scholarly journals The Impact of Anemia in Advanced Solid Tumors Treated with Sorafenib (SO) and Sunitinib (SU): A Pooled Analysis of 6 Trials

2012 ◽  
Vol 23 ◽  
pp. ix519
Author(s):  
S. Barni ◽  
K.F. Borgonovo ◽  
M. Ghilardi ◽  
M. Cabiddu ◽  
F. Maspero ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Pooled Analysis ◽  
Advanced Solid Tumors ◽  
The Impact

An evaluation of administrative data linkage for measurement of real-world outcomes of large clinical panel sequencing for advanced solid tumors.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 283-283
Author(s):  
Ramy Saleh ◽  
Philippe L. Bedard ◽  
Paul Nguyen ◽  
Eoghan Ruadh Malone ◽  
Celeste Yu ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Administrative Data ◽  
Real World ◽  
Short Interval ◽  
Common Disease ◽  
Advanced Solid Tumors ◽  
Vital Status ◽  
Treatment Matching ◽  
The Impact ◽  
Panel Sequencing

283 Background: There is limited real-world evidence of impact of large clinical panel sequencing on treatment-matching for patients with advanced solid tumors. The province of Ontario has a single payer, publicly funded health care system. We linked genomic testing results from a prospective province-wide trial, OCTANE (Ontario-Wide Cancer TArgeted Nucleic Acid Evaluation), to administrative data to determine the feasibility of this approach for evaluating survival and the impact of sequencing on treatment matching. Methods: We linked all Ontario patients from Princess Margaret (PM) with panel testing results (tumor-only 555-gene panel) to province-wide administrative data on treatments and outcomes. Patients were recruited from August 2016 to August 2018. Only clinically actionable variants based upon OncoKB annotation (Level 1 and 2) were assessed for genotype-informed treatment matching. Results: All 888 eligible patients were successfully linked to administrative data. Mean age was 58 (±13) years, 635 (71.5%) were female. Most common disease sites were ovary (26.4%), uterus (14.0%), colorectal (11.8%) and breast (9.5%). Administrative data vital status was more complete than trial collected data with 262 of 476 deaths only recorded in administrative data. Median survival was 1.70 years (95% confidence interval 1.50-1.91). 247 (27.8%) had actionable mutations, most commonly PIK3CA (54.7%), BRCA1 (15.8%), BRCA2 (15.0%) and BRAF (8.9%). 37 (15.0%) and 42 (17.0%) patients with actionable mutations received targeted therapy within 6 and 12 months of test report date, respectively. Conclusions: This is the first known feasibility study of linked administrative data to measure outcomes of large clinical panel sequencing for patients with advanced solid tumors. Vital status was more complete with administrative data compared to trial-collected data, and treatment data was successfully linked. About one in twenty-one enrolled patients received genome-informed treatments within 12 months, or about one in six of all patients with actionable mutations. This may be due to short interval follow up, trial and drug access, successful standard of care treatments, early patient deterioration or limited alterations covered by the panel, among other causes.

scholarly journals Safety profile of tepotinib in patients with advanced solid tumors: Pooled analysis of phase I and II data

2019 ◽  
Vol 30 ◽  
pp. v181-v182
Author(s):  
T. Decaens ◽  
B.-Y. Ryoo ◽  
G.S. Falchook ◽  
R. Veillon ◽  
T. Doi ◽  
...  
Keyword(s):  
Phase I ◽  
Solid Tumors ◽  
Safety Profile ◽  
Pooled Analysis ◽  
Advanced Solid Tumors ◽  
Phase I And Ii

Safety and tolerability of MEDI0562 in combination with durvalumab or tremelimumab in patients with advanced solid tumors.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 3003-3003
Author(s):  
Jonathan Wade Goldman ◽  
Sarina Anne Piha-Paul ◽  
Brendan D. Curti ◽  
Katrina Pedersen ◽  
Todd Michael Bauer ◽  
...  
Keyword(s):  
T Cells ◽  
Solid Tumors ◽  
Memory T Cells ◽  
Phase 1 ◽  
Evaluation Criteria ◽  
Maximum Tolerated Dose ◽  
Clinical Activity ◽  
Advanced Solid Tumors ◽  
Open Label ◽  
The Impact

