scholarly journals Maximum Resection and Immunotherapy Improve Glioblastoma Patient Survival: A Single-institution Prognostic Analysis 

2021 ◽  
Author(s):  
Eiichi Ishikawa ◽  
Narushi Sugii ◽  
Masahide Matsuda ◽  
Hidehiro Kohzuki ◽  
Takao Tsurubuchi ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Proton Therapy ◽  
Tumor Vaccine ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Univariate Analysis ◽  
Intraoperative Mri ◽  
Survival Ratio ◽  
Term Survival

Abstract Purpose. Glioblastoma (GBM) is a refractory disease with a poor prognosis and various methods, including maximum resection and immunotherapy, have been tested to improve outcomes. This retrospective study analyzed the prognostic factors of initially diagnosed glioblastoma patients at our institution to analyze the effect of these methods on prognosis. Methods. Two hundred seventy-seven patients with initially diagnosed glioblastoma who were treated in our institution from 2009 to 2020. Various data, including extent of removal (EOR) and type of adjuvant therapy, were examined and prognostic relationships were analyzed. Results. The median OS of the entire 277-case cohort, 200 non-biopsy cases, and 77 biopsy cases were 16.6 months, 19.7 months, and 9.7 months, respectively. Gross total removal (GTR; 100% of EOR) was achieved in 32.9% of the cases. Univariate analysis revealed younger age, right side, higher Karnofsky performance status, GTR, intraoperative MRI use for removal, proton therapy, combination immunotherapy, and discharge to home as good prognostic factors. Intraoperative MRI use and EOR were closely related. In the multivariate analysis, GTR, proton therapy, and combination of immunotherapies including autologous formalin-fixed tumor vaccine were the significant prognostic factors. A multivariate analysis of 91 GTR cases showed that immunotherapy contributed to prognostic improvements. The median OS and 5-year OS% values were 36.9 months and 43.3% in GTR cases receiving immunotherapy. Conclusion. GTR, proton therapy, and immunotherapy were good prognostic factors in single-center GBM cases. Tumor vaccine therapy for GTR cases achieved a notably high median survival time and long-term survival ratio, indicating its usefulness in GTR cases.

scholarly journals Maximum resection and immunotherapy improve glioblastoma patient survival: a retrospective single-institution prognostic analysis

BMC Neurology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eiichi Ishikawa ◽  
Narushi Sugii ◽  
Masahide Matsuda ◽  
Hidehiro Kohzuki ◽  
Takao Tsurubuchi ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Proton Therapy ◽  
Tumor Vaccine ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Univariate Analysis ◽  
Survival Ratio ◽  
Term Survival ◽  
Prognostic Analysis

AbstractGlioblastoma (GBM) is a refractory disease with a poor prognosis and various methods, including maximum resection and immunotherapy, have been tested to improve outcomes. In this retrospective study we analyzed the prognostic factors of 277 newly diagnosed GBM patients over 11 years of consecutive cases at our institution to evaluate the effect of these methods on prognosis. Various data, including the extent of removal (EOR) and type of adjuvant therapy, were examined and prognostic relationships were analyzed. The median overall survival (OS) of the entire 277-case cohort, 200 non-biopsy cases, and 77 biopsy cases was 16.6 months, 19.7 months, and 9.7 months, respectively. Gross total removal (GTR; 100% of EOR) was achieved in 32.9% of the cases. Univariate analysis revealed younger age, right side, higher Karnofsky performance status, GTR, intraoperative magnetic resonance imaging (MRI) use for removal, proton therapy, combination immunotherapy, and discharge to home as good prognostic factors. Intraoperative MRI use and EOR were closely related. In the multivariate analysis, GTR, proton therapy, and a combination of immunotherapies, including autologous formalin-fixed tumor vaccine, were the significant prognostic factors. A multivariate analysis of 91 GTR cases showed that immunotherapy contributed to prognostic improvements. The median OS and 5-year OS % values were 36.9 months and 43.3% in GTR cases receiving immunotherapy. In conclusion, GTR, proton therapy, and immunotherapy were good prognostic factors in single-center GBM cases. Tumor vaccine therapy for GTR cases achieved a notably high median survival time and long-term survival ratio, indicating its usefulness in GTR cases.

