ONCAlert | 2018 ASCO Annual Meeting
Colorectal Cancer Case Studies

Tara Seery, MD: Regorafenib Dose Adjustments

Tara Seery, MD
Published Online:Mar 18, 2016
Marie, a 61-year-old female, is diagnosed with mCRC in July of 2013 after presenting to her PCP with symptoms of abdominal fullness and abnormal bowel movements of several weeks' duration.

mCRC with Tanios Bekaii-Saab, MD and Tara Seery, MD: Case 1

What are the principle recommendations for dose adjustments in patients like Marie on regorafenib therapy?

The dose adjustments for regorafinib are very well laid out. If a patient develops a hand-foot reaction, if it is a grade 2, you must reduce the dose right away. Dose reductions are in 40 mg increments. if a patient then develops a grade 3 hand-foot skin reaction, then you have to stop the medication, let the skin reaction resolve, and then start at a lower dose.

For other side effects, either grade 3 or grade 4, you must hold the medication and let the side effect resolve, and then start at a lower dose of 40 mg or less. For hypertension, if a patient develops a grade 2 hypertension with symptoms, then you must stop the drug, and once that hypertension improves then you can restart at a lower level.

Case 1: mCRC

Marie K. is a 61-year-old female from Indianapolis, Indiana, who works as a corporate IT consultant. In July of 2013, she was diagnosed with mCRC after presenting to her PCP with symptoms of abdominal fullness and abnormal bowel movements of several weeks’ duration.

  • Medical history is notable for hip replacement in 2011, and mild GERD
  • CT scans of the abdomen and pelvis suggest presence of multiple peritoneal implants with mild ascites
  • Her initial biopsy showed a well-differentiated adenocarcinoma with molecular testing showed RAS-WT and BRAF- WT disease
  • She received initial therapy with FOLFIRI and cetuximab, and showed good response after 4 cycles

In March of 2014, she returned to her oncologist for a follow-up, and her CT scan showed evidence of progression, with visceral peritoneal metastases and ascites, as well as increasing CEA levels (40.2 ng/mL); her ECOG performance status at time of progression was 0

  • She was switched to FOLFOX and bevacizumab, with a good response. She had a marked decrease in CEA levels and improvement in her abdominal ascites after 3 cycles of therapy

In January of 2015, she returned for follow up with symptoms of abdominal fullness, increasing fatigue, and declining performance status (PS 1); PET/CT scan at that time showed marked progression of multiple target lesions.

  • She began treatment with regorafenib at a dose of 160 mg, but treatment was interrupted for 1 week after she developed moderate fatigue and grade 3 hand-foot skin reaction (HFSR); her liver function tests were within normal limits before and during treatment
  • Her condition improved, and treatment with regorafenib was re-initiated at a dose of 120 mg
  • Patient tolerated the reduced dose, with some mild fatigue, through 8 cycles of treatment; her disease remained stable on PET/CT at her 2-, 4-, and 6-month assessments, and performance status improved (PS 0)
  • She was scheduled to undergo oral surgery (dental implants) in October of 2015, and her treatment was interrupted 2 weeks prior to surgery

She returns for follow up 4 weeks after the procedure, with good wound healing and a PS of 0. Her PET/CT scan shows moderate progression of the peritoneal metastases and several new hepatic lesions. Her CEA has also increased to 27.7 ng/mL. Liver and kidney function remain within normal limits.

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