scholarly journals Real-World Health-Related Quality of Life in Patients with Diffuse Large B-Cell Lymphoma: Comparisons with Reference Populations and By Line of Therapy

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4111-4111
Author(s):  
Qiufei Ma ◽  
Abigail Bailey ◽  
Neil Milloy ◽  
Jake Butcher ◽  
Ruben G.W Quek ◽  
...  

Abstract Introduction: Diffuse large B-cell lymphoma (DLBCL) is the most common type of aggressive non-Hodgkin's lymphoma (NHL) constituting 30-58% of all NHL (Tilly et al, 2015; Thieblemont et al, 2020). Treatment can include intensive multiagent chemotherapy and other novel therapies which carries risk for toxicities. Despite this, we lack data comprehensively depicting the quality of life of real-world patients with DLBCL, particularly in the modern era with novel therapies. Therefore, we aimed to compare Quality of Life (QoL) to reference populations and assess real-world DLBCL patients across multiple countries and lines of therapy. Methods: Real-world data were drawn from the Adelphi DLBCL Disease Specific Programme™ (DSP), a point-in-time survey of hematologists, hemato-oncologists, oncologists and their patients with DLBCL conducted in France (FR), Germany (DE), Italy (IT), Spain (SP), the United Kingdom (UK) and the United States of America (US) between Jan-May 2021. Patients were asked to voluntarily complete a patient self-completion form (PSC) capturing demographics and QoL data through the use of patient-reported outcome instruments: the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30), EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L), EQ-5D-5L Visual Analogue Scale and Work Productivity and Activity Impairment questionnaire. Bivariate analysis was conducted to compare all cancer and NHL-specific reference values from the EORTC QLQ-C30 manual (Scott et al, 2008) to DLBCL DSP data, and to review QoL across lines of therapy, defined as first line and second line (1L+2L) and third line and above (3L+). Statistical significance level was set at p<.05. If functional scores were lower, when compared to reference values, within the DSP, this was indicative of a worse QoL in patients with DLBCL. For symptomatic scores the opposite was true; should the DSP value be higher, this was indicative of a worse QoL in patients with DLBCL. Results: Data analysis was conducted on 441 patients with DLBCL who completed a PSC (FR: n=80, DE: n=150, IT: n=54, SP: n=43, UK: n=34, US: n=80); at data collection, mean (standard deviation) age was 64.6 (12.39) years, 36% of patients were female, 19% working full- or part-time and 80% were relapsed/refractory, 29% were 3L+. 8%, 24%, 28% and 40% were at Ann Arbor disease stage I, II, III and IV respectively at the time of data collection. When comparing DLBCL DSP values to EORTC QLQ-C30 all cancer reference values for functional scores (Table 1), global health status, physical functioning, role functioning, emotional functioning, cognitive functioning and social functioning were significantly worse than all cancer reference values. In terms of symptoms, DSP values for fatigue, nausea and vomiting, dyspnea, appetite loss and diarrhea were significantly worse than all cancer reference values (Table 2). Results were mixed when comparing with EORTC QLQ-C30 NHL-specific reference values (Table 1) for functional scores; global health status was significantly worse for the DLBCL DSP population, whilst role functioning, cognitive functioning and social functioning were significantly better than NHL reference values. Significantly worse symptom scores were observed in the DLBCL DSP population (Table 2) for nausea and vomiting, pain, dyspnea and diarrhea when compared with the reference values. Functioning scores were significantly worse in 3L+ patients vs 1L+2L for global health status, physical functioning, role functioning, cognitive functioning and social functioning (Table 3). Fatigue, dyspnea and diarrhea symptomatic scores were significantly worse in 3L+ vs 1L+2L patients. Symptom burden was high across all lines of therapy (Table 4). Conclusion: Real-world patients with DLBCL demonstrated significantly worse QoL when compared with a general cancer reference population with respect to all functional scores, as well as fatigue, nausea and vomiting, dyspnea, appetite loss and diarrhea, underscoring the high symptom burden experienced by patients with DLBCL. Patients with DLBCL on 3L+ had significantly worse QoL than those on earlier lines of therapy with respect to global health status, physical functioning, role functioning, cognitive functioning and social functioning, fatigue, dyspnea and diarrhea indicating an unmet need in novel treatment options to help improve QoL in later lines. Figure 1 Figure 1. Disclosures Ma: Regeneron Pharmaceuticals Inc.: Current Employment, Current holder of individual stocks in a privately-held company. Quek: Regeneron Pharmaceuticals Inc.: Current Employment, Current holder of individual stocks in a privately-held company.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4097-4097
Author(s):  
Juan W. Valle ◽  
Antoine Hollebecque ◽  
Junji Furuse ◽  
Lipika Goyal ◽  
Funda Meric-Bernstam ◽  
...  

