The Library
Neo-escape : Neoadjuvant extended sequential chemotherapy with adjuvant postoperative treatment for epithelial nonmucinous advanced inoperable peritoneal malignancy
Tools
Poole, Christopher J., Marshall, A. (Andrea), Higgins, Helen B., Fletcher, J., Williams, S. J., Lo, N., Fernando, I. N., Osborne, R., Crawford, S. M., Rafii, S., Gill, S. and Dunn, Janet A. (2012) Neo-escape : Neoadjuvant extended sequential chemotherapy with adjuvant postoperative treatment for epithelial nonmucinous advanced inoperable peritoneal malignancy. Journal of Clinical Oncology, 30 (15). p. 1.
Research output not available from this repository.
Request-a-Copy directly from author or use local Library Get it For Me service.
Official URL: http://ascopubs.org/doi/abs/10.1200/jco.2012.30.15...
Abstract
Background: Neo-Escape was designed to exploit fully the modest non-cross resistance of carboplatin (CBDCA) and paclitaxel (ptx) in an extended sequential regimen, with dose-dense ptx, and address feasibility of combining gemcitabine (gem) with either CBDCA or ptx. Methods: A randomised phase II trial in patients (pts) with untreated (FIGO stage 3C/4) inoperable ovarian, fallopian, or primary peritoneal carcinoma to assess feasibility of two regimens of sequential neoadjuvant-then-adjuvant chemotherapy (CT); (a) CBDCA AUC 2.5 and gem 1000mg/m2 repeated days 1 and 8 q 3 wks x 6 cycles, then ptx 175mg/m2 q 2 wks x 6 cycles (CG-P) or (b) CBDCA AUC 6 q 3 wks x 6 cycles, then ptx 175mg/m2 and gem 2000mg/m2 q 2 wks x 6 cycles (C-PG). All pts were considered for delayed 1o debulking surgery after neoadjuvant CT. The 1o feasibility outcome was % pts completing 12 cycles of CT. Using Fleming’s single stage procedure 44 patients on each arm were needed to test null hypothesis of feasibility ≤60% with 5% 1-sided significance level and 90% power. 2o outcomes included safety, PFS and ORR. Pts were stratified by serum albumin, stage and tumor differentiation. Results: 75 pts were recruited Sept 2007 - May 2011 (28 CG-P; 47 C-PG), median age 62 yr (range 21-75). Recruitment to CG-P closed early due to futility. 52% had albumin >35g/L, 68% FIGO stage 3C and 80% poorly differentiated tumors. 64% on CG-P and 55% on C-PG had debulking surgery as planned and a further 4% on CG-P and 13% on C-GP after completion of all CT. For CG-P 35% achieved 0cm, 35% <1cm and 30% ≥ 1cm residuum; for C-GP 34% 0cm, 13% <1cm and 34% ≥1cm, 19% TBC. 14/28 pts on CG-P completed all 12 cycles (feasibility 50%; 95% CI 31-67%); 37/47 pts on C-PG (feasibility 79% (95% CI 64-88). Main reason for early discontinuation was toxicity on CG-P and disease progression on C-PG. Similar proportions of pts on each arm had dose reductions (68%) or delays (86% on CG-P; 89% on C-PG), mainly for toxicity. 82% of pts experienced grade 3/4 toxicity on CG-P; 72% on C-PG. Median PFS for CG-P is 14.3 mths (95% CI 11.6-15.7mths) and 13.0 mths (95% CI 11.5-15.4mths) for C-PG. Conclusions: CG-P was not feasible at these doses using pre-specified criteria, but C-PG is feasible.
Item Type: | Journal Item | ||||
---|---|---|---|---|---|
Subjects: | R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer) | ||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
||||
Journal or Publication Title: | Journal of Clinical Oncology | ||||
Publisher: | American Society of Clinical Oncology | ||||
ISSN: | 0732-183X | ||||
Official Date: | 2012 | ||||
Dates: |
|
||||
Volume: | 30 | ||||
Number: | 15 | ||||
Page Range: | p. 1 | ||||
Status: | Peer Reviewed | ||||
Publication Status: | Published | ||||
Access rights to Published version: | Restricted or Subscription Access |
Request changes or add full text files to a record
Repository staff actions (login required)
View Item |