P1.15-33 Real-World Data on Prognostic Factors for Overall Survival in NSCLC Patients Treated with Bevacizumab Combination Therapy

The prognosis of multiple myeloma (MM) has improved with the introduction of novel agents. These data are largely derived from clinical trials and might not reflect real-world patient outcomes accurately. We surveyed real-world data from 284 patients newly diagnosed with MM between 2010 and 2018 in Miyazaki Prefecture. The median follow-up period was 32.8 months. The median age at diagnosis was 71 years, with 68% of patients aged >65 years. The International Staging System (ISS) stage at diagnosis was I in 18.4% of patients, II in 34.1%, and III in 47.5%. Bortezomib-containing regimens were preferred as initial treatment; they were used in 147 patients (51.8%). In total, 80% of patients were treated with one or more novel agents (thalidomide, lenalidomide, or bortezomib). Among 228 patients who were treated with novel agents as an initial treatment, the overall response rate (partial response (PR) or better) to initial treatment was 78.4%, and the median time to next treatment (TTNT) was 11.6 months. In the multivariate analysis, PR or better responses to initial treatment were independently favorable prognostic factors for TTNT. The median survival time after initial therapy for patients with novel agents was 56.4 months and 3-year overall survival (OS) was 70.4%. In multivariate analysis, ISS stage I/II disease and PR or better response to initial treatment, and autologous stem cell transplantation (ASCT) were identified as independent prognostic factors for overall survival (OS).

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Socioeconomic Status Is an Independent Prognostic Factor for Overall Survival in Patients With Multiple Myeloma: Real-World Data From a Cohort of 223 Patients

Clinical Lymphoma Myeloma & Leukemia ◽

10.1016/j.clml.2020.05.013 ◽

2020 ◽

Vol 20 (10) ◽

pp. 704-711

Author(s):

Stergios Intzes ◽

Marianthi Symeonidou ◽

Konstantinos Zagoridis ◽

Zoe Bezirgiannidou ◽

Aikaterini Pentidou ◽

...

Keyword(s):

Multiple Myeloma ◽

Socioeconomic Status ◽

Overall Survival ◽

Prognostic Factor ◽

Real World ◽

Independent Prognostic Factor ◽

Real World Data ◽

World Data

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The rate of tumor growth, g, as a biomarker for overall survival (OS) in prostate cancer (PC) in clinical trials as well as in real-world data from the Veterans Administration Medical Centers (VAMCs).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.5074 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 5074-5074

Author(s):

Harshraj Leuva ◽

Mengxi Zhou ◽

Julia Wilkerson ◽

Keith Sigel ◽

Ta-Chueh Hsu ◽

...

Keyword(s):

