Analysis of progression-free survival data using a discrete time survival model that incorporates measurements with and without diagnostic error

2010 ◽  
Vol 7 (6) ◽  
pp. 634-642 ◽  
Author(s):  
Sally Hunsberger ◽  
Paul S Albert ◽  
Lori Dodd
Keyword(s):  
Discrete Time ◽  
Survival Data ◽  
Progression Free Survival ◽  
Diagnostic Error ◽  
Survival Model ◽  
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.

Treatment patterns and outcomes among t(11;14) myeloma patients in a real-world setting.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e19531-e19531 ◽  
Author(s):  
Andrew David Norden ◽  
Shivam Mathura ◽  
Eric Hansen ◽  
Stuart L. Goldberg ◽  
David Samuel DiCapua Siegel
Keyword(s):  
Real World ◽  
Survival Data ◽  
Median Overall Survival ◽  
Progression Free Survival ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
First Line ◽  
Free Survival ◽  
Real World Setting ◽  
Standard Risk

e19531 Background: There is uncertainty about the prognostic and predictive significance of t(11;14), long considered a standard risk cytogenetic abnormality in multiple myeloma (MM). This translocation is associated with elevated BCL-2 expression which may explain responses to venetoclax that have been reported previously. In a real-world database derived from EMR data, we sought to characterize real-world treatment patterns and outcomes from this unique MM cohort. Methods: Records for MM patients with t(11;14) diagnosed between 2000 and 2017 were identified in the COTA real-world database. Descriptive statistics were used to summarize the data. Results: 399 MM patients with t(11;14) were identified. Patient characteristics are summarized in the Table. The most frequent first-line treatments were bortezomib + dexamethasone + lenalidomide (134, 33.6%), bortezomib + cyclophosphamide + dexamethasone (69, 17.3%), and bortezomib + dexamethasone (60, 15.0%). Six (1.5%) patients received venetoclax. Response and progression-free survival data are being analyzed and will be presented at the meeting. Median overall survival was 14.3 (95% CI 10.4 – not yet reached) years. Conclusions: Real-world databases are useful in describing treatment patterns and outcomes in narrowly defined cohorts such as MM with t(11;14). The OS result reported here is unexpectedly long and will be fully explored prior to presentation. [Table: see text]

Vemurafenib in patients with BRAFV600 mutant glioma: A cohort of the histology-independent VE-basket study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 2004-2004 ◽  
Author(s):  
David Michael Hyman ◽  
Thomas Joseph Kaley ◽  
Antoine Hollebecque ◽  
Vivek Subbiah ◽  
Jordi Rodon Ahnert ◽  
...  
Keyword(s):  
Survival Data ◽  
Kinase Inhibitor ◽  
Malignant Gliomas ◽  
Progression Free Survival ◽  
Melanocytic Nevus ◽  
Open Label ◽  
Free Survival ◽  
Best Response ◽  
Pilocytic Astrocytomas ◽  
Secondary Endpoints

