scholarly journals Interpreting progression-free survival and overall survival data in biosimilar clinical studies: considerations based on a recent rituximab biosimilar study

2017 ◽  
Vol 28 ◽  
pp. v361
Author(s):  
J. Amersdorffer ◽  
Y. Li ◽  
S. Alexandrova ◽  
A. Zubel ◽  
E. Sasse ◽  
...  
Keyword(s):  
Overall Survival ◽  
Survival Data ◽  
Clinical Studies ◽  
Progression Free Survival ◽  
Free Survival

scholarly journals Assessment of the results and the haematologic side effects of the 3D conformal and the IMRT/ARC therapies delivered during the craniospinal irradiation of childhood tumors, in a follow-up period of 5 years

2020 ◽  
Author(s):  
Zoltán Lőcsei ◽  
Róbert Farkas ◽  
Kornélia Borbásné Farkas ◽  
Klára Sebestyén ◽  
Zsolt Sebestyén ◽  
...  
Keyword(s):  
Overall Survival ◽  
Side Effects ◽  
Survival Data ◽  
Organs At Risk ◽  
Progression Free Survival ◽  
Craniospinal Irradiation ◽  
Free Survival ◽  
Laboratory Parameters ◽  
Childhood Tumors

Abstract Objectives The craniospinal irradiation (CSI) of childhood tumors with Rapidarc technique is a new way of treatment. Our objective was to compare the acute haematologic toxicity pattern during 3D conformal radiotherapy with the application of the novel techniques. Materials and methods Data from patients treated between 2007 and 2014 has been collected and seven patients were identified in each of both treatment groups. The acute blood toxicity results were obtained, after establishing a general linear model, by using the SPSS software. Furthermore, the dose exposure of the organs-at-risk has been compared. Patients have been followed-up for a minimum of five years, then progression-free survival and overall survival data were assessed. Results After the assessment of the laboratory parameters of the two groups, it may be concluded that no significant differences were detected in terms of the mean dose exposures of the normal tissues or the acute hematological side-effects during the IMRT/ARC and the 3D conformal treatment. Laboratory parameters significantly decreased compared to the baseline values during the treatment weeks. Nevertheless, no significant differences were detected between the two groups. No remarkable differences were confirmed between the two groups regarding the five-year progression-free survival and overall survival, and no signs of serious irradiation organ toxicity were observed during the follow-up period in either of the groups. Conclusion Rapidarc technique can be used safely even for the treatment of childhood tumors, as the extent of normal tissue dose exposures and that of acute hematological side effects is not higher.

Metastatic and unresectable biliary tract tumors: A single-center retrospective review.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14733-e14733
Author(s):  
Maria Vieito ◽  
Nieves Martinez Lago ◽  
Santiago Aguin Losada ◽  
Rafael Lopez ◽  
Sonia Candamio ◽  
...  
Keyword(s):  
Overall Survival ◽  
Biliary Tract ◽  
Survival Data ◽  
Performance Status ◽  
Progression Free Survival ◽  
Epidemiological Data ◽  
Second Line ◽  
Free Survival ◽  
Medical Electronic ◽  
Oncology Unit

e14733 Background: Biliary tract tumours are rare and often poor prognosis cancers that comprise cholangiocarcinomas, ampullary tumours and gallbladder cancers. Methods: Medical Electronic Records for patients diagnosed between January 2008 and December 2010 and treated at a medical oncology unit were reviewed, and clinical and epidemiological data for patients were retrieved. Results: We have found 28 patients with a distribution with a clear majority of men (60%), with a median age of 66 years (range 45-80).Patients were mostly metastatic (85%) at diagnosis and the majority of patients had intrahepatic cholangiocarcinoma (60%) as diagnosis and debuted with large intrahepatic masses and metastatic disease.Those with tumours arising outside the liver (40%) had obstructive jaundice (28%) or cholangitis (26%) at diagnosis and needed in most cases biliary stenting (33%).Six patients had PS2 at diagnosis and received gemcitabine monotherapy. Only one patient remaining progression free at 6 months and none of them received treatment at progression, the mean PFS was of 5.3 months and the OS was of 8.3 months.Of 22 patients with good performance status, 12 of them with a mean age of 60 years received polychemotherapy with GEMOX or CDDP-gem with PFS of 7. 3 months and OS of 12. 3 months.The other 10 patients (with a mean age of 65 years) received gemcitabine as monotherapy with a PFS of 7. 9 months and a OS of 11. 4 months.Eight patients were treated with second line therapy with no responses and a mean of PFS of 2 months, OS was not superior to patients who did not receive second line treatment. Conclusion: Our patients with biliary tract tumours had a mean progression free survival of 8.2 months and a mean overall survival of 12.3 months with 5 patients remaining progression free more than 20 months after beginning treatment. This survival data are compatible with those reported in recent clinical trials although we did not find improvements in survival with polychemotherapy and second line therapies. Conclusions: Taken as a whole our patients with biliary tract tumours had a mean progression free survival of 8.2 months and a mean overall survival of 12.3 months with 5 patients remaining progression free more than 20 months after beginning treatment.

