Serum cathepsin B (CB) levels are prognostic in chemotherapy-naive patients (pts) with advanced non-small cell lung cancer (NSCLC) and performance status (PS) of 2

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18036-18036
Author(s):  
J. W. Singer ◽  
F. B. Oldham ◽  
B. Bandstra ◽  
L. Sandalic ◽  
J. Bianco ◽  
...  
Keyword(s):  
Median Survival ◽  
Advanced Nsclc ◽  
Performance Status ◽  
Phase Iii ◽  
Serum Samples ◽  
Protein Levels ◽  
Lysosomal Cysteine Protease ◽  
Phase Iii Trials ◽  
And Performance ◽  
The Impact

18036 Background: CB is an estrogen-influenced lysosomal cysteine protease produced by tumor cells and tumor-associated macrophages; tumor tissue CB protein levels and proteolytic activity are prognostic in NSCLC (Anticancer Res. 2004; 24:4147–61). The prognostic value of serum CB has not previously been evaluated in NSCLC. Here we evaluate the impact of pretreatment CB levels on survival in pts from 2 phase III trials in advanced NSCLC, STELLAR 3 and 4. These trials compared paclitaxel poliglumex (PPX) against commonly used regimens. As the intratumoral metabolic pathway of PPX is characterized by the CB-mediated release of paclitaxel (P) from a polymeric backbone (Ca Chemother Pharm. 2006. Epub ahead of print), correlation of CB levels with PPX efficacy was assessed as well. Methods: Pretreatment serum samples from 450 chemo-naive pts with advanced NSCLC and PS 2 enrolled in STELLAR 3 (P + carboplatin (C) v. PPX + C) (N=315) and STELLAR 4 (vinorelbine or gemcitabine v. PPX) (N=135) were assayed for CB by ELISA (ICON Labs). Values were assessed by quartiles and there was a clear breakpoint at the median. Pts were categorized as high or low CB based on values above or below the median (64 ng/ml). The effect of CB levels on survival was evaluated by log rank for pooled pts from the studies. Results: As detailed in the table , median survival for non-PPX-treated pts was worse if CB was high; in contrast, median survival for PPX-treated pts did not differ by CB level. Pts with high CB receiving PPX showed a trend towards better survival compared to those receiving control regimens. Conclusions: The data suggest that serum CB may be prognostic biomarker for NSCLC. Retrospective analysis suggests a trend towards improved survival in patients with high CB receiving PPX; prospective studies are required to confirm this observation. [Table: see text] No significant financial relationships to disclose.

Twenty-Two Years of Phase III Trials for Patients With Advanced Non–Small-Cell Lung Cancer: Sobering Results

2001 ◽  
Vol 19 (6) ◽  
pp. 1734-1742 ◽  
Author(s):  
Oscar S. Breathnach ◽  
Boris Freidlin ◽  
Barbara Conley ◽  
Mark R. Green ◽  
David H. Johnson ◽  
...  
Keyword(s):  
Lung Cancer ◽  
North America ◽  
Small Cell Lung Cancer ◽  
Median Survival ◽  
Advanced Nsclc ◽  
Small Cell ◽  
Phase Iii ◽  
Advanced Stage ◽  
Small Cell Lung ◽  
Phase Iii Trials

