Line Chemotherapy: A Pooled Analysis of 12 EORTC Soft Tissue and Bone Sarcoma Group Trials

Younger, Eugenie; Litière, Saskia; Cesne, Axel Le; Mir, Olivier; Gelderblom, Hans; Italiano, Antoîne; Marréaud, Sandrine; Jones, Robin L.; Gronchi, Alessandro; Graaf, Winette T.A. van der

doi:10.1634/theoncologist.2017-0598

Cited by 26 publications

(13 citation statements)

References 31 publications

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“…Notably, the median age of patients included in this study was 79 years, much older than the threshold of 65 years commonly used to define elderly patients. 23 This population is usually greatly underrepresented in STS trials, as reported recently by the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. 23 In this analysis of 13 trials, the percentage of enrolled patients aged ≥65 years was only 12.4%, and the median age within this small percentage of patients was relatively low (68 years).…”

Section: Discussionmentioning

confidence: 99%

“…23 This population is usually greatly underrepresented in STS trials, as reported recently by the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. 23 In this analysis of 13 trials, the percentage of enrolled patients aged ≥65 years was only 12.4%, and the median age within this small percentage of patients was relatively low (68 years). This is in contrast to the fact that 40% to 50% of new diagnoses of STS each year are performed in elderly patients and further highlights the burning issue of the age gap between clinical trials and everyday clinical practice.…”

Section: Discussionmentioning

confidence: 99%

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Pharmacokinetics, safety, and activity of trabectedin as first‐line treatment in elderly patients who are affected by advanced sarcoma and are unfit to receive standard chemotherapy: A phase 2 study (TR1US study) from the Italian Sarcoma Group

Grosso

D’Ambrosio

Zucchetti

et al. 2020

Cancer

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BACKGROUND: Although elderly patients (≥70 years) represent 30% of new diagnoses of soft tissue sarcoma (STS), they are underrepresented in clinical trials and are often unfit to receive standard anthracycline-based chemotherapy. Trabectedin is registered as a second-line treatment for advanced STS and is characterized by a favorable safety profile. METHODS: The aim of this single-arm, phase 2 study was to investigate trabectedin (scheduled dose, 1.3-1.5 mg/m 2) as a first-line treatment in elderly patients with advanced stage STS who are inoperable and are unfit to receive standard anthracycline-based chemotherapy. The coprimary endpoints were progression-free survival at 3 months (PFS3) and the rate of clinically limiting toxicities (CLTs). We also conducted an ancillary study on pharmacokinetics. RESULTS: Twenty-four patients (12 men and 12 women) with a median age of 79 years (interquartile range [IQR], 74-83 years) were enrolled. The histological subtype was leiomyosarcoma in 46%, liposarcoma in 33%, and other histotypes in 21%. The median number of trabectedin courses was 4 (IQR, 3-6), with 7 patients (29%) receiving ≥6 cycles. Eight patients (33%) required dose reductions. The most frequent grade 3/4 adverse events were neutropenia in 9 patients (38%), fatigue in 5 patients (21%), and aminotransferase elevation in 5 patients (21%). PFS3, median PFS, and overall survival were 71% (80% CI, 57%-81%), 4 months, and 12 months, respectively. Ten patients (42% [80% CI, 28%-57%]) experienced CLTs. Trabectedin C max , half-life, clearance, and distribution volume were 1.28 ng/mL (standard deviation [SD], 0.58 ng/mL), 26.70 hours (SD, 9.09 hours), 39.98 L/h/m 2 (SD, 14.08 L/h/m 2), and 1460 L/m 2 (SD, 561 L/m 2), respectively. CONCLUSION: Trabectedin can be administered safely to elderly patients with STS who are unfit to receive anthracyclines. Pharmacokinetics in the elderly population was superimposable to historical data.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Pharmacokinetics, safety, and activity of trabectedin as first‐line treatment in elderly patients who are affected by advanced sarcoma and are unfit to receive standard chemotherapy: A phase 2 study (TR1US study) from the Italian Sarcoma Group

Grosso

D’Ambrosio

Zucchetti

et al. 2020

Cancer

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“… 18 In contrast, key issues that must be considered in treatment of elderly patients are physiological changes associated with aging, functional and role functioning, comorbidities, cognitive status and polypharmacy. 19 Lack of representation in clinical trials is seen in both AYA and elderly patients. 20 , 21 A recent study identified significant age-related differences in the sarcoma patient journey that are not only related to variations in sarcoma subtypes, such as more incorrect diagnoses and higher burden of treatment in younger patients and less referral to rehabilitation services in the elderly.…”

