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Transdermal granisetron for the prevention of chemotherapy-induced nausea and vomiting in metastatic colorectal cancer patients with high risk of bowel obstruction treated with temozolomide

Date

09 Oct 2016

Session

Poster display

Presenters

Maria Alessandra Calegari

Citation

Annals of Oncology (2016) 27 (6): 497-521. 10.1093/annonc/mdw390

Authors

M.A. Calegari1, S. Monterisi1, A. Orlandi1, A. Inno2, R. Barile1, S. Corallo1, C. Di Dio1, V. Zurlo1, M. Basso1, A. Cassano1, C. Barone1

Author affiliations

  • 1 Medicina Interna - U.o.c. Di Oncologia Medica, Policlinico Universitario A. Gemelli, 00168 - Roma/IT
  • 2 Medical Oncology, Ospedale S.Cuore, 37024 - Negrar/IT
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Background

Temozolomide (TMZ) showed efficacy in patients with refractory metastatic colorectal cancer (mCRC) and MGMT promoter methylation. As moderately emetogenic chemotherapy, TMZ requires administration of 5HT3 antagonists for chemotherapy-induced nausea and vomiting (CINV) prevention. Both TMZ and 5HT3 antagonists could cause constipation; besides mCRC patients might have a high risk of bowel obstruction due to disease features (adhesions, local relapses and peritoneal carcinomatosis) and use of opioids. In an ongoing phase II trial we performed an exploratory analysis to compare efficacy and safety of two antiemetic regimens with different risk of constipation.

Methods

32 patients with refractory MGMT hypermethylated mCRC receiving TMZ (200 mg/m2/day on days 1-5 every 4 weeks) were assigned with a ratio of 2:1 to oral metoclopramide (10 mg PO TID on days 1-5) or transdermal granisetron (Sancuso®) (3.1 mg/24 h on days 1-7). Patient filled in a diary reporting nausea, emetic episodes and constipation. Adverse events were recorded and scored according to CTCAE. A two-sided Fisher's exact test was used to evaluate differences in nausea, vomiting, constipation and bowel obstruction (p-value

Results

From July 2013 to January 2016, 22 patients received metoclopramide and 10 patients granisetron. Patients' characteristics were well balanced between the two groups both for previous abdominal surgery and opioid therapy, whereas peritoneal carcinomatosis rate was higher in patients receiving granisetron (60 vs 13.6%). The incidence of CINV was statistically significant lower in the granisetron group both for nausea (0 vs 95%, p 

Conclusions

Our results showed that transdermal granisetron is more effective in CINV prevention and as safe as oral metoclopramide in terms of rate of constipation and bowel obstruction in patients affected by mCRC receiving TMZ. Thus transdermal granisetron might represent a standard in CINV prevention in this setting.

Clinical trial identification

EudraCT 2012-002766-13

Legal entity responsible for the study

Fondazione Policlinico "A. Gemelli", Rome

Funding

Fondazione Policlinico "A. Gemelli", Rome

Disclosure

All authors have declared no conflicts of interest.

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