scholarly journals RADT-26. LASER INTERSTITIAL THERMAL THERAPY FOR RECURRENT GLIOBLASTOMA: POOLED ANALYSES OF AVAILABLE LITERATURE

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii187-ii187
Author(s):  
Amanda Munoz Casabella ◽  
Masum Rahman ◽  
Mohammed Alvi ◽  
Desmond Brown
Keyword(s):  
Overall Survival ◽  
Survival Data ◽  
Yttrium Aluminum Garnet ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Recurrent Glioblastoma ◽  
Thermal Therapy ◽  
Fe Model ◽  
Free Survival ◽  
Laser Interstitial Thermal Therapy

Abstract INTRODUCTION Laser Interstitial Thermal Therapy (LITT) is a novel treatment modality that has been used for an array of intracranial pathology. In the current manuscript, we sought to conduct a systematic review and meta-analysis to summarize all available literature to date, on outcomes of patients with recurrent GBM (r-GBM) undergoing LITT, pooling together quantitatively the overall survival and progression-free survival data. METHODS A comprehensive literature search was performed to retrieve all studies investigating overall survival, post-procedure survival, and progression-free survival outcomes of patients with r-GBM undergoing LITT. All statistics were pooled together by the meta-analysis of the mean using a weighted random-effects (RE) or fixed-effect (FE) model. RESULTS Eleven studies were included in the final cohort, representing a total of 134 patients with rGBM. The pooled mean age of the cohort at the time of recurrence diagnosis was found to be 56.7 ± 4.56 while 41% of the cohort were females. For the delivery of LITT, two studies utilized neodymium-yttrium aluminum-garnet laser (Neodp-YAG Laser), three studies utilized the Visualase system, five studies utilized the Neuroblate system, and one study used both the Neuroblate and the Visualase system. A total of eight studies with 107 patients had available data for overall median survival. The pooled overall survival was found to be 18.6 months (95%CI 16.2-21.1). A total of six studies with 93 patients had available data for post-LITT survival. The pooled post-LITT survival was found to be 10.1 months (95%CI 8.8-11.6). A total of eight studies with 119 patients had available data for progression-free survival. The pooled progression-free survival was found to be 6 months (95%CI 5.3-6.7). CONCLUSION LITT is a novel minimally invasive procedure which, when used with optimal adjuvant therapy, may confer survival benefit for patients with r-GBM.

scholarly journals Combination of HAI-FUDR and Systemic Gemcitabine and Cisplatin in Unresectable Cholangiocarcinoma: A Dose Finding Single Center Study

Oncology ◽  
2021 ◽  
Vol 99 (5) ◽  
pp. 300-309
Author(s):  
Heike Pietge ◽  
Patricia Sánchez-Velázquez ◽  
Dilara Akhoundova ◽  
Alexander Siebenhüner ◽  
Thomas Winder ◽  
...  
Keyword(s):  
Overall Survival ◽  
Survival Data ◽  
Treatment Options ◽  
Hepatic Arterial Infusion ◽  
Progression Free Survival ◽  
Maximum Tolerated Dose ◽  
Dose Finding ◽  
Free Survival ◽  
Single Center Study ◽  
Tract Infections