Section: Introductionmentioning

confidence: 99%

The age-related impact of surviving sarcoma on health-related quality of life: data from the SURVSARC study

et al. 2021

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Background: Health-related quality of life (HRQoL) data of sarcoma survivors are scarce and the impact of age remains unclear. The aims of this population-based study were to (i) compare HRQoL scores amongst three age-groups [adolescents and young adults (AYA, aged 18-39 years), older adults (OA, aged 40-69 years) and elderly (aged !70 years)]; (ii) compare HRQoL of each sarcoma survivor age group with an age-and sex-matched normative population sample; (iii) determine factors associated with low HRQoL per age group. Methods: Dutch sarcoma survivors, who were 2-10 years after diagnosis, were invited to complete the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30-questions questionnaire on HRQoL. Results: In total, 1099 survivors (58% response rate) completed the questionnaire: 186 AYAs, 748 OAs and 165 elderly. The median time since diagnosis for all patients was 5.2 years. Bone sarcomas were seen in 41% of AYAs, 22% of OAs and in 16% of elderly survivors (P < 0.01). AYA and OA survivors reported statistically significant and clinically meaningful worse physical, role, cognitive, emotional and social functioning compared with a matched norm population, which was not the case for elderly survivors. AYAs reported significantly worse scores on emotional and cognitive functioning compared with OA and elderly survivors. Malignant peripheral nerve sheath tumour, osteosarcoma and chordoma were the subtypes of which survivors reported the lowest HRQoL scores in comparison with the norm. For all age groups, chemotherapy, having a bone sarcoma and having comorbidities were most frequently associated with low scores on HRQoL subscales, whereas a shorter time since diagnosis was not. Conclusion: In this nationwide sarcoma survivorship study, the disease and its treatment had relatively more impact on the HRQoL of AYA and OA survivors than on elderly survivors. These results emphasise the need for personalised followup care that not only includes risk-adjusted care related to disease relapse, but also age-adjusted care.

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“…Another important point of view is that elderly patients are generally underrepresented or excluded from cancer clinical trials, whereas they represent an increasing population in "real life" medical oncology [9,10]. This has negatively impacted our knowledge of sarcoma treatment efficacy for this age group, although the scenario seems to be evolving in the last few years.…”

Section: Introductionmentioning

confidence: 99%

The Real-Life Journey of Elderly Patients in Soft Tissue and Bone Sarcomas: A Retrospective Analysis from a Sarcoma Referral Center

Ferraresi

Vari

Rossi

et al. 2020

JCM

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The high complexity of multimodality treatment frequently results in undertreatment of elderly sarcoma patients, and this may be one of the factors that influence their prognosis. We describe the real-life approach to a population of patients aged over 70 with both soft tissue (STS) and bone sarcomas (BS) followed by our Sarcoma Disease Management Team from 2012 to 2017. One-hundred and twenty-three patients with a median age of 77 years (range: 70–92) were identified. STS were the most common histological subtypes (94%) and the grade was high in 79/123 patients (64%). At diagnosis, 88% of patients had localized disease (LD) and 12% were metastatic (MD). Overall, 96% of patients with LD underwent surgery, 46/54 (85%) with high grade STS patients underwent complementary radiotherapy, and 10/54 (19%) received adjuvant treatments. Twelve out of 33 patients who relapsed (36%) underwent local therapies. Seventeen (52%) and eight (24%) patients were treated with first-line and second-line medical treatments, respectively. Tolerability to systemic treatments was fairly good. Overall, 21% of the patients with advanced disease were candidates for best supportive care alone. Our case series of elderly patients with both STS and BS shows that personalized multidisciplinary treatment can nevertheless be offered to this frail population in order to control the evolution of disease.

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Outcomes of Elderly Patients with Advanced Soft Tissue Sarcoma Treated with First-Line Chemotherapy: A Pooled Analysis of 12 EORTC Soft Tissue and Bone Sarcoma Group Trials

Cited by 26 publications

References 31 publications

Pharmacokinetics, safety, and activity of trabectedin as first‐line treatment in elderly patients who are affected by advanced sarcoma and are unfit to receive standard chemotherapy: A phase 2 study (TR1US study) from the Italian Sarcoma Group

Pharmacokinetics, safety, and activity of trabectedin as first‐line treatment in elderly patients who are affected by advanced sarcoma and are unfit to receive standard chemotherapy: A phase 2 study (TR1US study) from the Italian Sarcoma Group

The age-related impact of surviving sarcoma on health-related quality of life: data from the SURVSARC study

The Real-Life Journey of Elderly Patients in Soft Tissue and Bone Sarcomas: A Retrospective Analysis from a Sarcoma Referral Center

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