3003 Background: We report safety and tolerability of MEDI0562, a humanized IgG1κ OX40 monoclonal antibody (mAb), in combination with durvalumab (durva; anti-PD-L1 mAb) or tremelimumab (treme; anti-CTLA-4 mAb) in patients (pts) with previously treated advanced solid tumors. Methods: In this phase 1, open-label study (NCT02705482), adult pts received escalating doses of MEDI0562 (2.25, 7.5 or 22.5 mg/kg) every 2 wks (Q2W) in combination with durva (1500 mg/kg) or treme (75 or 225 mg/kg) Q4W, until confirmed disease progression or unacceptable toxicity. Tumor assessments were performed Q8W with immune-related Response Evaluation Criteria in Solid Tumors. Results: In total, 27 and 31 pts received MEDI0562 + durva or treme, across 5 dose combination cohorts (3 + 3 design), with a maximum tolerated dose of 7.5 mg MEDI0652 + 1500 mg durva and maximum administered dose of 10 mg MEDI0562 + 225 mg treme. Median duration of exposure was 12.0 (range 2.0–80.9) and 8.0 (range 2.0–42.0) wks, respectively. Two (22.5 mg MEDI10562 + durva) and 3 (2.25 mg MEDI0652 + 225 mg treme, 22.5 mg MEDI0562 + 75 and 225 mg treme) dose limiting toxicities were observed. For MEDI0562 + durva and MEDI0562 + treme groups respectively, treatment-emergent adverse events (TEAEs) were reported in 96.3% and 100% of pts; most common TEAEs were fatigue (55.6%) and pruritus (45.2%), Gr 3/4 TEAEs occurred in 74.1% and 67.7%; and MEDI0562-related AEs were reported in 20 (74.1%) and 24 (77.4%) pts. Six TEAEs in each group led to MEDI0562 discontinuation (22.2% and 19.4%, respectively), 2 led to death (renal failure [7.5 mg MEDI0562 + durva], multiple organ dysfunction syndrome [22.5 mg MEDI0562 + 225 mg treme]). Three response evaluable pts had PR (11.5% [7.5 and 22.5 mg MEDI0562 + durva, n = 26]). Median overall survival was 17.4 and 11.9 mos for MEDI0562 + durva and MEDI0562 + treme, with stable disease seen in 9 pts from each group, 34.6% vs 29.0%, respectively. Serum exposure of MEDI0562 increased dose proportionally. Post treatment serum antidrug antibody (ADA) was detected in 20 pts from MEDI0562 + durva and MEDI0562 + treme (74.1% and 71.4%, respectively). The impact of ADA on MEDI0562 pharmacokinetics was seen at all doses. Mean percentage of Ki67+CD4+ and Ki67+CD8+ memory T cells increased, while mean percentage of OX40+CD4+ memory T cells decreased following the first dose of MEDI0562 + durva or treme. Conclusions: The safety profile of MEDI0562 in combination with durva or treme was similar between groups. Clinical activity was observed with MEDI0562 + durva in pts with advanced solid tumors. Clinical trial information: NCT02705482 .

An evaluation of administrative data linkage for measurement of real-world outcomes of large clinical panel sequencing for advanced solid tumors.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19303-e19303
Author(s):  
Ramy Saleh ◽  
Philippe L. Bedard ◽  
Paul Nguyen ◽  
Eoghan Ruadh Malone ◽  
Celeste Yu ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Administrative Data ◽  
Real World ◽  
Short Interval ◽  
Common Disease ◽  
Advanced Solid Tumors ◽  
Vital Status ◽  
Treatment Matching ◽  
The Impact ◽  
Panel Sequencing

e19303 Background: There is limited real-world evidence of impact of large clinical panel sequencing on treatment-matching for patients with advanced solid tumors. The province of Ontario has a single payer, publicly funded health care system. We linked genomic testing results from a prospective province-wide trial, OCTANE (Ontario-Wide Cancer TArgeted Nucleic Acid Evaluation), to administrative data to determine the feasibility of this approach for evaluating survival and the impact of sequencing on treatment matching. Methods: We linked all Ontario patients from Princess Margaret (PM) with panel testing results (tumor-only 555-gene panel) to province-wide administrative data on treatments and outcomes. Patients were recruited from August 2016 to August 2018. Only clinically actionable variants based upon OncoKB annotation (Level 1 and 2) were assessed for genotype-informed treatment matching. Results: All 888 eligible patients were successfully linked to administrative data. Mean age was 58 (±13) years, 635 (71.5%) were female. Most common disease sites were ovary (26.4%), uterus (14.0%), colorectal (11.8%) and breast (9.5%). Administrative data vital status was more complete than trial collected data with 262 of 476 deaths only recorded in administrative data. Median survival was 1.70 years (95% confidence interval 1.50-1.91). 247 (27.8%) had actionable mutations, most commonly PIK3CA (54.7%), BRCA1 (15.8%), BRCA2 (15.0%) and BRAF (8.9%). 37 (15.0%) and 42 (17.0%) patients with actionable mutations received targeted therapy within 6 and 12 months of test report date, respectively. Conclusions: This is the first known feasibility study of linked administrative data to measure outcomes of large clinical panel sequencing for patients with advanced solid tumors. Vital status was more complete with administrative data compared to trial-collected data, and treatment data was successfully linked. About one in twenty-one enrolled patients received genome-informed treatments within 12 months, or about one in six of all patients with actionable mutations. This may be due to short interval follow up, trial and drug access, successful standard of care treatments, early patient deterioration or limited alterations covered by the panel, among other causes.

