title: The Relationship Between the Adverse Events and Efficacy of Sorafenib in Patients With Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Study from Northwest China.
abstract: The aim of the study is to evaluate the relationship between the adverse events and efficacy of sorafenib in patients with metastatic renal cell carcinoma (mRCC), with a purpose to guide the judgment of efficacy in sorafenib treatment.Eighty-three mRCC patients who received sorafenib therapy at northwest China were studied retrospectively. Univariate and multivariate analyses were performed to correlate tumor response, progression-free survival (PFS), and overall survival (OS) with adverse event types and grades.Among 83 patients who underwent sorafenib therapy, 2 cases (2.4%) had completed response (CR), 14 cases (16.9%) had partial response (PR), 57 cases (68.7%) had stable disease (SD), and 10 cases (12.0%) developed progressive disease (PD). The median PFS and OS were 15.0 and 29.0 months, respectively. The most frequent grade 1 or 2 adverse events included hand-foot syndrome (68.7%), diarrhea (54.2%), and alopecia (51.8%). The most common grade 3 or 4 adverse events were hand-foot syndrome (6.0%), hypertension (4.8%), and diarrhea (3.6%). The frequency and severity of adverse events correlated with tumor response rate (both with P < 0.05). Multivariate analysis showed the independent predictors of better PFS included rash (OR 0.307, 95%CI 0.148-0.636, P = 0.001) and diarrhea (OR 0.391, 95%CI 0.169-0.783, P = 0.008). Elevated transaminase was the independent predictor of poor PFS (OR 2.606, 95%CI 1.299-5.532, P = 0.012). For OS, rash (OR 0.473, 95%CI 0.253-0.886, P = 0.019) and diarrhea (OR 0.321, 95%CI 0.171-0.605, P = 0.000) correlated with better OS.Sorafenib-related adverse events are associated with efficacy in patients with mRCC from northwest China. Rash and diarrhea are independent protective factors of both PFS and OS, and elevated transaminase is an independent risk factor of PFS. A large prospective study is warranted.
authors.affiliation: From the Department of Urology, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province (YZ, FW, GW, LZ, JY); Department of Urology, General Hospital of Lanzhou Military Area Command of Chinese PLA (YW); Department of Urology, The Second Affiliated Hospital of Lanzhou University, Lanzhou, Gansu Province (ZW); Department of Urology, Affiliated Tumor Hospital of Xinjang Medical University (PC); Department of Urology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi (QW); Department of Urology, Xinjiang karamay Central Hospital, Karamay (JL); Department of Urology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang Uyghur Autonomous Region (YW); Department of Urology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia Hui Autonomous Region (PL); Department of Urology, Qinghai University Affiliated Hospital, Xining, QingHai Province (JW); and Department of Urology, First People's Hospital of Shizuishan, Shizuishan, Ningxia Hui Autonomous Region, China (XL).
authors.forename: Yu
authors.initials: Y
authors.lastname: Zheng
authors.forename: Fuli
authors.initials: F
authors.lastname: Wang
authors.forename: Guojun
authors.initials: G
authors.lastname: Wu
authors.forename: Longlong
authors.initials: L
authors.lastname: Zhang
authors.forename: Yangmin
authors.initials: Y
authors.lastname: Wang
authors.forename: Zhiping
authors.initials: Z
authors.lastname: Wang
authors.forename: Peng
authors.initials: P
authors.lastname: Chen
authors.forename: Qing
authors.initials: Q
authors.lastname: Wang
authors.forename: Jingyi
authors.initials: J
authors.lastname: Lu
authors.forename: Yujie
authors.initials: Y
authors.lastname: Wang
authors.forename: Peijun
authors.initials: P
authors.lastname: Li
authors.forename: Jian
authors.initials: J
authors.lastname: Wang
authors.forename: Xitao
authors.initials: X
authors.lastname: Lu
authors.forename: Jianlin
authors.initials: J
authors.lastname: Yuan
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D002681:China; D018450:Disease Progression; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D000077157:Sorafenib; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib