Abstract 1550P
Background
The EPAZ study (NCT01861951) recently showed that pazopanib was non-inferior to doxorubicin in patients ≥ 60 years treated in first line for advanced STS [1]. The current post hoc analysis aimed to assess the prognostic impact of frailty.
Methods
Patients ≥ 60 years with advanced STS were randomized for treatment with either pazopanib or doxorubicin [1]. Elderly minimal comprehensive geriatric assessment (GA) [consisted of G8 screening tool, Charlson Comorbidity Index (CCI), instrumental activities of daily living (IADL) and social situation] were assessed at baseline. Age > 75 years, liposarcoma, ECOG performance status = 2, G8 ≤ 14, IADL ≥ 1 and CCI ≥ 2 were tested for their impact on progression-free (PFS) and overall survival (OS), using Kaplan-Meier method and Cox proportional hazards model. Treatment was always included as a covariate in the Cox model.
Results
In univariate analyses, G8 score ≤ 14 was a negative prognostic factor for PFS and OS, while IADL score ≥ 1 showed no effect on PFS but was associated with poorer OS. On multivariate analysis, G8 ≤ 14 remained a negative prognostic factor for PFS (HR 1.82; 95%-CI 1.16 - 2.83; p = 0.009), but its prognostic relevance for OS was lost. IADL ≥1 had no influence on PFS but was prognostic for OS (HR 2.02; 95%-CI 1.21 - 3.38; p = 0.007). ECOG = 2 was the strongest negative predictor for PFS (HR 4.39; 95%-CI 1.87 - 10.30; p = 0.001) and OS (HR 3.74; 95%-CI 1.54 - 9.12; p = 0.004). Neither age nor CCI were prognostic factors for PFS or OS.
Conclusions
This post hoc analysis of the EPAZ trial demonstrated that age is not a denominator for outcome in elderly STS patients, even in advanced chronological age > 75 years. Instead, functional assessment such as ECOG PS, G8 and IADL are of prognostic value in STS. Geriatric assessment, additional to ECOG PS, should be used to counsel patients and tailor therapy to individual needs. 1.Grünwald V, Karch A, Schuler M, Schöffski P, Kopp HG, Bauer S, et al. Randomized Comparison of Pazopanib and Doxorubicin as First-Line Treatment in Patients With Metastatic Soft Tissue Sarcoma Age 60 Years or Older: Results of a German Intergroup Study. J Clin Oncol. 2020;38(30):3555-64.
Clinical trial identification
NCT01861951.
Editorial acknowledgement
Legal entity responsible for the study
Hannover Medical School.
Funding
Glaxo-Smith-Kline, which was transitioned to Novartis during the duration of the study.
Disclosure
R.W. Hamacher: Financial Interests, Personal, Invited Speaker: Lilly; Other, Other, Travel grant: Novartis; Other, Other, Travel grant: PharmaMar. M.K. Schuler: Financial Interests, Institutional, Funding: Novartis (Inst); Financial Interests, Personal, Funding: PharmaMar. P. Schöffski: Financial Interests, Personal, Invited Speaker, Honoraria: Deciphera Pharmaceuticals; Financial Interests, Personal, Invited Speaker, Honoraria: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker, Honoraria: Blueprint Medicines; Financial Interests, Institutional, Advisory Board: Plexxikon (Inst); Financial Interests, Institutional, Advisory Board: Eisai (Inst); Financial Interests, Institutional, Advisory Board: Loxo Oncology (Inst); Financial Interests, Institutional, Advisory Board: Eli Lilly (Inst); Financial Interests, Institutional, Advisory Board: Blueprint Medicines (Inst); Financial Interests, Institutional, Advisory Board: Ellipses Pharma (Inst); Financial Interests, Institutional, Advisory Board: Deciphera Pharmaceuticals (Inst); Financial Interests, Institutional, Advisory Board: Merck (Inst); Financial Interests, Institutional, Advisory Board: Servier (Inst); Financial Interests, Institutional, Advisory Board: Genmab (Inst); Financial Interests, Institutional, Advisory Board: Adaptimmune Therapeutics (Inst); Financial Interests, Institutional, Advisory Board: Intellisphere (Inst); Financial Interests, Institutional, Advisory Board: Transgene (Inst); Financial Interests, Institutional, Advisory Board: Exelixis (Inst); Financial Interests, Personal, Advisory Board: Deciphera Pharmaceuticals; Financial Interests, Institutional, Funding: CoBioRes (Inst); Financial Interests, Institutional, Funding: Eisai (Inst); Financial