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Impact of veliparib, paclitaxel dosing regimen, and germline BRCA status on the primary treatment of serous ovarian cancer - an ancillary data analysis of the VELIA trial.
Aghajanian, Carol; Swisher, Elizabeth M; Okamoto, Aikou; Steffensen, Karina Dahl; Bookman, Michael A; Fleming, Gini F; Friedlander, Michael; Moore, Kathleen N; Tewari, Krishnansu S; O'Malley, David M; Chan, John K; Ratajczak, Christine; Hashiba, Hideyuki; Wu, Meijing; Dinh, Minh H; Coleman, Robert L.
Afiliação
  • Aghajanian C; Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: aghajanc@MSKCC.ORG.
  • Swisher EM; Department of Obstetrics and Gynecology, University of Washington, Seattle, WA, USA.
  • Okamoto A; Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan.
  • Steffensen KD; Department of Oncology, Lillebaelt University Hospital of Southern Denmark, Vejle, Denmark.
  • Bookman MA; Kaiser Permanente Northern California, San Francisco, CA, USA.
  • Fleming GF; The University of Chicago Medicine, Chicago, IL, USA.
  • Friedlander M; Prince of Wales Clinical School UNSW, Prince of Wales Hospital and ANZGOG, Sydney, Australia.
  • Moore KN; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
  • Tewari KS; University of California, Irvine Medical Center, Orange, CA, USA.
  • O'Malley DM; The Ohio State University Comprehensive Cancer Center - James, Columbus, OH, USA.
  • Chan JK; Palo Alto Medical Foundation, California Pacific Medical Center, Sutter Health, San Francisco, CA, USA.
  • Ratajczak C; AbbVie Inc., North Chicago, IL, USA.
  • Hashiba H; AbbVie GK, Tokyo, Japan.
  • Wu M; AbbVie Inc., North Chicago, IL, USA.
  • Dinh MH; AbbVie Inc., North Chicago, IL, USA.
  • Coleman RL; US Oncology Research, The Woodlands, TX, USA.
Gynecol Oncol ; 164(2): 278-287, 2022 02.
Article em En | MEDLINE | ID: mdl-34930617
ABSTRACT

OBJECTIVE:

In the Phase 3 VELIA trial (NCT02470585), veliparib added to carboplatin plus paclitaxel concomitantly and as maintenance for women with newly-diagnosed advanced ovarian cancer significantly improved progression-free survival (PFS) versus chemotherapy alone. Here we present exploratory analyses by paclitaxel dosing schedule and germline BRCA (gBRCA) status.

METHODS:

Women with untreated ovarian carcinoma were randomized (111) to veliparib during chemotherapy and maintenance (veliparib-throughout), veliparib during chemotherapy followed by placebo maintenance (veliparib-combination only), or placebo during chemotherapy and maintenance (control). Chemotherapy included carboplatin plus dose-dense (DD; weekly) or every-3-week (Q3W) paclitaxel (a stratification factor at randomization), selected at the investigator's discretion pre-randomization. PFS was assessed by paclitaxel dosing schedule using a Cox proportional hazard model adjusted by treatment arm and stratification factors; safety was analyzed based on paclitaxel dosing schedule and gBRCA status.

RESULTS:

1132 patients were analyzed by paclitaxel schedule. Pooled treatment arms demonstrated longer median PFS with DD (n = 586) versus Q3W (n = 546) paclitaxel (ITT 20.5 vs 15.7 months, hazard ratio [HR] 0.77; homologous recombination proficient cancer 15.1 vs 11.8 months, HR 0.64; BRCAwt 18.0 vs 12.9 months, HR 0.70). Comparison between arms favored veliparib-throughout versus control in both DD (PFS, 24.2 vs 18.3 months, hazard ratio 0.67) and Q3W (19.3 vs 14.6, hazard ratio 0.69) subgroups. DD paclitaxel was associated with higher incidence of Grade 3/4 neutropenia, fatigue, and anemia versus Q3W. There were no differences in toxicity between gBRCAm (n = 211) and gBRCAwt (n = 902) subgroups.

CONCLUSIONS:

DD paclitaxel was tolerable and associated with longer PFS in the HR proficient and gBRCAwt groups, versus Q3W. gBRCA status did not impact safety.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Ovarianas / Benzimidazóis / Protocolos de Quimioterapia Combinada Antineoplásica / Paclitaxel / Neoplasias Císticas, Mucinosas e Serosas / Síndrome Hereditária de Câncer de Mama e Ovário / Inibidores de Poli(ADP-Ribose) Polimerases / Carcinoma Epitelial do Ovário Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Aged / Aged80 / Female / Humans / Middle aged Idioma: En Revista: Gynecol Oncol Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Ovarianas / Benzimidazóis / Protocolos de Quimioterapia Combinada Antineoplásica / Paclitaxel / Neoplasias Císticas, Mucinosas e Serosas / Síndrome Hereditária de Câncer de Mama e Ovário / Inibidores de Poli(ADP-Ribose) Polimerases / Carcinoma Epitelial do Ovário Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Aged / Aged80 / Female / Humans / Middle aged Idioma: En Revista: Gynecol Oncol Ano de publicação: 2022 Tipo de documento: Article