PURPOSE: To determine the changes in clinical trials and outcomes of patients with advanced-stage non–small-cell lung cancer (NSCLC) treated on phase III randomized trials initiated in North America from 1973 to 1994. PATIENTS AND METHODS: Phase III trials for patients with advanced-stage NSCLC were identified through a search of the National Cancer Institute’s Cancer Therapy Evaluation Program database from 1973 to 1994, contact with Cooperative Groups, and by literature search of MEDLINE. Patients with advanced NSCLC treated during a similar time interval were also examined in the SEER database. Trends were tested in the number of trials, in the number and sex of patients entered on the trials, and in survival over time. RESULTS: Thirty-three phase III trials were initiated between 1973 and 1994. Twenty-four trials (73%) were initiated within the first half of this period (1973 to 1983) and accounted for 5,359 (64%) of the 8,434 eligible patients. The median number of patients treated per arm of the trials rose from 77 (1973 to 1983) to 121 (1984 to 1994) (P < .001). Five trials (15%) showed a statistically significant difference in survival between treatment arms, with a median prolongation of the median survival of 2 months (range, 0.7 to 2.7 months). CONCLUSION: Analysis of past trials in North America shows that the prolongation in median survival between two arms of a randomized study was rarely in excess of 2 months. Techniques for improved use of patient resources and appropriate trial design for phase III randomized therapeutic trials with patients with advanced NSCLC need to be developed.

scholarly journals Cisplatin-Based First-Line Treatment of Elderly Patients With Advanced Non–Small-Cell Lung Cancer: Joint Analysis of MILES-3 and MILES-4 Phase III Trials

2018 ◽  
Vol 36 (25) ◽  
pp. 2585-2592 ◽  
Author(s):  
Cesare Gridelli ◽  
Alessandro Morabito ◽  
Luigi Cavanna ◽  
Andrea Luciani ◽  
Paolo Maione ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Advanced Nsclc ◽  
Performance Status ◽  
Progression Free Survival ◽  
Phase Iii ◽  
First Line ◽  
Free Survival ◽  
Phase Iii Trials ◽  
Health Status Score

Purpose To test the efficacy of adding cisplatin to first-line treatment for elderly patients with advanced non–small-cell lung cancer (NSCLC) within a combined analysis of two parallel phase III trials, MILES-3 and MILES-4. Patients and Methods Patients with advanced NSCLC who were older than age 70 years with Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned to gemcitabine or pemetrexed, without or with cisplatin. In each trial, 382 events were required to detect a hazard ratio (HR) of death of 0.75, with 80% power and two-tailed α of .05. Trials were closed prematurely because of slow accrual, but the joint database allowed us to analyze the efficacy of cisplatin on the basis of intention-to-treat and adjusted by trial, histotype, non-platinum companion drug, stage, performance status, sex, age, and size of the study center. Results From March 2011 to August 2016, 531 patients (MILES-3, 299; MILES-4, 232) were assigned to gemcitabine or pemetrexed without (n = 268) or with cisplatin (n = 263). Median age was 75 years, 79% were male, and 70% had nonsquamous histology. At a median 2-year follow-up, 384 deaths and 448 progression-free survival events were recorded. Overall survival was not significantly prolonged with cisplatin (HR, 0.86; 95% CI, 0.70 to 1.05; P = .14) and global health status score of quality of life was not improved, whereas progression-free survival (HR, 0.76; 95% CI, 0.63 to 0.92; P = .005) and objective response rate (15.5% v 8.5%; P = .02) were significantly better. Significantly more severe hematologic toxicity, fatigue, and anorexia were found with cisplatin. Conclusion The addition of cisplatin to single-agent chemotherapy does not significantly prolong overall survival, and it does not improve global health status score of quality of life in elderly patients with advanced NSCLC.

Impact of socioeconomic status on treatment outcome in patients with advanced esophagogastric cancer in Northern Ireland

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20531-e20531
Author(s):  
Y. Manikyam ◽  
G. G. Hanna ◽  
R. J. Harte ◽  
P. G. Henry ◽  
R. F. Houston ◽  
...  
Keyword(s):  
Socioeconomic Status ◽  
Northern Ireland ◽  
Median Survival ◽  
Performance Status ◽  
Locally Advanced ◽  
Ecog Performance Status ◽  
Disease Extent ◽  
Esophagogastric Cancer ◽  
And Performance ◽  
The Impact