Background: Unresectable cholangiocarcinoma has a poor prognosis and treatment options are limited. Combined systemic and intrahepatic chemotherapy may improve local control and enable downsizing. The aim of this study was to determine the maximum tolerated dose (MTD) of intravenous gemcitabine combined with intravenous cisplatin and hepatic arterial infusion (HAI) with floxuridine (FUDR) in patients with unresectable intrahepatic or hilar cholangiocarcinoma. Methods: Twelve patients were treated within a 3 + 3 dose escalation algorithm with 600, 800, or 1,000 mg/m2 gemcitabine and predefined doses of cisplatin 25 mg/m2 on days 1 and 8, q21, for 4 cycles, and FUDR 0.2 mg/kg on days 1–14 as continuous HAI, q28, for 3 cycles. Safety and toxicity as well as resectability rates after 3 months and preliminary survival data are reported. Results: The determined MTD for gemcitabine was 800 mg/m2. Dose limiting toxicities were neutropenic fever and biliary tract infections. In total, 27% of the patients showed partial remission and 73% stable disease. Although none of the patients achieved resectability after 3 months, the 3-year overall survival rate was 33%, median overall survival 23.9 months (range 1–49), and median progression-free survival 10.1 months (range 2–40). Conclusions: Intravenous gemcitabine/cisplatin plus HAI-FUDR is feasible and appears effective for disease control. Larger prospective studies evaluating this triplet combination are warranted.

Survival impact of the response at twelve weeks in patients with advanced gastric cancer received first-line chemotherapy.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 103-103
Author(s):  
Motoko Arakaki ◽  
Masahiko Aoki ◽  
Hiroshi Imazeki ◽  
Hirokazu Shoji ◽  
Yoshitaka Honma ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Advanced Gastric Cancer ◽  
Survival Data ◽  
Progression Free Survival ◽  
First Line ◽  
Her2 Positive ◽  
Free Survival ◽  
The Impact ◽  
Line Chemotherapy

103 Background: The continuation of first-line chemotherapy or the maintenance chemotherapy has been selected for advanced gastric cancer patients who have not progressed after 4 to 6 cycles of first-line chemotherapy. However, survival data about those patients remains unclear. We retrospectively assessed the impact of response at 12 weeks on survival for advanced gastric cancer who received first-line chemotherapy. Methods: Eligible patients had unresectable advanced gastric adenocarcinoma and treated for the combination chemotherapy with fluoropyrimidine and platinum from January 2010 to December 2017 in our hospital. Patients with HER2 positive were excluded. Patients were divided into three groups (PR, SD, or PD group) according to response at 12 weeks of first-line chemotherapy, and their overall survival and progression-free survival were assessed. Results: The total number of the subject was 249 whose median overall survival (mOS) and progression-free survival (mPFS) were 13.8 and 5.4 months. Among 152 patients with measurable lesions, 58, 42, and 52 patients achieved PR, SD, and PD at 12 weeks. mOS was 16.7 months in the PR group, 9.8 months in the SD group, and 5.7 months in the PD group. mPFS was 7.1 months in the PR group, 4.5 months in the SD group, and 1.7 months in the PD group. Among 97 patients without measurable lesions, 90 patients achieved nonCR/nonPD at 12 weeks of first-line chemotherapy whose mOS and mPFS were 17.9 months and 9.2 months while those were 9.6 months and 1.9 months in the remaining 7 patients with PD at 12 weeks. Conclusions: There were clear differences in survival among PR, SD, and PD at 12 weeks in patients with measurable lesions while patients without measurable lesions obtaining nonCR/nonPD at 12 weeks showed similar OS and PFS to those with measurable lesion obtaining PR in first-line chemotherapy for advanced gastric cancer. [Table: see text]

Treating relapsed and refractory metastatic germ cell tumours with high-dose chemotherapy with carboplatin and etoposide and autologous haematopoietic stem cell transplantation

2020 ◽  
pp. 107815522096454
Author(s):  
Ismail Erturk ◽  
Nuri Karadurmus ◽  
Halil Kızıloz ◽  
Ramazan Acar ◽  
Birol Yildiz ◽  
...  
Keyword(s):  
Overall Survival ◽  
Survival Data ◽  
Real Life ◽  
Progression Free Survival ◽  
High Dose Chemotherapy ◽  
Haematopoietic Stem Cell ◽  
High Dose ◽  
Free Survival ◽  
Real Life Data ◽  
Single Centre Study