4097 Background: In FOENIX-CCA2 (NCT02052778), a pivotal phase 2 study among iCCA patients (pts) with FGFR2 fusions/rearrangements, the highly selective, irreversible FGFR1–4 inhibitor futibatinib demonstrated a confirmed objective response rate of 41.7%, with a 9.7-month median duration of response. Adverse events were manageable with dosing modifications that did not adversely impact on response. We report outcomes for the preplanned analysis of Patient-Reported Outcomes (PROs) during futibatinib treatment as a secondary objective of FOENIX-CCA2. Methods: Pts enrolled in FOENIX-CCA2 had locally advanced/metastatic unresectable iCCA with FGFR2 fusions/rearrangements, ≥1 prior line of therapy (including gemcitabine/cisplatin) and ECOG PS 0-1. Pts received oral futibatinib 20 mg continuous QD dosing per 21-day cycle. PRO measures included EORTC-QLQ-C30 (1 global health, 5 functional, 9 symptom scales), EQ-5D-3L, and EQ visual analogue scale (VAS). PROs were collected at screening, cycles 2 and 4, every 3 cycles thereafter, and end of treatment. PRO data were evaluated up to cycle 13, the last visit before data were missing for >50% of the PRO population (PRO primary assessment time point). Results: 92/103 (89.3%) pts enrolled had PRO completion data at baseline and a minimum of 1 follow-up assessment (median age 58 y, 56.5% female), with 48 pts having PRO data at cycle 13. At baseline, mean (SD) EORTC QLQ-C30 global health status score was 70.1 (19.4) and EQ VAS score 71.7 (20.3). Mean EORTC QLQ-C30 global health status scores were maintained from baseline to cycle 13, corresponding to 9.0 months on treatment, with no clinically meaningful (≥10-point) changes in individual functional measures (Table). EORTC QLQ-C30 scores across individual symptom measures were also stable from baseline through cycle 13; only constipation showed an average of 10.0-point worsening at only cycle 4. Mean EQ VAS scores were sustained from baseline to cycle 13 (mean change ranging -1.8 to +4.8 across cycles), with values maintained within the population norm range from across 20 countries. Conclusions: Quality of life data from the phase 2 FOENIX-CCA2 trial show that physical, cognitive and emotional functioning, and overall health status were maintained among pts with advanced iCCA receiving futibatinib. Clinical trial information: NCT02052778. [Table: see text]


2008 ◽  
Vol 94 (6) ◽  
pp. 813-821 ◽  
Author(s):  
Leszek Miszczyk ◽  
Andrzej Tukiendorf ◽  
Aleksandra Gaborek ◽  
Jerzy Wydmański

Aims Evaluation of analgesic uptake, pain intensity, and quality-of-life changes after half-body irradiation of patients with bone metastases. Material and Methods Ninety-five patients (97 irradiations) were treated with single half-body irradiation fraction (3–8 Gy). Thirty-three patients had upper-half-body irradiation, 55 lower-half-body irradiation and 9 middle-half-body irradiation. The patients were examined on the day of irradiation, 2 and 4 weeks later, and then once a month. The intake of analgesics, pain level (from 0 to 10), and the quality of life (EORTC QLQ-C30) were evaluated. The fluctuations of pain levels and the particular scaling values of QLQ-C30 during a one-year period were analyzed (Kendall t correlation). Results Over the course of 5 months, the incidence of patients using strong opioids decreased from 43.8% to 33.3%, and the incidence of patients who did not need to resort to analgesics increased from 6.7% to 25%. The mean pain level decreased from 6.1 points (half-body irradiation) to 3.1 points 2 weeks later. An inverse correlation between pain level readings and time was statistically significant. An increase was observed in the values of the five functional scales as reflected on the EORTC QLQ-C30 questionnaire (four of which correlated significantly with the observation time). A similar situation prevailed with respect to global health status. A decrease was observed in most of the values on the symptoms scales; 6 saw a significant decrease, in correlation with the follow-up. Correlations were also found between pain intensity and functionality, and between symptoms scales readings and global health status. Conclusions Half-body irradiation of cancer patients suffering from painful multiple bone dissemination is an effective and simple treatment modality that affords significant quality-of-life improvement and pain relief, thus allowing for a reduction in the use of strong analgesics.