e20531 Background: The survival advantage for combination chemotherapy in advanced gastroesophageal adenocarcinoma is well documented. Epirubicin and cisplatin in combination with either 5FU (ECF) or capecitabine (ECX) result in response rates of 35–46% and a median survival of around 9 months in RCT. We report the impact of socioeconomic status on the outcome of ECF and ECX treatment in advanced gastroesophageal cancer patients in Northern Ireland between 2000 and 2007. Methods: All patients with advanced esophageal (O), gastric (G), or esophagogastric junction (OGJ) adenocarcinoma, receiving palliative chemotherapy from January 2000 to August 2007, were identified from our institutional database. Baseline demographics, clinical characteristics, treatment details, and clinical outcomes were recorded. Patients receiving chemotherapy in a clinical trial were excluded. Survival was estimated using the Kaplan-Meier method. Deprivation was assessed using the patient's home address deprivation index (DPI) (Northern Ireland Multiple Deprivation Measure 2005; May 2005. Northern Ireland Statistics and Research Agency. www.nisra.gov.uk ). Results: 274 eligible patients (m=200, f=74, O=114, OGJ=19, G=141) were identified. Median age was 62 years (range 22–83). 172 (62.8%) had ECOG performance status 0 or 1. 231 patients (84.3%) had metastatic disease, 43 (15.7%) had locally advanced disease. 216 (78.8%) patients received ECF and 58 (21.2%) patients received ECX. Overall median survival was 7.3 months. Treatment response and performance status were strong predictors of survival, however disease extent did not influence survival. Median survival was significantly longer in those with DPIs in the upper two quintiles than the lower 3 quintiles (9.5 months vs. 6.8 months, p=0.032). Conclusions: Outcomes achieved with palliative ECF/ECX treatment are similar to the reference clinical trials. Socioeconomic deprivation is significantly associated with reduced survival in this group of patients and is unrelated to disease extent at presentation; however it may be related to nutritional status and comorbidity and requires further investigation. No significant financial relationships to disclose.

A randomized phase III trial of single-agent pemetrexed (P) versus carboplatin and pemetrexed (CP) in patients with advanced non-small cell lung cancer (NSCLC) and performance status (PS) of 2.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7506-7506 ◽  
Author(s):  
Rogerio Lilenbaum ◽  
Mauro Zukin ◽  
Jose Rodrigues Pereira ◽  
Carlos H. Barrios ◽  
Ronaldo De Albuquerque Ribeiro ◽  
...  
Keyword(s):  
Combination Chemotherapy ◽  
Advanced Nsclc ◽  
Performance Status ◽  
Single Agent ◽  
Survival Rates ◽  
Standard Of Care ◽  
Patient Characteristics ◽  
Phase Iii ◽  
And Performance ◽  
Nsclc Patients

7506 Background: No standard of care exists for patients with advanced NSCLC and PS 2 and clinical practice ranges from supportive care to combination chemotherapy. Methods: In a Brazilian multicenter phase III randomized trial, advanced NSCLC patients, with any histology at first, amended to non-squamous only, PS 2, no prior chemotherapy, and adequate organ function, were randomized to P alone (500 mg/m2) or CP (AUC 5 + same P) administered every 3 weeks for 4 cycles. Stratification factors included stage (IIIB vs. IV); age (≥70 vs. <70); and weight loss (≥5 kg vs. <5kg). The primary endpoint was overall survival and the study was powered to demonstrate an improvement in median survival from 2.9 to 4.3 months based on a prior CALGB trial. Results: A total of 217 patients were enrolled from 8 centers in Brazil and 1 in the US from April 2008 to July 2011. Twelve patients were ineligible and excluded. The 2 arms (P=102; CP=103) were balanced for patient characteristics. 14 patients had squamous and another 12 had unknown histology. The response rates were P = 10% and CP = 24% (p=0.019). In the ITT population, the median PFS was P = 3.0 mo and CP = 5.9 mo (HR=0.46, 95% CI 0.34; 0.63, p<0.001) and median OS was P = 5.6 mo vs. CP = 9.1 mo (HR=0.57, 95% CI 0.41; 0.79, p=0.001). 1-year survival rates were 22% and 39% respectively. Similar results were seen when squamous patients were excluded from the analysis. Grade ¾ anemia (5.5%; 12%) and neutropenia (2.8%; 5.6%) were more frequent in CP. There were 4 treatment-related deaths in the CP arm. 30% of patients in each arm received 2nd line therapy Conclusions: Combination chemotherapy with CP significantly improves survival, with acceptable safety, in eligible patients with advanced NSCLC and PS 2, and represents a new standard.

