Carboplatin and paclitaxel for advanced endometrial cancer: Final overall survival and adverse event analysis of a phase III trial (NRG Oncology/GOG0209)

David S. Miller, Virginia L. Filiaci, Robert S. Mannel, David E. Cohn, Takashi Matsumoto, Krishnansu S. Tewari, Paul DiSilvestro, Michael L. Pearl, Peter A. Argenta, Matthew A. Powell, Susan L. Zweizig, David P. Warshal, Parviz Hanjani, Michael E. Carney, Helen Huang, David Cella, Richard Zaino, Gini F. Fleming

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)3841-3850
Number of pages10
JournalJournal of Clinical Oncology
Volume38
Issue number33
DOIs
StatePublished - Nov 20 2020

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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