Cisplatin versus carboplatin for the treatment of limited-stage small cell lung cancer (LS-SCLC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8565-8565
Author(s):  
Ibrahim Azar ◽  
Adam Austin ◽  
Seongho Kim ◽  
Hyejeong Jang ◽  
Malini Surapaneni ◽  
...  
Keyword(s):  
Standard Of Care ◽  
Wald Test ◽  
Curative Intent ◽  
Cox Proportional Hazard ◽  
Platinum Agent ◽  
Interval Censored ◽  
Multivariable Regression ◽  
Cox Proportional Hazard Regression ◽  
Multiagent Chemotherapy ◽  
Ecog Ps

8565 Background: Standard of care therapy for LS- SCLC is concurrent chemo-radiation (CRT) with a platinum-etoposide backbone. Cisplatin is traditionally the preferred platinum agent in the curative intent setting. Data comparing the efficacy of the less toxic carboplatin to cisplatin in LS-SCLC are lacking. Methods: Data from the National VA Cancer Cube were collected. Pathologically confirmed cases of LS-SCLC that received concurrent CRT with platinum-based multiagent chemotherapy were included. Interval-censored Weibull and Cox proportional hazard regression models were used to estimate median overall survival (OS) and hazard ratio (HR), respectively. Survival curves were compared by a Wald test. Results: 801 LS-SCLC patients who received carboplatin-based therapy (Carbo-SCLC) and 1018 who cisplatin-based therapy (Cis-SCLC) were included in the analysis. Median OS with Carbo-SCLC and Cis-SCLC were 2.13 years (95% CI 1.97-2.31) and 2.24 years (95% CI 2.09-2.4), respectively (HR=1.04;95% CI, 0.94-1.16; p=0.46). Subset analysis showed similar median OS for Carbo-SCLC and Cis-SCLC in patients with ECOG-PS of 0, 1 and 2, as well as patients in their 50s, 60s and >70. Multivariable regression analysis accounting for age and ECOG-PS shows a HR of 0.99 (95% CI 0.86-1.14; p=0.91). Conclusions: Concurrent CRT with carboplatin-etoposide was associated with similar OS compared to cisplatin-etoposide in LS-SCLC, irrespective of PS and age. Carboplatin’s advantageous toxicity profile and comparable OS indicate that it is an acceptable choice of platinum for LS- SCLC.[Table: see text]

Carboplatin versus cisplatin for the treatment of extensive-stage small cell lung cancer (SCLC): A National VA Database analysis.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 9061-9061
Author(s):  
Ibrahim Azar ◽  
Adam Austin ◽  
Seongho Kim ◽  
Hyejeong Jang ◽  
Amit Chopra ◽  
...  
Keyword(s):  
Performance Status ◽  
Young Patients ◽  
Standard Of Care ◽  
Wald Test ◽  
Toxicity Profile ◽  
Current Standard ◽  
Metastatic Setting ◽  
Extensive Stage ◽  
Ecog Ps ◽  
Favorable Toxicity Profile

9061 Background: Current standard of care first line treatment for extensive stage SCLC includes combination of platinum-etoposide doublet with an immune checkpoint inhibitor. Carboplatin is preferred over cisplatin in the extensive stage disease because of its favorable toxicity profile. Data comparing the efficacy of carboplatin with cisplatin in the metastatic setting are limited. Methods: Data from the National VA Cancer Cube database were compiled. Only pathologically confirmed cases of extensive stage SCLC that received platinum-based multiagent chemotherapy were included. Interval-censored Weibull and Cox proportional hazard regression models were used to estimate median overall survival (OS) and hazard ratio (HR), respectively. Two survival curves were compared by a Wald test. Results: Overall, 2600 SCLC cases were studied: 1968 received carboplatin-based therapy (Carbo-SCLC) while 632 received cisplatin-based therapy (Cis-SCLC). Median OS of Carbo-SCLC and Cis-SCLC was 0.71 years (95% CI 0.68-0.75) versus 0.70 years (95% CI 0.64-0.76), respectively (HR = 0.99; 95% CI 0.90-1.10; p = 0.90). Median OS of patients with ECOG-PS of 0, 1, 2 and 3 was similar for Carbo-SCLC and Cis-SCLC. HR of death for Carbo-SCLC compared to Cis-SCLC stratified by performance status were: ECOG-PS 0: 1.04 (95% CI 0.78-1.38; p = 0.80); ECOG-PS 1: 0.87 (95% CI 0.71-1.06; p = 0.17); ECOG-PS 2: 0.92 (95% CI 0.69-1.24; p = 0.6); ECOG- PS 3: 1.13 (95% CI 0.66-1.92; p = 0.66). Multivariable regression analysis accounting for age and ECOG-PS shows a HR of 0.92 (95% CI 0.80-1.05; p = 0.24). Conclusions: Cisplatin-based chemotherapy was not associated with a survival advantage over carboplatin-based chemotherapy in extensive-stage SCLC., including in patients with robust performance status and young patients. The findings from this large dataset along with the favorable toxicity profile of carboplatin support its use as the platinum agent of choice in extensive stage SCLC.