2004 Background: Recurrent malignant gliomas (MG) are a universally fatal disease in desperate need of better therapies. Pleiomorphic xanthoastrocytomas (PXA) and juvenile pilocytic astrocytomas (JPA) typically have better outcomes, although when recurrent, also represent an aggressive disease with no proven effective chemotherapy. BRAFV600 alterations have been identified in a substantial proportion of gliomas, including glioblastoma (GBM), astrocytoma, PXA, and JPA. The phase 2, open-label, histology-independent VE-BASKET study of vemurafenib, a selective BRAFV600 kinase inhibitor, in patients with BRAF mutation-positive non-melanoma tumors, included those with gliomas in the ‘all-others’ cohort. We now report final data for patients with recurrent gliomas. Methods: Patients received vemurafenib (960 mg bid) until disease progression or unacceptable toxicity. The primary endpoint was investigator-assessed response rate; secondary endpoints included clinical benefit rate (confirmed complete or partial response or stable disease lasting ≥6 months), progression-free survival (PFS), overall survival (OS), and toxicity. ClinicalTrials.gov NCT01524978. Results: 24 patients (median age 32 years; 18 female, 6 male) with glioma were treated, including mg (n = 11; 6 GBM and 5 anaplastic astrocytoma [AA]), PXA (n = 7), anaplastic ganglioglioma (AG, n = 3), JPA (n = 2), and unknown (n = 1). In patients with mg (n = 11), best response included PR (n = 1; AA), SD (n = 5), PD (n = 3), and unknown (n = 2). Two patients with mg had durable SD lasting 12.9 months (GBM) and 14.9 months (AA). In patients with PXA (n = 7), best response included CR (n = 1), PR (n = 2), SD (n = 3), and PD (n = 1). Additionally, 1 patient with JPA and 1 with AG achieved a PR. The most frequent AEs included arthralgia (67%), melanocytic nevus (38%), palmar-plantar erythrodysesthesia (38%), photosensitivity reaction (38%) and alopecia (33%). Conclusions: Vemurafenib demonstrated activity in patients with BRAFV600 mutant glioma. The safety profile was similar to that seen in previous melanoma studies. Survival data will be presented. Clinical trial information: NCT01524978.

Survival outcomes and risk group validation from SWOG S0925, a randomized phase II study of androgen deprivation (AD) +/- cixutumumab, in new metastatic hormone-sensitive prostate cancer (mHSPC).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 106-106
Author(s):  
Risa Liang Wong ◽  
Mai T. Duong ◽  
Catherine Tangen ◽  
Neeraj Agarwal ◽  
Heather H. Cheng ◽  
...  
Keyword(s):  
High Risk ◽  
Phase Ii ◽  
Survival Data ◽  
Progression Free Survival ◽  
High Volume ◽  
Baseline Risk ◽  
Castration Resistance ◽  
Free Survival ◽  
Randomized Phase Ii ◽  
Improve Rate

106 Background: Cixutumumab, a monoclonal antibody targeting insulin-like growth factor I receptor, did not improve rate of undetectable PSA at 28 weeks when combined with AD in the randomized phase II SWOG S0925 trial for patients with new mHSPC. We now present mature radiographic progression-free survival (rPFS) and overall survival (OS) analyses, along with pre-specified secondary and exploratory endpoints. Methods: We used Kaplan-Meier curves to analyze OS, rPFS, and castration resistance-free survival by treatment arm, disease volume (as per CHAARTED), and risk (as per LATITUDE). We explored differences in survival by treatment arm via covariate-adjusted Cox proportional hazard models adjusted for disease volume and risk. Results: The trial enrolled 210 patients, 105 per treatment arm. Median follow-up was 5.3 years. No difference was seen between treatment arms in OS (HR 1.01 [0.70-1.45]; p=0.97), rPFS (HR 1.17 [0.85-1.60]; p=0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p=0.88). At baseline, 105/198 (53.0%) patients had high risk and 119/210 (56.7%) had high volume disease. 17.3% of high volume patients were classified as low risk and 15.9% of low volume patients were classified as high risk; together, 16.7% of patients had discordant classification of high or low category for risk and volume. Adjusting for risk or volume yielded no differences in OS between arms. Inferior survival was observed in high risk (HR 1.89 [1.29-2.80]; p=0.001) and high volume (HR 2.75 [1.84-4.10]; p<0.0001) disease. Disease volume was a better fit to survival data than risk (AIC 878.3 vs. 889.2). Compared to patients achieving undetectable PSA at 28 weeks, inferior survival was observed in patients whose PSA was >0.2 to ≤4.0 ng/mL (HR 3.72 [1.99-6.95]; p<0.0001) or >4.0 ng/mL (HR 7.13 [4.24-11.9]; p<0.0001). Conclusions: In new mHSPC, adding cixutumumab to AD did not improve survival measures. Baseline risk and disease volume carried prognostic value for this distinct trial population, though disease volume was a better predictor of survival. PSA treatment response was a strong intermediate endpoint for survival. Clinical trial information: NCT01120236.

