Changes in patient-reported outcomes in patients diagnosed with and treated for multiple myeloma in the Connect MM registry.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8586-8586 ◽  
Author(s):  
Chris L. Pashos ◽  
Jatin J. Shah ◽  
Howard R. Terebelo ◽  
Brian G. Durie ◽  
Rafat Abonour ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Patient Reported Outcomes ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Staging System ◽  
Ecog Performance Status ◽  
Related Factors ◽  
Patient Reported ◽  
Ecog Ps ◽  
The Impact

8586 Background: Little is known about the impact of treatment on patient-reported outcomes (PROs) and health-related quality of life (HRQoL) in multiple myeloma (MM) patients (pts). The change in PROs of MM pts between baseline and 1 year was assessed relative to their baseline International Staging System (ISS) stage and Eastern Cooperative Oncology Group (ECOG) performance status (PS) score. Methods: Connect MM is a prospective US registry of MM pts initiated in 2009. Clinicians reported pt demographics, ECOG PS score, and ISS stage. PROs were collected at baseline and at 1 year utilizing the Functional Assessment of Cancer Therapy (FACT)-MM, EQ-5D, and Brief Pain Inventory (BPI). Changes in FACT-MM, EQ-5D, and BPI scores were analyzed by ISS stage and ECOG PS score in 636 pts meeting CRAB criteria from 189 centers. Results: Most pts were male (58%) and white (84%). Mean age was 66 years (± 11). Pts were treated in community (81%), academic (17%), or veterans/military (2%) settings. ISS stages of pts were: I (29%), II (35%), and III (35%). ECOG PS scores were 0 (37%), 1 (49%), 2 (11%), and 3 (3%). Improvements in overall HRQoL as shown by the FACT-MM and FACT-General (G) total scores, were observed across all ISS stages (P = 0.03 to < 0.0001) with no significant differences between stages. Improvements in FACT-MM and FACT-G total scores were observed with ECOG PS scores 1–3 (P = 0.03 to 0.005). Pts with poorer ECOG PS scores tended to have greater improvement in EQ-5D domains of mobility, self-care, and usual activities. HRQoL/functional ability improved in 4 of 5 FACT domains (except social/family; all others P < 0.0001), and in 4 of 5 EQ-5D domains (except pain/discomfort; all others, P = 0.01 to < 0.0001). BPI showed that overall average pain improved (P < 0.0005) over 1 year, but statistically significant differences by ISS stage or ECOG PS score were not observed. Conclusions: Connect MM data showed that overall HRQoL of MM pts improved between baseline and 1 year, with a consistent benefit observed across pts with different ISS stages and ECOG PS scores. Additional analysis should examine which disease- and treatment-related factors are associated with these HRQoL improvements.

scholarly journals Palliative Performance Scale: Polish validation in hospice setting - a prospective observational study

2020 ◽  
Author(s):  
Tomasz Dzierżanowski ◽  
Tomasz Gradalski ◽  
Michael Kozlowski
Keyword(s):  
Palliative Care ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Karnofsky Performance Score ◽  
Care Providers ◽  
Free Standing ◽  
Ecog Performance Status ◽  
Rehabilitation Outcomes ◽  
Ecog Ps ◽  
Performance Scale