Pembrolizumab (Pem) for advanced non-small cell lung cancer (aNSCLC): Efficacy and safety in everyday clinical practice.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20506-e20506
Author(s):  
Doran Ksienski ◽  
Elaine S. Wai ◽  
Nicole Croteau ◽  
Ashley Freeman ◽  
Leathia Fiorino ◽  
...  
Keyword(s):  
Regression Models ◽  
Multivariable Analysis ◽  
Efficacy And Safety ◽  
Logistic Regression Models ◽  
Cox Proportional Hazard ◽  
Kaplan Meier ◽  
Grade 5 ◽  
Grade 3 ◽  
Cox Proportional Hazard Regression ◽  
Ecog Ps

e20506 Background: In clinical trials, Pem improves overall survival (OS) compared to chemotherapy in a subset of patients (pts) with aNSCLC. Immune related adverse events (irAE) have correlated with improved OS in some studies. We explored efficacy and safety of Pem in a provincial population. Methods: aNSCLC pts treated with Pem between 06/2015 and 08/2018 at BC Cancer were retrospectively identified. Kaplan-Meier curves of OS from initiation of Pem were plotted and multivariable analysis (MVA) was performed with Cox proportional hazard regression models. 3, 6, and 9 month landmark Kaplan-Meier analysis was performed and log-rank tests used to determine the association of irAE subtypes with OS. Multivariable logistic regression models for irAE within 3 months of Pem initiation were also fit. Results: Characteristics of the 190 pt cohort: median age 70y (41-91), ECOG PS 2/3 at start of Pem: 34.2%, squamous histology: 22.1%, EGFR mutation: 3.7%, brain (13.7%) or liver (8.9%) metastases, PD-L1 expression ≥ 50%: 92.6%, treatment line: 1st/ ≥2nd: 74.2%/25.8%. Median cycles delivered 7 (range 1-35). With median survival follow-up of 6.1 months (range 0.03-39.8 months) and 43% pts decreased, median OS of Pem in the 1st line and ≥2nd line settings were 24.3 months (95% CI, 9.7-not reached, NR) and 13.4 months (95% CI, 8.1-NR), respectively. Pts with ECOG PS 2/3 had lower OS vs. ECOG PS 0/1 (5.8 months vs. 16.7 months, log-rank p < 0.0001). On MVA, only ECOG PS (p < 0.001) was associated with OS. 66 pts (34.7% of cohort) experienced 89 irAE; most common irAE: dermatitis (20pts), hypothyroidism (13pts), and pneumonitis (10pts). 8.4% of cohort developed grade 3 or 4 irAE; no grade 5 irAE. The odds of a grade ≥ 3 irAE within 3 months was 6.3 fold higher if ECOG 2/3 vs. 0/1 (p = 0.05). A weak association between pneumonitis and decreased OS at 9 month landmark (p = 0.09) was seen; otherwise no association with irAE subtypes at 3, 6, and 9 month landmarks was observed. Conclusions: In the whole cohort, clinical efficacy and toxicity of Pem was consistent with registration trials. Pts with ECOG PS 2/3 had a significantly lower OS and higher odds of developing grade ≥ 3 irAE than those with good ECOG PS 0/1.

scholarly journals Low serum parathyroid hormone is a risk factor for peritonitis episodes in incident peritoneal dialysis patients: a retrospective study

