scholarly journals Accelerated hyper-versus normofractionated radiochemotherapy with temozolomide in patients with glioblastoma: a multicenter retrospective analysis

2021 ◽  
Author(s):  
Rainer J. Klement ◽  
Ilinca Popp ◽  
David Kaul ◽  
Felix Ehret ◽  
Anca L. Grosu ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Standard Treatment ◽  
Treatment Time ◽  
Performance Status ◽  
Multivariable Analysis ◽  
Target Volume ◽  
Hyperfractionated Radiotherapy ◽  
Adjuvant Temozolomide ◽  
Multicenter Analysis

Abstract Background and purpose The standard treatment of glioblastoma patients consists of surgery followed by normofractionated radiotherapy (NFRT) with concomitant and adjuvant temozolomide chemotherapy. Whether accelerated hyperfractionated radiotherapy (HFRT) yields comparable results to NFRT in combination with temozolomide has only sparsely been investigated. The objective of this study was to compare NFRT with HFRT in a multicenter analysis. Materials and methods A total of 484 glioblastoma patients from four centers were retrospectively pooled and analyzed. Three-hundred-ten and 174 patients had been treated with NFRT (30 × 1.8 Gy or 30 × 2 Gy) and HFRT (37 × 1.6 Gy or 30 × 1.8 Gy twice/day), respectively. The primary outcome of interest was overall survival (OS) which was correlated with patient-, tumor- and treatment-related variables via univariable and multivariable Cox frailty models. For multivariable modeling, missing covariates were imputed using multiple imputation by chained equations, and a sensitivity analysis was performed on the complete-cases-only dataset. Results After a median follow-up of 15.7 months (range 0.8–88.6 months), median OS was 16.9 months (15.0–18.7 months) in the NFRT group and 14.9 months (13.2–17.3 months) in the HFRT group (p = 0.26). In multivariable frailty regression, better performance status, gross-total versus not gross-total resection, MGMT hypermethylation, IDH mutation, smaller planning target volume and salvage therapy were significantly associated with longer OS (all p < 0.01). Treatment differences (HFRT versus NFRT) had no significant effect on OS in either univariable or multivariable analysis. Conclusions Since HFRT with temozolomide was not associated with worse OS, we assume HFRT to be a potential option for patients wishing to shorten their treatment time.

Accelerated Hyper-Versus Normofractionated Radiochemotherapy with Temozolomide in Patients with Glioblastoma: A Multicenter Retrospective Analysis.

2021 ◽  
Author(s):  
Rainer J. Klement ◽  
Ilinca Popp ◽  
David Kaul ◽  
Felix Ehret ◽  
Anca L. Grosu ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Standard Treatment ◽  
Treatment Time ◽  
Performance Status ◽  
Multivariable Analysis ◽  
Target Volume ◽  
Hyperfractionated Radiotherapy ◽  
Adjuvant Temozolomide ◽  
Multicenter Analysis

Abstract Background and purpose The standard treatment of glioblastoma (GB) patients consists of surgery followed by normofractionated radiotherapy (NFRT) with concomitant and adjuvant temozolomide chemotherapy. Whether accelerated hyperfractionated radiotherapy (HFRT) yields comparable results to NFRT in combination with temozolomide has only sparsely been investigated. The objective of this study was to compare NFRT with HFRT in a multicenter analysis. Materials and methods A total of 484 GB patients from four centers were retrospectively pooled and analyzed. 310 and 174 patients had been treated with NFRT (30×1.8Gy or 30×2Gy) and HFRT (37×1.6Gy or 30×1.8Gy twice/day), respectively. The primary outcome of interest was overall survival (OS) which was correlated with patient-, tumor- and treatment-related variables via univariable and multivariable Cox frailty models. For multivariable modeling, missing covariates were imputed using multiple imputation by chained equations, and a sensitivity analysis was performed on the complete-cases-only dataset. Results After a median follow-up of 15.7 months (range 0.8-88.6 months), median OS was 16.9 months (15.0-18.7 months) in the NFRT group and 14.9 months (13.2-17.3 months) in the HFRT group (p=0.26). In multivariable frailty regression, better performance status, complete versus not complete resection, MGMT hypermethylation, IDH mutation, smaller planning target volume, no steroid administration, and salvage therapy were significantly associated with longer OS (all p<0.01). Treatment differences (HFRT versus NFRT) had no significant effect on OS in either univariable or multivariable analysis. Conclusions This analysis suggests that HFRT and temozolomide is a safe option for patients wishing to shorten their treatment time and does not affect OS.

