Safety, Efficacy, and Quality-of-Life Study of Lenalidomide Plus Dexamethasone In Previously Treated Patients with Multiple Myeloma: The Spanish Experience

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3045-3045 ◽  
Author(s):  
Adrian Alegre ◽  
Albert Oriol-Rocafiguera ◽  
Jose García-Laraña ◽  
María-Victoria Mateos ◽  
Anna Sureda ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Phase 3 ◽  
Meaningful Improvement ◽  
Emotional Function ◽  
History Of ◽  
Grade 3 ◽  
C 30 ◽  
Eortc Qlq

Abstract Abstract 3045 Background: Lenalidomide is an oral IMiD® immunomodulatory compound with a dual mechanism of action, namely tumoricidal and immunomodulatory activity, and established clinical efficacy and safety in patients with multiple myeloma (MM). Lenalidomide plus dexamethasone (Len + Dex) was well tolerated and demonstrated significant improvements in response and favorable overall survival (OS) compared with Placebo + Dex in 2 pivotal phase 3 registration trials in patients with relapsed/refractory MM (RRMM; Weber et al, NEJM 2007; Dimopoulos et al, NEJM 2007). Previously, in a phase 3, multicenter, single-arm, open-label, expanded-access study (MM-018), Len + Dex demonstrated a predictable safety profile that can preserve patient quality of life (QoL) (Yong et al Haematologica 2010 [abstract #0944]). Here we report efficacy, safety, and QoL data for patients enrolled in the Spanish cohort of MM-018. Methods: Patients with progressive disease after > 2 cycles of antimyeloma treatment, or after relapse from treatment, with ECOG performance status ≤ 2 received 28-day cycles of Len (25 mg/day, D 1–21) plus Dex (40 mg/day, D 1–4, 9–12, and 17–20 for cycles 1–4; D 1–4 in subsequent cycles). Endpoints included overall response (≥ partial response [PR] by European Group for Blood and Marrow Transplantation criteria) and QoL assessments measured by EORTC QLQ C-30 and EORTC QLQ MY-20 questionnaires at baseline and week 24. All prophylaxis was administered at the investigator's discretion. Results: Sixty-three patients receiving ≥ 1 dose of Len + Dex were evaluated for efficacy, safety, and QoL. Median age was 62 years (21 [33.3%] were > 65 years). Prior therapies included thalidomide (n = 15, 24%) and bortezomib (n = 37, 59%). Additionally, 5 (8%) patients had a history of deep vein thrombosis (DVT), and 23 (37%) had a history of peripheral neuropathy. A PR or better was observed in 49 (78%) patients, including complete response (CR) in 13 (21%), very good partial response (VGPR) in 13 (21%), and PR in 23 (37%) patients. Median time to first response and best response was 2.7 and 4.5 months, respectively. Median duration of response was 18.4 months. Response depth improved after long-term treatment with Len + Dex, and 32/63 (51%) patients received >12 cycles of therapy. Beyond 12 cycles of therapy, 8 patients achieved VGPR and 12 patients achieved CR; compared with 5 patients and 1 patient, respectively, prior to 12 cycles. Median time to progression and progression-free survival were both 13.3 months; median OS has not yet been reached. Forty-two (67%) patients remained on study at 6 months. Compliance to QoL assessment questionnaires was ≥ 80%. Patient-reported improvements in QoL and disease symptoms measured by both questionnaires were observed in nearly all scales. EORTC QLQ C-30 scores revealed clinically meaningful improvement (> 5 points) for global QoL (n = 15, 40%), fatigue (n = 16, 42%), emotional function (n = 15, 40%), physical function (n = 12, 32%), role function (n = 11, 29%), social function (n = 11, 29%), cognitive function (n = 10, 26%), and pain (n = 9, 24%) at 6 cycles compared with baseline. Preservation of QoL in role function, emotional function, social function, and pain scores was observed at 6 cycles when compared with baseline in responders (≥ PR). EORTC QLQ MY-20 results revealed no relevant median change (> 5 points) from baseline in all scales for all patients completing questionnaires at baseline and 6 cycles, except for a meaningful improvement in future perspective scores (median 11.1-point change). Adverse events observed in this study were consistent with those previously reported with Len + Dex. Grade 3/4 hematologic events were experienced by 40 (64%) patients, and included neutropenia (n = 32, 51%), thrombocytopenia (n = 11, 17%), anemia (n = 10, 18%), and febrile neutropenia (n = 4, 6%). DVT (all grades) was experienced by 5 (8%) patients, and only one grade 3/4 new-onset peripheral neuropathy was observed after 6 cycles of treatment. Conclusions: Len + Dex treatment in this expanded-access study demonstrated efficacy and predictable safety, consistent with that of previously published trials for patients with RRMM. More patients achieved VGPR and CR after long-term therapy compared with those receiving < 12 cycles of therapy. Furthermore, QoL assessments at baseline and 6 months revealed that patients treated with Len + Dex showed meaningful improvements in certain QoL and symptom scores. Disclosures: Oriol-Rocafiguera: Celgene: Consultancy; Janssen-Cilag: Consultancy; Novartis: Consultancy. García-Laraña:Celgene: Consultancy; Janssen-Cilag: Consultancy. Mateos:Celgene: Honoraria. Cibeira:Celgene: Honoraria for Lectures; Janssen-Cilag: Honoraria for Lectures; Pharmion: Honoraria for Lectures. Knight:Celgene: Employment. Rosettani:Celgene Corporation: Employment.

