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A randomised, placebo-controlled trial of weekly paclitaxel and saracatinib (AZD0530) in platinum-resistant ovarian, fallopian tube or primary peritoneal cancer

McNeish, IA, Ledermann, JA, Webber, L, James, L, Kaye, SB, Hall, M, Hall, G, Clamp, A, Earl, H, Banerjee, S, Kristeleit, R, Raja, F, Feeney, A, Lawrence, C, Dawson-Athey, L, Persic, M and Khan, I (2014) A randomised, placebo-controlled trial of weekly paclitaxel and saracatinib (AZD0530) in platinum-resistant ovarian, fallopian tube or primary peritoneal cancer Annals of Oncology, 25 (10). pp. 1988-1995.

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Abstract

Background: We investigated whether the Src inhibitor saracatinib (AZD0530) improved efficacy of weekly paclitaxel in platinum-resistant ovarian cancer. Patients and methods: Patients with platinum-resistant ovarian, fallopian tube or primary peritoneal cancer were randomised 2 : 1 to receive 8-week cycles of weekly paclitaxel (wPxl; 80 mg/m2/week ×6 with 2-week break) plus saracatinib (S; 175 mg o.d.) or placebo (P) continuously, starting 1 week before wPxl, until disease progression. Patients were stratified by taxane-free interval (<6 versus ≥6 months/no prior taxane). The primary end point was progression-free survival (PFS) rate at 6 months. Secondary end points included overall survival (OS) and response rate (RR). Results: A total of 107 patients, median age 63 years, were randomised. Forty-three (40%) had received >2 lines of prior chemotherapy. The 6-month PFS rate was 29% (wPxl + S) versus 34% (wPxl + P) (P = 0.582). Median PFS was 4.7 versus 5.3 months (hazard ratio 1.00, 95% confidence interval 0.65–1.54; P = 0.99). RR (complete + partial) was 29% (wPxl + S) versus 43% (wPxl + P), P value = 0.158. Grade 3/4 adverse events were 36% versus 31% (P = 0.624); the most frequent G3/4 toxicities were vomiting (5.8% saracatinib versus 8.6% placebo), abdominal pain (5.8% versus 0%) and diarrhoea (4.3% versus 5.7%). Febrile neutropenia was more common in the saracatinib arm (4.3%) than placebo (0%). Response, PFS and OS were all significantly (P < 0.05) better in patients with taxane interval ≥6 months/no prior taxane (n = 85) than those <6 months (n = 22), regardless of randomisation. Conclusions: Saracatinib does not improve activity of weekly paclitaxel in platinum-resistant ovarian

Item Type: Article
Subjects : Medical Science
Divisions : Faculty of Health and Medical Sciences > School of Biosciences and Medicine
Authors :
AuthorsEmailORCID
McNeish, IAUNSPECIFIEDUNSPECIFIED
Ledermann, JAUNSPECIFIEDUNSPECIFIED
Webber, LUNSPECIFIEDUNSPECIFIED
James, LUNSPECIFIEDUNSPECIFIED
Kaye, SBUNSPECIFIEDUNSPECIFIED
Hall, MUNSPECIFIEDUNSPECIFIED
Hall, GUNSPECIFIEDUNSPECIFIED
Clamp, AUNSPECIFIEDUNSPECIFIED
Earl, HUNSPECIFIEDUNSPECIFIED
Banerjee, SUNSPECIFIEDUNSPECIFIED
Kristeleit, RUNSPECIFIEDUNSPECIFIED
Raja, FUNSPECIFIEDUNSPECIFIED
Feeney, AUNSPECIFIEDUNSPECIFIED
Lawrence, CUNSPECIFIEDUNSPECIFIED
Dawson-Athey, LUNSPECIFIEDUNSPECIFIED
Persic, MUNSPECIFIEDUNSPECIFIED
Khan, IUNSPECIFIEDUNSPECIFIED
Date : 1 October 2014
Funders : Cancer Research UK
Identification Number : 10.1093/annonc/mdu363
Copyright Disclaimer : © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.
Uncontrolled Keywords : Life Sciences & Biomedicine, Oncology, ovarian cancer, weekly paclitaxel, platinum-resistant, Src, taxane-free-interval, SRC TYROSINE KINASE, SOLID TUMORS
Related URLs :
Depositing User : Symplectic Elements
Date Deposited : 20 Jul 2016 16:51
Last Modified : 20 Jul 2016 16:51
URI: http://epubs.surrey.ac.uk/id/eprint/811219

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