M E L van der Burg1, W Onstenk1, I A Boere2, M Look1, P B Ottevanger3, D de Gooyer4, L G M Kerkhofs5, F A A Valster6, J B Ruit7, A G P M van Reisen8, S H Goey9, A M E van der Torren10, D ten Bokkel Huinink11, T C Kok12, J Verweij1, H C van Doorn13. 1. Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. 2. Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. Electronic address: i.boere@erasmusmc.nl. 3. Department of Medical Oncology, Radboud University Medical Centre, Nijmegen, The Netherlands. 4. Department of Internal Medicine, Franciscus Hospital, Roosendaal, The Netherlands. 5. Department of Internal Medicine, Admiraal de Ruyter Hospital, Vlissingen, The Netherlands. 6. Department of Internal Medicine, Lievensberg Hospital, Bergen op Zoom, The Netherlands. 7. Department of Internal Medicine, Vlietland Hospital, Schiedam, The Netherlands. 8. Department of Internal Medicine, ZorgSaam Zeeuws-Vlaanderen, Terneuzen, The Netherlands. 9. Department of Internal Medicine, Tweesteden Hospital, Tilburg, The Netherlands. 10. Department of Internal Medicine, Groene Hart Hospital, Gouda, The Netherlands. 11. Department of Internal Medicine, Diakonessenhuis, Utrecht, The Netherlands. 12. Department of Internal Medicine, Maasstad Hospital, Rotterdam, The Netherlands. 13. Department of Gynecological Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Abstract
BACKGROUND:Weekly paclitaxel/carboplatin might improve survival in platinum-resistant epithelial ovarian cancer (EOC). We compared efficacy of first-line weekly to three-weekly paclitaxel/cis- or carboplatin (PCw and PC3w) induction therapy, followed by either three or six PC3w cycles. PATIENTS AND METHODS: In this multicentre, randomised phase III trial with 2×2 design, patients with FIGO stageIIb-IV EOC were randomised to six cycles PCw (paclitaxel 90mg/m(2), cisplatin 70mg/m(2) or carboplatin AUC 4) or three cycles PC3w (paclitaxel 175mg/m(2), cisplatin 75mg/m(2) or carboplatin AUC 6), followed by either three or six cycles PC3w. Primary endpoints were progression free survival (PFS) and overall survival (OS). Secondary endpoints were response rate (RR) and toxicity. RESULTS: Of 267 eligible patients, 133 received PCw and 134 PC3w. The first 105 patients received cisplatin, after protocol amendment the subsequent 162 patients received carboplatin. Weekly cisplatin was less well tolerated than weekly carboplatin. All PC3w cycles were well tolerated. At the end of all treatments, RR was 90.8% with no differences between the treatment arms. After a follow-up of median 10.3years (range 7.1-14.8), median PFS was 18.5 (95% confidence interval (CI) 15.9-21.0) months for PCw and 16.4 (95% CI 13.5-19.2) months for PC3w (p=0.78). Median OS was 44.8 (95% CI 33.1-56.5) months for PCw and 41.1 (95% CI 34.4-47.7) months for PC3w (p=0.98). CONCLUSIONS: There was no benefit in terms of OS, PFS or RR for a weekly regimen nor for extended chemotherapy as first-line treatment for EOC in European patients.
RCT Entities:
BACKGROUND: Weekly paclitaxel/carboplatin might improve survival in platinum-resistant epithelial ovarian cancer (EOC). We compared efficacy of first-line weekly to three-weekly paclitaxel/cis- or carboplatin (PCw and PC3w) induction therapy, followed by either three or six PC3w cycles. PATIENTS AND METHODS: In this multicentre, randomised phase III trial with 2×2 design, patients with FIGO stage IIb-IV EOC were randomised to six cycles PCw (paclitaxel 90mg/m(2), cisplatin 70mg/m(2) or carboplatin AUC 4) or three cycles PC3w (paclitaxel 175mg/m(2), cisplatin 75mg/m(2) or carboplatin AUC 6), followed by either three or six cycles PC3w. Primary endpoints were progression free survival (PFS) and overall survival (OS). Secondary endpoints were response rate (RR) and toxicity. RESULTS: Of 267 eligible patients, 133 received PCw and 134 PC3w. The first 105 patients received cisplatin, after protocol amendment the subsequent 162 patients received carboplatin. Weekly cisplatin was less well tolerated than weekly carboplatin. All PC3w cycles were well tolerated. At the end of all treatments, RR was 90.8% with no differences between the treatment arms. After a follow-up of median 10.3years (range 7.1-14.8), median PFS was 18.5 (95% confidence interval (CI) 15.9-21.0) months for PCw and 16.4 (95% CI 13.5-19.2) months for PC3w (p=0.78). Median OS was 44.8 (95% CI 33.1-56.5) months for PCw and 41.1 (95% CI 34.4-47.7) months for PC3w (p=0.98). CONCLUSIONS: There was no benefit in terms of OS, PFS or RR for a weekly regimen nor for extended chemotherapy as first-line treatment for EOC in European patients.
Authors: Charlotte Gamble; Laura J Havrilesky; Evan R Myers; Junzo P Chino; Scott Hollenbeck; Jennifer K Plichta; P Kelly Marcom; E Shelley Hwang; Noah D Kauff; Rachel A Greenup Journal: Ann Surg Oncol Date: 2017-07-11 Impact factor: 5.344
Authors: Jorge G Gomez-Gutierrez; Neal Bhutiani; Molly W McNally; Phillip Chuong; Wenyuan Yin; Meredith A Jones; Matthew R Zeiderman; William E Grizzle; Lacey R McNally Journal: Biotech Histochem Date: 2020-08-03 Impact factor: 1.718