scholarly journals Reconstructive Surgery in Soft Tissue Sarcomas—Long-Term Outcome and Quality of Life

2017 ◽  
Vol 102 (11-12) ◽  
pp. 480-488
Author(s):  
Reiner Wirbel ◽  
Steffen Weber ◽  
Angela Olinger ◽  
Wolf Mutschler ◽  
Tim Pohlemann
Keyword(s):  
Quality Of Life ◽  
Functional Outcome ◽  
Reconstructive Surgery ◽  
Soft Tissue Sarcomas ◽  
Tumor Stage ◽  
Stage Ii ◽  
C 30 ◽  
Eortc Qlq

The long-term oncological and functional outcome including quality of life should be evaluated in soft tissue sarcomas (STS). The need for reconstructive surgery with possible influence on the results should also be analyzed. Tumor stage mainly influences the prognosis of STS. Advances in reconstructive surgery mostly allow limb salvage. Limited information exists about functional outcome and life quality. A total of 86 patients (51 men, 35 women, mean age 50.5 years) with a minimum follow-up of 10 years were analyzed. We determined the oncological outcome (local recurrences, metastases, overall survival) of tumors at varying stages: stage I (n = 30), stage II (n = 52), and stage III (n = 4). Functional outcome and quality of life of the survivors were measured using the Musculoskeletal Tumor Society (MSTS) criteria and the EORTC-QLQ-C-30 (European Organisation for Research and Treatment of Cancer-Quality of Life-Questionnaire-Core-30 module) questionnaire. Tumor stage influenced the survival and the development of metastases. Survival rates were 89.5 and 88% after 5 and 10 years in stage I, and 56.5 and 49% in stage II tumors. Surgical margin influenced the development of local recurrence. Reconstructive procedures were necessary in 27 patients. After a median follow-up of 144 months, 36 patients were dead: 29 of their malignancy and 7 of other diseases. Fifty long-term survivors presented good results for MSTS (mean score: 82.4) and EORTC-QLQ-C-30 (mean score: 79.8), the results were independent on the need of reconstructive surgery. In stage II STS, the survival drops even after 5 years. The surgical treatment of STS requires the knowledge of different reconstructive techniques; functional results and quality of life are not compromised by the need for reconstructive surgery.