507 NEOADJUVANT AND ADJUVANT CHEMOTHERAPIES FOR PATIENTS WHO UNDERWENT RESECTION FOR SQUAMOUS CELL CARCINOMA CF THE THORACIC ESOPHAGUS

2020 ◽  
Vol 33 (Supplement_1) ◽  
Author(s):  
J Liu ◽  
Y Wang
Keyword(s):  
Squamous Cell Carcinoma ◽  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Survival Rate ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Univariate Analysis ◽  
Entire Group ◽  
Thoracic Esophagus ◽  
Term Survival

Abstract   The efficacy of neo-adjuvant chenmotherapy (NCT) and adjuvant chemotherapy (ACT) for squamous cell carcinoma (SCC) of the esophagus has not been fully expounded. This study analyzed the prognostic factors of patients who underwent esophagectomy for SCC of the thoracic esophagus, specially focused on NCT and ACT. Methods From January 2008 to January 2016, 1075 consecutive patients underwent esophgagectomy for stage T3-T4 SCC of the thoracic esophagus. Propensity-score matching (PSM) analyses were conducted in patients who underwent NCT, surgery alone (SA) and ACT. After PSM, there were 83 patients in NCT, 249 patients in SA and 249 patients in ACT group. Postoperative outcomes and prognostic factors of patients in the three groups were analyzed. Univariate analysis was performed using the Kaplan–Meier method and multivariate analysis using the Cox proportional hazard model. Differences were considered to be statistically significant when P < 0.05. Results The incidence of main postoperative complications was 9.6% (8/83) in NCT group compared to 6.8% (34/498) in SA and ACT groups (P = 0.834). In NCT group, 20 patients (24.1%) were downstaged by NCT and 63 patients (75.9%) remained stable. The 3-year survival rate of the entire group was 51.0%, and the 5-year survival rate was 33.4%. The 5-year survival rate was 32.2% in NCT group, 50.9% in ACT, and 19.5% in SA patients. In univariate analysis, both NCT and ACT were associated with long-term survival. In multivariate analysis, however, ACT rather than NCT was independent prognostic factor. Conclusion This study supports the use of postoperative ACT for patients with stage T3 or T4 SCC of the thoracic esophagus, but the effect of NCT needs further study.

scholarly journals Impact of Superselective Intra-Arterial and Systemic Chemoradiotherapy for Gingival Carcinoma; Analysis of Treatment Outcomes and Prognostic Factors

2020 ◽  
Author(s):  
Yuki Mukai ◽  
Yuichiro Hayashi ◽  
Izumi Koike ◽  
Toshiyuki Koizumi ◽  
Madoka Sugiura ◽  
...  
Keyword(s):  
Overall Survival ◽  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Clinical Stage ◽  
Performance Status ◽  
Univariate Analysis ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Free Survival

Abstract Background: We compared outcomes and toxicity between radiation therapy (RT) with concurrent retrograde super-selective intra-arterial chemotherapy (IACRT) and RT with concurrent systemic chemoradiotherapy (SCRT), for gingival carcinoma (GC).　Methods: We included 84 consecutive patients who were treated for GC ≥ stage III, from 2006 to 2018, in this retrospective analysis (IACRT group: n=66; SCRT group: n=18).Results: Median follow-up time was 24 (range: 1–124) months. The median prescribed dose was 60 (6–70.2) Gy (IACRT group: 60 Gy; SCRT group:69 Gy). At 3 years, the two groups significantly differed in overall survival (OS; IACRT: 78.75%, 95% confidence interval [CI]: 66.00–87.62; SCRT: 50.37%, 95% CI: 27.58–73.0; P = 0.039), progression-free survival (PFS; IACRT: 75.64%, 95% CI: 62.69–85.17; SCRT: 41.96%, 95% CI: 17.65–70.90; P = 0.028) and local control (LC; IACRT: 77.17%, 95% CI: 64.23–86.41; SCRT: 41.96%, 95% CI: 17.65–70.90; P = 0.015). In univariate analysis, age ≥ 65, decreased performance status (PS) and SCRT were significantly associated with worse outcomes (P < 0.05). In multivariate analysis, age ≥ 65 years, clinical stage IV, and SCRT were significantly correlated with poor OS (P < 0.05). Patients with poorer PS had significantly worse PFS.Conclusions: This is the first report to compare outcomes from IACRT and SCRT among patients with GC. IACRT is an effective and organ-preserving treatment for GC.Trial registration: retrospectively registered