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yuqi Yang ◽  
Jingjing Da ◽  
Yi Jiang ◽  
Jing Yuan ◽  
Yan Zha
Keyword(s):  
Risk Factor ◽  
Peritoneal Dialysis ◽  
Parathyroid Hormone ◽  
Proportional Hazard ◽  
Serum Parathyroid Hormone ◽  
Cox Proportional Hazard ◽  
Cox Proportional Hazard Regression ◽  
Gram Negative Organisms ◽  
Serum Pth

Abstract Background Serum parathyroid hormone (PTH) levels have been reported to be associated with infectious mortality in peritoneal dialysis (PD) patients. Peritonitis is the most common and fatal infectious complication, resulting in technique failure, hospital admission and mortality. Whether PTH is associated with peritonitis episodes remains unclear. Methods We examined the association of PTH levels and peritonitis incidence in a 7-year cohort of 270 incident PD patients who were maintained on dialysis between January 2012 and December 2018 using Cox proportional hazard regression analyses. Patients were categorized into three groups by serum PTH levels as follows: low-PTH group, PTH < 150 pg/mL; middle-PTH group, PTH 150-300 pg/mL; high-PTH group, PTH > 300 pg/mL. Results During a median follow-up of 29.5 (interquartile range 16–49) months, the incidence rate of peritonitis was 0.10 episodes per patient-year. Gram-positive organisms were the most common causative microorganisms (36.2%), and higher percentage of Gram-negative organisms was noted in patients with low PTH levels. Low PTH levels were associated with older age, higher eGFR, higher hemoglobin, calcium levels and lower phosphate, alkaline phosphatase levels. After multivariate adjustment, lower PTH levels were identified as an independent risk factor for peritonitis episodes [hazard ratio 1.643, 95% confidence interval 1.014–2.663, P = 0.044]. Conclusions Low PTH levels are independently associated with peritonitis in incident PD patients.

Factors affecting progression to permanent atrial fibrillation in an unselected population of patients with non-permanent form of atrial fibrillation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V.L Malavasi ◽  
E Fantecchi ◽  
V Tordoni ◽  
L Melara ◽  
A Barbieri ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cox Regression ◽  
Area Under The Curve ◽  
Roc Curves ◽  
Factors Affecting ◽  
Cox Proportional Hazard ◽  
Significant Difference ◽  
History Of ◽  
Unselected Population ◽  
Cox Proportional Hazard Regression

Abstract Background Natural history of atrial fibrillation (AF) shows a progression of arrhythmia from non-permanent to permanent AF. Permanent AF was found associated with a worse prognosis than non-permanent one. Aim To assess the factors associated with progression to permanent AF in an unselected population of AF patients with non-permanent AF. Methods In this prospective study we enrolled in- as well as out-patients with non-permanent AF and age ≥18 years, with at least one episode of ECG-documented AF within 1 year. The patients were followed-up at 1 month and every 6 months thereafter. Results Out of 523 patients, 314 (60%) were in non-permanent AF (80 [25.5%] paroxysmal AF, 165 [52.5%] persistent AF, 69 [2%] first diagnosed AF), mostly male (188, 59.9%), median age 71 years (IQ range 62–77), median CHA2DS2VASc 3 (1–4), median HATCH score 1 (1–2). After a median follow-up of 701 (IQ range 437–902) days, 66 patients (21%) showed permanent AF. CHA2DS2VASc and HATCH scores were incrementally associated to progression to permanent AF (CHA2DS2VASc χ2 p=0.001; HATCH χ2 p=0.017; p for trend CHA2DS2VASc &lt;0.001, HATCH p=0.001). At multivariable Cox proportional hazard regression the following variables were significantly associated with AF progression: age (hazard ratio [HR] 1.041; 95% CI: 1.004–1.079; p=0.028), at least moderate left atrial (LA) enlargement (&gt;42 ml/m2) (HR 2.092; 95% CI: 1.132–3.866; p=0.018), antiarrhythmics drugs after the enrollment (HR 0.087; 95% CI: 0.011–0.662; p=0.018), EHRA score &gt;2 (HR 0.351; 95% CI: 0.158–0.779; p=0.010) and Valvular HD (HR 2.161; 95% CI: 1.057–4.420; p=0.035). Adding LA dilation to HATCH score (HATCH-LA) and assigning 2 points based on multivariable Cox regression, HATCH-LA was statistically better in ROC curves in prediction of AF progression vs HATCH score (area under the curve 0.695 vs 0.636; DeLong p=0.0225). Survival-free curves on freedom from permanent AF using as discriminator HATCH-LA score ≤2 vs &gt;2 led to a statistically significant difference (χ2=16.080 p&lt;0.001), but the same was not found for HATCH score (χ2 =3.099; p=0.078). Conclusions In patients without permanent AF, progression of AF was independentely related to age, LA dilation, AF symptoms severity, antiarrhythmic drugs and Valvular HD. HATCH score predicted AF progression and adding to it LA dilation (at least moderate) improved patients stratification for the risk of evolution to permanent AF. Funding Acknowledgement Type of funding source: None