Abstract 17492: Extent and Pattern of Late Gadolinium Enhancement Predict Arrhythmic Events in Patients With Nonischemic Dilated Cardiomyopathy

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Dong Geum Shin ◽  
Hye-Jeong Lee ◽  
Junbeom Park ◽  
Young Jin Kim ◽  
Jae-Sun Uhm ◽  
...  
Keyword(s):  
Late Gadolinium Enhancement ◽  
Ventricular Arrhythmia ◽  
Dilated Cardiomyopathy ◽  
Cardiac Death ◽  
Primary Outcome ◽  
Multivariable Analysis ◽  
Gadolinium Enhancement ◽  
Nonischemic Dilated Cardiomyopathy ◽  
The Impact

Background: Late gadolinium enhancement (LGE) by cardiac MR (CMR) has been related to adverse clinical outcomes in patients with nonischemic dilated cardiomyopathy (NIDC). But, a statistically significant association between LGE and arrhythmic risk in NIDC has not been demonstrated consistently. This study evaluated the impact of the presence, location and pattern of LGE on arrhythmic risk prediction in NICM. Methods: This study included 365 patients (54±15years) with NICM who underwent CMR. The extent, location and pattern of LGE were categorized. We analyzed for the primary outcome of ventricular arrhythmia (VA) including sustained or nonsustained ventricular tachycardia (VT), appropriate implantable cardioverter-defibrillator (ICD) intervention and ventricular fibrillation (VF). Cardiac death and hospitalization for heart failure (HF) were evaluated as secondary outcomes. Results: LGE was seen in 267 (73 %) patients. During median follow-up of 44±36 months, patients with LGE had higher incidence of cardiac death (15 % vs. 2 %, p<0.001), hospitalization for HF (40 % vs. 15 %, p<0.001) and VA (14% vs. 6%, p=0.03). In multivariable analysis, the presence of LGE (HR 2.78; 95% CI 1.10-7.02; p=0.03) was the independent predictor of arrhythmias. Patients with extensive LGE had higher VA (32% vs. 10%, p<0.001) with lower cumulative survival free of VA than those without extensive LGE (p=0.001). The frequent LGE location was as follows: LV septum 64%, LV-RV junction 42% and inferior 10%. VA was lower in patients with than without localized LGE limited to LV-RV junction (21% vs. 46%, p=0.005). Interestingly, while the incidence of ventricular arrhythmia was higher in patients with transmural LGE (29% vs. 10%, p=0.003), it was lower in those with patch LGE (2% vs. 16%, p=0.02) than the other patients. Conclusions: In patients with NICM, the LGE was an independent prognostic predictor of VA. Extensive LGE and specific location of LGE was related with the arrhythmic events.

Brain metastases in patients treated with targeted therapy for metastatic renal cell carcinoma (mRCC).

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 326-326
Author(s):  
H. Alharbi ◽  
T. K. Choueiri ◽  
C. K. Kollmannsberger ◽  
S. North ◽  
M. J. MacKenzie ◽  
...  
Keyword(s):  
Overall Survival ◽  
Targeted Therapy ◽  
Brain Metastases ◽  
Treatment Time ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Local Treatment ◽  
Multivariable Analysis ◽  
First Line ◽  
The Brain