Prevalence and Prognostic Factors of EBV-Positive DLBCL of the Elderly In Peru

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4166-4166
Author(s):  
Brady Beltran ◽  
Domingo Morales ◽  
Pilar Quinones ◽  
Aly Gallo ◽  
Marco Lopez-Ilasaca ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Survival Analysis ◽  
Prognostic Factors ◽  
Clinical Stage ◽  
Performance Status ◽  
Univariate Analysis ◽  
B Cell Lymphoma ◽  
The Elderly ◽  
Female Ratio ◽  
Immunohistochemical Profile

Abstract Abstract 4166 Background: EBV-positive diffuse large B-cell lymphoma (DLBCL) of the elderly is an entity recently described and included in the WHO classification of lymphomas. It usually affects patients older than 50 years with poor responses to chemotherapy and short survival. However, the majority of the cases are from Asian origin. In fact, in Western countries the incidence of EBV in patients with DLBCL is reported as <5%. The primary objective of this study is to establish the prevalence of EBV in patients with DLBCL and identify prognostic factors in these patients. Patients and methods: We investigated the EBV status by detection of EBV-encoded RNA (EBER) using a chromogenic in situ hybridization (CISH) technique in newly diagnosed patients with primarily nodal DLBCL, identified between January 2002 and December 2009. Clinical data were reviewed retrospectively and biopsies were analyzed for the presence of EBER by CISH and the immunohistochemical expression of BCL6, CD10 and MUM-1/IRF4 using standard procedures. Chi-square was used to compare the characteristics between EBER-positive and EBER-negative cases and to evaluate the association between complete response (CR) to chemotherapy and other clinical variables. Univariate survival estimates in patients who received chemotherapy were obtained using the Kaplan-Meier method. The multivariate survival analysis was performed using the Cox proportional-hazard regression test. Results: A total of 134 consecutive patients were eligible and were included in the comparative clinical analysis. In this cohort, the median age was 71 years (range 23–84) with a male-to-female ratio of 1.1 (71 male and 65 female cases) and a median overall survival (OS) of 47 months. 75% of the cases were 60 years or older, 62% had advanced clinical stage (III or IV), 63% has elevated LDH levels, 13% had involvement of 2 or more extranodal sites, 48% had an ECOG performance status of 2 or higher and 71% had a non-germinal center (NGC) immunohistochemical profile. Nineteen patients were positive for EBER but only 17 patients were included in the analysis because 2 patients were older than 50 years. When comparing EBER-positive and EBER-negative cases, there was an association between EBER expression and a worse outcome (p=0.003). EBER expression was not associated with gender, age, performance status, LDH levels, clinical stage, number of extranodal sites, B symptoms, immunohistochemical profile, overall response rate (ORR), CR rate, exposure to chemotherapy or IPI score. The only factors associated with CR were IPI score (p=0.047) and B symptoms (p=0.0004). Ninety nine patients received chemotherapy and were included in our survival analysis. In the univariate analysis, age over 60, performance status, LDH levels, number of extranodal sites, clinical stage, immunohistochemical profile and EBER expression were associated with OS. EBER-positive patients had a median OS of 12 months vs. 47 months in EBER-negative patients (p=0.045; Figure). In the multivariate analysis, performance status, LDH levels and EBER expression were independent factors for OS (p=0.02, 0.01 and 0.006, respectively). When evaluating EBER expression against the IPI score, both were independent prognostic factors for OS (p=0.002 and 0.03, respectively). Conclusions: The prevalence of EBV-positive DLBCL of the elderly in Peru is the highest reported in the world (13%). DLBCL patients expressing EBER had a worse outcome in comparison to EBER-negative DLBCL patients. In the multivariate analysis, EBER expression in the tumoral cells was an independent prognostic factor for OS along with the IPI score. Disclosures: No relevant conflicts of interest to declare.