Prostate Cancer ◽

Clinical Trial ◽

Overall Survival ◽

Clinical Trials ◽

Tumor Growth ◽

Real World ◽

Clinical Trial Data ◽

Trial Data ◽

Real World Data ◽

World Data

5074 Background: Novel assessments of efficacy are needed to improve determination of treatment outcomes in clinical trials and in real-world settings. Methods: Cancer treatments usually lead to concurrent regression and growth of the drug-sensitive and drug-resistant fractions of a tumor, respectively. We have exploited novel methods of analysis that assess these two simultaneous processes and have estimated rates of tumor growth ( g) and regression ( d) in over 30,000 patients (pts) with diverse tumors. Results: In prostate cancer (PC) we have analyzed both clinical trial and real-world data from Veterans. Using clinical trial data from 6819 pts enrolled in 15 treatment arms we have established separately and by combining all the data that g correlates highly (p<0.0001) with overall survival (OS) – slower g associated with better OS. In PC, abiraterone (ABI) and docetaxel (DOC) are superior to placebo, prednisone and mitoxantrone. ABI (median g =0.0017) is superior to DOC ( g=0.0021) in first line (p=0.0013); and ABI in 2nd line ( g=0.0034) is inferior to ABI in 1st line ( g=0.0017; p<0.0001). Finally, using combined clinical trial data as a benchmark we could assess the efficacy of novel therapies in as few as 30-40 patients. Amongst 7457 Veterans, the median g on a taxane ( g=0.0022) was similar to that from clinical trials ( g=0.0012). Although only 258 Veterans received cabazitaxel (CAB), g values for CAB ( g=0.0018) and DOC ( g=0.0023) were indistinguishable (p=0.3) consistent with their identical mechanism of action. Finally, outcomes with DOC in African American (AA) ( g=0.00212) and Caucasian ( g=0.00205) Veterans were indistinguishable (p=0.9) and comparable across all VAMCs. Conclusions: The rate of tumor growth, g, is an excellent biomarker for OS both in clinical trials and in real-world settings. g allows comparisons between trials and for large trial data sets to be used as benchmarks of efficacy. Real-world outcomes in the VAMCs are similar to those in clinical trials. In the egalitarian VAMCs DOC efficacy in PC is comparable in AA and Caucasian Veterans -- indicating inferior outcomes reported in AAs are likely due to differential health care access, not differences in biology.

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Using real world data to examine outcomes in immunotherapy-treated patients with metastatic non-small cell lung cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e21715 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e21715-e21715

Author(s):

Sierra Luciano ◽

Christian Haudenschild ◽

Seth Kuranz

Keyword(s):

Overall Survival ◽

Real World ◽

Small Cell ◽

Advanced Stage ◽

Small Cell Lung ◽

Real World Data ◽

Treatment Pathways ◽

Time To Treatment ◽

World Data

e21715 Background: Important questions have been raised about whether real world data (RWD) can be relied upon to support clinical and regulatory decision-making. The aims of this study were to assess overall survival (OS), time-to-treatment (TTT), follow-up time, and treatment pathways in metastatic non-small cell lung cancer (mNSCLC) patients treated with programmed cell death protein 1 inhibitors (PD-1i). Methods: Two mNSCLC cohorts were identified in a US based EMR network. To explore treatment pathways, patients had to have an advanced (stage 3/4) diagnosis of NSCLC confirmed by a tumor registry record. A line of treatment (LOT) was defined as a PD-1i or chemotherapy taken within 30 days. OS, time to treatment, and follow-up time were also calculated. In another cohort patients had to have at least one PD-1i (pembrolizumab, nivolumab, durvalumab, or atezolizmab) and an oncology treatment within 3 months of an advanced stage diagnosis. OS was calculated using Kaplan-Meier analysis and stratified by time after nivolumab approval, quarter of PD-1i initiation, and line of therapy of first PD-1i. Patient characteristics were defined by ICD, CPT, LOINC, and RxNorm terminology. Results: Median overall survival was found to be 213 days (IQR 109, 425.25). In the treatment pathways analysis, 58.3% of patients started on a non-PD-1i chemotherapy as an initial line of treatment for mNSCLC. PD-1i was the most common second line treatment and 41.4% of patients who started on a non-PD-1i therapy switched to a PD-1i as their second line therapy. Median time from advanced diagnosis to PD-1i inhibitor initiation (9.6 months (IQR 3.45, 21.45)) and median structured follow-up times from advanced diagnosis (21.87 months (IQR 11.94, 38.97)) and from inhibitor initiation (8.71 months (3.06, 17.26)) were comparable to results found in other RWD. Conclusions: Overall survival, time to treatment, and other outcomes were consistent with comparable RWD sources, (Stewart M, 2019; Sean K 2018) regardless of treatment timeframe. We demonstrated that our real world evidence based approach provides a robust method for analyzing clinical outcomes, supporting the validity of real world data to complement clinical trials and inform clinical decisions.

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Prognostic factors for early relapse in non-metastatic triple negative breast cancer — real world data

Reports of Practical Oncology & Radiotherapy ◽

10.5603/rpor.a2021.0073 ◽

2021 ◽

Author(s):

Rita Félix Soares ◽

Ana Rita Garcia ◽

Ana Raquel Monteiro ◽

Filipa Macedo ◽

Tatiana Cunha Pereira ◽

...