Long-term quality of life and nutritional results after laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy for early gastric cancer: Secondary outcomes of a multicenter, randomized phase 3 trial (SENORITA).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4054-4054
Author(s):  
Bang Wool Eom ◽  
Hong Man Yoon ◽  
Young-Woo Kim ◽  
Jae Seok Min ◽  
Ji Yeong An ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Gastric Cancer ◽  
Early Gastric Cancer ◽  
Phase 3 ◽  
Navigation Surgery ◽  
Sentinel Node Navigation Surgery ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

4054 Background: Laparoscopic sentinel node navigation surgery (LSNNS) has been suggested as an alternative to laparoscopic standard gastrectomy (LSG) in early gastric cancer patients to improve long-term quality of life (QOL) and nutritional outcomes. Here, we present 3-year results of patient-reported quality of life (QOL) and nutrition, secondary endpoints of SENORITA trial. Methods: SENORITA is a prospective multicenter randomized phase 3 trial. Patients diagnosed with early gastric cancer of 3 cm or less were randomly allocated (1:1) to LSNNS for stomach preservation or LSG. The primary endpoint was 3-year disease-free survival. In this study, we analyzed QOL assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC stomach module (STO22) and nutritional parameters at 3, 12, 24, and 36 months after surgery. Linear mixed model analyses was used to evaluate differences between the two groups. This trial is registered with ClinicalTrials.gov, NCT01804998. Results: From March 2013 to March 2017, a total of 580 patients were randomly assigned and 527 patients were included in the modified intention-to-treat analysis population (258 in LSNNS and 269 in LSG group). QOL questionnaires were available for 99.4% of patients at baseline and then for 92.2%, 83.2%, 72.8%, and 66.9% at 3, 12, 24, and 36 months after surgery, respectively. The LSNNS group had higher physical function score than the LSG group at all time points (p = 0.002). However, there were no significant differences in other scales of EORTC QLQ-C30. Regarding EORTC QLQ-STO22, pain, eating restriction, anxiety, and taste scores were lower (better QOL) at all time points in the LSNNS group than in the LSG group (p = 0.002, < 0.001, < 0.001, and < 0.001, respectively). The summary score of EORTC QLQ-STO22 was also higher in the LSNNS group representing better QOL (p < 0.001). Body mass index, hemoglobin and total protein were significantly higher in the LSNNS group compared with the LSG group. Conclusions: The LSNNS group had better physical function and less symptoms, including pain, eating restriction, anxiety, and taste change compared with the LSG group. Moreover, the nutritional parameters were better maintained in the LSNNS group than in the LSG group. These findings showed benefits of stomach preserving surgery in LSNNS and can be used to help decision making about treatment for patients with early gastric cancer. Clinical trial information: NCT01804998.

scholarly journals Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair

Hernia ◽  
2021 ◽  
Author(s):  
M. M. J. Van Rooijen ◽  
T. Tollens ◽  
L. N. Jørgensen ◽  
T. S. de Vries Reilingh ◽  
G. Piessen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hernia Repair ◽  
Hernia Recurrence ◽  
Recurrence Rates ◽  
Elective Repair ◽  
Significant Difference ◽  
Grade 3

Abstract Introduction Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. Methods A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm2, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months. Results Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery. Conclusion After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations. Trial registration Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.

ENGOT-en11/GOG-3053/KEYNOTE-B21: Phase 3 study of pembrolizumab or placebo in combination with adjuvant chemotherapy with/without radiotherapy in patients with newly diagnosed high-risk endometrial cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS5608-TPS5608
Author(s):  
Toon Van Gorp ◽  
Mansoor Raza Mirza ◽  
Alain Lortholary ◽  
David Cibula ◽  
Axel Walther ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Endometrial Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Combination Therapy ◽  
Stage I ◽  
Newly Diagnosed ◽  
Phase 3 ◽  
Eortc Qlq