326 Background: Patients with brain metastases from advanced RCC treated in the targeted therapy era are not well characterized. Methods: Data from patients with mRCC treated with targeted therapy were collected through the International mRCC Database Consortium from 6 centers. Results: One hundred six out of 705 (15%) patients with mRCC had brain metastases. Forty-seven patients had brain metastases at the start of first-line anti-VEGF therapy and the rest developed metastases during follow-up. Of the patients with brain metastases, 6%, 68%, and 26% were in the favorable, intermediate and poor prognosis groups, respectively, per the Heng et al JCO 2009 criteria. Ninety percent had cerebral metastases, 17% had cerebellar metastases, 40% had a Karnofsky performance status (KPS) <80%, and 81% had symptoms of brain metastases. The median largest size and number of brain metastases was 1.8 cm (range 0.2–6.6) and 1 (range 1–20), respectively. Patients were treated with first-line sunitinib (n=77), sorafenib (n=23), bevacizumab (n=5), and temsirolimus (n=1). Local disease treatment included whole brain radiotherapy (81%), stereotactic radiosurgery (25%), and neurosurgery (25%). The brain metastases of 59 patients were evaluable and based on the local treatment and/or targeted therapy achieved 7 (12%) complete responses, 23 (39%) partial responses, 14 (24%) patients with stable disease, and 15 (25%) patients with progressive disease in the brain metastases. Patients with more than 4 brain metastases vs. those with no more than 4 have an overall survival time from diagnosis of brain metastasis of 3.9 vs. 15.4 months (p=0.0051). Previous nephrectomy, sarcomatoid, and non-clear cell histology are not associated with development of brain metastases. On multivariable analysis, KPS<80% (p=0.0139), diagnosis to treatment with targeted therapy <1 year (p=0.0012), and higher number of brain metastases (p=0.0311) were associated with worse survival from diagnosis of brain metastases. Conclusions: In patients with brain metastases from RCC, KPS at start of therapy, diagnosis to treatment time and number of brain metastases may be prognostic factors for overall survival. [Table: see text]

Triple induction chemotherapy and chemoradiotherapy in locally advanced esophageal cancer: Final results of a multicenter phase II trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4568-4568
Author(s):  
W. M. Eisterer ◽  
A. De Vries ◽  
B. Spechtenhauser ◽  
D. Kendler ◽  
A. Königsrainer ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Performance Status ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
R0 Resection ◽  
Ecog Performance Status ◽  
Blurred Vision ◽  
Hyperfractionated Radiotherapy

4568 Background: Surgery is the standard treatment for patients with resectable esophageal carcinoma, but 5-year survival rates rarely exceed 20%. Neoadjuvant chemoradiotherapy (CRT) may lead to downstaging of the tumor and thus improve the possibility of complete oncologic resection. Docetaxel (Dx) showed considerable activity in combination with hyperfractionated radiotherapy and only moderate toxicity. We evaluated a triple neoadjuvant regime including Dx in patients with locally advanced esophageal adenocarcinoma (AC) or squamos cell carcinoma (SCC). Methods: 24 patients (pts) with AC (n=8) or SCC (n=16) medically fit, no prior therapy, ECOG-performance status = 2 were included. Pts received 2 cycles of cisplatin (Cis) 15mg/ms2 d1–5, 5-fluorouracil (5-FU) 750mg/m2 continuous infusion (CI) d1–5, and Dx 75mg/m2 d1 repeated every 29 days followed by radiotherapy (RT) 39.6 Gy total dose (daily fraction 1.8Gy) concomitant to Dx 15mg/m2 on days 1, 8, 15, 22 and 5-FU 300mg/m2 CI on the days of RT followed by resection or definitive RT up to 59.6 Gy in case of inoperability. Results: See table . Grade 3/4 toxicity (n/%): neutropenia 10/43%, diarrhea 4/18%, alopecia 2/9%; deep vein thrombosis 1/5%, blurred vision 1/5%, fever 1/5%, pulmonary embolus 1/5%, arterial hypertension 1/5%. 1 pt died 39 days post resection due to fatal anastomical bleeding. 6/16 operated pts (37%) showed morbidity (anastomical stenosis/insufficiency, fistula, nervus recurrens palsy). 4/22 pts (18%) died 7- 25 months after therapy due to metastatic disease. At a median follow-up of 12 months 18 pts (82%) are alive, median survival has not been reached yet. Conclusions: Triple induction CT and CRT with Dx, Cis, and 5-FU is safe, feasible, and effective with CPR in 31%, downstaging in 81% and R0-resection in 100% of pts. Main toxicities are neutropenia (43%) and postoperative morbidity (37%). A follow-up phase II trial of triple induction therapy in combination with an EGFR-directed antibody is planned. [Table: see text] No significant financial relationships to disclose.