Interests, Institutional, Funding: G1 Therapeutics (Inst); Financial Interests, Institutional, Funding: PharmaMar (Inst); Financial Interests, Institutional, Funding: Novartis (Inst); Financial Interests, Institutional, Other, Travel, Accommodations, Expenses: MSD (Inst); Financial Interests, Institutional, Other, Travel, Accommodations, Expenses: Ipsen (Inst); Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Boehringer Ingelheim. H. Kopp: Financial Interests, Personal, Invited Speaker, Honoraria: MSD Oncology; Financial Interests, Personal, Invited Speaker, Honoraria: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker, Honoraria: LEO Pharma; Financial Interests, Personal, Invited Speaker, Honoraria: PharmaMar; Financial Interests, Personal, Invited Speaker, Honoraria: Roche; Financial Interests, Personal, Invited Speaker, Honoraria: Pfizer; Financial Interests, Personal, Invited Speaker, Honoraria: Chugai Pharma; Financial Interests, Personal, Invited Speaker, Honoraria: Takeda; Financial Interests, Personal, Invited Speaker, Honoraria: Novartis; Financial Interests, Personal, Invited Speaker, Honoraria: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: MSD Oncology; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Funding, Travel, Accommodations, Expenses: Sanofi; Financial Interests, Personal, Funding, Travel, Accommodations, Expenses: Eli Lilly; Financial Interests, Personal, Funding, Travel, Accommodations, Expenses: Amgen; Financial Interests, Personal, Funding, Travel, Accommodations, Expenses: Novartis; Financial Interests, Personal, Funding, Travel, Accommodations, Expenses: PharmaMar; Financial Interests, Personal, Funding, Travel, Accommodations, Expenses: Boehringer Ingelheim; Financial Interests, Personal, Funding, Travel, Accommodations, Expenses: MSD Oncology; Financial Interests, Personal, Funding, Travel, Accommodations, Expenses: Bristol Myers Squibb; Financial Interests, Personal, Funding, Travel, Accommodations, Expenses: Roche. S. Bauer: Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: PharmaMar; Financial Interests, Personal, Advisory Board: ADC Therapeutics; Financial Interests, Personal, Advisory Board: Blueprint Medicines; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Deciphera; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Plexxikon; Financial Interests, Personal, Advisory Board: PharmaMar; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Nanobiotix; Financial Interests, Personal, Advisory Board: Janssen-Cilag; Financial Interests, Personal, Advisory Board: Exelixis; Financial Interests, Personal and Institutional, Funding: Novartis. B. Kasper: Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Springworks Therapeutics; Financial Interests, Personal, Funding: PharmaMar; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: PharmaMar. L.H. Lindner: Financial Interests, Personal, Ownership Interest, Stock and Other Ownership Interests: Thermosome; Financial Interests, Personal, Invited Speaker, Honoraria: Eli Lilly; Financial Interests, Personal, Invited Speaker, Honoraria: PharmaMar; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Advisory Board: Jazz Pharmaceuticals; Financial Interests, Personal, Advisory Board: EL medconsult; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Institutional, Funding: Sennewald (Inst); Other, Personal, Other, Patents, Royalties, Other Intellectual Property: Thermosensitive liposomes based on DPPG2; Financial Interests, Personal, Invited Speaker, Travel, Accommodations, Expenses: PharmaMar; Financial Interests, Personal, Invited Speaker, Travel, Accommodations, Expenses: Eli Lilly. J. Chemnitz: Financial Interests, Personal, Invited Speaker, Honoraria: Roche; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: PharmaMar. M. Crysandt: Financial Interests, Personal, Invited Speaker, Honoraria: Novartis; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Gilead Sciences; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Celgene; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Amgen. A. Stein: Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Servier; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Sanofi; Financial Interests, Personal, Speaker’s