Abstract Background: Measuring functional status in palliative care may help clinicians to assess a patient’s prognosis, recommend adequate therapy, avoid futile or aggressive medical care, consider hospice referral, and evaluate provided rehabilitation outcomes. An optimized, widely used, and validated tool is preferable. The Palliative Performance Scale Version 2 (PPSv2) is currently one of the most commonly used performance scales in palliative settings. The aim of this study is the translation and validation process of a Polish translation of this tool (PPSv2-Polish). Methods: Two hundred patients consecutively admitted to a free-standing hospice were evaluated twice during 2 consecutive days for test-retest reliability. In the first evaluation, two different care providers independently evaluated the same patient to establish inter-rater reliability values. PPS-Polish was compared with the Karnofsky Performance Score (KPS), Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG PS), and Barthel Activities of Daily Living (ADL) Index to determine its construct validity. Results: A high level of full agreement between test and retest was seen (63%), and a good intra-class correlation coefficient of 0.85 (P<0.0001) was achieved. Excellent agreement between raters was observed when using PPSv2-Polish (Cohen’s kappa 0.91; P<0.0001). Satisfactory correlations with the KPS and good correlations with ECOG PS and Barthel ADL were noticed. Persons who had shorter prognoses and were predominantly bedridden also had lower scores measured by the PPSv2-Polish, KPS and Barthel ADL. A strong correlation of 0.77 between PPSv2-Polish scores and survival time was noted (P<0.0001). Moderate survival correlations were seen between KPS, ECOG PS, and Barthel ADL of 0.41; -0.62; and 0.58, respectively (P<0.0001). Conclusion: PPSv2-Polish is a valid and reliable tool measuring performance status in a hospice population and can be used in daily clinical practice in palliative care and research.

Optimizing Treatment for Elderly Patients With Newly Diagnosed Multiple Myeloma: A Personalized Approach

2016 ◽  
Vol 34 (30) ◽  
pp. 3600-3604 ◽  
Author(s):  
Alessandra Larocca ◽  
Antonio Palumbo
Keyword(s):  
Multiple Myeloma ◽  
Group Performance ◽  
Performance Status ◽  
Relevant Literature ◽  
Eastern Cooperative Oncology Group ◽  
Staging System ◽  
Phase Iii ◽  
Bone Lesions ◽  
Best Response ◽  
Personalized Approach

The Oncology Grand Rounds series is designed to place original reports published in the Journal into clinical context. A case presentation is followed by a description of diagnostic and management challenges, a review of the relevant literature, and a summary of the authors’ suggested management approaches. The goal of this series is to help readers better understand how to apply the results of key studies, including those published in Journal of Clinical Oncology, to patients seen in their own clinical practice. An 84-year-old woman presented with bone pain and lytic bone lesions in April 2010. Diagnosis of multiple myeloma was based on the presence of an immunoglobulin G lambda serum M protein (4,784 mg/dL) and confirmed by the findings of bone marrow plasma cell infiltration, with t(11;14) chromosomal abnormality detected by fluorescence in situ hybridization analysis. The patient’s medical history was significant for hypertension; she had an Eastern Cooperative Oncology Group performance status of 1, International Staging System (ISS) stage of 1, and Durie–Salmon stage of IIIA. In May 2010, the patient was enrolled in a randomized phase III trial comparing different lenalidomide-based treatments and received induction with lenalidomide plus dexamethasone (nine cycles) followed by lenalidomide maintenance. The patient started treatment with lenalidomide 25 mg per day for 21 days and reduced-dose dexamethasone 20 mg per week per protocol because of age. Induction was well tolerated; no relevant complications occurred, except for grade 1 fatigue and grade 1 diarrhea. Best response was partial response. In March 2011, she started maintenance with lenalidomide 10 mg per day. A dose reduction of lenalidomide 5 mg per day was required because of grade 2 diarrhea. In July 2015, the patient experienced relapse, with painful collapse of L3 vertebral body.

Variation in Health-Related Quality of Life by ECOG Performance Status and Fatigue Among Patients with Chronic Lymphocytic Leukemia

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4591-4591 ◽  
Author(s):  
Chris L. Pashos ◽  
Christopher R Flowers ◽  
Mark Weiss ◽  
Nicole Lamanna ◽  
Charles M Farber ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Research Funding ◽  
Performance Status ◽  
Clinical Practices ◽  
Employment Equity ◽  
Ecog Performance Status ◽  
Advisory Committees ◽  
Equity Ownership ◽  
Ecog Ps ◽  
The Impact