Serum-free estradiol (E2) levels are prognostic in men with chemotherapy-naive advanced non-small cell lung cancer (NSCLC) and performance status (PS) 2

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7683-7683 ◽  
Author(s):  
H. Ross ◽  
F. B. Oldham ◽  
B. Bandstra ◽  
L. Sandalic ◽  
J. Bianco ◽  
...  
Keyword(s):  
Postmenopausal Women ◽  
Advanced Nsclc ◽  
Performance Status ◽  
High Serum ◽  
Phase Iii ◽  
Rank Test ◽  
Serum Free ◽  
Male Patients ◽  
And Performance ◽  
Normal Men

7683 Background: In women with advanced NSCLC, premenopausal estradiol levels are associated with a worse survival than postmenopausal levels, suggesting an adverse effect of estradiol on prognosis in NSCLC (JCO 2006, 24(18S):7038; JCO 2006, 24:59–63). Levels of E2, produced from testosterone by aromatase, are often higher in men than in postmenopausal women (Ann Intern Med. 2000, 133:951–63). To investigate the effect of E2 on prognosis in male patients (pts) with advanced NSCLC, total and free E2 levels were assayed in pretreatment samples from men participating in 2 randomized phase III studies, STELLAR 3 and 4. Methods: Free serum E2 levels were measured prior to chemotherapy using a radioimmuno-assay in samples from 289/307 male pts with advanced NSCLC and PS2 enrolled in STELLAR 3 (paclitaxel + carboplatin (C) v. paclitaxel poliglumex (PPX) + C) and STELLAR 4 (vinorelbine or gemcitabine v. PPX). The effect of free E2 levels on survival was evaluated by log rank test. Male pts were categorized as high or low E2 based on values above or below the median (0.42 pg/ml; range: 0.1–2.95).The assay range for normal men is 0.2 - 0.5 pg/ml; in pre- and postmenopausal women, the range is 0.80- 3.45 and 0.12 - 0.39 pg/ml, respectively. Results: Hazard ratio's (HR), median, and 1-yr survival are summarized in the table . Survival was worse for male pts with E2 values higher than the median compared to those below the median (HR 1.56, p = .0008). This difference in survival was not dependent on treatment arm as survival was similar for male pts > 0.42 pg/ml receiving either PPX or control. Conclusions: High serum free E2 levels are associated with shorter survival in men with advanced NSCLC, consistent with the shorter survival noted in NSCLC in premenopausal compared to older women. While PPX is associated with improved survival in women with premenopausal E2 levels (JCO 2006, 24(18S):7039), the relatively low levels of E2 in men may be insufficient to affect survival in male pts receiving PPX. [Table: see text] [Table: see text]

A nomogram predicting survival of patients (pts) with metastatic or unresectable urothelial cancer (UC) treated with cisplatin-based chemotherapy

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5055-5055 ◽  
Author(s):  
D. F. Bajorin ◽  
I. Ostrovnaya ◽  
A. Iasonos ◽  
M. I. Milowsky ◽  
M. Boyle ◽  
...  
Keyword(s):  
Median Survival ◽  
Phase Ii ◽  
Cox Model ◽  
Performance Status ◽  
Phase Iii ◽  
Poor Performance Status ◽  
Long Term Outcome ◽  
Phase Ii Studies ◽  
Phase Iii Trials ◽  
Pre Treatment