Author(s):  
Selda Çakın Ünnü ◽  
Ilkay Tugba Unek ◽  
Ömercan Topaloğlu

Objective: The self-administered questionnaires by the patients are among the most important methods to evaluate the patient’s health related quality of life. The objective of the study was to evaluate the effect of chemotherapy on quality of life of the patients receiving palliative chemotherapy with the diagnosis of metastatic gastric and colorectal cancer by using EORTC QLQ-C30. Methods: This study included 100 patients who were treated with palliative chemotherapy for the diagnosis of metastatic gastric or colorectal cancer in İzmir Tepecik Education and Research Hospital Department of Medical Oncology between 2011-2012. The EORTC QLQ-C30 questionnaire was filled twice by the patients before chemoterapy started and after chemotherapy completed. Results: When the two questionnaires were compared, it was found that global health status and physical functioning did not change after the chemotherapy. Role functioning, cognitive functioning, and social functioning impaired but emotional functioning improved (p<0.05). After the chemoterapy, scores of fatigue and constipation decreased but financial difficulties increased (p<0.05). The symptom scores of nausea-vomitting, pain, dyspnea, insomnia, anorexia, diarrhea did not change. Conclusion: The results of this study suggested that a quality of life assessment with the EORTC QLQ-C30 questionnaire would be beneficial in patients with metastatic gastric and colorectal cancer. In this way, impairments in functional scores, global health status and symptom scores that may occur after chemotherapy can be detected, clinicians can be helped to decide on the switch to chemotherapy regimens that are similar in effectiveness but have different side effects profile, the patients’ quality of life can be improved as a result of the application of the necessary palliative treatments.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3593-3593
Author(s):  
Anna Maria Frustaci ◽  
Michele Nichelatti ◽  
Marina Deodato ◽  
Maddalena Mazzucchelli ◽  
Marco Montillo ◽  
...  

Abstract The clinical course of WM widely differs among patients, with some manifesting symptoms as a consequence of the monoclonal IgM component or lymphoma infiltration. IgM-MGUS is generally asymptomatic while, in some cases, paraprotein-related manifestations may occur. Patients with IgM-MGUS should perform a regular follow-up as they are at risk of developing WM or other B-cell lymphoproliferative disorders (1.5-2% per year). Although WM typically afflicts the elderly, there are no studies addressing the impact of ECOG performance status and comorbidities on patients' outcome. Furthermore, to our knowledge health-related quality of life (HRQOL) has never been evaluated in this category. The aim of this study is to analyze the impact of diagnosis and patients' characteristics on quality of life. From October 2017, HRQOL was assessed in 103 patients (37 WM with previous or ongoing treatment [tWM]; 29 asymptomatic MW [aWM]; 37 IgM-MGUS) by the administration of EORTC QLQ-C30, HADS, FACT-GOG neurotoxicity and EQ-5D-5L questionnaires. Demographic anamnestic and disease-related data were also collected for each patient. The same questionnaires continue to be administered every 6 months for 3 years, in order to capture changes in HRQOL over time. Patients features are reported in table 1. No significant differences in terms of age, sex distribution, age at diagnosis, months from diagnosis, ECOG performance status, CIRS or number of concomitant medications, were detected among the 3 groups (table 1). As regards CIRS, the organ systems mainly involved resulted: vascular and genitourinary for tWM, genitourinary for aWM and vascular, respiratory and genitourinary for IgM-MGUS. Among the 3 groups no statistical differences were reported when analyzing: EORTC QLQ-C30 global health status, functional scales (physical, role, emotional, cognitive and social functioning) and symptoms scale, EQ-5D VAS score, HADS anxiety and depression scores or FACT-GOG neurotoxicity score. Males had higher global health status and emotional function when compared to females both in IgM-MGUS and WM patients. Higher CIRS score and ECOG status negatively impacted on global health status, physical function, EQ-5D VAS score and anxiety both in WM and IgM-MGUS. WM patients with longer time from diagnosis showed a significantly worse emotional function. Patients-reported symptoms that could be referred to peripheral neuropathy (PN, 39 patients) resulted the only significant parameter negatively impacting on HRQOL (global health status, functional and symptoms scales according to EORTC QLQ-C30 and EQ-5D VAS score) and also affecting HADS anxiety score. The diagnosis of PN was confirmed by neurologic tests only in 16/39 subjects that, compared with the rest of the population, showed older age (p .019), older age at diagnosis (p . 015) and higher ECOG status (p .005). In these patients, EORTC QLQ-C30 detected a reduced cognitive function (p .0031), while HADS a greater perception of anxiety (p .0015). No differences were recorded for EQ-5D VAS score or HADS depression scale. In conclusion, in our series diagnosis per se didn't seem to affect HRQOL which was negatively influenced by high ECOG status and comorbidities. Emotional function meaningfully deteriorated as the time lapse from diagnosis became longer. Quality of life was significantly altered in patients reporting symptoms of PN and this was confirmed by all the questionnaires. Longer follow up is needed to confirm these preliminary data. Disclosures Montillo: Roche: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria, Speakers Bureau; Gilead: Consultancy, Honoraria, Speakers Bureau. Tedeschi:Janssen: Consultancy, Speakers Bureau; AbbVie: Consultancy; Gilead: Consultancy.


