Mir Mohmad Hussain, Changal Khalid Hamid, Aziz Shiekh Aejaz, Bhat Gull Mohammad, Lone Abdul Rashid
Department of Medical Oncology, Sher-i-Kashmir Institute Of Medical Sciences (SKIMS), Srinagar, India.
Department of Internal Medicine, Sher-i-Kashmir Institute Of Medical Sciences (SKIMS), Srinagar, India.
Int Urol Nephrol. 2016 Nov;48(11):1811-1816. doi: 10.1007/s11255-016-1380-2. Epub 2016 Jul 23.
Metastatic renal cell carcinoma (mRCC) has historically been refractory to cytotoxic and hormonal agents. IL-2 and IFN-α provide response in a minority of patients. Small molecule tyrosine kinase inhibitors and monoclonal antibodies have established a role in the setting of mRCC. However, there is a lack of data from the Indian subcontinent. The aim of this study was to look whether our patients behave similarly as reported in the Western data to targeted agents, especially sunitinib.
The study was a prospective observational study conducted for a period of 5 years from 2011 to 2016. Sixty-three patients received targeted agents and were recruited in the study. Five patients were excluded for various reasons, and three were lost to follow-up. Fifty-five patients were properly studied and followed up. Fifty patients received sunitinib, four patients received sorafenib, and one patient received parenteral temsirolimus. Patients were followed for AEs and survival.
The most common AEs in patients taking sunitinib were fatigue (70 %), hand-foot syndrome (62 %), skin rash (58 %), mucosal inflammation (58 %), anorexia (42 %), skin discoloration (42 %), followed by dry mouth, dysgeusia, dyspepsia, dry skin, dry mouth, hair color changes, hypothyroidism, alopecia, oral pain/stomatitis, hypertension, decreased weight, photosensitivity, peripheral edema, erythema, and others. The median overall survival in our patients was 13.2 (95 % CI 10.1-16.5), progression-free survival was 8.1 months (95 % CI 6.4-10.5), and objective response was seen in 36 %.
Non-Western patients behave differently with sunitinib therapy compared to Western patients. Our patients have more mucocutaneous side effects and lesser overall survival.
转移性肾细胞癌(mRCC)历来对细胞毒性药物和激素药物难治。白细胞介素-2和干扰素-α仅能使少数患者产生反应。小分子酪氨酸激酶抑制剂和单克隆抗体在mRCC治疗中已确立了作用。然而,印度次大陆缺乏相关数据。本研究的目的是观察我们的患者对靶向药物(尤其是舒尼替尼)的反应是否与西方数据报道的相似。
本研究是一项前瞻性观察性研究,从2011年至2016年进行了5年。63例接受靶向药物治疗的患者被纳入研究。5例患者因各种原因被排除,3例失访。对55例患者进行了适当的研究和随访。50例患者接受舒尼替尼治疗,4例患者接受索拉非尼治疗,1例患者接受静脉注射替西罗莫司治疗。对患者进行不良事件和生存情况的随访。
服用舒尼替尼的患者中最常见的不良事件为疲劳(70%)、手足综合征(62%)、皮疹(58%)、黏膜炎症(58%)、厌食(42%)、皮肤变色(42%),其次是口干、味觉障碍、消化不良、皮肤干燥、头发颜色改变、甲状腺功能减退、脱发、口腔疼痛/口腔炎、高血压、体重减轻、光敏反应、外周水肿、红斑等。我们患者的中位总生存期为13.2个月(95%CI 10.1 - 16.5),无进展生存期为8.1个月(95%CI 6.4 - 10.5),客观缓解率为36%。
与西方患者相比,非西方患者接受舒尼替尼治疗时表现不同。我们的患者有更多的皮肤黏膜副作用且总生存期较短。