Dana M Chase1, Helen Huang2, Cassandra D Foss3, Lari B Wenzel4, Bradley J Monk5, Robert A Burger6. 1. University of Arizona Cancer Center at Dignity Health St. Joseph's Hospital and Medical Center, Phoenix, AZ 85013, USA. Electronic address: Dana.Chase@DignityHealth.org. 2. NRG Oncology Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, NY 14263, USA. Electronic address: hhuang@gogstats.org. 3. University of Arizona Cancer Center at Dignity Health St. Joseph's Hospital and Medical Center, Phoenix, AZ 85013, USA. Electronic address: cassandrafoss@gmail.com. 4. University of California Irvine, Irvine, CA 92697, USA. Electronic address: lwenzel@uci.edu. 5. University of Arizona Cancer Center at Dignity Health St. Joseph's Hospital and Medical Center, Phoenix, AZ 85013, USA. Electronic address: Bradley.Monk@DignityHealth.org. 6. University of Pennsylvania-Philadelphia, Philadelphia, PA 19104, USA. Electronic address: robert.burger@uphs.upenn.edu.
Abstract
OBJECTIVES: To describe characteristics associated with neurotoxicity (NT) in advanced ovarian cancer patients treated on Gynecologic Oncology Group 218 and examine effect of substituting docetaxel for paclitaxel in these patients. METHODS: The development of NT was defined as Common Toxicity Criteria grade (G)≥1. The association between substitution with docetaxel and NT improvement was explored with generalized estimating equations adjusting for treatment cycle and NT grading at previous cycle. RESULTS: Of 1864 evaluable patients, 1329 (71%) developed G≥1 NT during the study. Nearly half appeared within the first two cycles of chemotherapy, with 31% experiencing G≥2. Older patients or those with worse quality of life (QoL) scores at baseline (p<0.05) were more likely to experience NT. One-hundred-six patients received docetaxel as substitute for paclitaxel. Of them, 47 patients started with docetaxel at cycle one due to reaction to paclitaxel (n=32), fear of NT (n=4), and other reasons (n=11), whereas 59 patients switched todocetaxel during cycle 2-6 due to NT (n=32), reaction to paclitaxel (n=19), and other reasons (n=8). Although the protocol instructed otherwise, the majority continued paclitaxel despite G≥2 NT symptoms. There was no evidence that substitution with docetaxel improved NT (Odds Ratio: 1.57; 95% CI 0.98-2.54; p>0.05). Of 59 patients who switched to docetaxel, only seven (12%) discontinued taxane prior to chemotherapy completion. A roughly equal chance of worsening NT was reported on paclitaxel (6%) as on docetaxel (5%). CONCLUSIONS: Age and worse QoL at baseline are associated with NT. Substitution of docetaxel did not improve NT symptoms.
RCT Entities:
OBJECTIVES: To describe characteristics associated with neurotoxicity (NT) in advanced ovarian cancerpatients treated on Gynecologic Oncology Group 218 and examine effect of substituting docetaxel for paclitaxel in these patients. METHODS: The development of NT was defined as Common Toxicity Criteria grade (G)≥1. The association between substitution with docetaxel and NT improvement was explored with generalized estimating equations adjusting for treatment cycle and NT grading at previous cycle. RESULTS: Of 1864 evaluable patients, 1329 (71%) developed G≥1 NT during the study. Nearly half appeared within the first two cycles of chemotherapy, with 31% experiencing G≥2. Older patients or those with worse quality of life (QoL) scores at baseline (p<0.05) were more likely to experience NT. One-hundred-six patients received docetaxel as substitute for paclitaxel. Of them, 47 patients started with docetaxel at cycle one due to reaction to paclitaxel (n=32), fear of NT (n=4), and other reasons (n=11), whereas 59 patients switched to docetaxel during cycle 2-6 due to NT (n=32), reaction to paclitaxel (n=19), and other reasons (n=8). Although the protocol instructed otherwise, the majority continued paclitaxel despite G≥2 NT symptoms. There was no evidence that substitution with docetaxel improved NT (Odds Ratio: 1.57; 95% CI 0.98-2.54; p>0.05). Of 59 patients who switched to docetaxel, only seven (12%) discontinued taxane prior to chemotherapy completion. A roughly equal chance of worsening NT was reported on paclitaxel (6%) as on docetaxel (5%). CONCLUSIONS: Age and worse QoL at baseline are associated with NT. Substitution of docetaxel did not improve NT symptoms.
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