Multicenter comparison of outcomes for clinical and pathologic T3a renal cell carcinoma.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 758-758
Author(s):  
Aaron Bradshaw ◽  
Fady Ghali ◽  
Nathan Miller ◽  
Cathrine Keiner ◽  
Raksha Dutt ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Primary Outcome ◽  
Cox Regression ◽  
Multivariable Analysis ◽  
Rank Test ◽  
Similar Proportion ◽  
Secondary Outcomes

758 Background: The identification of venous thrombus in patients with renal cell carcinoma (RCC) is particularly challenging, with a substantial number upstaged to pathologic T3a following intervention. We compared survival outcomes between patients with initial cT3a status versus those upstaged to pT3a. Methods: This is a retrospective, multicenter analysis of patients with cT3a or pT3a RCC who underwent operative management. Primary outcome was recurrence-free survival (RFS). Secondary outcomes were overall survival (OS) and cancer-specific survival (CSS). Cox regression multivariable analysis (MVA) was utilized for primary outcome. Kaplan-Meier analyses (KMA) were conducted to describe RFS, OS, and CSS with log-rank test comparing clinical and upstaged pathologic T3a groups. Results: 770 patients were analyzed (cT3a 184, pT3a 586, median follow-up 28 months). Average pathologic tumor size was smaller in pT3a (7.2 cm vs 8.7 cm, p < 0.01), with no significant differences in clinical variables. A similar proportion underwent radical nephrectomy (vs. partial) (89.7% cT3a and 85.0% pT3a, p = 0.11) with no significant different in positive margin rate (3.8% cT3a, 4.8% pT3a, p = 0.23). However, a higher proportion of patients with cT3a disease were pathologically node positive (19.0% vs. 10.8%, p < 0.01) and demonstrated a higher rate of recurrence (cT3a 51.1% vs. pT3a 34.1%, p < 0.01) despite shorter mean follow-up (cT3a 33.0 vs. pT3a 50.7 mo, p < 0.01). MVA for RFS revealed cT3a staging (pT3a referent, HR 1.72, p < 0.01), positive margins (HR 2.85, p < 0.01), and clear cell histology (HR 1.68, p < 0.01) to be independently associated with higher recurrence rate, while partial nephrectomy (radical referent, HR 0.259, p < 0.01) was associated with a decreased rate. KMA revealed 5-year RFS of 34.4% and 60.6% for cT3a and pT3a respectively (p < 0.01). KMA for secondary outcomes revealed 5-year OS rates of 56.7% and 62.0% (p = 0.02) and 5-year CSS of 74.4% and 67.7% for cT3a and pT3a respectively (p = 0.01). Conclusions: Patients with cT3a RCC have poorer oncologic outcomes than those with upstaged pT3a RCC. Suspected venous involvement on pre-operative imaging may indicate more aggressive or advanced disease than that found during surgery.

scholarly journals Prospective, Observational Study of Pain and Analgesic Prescribing in Medical Oncology Outpatients With Breast, Colorectal, Lung, or Prostate Cancer

2012 ◽  
Vol 30 (16) ◽  
pp. 1980-1988 ◽  
Author(s):  
Michael J. Fisch ◽  
Ju-Whei Lee ◽  
Matthias Weiss ◽  
Lynne I. Wagner ◽  
Victor T. Chang ◽  
...  
Keyword(s):  
Pain Management ◽  
Pain Treatment ◽  
Performance Status ◽  
Multivariable Analysis ◽  
Initial Assessment ◽  
Explanatory Variables ◽  
Patients With Cancer ◽  
Pain Management Index ◽  
Treatment Adequacy