Final Results of Phase III SYMMETRY Study: Randomized, Double-Blind Trial of Elesclomol Plus Paclitaxel Versus Paclitaxel Alone As Treatment for Chemotherapy-Naive Patients With Advanced Melanoma

2013 ◽  
Vol 31 (9) ◽  
pp. 1211-1218 ◽  
Author(s):  
Steven J. O'Day ◽  
Alexander M.M. Eggermont ◽  
Vanna Chiarion-Sileni ◽  
Richard Kefford ◽  
Jean Jacques Grob ◽  
...  
Keyword(s):  
Survival Data ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Advanced Melanoma ◽  
Phase Iii ◽  
Double Blind ◽  
Free Survival ◽  
End Point ◽  
Phase Iii Study ◽  
Induced Apoptosis

Purpose Elesclomol, an investigational first-in-class compound, induces oxidative stress, triggers mitochondrial-induced apoptosis in cancer cells, and shows synergy with taxanes in tumor models. Following completion of a phase II trial of elesclomol in combination with paclitaxel that met its primary end point of progression-free survival (PFS), this randomized, double-blind, controlled phase III study was conducted to confirm the efficacy and tolerability of elesclomol in combination with paclitaxel versus paclitaxel alone in patients with advanced melanoma. Patients and Methods Patients with stage IV chemotherapy-naive melanoma (n = 651) were randomly assigned 1:1 to paclitaxel 80 mg/m2 either alone or in combination with elesclomol 213 mg/m2 administered weekly for 3 weeks of a 4-week cycle. Patients were stratified by prior systemic treatment, M1 subclass, and baseline lactate dehydrogenase (LDH) levels. The primary end point was PFS. Results The study did not achieve its PFS end point (hazard ratio, 0.89; P = .23). The study was stopped when an early overall survival data analysis indicated an imbalance in total deaths favoring paclitaxel, predominantly in patients with high LDH levels. A prospectively defined subgroup analysis revealed a statistically significant improvement in median PFS for the combination in patients with normal baseline LDH. Conclusion The addition of elesclomol to paclitaxel did not significantly improve PFS in unselected patients with advanced melanoma. The association between baseline LDH and clinical outcomes suggests that LDH may be a predictive factor for treatment with this combination, consistent with recent findings on the association between elesclomol anticancer activity and cellular metabolic state.

scholarly journals Surgical management of complex spinal cord lipomas: how, why, and when to operate. A review

2019 ◽  
Vol 23 (5) ◽  
pp. 537-556 ◽  
Author(s):  
Dachling Pang
Keyword(s):  
Spinal Cord ◽  
Survival Data ◽  
Progression Free Survival ◽  
Partial Resection ◽  
Total Resection ◽  
Multiple Series ◽  
Free Survival ◽  
Anatomical Relationship ◽  
Aggressive Surgical Approach

This review summarizes the classification, anatomy, and embryogenesis of complex spinal cord lipomas, and it describes in some detail the new technique of total lipoma resection and radical reconstruction of the affected neural placode. Its specific mission is to tackle two main issues surrounding the management of complex dysraphic lipomas: whether total resection confers better long-term benefits than partial resection and whether total resection fares better than conservative treatment—i.e., no surgery—for asymptomatic lipomas. Accordingly, the 24-year progression-free survival data of the author and colleagues’ series of over 300 cases of total resection are compared with historical data from multiple series (including the author and colleagues’ own) of partial resection, and total resection data specifically for asymptomatic lesions are compared with the two known series of nonsurgical treatment of equivalent numbers of patients. These comparisons amply support the author’s recommendation of total resection for most complex lipomas, with or without symptoms. The notable exception is the asymptomatic chaotic lipoma, whose peculiar anatomical relationship with the neural tissue defies even this aggressive surgical approach and consequently projects worse results (admittedly of a small number of cases) than for the other two lipoma subtypes of dorsal and transitional lesions. Prophylactic resection of asymptomatic chaotic lipomas is therefore not currently endorsed.

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