Browsing by Author "Koshkin, Vadim S"

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    Clinical activity of nivolumab in patients with non-clear cell renal cell carcinoma.
    (Journal for immunotherapy of cancer, 2018-01-29) Koshkin, Vadim S; Barata, Pedro C; Zhang, Tian; George, Daniel J; Atkins, Michael B; Kelly, William J; Vogelzang, Nicholas J; Pal, Sumanta K; Hsu, JoAnn; Appleman, Leonard J; Ornstein, Moshe C; Gilligan, Timothy; Grivas, Petros; Garcia, Jorge A; Rini, Brian I
    Nivolumab is approved for patients with metastatic renal cell carcinoma (mRCC) refractory to prior antiangiogenic therapy. The clinical activity of nivolumab in patients with non-clear cell RCC subtypes remains unknown as these patients were excluded from the original nivolumab trials.Patients from 6 centers in the United States who received at least one dose of nivolumab for non-clear cell mRCC between 12/2015 and 06/2017 were identified. A retrospective analysis including patient characteristics, objective response rate according to RECIST v1.1 and treatment-related adverse events (TRAEs) was undertaken.Forty-one patients were identified. Median age was 58 years (33-82), 71% were male, and majority had ECOG PS 0 (40%) or 1 (47%). Histology included 16 papillary, 14 unclassified, 5 chromophobe, 4 collecting duct, 1 Xp11 translocation and 1 MTSCC (mucinous tubular and spindle cell carcinoma). Among 35 patients who were evaluable for best response, 7 (20%) had PR and 10 (29%) had SD. Responses were observed in unclassified, papillary and collecting duct subtypes. In the entire cohort, median follow-up was 8.5 months and median treatment duration was 3.0 months. Median PFS was 3.5 months and median OS was not reached. Among responders, median time to best response was 5.1 months, and median duration of response was not reached as only 2 out of 7 responders had disease progression during follow-up. TRAEs of any grade were noted in 37% and most commonly included fatigue (12%), fever (10%) and rash (10%). Nivolumab treatments were postponed in 34% and discontinued in 15% of patients due to intolerance. No treatment-related deaths were observed.Nivolumab monotherapy demonstrated objective responses and was well tolerated in a heterogeneous population of patients with non-clear cell mRCC. In the absence of other data in this treatment setting, this study lends support to the use of nivolumab for patients with metastatic non-clear cell renal cell carcinoma.
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    Clinical characteristics, racial inequities, and outcomes in patients with breast cancer and COVID-19: A COVID-19 and cancer consortium (CCC19) cohort study.
    (eLife, 2023-10) Nagaraj, Gayathri; Vinayak, Shaveta; Khaki, Ali Raza; Sun, Tianyi; Kuderer, Nicole M; Aboulafia, David M; Acoba, Jared D; Awosika, Joy; Bakouny, Ziad; Balmaceda, Nicole B; Bao, Ting; Bashir, Babar; Berg, Stephanie; Bilen, Mehmet A; Bindal, Poorva; Blau, Sibel; Bodin, Brianne E; Borno, Hala T; Castellano, Cecilia; Choi, Horyun; Deeken, John; Desai, Aakash; Edwin, Natasha; Feldman, Lawrence E; Flora, Daniel B; Friese, Christopher R; Galsky, Matthew D; Gonzalez, Cyndi J; Grivas, Petros; Gupta, Shilpa; Haynam, Marcy; Heilman, Hannah; Hershman, Dawn L; Hwang, Clara; Jani, Chinmay; Jhawar, Sachin R; Joshi, Monika; Kaklamani, Virginia; Klein, Elizabeth J; Knox, Natalie; Koshkin, Vadim S; Kulkarni, Amit A; Kwon, Daniel H; Labaki, Chris; Lammers, Philip E; Lathrop, Kate I; Lewis, Mark A; Li, Xuanyi; Lopes, Gilbert de Lima; Lyman, Gary H; Makower, Della F; Mansoor, Abdul-Hai; Markham, Merry-Jennifer; Mashru, Sandeep H; McKay, Rana R; Messing, Ian; Mico, Vasil; Nadkarni, Rajani; Namburi, Swathi; Nguyen, Ryan H; Nonato, Taylor Kristian; O'Connor, Tracey Lynn; Panagiotou, Orestis A; Park, Kyu; Patel, Jaymin M; Patel, Kanishka GopikaBimal; Peppercorn, Jeffrey; Polimera, Hyma; Puc, Matthew; Rao, Yuan James; Razavi, Pedram; Reid, Sonya A; Riess, Jonathan W; Rivera, Donna R; Robson, Mark; Rose, Suzanne J; Russ, Atlantis D; Schapira, Lidia; Shah, Pankil K; Shanahan, M Kelly; Shapiro, Lauren C; Smits, Melissa; Stover, Daniel G; Streckfuss, Mitrianna; Tachiki, Lisa; Thompson, Michael A; Tolaney, Sara M; Weissmann, Lisa B; Wilson, Grace; Wotman, Michael T; Wulff-Burchfield, Elizabeth M; Mishra, Sanjay; French, Benjamin; Warner, Jeremy L; Lustberg, Maryam B; Accordino, Melissa K; Shah, Dimpy P; COVID-19 and Cancer Consortium