5055 Background: Cisplatin-based chemotherapy is the standard of care for pts with metastatic or unresectable UC with phase III studies reporting median survivals of 12–15 months. Even more survival variation exists in phase II studies and this disparity is most frequently due to prognostic factors and not individual regimens. Thus, better tools are needed to predict survival both for individual pts and to balance phase III trials. Nomograms have utility in predicting short- and long-term outcome in muscle-invasive UC treated by surgery but they have not been explored in more advanced UC. Methods: We identified 308 pts with metastatic and/or unresectable UC treated on prospective phase II MSKCC protocols of cisplatin-based therapy containing 3–5 total chemotherapy agents. 203 pts received methotrexate, vinblastine, doxorubicin and cisplatin (MVAC), 45 had ifosfamide, paclitaxel and cisplatin (ITP) and 60 pts received doxorubicin plus gemcitabine (AG) followed by ITP (AG-ITP). Survival distributions were compared across trials. Pre-treatment characteristics were then assessed for impact on survival and a nomogram from a fitted Cox model was created to predict 1-yr, 2-yr, 5-yr and median survival. Results: No difference in median survivals were seen among the 3 regimens; median survival was 14.8 months for MVAC, 18.0 months for ITP and 16.1 months for AG- ITP (p=NS). Median survival for all pts was 12.99 months; 268 pts died and 40 pts were censored. 288 pts had all pre-treatment data. Characteristics most associated with survival included visceral metastases (present versus absent, p=.00001) and Karnofsky poor performance status (≥ 80 versus < 80, p= .0005) followed by hemoglobin (normal versus < normal, p=.01) and albumin (actual values, p<.02). These characteristics were then used to construct a nomogram utilizing all 4 factors to predict probabilities of 1-yr, 2-yr, and 5-yr survival. Conclusions: The number and sequence of drugs utilized in cisplatin-based chemotherapy did not substantially impact survival of pts with advanced UC. A nomogram of pre-treatment clinical factors can predict probability of pt survival at 1 yr, 2yrs, and 5 yrs. This nomogram may also be useful to balance treatment arms in phase III trials. No significant financial relationships to disclose.

Bortezomib + gemcitabine (Gem)/carboplatin (Carbo) results in encouraging survival in advanced non-small cell lung cancer (NSCLC): Results of a phase II Southwest Oncology Group (SWOG) trial (S0339)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7017-7017 ◽  
Author(s):  
A. M. Davies ◽  
J. McCoy ◽  
P. N. Lara ◽  
P. H. Gumerlock ◽  
J. Crowley ◽  
...  
Keyword(s):  
Median Survival ◽  
Phase Ii ◽  
Advanced Nsclc ◽  
Response Rate ◽  
Phase Ii Study ◽  
Performance Status ◽  
Single Agent ◽  
Stage Iiib ◽  
Phase Iii ◽  
Survival Times

7017 Background: Bortezomib (PS-341), a small molecule proteasome inhibitor, has single agent activity in NSCLC and potentiates Gem/Carbo in pre-clinical models in a sequence-specific manner (Mortensen, Cancer Chem Pharm, 2004). A phase I trial of Gem/Carbo + PS-341 in patients (pts) with advanced NSCLC yielded an encouraging response rate of 48%. Here we describe the results of a SWOG phase II study of this regimen in advanced NSCLC. Methods: 114 eligible chemonaive stage IV and selected stage IIIB (pleural effusion) NSCLC pts received Gem 1000 mg/m2 on days 1, 8 and Carbo AUC 5 on day 1, followed 1 hour later by PS-341 1.0 mg/m2 on days 1, 4, 8, 11, with cycles repeated every 3 weeks. Non-progressing pts could continue PS-341 alone after 4 cycles. Results: Pt characteristics: Median age: 64 years; Sex M/F = 68/46; Performance status 0/1 = 50/64; stage IIIB/IV = 13/101. Response rate: 20% (95% CI 13–29%); 66% (95% CI 56–75%) had stable disease. At a median follow-up of 13 months, progression free and median survival times were 5 months (95% CI 3.5–5.3) and 11 months (95% CI 8.2–12.5). One-year survival was 46% (95% C.I. 37–55%). Most common grade 3/4 toxicities: neutropenia (52%), thrombocytopenia (63%), and fatigue (13%). Ongoing correlative studies are examining markers of proteasome inhibition (Bcl2 family, NFKB, IKB) and hypoxia (PAI-1, VEGF, OPN, HIF-1) in tumor tissue and surrogate specimens. Conclusions: The 11 month median survival achieved with the addition of PS-341 to Gem/Carbo in this phase II study is unprecedented in prior SWOG trials in advanced NSCLC, and does not appear to be explained by altered patient characteristics. The toxicity profile of this regimen is favorable. A phase III trial of Gem/Carbo ± Bortezomib in advanced stage NSCLC is under development. Supported by CA38926, CA32102. No significant financial relationships to disclose.

