@article{a77dcfa5ab8a4e0c9535e1e712536770,
title = "OV21/PETROC: A randomized Gynecologic Cancer Intergroup phase II study of intraperitoneal versus intravenous chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer",
abstract = "Background: The purpose of this multistage, adaptively, designed randomized phase II study was to evaluate the role of intraperitoneal (i.p.) chemotherapy following neoadjuvant chemotherapy (NACT) and optimal debulking surgery in women with epithelial ovarian cancer (EOC). Patients and methods: We carried out a multicenter, two-stage, phase II trial. Eligible patients with stage IIB-IVA EOC treated with platinum-based intravenous (i.v.) NACT followed by optimal (<1 cm) debulking surgery were randomized to one of the three treatment arms: (i) i.v. carboplatin/paclitaxel, (ii) i.p. cisplatin plus i.v./i.p. paclitaxel, or (iii) i.p. carboplatin plus i.v./i.p. paclitaxel. The primary end point was 9-month progressive disease rate (PD9). Secondary end points included progression-free survival (PFS), overall survival (OS), toxicity, and quality of life (QOL). Results: Between 2009 and 2015, 275 patients were randomized; i.p. cisplatin containing arm did not progress beyond the first stage of the study after failing to meet the pre-set superiority rule. The final analysis compared i.v. carboplatin/paclitaxel (n=101) with i.p. carboplatin, i.v./i.p. paclitaxel (n=102). The intention to treat PD9 was lower in the i.p. carboplatin arm compared with the i.v. carboplatin arm: 24.5% (95% CI 16.2% to 32.9%) versus 38.6% (95% CI 29.1% to 48.1%) P=0.065. The study was underpowered to detect differences in PFS: HR PFS 0.82 (95% CI 0.57-1.17); P=0.27 and OS HR 0.80 (95% CI 0.47-1.35) P=0.40. The i.p. carboplatin-based regimen was well tolerated with no reduction in QOL or increase in toxicity compared with i.v. administration alone. Conclusion: In women with stage IIIC or IVA EOC treated with NACT and optimal debulking surgery, i.p. carboplatin-based chemotherapy is well tolerated and associated with an improved PD9 compared with i.v. carboplatin-based chemotherapy. Clinical trial number: clinicaltrials.gov, NCT01622543.",
keywords = "I.p. chemotherapy, Neoadjuvant, Ovarian cancer",
author = "Provencher, {D. M.} and Gallagher, {C. J.} and Parulekar, {W. R.} and Ledermann, {J. A.} and Armstrong, {D. K.} and M. Brundage and C. Gourley and I. Romero and A. Gonzalez-Martin and M. Feeney and P. Bessette and M. Hall and Weberpals, {J. I.} and G. Hall and Lau, {S. K.} and P. Gauthier and M. Fung-Kee-Fung and Eisenhauer, {E. A.} and C. Winch and D. Tu and MacKay, {H. J.}",
note = "Funding Information: Canada: Dr H. Bliss Murphy Cancer Centre: Patti Power; QEII Health Sciences Centre: Katharina Keiser; Atlantic Health Sciences Corporation: Margot Burnell; Centre Hospitalier Universitaire De Sherbrooke: Paul Bessette; CHUQ-Pavillon Hotel-Dieu de Quebec: Marie Plante; Hopital Maisonneuve-Rosemount: Suzanne Fortin; McGill University (Jewish General Hospital): Susie Lau; CHUM-Hopital Notre-Dame: Diane Provencher; Cancer Centre of Southeastern Ontario at Kingston: Julie Francis; Ottawa Health Research Institute: Johanne Weberpals; Princess Margaret Hospital: Amit Oza; London Regional Cancer Program: Jacob McGee; Tom Baker Cancer Centre: Prafull Ghatage; Cross Cancer Institute: Valerie Capstick; Vancouver Cancer Centre: Anna Tinker; Fraser Valley Cancer Centre: Ursula Lee; Cancer Centre for the Southern Interior: Marianne Taylor. NCRI (UCL), UK: Mount Vernon: Marcia Hall; Royal Marsden Hospital: Martin Gore; Derriford Hospital: Dennis Yiannakis; Western General Hospital: Charlie Gourley; Liverpool Women{\textquoteright}s Hospital: Rosemary Lord; The Christie Hospital: Andrew Clamp; University College Hospital: Jonathan Ledermann; St. James{\textquoteright}s University Hospital: Geoff Hall; St. Bartholomew{\textquoteright}s Hospital: Chris Gallagher, Michelle Lockley; Clatterbridge Centre for Oncology: Rosemary Lord; St. Marys Hospital: Richard Clayton; Wexham Park Hospital: Marcia Hall. GEICO, Spain: H. Valle Hebron: Ana Oaknin, Antonio Gill; IVO: Ignacio Romero, Christina Zorrero; H. Clinico Universitario de Valencia: Andres Cervantes, Victor Martin; H. Alcorcon: Susana Hernando, Judith Albareda; H. Clinic De Barcelona: Cecila Orbegozo, Sergio Martinez; Ico L{\textquoteright}Hospitalet: Beatriz Pardo, Jordi Ponce; H. Sant Pau; Alfonso Gomez de Liano, Ramon Rovira. SWOG, USA: Coxhealth—Cancer Research for the Ozarks NCORP (MO042): Robert L. Carolla; University of Oklahoma Health Sciences Center – Stephenson Cancer Centre (OK003): Robert S. Mannel; Women & Infants Hospital of Rhode Island (RI012): Cara A. Mathews; University of Utah – Huntsman Cancer Institute (UT003): Theresa L. Werner. Funding Information: Canadian Cancer Society Research Institute (CCSRI) (#015469 and 021039); Cancer Research UK (CRUK) (CC14202/A10994); National Institute for Health Research (NIHR) study funded by Cancer Research UK Grant A18781; and SWOG NIH/NCI (CA180888, CA180798, CA189822, and CA180818). Publisher Copyright: {\textcopyright} The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.",
year = "2018",
month = feb,
day = "1",
doi = "10.1093/annonc/mdx754",
language = "English (US)",
volume = "29",
pages = "431--438",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "Oxford University Press",
number = "2",
}