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Randomized Phase III Trial of Whole-Abdominal Irradiation Versus Doxorubicin and Cisplatin Chemotherapy in Advanced Endometrial Carcinoma: A Gynecologic Oncology Group Study
Open accessAbstract
Purpose: To compare whole-abdominal irradiation (WAI) and doxorubicin-cisplatin (AP) chemotherapy in women with stage III or IV endometrial carcinoma having a maximum of 2 cm of postoperative residual disease. Patients and Methods: Four hundred twenty-two patients were entered onto this trial. Of 396 assessable patients, 202 were randomly allocated to receive WAI, and 194 were allocated to receive AP. Irradiation dosage was 30 Gy in 20 fractions, with a 15-Gy boost. Chemotherapy consisted of doxorubicin 60 mg/m 2 and cisplatin 50 mg/m 2 every 3 weeks for seven cycles, followed by one cycle of cisplatin. Results: Most patient and tumor characteristics were well balanced. The median patient age was 63 years; 50% had endometrioid tumors. Median follow-up time was 74 months. The hazard ratio for progression adjusted for stage was 0.71 favoring AP (95% CI, 0.55 to 0.91; P < .01). At 60 months, 50% of patients receiving AP were predicted to be alive and disease free when adjusting for stage compared with 38% of patients receiving WAI. The stage-adjusted death hazard ratio was 0.68 (95% CI, 0.52 to 0.89; P < .01) favoring AP. Moreover, at 60 months and adjusting for stage, 55% of AP patients were predicted to be alive compared with 42% of WAI patients. Greater acute toxicity was seen with AP. Treatment probably contributed to the deaths of eight patients (4%) on the AP arm and five patients (2%) on the WAI arm. Conclusion: Chemotherapy with AP significantly improved progression-free and overall survival compared with WAI. Nevertheless, further advances in efficacy and reduction in toxicity are clearly needed.
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Cited by
Walker, J. L., Piedmonte, M. R., Spirtos, N. M., Eisenkop, S. M., Schlaerth, J. B., Mannel, R. S., Spiegel, G., Barakat, R., Pearl, M. L., & Sharma, S. K. (2009) · Journal of Clinical Oncology · doi:10.1200/jco.2009.22.3248 · Cited by 1,288
Self-citationRossi, E. C., Kowalski, L. D., Scalici, J., Cantrell, L., Schuler, K., Hanna, R. K., Method, M., Ade, M., Ivanova, A., & Boggess, J. F. (2017) · The Lancet Oncology · doi:10.1016/s1470-2045(17)30068-2 · Cited by 937
Endometrial cancer: A review and current management strategies: Part II
Burke, W. M., Orr, J., Leitao, M., Salom, E., Gehrig, P., Olawaiye, A. B., Brewer, M., Boruta, D., Herzog, T. J., & Shahin, F. A. (2014) · Gynecologic Oncology · doi:10.1016/j.ygyno.2014.06.003 · Cited by 459
Salani, R., Backes, F. J., Fung Kee Fung, M., Holschneider, C. H., Parker, L. P., Bristow, R. E., & Goff, B. A. (2011) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2011.03.008 · Cited by 428
Cancer of the corpus uteri: 2021 update
Koskas, M., Amant, F., Mirza, M. R., & Creutzberg, C. L. (2021) · International Journal of Gynecology & Obstetrics · doi:10.1002/ijgo.13866 · Cited by 298
Metadata
- Authors
- Randall, M. E., Filiaci, V. L., Muss, H., Spirtos, N. M., Mannel, R. S., Fowler, J., Thigpen, J. T., & Benda, J. A.
- Venue
- Journal of Clinical Oncology
- Published
- 2006-01-01
- Volume
- 24
- Issue
- 1
- Pages
- 36-44
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2098960933
- Cited by
- 872
- References
- 20
- FWCI
- 37.39
- Type
- journal article
- Language
- en
- Open access
- bronze
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