Cancers ◽  
2019 ◽  
Vol 12 (1) ◽  
pp. 75 ◽  
Author(s):  
Lucia Marin-Barrera ◽  
Andres J. Muñoz-Martin ◽  
Eduardo Rios-Herranz ◽  
Ignacio Garcia-Escobar ◽  
Carmen Beato ◽  
...  

Although there is published research on the impact of venous thromboembolism (VTE) on quality of life (QoL), this issue has not been thoroughly investigated in patients with cancer—particularly using specific questionnaires. We aimed to examine the impact of acute symptomatic VTE on QoL of patients with malignancies. This was a multicenter, prospective, case-control study conducted in patients with cancer either with (cases) or without (controls) acute symptomatic VTE. Participants completed the EORTC QLQ-C30, EQ-5D-3L, PEmb-QoL, and VEINES-QOL/Sym questionnaires. Statistically significant and clinically relevant differences in terms of global health status were examined. Between 2015 and 2018, we enrolled 425 patients (128 cases and 297 controls; mean age: 60.2 ± 18.4 years). The most common malignancies were gastrointestinal (23.5%) and lung (19.8%) tumors. We found minimally important differences in global health status on the EQ-5D-3L (cases versus controls: 0.55 versus 0.77; mean difference: −0.22) and EORTC QLQ-C30 (47.7 versus 58.4; mean difference: −10.3) questionnaires. There were minimally important differences on the PEmb-QoL questionnaire (44.4 versus 23; mean difference: −21.4) and a significantly worse QoL on the VEINES-QOL/Sym questionnaire (42.7 versus 51.7; mean difference: −9). In conclusion, we showed that acute symptomatic VTE adversely affects the QoL of patients with malignancies.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5385-5385
Author(s):  
Benjamin Kasenda ◽  
Gabriele Ihorst ◽  
Heidi Fricker ◽  
Elke Valk ◽  
Elisabeth Schorb ◽  
...  