Prognosis Value of Flt3 Internal Tandem Duplication and P-Glycoprotein Functionality, in 171 AML.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2375-2375
Author(s):  
Christophe Marzac ◽  
Irene Teyssandier ◽  
Jean Yves Perrot ◽  
Anne Marie Faussat ◽  
Ruoping Tang ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Performance Status ◽  
Univariate Analysis ◽  
Disease Free Survival ◽  
Internal Tandem Duplication ◽  
Free Survival ◽  
Atp Binding Cassette Transporter ◽  
Mutational Status ◽  
Disease Free

Abstract Adult acute myeloid leukemia (AML) with intermediate cytogenetic remains a very heterogeneous group of patients with highly variable individual prognosis. Emerging data suggest that some molecular markers could help to refine cytogenetic stratification. Here we focused on ABCB1 (MDR1/Pgp) ATP-binding cassette transporter activity and fms-like tyrosine kinase mutations (Flt3/ITD) because their individual prognosis value is well demonstrated and because they may lead to targeted therapy. Therefore we assessed Pgp activity using JC-1 probe and Flt3 exon 14 mutational status by standard PCR and realised a multivariate analysis in 171 adult AML patients treated in the EORTC protocols. Flt3/ITD (ITD+) and high Pgp activity (Pgp+) were found in 26/171 (15%) and 55/171 (32%) of the patients, respectively. The repartition was remarkable in that, as defined with our criteria, both were negative in 94/171 (55%, Pgp-ITD- group) or mutually exclusive in 73/171 (43%, Pgp-ITD+ and Pgp+ITD- groups) and only 4/171 (2%, Pgp+ITD+ group) were positive for both. In univariate analysis complete remission (CR) rates for ITD+ were 38% vs 61% for ITD- patients (p=0.034) and 47% vs 62% (p=0.06) for Pgp+ vs Pgp- patients. Individually, both parameters were strong predicators for overall survival (OS) (p=0,02) but not for disease free survival. In multivariate analysis Pgp+ITD+ (p&lt;0.0001) and age (p=0.0022) were independent prognostic factors for CR achievement. For OS, CR achievement (p&lt;0.0001), WHO performance status (p=0.0007) and Pgp+ITD+ (p=0.0014) were also independent prognostic factors. In 98 patients with intermediate cytogenetic CR rates for ITD+ were 40% vs 62% for ITD- patients (p=0.099) and 41% vs 67% (p=0.014) for Pgp+ vs Pgp- patients. In the Pgp-ITD- group (47/98 patients), CR rate was 70% vs 44% for others (p= 0.012). The 4 years OS achieved 48% vs 16% (p&lt;0.0001) and DFS was 56% versus 27% (p=0.024). Furthermore, OS curves of the intermediate cytogenetic-Pgp-ITD- group were not significantly different from the favorable cytogenetic group. In conclusion Flt3-ITD and P-gp activity are independent and additive prognostic factors, which provide a powerful risk classification that can be used to stratify the treatment of intermediate cytogenetic AML patients. Figure Figure

Prognostic factors (PFs) of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel (nab-P) plus gemcitabine (G) versus G alone in patients (pts) with metastatic pancreatic cancer (MPC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4059-4059 ◽  
Author(s):  
Malcolm J. Moore ◽  
Daniel D. Von Hoff ◽  
Thomas J. Ervin ◽  
Francis P. Arena ◽  
E. Gabriela Chiorean ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Liver Metastases ◽  
Treatment Effect ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Univariate Analysis ◽  
Phase Iii ◽  
Risk Of Death ◽  
Increased Risk ◽  
Metastatic Sites