Abstract Abstract 4591 Introduction: Clinicians and investigators appreciate the value of measuring HRQOL for monitoring CLL and the impact of treatments, and commonly use ECOG performance status (PS) and clinician-reported patient fatigue as surrogates for HRQOL in clinical practice. However, limited data exist on the relationships between PS, fatigue, and HRQOL in CLL patients (pts) undergoing treatment in clinical practices. We examined the associations between these measures and 3 psychometrically validated, patient-reported, HRQOL instruments: the Brief Fatigue Inventory (BFI), EQ-5D, and Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu). Methods: Data were collected as part of Connect CLL®, a prospective observational registry initiated in March 2010 involving US practices. Data on pt demographics and clinical characteristics were provided by clinicians. HRQOL was self-reported by pts at enrollment using the BFI, EQ-5D, and FACT-Leu. Mean BFI, EQ-5D and FACT-Leu scores were analyzed by ECOG PS and clinician-reported fatigue. Differences in HRQOL scores between sub-cohorts were assessed by ANOVA. Results: HRQOL data were reported by 604 pts enrolled from 10 academic, 148 community, and 3 government centers. Pts were predominantly male (62%) and white (90%); mean age was 70 (standard deviation 11) years. BFI data (scale: 0 [no fatigue] - 10 [worst fatigue]) indicated that on average pts report that global fatigue, fatigue severity and fatigue-related interference worsen by ECOG severity (Table 1) and are statistically associated with clinician-reported fatigue (Table 2). Mean EQ-5D overall HRQOL as measured by a Visual Analogue Scale (VAS) from 0 (worst) to 100 (best) worsens by ECOG severity and is significantly worse in pts with fatigue. Mean EQ-5D domain scores (scale: 1 [no problem], 2 [some problems], 3 [incapacity]) indicated that pain/discomfort, mobility and usual activities increase in severity as ECOG worsens and in pts with fatigue. FACT-Leu domains except social/family were statistically worse with worse ECOG PS and in pts with fatigue. Conclusions: Initial results from Connect CLL® indicate that HRQOL worsens with worsening ECOG PS, especially in physical / functioning domains, pain/discomfort, and mobility, and worsens across multiple domains among pts whose physicians reported fatigue. Future analyses should be conducted on how HRQOL, PS and fatigue may change over time with changes in CLL, and how they are influenced by therapies. These results may serve as baseline reference. Disclosures: Pashos: Celgene: Membership on an entity's Board of Directors or advisory committees. Flowers:Genentech/Roche (unpaid): Consultancy; Celgene: Consultancy; Millennium/Takeda: Research Funding; Wyeth: Research Funding; Novartis: Research Funding. Weiss:Celgene: Membership on an entity's Board of Directors or advisory committees. Lamanna:Celgene: Membership on an entity's Board of Directors or advisory committees. Farber:Celgene: Membership on an entity's Board of Directors or advisory committees. Kipps:Igenica: Equity Ownership, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Research Funding; Abbot Industries: Research Funding; Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Genentech: Research Funding; GSK: Research Funding; Gilead Sciences: Consultancy, Research Funding; Amgen: Research Funding. Lerner:Celgene: Membership on an entity's Board of Directors or advisory committees. Kay:Celgene: Membership on an entity's Board of Directors or advisory committees. Sharman:Celgene: Membership on an entity's Board of Directors or advisory committees. Grinblatt:Celgene: Membership on an entity's Board of Directors or advisory committees. Flinn:Celgene: Membership on an entity's Board of Directors or advisory committees. Kozloff:Celgene: Membership on an entity's Board of Directors or advisory committees. Swern:Celgene Corporation: Employment, Equity Ownership. Kahn:Celgene Corporation: Employment, Equity Ownership. Street:Celgene: Employment, Equity Ownership. Sullivan:Celgene: Employment, Equity Ownership. Keating:Celgene: Membership on an entity's Board of Directors or advisory committees.