Abstract Background Primary CNS lymphoma (PCNSL) is a rare extra nodal non-Hodgkin lymphoma. High-dose methotrexate (HD-MTX) based treatment has improved prognosis, but little is known about the development of quality of life (QoL) during treatment and follow-up from prospective trials. Methods We pooled data from three prospective trials including 225 immunocompetent patients with PCNSL (186 [83%] with newly diagnosed and 39 [17%] with relapsed disease) - all received HD-MTX based polychemotherapy with rituximab. QoL was a pre-specified secondary endpoint in all trials and evaluated using the EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaire at start of treatment, after completion of treatment and during follow-up. We used descriptive statistics to summarize QoL over time. To investigate the development of QoL over time adjusted for age and Karnofsky performance status (KPS), we used multivariable linear regression models with a random effect to account for repeat measurements. We also did two separate analyses for patients with newly diagnosed PCNSL and relapsed disease. Multiple imputations were applied for missing values within a questionnaire, but we did not impute values of questionnaires that were missing completely. We herein report results on the global health status (GHS, item 30 of EORTC QLQ-C30, higher values represent better QoL) and the predominant item of the EORTC QLQ-BN20 (future uncertainty, higher values represent worse QoL). A change of 10% on the respective scale was considered as a clinically meaningful difference (Osoba et al, Eur J Cancer. 2005 Jan;41(2):280-7 and Maringwa et al, Ann Oncol. 2011 Sep;22(9):2107-12). Results The median age and KPS was 62 years (range 20 to 85) and 80% (30% to 100%), respectively, 119 (52%) were female. Before treatment, the median GHS of the EORTC QLQ-C30 was 50 (interquartile range [IQR] 33 to 67) reflecting substantial impaired QoL. After completion of treatment, the median GHS significantly increased by 17 points to a median of 67 (IQR 50 to 71) (P<0.001), which reflects a clinically meaningful difference. This positive effect was consistent in multivariable analysis (beta coefficient 0.37, p<0.001). Patient with a better KPS before starting treatment had a higher chance that their QoL improved over time (beta coefficient 0.26, p=0.0029). There was no difference regarding GHS between patients with newly diagnosed PCNSL or patients with relapsed disease before starting treatment (median GHS both 50). However, in patients with relapsed disease, numerical increase of GHS over time did not reach statistical significance (beta coefficient 0.36, p=0.2185) likely to limited power in the multivariable analysis. The overall development of GHS over time is shown in Figure 1. The dip at months 17 and 18 area is associated with disease relapse. Regarding the EORTC QLQ-BN20 questionnaire, the predominant issue for patients was future uncertainty (median 42, IQR 17 to 67) before starting treatment, which significantly improved after treatment to 25 (IQR 8 to 33) (p<0.001). In multivariable analysis, future uncertainty also improved significantly in separate analyses for patients with newly diagnosed PCNSL (beta coefficient -0.45, p=0.005) and relapsed disease (beta coefficient -0.89, p=0.0049). The overall development of future uncertainty over time is shown in Figure 2. The increase at months 17 and 18 area is associated with disease relapse. Conclusions Patients with newly diagnosed or relapsed PCNSL reported substantial impaired QoL before starting treatment. However, after treatment with HD-MTX based chemotherapy, QoL significantly improved over time and patients were also more confident regarding their future. Results from our analyses provide a reference for future studies on this important issue in the care of patients with PCNSL. At the meeting we will present further analyses and results from all domains of the EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires. Figure 1 Global Health Status development from the EORTC QLQ-C30 questionnaire (higher values denote better quality of life) Figure 1. Global Health Status development from the EORTC QLQ-C30 questionnaire (higher values denote better quality of life) Figure 2 Future uncertainty from the EORTC QLQ-BN20 questionnaire (lower values denote better quality of life) Figure 2. Future uncertainty from the EORTC QLQ-BN20 questionnaire (lower values denote better quality of life) Disclosures Kasenda: Riemser: Other: Travel Support. Illerhaus:Riemser, Amgen: Honoraria.


2020 ◽  
Vol 26 (6) ◽  
pp. 1421-1428
Author(s):  
Ebrahim Salehifar ◽  
Ghasem Janbabaei ◽  
Abbas Alipour ◽  
Nasim Tabrizi ◽  
Razieh Avan

Purpose Taxane-induced peripheral neuropathy (TIPN) is a common and bothersome toxicity. This study aimed to determine the incidence and severity of TIPN in patients with breast cancer and to investigate the relationship between TIPN and quality of life. Methods A total of 82 breast cancer patients with TIPN symptoms were included in this study. The criteria of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03) and the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) were used to evaluate grading of sensory neuropathy and quality of life, respectively. Analysis of the data was done by IBM SPSS statistics version 23. Results A total of 346 patients received taxane-based chemotherapy and 82 patients (23.7%) experience TIPN. The mean (SD) global health status/quality of life, physical functioning, role functioning, and pain subscales were 60.63 (5.26), 80.64 (9.05), 81.77 (10.41), and 43.88 (11.27), respectively. There were significant negative correlations between global health status/quality of life, physical functioning, and role functioning subscales with the grade of neuropathy (r = −0.33, −0.80, and −0.61, respectively) and positive correlation between pain subscale and the grade of neuropathy (r = 0.70). Conclusion This study shows a clear association between TIPN and worsened quality of life. These findings emphasize on detecting and management of TIPN in an effort to improve the quality of life of breast cancer patients.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e14573-e14573
Author(s):  
Alice Chia-chi Wei ◽  
Pablo Emilio Serrano Aybar ◽  
Sean P. Cleary ◽  
Natalie G. Coburn ◽  
Paul David Greig ◽  
...  