4059^ Background: In MPACT, pts who received nab-P + G vs G had improved overall survival (OS; median 8.5 vs 6.7 mo; HR 0.72; p= 0.000015). Here we assessed potential PFs of OS. Methods: 861 pts with MPC were randomized 1:1, stratified by region, presence of liver metastases, and Karnofsky performance status (KPS), to nab-P + G or G. OS was described in subgroups. A step-wise multivariate analysis (with significance level for entry of 0.20 and for stay of 0.10) was performed to evaluate the treatment effect and identify possible predictors of OS. Results: Pts with poorer PFs had a shorter median OS, consistent with the literature, and OS consistently favored nab-P + G in pts with these PFs (Table). Region of Eastern Europe, age ≥ 65 years, poorer KPS, presence of liver metastases, and number of metastatic sites all predicted OS (increased risk of death). The treatment effect remained significant (HR 0.72; 95% CI, 0.605 - 0.849; p < 0.0001, Cox proportional hazards [CPH] model). In another multivariate analysis in which baseline CA19-9 was added to the final model described above, the treatment effect HR was 0.67 (95% CI, 0.573 - 0.794; p < 0.0001, CPH model). Baseline CA19-9, a predictor of OS by univariate analysis, was not predictive after correction for the above factors. Conclusions: In MPACT, the most important predictors of OS were KPS, age, presence of liver metastases, number of metastatic sites, and region. After correcting for these factors, assignment to nab-P + G was an independent significant predictor of improved survival. Clinical trial information: NCT00844649. [Table: see text]

scholarly journals The Prognostic Factors and Outcome of Adult Medulloblastoma: Where We Stand

2016 ◽  
Vol 101 (7-8) ◽  
pp. 352-360
Author(s):  
Kamuran Ibis ◽  
Ahmet Karadeniz ◽  
Rasim Meral ◽  
Murat Guveli ◽  
Mert Basaran ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Univariate Analysis ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Craniospinal Irradiation ◽  
Subtotal Resection ◽  
Duration Of Symptoms ◽  
Adult Medulloblastoma

We designed our study to analyze the prognostic factors and treatment outcomes of adult medulloblastoma patients who received postoperative craniospinal irradiation. Fourty-three patients who were treated due to medulloblastoma at Istanbul University, Institute of Oncology between 1990 and 2013 were retrospectively analyzed. All of the patients were older than 18 years, with a median age of 27 years (range, 18–51 years). In 40 (93%) patients, total resection of the tumor was achieved, and 3 (7%) patients had undergone a subtotal tumoral resection. Risk assessment revealed 7 high-risk and 36 standard-risk patients. All patients received postoperative craniospinal irradiation, delivering a median craniospinal dose of 36 Gy, with an additional boost to the posterior fossa up to 54 Gy. Fifteen patients received chemotherapy. The median follow-up was 62 months (range, 3–213 months). The 5-year, 10-year, overall, and disease-free survival rates were 63%, 51%, 66%, and 55%, respectively. Univariate analysis revealed that hydrocephalus, initial local recurrence, subtotal resection in primary surgery, initial Karnofsky performance status ≤70, duration of symptoms shorter than 30 days, and primary site dose &lt; 54 Gy were found to be negative prognostic factors. Toxicity was moderate. The main therapy in adult medulloblatoms is craniospinal irradiation following surgery. The prognostic factors and outcomes of the patients in our study are concordant with previous reports in the literature.

scholarly journals Survival and Prognostic Factors of 40 Patients with Pulmonary Oligometastases Treated with Tomotherapy Hypofractionated Radiotherapy

2021 ◽  
Author(s):  
Rujun Chen ◽  
Yajun Zhang ◽  
Mengmeng Li ◽  
Xin Chen ◽  
Qian Sun ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Local Control ◽  
Lung Metastases ◽  
Karnofsky Performance Status ◽  
Treatment Plan ◽  
Performance Status ◽  
Univariate Analysis ◽  
Hypofractionated Radiotherapy ◽  
Good Survival ◽  
Toxic Reaction