Keyword(s):

Breast Cancer ◽

Prognostic Factors ◽

Triple Negative Breast Cancer ◽

Real World ◽

Triple Negative ◽

Real World Data ◽

Early Relapse ◽

World Data

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PS1456 FAVORABLE OVERALL SURVIVAL OF IMETELSTAT-TREATED RELAPSED/REFRACTORY MYELOFIBROSIS PATIENTS COMPARED WITH CLOSELY MATCHED REAL WORLD DATA

HemaSphere ◽

10.1097/01.hs9.0000564088.98639.88 ◽

2019 ◽

Vol 3 (S1) ◽

pp. 669-670 ◽

Cited By ~ 3

Author(s):

A. Kuykendall ◽

Y. Wan ◽

J. Mascarenhas ◽

J.-J. Kiladjian ◽

A. Vannucchi ◽

...

Keyword(s):

Overall Survival ◽

Real World ◽

Real World Data ◽

World Data

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Overall survival of cetuximab administered every two weeks versus weekly in real-world data of U.S. patients with metastatic colorectal cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.4_suppl.23 ◽

2020 ◽

Vol 38 (4_suppl) ◽

pp. 23-23 ◽

Cited By ~ 1

Author(s):

Chris Pescott ◽

Michael Batech ◽

Emmanuelle Boutmy ◽

Philippe Ronga ◽

Francois-Xavier Lamy

Keyword(s):

Colorectal Cancer ◽

Overall Survival ◽

Metastatic Colorectal Cancer ◽

Real World ◽

Cox Model ◽

Small Sample Size ◽

Small Sample ◽

Patient Death ◽

Real World Data ◽

World Data

23 Background: Cetuximab (CET) administered weekly (q1w) at 250 mg/m², after an initial dose of 400 mg/m², is approved in combination with chemotherapy (CT) for the treatment of (K) RAS wild-type metastatic colorectal cancer (mCRC). The use of CET 500 mg/m2 administered with CT every 2 weeks (q2w) is according to US clinical practice guidelines and observed routinely. In this study, we compared q2w vs q1w regimens on overall survival (OS) in a presumed first-line (1L) treatment subcohort and present updated data on the noninferiority of q2w vs q1w in line-agnostic (1L+) treatment using US real-world data. Methods: Using IBM MarketScan, a large US insurance claims database, we classified a cohort of mCRC patients treated between 07/2010 and 12/2016 with CET+CT as q1w or q2w based on observed infusion patterns. Absence of mCRC-related treatment claims preceding CET initiation date (defined as the index date) qualified as CET treated in 1L. A validated algorithm was used to determine patient death. Confounding was accounted for using high-dimensional propensity scoring (hdPS) with inverse probability of treatment weights. OS was compared using Cox proportional hazards regression. Imbalanced confounders after hdPS were added to the Cox model. In 1L+, noninferiority of the q2w regimen was tested with a margin hazard ratio (HR) of 1.25. However, noninferiority could not be tested in 1L due to the small sample size; a test for difference was used instead. Results: Of 2,730 CET-exposed mCRC patients (updated), 1,779 (65.2%) and 951 (34.8%) were classified in q1w and q2w groups, respectively, among which 557 (31.3%) and 316 (33.2%) received CET in 1L. The HR (95% CI) for OS of q2w vs q1w in 1L was 1.10 (0.92-1.31; crude), and 1.05 (0.86-1.29; adjusted; p for difference: 0.625). In 1L+, crude and adjusted HRs were 1.05 (0.94-1.18) and 0.94 (0.85-1.03), respectively, rejecting the inferiority hypothesis at p < 0.001. Conclusions: Only a third of patients received CET in 1L in this study. OS was statistically noninferior in q2w vs q1w in 1L+, and adjusted results in 1L suggest no differences between both treatment schedules. However, more data would be needed to formally test the noninferiority hypothesis in 1L.

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