scholarly journals Co-Clinical Trials: An Innovative Drug Development Platform for Cholangiocarcinoma

2021 ◽  
Vol 14 (1) ◽  
pp. 51
Author(s):  
Brinda Balasubramanian ◽  
Simran Venkatraman ◽  
Kyaw Zwar Myint ◽  
Tavan Janvilisri ◽  
Kanokpan Wongprasert ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Targeted Therapy ◽  
Drug Development ◽  
Surgical Resection ◽  
Treatment Options ◽  
Standard Of Care ◽  
Time Data ◽  
Current Standard ◽  
Innovative Drug ◽  
Curative Intent

Cholangiocarcinoma (CCA), a group of malignancies that originate from the biliary tract, is associated with a high mortality rate and a concerning increase in worldwide incidence. In Thailand, where the incidence of CCA is the highest, the socioeconomic burden is severe. Yet, treatment options are limited, with surgical resection being the only form of treatment with curative intent. The current standard-of-care remains adjuvant and palliative chemotherapy which is ineffective in most patients. The overall survival rate is dismal, even after surgical resection and the tumor heterogeneity further complicates treatment. Together, this makes CCA a significant burden in Southeast Asia. For effective management of CCA, treatment must be tailored to each patient, individually, for which an assortment of targeted therapies must be available. Despite the increasing numbers of clinical studies in CCA, targeted therapy drugs rarely get approved for clinical use. In this review, we discuss the shortcomings of the conventional clinical trial process and propose the implementation of a novel concept, co-clinical trials to expedite drug development for CCA patients. In co-clinical trials, the preclinical studies and clinical trials are conducted simultaneously, thus enabling real-time data integration to accurately stratify and customize treatment for patients, individually. Hence, co-clinical trials are expected to improve the outcomes of clinical trials and consequently, encourage the approval of targeted therapy drugs. The increased availability of targeted therapy drugs for treatment is expected to facilitate the application of precision medicine in CCA.

scholarly journals AB0292 EFFICACY AND SAFETY OF TWO BIOSIMILAR ETANERCEPT AFTER THE SWITCH FROM THEIR CORRESPONDING ORIGINATOR IN THE TREATMENT OF PATIENTS WITH AUTOIMMUNE ARTHRITIS; A RETROSPECTIVE ANALYSIS IN A REAL LIFE SETTING

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1445.1-1445
Author(s):  
F. Girelli ◽  
A. Ariani ◽  
M. Bruschi ◽  
A. Becciolini ◽  
L. Gardelli ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Disease Duration ◽  
Retention Rate ◽  
Real Life ◽  
Autoimmune Arthritis ◽  
Proportional Hazard ◽  
Hazard Regression ◽  
Cox Proportional Hazard ◽  
Real Life Setting ◽  
Cox Proportional Hazard Regression

