ONCAlert | 2018 ASCO Annual Meeting
Colorectal Cancer Case Studies

Tara Seery, MD: Main Adverse Events With Regorafenib

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 main adverse events associated with regorafenib?

The main adverse event of Stivarga is skin reaction. Hand-foot skin reaction is very common, and patients can also have a rash. Other common side effects include fatigue. Unfortunately, the majority of patients are coming in with some sort of fatigue.

Anorexia is another one and it's not uncommon for patients to have dysgeusia and an overall lack of appetite. Furthermore, you could have diarrhea, which can be easily treated with imodium.

Hypertension is another common side effect and blood pressure needs to be monitored weekly on patients. The other side effects are not as common, but it's still important that you see the patient on a weekly basis when you are initiating this drug.

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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