Bureau: Bayer; Financial Interests, Personal, Speaker’s Bureau: Eli Lilly; Financial Interests, Personal, Speaker’s Bureau: Celgene; Financial Interests, Personal, Speaker’s Bureau: Amgen; Financial Interests, Personal, Speaker’s Bureau: Merck; Financial Interests, Personal, Speaker’s Bureau: Servier; Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb; Financial Interests, Institutional, Funding: Roche (Inst); Financial Interests, Institutional, Funding: Sanofi (Inst); Financial Interests, Institutional, Funding: Merck (Inst); Financial Interests, Institutional, Funding: Bristol Myers Squibb (Inst); Financial Interests, Institutional, Funding: Servier (Inst); Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Bristol Myers Squibb; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Merck. B. Steffen: Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Daiichi-Sankyo Ocology Europe; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Pfizer Pharma; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Lilly Deutschland. S. Richter: Financial Interests, Personal, Advisory Board: PharmaMar; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: PharmaMar; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Eli Lilly. G. Egerer: Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Speaker’s Bureau: Eli Lilly; Financial Interests, Personal, Speaker’s Bureau: PharmaMar; Financial Interests, Personal, Speaker’s Bureau: MSD. P. Ivanyi: Financial Interests, Personal, Invited Speaker, Honoraria: Bayer Vital; Financial Interests, Personal, Invited Speaker, Honoraria: Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker, Honoraria: Novartis; Financial Interests, Personal, Invited Speaker, Honoraria: AstraZeneca; Financial Interests, Personal, Invited Speaker, Honoraria: Ipsen; Financial Interests, Personal, Invited Speaker, Honoraria: Eisai; Financial Interests, Personal, Invited Speaker, Honoraria: AIM (Working Party Interdisciplinary Medicine); Financial Interests, Personal, Invited Speaker, Honoraria: EUSA Pharma; Financial Interests, Personal, Invited Speaker, Honoraria: Roche Pharma; Financial Interests, Personal, Invited Speaker, Honoraria: MSD Oncology; Financial Interests, Personal, Invited Speaker, Honoraria: Merck Serono; Financial Interests, Personal, Advisory Board: Bayer/Vital; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Merck Serono; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Bristol Myers Squibb; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Ipsen. V. Grünwald: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: EISAI; Financial Interests, Personal, Invited Speaker: EISAI; Financial Interests, Personal, Advisory Board: EUSAPharm; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Janssen-Cilag; Financial Interests, Personal, Advisory Board: Merck Serono; Financial Interests, Personal, Invited Speaker: Merck Serono; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Nanobiotix; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Stocks/Shares: AstraZeneca; Financial Interests, Personal, Stocks/Shares: BMS; Financial Interests, Personal, Stocks/Shares: MSD; Financial Interests, Personal, Stocks/Shares: Seattle Genetics; Non-Financial Interests, Personal, Other, Steering Committee Member: BMS; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Personal and Institutional, Other, Steering Committee Member: EISAI; Non-Financial Interests, Personal and Institutional, Other, Steering Committee Member: Ipsen; Financial Interests, Personal and Institutional, Research Grant: Ipsen; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Personal and Institutional, Other, Steering Committee Member: Novartis; Non-Financial Interests, Personal and Institutional, Research Grant: Pfizer; Non-Financial Interests, Personal and Institutional, Other, Trial Chair: PharmaMar; Non-Financial Interests, Personal, Member: ASCO; Non-Financial Interests, Personal, Advisory Board: German Cancer Society; Non-Financial Interests, Personal, Member: German medical Oncology and Hematology Society; Non-Financial Interests, Personal, Leadership Role: Working Group medical oncology. All other authors have declared no conflicts of interest.