Background:The available biosimilars of etanercept are as effective and well tolerated as their bio originator molecule in the naive treatment of chronic autoimmune arthritis. More data about the switching from the bio originator are needed.Objectives:To compare the clinical outcomes of the treatment with etanercept biosimilars (SB4 and GP2015) naïve and after the switch from their corresponding originator in patients affected by autoimmune arthritis in a real life settingMethods:We retrospectively analyzed the baseline characteristics and the retention rate in a cohort of patients who received at least a course of etanercept (originator or biosimilar) in our Rheumatology Units from January 2000 to January 2020. We stratified the study population according to biosimilar use. Descriptive data are presented by medians (interquartile range [IQR]) for continuous data or as numbers (percentages) for categorical data. Drug survival distribution curves were computed by the Kaplan-Meier method and compared by a stratified log-rank test. A Cox proportional hazards regression analysis stratified by indication, drug, age, disease duration, sex, treatment line, biosimilar use and prescription year was performed. P values≤0.05 were considered statistically significant.Results:477 patients (65% female, median age 56 [46-75] years, median disease duration 97 [40.25-178.75] months) treated with etanercept were included in the analysis. 257 (53.9%) were affect by rheumatoid arthritis, 139 (29.1%) by psoriatic arthritis, and 81 (17%) by axial spondylarthritis. 298 (62.5%) were treated with etanercept originator, 97 (20.3%) with SB4, and 82 (17.2%) with GP2015. Among the biosimilars 90/179 (50.3%) patients were naïve to etanercept treatment. Among the 89 switchers we observed 8 treatment discontinuations: one due to surgical infection complication, three due to disease flare, two due to subjective worsening and one due to remission. The overall 6- and 12-month retentions rate were 92.8% and 80.2%. The 6- and 12-month retention rate for etanercept, SB4 and GP2015 were 92.7%, 93.4% and 90.2%, and 82%, 74.5% and 88.1% respectively, without significant differences among the three groups (p=0.374). Patients switching from originator to biosimilars showed and overall higher treatment survival when compared to naive (12-month retention rate 81.2% vs 70.8%, p=0.036). The Cox proportional hazard regression analysis highlighted that the only predictor significantly associated with an overall higher risk of treatment discontinuation was the year of prescription (HR 1.08, 95% CI 1.04 to 1.13; p<0.0001).Conclusion:In our retrospective study etanercept originator and its biosimilars (SB4 and GP2015) showed the same effectiveness. Patients switching from originator to biosimilar showed an significant higher retention rate when compared to naive. The only predictor of treatment discontinuation highlighted by the Cox proportional hazard regression analysis was the year of treatment prescription.Disclosure of Interests:Francesco Girelli: None declared, Alarico Ariani: None declared, Marco Bruschi: None declared, Andrea Becciolini Speakers bureau: Sanofi-Genzyme, UCB and AbbVie, Lucia Gardelli: None declared, Maurizio Nizzoli: None declared

Manual occupations with high all-cause mortality: The contribution of socioeconomic and occupational characteristics

2020 ◽  
pp. 140349482096065
Author(s):  
Hanna Rinne ◽  
Mikko Laaksonen
Keyword(s):  
High Mortality ◽  
Excess Mortality ◽  
Proportional Hazard ◽  
Individual Level ◽  
Cox Proportional Hazard ◽  
Occupational Characteristics ◽  
Study Population ◽  
Cox Proportional Hazard Regression ◽  
Year 2000

Aims: Most high mortality-risk occupations are manual occupations. We examined to what extent high mortality of such occupations could be explained by education, income, unemployment or industry and whether there were differences in these effects among different manual occupations. Methods: We used longitudinal individual-level register-based data, the study population consisting of employees aged 30–64 at the end of the year 2000 with the follow-up period 2001–2015. We used Cox proportional hazard regression models in 31 male and 11 female occupations with high mortality. Results: There were considerable differences between manual occupations in how much adjusting for education, income, unemployment and industry explained the excess mortality. The variation was especially large among men: controlling for these variables explained over 50% of the excess mortality in 23 occupations. However, in some occupations the excess mortality even increased in relation to unadjusted mortality. Among women, these variables explained a varying proportion of the excess mortality in every occupation. After adjustment of all variables, mortality was no more statistically significantly higher than average in 14 occupations among men and 2 occupations among women. Conclusions: The high mortality in manual occupations was mainly explained by education, income, unemployment and industry. However, the degree of explanation varied widely between occupations, and considerable variation in mortality existed between manual occupations after controlling for these variables. More research is needed on other determinants of mortality in specific high-risk occupations.

