University of Pennsylvania, Philadelphia, PA
Emily Meichun Ko , James Java , Kathryn Schmitz , Marcus Randall , Jeffrey Bloss , Gini F. Fleming , David H. Moore , Bradley J. Monk , Hyman B. Muss , Linda Van Le
Background: To evaluate chemotoxicity and quality of life (QOL) in older women undergoing treatment for recurrent and advanced cervical cancer within Gynecologic Oncology Group (GOG) phase III chemotherapy trials. Methods: 5 trials (GOG 110, 149, 169, 179, 204) were used to characterize chemotoxicity profiles by age. ‘Older’ was defined as age ≥ 65. Toxicity was based on GOG or CTC scales. Concordant chemotherapy arms between trials were pooled: Cisplatin (C), cisplatin/ifosfamide (CI); cisplatin/topotecan (CT); cisplatin/paclitaxel (CP). Categorical variables were compared using the Pearson chi-square test. The Cox PH model was used to evaluate prognostic factors (at baseline or before a landmark) and to estimate the adjusted effects on survival. Poisson models of toxicity as a function of age were examined. Associations between age and QOL using Fact-G and Fact-Cx (GOG 169,179, 204) were assessed with linear mixed models. Results: 1201 women were evaluated (C: 407; CI: 288; CT: 255; CP: 251). Median age was 65 (IQR 58–71) and 107 were age ≥ 65. Being older was associated with improved PFS for C (HR 0.99, 95%CI .98-1.00) and CT (HR 0.98, 95%CI 0.96-0.99); and improved OS in CP (HR0.98, 95CI 0.97-1.00) and CT (HR 0.98, 95%CI0.97-0.99) in adjusted models. The most frequent grade ≥ 3 toxicities in those age ≥ 65 were leukopenia (85% for CP; 80% for CT; 92% for CI), anemia (40% for CT) and thrombocytopenia (40% in CT). Neuropathy and neurologic toxicity did not differ by age for any regimen. Grade ≥ 3 toxicities that differed significantly by age and were most frequent in older women included leukopenia (85%, p = 0.058) for CP; nausea-vomiting (30%, p = 0.03) and metabolic (25%, p = 0.04) for CT. However, age was not associated with overall toxicity for any regimen in the adjusted models. Toxicity did not confound age-dependent outcomes on PFS or OS. QOL did not differ by age group for any regimen. Conclusions: Older age was not associated with severe toxicity or poorer quality of life in women who underwent chemotherapy for advanced or recurrent cervical cancer in phase III national consortia trials. Older patients should be encouraged to participate in cervical cancer trials.
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