Purpose Pain is prevalent among patients with cancer, yet pain management patterns in outpatient oncology are poorly understood. Patients and Methods A total of 3,123 ambulatory patients with invasive cancer of the breast, prostate, colon/rectum, or lung were enrolled onto this prospective study regardless of phase of care or stage of disease. At initial assessment and 4 to 5 weeks later, patients completed a 25-item measure of pain, functional interference, and other symptoms. Providers recorded analgesic prescribing. The pain management index was calculated to assess treatment adequacy. Results Of the 3,023 patients we identified to be at risk for pain, 2,026 (67%) reported having pain or requiring analgesics at initial assessment; of these 2,026 patients, 670 (33%) were receiving inadequate analgesic prescribing. We found no difference in treatment adequacy between the initial and follow-up visits. Multivariable analysis revealed that the odds of a non-Hispanic white patient having inadequate pain treatment were approximately half those of a minority patient after adjusting for other explanatory variables (odds ratio, 0.51; 95% CI, 0.37 to 0.70; P = .002). Other significant predictors of inadequate pain treatment were having a good performance status, being treated at a minority treatment site, and having nonadvanced disease without concurrent treatment. Conclusion Most outpatients with common solid tumors must confront issues related to pain and the use of analgesics. There is significant disparity in pain treatment adequacy, with the odds of undertreatment twice as high for minority patients. These findings persist over 1 month of follow-up, highlighting the complexity of these problems.

P796Intensive blood pressure treatment significantly increases visit-to-visit systolic blood pressure variability. A randomized clinical trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
O L Rueda-Ochoa ◽  
L Z Rojas Sanchez ◽  
M A Ikram ◽  
J W Deckers ◽  
O H Franco ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Primary Outcome ◽  
Total Population ◽  
Standard Treatment ◽  
Intensive Treatment ◽  
Pressure Treatment ◽  
Treatment Groups ◽  
Blood Pressure Treatment ◽  
Intensive Blood Pressure

Abstract Background Intensive blood pressure lowering is increasingly gaining attention. Besides higher baseline blood pressure, visit-to-visit variability has showed association with target organ damage and major adverse cardiovascular outcomes in multiple medical reports. Purpose Our aim was to assess the effect of intensive treatment on systolic blood pressure (SBP) visit-to-visit variability in the SPRINT trial population during follow-up. Methods We included 9068 SPRINT participants with 128139 repeated SBP measurements. Participants were randomly assigned to intensive (SBP <120 mmHg) vs standard treatment (SBP between 135–139 mmHg). The primary outcome was a composite outcome of myocardial infarction, other acute coronary syndromes, acute decompensated heart failure, stroke, and cardiovascular mortality. We calculated the coefficient of variation (CV) and standard deviation (SD), taking into account all SBP measurements prior to the SPRINT primary outcome. Comparison of CV between intensive and standard treatment in the total SPRINT population and among different subgroups was made. Results CVs in intensive treatment groups were higher in total population and in all groups under study (See table). While second and third CV quartile showed a larger tendency to increase the risk for the primary SPRINT outcome in the intensive treatment compared to the standard treatment group, fourth CV quartiles were significantly associated with increase in primary SPRINT outcome in both intensive and standard treatment groups. Coefficient of variation in SPRINT trial Group Intensive treatment Standard treatment Total population 9.80 (3.22)* 8.52 (2.96) Females 10.46 (3.29)* 9.18 (3.15) Black person 9.99 (3.38)* 8.82 (3.15) Prevalence CKD 10.14 (3.22)* 9.12 (3.06) Prevalence CVD 10.28 (3.32)* 8.93 (3.23) ≥75 year 10.40 (3.18)* 9.01 (3.07) SAEs 10.30 (3.39)* 9.08 (3.13) (CKD: chronic kidney disease; CVD: cardiovascular disease; SAEs: serious adverse events. *P<0.05). Conclusions Intensive blood pressure treatment significantly increases SBP visit-to-visit variability in total SPRINT population and in all subgroups under study. Additional longitudinal studies with long-term follow-up are warranted to evaluate the impact of increases in SBP visit-to-visit variability due to intensive treatment on risk of major cardiovascular events.

scholarly journals Robotic radiosurgery treatment in liver tumors: Early experience from an Indian center

