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Introduction: There are limited real-world data on the effectiveness of strategies used to manage adverse events (AEs) in patients with advanced renal cell carcinoma (RCC) treated with axitinib. This retrospective chart review examined the AE profile and effect of axitinib modifications on AE resolution/improvement and treatment discontinuation., Methods: A retrospective physician-administered chart review was conducted. Adult patients with advanced RCC treated with first-line axitinib plus checkpoint inhibitor (CPI) therapy (ie, avelumab or pembrolizumab) and who had documented frequently reported axitinib-related AEs of fatigue, diarrhea, nausea, hypertension, or palmar-plantar erythrodysesthesia were included. Physician characteristics, patient characteristics, AE characteristics, AE management strategies used, AE resolution/improvement, and treatment duration were described. The effect of strategies used to manage AEs (axitinib dose reduction or treatment interruption) on AE resolution/improvement was evaluated by logistic regression., Results: Among 219 patients (median age: 62 years, 65% male), 70 (32%) were treated with axitinib + avelumab and 149 (68%) received axitinib + pembrolizumab. Axitinib modifications increased the likelihood of AE resolution/improvement compared with no modifications (adjusted odds ratio: 6.34, P < .001). In the subset of patients who discontinued treatment among those with or without axitinib modifications, mean treatment duration was 7.0 and 1.7 months, respectively., Conclusion: Toxicities experienced by patients with advanced RCC treated with first-line axitinib-CPI in the real world can be effectively managed by axitinib modifications, thereby prolonging treatment duration. (Clinicaltrials.gov identifier: NCT04682587)., Competing Interests: Disclosure Yousef Zakharia is on the advisory board for Bristol Myers Squibb, Amgen, Roche Diagnostics, Novartis, Janssen, Eisai, Exelixis, Castle Bioscience, Array, Bayer, Pfizer, Clovis, and EMD Serono; and has received institution clinical trial support from NewLink Genetics, Pfizer, Exelixis, Eisai, and DSMC: Janssen Research and Development, and consultant honoraria from Pfizer and Novartis. Lynn Huynh, Rose Chang, Sanjana Sundaresan, and Mei S. Duh are employees of Analysis Group, Inc., which received funds from Pfizer to conduct this study and for manuscript development. Shawn Du and Selina Pi were employees of Analysis Group, Inc. at the time the study was conducted. Giovanni Zanotti and Despina Thomaidou are employees of Pfizer, Inc. and may hold stock or stock options in Pfizer., (Copyright © 2023. Published by Elsevier Inc.)

Objectives: This study developed, and established the content validity, of a conversation aid tool (CAT) for use in clinical practice with renal cell carcinoma (RCC) patients who receive a curative nephrectomy and are at high-risk of recurrence. The CAT was pilot tested in a sample of RCC patients to establish whether the CAT increases knowledge of RCC, treatment options (such as adjuvant therapy), and care options., Methods: A cross-sectional, mixed methods design was used involving initial, exploratory interviews with RCC patients, RCC specialists and a steering group. Further content validation interviews were conducted with RCC patients and specialists. A web-based survey was conducted with RCC patients (N = 60), to compare the CAT versus a standard of care (SOC) consultation comparator tool on patient knowledge., Results: Findings from exploratory interviews were used to develop the CAT. Content validation interviews demonstrated that the CAT was well understood and relevant to RCC patients. The web-based survey demonstrated that viewing the CAT significantly improved participants knowledge of RCC, and care options, when compared to the SOC., Conclusion: The findings highlight that the CAT is a relevant, comprehensive and well-understood tool for use in the post-nephrectomy consultation., Practice Implications: Use of the CAT may increase patient knowledge of RCC and care options., Competing Interests: Declaration of Competing Interest This study was sponsored by Pfizer. GZ is an employee of Pfizer Ltd and DB was an employee of Pfizer Ltd when the research was conducted. SB, EE, EB, and RL are employees of Adelphi Values and CJ and BB were employees of Adelphi Values when the research was conducted. All employees of Adelphi Values were paid consultants to Pfizer in connection