Actigraphy as an objective measure of performance status in patients with advanced cancer.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 62-62 ◽  
Author(s):  
William F. Pirl ◽  
Daisuke Fujisawa ◽  
Jamie Stagl ◽  
Justin Eusebio ◽  
Lara Traeger ◽  
...  
Keyword(s):  
Physical Activity ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Objective Measure ◽  
Stage Iv ◽  
Self Report ◽  
Subjective Rating ◽  
Metabolic Equivalents ◽  
Patient Reported ◽  
Ecog Ps

62 Background: Treatment decisions are often based on performance status (PS), a subjective rating of patient functioning derived from observation and patient-report. Devices that monitor physical activity, such as wrist actigraphs, can accurately measure the percent of time a person is immobile while awake (awake immobile). Thus, actigraphy may have potential to better estimate true PS. We compared actigraphy to both Eastern Cooperative Oncology Group PS (ECOG PS) and patient-reported physical activity as predictors of survival in patients with stage IV non-small cell lung cancer (NSCLC). Methods: Participants (n = 41) were ambulatory patients with stage IV NSCLC receiving care at MGH. Participants wore a watch-sized accelerometer device (ACTIWATCH 2) for three consecutive 24-hour periods (72 hours) and completed a self-report questionnaire about physical activity, scored as METS (metabolic equivalents) per week. Patients’ oncologists rated their ECOG PS (0-5) at the end of the 72-hour actigraphy period. Relationships among ECOG PS, awake immobile, and METs per week were tested with Pearson correlations. A ROC curve for 6-month survival was used to determine a meaningful cut-off for awake immobile. Unadjusted Cox regression models tested associations with survival from assessment times. Results: Participants’ ECOG PS ratings were: 0 (22%), 1 (63%), 2 (12%), and 3 (2%). ECOG PS and awake immobile were correlated (r = .42, p < .01). METS per week was correlated only with ECOG PS (r = -.35, p = .03). At time of analysis, 15 patients had died with a minimum follow up of 9 months. Among all patients, survival was predicted by ECOG PS, HR = 3.77 (95% CI 1.70-8.35), p < .01; awake immobile as both as a continuous (percentage points) and categorical ( > 23%) variable, HR = 1.04 (95% CI 1.00-1.09), p = .05 and HR = 4.12 (95% CI 1.37-12.39), p = .01, respectively; but not METS per week. Among patients with good EGOC PS (0-1), only awake immobile ( > 23%) predicted survival, HR = 5.80 (95% CI 1.39-24.12), p = .02. Moreover, within the largest ECOG group (PS1), awake immobile ( > 23%) still predicted survival, HR = 5.53 (95% CI 1.18-25.94), p = .03. Conclusions: Actigraphy, an objective measure of patient activity, may have utility in determining patient PS.

Descriptive and Prognostic Value of Patient-Reported Outcomes: The Bortezomib Experience in Relapsed and Refractory Multiple Myeloma

2006 ◽  
Vol 24 (6) ◽  
pp. 976-982 ◽  
Author(s):  
Dominique Dubois ◽  
Ravinder Dhawan ◽  
Helgi van de Velde ◽  
Dixie Esseltine ◽  
Sanjay Gupta ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Survival Analysis ◽  
Functional Assessment ◽  
Patient Reported Outcomes ◽  
Gynecologic Oncology Group ◽  
Life Questionnaire ◽  
Minor Response ◽  
Patient Reported ◽  
The Impact ◽  
Complementary Value