Abstract Background: With continued improvement in radiotherapy technology, hypofractionated radiotherapy has helped achieve good results in the local control and toxicity of pulmonary oligometastases. This study aimed to investigate the efficacy of radiotherapy and the prognostic factors that affect survival in patients with pulmonary oligometastases who undergo helical tomotherapy (TOMO) hypofractionated radiotherapy.Methods: Ninety pulmonary oligometastases in 40 patients (26 males, 14 females; median age 57 years) were retrospectively investigated and treated with hypofractionated radiotherapy in the Department of Oncology and Radiotherapy of the First Affiliated Hospital of Bengbu Medical College during 2018-2020. Their Karnofsky performance status (KPS) was ≥70 points. The primary endpoints were overall survival (OS), local control (LC), and progression-free survival (PFS), and we determine the related influencing factors.Results: The median gross tumor volume (GTV) and planning target volume (PTV) were 9.7 cm³ (range 1.1–287.0 cm³) and 56.9 cm³ (range 16.3–494.2 cm³), respectively, the median biological effective dose, α/β=10 (BED10), was 76.8 Gy (range 56-96 Gy), and four-dimensional computed tomography positioning was applied to 52.5% of the patients. All patients completed the treatment plan during a median follow-up of 16.1 months (range 4.9–33.3 months). The 1- and 2-year OS rates were 90.3% and 55.2%, respectively. The 1- and 2-year LC rates were 80.8% and 64.7%, respectively. The 1- and 2-year PFS rates were 47.3% and 28.4%, respectively. Univariate analysis revealed that colorectal primary (p=0.004), age >57 years (p=0.037), and number of organ metastases ≥2 (p=0.046) were associated with OS, whereas disease-free interval (DFI) ≤17.4 months (p=0.032), number of lung metastases≥2 (p=0.049), and PTV >56.9 cm³ (p=0.041) were associated with LC; and number of metastatic organs ≥2 (p=0.015) was independently associated with PFS. In multivariate analysis, colorectal cancer (p=0.010) and age >57 years (p=0.009) were significantly associated with OS. No > grade 3 toxic reaction.Conclusions: The median OS, LC, and PFS rates of TOMO hypofractionated radiotherapy for pulmonary oligometastases were 24.9, 25.9, and 11.8 months, respectively, showing that good survival rates and low toxicity could still be achieved using the medium dose.

Multivariate analysis including biomarkers in the phase III RADIANT-2 study of octreotide LAR plus everolimus (E+O) or placebo (P+O) among patients with advanced neuroendocrine tumors (NET).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4014-4014 ◽  
Author(s):  
James C. Yao ◽  
John D. Hainsworth ◽  
Edward M. Wolin ◽  
Marianne E. Pavel ◽  
Eric Baudin ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Proportional Hazards Model ◽  
Performance Status ◽  
Univariate Analysis ◽  
Primary Site ◽  
Cox Proportional Hazards Model ◽  
Bone Involvement ◽  
Phase Iii ◽  
Rank Test

4014 Background: In this large phase III trial, median progression-free survival (PFS) improved by 5.1 mo with E+O compared to P+O in patients (pts) with NET associated with carcinoid syndrome. Baseline imbalances including WHO performance status (PS) and primary site favoring P+O confounded primary analysis. Chromogranin A (CgA) and 5-hydroxyindoleacetic acid (5-HIAA) are important biomarkers in NET. Analyses were performed to identify prognostic factors and adjust for baseline imbalances. Methods: Pts were randomized to E+O (n=216) or P+O (n=213). Potential prognostic factors including baseline CgA (≤2×ULN vs >2×ULN), baseline 5-HIAA (≤median vs >median at baseline), age (<65 vs ≥65), gender, race, WHO PS (0 vs 1, 2), primary site (lung vs other), prior somatostatin analog use (yes vs no), duration from diagnosis (<6 mo, 6-24 mo, 2-5 yr, >5 yr), and organs involved (liver, bone) were assessed in univariate analysis using the log rank test and stepwise regression using Cox proportional hazards model. Results: Median PFS (mo) was significantly longer for pts with nonelevated CgA (27 vs 11; p<.001) and nonelevated 5-HIAA (17 vs 11; p<.001). Analyses also indicated age (14 vs 12; p=.01), WHO PS (17 vs 11; p=.004), liver involvement (14 vs not reached; p=.02), bone metastases (8 vs 15; p<.001), and lung as primary site (11 vs 14; p=.06) as potentially prognostic. Multivariate analysis indicated that significant prognostic factors for PFS included baseline CgA (HR, 0.47; CI, 0.34-0.65; p<.001), WHO PS (HR, 0.69; CI, 0.52-0.90; p=.006), bone involvement (HR, 1.52; CI, 1.06-2.18; p=.02), and lung as primary site (HR, 1.55; CI, 1.01-2.36; p=.04). Adjusted for covariates, a 38% reduction in risk of progression was observed for E+O (HR, 0.62; 95% CI, 0.51-0.87; p=.003). Conclusions: In the phase III RADIANT-2 trial, baseline CgA levels, WHO PS, lung as primary site, and bone involvement were important prognostic factors. Exploratory analysis adjusted for these prognostic factors indicated significant benefit of everolimus therapy.

