TY - JOUR
T1 - Carboplatin and paclitaxel for advanced endometrial cancer
T2 - Final overall survival and adverse event analysis of a phase III trial (NRG Oncology/GOG0209)
AU - Miller, David S.
AU - Filiaci, Virginia L.
AU - Mannel, Robert S.
AU - Cohn, David E.
AU - Matsumoto, Takashi
AU - Tewari, Krishnansu S.
AU - DiSilvestro, Paul
AU - Pearl, Michael L.
AU - Argenta, Peter A.
AU - Powell, Matthew A.
AU - Zweizig, Susan L.
AU - Warshal, David P.
AU - Hanjani, Parviz
AU - Carney, Michael E.
AU - Huang, Helen
AU - Cella, David
AU - Zaino, Richard
AU - Fleming, Gini F.
N1 - Publisher Copyright:
© 2020 by American Society of Clinical Oncology
PY - 2020/11/20
Y1 - 2020/11/20
N2 - 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.
AB - 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.
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U2 - 10.1200/JCO.20.01076
DO - 10.1200/JCO.20.01076
M3 - Article
C2 - 33078978
AN - SCOPUS:85096358999
SN - 0732-183X
VL - 38
SP - 3841
EP - 3850
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 33
ER -