TPS5608 Background: Pembrolizumab, a selective humanized anti–PD-1 monoclonal antibody, has demonstrated activity in patients with previously treated mismatch repair (MMR) deficient (dMMR; 57.1% ORR as monotherapy and 63.6% ORR as combination therapy with lenvatinib) and MMR proficient (pMMR; 36.2% ORR as combination therapy with lenvatinib) endometrial cancer (EC). ENGOT-en11/GOG-3053/KEYNOTE-B21 is a phase 3, randomized, double-blind study of pembrolizumab or placebo in combination with adjuvant chemotherapy with/without radiotherapy in patients with EC. Methods: Eligible patients are ≥18 years old with newly diagnosed, histologically confirmed high-risk (stage I/II non-endometrioid, stage III/IVa, p53 abnormality) EC (carcinoma or carcinosarcoma) following surgery with curative intent with no evidence of disease post-operatively or on imaging, and without prior systemic therapy/radiotherapy. In total, ̃990 patients are randomized to receive pembrolizumab 200 mg or placebo Q3W for 6 cycles + chemotherapy (carboplatin area under the curve [AUC] 5 or 6 + paclitaxel 175 mg/m2 Q3W or carboplatin AUC 2 or 2.7 + paclitaxel 60 mg/m2 QW) in stage 1. Patients receive pembrolizumab 400 mg or placebo Q6W for 6 cycles in stage 2 per their treatment assignment. At the investigator’s discretion, radiotherapy (external beam radiotherapy [EBRT] and/or brachytherapy) ± radiosensitizing cisplatin 50 mg/m2 (days 1 and 29) may be administered after completion of chemotherapy. Randomization is stratified by MMR status (pMMR vs dMMR) and, within pMMR, by planned radiation therapy (cisplatin-EBRT vs EBRT vs no EBRT), histology (endometrioid vs non-endometrioid), and International Federation of Gynecology and Obstetrics (FIGO) surgical stage (I/II vs III/IVA). Dual primary endpoints are disease-free survival (DFS; per investigator assessment) and overall survival (OS), both estimated by the Kaplan-Meier method, with a stratified log-rank test to assess treatment differences and a Cox proportional hazard model with Efron’s method of tie handling to assess the magnitude of treatment differences. Secondary endpoints include DFS (per blinded independent central review), DFS (per investigator assessment) and OS by biomarker status (PD-L1 and tumor mutational burden), safety (per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0) and quality of life (per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] and Endometrial Cancer Module [EORTC QLQ-EN24]). The study began enrollment in December 2020. Clinical trial information: NCT04634877.

scholarly journals Quality of life among ovarian cancer survivors in Haji Adam Malik General Hospital Medan, Indonesia

2020 ◽  
Vol 11 (2) ◽  
pp. 133-139
Author(s):  
Kristivani Br Ginting ◽  
Muhammad Rizki Yaznil ◽  
M. Oky Prabudi ◽  
Lili Rahmawati
Keyword(s):  
Quality Of Life ◽  
Ovarian Cancer ◽  
Cancer Survivors ◽  
General Hospital ◽  
Detection Methods ◽  
Cross Sectional ◽  
Eortc Qlq C30 ◽  
C 30 ◽  
Eortc Qlq