scholarly journals Prognostic value of blood-based fibrosis biomarkers in patients with metastatic colorectal cancer receiving chemotherapy and bevacizumab

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Neel I. Nissen ◽  
Stephanie Kehlet ◽  
Mogens K. Boisen ◽  
Maria Liljefors ◽  
Christina Jensen ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Collagen Type ◽  
Performance Status ◽  
Drug Uptake ◽  
Collagen Type Iii ◽  
Serum Samples ◽  
Type Iii ◽  
Poor Treatment ◽  
And Performance

AbstractA desmoplastic colorectal cancer stroma, characterized by excess turnover of the cancer-associated fibroblast derived collagens type III and VI, can lead to reduced drug-uptake and poor treatment response. We investigated the association between biomarkers of collagen type III and VI and overall survival (OS) in patients with metastatic colorectal cancer (mCRC). Serum samples were collected from 252 patients with mCRC prior to treatment with bevacizumab and chemotherapy. Serum concentrations of biomarkers reflecting formation of collagen type III (PRO-C3) and VI (PRO-C6) and degradation of collagen type VI (C6M and C6Mα3) were determined by ELISA. The biomarkers were evaluated for associations with OS, individually, combined, and after adjusting for carcinoembryonic antigen (CEA), lactate dehydrogenase (LDH) and performance status (PS). High baseline levels (> median) of each collagen biomarker were significantly associated with shorter OS (PRO-C3: HR = 2.0, 95%CI = 1.54–2.63; PRO-C6: HR = 1.6, 95%CI = 1.24–2.11; C6M: HR = 1.4, 95%CI = 1.05–1.78; C6Mα3: HR = 1.6, 95%CI = 1.16–2.07). PRO-C3 and PRO-C6 remained significant after adjustment for CEA, LDH and PS. Weak correlations were seen between the collagen biomarkers (r = 0.03–0.59) and combining all improved prognostic capacity (HR = 3.6, 95%CI = 2.30–5.76). Collagen biomarkers were predictive of shorter OS in patients with mCRC. This supports that collagen- and CAF biology is important in CRC.

scholarly journals RADT-23. IMPACT OF REIRRADIATION UTILIZING STEREOTACTIC RADIOSURGERY ON RECURRENT GLIOBLASTOMA

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii186-ii186
Author(s):  
O’Dell Patrick ◽  
H Nickols ◽  
R LaRocca ◽  
K Sinicrope ◽  
D Sun ◽  
...  
Keyword(s):  
Stereotactic Radiosurgery ◽  
Median Survival ◽  
High Performance ◽  
Performance Status ◽  
Treatment Options ◽  
Methylation Status ◽  
Initial Therapy ◽  
Recurrent Glioblastoma ◽  
Control Group ◽  
The Impact