Purpose Bortezomib, a boronic acid dipeptide, has been recently introduced as a new approach to treating multiple myeloma (MM). The goal of this work was to evaluate the added value of patient-reported outcomes (PRO) in the interpretation of bortezomib clinical trial outcomes. Patients and Methods Two hundred two patients with relapsed, refractory MM were treated with bortezomib as part of the SUMMIT (Study of Uncontrolled Multiple Myeloma Managed with Proteasome Inhibition Therapy) study. Patients were administered the following four PRO measures at several time points: the European Organisation for Research and Treatment of Cancer (EORTC) core Quality of Life Questionnaire (QLQ-C30) and the myeloma-specific module (QLQ-MY24), the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale, and the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG) Neurotoxicity (Ntx) scale. Minimal important difference (MID) thresholds were used to define patients as improved, stable, or worsened. A survival analysis was conducted to assess the predictive power of PRO data. Results For the total population, there was a positive change between baseline and best end point. Consistent with the clinical responses, change in PRO scores showed statistically significant differences between response groups with PRO improvement in patients with complete response (CR) or partial response (PR), mostly stable scores in patients with minor response or no change, and deterioration in most scores for patients with progressive disease. Change in scores for neuropathy-related symptoms was reasonably stable. In contrast, fatigue scores significantly improved for patients with CR or PR. When various MID thresholds were applied, the proportion of improved patients exceeded 35% for several domains within all change group definitions. Moreover, survival analysis results demonstrated the additional prognostic information PRO data can provide to supplement clinical data. Conclusion This study demonstrated the complementary value for PRO assessments in further interpreting clinical response, the impact of adverse effects, and patient prognosis in clinical trials.

scholarly journals Trajectories of hospitalization in three groups of patients with incurable gastric cancer identified by hierarchical clustering: A retrospecitve analysis

2020 ◽  
Author(s):  
Yasuko Murakawa ◽  
Masato Sakayori ◽  
Kazunori Otsuka
Keyword(s):  
Gastric Cancer ◽  
Hierarchical Clustering ◽  
Clinical Course ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Ecog Performance Status ◽  
Advanced Malignancy ◽  
Clinical Phase ◽  
Solid Malignancies ◽  
Ecog Ps

Abstract Purpose: The therapeutic goal for advanced solid malignancies is not to achieve cure but to prolong survival and maintain quality of life (QOL). To date, no study has reported the trajectory of the QOL throughout the clinical course of a patient with advanced malignancy. As hospitalization is considered a predictor of QOL, we retrospectively analyzed the trajectory of hospitalization in patients with incurable gastric cancer throughout the clinical course. Methods: The data of 85 patients with incurable gastric cancer were collected, including age, sex, Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), treatment, histology, sites of metastases at first consultation, planned and unplanned hospitalization throughout the clinical course , and overall survival (OS). We ranked the patients by OS and hospitalization using a hierarchical clustering analysis. Results: Three clusters were identified corresponding to short, intermediate, and long OS/hospitalization (Clusters 1, 2, and 3, respectively). Patients in Cluster 3 were more likely to have an ECOG PS of 0–2 and receive palliative chemotherapy than the other clusters. No other differences in histology, age, sex, and or extra-peritoneal metastasis sites were observed between the three groups. In Cluster 3, planned hospitalization accumulated gradually during the early clinical phase, while unplanned hospitalization accumulated rapidly in later phases. Conclusions: No specific characteristics were associated with short, intermediate, and long OS/hospitalization. Patients in the long OS/hospitalization group exhibited a rapid accumulation of unplanned hospitalization during the latter clinical course. Further research is needed to identify specific predictors of and measures to avoid a long OS/hospitalization.

Understanding the symptom experience of breast cancer outpatients: The validity and utility of the M.D. Anderson Symptom Inventory (MDASI).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9106-9106
Author(s):  
Tito R. Mendoza ◽  
Fengmin Zhao ◽  
Charles S. Cleeland ◽  
Lynne I. Wagner ◽  
Linda J. Patrick-Miller ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Assessment Method ◽  
Patient Reported Outcome ◽  
Symptom Experience ◽  
Breast Cancer Patients ◽  
Ecog Performance Status ◽  
Patient Reported