Latar belakang: Kanker ovarium memiliki angka mortalitas yang cukup tinggi dikarenakan gejalanya yang tidak spesifik, sering ditemukan pada stadium lanjut, dan belum adanya metode deteksi dini yang sudah terbukti. Untuk menilai keberhasilan terapi penyintas kanker ovarium, tidak hanya dinilai dari aspek klinis tetapi juga dinilai dari kualitas hidup penyintas kanker ovarium yang penilaiannya berdasarkan skala fungsional dan skala gejala dalam kuesioner EORTC QLQ C30 dan EORTC QLQ OV28. Metode: Penelitian ini menggunakan desain penelitian cross sectional, menggunakan data primer dari hasil wawancara dengan kuesioner EORTC QLQ C30 dan EORTC QLQ OV28 serta data sekunder yang berasal dari rekam medik di RSUP Haji Adam Malik Medan tahun 2017 - 2018. Sampel penelitian dipilih dengan metode total sampling dari seluruh data rekam medik yang memenuhi kriteria penelitian.   Hasil: Hasil penelitian ini didapatkan kualitas hidup global penyintas kanker ovarium 89.36% adalah baik, dan 10.64% adalah sedang serta tidak ada yang memiliki kualitas hidup buruk. Namun, didapatkan adanya gangguan pada skala fungsional berupa: fungsi emosional, fungsi kognitif, fungsi seksual, dan sikap terhadap penyakit, serta adanya permasalahan pada skala gejala berupa: kelelahan, nyeri, neuropati perifer, dan gejala menopause. Didapatkan juga tidak ada hubungan karakteristik usia, jenis histopatologis, stadium, lama terapi dengan kualitas hidup penyintas kanker ovarium, namun terdapat hubungan antara jenis terapi dengan kualitas hidup penyintas kanker ovarium. Kesimpulan: Kualitas hidup penyintas kanker ovarium secara global adalah baik. Kata Kunci: Kualitas Hidup, Penyintas Kanker Ovarium, EORTC QLQ C-30, EORTC QLQ     OV-28   Abstract Background: Ovarian cancer has a high mortality rate due to nonspecific symptoms, often found at an advanced stage, and also the absence of proven early detection methods. To assess the success of ovarian cancer survivors therapy, it is not only assessed from the clinical aspect but also from the quality of life of ovarian cancer survivors which is based on the functional and symptom scale in the EORTC QLQ C30 and EORTC QLQ OV28 questionnaires.  Methods: This study used a cross-sectional study design, using primary data from interviews with the survivors based on the questionnaire EORTC QLQ C30 and EORTC QLQ OV28 as well as secondary data derived from medical records at Haji Adam Malik General Hospital Medan in 2017 - 2018. The research sample was used with a total sampling method from all medical record data that fulfill the research criteria.  Result: The quality of life of ovarian cancer survivors is generally good (89.36%), meanwhile the rest is moderate (10.64%) without the poor quality of life. However, there are disorders on the functional scale in the form of emotional function, cognitive function, sexual function, and attitude toward disease. Likewise on the scale of symptoms, there are problems including: fatigue, pain, peripheral neuropathy, and menopausal symptoms.  Conclusion: The quality of life of ovarian cancer survivors globally is good. Keywords: Quality of Life, Ovarian Cancer Survivors, EORTC QLQ C-30, EORTC QLQ OV-28  

scholarly journals Psychosocial Aspects and Quality of Life in Cancer Patients undergoing Surgery

2021 ◽  
Vol 12 (4) ◽  
pp. 78-84
Author(s):  
M. Bakos ◽  
T. Jankovic ◽  
M. Vidiscak ◽  
S. Durdik
Keyword(s):  
Quality Of Life ◽  
Cancer Patients ◽  
Negative Impact ◽  
European Organization ◽  
Term Survival ◽  
Physical Relationship ◽  
End Of Treatment ◽  
Eortc Qlq

Introduction:Quality of life in cancer patients and probably also long term survival is negatively affected with fear of the recurrence of cancer and consequences of aggressive therapy. This is the reason for anxiety, depressions, and frustration which are accompanied by cognitive, emotional and behavioral disorders in their physical, relationship, sexual and social func- tioning. The aim of our study is to analyze the dynamics of evolution of the psychosocial loads and qualitative changes its symptomatology in cancer patients who survival 1-4 years after surgery. Material and methods:For assessment of psychosocial mor- bidity ́s in measure in surgery patients standardized question- naires of European Organization for Research and Treatment of Cancer- questionnaire EORTC QLQ-C30.3 (Quality of Life- C.30.3) and its module EORTC QLQ- BR23 were used. Results:The degree of psychosocial mortality in survival pa- tients one year after MRM in our group clearly demonstrated that these patients suffered because of consequences of psy- chosocial loads. It results from fear of recurrence of cancer and next functional, emotional, cognitive and social disorders with- out regard for surgery range. The degree of psychosocial loads in patients after MRM is still more than 4 years after end of treatment. Results show, that after the end of treatment there are many changes in their lives - anxiety and depressions can lead to psychical lability because of higher doubts, nervous- ness, irritability, helplessness and loneliness in their sufferers. Conclusion:Out-patient psychosocial interventions and pre- ventions because of negative impact of ongoing and changing psychosocial loads becomes necessary. It means that there is negative impact on quality of life; of long term cancer remis- sion and survival of patients after surgery.