Association of Dementia-Related Psychosis With Long-term Care Use and Death

Neurology ◽  
2021 ◽  
Vol 96 (12) ◽  
pp. e1620-e1631
Author(s):  
James B. Wetmore ◽  
Yi Peng ◽  
Heng Yan ◽  
Suying Li ◽  
Muna Irfan ◽  
...  
Keyword(s):  
Long Term Care ◽  
Fold Increase ◽  
Proportional Hazard ◽  
Comorbid Conditions ◽  
Term Care ◽  
Risk Of Death ◽  
Cox Proportional Hazard ◽  
Increased Risk ◽  
Cox Proportional Hazard Regression

ObjectiveTo determine the association of dementia-related psychosis (DRP) with death and use of long-term care (LTC); we hypothesized that DRP would be associated with increased risk of death and use of LTC in patients with dementia.MethodsA retrospective cohort study was performed. Medicare claims from 2008 to 2016 were used to define cohorts of patients with dementia and DRP. Outcomes were LTC, defined as nursing home stays of >100 consecutive days, and death. Patients with DRP were directly matched to patients with dementia without psychosis by age, sex, race, number of comorbid conditions, and dementia index year. Association of DRP with outcomes was evaluated using a Cox proportional hazard regression model.ResultsWe identified 256,408 patients with dementia. Within 2 years after the dementia index date, 13.9% of patients developed DRP and 31.9% had died. Corresponding estimates at 5 years were 25.5% and 64.0%. Mean age differed little between those who developed DRP (83.8 ± 7.9 years) and those who did not (83.1 ± 8.7 years). Patients with DRP were slightly more likely to be female (71.0% vs 68.3%) and white (85.7% vs 82.0%). Within 2 years of developing DRP, 16.1% entered LTC and 52.0% died; corresponding percentages for patients without DRP were 8.4% and 30.0%, respectively. In the matched cohort, DRP was associated with greater risk of LTC (hazard ratio [HR] 2.36, 2.29–2.44) and death (HR 2.06, 2.02–2.10).ConclusionsDRP was associated with a more than doubling in the risk of death and a nearly 2.5-fold increase in risk of the need for LTC.

P14.90 Survival outcomes and prognostic factors in glioblastoma patients treated with radiotherapy plus concomitant and adjuvant temozolomide - real-world study

2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii55-ii55
Author(s):  
M J Sousa ◽  
J Magalhães ◽  
R Basto ◽  
C Costa ◽  
A Pego ◽  
...  
Keyword(s):  
Survival Rate ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Rank Test ◽  
Survival Outcomes ◽  
Hematologic Toxicity ◽  
Current Standard ◽  
Adjuvant Temozolomide ◽  
Standard Of Care Treatment ◽  
Ecog Ps

Abstract BACKGROUND Glioblastoma (GBM) is the most common and aggressive primary malignant brain tumour in adults. The current standard of care for newly diagnosed GBM is maximal surgical resection, followed by radiotherapy plus concomitant and adjuvant temozolomide (TMZ). This study aimed to evaluate the survival outcomes and identify predictors of survival among these patients. MATERIAL AND METHODS We performed a single-centre retrospective analysis of GBM patients treated with radiotherapy plus concomitant and adjuvant TMZ from 2013 to 2020. The analyses of progression-free survival (PFS) and overall survival (OS), each one evaluated starting from initial diagnosis, were performed. Survival curves were estimated with the Kaplan- Meier method and compared using the log-rank test. RESULTS Fifty-eight patients were identified. The median age was 61 years (range 18- 80), 51 (88%) patients were in ECOG-PS 0–1, 6 (10%) patients had isocitrate dehydrogenase (IDH) mutation and 53 (91%) of patients had undergone debulking surgery. At a median follow-up of 21 months, median OS was 12.8 months (95% confidence interval [CI] 9.7–15.9), whereas median PFS was 9.5 months (95% CI 8.5–10.5). The 1-year survival rate was 42% and the 2-year survival rate was 10%. Grade 3 or 4 hematologic toxicity occurred in 11 (19%) patients. Twenty-five (42%) patients completed at least 6 cycles of TMZ monotherapy with statistically significant differences between this sub-group and those who weren’t able to continue TMZ monotherapy [median OS 19.3 months (95% CI 14.4–24.2) vs 10.6 months (95% CI 7.8–13.4) p&lt;0.001]. ECOG-PS = 0 [median OS 16.7 months (95% CI 13.4–20.0, p=0.001)] and patients under 65 years of age [median OS 15.6 months (95% CI 12.3–18.9, p=0.02) were associated with significantly better median OS. CONCLUSION The current standard of care treatment for GBM remains poor. An important factor predictor of survival is the completion of the 6 maintenance cycles of TMZ. At baseline, ECOG PS and the patient’s age could be used to define patient prognosis.

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