9106 Background: Breast cancer and its treatments can produce multiple symptoms that cause distress and impair function. The MDASI, a patient-reported outcome measure of symptoms (sxs) and functional interference has been validated in general oncology and has the potential to inform symptom experience and guide treatment specific to breast cancer patients (pts). Methods: The Eastern Cooperative Oncology Group (ECOG) conducted the Symptom Outcomes and Practice Patterns (SOAPP) study at academic and community medical oncology clinics and included pts with breast cancer of all stages and phases of care. At baseline and 4 weeks, pts completed the MDASI. Symptom experiences and psychometric properties of the MDASI in breast cancer pts (n = 1544) were analyzed. Results: The median age was 58 years, and the race/ethnicity included 11% black and 8% hispanic. 5% had ECOG performance status (PS) ≥2. The 5 most prevalent moderate/severe sxs reported at baseline were fatigue (31%), disturbed sleep (27%), drowsiness (21%), hair loss (22%) and dry mouth (19%); moderate/severe skin rash (6%) and vomiting (4%) were the least prevalent. At follow-up, about 1/3 of patients had moderate/severe fatigue and 19% had moderate/severe pain and distress. Internal consistency and test-retest reliability were good, with Cronbach alphas of ≥0.85 and intraclass correlations of ≥0.76 for all subscales. Among those whose PS was stable or improving, the change scores in sx severity improved most for sleep disturbance, numbness/tingling, and difficulty remembering things. Significantly higher scores and moderately large effects for the severity scale were reported by pts with poorer PS (ES=.61) and those with local/regional/metastatic disease (ES=.67). Results were similar for the interference scale. Pts whose quality of life (QOL) declined showed greater increase in severity (1.1 vs .07, p<.001) from baseline to follow-up than pts whose QOL was unchanged, demonstrating sensitivity to change. Conclusions: Breast cancer pts have significant sx burden despite well-preserved PS. The MDASI is a valid, reliable, and sensitive sx assessment method for research and patient care in breast cancer outpatients.

ECOG Performance Status Affects Efficacy, but Not Safety, of Lenalidomide/Dexamethasone in Relapsed/Refractory Multiple Myeloma (MM009/010 Sub-Analysis).

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 2721-2721
Author(s):  
Asher A. Chanan-Khan ◽  
Meletios Dimopoulos ◽  
Donna Weber ◽  
Marta Olesnyckyj ◽  
Zhinuan Yu ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Clinical Response ◽  
Therapeutic Option ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Complete Response ◽  
Response To Therapy ◽  
Phase Iii ◽  
Ecog Performance Status ◽  
Double Blind

Abstract Background: Eastern Cooperative Oncology Group (ECOG) performance status is a prognostic factor in patients with multiple myeloma (MM). Lenalidomide (Len) is an oral immunomodulatory drug that is effective against relapsed/refractory MM (rrMM). In 2 prospective, randomized, double–blind, placebo–controlled phase III trials in patients with rrMM (MM–009 and MM–010), the combination of Len/Dexamethasone (Dex) induced a significantly higher overall response (OR) rate and complete response (CR) rate, as well as significantly longer overall survival (OS) and time–to–progression (TTP), compared with Dex alone. To investigate whether patients’ performance status has an impact on clinical response, we compared the efficacy and tolerability of Len/Dex in patients with baseline ECOG score =0 and >0. Methods: Data for patients with a baseline ECOG score recorded were pooled from the MM-009 and MM-010 studies (n= 690). Patients were randomized to receive Len (25 mg/day on days 1–21 of each 28–day cycle), or placebo. Both groups received Dex 40 mg PO q.d. on days 1–4, 9–12, and 17–20 (for the first 4 cycles). After 4 cycles, Dex 40 mg/day was administered only on days 1–4. Response to therapy, TTP, OS, and adverse events (AE) were assessed. Response rate and TTP are based on data obtained before unblinding (June 2005 [MM–009] and August 2005 [MM–010]). Results: Of 302 patients with an ECOG score of 0 at baseline, 152 were treated with Len/Dex and 150 with Dex alone. For those with an ECOG score >0, 192 received Len/Dex and 196 received Dex alone. Baseline characteristics were balanced between treatment groups. Patients with baseline ECOG score ≥0 had significantly higher OR rates with Len/Dex (59% and 62%, respectively) compared with Dex alone (both 22%; Table). In both ECOG groups, Len/Dex resulted in a significantly longer median TPP compared with Dex alone. In those with ECOG score >0, a significant improvement in OS was noted with Len/Dex treatment. No difference in median TTP was observed between patients with ECOG score ≥0 among Len/Dex-treated patients. Also, ECOG status did not affect tolerability profiles. Grade 3–4 hematological AE in patients with ECOG ≥0 treated with Len/Dex were higher than those treated with Dex alone and included neutropenia (31–39% vs 3–4%), thrombocytopenia (13–13% vs 4–8%), and anemia (9–12% vs 5–7%). Febrile neutropenia was reported in ≤3% of patients. Conclusion: Len/Dex was superior to Dex alone in patients with rrMM. This superiority of Len/Dex was irrespective of baseline performance status of the patients enrolled. Based on this analysis, we conclude that Len/Dex is an important therapeutic option in patients with rrMM despite suboptimal performance status. ECOG=0 ECOG>0 Len/Dex (n=152) Dex (n=150) P Len/Dex (n=192) Dex (n=196) P Clinical response, % OR 59 22 <0.001 62 22 <0.001 CR 12 1 <0.001 16 3 <0.001 PR 39 20 <0.001 35 18 <0.001 Median TTP, weeks 44.3 20.1 <0.001 57.0 20.1 <0.001 Median OS, weeks 156.0 159.1 NS 141.6 103.7 <0.01

