Eligibility for phase 3 clinical trials of systemic therapy in real-world patients with metastatic renal cell cancer managed in a rural region

Med Oncol. 2017 Sep;34(9):149. doi: 10.1007/s12032-017-1002-6. Epub 2017 Jul 26.

Abstract

Previous research has identified disparities between urban and rural cancer care, including clinical trial access. Therefore, we addressed three different questions in patients with metastatic renal cell cancer managed according to national guidelines in a rural Norwegian standard practice setting. (1) How many patients would have been eligible for three recent landmark randomized clinical trials? (2) Is survival different between eligible and non-eligible patients receiving first-line systemic therapy? (3) Is survival different between eligible patients and published trial results? We performed a retrospective analysis of 101 consecutive patients (2006-2016). Only 52% of the patients were eligible for the first-line study of pazopanib versus sunitinib. The main reasons for violating inclusion or exclusion criteria were presence of brain metastases, absence of clear cell histology, and poor performance status. Even fewer patients were eligible for trials of nivolumab and cabozantinib in pre-treated patients. Eligible patients had significantly better survival than non-eligible patients, median 29.2 versus 8.5 months (p = 0.0001). These results confirm that many patients from rural practices do not fulfill all mandatory trial eligibility criteria. However, eligible patients managed according to national guidelines had survival outcomes in line with published first-line trial results.

Keywords: Metastatic renal cell cancer; Prognosis; Rural care; Systemic therapy; Trial participation.

MeSH terms

  • Aged
  • Anilides / therapeutic use
  • Antibodies, Monoclonal / therapeutic use
  • Antineoplastic Agents / therapeutic use*
  • Brain Neoplasms / drug therapy
  • Carcinoma, Renal Cell / drug therapy*
  • Clinical Trials, Phase III as Topic
  • Female
  • Humans
  • Indazoles
  • Indoles / therapeutic use
  • Kidney Neoplasms / drug therapy*
  • Male
  • Middle Aged
  • Nivolumab
  • Pyridines / therapeutic use
  • Pyrimidines / therapeutic use
  • Pyrroles / therapeutic use
  • Retrospective Studies
  • Rural Population
  • Sulfonamides / therapeutic use
  • Sunitinib

Substances

  • Anilides
  • Antibodies, Monoclonal
  • Antineoplastic Agents
  • Indazoles
  • Indoles
  • Pyridines
  • Pyrimidines
  • Pyrroles
  • Sulfonamides
  • cabozantinib
  • Nivolumab
  • pazopanib
  • Sunitinib