Tumor marker and measurement fluctuations may not reflect treatment efficacy in patients with medullary thyroid carcinoma on long-term RET inhibitor therapy

Ann Oncol. 2013 Sep;24(9):2256-61. doi: 10.1093/annonc/mdt177. Epub 2013 May 14.

Abstract

Background: RET kinase inhibitors have significant activity in patients with medullary thyroid carcinoma (MTC).

Patients and methods: We retrospectively reviewed the electronic medical record for patterns of calcitonin, carcinoembryonic antigen (CEA) and tumor measurement responses in consecutive patients with MTC who received treatment with a RET inhibitor for at least 6 months.

Results: Twenty-six patients who received RET kinase inhibitors for at least 6 months were included. All patients experienced an initial decline in calcitonin; 20 (77%) demonstrated later fluctuations in calcitonin, which spiked above baseline levels in 9 individuals (35%). Twenty of the 22 patients (91%) with elevated CEA experienced a decline with treatment, with 11 individuals (50%) later demonstrating transient fluctuations in CEA, including spikes above baseline in 7 patients (32%). Ten of the 26 patients (38%) also demonstrated short-lived fluctuations in RECIST measurements, including changes of over 20% from nadir values. Vacillations in calcitonin, CEA and measurements often occurred repeatedly in individual patients and did not regularly correlate with each other.

Conclusions: Repeated transient fluctuations in tumor markers and measurements are a characteristic of patients with MTC receiving treatment with RET inhibitors, and such short-term vacillations may not reflect responsiveness over the long term.

Clinical trials included: NCT00215605; NCT00244972; NCT00121680; NCT00495872.

Keywords: RET inhibition; calcitonin; carcinoembryonic antigen; medullary thyroid carcinoma.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anilides / therapeutic use
  • Antineoplastic Agents / therapeutic use
  • Biomarkers, Tumor / blood*
  • Biomarkers, Tumor / genetics
  • Calcitonin / blood*
  • Carcinoembryonic Antigen / blood*
  • Carcinoma, Neuroendocrine
  • Disease Progression
  • Female
  • Humans
  • Indoles / therapeutic use
  • Male
  • Middle Aged
  • Niacinamide / analogs & derivatives
  • Niacinamide / therapeutic use
  • Phenylurea Compounds / therapeutic use
  • Proto-Oncogene Proteins c-ret / antagonists & inhibitors*
  • Proto-Oncogene Proteins c-ret / genetics
  • Pyridines / therapeutic use
  • Pyrroles / therapeutic use
  • Quinolines / therapeutic use
  • Quinolones / therapeutic use
  • Retrospective Studies
  • Sorafenib
  • Sunitinib
  • Thyroid Neoplasms / drug therapy*
  • Thyroid Neoplasms / genetics
  • Treatment Outcome
  • Valproic Acid / therapeutic use

Substances

  • Anilides
  • Antineoplastic Agents
  • Biomarkers, Tumor
  • Carcinoembryonic Antigen
  • Indoles
  • Phenylurea Compounds
  • Pyridines
  • Pyrroles
  • Quinolines
  • Quinolones
  • cabozantinib
  • Niacinamide
  • Valproic Acid
  • Calcitonin
  • Sorafenib
  • Proto-Oncogene Proteins c-ret
  • RET protein, human
  • lenvatinib
  • tipifarnib
  • Sunitinib

Supplementary concepts

  • Thyroid cancer, medullary

Associated data

  • ClinicalTrials.gov/NCT00121680
  • ClinicalTrials.gov/NCT00215605
  • ClinicalTrials.gov/NCT00244972
  • ClinicalTrials.gov/NCT00495872