O-135 Long term secondary efficacy of linzagolix for heavy menstrual bleeding (HMB) due to uterine fibroids (UF): 52-week results from two placebo-controlled, randomized, phase 3 trials

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
H Taylor ◽  
J Donnez ◽  
F Petraglia ◽  
K Gemzell Danielsson ◽  
S Renner ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Score ◽  
Uterine Fibroids ◽  
Heavy Menstrual Bleeding ◽  
Menstrual Bleeding ◽  
Phase 3 ◽  
Once Daily ◽  
Secondary Endpoints

Abstract Study question Are symptomatic improvements in women with UF observed after 24 weeks of linzagolix treatment with or without add-back therapy (ABT) maintained over 52 weeks? Summary answer Improvements in anemia, pain and quality of life previously reported at 24 weeks were maintained at 52 weeks. What is known already We previously reported that partial or full suppression of estradiol (E2) with once daily doses of either 100 or 200 mg linzagolix for 24 weeks, with or without ABT, were effective in reducing heavy menstrual bleeding associated with uterine fibroids, improving other symptoms such as pain and anemia and improving quality of life. Here we report the maintenance of effect on secondary endpoints after 52 weeks of treatment. Study design, size, duration Linzagolix is an investigational, oral GnRH antagonist being developed to treat HMB due to UF. PRIMROSE 1 (P1, USA, NCT03070899) and PRIMROSE 2 (P2, Europe and USA, NCT03070951) are randomized, double-blind, placebo-controlled Phase 3 trials, with essentially identical design, investigating the efficacy and safety of linzagolix with and without hormonal add-back therapy (ABT: 1 mg estradiol/0.5 mg norethindrone acetate) once daily for 52 weeks. Participants/materials, setting, methods Participants had HMB due to UF (&gt;80mL menstrual blood loss (MBL)/cycle) and were equally randomized to: placebo, linzagolix 100mg, linzagolix 100mg+ABT, linzagolix 200mg, or linzagolix 200mg+ABT. After 24 weeks, subjects originally randomized to placebo or linzagolix 200mg were switched to linzagolix 200mg+ABT except in P1 where 50% placebo subjects continued placebo until 52 weeks. Secondary efficacy assessments included hemoglobin, pain (0–10 numeric rating scale) and health related quality of life (HRQL) on the UF-QoL questionnaire. Main results and the role of chance P1 trial subjects (n = 526) had a mean age of 42 years, pain score of 6.6 and HRQL total score (0–100) of 36.4 and 63% were Black. P2 trial subjects (n = 511) had a mean age of 43 years, pain score 4.8 and HRQL total score of 46.1 and 5% were Black. Mean baseline MBL was about 200 mL per cycle in both studies. In both trials, significant improvements compared to placebo observed at week 24 for secondary endpoints, including pain, anemia and QoL in all linzagolix treatment groups were maintained at 52 weeks. Mean±SD hemoglobin levels in anemic patients (&lt;12 g/dL) increased from baseline by 1.7±1.9, 1.9±1.7, 2.2±2.4, 2.7±1.9 in P1 and 1.2±1.9, 2.9±1.8, 2.4±2.1, 3.0±1.4 in P2 in the 100mg, 100mg+ABT, 200mg/200mg+ABT, 200mg+ABT groups, respectively, compared to 0.6±1.8 with placebo (P1). Mean±SD change from baseline in pain scores were -3.3±3.1, -2.7±3.2, -2.6±3.0, -3.9±3.2 in P1 and -2.6±3.1, -2.6±2.8, -3.0±2.6, -2.8±3.0 in P2 in the 100mg, 100mg+ABT, 200mg/200mg+ABT, 200mg+ABT groups, respectively, compared to -0.4±2.5 with placebo (P1). Mean±SD change in HRQL total scores were 25.0±26.2, 34.2±30.1, 29.7±29.2, 38.3±29.2 in P1 and 16.8±24.0, 29.6±23.2, 31.9±26.8, 30.7±26.0 in P2 in the 100mg, 100mg+ABT, 200mg/200mg+ABT, 200mg+ABT groups, respectively, compared to 14.6±23.9 with placebo (P1). Limitations, reasons for caution Here we report data in both trials up to 52 weeks of treatment. No statistical comparisons were done at 52 weeks (the primary analysis was done after 24 weeks treatment). Post-treatment follow-up will provide more information in symptom recurrence after stopping treatment. Wider implications of the findings All linzagolix treatments provided sustained benefit. Two regimens previously identified for potential long-term treatment, 200mg with ABT and 100mg without ABT, provided sustained improvements of anemia, pain and associated quality of life. These different treatment regimens could be important to address the diverse needs of women suffering from uterine fibroids. Trial registration number ClinicalTrials.gov: NCT03070899, NCT03070951