2018 ◽  
Vol 07 (03) ◽  
pp. 175-182 ◽  
Author(s):  
Debnarayan Dutta ◽  
Sathiya Krishnamoorthy ◽  
H. Sudahar ◽  
M. Muthukumaran ◽  
T. Ramkumar ◽  
...  
Keyword(s):  
Liver Tumors ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Liver Lesion ◽  
Target Volume ◽  
Prior Treatment ◽  
Related Factors ◽  
Robotic Radiosurgery ◽  
Local Progression

Abstract Purpose: The purpose of this study is to report CyberKnife experience in hepatocellular carcinoma (HCC) and liver metastasis (LM). Materials and Methods: Fifty liver lesions in 31 consecutive patients with liver lesion [mean age 54.5 years (range 32-81 years), 77% were male patient, GTV <10cc in 5 patients, 11-90cc in 18 & >90cc in 8 patients respectively. Eighty percentage (25/31) had prior treatment (chemotherapy 18 patient & TACE in 7 patients). Dosage schedule was 21-45Gy/3# (mean PTV dose 33Gy, Prescription isodose 84%, target coverage 94%). Mean CI, nCI & HI were 1.19, 1.31 & 1.18 respectively. Mean liver dose was 5.4 Gy, 800 cc liver dose 11.1 Gy; Results: At mean follow-up of 12.5 months (range 1.9–44.6 months), 19 patients were expired and 12 were alive (nine patient with stable disease, two local progression, and one with metastasis). Median overall survival (OS) of all patients are 9 months (1.9–44.6 months), in HCC patients 10.5 months (2.1–44.6 months) and MT 6.5 months (1.9–24.6 months) respectively. Gr-I-II GI toxicities were in 11/50 (22%) patients. OS was influenced by PS (Karnofsky Performance Status 70–80 vs. 90–100: 9.9 vs. 16.4; P = 0.024), Child-Pugh (CP A/B vs. C: 23.6 vs. 6.5; P = 0.069), cirrhosis (only fatty liver vs. diffuse cirrhosis: 17.8 vs. 10.6; P = 0.003), prior treatment (no Rx vs. prior Rx: 30.1 vs. 8.2; P = 0.08), number of lesions (single vs. multiple: 16.4 vs. 6.9; P = 0.001), and target volume (<10 cc vs. >90 cc: 24.6 vs. 11.2; P = 0.03). Conclusion: Stereotactic body radiation therapy is a safe and effective treatment. Patient related factors such as performance status, Child-Pugh classification, cirrhosis status, prior treatment, number of liver lesion & target volume (GTV) influence the survival functions.

Critical impact of radiotherapy protocol compliance and quality in the treatment of retroperitoneal sarcomas: Results from the 62092-22092 STRASS trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11566-11566
Author(s):  
Rick L.M. Haas ◽  
Jean-Jacques Stelmes ◽  
Facundo Zaffaroni ◽  
Enrico Clementel ◽  
Raquel Bar Deroma ◽  
...  
Keyword(s):  
Treatment Time ◽  
Performance Status ◽  
Composite Endpoint ◽  
Target Volume ◽  
Phase Iii ◽  
Quality Assurance Program ◽  
Neoadjuvant Radiotherapy ◽  
Overall Treatment Time ◽  
Cancer Society ◽  
The Impact

