Background: In the phase III IMpassion130 trial, combining atezolizumab with first-line nanoparticle albumin-boundpaclitaxel for advanced triple-negative breast cancer (aTNBC) showed a statistically significant progression-free survival (PFS) benefit in the intention-to-treat (ITT) and programmed death-ligand 1 (PD-L1)-positive populations, and a clinically meaningful overall survival (OS) effect in PD-L1-positive aTNBC. The phase III KEYNOTE-355 trial adding pembrolizumab to chemotherapy for aTNBC showed similar PFS effects. IMpassion131 evaluated first-line atezolizumabepaclitaxel in aTNBC. Patients and methods: Eligible patients [no prior systemic therapy or 12 months since (neo)adjuvant chemotherapy] were randomised 2:1 to atezolizumab 840 mg or placebo (days 1, 15), both with paclitaxel 90 mg/m 2 (days 1, 8, 15), every 28 days until disease progression or unacceptable toxicity. Stratification factors were tumour PD-L1 status, prior taxane, liver metastases and geographical region. The primary endpoint was investigator-assessed PFS, tested hierarchically first in the PD-L1-positive [immune cell expression 1%, VENTANA PD-L1 (SP142) assay] population, and then in the ITT population. OS was a secondary endpoint. Results: Of 651 randomised patients, 45% had PD-L1-positive aTNBC. At the primary PFS analysis, adding atezolizumab to paclitaxel did not improve investigator-assessed PFS in the PD-L1-positive population [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.60-1.12; P ¼ 0.20; median PFS 6.0 months with atezolizumabepaclitaxel versus 5.7 months with placeboepaclitaxel]. In the PD-L1-positive population, atezolizumabepaclitaxel was associated with more favourable unconfirmed best overall response rate (63% versus 55% with placeboepaclitaxel) and median duration of response (7.2 versus 5.5 months, respectively). Final OS results showed no difference between arms (HR 1.11, 95% CI 0.76-1.64; median 22.1 months with atezolizumabepaclitaxel versus 28.3 months with placeboe paclitaxel in the PD-L1-positive population). Results in the ITT population were consistent with the PD-L1-positive population. The safety profile was consistent with known effects of each study drug. Conclusion: Combining atezolizumab with paclitaxel did not improve PFS or OS versus paclitaxel alone. ClinicalTrials.gov: NCT03125902.
Background:Cancer related fatigue (CRF) is a problem that is highly under reported, under recognized and thus, under treated. About 80% of patients receiving chemotherapy/radiotherapy experience CRF, making it the most common side effect of cancer treatment. Functional assessment of chronic illness therapy fatigue (FACIT-F) version-4 is a 13 item questionnaire that has been used to measure the level of fatigue of cancer patients during their daily activities over the past 7 days.Materials and Methods:92 patients of age 18 years and above attending the oncology Out Patient Department (OPD) of a regional cancer center were recruited in this study and were given FACIT-F questionnaire. The relevant sociodemographic parameters were obtained from the medical records of the patients. The internal consistency of the 13 items was measured using the Cronbach's alpha.Results:The Cronbach alpha coefficient for FACIT-F scale in our study was found to be 0.74. Kendall's coefficient of concordance was estimated to be 0.080. The correlation between Eastern Cooperative Oncology Group (ECOG) performance status and mean score of FACIT-F was studied, Pearson correlation coefficient was estimated to be 0.271 (P = 0.009).Conclusions:FACIT-F is a brief, simple, easy to administer and patient friendly tool to measure the fatigue in last 7 days. CRF should be given adequate attention from the beginning of the treatment to improve the quality of life of cancer patients.
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