Introduction and aim To demonstrate the real-life data about patients who underwent AHSCT due to GCT. Methods Between November 2016 and April 2020, 64 patients who received CE as high-dose chemotherapy for AHSCT in the Gulhane Education and Research Hospital were included in the study. Sixty-one patients received one AHSCT with CE chemotherapy regimen. Survival data and clinical characteristics were evaluated retrospectively. Results The mean age of the patients were 31.9 ± 9 (min-max:18–55). With a median follow-up of 10.7 ± 8.7 months, the 1-year progression-free survival (PFS) rate was 57.8%, and the 1-year overall survival rate was 77.5%. Median overall survival (OS) and progression-free survival (PFS) times were 21.5 ± 1.8 (95% CI: 14.5–33.4) and 20 ± 2 months, respectively. The response rate was 72%. There were three treatment-related deaths. Conclusion This sizeable single-centre study shows that patients with relapsed metastatic GCT are curable by CE as high dose chemotherapy plus AHSCT with reliable toxicity even for a single cycle.

LINAC-based stereotactic radiosurgery/radiotherapy for brain metastases in patients with breast cancer

2021 ◽  
pp. 1-9
Author(s):  
Ankita Gupta ◽  
Budhi Singh Yadav ◽  
Nagarjun Ballari ◽  
Namrata Das ◽  
Ngangom Robert
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Brain Metastases ◽  
Stereotactic Radiosurgery ◽  
Progression Free Survival ◽  
Rank Test ◽  
Karnofsky Performance Score ◽  
Breast Cancer Patients ◽  
Free Survival ◽  
Prior Surgery

Abstract Background: Brain metastases (BM) are common in patients with HER2-positive and triple-negative breast cancer. In this study we aim to report clinical outcomes with LINAC-based stereotactic radiosurgery/radiotherapy (SRS/SRT) for BM in patients of breast cancer. Methods: Clinical and dosimetric records of breast cancer patients treated for BM at our institute between May, 2015 and December, 2019 were retrospectively reviewed. Patients of previously treated or newly diagnosed breast cancer with at least a radiological diagnosis of BM; 1–4 in number, ≤3·5 cm in maximum dimension, with a Karnofsky Performance Score of ≥60 were taken up for treatment with SRS. SRT was generally considered if a tumour was >3·5 cm in diameter, near a critical or eloquent structure, or if the proximity of moderately sized tumours would lead to dose bridging in a single-fraction SRS plan. The median prescribed SRS dose was 15 Gy (range 7–24 Gy) and SRT dose was 27 Gy in 3 fractions. Clinical assessment and MR imaging was done at 6 weeks post-SRS and then every 3 months thereafter. Intracranial progression-free survival (PFS) and overall survival (OS) were calculated using Kaplan–Meier method and subgroups were compared using log rank test. Results: Total, 40 tumours were treated in 31 patients. The median tumour diameter was 2·3 cm (range 1·0–4·6 cm). SRS and SRT were delivered in 27 and 4 patients, respectively. SRS/SRT was given as a boost to whole brain radiotherapy (WBRT) in four patients and as salvage for progression after WBRT in six patients. In general, nine patients underwent prior surgery. The median follow-up was 7·9 months (0·2–34 months). Twenty (64·5%) patients developed local recurrence, 10 (32·3%) patients developed distant intracranial relapse and 7 patients had both local and distant intracranial relapse. The estimated local control at 6 months and 1 year was 48 and 35%, respectively. Median intracranial progression free survival (PFS) was 3·73 months (range 0·2–25 months). Median intracranial PFS was 3·02 months in patients who received SRS alone or as boost after WBRT, while it was 4·27 months in those who received SRS as salvage after WBRT (p = 0·793). No difference in intracranial PFS was observed with or without prior surgery (p = 0·410). Median overall survival (OS) was 21·7 months (range 0·2–34 months) for the entire cohort. Patients who received prior WBRT had a poor OS (13·31 months) as compared to SRS alone (21·4 months; p = 0·699). Conclusion: In patients with BM after breast cancer SRS alone, WBRT + SRS and surgery + SRS had comparable PFS and OS.

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