Abstract BACKGROUND Patients who have recurrent glioblastoma have limited treatment options. We conducted a retrospective review of patients with recurrent glioblastoma treated with standard initial radiation and temozolomide with tumor treating fields to investigate whether reirradiation using radiosurgery would be associated with improved outcomes. METHODS We reviewed the records of 54 consecutively treated patients with recurrent glioblastoma with ECOG 0 or 1 at recurrence and conducted Kaplan-Meier analysis with Log-rank testing to determine significance between groups. RESULTS We identified 24 patients who were treated without radiation therapy (control) while 30 patients underwent re-irradiation using radiosurgery (ReSRS) with a median total dose of 25Gy in five fractions. All patients had completed standard initial therapy, and there was no difference in the time to recurrence between the two groups (10 months for control, 15 months for ReSRS, [P = 0.17, HR for progression 0.65 (95% CI 0.38-1.13)]. A larger proportion of patients in the control arm (54%) had subtotal or gross total resection of the recurrence compared with the ReSRS group (44%, P &lt; 0.05). The majority of patients had recurrence confirmed with biopsy (18/22 in control group, 25/31 in the ReSRS group). MGMT methylation status did not differ between control vs ReSRS (29% vs. 27%). ReSRS was associated with improved median survival from the time of first recurrence of 11.6 months versus 3.8 months in the control arm [P&lt; 0.0001, HR for death 0.33 (95% CI 0.18-0.6)]. CONCLUSIONS In a group of patients with high performance status diagnosed with recurrent glioblastoma, reirradiation with stereotactic radiosurgery was associated with nearly one year median survival after recurrence. Additional analyses are warranted to determine the impact of concurrent systemic therapies with irradiation and underlying tumor or patient factors to predict outcomes.

Irradiation Fields and Doses in Glioblastoma Multiforme: Are Current Standards Adequate?

2001 ◽  
Vol 87 (2) ◽  
pp. 85-90 ◽  
Author(s):  
Michele Reni ◽  
Cesare Cozzarini ◽  
Maria Grazia Panucci ◽  
Giovanni Luca Ceresoli ◽  
Andrés José María Ferreri ◽  
...  
Keyword(s):  
Glioblastoma Multiforme ◽  
Performance Status ◽  
Phase Iii ◽  
Control Group ◽  
Whole Brain ◽  
Female Ratio ◽  
Brain Irradiation ◽  
Impact On Survival ◽  
Prospective Trials ◽  
The Impact

Aims and background The optimum conventional radiotherapy in glioblastoma multiforme patients has not been clearly defined by prospective trials. To better characterize a standard radiotherapy in glioblastoma multiforme, the impact on survival of different fields and doses was analyzed in a retrospective single center series. Methods One hundred and forty-seven patients with glioblastoma multiforme, submitted to biopsy only (n = 15), subtotal (n = 48) or total resection (n = 82) and who completed the planned postsurgical radiotherapy, were considered. The median age was 57 years, the male/female ratio 1.5/1, and the performance status ≥70 in 76%. Whole brain irradiation, followed by a boost to partial brain, was used in 75 cases with a whole brain dose of 44–50 Gy (median, 46) and a partial brain dose of 56–70 Gy (median, 60 Gy). Partial brain irradiation alone was used in 72 patients with a dose of 56–70 Gy (median, 61 Gy). Ninety-eight patients received 56–60 Gy (median, 59 Gy) to partial brain whereas 49 patients received 61–70 Gy (median, 63 Gy). Results There was an almost significantly longer survival in patients irradiated to the partial brain alone with respect to those also receiving whole brain radiotherapy (P = 0.056). Doses <60 Gy significantly prolonged survival (P = 0.006). Multivariate analysis confirmed that the impact on survival of radiation dose was independent of age, performance status, extent of surgery, field of irradiation and the use of chemotherapy. The extent of irradiation field was not independently related to improved survival. Conclusions Our retrospective findings suggest that we reflect on the adequacy of the current standard irradiation parameters. Well-designed prospective trials are necessary to standardize the radiotherapy control group in patients with glioblastoma multiforme to be compared in phase III trials with innovative therapeutic approaches.

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