Elderly and frail patients with multiple myeloma (MM) are more vulnerable to the toxicity of combination therapies, often resulting in treatment modifications and suboptimal outcomes. The phase 3 BOSTON study showed that once-weekly selinexor and bortezomib with low-dose dexamethasone (XVd) improved PFS and ORR compared with standard twice-weekly bortezomib and moderate-dose dexamethasone (Vd) in patients with previously treated MM. This is a retrospective subgroup analysis of the multicenter, prospective, randomized BOSTON trial. Post hoc analyses were performed to compare XVd versus Vd safety and efficacy according to age and frailty status (<65 and ≥65 years, nonfrail and frail). Patients ≥65 years with XVd had higher ORR (OR 1.77, p = .024), ≥VGPR (OR, 1.68, p = .027), PFS (HR 0.55, p = .002), and improved OS (HR 0.63, p = .030), compared with Vd. In frail patients, XVd was associated with a trend towards better PFS (HR 0.69, p = .08) and OS (HR 0.62, p = .062). Significant improvements were also observed in patients <65 (ORR and TTNT) and nonfrail patients (PFS, ORR, ≥VGPR, and TTNT). Patients treated with XVd had a lower incidence of grade ≥ 2 peripheral neuropathy in ≥65 year-old (22% vs. 37%; p = .0060) and frail patients (15% vs. 44%; p = .0002). Grade ≥3 TEAEs were not observed more often in older compared to younger patients, nor in frail compared to nonfrail patients. XVd is safe and effective in patients <65 and ≥65 and in nonfrail and frail patients with previously treated MM.

• MeSH
• Bortezomib administration & dosage   adverse effects   MeSH
• Dexamethasone administration & dosage   adverse effects   MeSH
• Progression-Free Survival MeSH
• Adult MeSH
• Gastrointestinal Diseases chemically induced   MeSH
• Hydrazines administration & dosage   adverse effects   MeSH
• Kaplan-Meier Estimate MeSH
• Clinical Trials, Phase III as Topic statistics & numerical data   MeSH
• Frailty complications   diagnosis   MeSH
• Hematologic Diseases chemically induced   MeSH
• Middle Aged MeSH
• Humans MeSH
• Multiple Myeloma complications   drug therapy   MeSH
• Multicenter Studies as Topic statistics & numerical data   MeSH
• Peripheral Nervous System Diseases chemically induced   MeSH
• Antineoplastic Combined Chemotherapy Protocols adverse effects   therapeutic use   MeSH
• Randomized Controlled Trials as Topic statistics & numerical data   MeSH
• Retrospective Studies MeSH
• Drug Administration Schedule MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Severity of Illness Index MeSH
• Triazoles administration & dosage   adverse effects   MeSH
• Age Factors MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Comparative Study MeSH

Do studie bylo zařazeno celkem 144 pacientů. Na začátku studie nebyly mezi skupinami žádné rozdíly, co se týče demografických ukazatelů a závažnosti onemocnění. Průměrné trvání nemoci bylo 8 let, průměrná bolest kolem 60 mm na VAS a Lequesnův index 12. V hodnotě základní ukazatel (pain invisity diference – PID) došlo na konci k signifikantně vyššímu poklesu u Geladrinku Forte oproti placebu (29 ± 3,0 mm vs. 19,0 ± 3,0 mm, p = 0,0427). Rozdíl nebyl signifikantní u kolagenního hydrolyzátu oproti placebu (25 ± 3,6 vs. 19,0 ± 3,0, p = 0,12) v populaci ITT. Při hodnocení pacientů, kteří dokončili studii, byl rozdíl oproti placebu významný jak u Geladrinku Forte (p = 0,016), tak u kolagenního hydrolyzátu (p = 0,04). Rozdíly u algofunkčního indexu nebyly významné. Pacienti u Geladrinku Forte užívali o 40 % méně záchranné medikace. V toleranci léčených skupin nebyly žádné rozdíly. Složený přípravek Geladrink Forte je účinný v léčbě bolestivé gonartrózy.

A total of 144 patients were included in the study. In the beginning there were no differences between the groups concerning demographic parameters or the severity of the disease. The average duration of the disease was 8 years; the average pain was around 60 mm on VAS and Lequesne index 12. There was a significantly greater decline in the value of the basic parameters (pain intensity difference – PID) at the end in Geladrink Forte compared to the placebo (29 ± 3.0 mm compared to 19.0 ± 3.0 mm, p = 0.0427). The difference was not significant in collagenous hydrolysate compared to the placebo (25 ± 3.6 against 19.0 ± 3.0, p = 0.12) in population ITT. The difference during the evaluation of the patients who completed the study compared to the placebo was significant in Geladrink Forte (p = 0.016) as well as in collagenous hydrolysate (p= 0.04). Differences in the algo-functional index were not significant. Patients on Geladrink Forte used 40% less emergency medication. There was no difference in the tolerance of the treatment groups. The Geladrink Forte composite preparation is efficient in the treatment of painful knee osteoarthritis.

• Keywords
• Geladrink forte,
• MeSH
• Amino Acids drug effects   MeSH
• Osteoarthritis, Knee drug therapy   MeSH
• Pain drug therapy   MeSH
• Walking MeSH
• Double-Blind Method MeSH
• Drug Evaluation MeSH
• Cartilage, Articular drug effects   MeSH
• Collagen therapeutic use   MeSH
• Nonprescription Drugs MeSH
• Humans MeSH
• Multicenter Studies as Topic statistics & numerical data   MeSH
• Dietary Supplements MeSH
• Randomized Controlled Trials as Topic statistics & numerical data   MeSH
• Statistics as Topic MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans MeSH
• Publication type
• Review MeSH