e14573 Background: The combination of intra- and extra-hepatic metastases (IHM and EHM) from colorectal cancer (CRC) has traditionally been considered a contraindication for surgery. Currently there is a growing interest in resecting IHM and EHM. The purpose of this study was to evaluate the health related quality of life (HRQoL) of patients with IHM and EHM from CRC undergoing complete metastasectomy. Methods: Participants with any number of CRC IHM and up to 3 foci of EHM, resectable with RO intent were eligible for the HRQoL component of a Phase-II multi-institutional trial. The effects of therapy on HRQoL were evaluated using: EORTC-QLQ C30, EORTC-LMC21 and FACT-HEP at baseline, prior to surgery and at 4, 8 and 12 months following complete metastasectomy. Results were compared to baseline. >10% mean score change was considered a minimally important clinical difference (MICD). Results: Twenty-five participants were enrolled with a median age: 57 (range: 32-84) years. Protocol surgery was completed in 18/25 (72%) including 11/25 (44%) staged resections. Perioperative morbidity and mortality was 11/25 (44%) and 1/25 (4%), respectively. Median disease-free survival was 6 (range: 0-17) months. 22/25, 88% participants underwent perioperative chemotherapy. EORTC-QLQ C30 Global-HRQoL remained statistically and clinically unchanged compared to baseline at 4 and 8 months but had a MCID decrease at 12 months (mean score change: 15.3) that was not statistically significant. This was associated with a significant decrease in social and role functioning and an increase in fatigue, pain and dyspnea. FACT-Hep score was statistically lower at 4 months post surgery, without reaching a MICD. There was no difference in any of the subscales analyzed in regards to sex, age or the presence of peri-operative complications. Conclusions: Aggressive metastasectomy of multi-site CRC is feasible and safe. Despite disease recurrence in the majority of patients there was no significant deterioration of Global HRQoL as a result of treatment. There was a transient effect on symptoms including fatigue, pain dyspnea and role functioning, which improved by 12 months. Clinical trial information: NCT00606398.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5030-5030
Author(s):  
Amarnath Challapalli ◽  
Susan Masson ◽  
Paul White ◽  
Narges Dailami ◽  
Sylvia Pearson ◽  
...  

5030 Background: Neoadjuvant cisplatin-based combination chemotherapy (NAC) improves survival in muscle invasive bladder cancer (MIBC). However, response rates and survival remain suboptimal. We sought to evaluate the efficacy, safety and tolerability of cisplatin cabazitaxel combination in this patient group. Methods: A phase 2 single arm trial (Simon 2 stage), to recruit at least 26 evaluable patients was designed with 80% power to detect the primary endpoint, objective response rate (ORR) of > 35%. ORR was defined as pathological complete response (pCR) plus partial response (pathological downstaging), measured by pathologic staging (T2 or greater at diagnosis, to T1 or less at radical cystectomy). Treatment was with Cisplatin 70mg/m2 and Cabazitaxel 15mg/m2 on day 1 of a 21 day cycle, for 4 cycles prior to surgery. Toxicity was recorded using CTCAE v.4.03. Quality of Life (QoL) data were collected at baseline, prior to each cycle of chemotherapy and at 3-5 weeks after 4th cycle of chemotherapy using EQ-5D and EORTC QLQ-C30, BLM30 questionnaires. Results: Objective response was seen in 15 out of 26 evaluable patients, 57.7% and over a third of patients achieved pCR (9/26; 34.6%). 78% (21/27) of patients completed all cycles of treatment, with only 6.7% of the reported adverse events (AEs) being graded 3 or 4. There were 6 treatment related SAEs reported but no SUSARs. In patients who achieved objective response the median progression free (PFS) and overall survival (OS) were not reached (median follow up: 41.5m). In contrast, median PFS (7.2m) and OS (16.9m) were significantly worse (p = 0.001) in patients who did not respond. Response rates for EORTC QLQ-C30, BLM 30 and EQ5D questionnaires was 70.4, 70.4 & 63% respectively, at end of treatment. There was no significant difference in EORTC QLQ C30 summary, global health scores and EQ5D score with treatment. There was a significant decline in mean QLQ C30 domain scores after 1st cycle compared to baseline, but no further deterioration with subsequent cycles of chemotherapy. Conclusions: Cabazitaxel with cisplatin as NAC of MIBC can be considered a safe, well-tolerated and effective regimen with higher pCR rate of 34.6%. This compares favorably to that with Cisplatin/Gemcitabine (23-26%). Minimal changes in Global Health & EQ5D observed during NAC further demonstrates the excellent tolerability of this regimen and to our knowledge are the first data regarding QoL in NAC in MIBC. These results warrant further evaluation in a larger phase 3 study. Clinical trial information: 2011 004090 82 .


2021 ◽  
Vol 156 ◽  
pp. S29-S30
Author(s):  
María del Mar Onteniente Gomis ◽  
Belén Navarro Matilla ◽  
Ramón María Pujol Vallverdú ◽  
Andrea Combalia Escudero ◽  
Irma Zapata Paz ◽  
...  

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