Abstract
Purpose
To compare rates of complete response (no emesis, retching, or rescue antiemetics) in the late phase (days 4–7 post-chemotherapy) of cycle 1 between transdermal granisetron and oral ondansetron in cervical, endometrial, or vaginal cancer survivors undergoing chemoradiation at The University of Texas MD Anderson Cancer Center and LBJ Hospital in Houston, TX.
Methods
In this non-blinded parallel design trial, eligible patients received a granisetron patch replaced every 7 days or 8 mg of ondansetron thrice daily continued for 72 h after chemotherapy completion. Data were collected on medication compliance, episodes of chemotherapy-induced nausea and vomiting (CINV), use of rescue antiemetics, and effects of CINV on quality of life.
Results
Seventy-five survivors receiving chemoradiation for cervical (n = 61), endometrial (n = 12), or vaginal (n = 2) cancer were electronically randomized to transdermal granisetron (n = 41) or oral ondansetron (n = 34). In the late phase of cycle 1, the rate of complete response was 49.8% (95% CI, 35.2–64.3%) for transdermal granisetron and 39.7% (95% CI, 24.4–56.1%) for oral ondansetron. The posterior probability that transdermal granisetron achieved a higher success rate in controlling late-onset CINV compared with oral ondansetron was 82%. During the acute phase (day 1 post-chemotherapy) of cycles 2 and 3, transdermal granisetron patients used more rescue antiemetics than oral ondansetron patients (p = 0.006 and p = 0.003, respectively). Otherwise, no between-group differences in CINV events were observed. Medication compliance and the effect of CINV on quality of life were similar between groups.
Conclusion
Transdermal granisetron was 82% more like to control CINV than oral ondansetron in the late phase of cycle 1 and performed similarly to oral ondansetron in all other cycles. Transdermal granisetron should be considered an option as prophylactic antiemetic therapy for gynecologic cancer survivors undergoing chemoradiation.
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Funding
This study was supported in part by Kiowa Kirin and the National Cancer Institute under award number P30CA016672, which supports the MD Anderson Cancer Center Clinical Trials Support Resource.
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Concept and design, MF; acquisition, analysis, or interpretation of the data, all authors; statistical analysis, BF; study supervision, MF; approval of the final version of the manuscript, all authors; drafting of the manuscript, SA and MF; critical revision of the manuscript for important intellectual consent, all authors.
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Dr. Frumovitz reports personal fees from Genetech, personal fees from Ipsen, grants, personal fees, and non-financial support from Stryker, outside the submitted work. No other conflicts exist for other authors.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (IRB, 2011-1107) and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
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Armbruster, S.D., Fellman, B.M., Jhingran, A. et al. A phase III study of transdermal granisetron versus oral ondansetron for women with gynecologic cancers receiving pelvic chemoradiation. Support Care Cancer 29, 213–222 (2021). https://doi.org/10.1007/s00520-020-05484-z
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DOI: https://doi.org/10.1007/s00520-020-05484-z