Multivariate analysis including biomarkers in the phase III RADIANT-2 study of octreotide LAR plus everolimus (E+O) or placebo (P+O) among patients with advanced neuroendocrine tumors (NET).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 157-157 ◽  
Author(s):  
James C. Yao ◽  
John D. Hainsworth ◽  
Edward M. Wolin ◽  
Marianne E. Pavel ◽  
Eric Baudin ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Proportional Hazards Model ◽  
Performance Status ◽  
Univariate Analysis ◽  
Primary Site ◽  
Cox Proportional Hazards Model ◽  
Bone Involvement ◽  
Phase Iii ◽  
Rank Test

157 Background: In this large phase III trial, median progression-free survival (PFS) improved by 5.1 mo with E+O compared to P+O in patients (pts) with NET associated with carcinoid syndrome. Randomization imbalances including WHO performance status (PS), and primary site favoring P+O confounded primary analysis. Chromogranin A (CgA) and 5-hydroxyindoleacetic acid (5-HIAA) are important biomarkers in NET. Analyses were performed to identify prognostic factors and adjust for randomization imbalances. Methods: Pts were randomized to E+O (n=216) or P+O (n=213). Potential prognostic factors including baseline CgA (≤2×ULN vs >2×ULN), baseline 5-HIAA (≤median vs >median), age (<65 vs ≥65), gender, race, WHO PS (0 vs 1, 2), primary site (lung vs other), prior somatostatin analog use (yes vs no), duration from diagnosis (<6 mo, 6-24 mo, 2-5 yr, >5 yr), and organs involved (liver, bone) were assessed in univariate analysis using the log rank test and a stepwise regression using Cox proportional hazards model. Results: Randomization resulted in significant imbalance in baseline CgA (median [ng/mL], 251 E+O vs 137 P+O). Median PFS (mo) was significantly longer for pts with nonelevated CgA (27 vs 11; P<.001) and nonelevated 5-HIAA (17 vs 11; P<.001). Analyses also indicated age (14 vs 12; P=.01), WHO PS (17 vs 11; P=.004), liver involvement (14 vs not reached; P=.02), bone metastases (8 vs 15; P<.001), and lung as primary site (11 vs 14; P=.06) as potentially prognostic. Multivariate analysis indicated that significant prognostic factors for PFS included baseline CgA (HR, 0.47; CI, 0.34-0.65; P<.001), WHO PS (HR, 0.69; CI, 0.52-0.90; P=.006), bone involvement (HR, 1.52; CI, 1.06-2.18; P=.02), and lung as primary site (HR, 1.55; CI, 1.01-2.36; P=.04). Adjusted for covariates, a 38% reduction in risk of progression was observed for E+O (HR, 0.62; 95% CI, 0.51-0.87; P=.003). Conclusions: In the phase III RADIANT-2 trial, baseline CgA levels, WHO PS, lung as primary site, and bone involvement were important prognostic factors. Exploratory analysis adjusted for these prognostic factors indicated significant benefit for everolimus therapy.

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