OS09.7.A Quality of life outcomes in patients with incidental and operated meningiomas: the QUALMS study

2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii12-ii13
Author(s):  
S M Keshwara ◽  
A I Islim ◽  
C P Millward ◽  
C S Gillespie ◽  
G E Richardson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Global Health ◽  
Cognitive Functioning ◽  
Emotional Health ◽  
Health Score ◽  
Sf 36 ◽  
Eortc Qlq

Abstract BACKGROUND Long-term Health-Related Quality of Life (HRQoL) is an important measure of patient wellbeing. There is a paucity of studies evaluating HRQoL in meningioma patients. MATERIAL AND METHODS Cross-sectional study of adult patients with an incidental or symptomatic intracranial meningioma. Patients with less than 5 years of follow-up, a history of craniospinal radiation or neurofibromatosis type 2 were excluded. HRQoL was evaluated with SF-36, EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires. Outcome determinants were evaluated using a multi-variable linear regression analysis, adjusted for patient, tumour and treatment characteristics, and duration of follow-up. RESULTS 699 patients were invited to participate and 246 responded: 118 (48%) had an incidental meningioma. Mean age at diagnosis was 56.8 years (SD=13) and 81% were female. Median time from diagnosis to completion of questionnaire was 8.5 years (IQR 6.8–11.5). During follow-up, 158 patients (64.2%) had at least one operation for their meningioma and 47 patients (19.1%) had radiotherapy. Of those operated, 126 (79.7%) had WHO grade 1 and 24 (15.2%) had grade 2 meningiomas. Compared to normative population values, meningioma patients reported a worse SF-36 general health score (mean 61.9 vs 56.5, P=0.003) but a similar QLQ-C30 global health score (mean 62.3 vs 65.8, P=0.039), worse SF-36 and QLQ-C30 physical functioning scores (mean 74.1 vs 64.6, P&lt;0.001 and mean 81.8 vs 76.5, P=0.007) and similar SF-36 and QLQ-C30 emotional health scores (mean 72.2 vs 70.9, P=0.367 and mean 71.0 vs 71.9, P=0.960). QLQ-C30 cognitive functioning was worse (mean 80.5 vs 71.4, P&lt;0.001). Compared to the meningioma literature, QLQ-BN20 seizure burden was similar (mean 2.0 vs 1.6, P=0.760). A worse performance status at diagnosis was associated with an inferior QLQ-C30 global health score (β-coefficient=-4.9 [95% CI -9.1-(-)0.6] P=0.024). Number of surgeries was significantly associated with a worse QLQ-C30 cognitive functioning score (β-coefficient=-7.0 [95% CI -13.2-(-)0.9], P=0.025). Anti-epileptic drug use was associated with a significantly worse QLQ-C30 emotional health score (β-coefficient=-10.9 [95% CI -21.7-(-)0.01], P=0.050). CONCLUSION Meningioma patients have long-term HRQoL impairments affecting their physical and cognitive functions. An understanding that multiple surgeries affects cognitive function, and the need for anti-epileptic drugs equate to poorer emotional health, could help target appropriate therapies and support in the future.

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