with the development of this manuscript. GDS and MS were financially compensated by Pfizer for participation in the RCC specialists’ interview but were not financially compensated for their involvement in the study or the development of this manuscript. GDS has also received educational grants from Pfizer, AstraZeneca and Intuitive Surgical; consultancy fees from Pfizer, Merck, EUSA Pharma and CMR Surgical; travel expenses from Pfizer and Speaker fees from Pfizer., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: The present retrospective, longitudinal cohort study assessed the association between the first-line sunitinib treatment duration and clinical outcomes with second-line immuno-oncology (IO) therapy among patients with metastatic renal cell carcinoma (mRCC)., Patients and Methods: A total of 161 patients with mRCC who had been treated with first-line sunitinib and subsequent IO therapy from select International mRCC Database Consortium centers were included. The overall survival, time to next therapy, time to treatment discontinuation, and real-world physician-assessed best response measured from IO therapy initiation were analyzed and compared between patients treated with first-line sunitinib for ≥ 6 months and those treated for < 6 months., Results: The 116 patients treated with sunitinib for ≥ 6 months tended to be older and to have a better International mRCC Database Consortium risk than the 45 patients treated for < 6 months (favorable, 36% vs. 8%, P = .001; intermediate, 59% vs. 70%, P = .21; poor, 5% vs. 22%, P = .007). The receipt of sunitinib for ≥ 6 months versus < 6 months was associated with longer survival (hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.21-0.87; P = .02). No significant association was observed between the first-line sunitinib duration and second-line IO outcomes, including the time to next therapy (HR, 0.89; 95% CI, 0.52-1.51; P = .66), time to treatment discontinuation (HR, 0.85; 95% CI, 0.54-1.34; P = .49), and tumor response (odds ratio, 0.73; 95% CI, 0.22-2.49; P = .62)., Conclusions: We found no statistically significant association between the first-line sunitinib duration and clinical outcomes with second-line IO therapy. Patients receiving first-line sunitinib for ≥ 6 months compared with < 6 months was associated with better overall survival, although potential unadjusted confounders could have been present. These findings support the paradigm that previous therapy will not dictate the effectiveness of subsequent immunotherapy., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Purpose: To describe treatment patterns and clinical outcomes among postmenopausal women with metastatic ER + /HER-2 - breast cancer treated with ≥ 2 lines of endocrine therapy or chemotherapy in the metastatic setting., Patients and Methods: Retrospective medical record review was conducted in Canada, the United Kingdom, Belgium, the Netherlands, Germany, Spain, and France. Baseline characteristics were assessed at the date of metastatic diagnosis. Time to progression (TTP) and overall survival (OS) were estimated by Kaplan-Meier analyses. Multivariable models were used to evaluate factors associated with disease progression., Results: Among 901 patients, the mean (standard deviation) age at metastatic diagnosis was 62.7 (9.7) years; 67.26% were initially diagnosed with metastatic disease, 66.37% had visceral disease, and 25.86% had bone metastasis only. Two-thirds of patients received endocrine therapy for first-line treatment. Fifty-nine percent received endocrine therapy, and 37.18% received chemotherapy for second-line treatment. The most common reason for stopping treatment was disease progression. Median (95% confidence interval [CI]) TTP on first-line endocrine treatment was 11.3 (10.7-12.2) months and 7.0 (6.3-7.9) months on chemotherapy. Median (95% CI) TTP on second-line endocrine therapy was 8.1 (7.5-9.1) months and 6.1 (5.4-6.8) months on chemotherapy. Median (95% CI) OS was 68.6 (52.2-83.7) months after first-line endocrine therapy and 39.7 (34.5-48.7) months after chemotherapy., Conclusion: Patients prescribed endocrine therapy had longer TTP and OS than patients prescribed chemotherapy in the first- and second-line settings. Disease progression was less than a year regardless of treatment type and line of therapy, indicating a need for treatments that delay progression without affecting quality of life among these patients., (Copyright © 2017 Elsevier Inc. All rights reserved.)