    Background

    Limited information is available for patients with breast cancer (BC) and coronavirus disease 2019 (COVID-19), especially among underrepresented racial/ethnic populations.

    Methods

    This is a COVID-19 and Cancer Consortium (CCC19) registry-based retrospective cohort study of females with active or history of BC and laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection diagnosed between March 2020 and June 2021 in the US. Primary outcome was COVID-19 severity measured on a five-level ordinal scale, including none of the following complications, hospitalization, intensive care unit admission, mechanical ventilation, and all-cause mortality. Multivariable ordinal logistic regression model identified characteristics associated with COVID-19 severity.

    Results

    1383 female patient records with BC and COVID-19 were included in the analysis, the median age was 61 years, and median follow-up was 90 days. Multivariable analysis revealed higher odds of COVID-19 severity for older age (aOR per decade, 1.48 [95% CI, 1.32-1.67]); Black patients (aOR 1.74; 95 CI 1.24-2.45), Asian Americans and Pacific Islander patients (aOR 3.40; 95 CI 1.70-6.79) and Other (aOR 2.97; 95 CI 1.71-5.17) racial/ethnic groups; worse ECOG performance status (ECOG PS ≥2: aOR, 7.78 [95% CI, 4.83-12.5]); pre-existing cardiovascular (aOR, 2.26 [95% CI, 1.63-3.15])/pulmonary comorbidities (aOR, 1.65 [95% CI, 1.20-2.29]); diabetes mellitus (aOR, 2.25 [95% CI, 1.66-3.04]); and active and progressing cancer (aOR, 12.5 [95% CI, 6.89-22.6]). Hispanic ethnicity, timing, and type of anti-cancer therapy modalities were not significantly associated with worse COVID-19 outcomes. The total all-cause mortality and hospitalization rate for the entire cohort was 9% and 37%, respectively however, it varied according to the BC disease status.

    Conclusions

    Using one of the largest registries on cancer and COVID-19, we identified patient and BC-related factors associated with worse COVID-19 outcomes. After adjusting for baseline characteristics, underrepresented racial/ethnic patients experienced worse outcomes compared to non-Hispanic White patients.

    Funding

    This study was partly supported by National Cancer Institute grant number P30 CA068485 to Tianyi Sun, Sanjay Mishra, Benjamin French, Jeremy L Warner; P30-CA046592 to Christopher R Friese; P30 CA023100 for Rana R McKay; P30-CA054174 for Pankil K Shah and Dimpy P Shah; KL2 TR002646 for Pankil Shah and the American Cancer Society and Hope Foundation for Cancer Research (MRSG-16-152-01-CCE) and P30-CA054174 for Dimpy P Shah. REDCap is developed and supported by Vanderbilt Institute for Clinical and Translational Research grant support (UL1 TR000445 from NCATS/NIH). The funding sources had no role in the writing of the manuscript or the decision to submit it for publication.

    Clinical trial number

    CCC19 registry is registered on ClinicalTrials.gov, NCT04354701.