11566 Background: The EORTC 22092-62092 STRASS trial failed to detect a superiority of neoadjuvant radiotherapy in patients with retroperitoneal sarcoma as compared to surgery alone. As radiotherapy (RT) was the experimental treatment, a comprehensive quality assurance program (RTQA) has been included in the study protocol in order to detect and correct potential RT deviations. We report here the overall trial RTQA results and its potential impact on patient’s outcomes in this international phase III trial. Methods: Plans from all patients randomized to the experimental preoperative RT arm were submitted to a multidisciplinary RTQA team, consisting of medical physicists and radiation-oncologists. Target volume parameters and tumor dose coverage were prospectively reviewed by the RTQA team but not all plans were made compliant. In order to evaluate the impact on oncological outcomes, a composite endpoint, overall RT compliance status, was created; patients were classified into two major groups: RT compliant (RC) group and non-compliant (NRC) group, defining whether RT was as concisely per protocol or not. This composite endpoint combined the information related to PTV coverage, target delineation, total dose received and overall treatment time. Both abdominal recurrence-free survival (ARFS) and OS were compared between RC and NRC patients using Cox’s proportional hazard model adjusted for age, sex, WHO performance status, tumor grade, histological subtype and tumor size at baseline (millimeters). Results: After final review, 75.2% (94 out of 125) of patients had compliant RT plans (65.6% were already compliant at first submission to RTQA team and 9.6% were made compliant after review). Most patients in the NRC (77.4%) had deviations linked to incorrect target volume delineations. 3-year ARFS was 67.2% (95% Confidence interval (CI): 58.0 – 77.8%) and 48.4% (34.3 – 68.2%) for RC and NRC group, respectively (adjusted HR: 2.64, 95% CI: 1.38 – 5.07, p = 0.003). Corresponding OS at 3 years was 89.9% (95% CI: 83.6 – 96.3%) and 75.4% (95% CI: 61.9 – 91.8%) in the RC and NRC group with a trend in favor of RC (adjusted HR: 2.76, 95% CI: 0.91 – 8.43, p = 0.074). Conclusions: To our knowledge, this is the first RTQA evaluation of a phase III sarcoma trial. The data suggests a significant benefit in terms of ARFS and a trend for OS in favor of the RT compliant group. RTQA in prospective clinical trials, investigating new RT techniques, dose levels and indications, continues to be an important and integral part of trial designing. Funding Source: EORTC, EORTC Cancer Research Fund, EUROSARC FP7 278472 and Kom op tegen Kanker (Stand up to Cancer), the Flemish Cancer Society.

Promising results of multi-intensified treatment of small-cell lung cancer (SCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17135-17135
Author(s):  
O. Brodin ◽  
K. Lamberg ◽  
D. Anjedani ◽  
B. Lödén ◽  
R. Henriksson ◽  
...  
Keyword(s):  
Standard Treatment ◽  
Phase Ii Study ◽  
Performance Status ◽  
Treatment Intensification ◽  
Extensive Disease ◽  
Randomized Phase Ii ◽  
Number Of Patients ◽  
Inclusion Rate ◽  
Higher Doses

17135 Background: In spite of the obvious chemosensitivity of SCLC only 10–15% of patients with limited disease (LD) live for 5 years and hardly any of those with extensive disease (ED). Intensification of treatment has not got a break-through, though there are studies demonstrating an improved survival from shortened intervals, three drugs instead of two and higher doses at first treatment. We have performed a study combining these three ways of treatment intensification. Methods: Patients with confirmed SCLC, in performance status 0–2, below 76 were included in a randomized phase II study. Randomisation was performed between standard treatment (S): Carboplatin 6 AUC day 1 and Etopside 100 mg/m2 day1–3, 6 courses with 3 weeks intervals. Radiotherapy was given with 1.5 Gy bid to 45 Gy in patients with LD starting simultaneously with course 2. And between intensified treatment (I): Ifosfamide 5000 mg/m2 day 1 at first course, 3000 mg/m2 at courses 2–6 and Carboplatin and Etoposide as in the S-group. Six courses were given with 2 weeks interval which was possible by giving G-CSF (Neupogen) day 4 of each course. A dose escalation schedule, if low effect on bone-marrow was applied in the I-group. Radiotherapy was given as in the S-group. Results: Forty-two patients were included during three years. Inclusion rate, however, decreased spontaneously, and the inclusion was stopped. Twenty-four patients had ED and 18 LD. After four years follow-up 4/7 (57%) LD patients are still alive without disease in the I group and 3/11 (27%) in the S group, of which 1 has relapsed. In the ED patients 1/11 (9%) is alive without disease in the I group and 0/13 in the S group. Conclusions: The low number of patients does not permit any firm conclusion concerning survival even if the results are promising. Intensified treatment in this way is feasible even if mainly thrombocytopenia and fatigue are problems in the I group. No significant financial relationships to disclose.

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