scholarly journals Safety profile of avelumab in patients with advanced solid tumors: A pooled analysis of data from the phase 1 JAVELIN solid tumor and phase 2 JAVELIN Merkel 200 clinical trials

Cancer ◽  
2018 ◽  
Vol 124 (9) ◽  
pp. 2010-2017 ◽  
Author(s):  
Karen Kelly ◽  
Jeffrey R. Infante ◽  
Matthew H. Taylor ◽  
Manish R. Patel ◽  
Deborah J. Wong ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Solid Tumors ◽  
Solid Tumor ◽  
Safety Profile ◽  
Phase 1 ◽  
Pooled Analysis ◽  
Advanced Solid Tumors ◽  
Phase 2

Association of survival with chemotherapy intensity, myelosuppression, and supportive care in patients with advanced solid tumors.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6534-6534 ◽  
Author(s):  
Gary H. Lyman ◽  
Marek S. Poniewierski ◽  
Adane Fekadu Wogu ◽  
Eva Culakova ◽  
Nicole Maria Kuderer ◽  
...  
Keyword(s):  
Supportive Care ◽  
Solid Tumors ◽  
Advanced Cancer ◽  
Absolute Risk ◽  
Phase 1 ◽  
Dose Intensity ◽  
Cancer Type ◽  
Advanced Solid Tumors ◽  
Phase 2 ◽  
The Impact

6534 Background: The value of chemotherapy and supportive care for advanced cancer has been questioned. Two systematic reviews were conducted to study the impact of chemotherapy-induced myelosuppression and supportive care on subsequent survival. Methods: Phase 1 identified trials evaluating the relationship of chemotherapy associated with myelosuppression and subsequent survival in patients with cancer. Phase 2 evaluated randomized controlled trials (RCTs) chemotherapy with or without G-CSF support for advanced cancer. Outcomes included hazard ratios (HR), relative risk (RR) and absolute risk (AR) ±95% CI. Results: In Phase 1, 11 of 25 identified studies were conducted in patients with advanced/metastatic disease with 10 in patients with solid tumors. Among the 7 studies in patients with solid tumors reporting survival outcomes, a consistent association between chemotherapy-associated myelosuppression and reduced mortality was observed (HR=0.69; 0.61-0.77; P<.0001). A significant interaction between myelosuppression and cancer type for mortality was observed (P=.046) with significant effects observed for all tumor types. In Phase 2, 22 of 61 RCTs identified were in patients with stage IV solid tumors. Mortality was reduced with chemotherapy with G-CSF support overall (RR=0.95; 0.92-0.98; P=.003) and in patients with non-small cell lung cancer (RR=0.90; P=.037; AR=-6.6%; P=.014), sarcomas (RR=0.73; P=.007; AR=-22.1%; P=.004) or urothelial cancers (RR=0.87; P=.019; AR=-11.4%; P=.016). Reductions in mortality were seen with dose dense chemotherapy (RR=0.88; P=.021; AR=-10.0%; P=.019) and when survival was the primary outcome (n=11;RR=0.92; P=.022; AR=-5.2%; P=.001) with a trend toward greater benefit with longer duration of follow-up (P=.071). Conclusions: Studies of patients with advanced solid tumors demonstrate favorable effects of chemotherapy effect on survival. Chemotherapy treatment resulting in myelosuppression is associated with reduced mortality. RCTs of patients with advanced/metastatic solid tumors confirm that greater chemotherapy dose intensity with G-CSF support is associated with greater reductions in mortality.

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