PURPOSE Limitations of the paclitaxel-doxorubicin-cisplatin (TAP) regimen in the treatment of endometrial cancer include tolerability and cumbersome scheduling. The Gynecologic Oncology Group studied carboplatin plus paclitaxel (TC) as a noninferior alternative to TAP. METHODS GOG0209 was a phase III, randomized, noninferiority, open-label trial. Inclusion criteria were stage III, stage IV, and recurrent endometrial cancers; performance status 0-2; and adequate renal, hepatic, and marrow function. Prior radiotherapy and/or hormonal therapy were permitted, but chemotherapy, including radio-sensitization, was not. Patients were treated with doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 (day 1), followed by paclitaxel 160 mg/m2 (day 2) with granulocyte colony-stimulating factor or paclitaxel 175 mg/m2 and carboplatin area under the curve 6 (day 1) every 21 days for seven cycles. The primary endpoint was overall survival (OS; modified intention to treat). Progression-free survival (PFS), health-related quality of life (HRQoL), and toxicity were secondary endpoints. RESULTS From 2003 to 2009, 1,381 women were enrolled. Noninferiority of TC to TAP was concluded for OS (median, 37 v 41 months, respectively; hazard ratio [HR], 1.002; 90% CI, 0.9 to 1.12), and PFS (median, 13 v 14 months; HR, 1.032; 90% CI, 0.93 to 1.15). Neutropenic fever was reported in 7% of patients receiving TAP and 6% of those receiving TC. Grade. 2 sensory neuropathy was recorded in 26% of patients receiving TAP and 20% receiving TC (P 5.40). More grade $ 3 thrombocytopenia (23% v 12%), vomiting (7% v 4%), diarrhea (6% v 2%), and metabolic (14% v 8%) toxicities were reported with TAP. Neutropenia (52% v 80%) was more common with TC. Small HRQoL differences favored TC. CONCLUSION With demonstrated noninferiority to TAP, TC is the global first-line standard for advanced endometrial cancer.
Bibliographical noteFunding Information:
Supported by National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (CA 27469), Gynecologic Oncology Group Statistical Office (CA 37517), NRG Oncology (1 U10 CA180822), NRG Operations (U10CA180868), and UG1CA189867 (National Cancer Institute Community Oncology Research Program). The study’s data safety and monitoring board (DSMB) comprised scientists
Supported by National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (CA 27469), Gynecologic Oncology Group Statistical Office (CA 37517), NRG Oncology (1 U10 CA180822), NRG Operations (U10CA180868), and UG1CA189867 (National Cancer Institute Community Oncology Research Program). The study's data safety and monitoring board (DSMB) comprised scientists approved by the funder. The funder did not write the manuscript or decide where it should be submitted. The funder approved the study design. Collected data were provided to the funder for database upload. The DSMB evaluated and interpreted summarized data. The funder's Cancer Therapeutics Evaluation Program reviewed and approved the final version of the manuscript before submission. D.S.M. and V.L.F. had full access to all the data in the study after the data analysis and interpretation by the DSMB had been completed. The decision to submit for publication was made by the corresponding author and approved by all other authors and the NRG Oncology Publications Committee.
© 2020 by American Society of Clinical Oncology
PubMed: MeSH publication types
- Clinical Trial, Phase III
- Journal Article
- Multicenter Study
- Randomized Controlled Trial
- Research Support, N.I.H., Extramural