scholarly journals ECOG and BMI as preoperative risk factors for severe postoperative complications in ovarian cancer patients: results of a prospective study (RISC-GYN—trial)

2021 ◽  
Author(s):  
Melisa Guelhan Inci ◽  
Julia Rasch ◽  
Hannah Woopen ◽  
Kristina Mueller ◽  
Rolf Richter ◽  
...  
Keyword(s):  
Risk Factors ◽  
Ovarian Cancer ◽  
Postoperative Complications ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Patient Characteristics ◽  
Fresh Frozen Plasma ◽  
Physical Status Classification ◽  
Ecog Ps ◽  
The Impact

Abstract Background Accompanying co-morbidities in patients with ovarian cancer are of major relevance for scheduling debulking surgery, especially in the anesthesiological consultations. Aim of this study was to evaluate the impact of co-morbidities and patient characteristics on postoperative complications. Methods Patients undergoing maximal cytoreductive surgery were prospectively enrolled from October 2015 to January 2017. Various variables were recorded, such as the Charlson comorbidity index, Eastern cooperative oncology group scale of performance status (ECOG PS) and the American society of anesthesiologists physical status classification system (ASA PS). Surgical complications were graded using the Clavien–Dindo criteria. Logistic regression models were used to analyze risk factors for severe postoperative complications. Results Of 106 enrolled patients, 19 (17.9%) developed severe postoperative complications grade ≥ IIIb according to Clavien–Dindo criteria. In the multivariable regression analysis impaired (ECOG PS) > 1 (odds ratio OR) 13.34, 95% confidence interval (CI) 1.74–102.30, p = 0.01), body mass index (BMI) > 25 kg/m2 (OR 10.48, 95% CI 2.38–46.02, p = 0.002) along with the use of intraoperative norepinephrine > 0.11 µg/kg/min (OR 4.69, 95% CI 1.13–19.46, p = 0.03) and intraoperative fresh frozen plasma (FFP) > 17 units (OR 4.11, 95% CI 1.12–15.14, p = 0.03) appeared as significant predictors of severe postoperative complications. Conclusion We demonstrated that neither the presence of a certain comorbidity nor the summation of the co-morbidities were associated with adverse outcome. Patient characteristics, such as ECOG PS > 1 and obesity (BMI > 25 kg/m2), are highly predictive factors for severe postoperative complications. The analysis of intraoperative data showed that the need for more than > 0.11 µg/kg/min of norepinephrine and transfusions of FFPs more than 17 units were strongly associated with severe postoperative complications.

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